### STEVEN RAY GREEN AND ASSOCIATES
NATIONALLY CERTIFIED COURT REPORTING

404/733

- 6070 **THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES**

**PUBLIC HEALTH SERVICE CENTERS FOR DISEASE CONTROL AND PREVENTION** 

**NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH**

**WORLD TRADE CENTER HEALTH PROGRAM**

FOURTH MEETING

**SCIENTIFIC/TECHNICAL ADVISO RY** 
**COMMITTEE (STAC) MEETING**

February 14, 2014

The verbatim transcript of the
Meeting of the Scientific/Technical Ad v isory
Committee Meeting held t elephonically on February

14, 2014, 9:30 a.m.

### 2

**C O N T E N T S**
February 14, 2014

WELCOME AND I N TRODUCTION 8 DR. PAUL J. MIDDENDORF and DR. ELIZABETH WARD

CHARGE TO THE COMMITTEE 1 1 DR. JOHN HOWARD

BRIEF UPDATE ON WTC HEALTH PROGRAM 1 2 JESSICA BILICS

OVERVIEW OF WTC HEALTH RESEARCH 17 DR. ALLEN ROBISON and DR. TRAVIS KUBALE

WTC HEALTH RE GISTRY RESEARCH 2 4 DR. MARK FARFEL and DR. STEVEN STELLMA N
WTC CLINICAL CENTERS OF EXCELLENCE/ 33 DATA CENTERS RESEARCH NEEDS DR. LAURA CROWLEY

PUBLIC COMMENTS 41 DR. PAUL J. MIDDENDORF

DISCUSSION OF RESEARCH NEEDS AND 5 1 DEVELOPMENT OF RECOMMENDATIO NS DR. ELIZABETH WARD

ADMINISTRATIVE ISSUES AND ADJOURN 1 34 DR. ELIZABETH WARD and DR. PAUL J. MIDDENDORF

COURT REPORTER’S CERTIFI CATE 137

### 3

**TRANSCRIPT LEGEND**
The following transcript contains quoted material. Such material is reproduced as read or spok en. In the following transcript: a dash (

-- ) indicates an unintentional or purposeful interruption of a sentence. An ellipsis (. . .) indicates halting speech or an unfinished sentence in dialogue or omission(s) of word(s) when reading written material.

-- (sic) denotes an incorrect usage or pronunciation of a word which is transcribed in its original form as reported.

-- (ph ) indicates a phonetic spelling of the word if no confirmation of the correct spelling is available.

-- "uh

- huh" represents an affir mative response, and "uh

- uh" represents a negative response.

-- "*" denotes a spelling based on phonetics, without reference available.

-- “^” represents indiscernible or indiscernible speech or speaker failure, usually failure to use a microphone or multiple speakers speaking simultaneously; also telephonic failure.

### 4

**P A R T I C I P A N T S**
(alphabetically)

THOMAS ALDRICH, COMMITTEE MEMBER HEIDI ALEXANDER, PUBLIC COMMENTER JESSICA BILICS, SPEAKER LAURA CROWLEY, MD

- DEPUTY DIRECTOR, MT . SINAI CCE JOHN DEMENT, COMMITTEE MEMBER MARK FARFEL, ScD

- WTC HEALTH REGISTRY DIRECTOR KIMBERLY FLYNN, COMMITTEE MEMBER ROBERT HARRISON, COMMITTEE MEMBER JOHN HOWARD, MD

- PROGRAM ADMINISTRATOR CATHERINE HUGHES, COMMITTEE MEMBER TRAVIS KUBALE, PhD

- NIO SH OFFICE OF EXTRAMURAL PROGRAMS STEVEN MARKOWITZ, COMMITTEE MEMBER GUILLE ME J I A, COMMITTEE MEMBER JIM MELIUS, PUBLIC COMMENTER PAUL J. MIDDENDORF, PhD

- DESIGNATED FEDERAL OFFICIAL LILA NORDSTROM, PUBLIC COMMENTER CAROL NORTH, COMMITTEE MEMBER MARY PERILL O, PUBLIC COMMENTER JULIA QUINT, COMMITTEE MEMBER ALLEN ROBISON, PhD

- NIOSH DIRECTOR OF OEP WILLIAM ROM, COMMITTEE MEMBER SUSAN SIDEL, COMMITTEE MEMBER STEVEN STELLMAN, PhD, MPH

- WTC HEALTH REGISTRY RESEARCH DIRECTOR GLENN TALASKA, COMMITTEE MEMBER LE O TRASANDE, COMMITTEE MEMBER ELIZABETH WARD , PhD

- CHAIR

### 5

**Committee Members** 

### 1 **Occupational Physicians with Experience in Treating WTC Rescue and Recovery** 

### 2 **Workers:** 

### 3 4 Steven Markowitz, M.D. 

### 5 Professor of Environmental Sciences and Director of The Center for The Biology of Natural 

### 6 Systems at Queens College, City University of New York, New York City. 

### 7 William Rom, M.D., M.P.H. 

### 8 Professor of Medicine and Environmental Medicine, New York University School of Medicine 

### 9 Director, Division of Pulmonary and Critical Care Medicine, School of Medicine, New York 

### 10 University, New York City. 

### 11
12 **Occupational Physicians:** 

### 13 14 Robert Harrison, M.D., M.P.H. 

### 15 Clinical Professor of Medicine, University of California, San Francisco; 

### 16 Chief, Occupational Health Surveillance and Evaluation Program, California Department of Public 

### 17 Health, San Francisco. 

### 18 Virginia Weaver, M.D., M.P.H. 

### 19 Director, Occupational and Environmental Medicine Residency, Bloomberg School of Public 

### 20 Health, Johns Hopkins University, Baltimore. 

### 21
22 **Physician with Pulmonary Me dicine Expertise:**  

### 23 Thomas K. Aldrich, M.D. 

### 24 Professor of Medicine and Director of The Pulmonary Training Program, Albert Einstein College 

### 25 of Medicine, Yeshiva University, New York City. 

### 26 Representatives of WTC Responders: 

### 27 28 Stephen Cassidy 

### 29 President, Uniformed Firefighters Association of Greater New York, Local 94 I.A.F.F. AFL

- CIO 

### 30

### 6

Valerie Dabas 

### 1 Human Resources Analyst, Patrolmen’s Benevolent Association of the City of New York, Inc., 

### 2 New York City. 

### 3 Guillermina Mejia, M.P.H 

### 4 Certified Health Education Specialist , Principal Program Coordinator, Safety and Health 

### 5 Department, American Federation of State, County, and Municipal Employees, District Council 

### 6 37, New York City. 

### 7
8 **Representative of Certified**

**- Eligible WTC Survivors:**  

### 9 10 Kimberly Flynn, 

### 11 Co

- Founder, Director, 9/ 11 Environmental Action 

### 12 Catherine McVay Hughes 

### 13 Vice Chairman, Community Board 1 World Trade Center Redevelopment Committee, Lower 

### 14 Manhattan World Trade Center Redevelopment, New York City. 

### 15 Susan Sidel, J.D. 

### 16 Resident of New York City and volunteer WTC respo nder. 

### 17
18 **Industrial Hygienist:** 

### 19 John Dement, Ph.D. 

### 20 Professor, Community and Family Medicine, Duke University Medical School, Durham, N.C. 

### 21
22 **Toxicologist:** 

### 23 Julia Quint, Ph.D. 

### 24 Research Scientist Supervisor II and Chief, Hazard Evaluation System and Information Se rvice 

### 25 (HESIS), Occupational Health Branch, California Department of Public Health (retired), Oakland. 

### 26 **Epidemiologist:** 

### 27 Elizabeth Ward, Ph.D. (Advisory Committee Chair

- Person) 

### 28 National Vice

- President for Intramural Research, American Cancer Society, Atlanta. 

### 29
30
31

### 7

**Mental Health Professional:** 

### 1 Carol S. North, M.D. M.P.E. 

### 2 Professor, Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas. 

### 3
4 **Environmental Health Specialists:** 

### 5 Glenn Talaska, Ph.D. 

### 6 Certified Industrial Hygienist, Professor, Dep artment of Environmental Health, University of 

### 7 Cincinnati, Cincinnati. 

### 8 Leonardo Trasande, M.D., M.P.P. 

### 9 Associate Professor in Pediatrics, Environmental Medicine and Health Policy, New York 

### 10 University; Associate Attending in Pediatrics, Bellevue Hospital Ce nter, New York City. 

### 11 12 13 **Designated Federal Official:** 

### 14 Paul J. Middendorf, Ph.D., CIH 

### 15 Senior Scientist 

### 16 CDC/NIOSH/Office of the Director 

### 17 Cincinnati, Ohio 

### 18 19 20

### 8

**P R O C E E D I N G S** 

### 1 (9: 35 a.m.) 

### 2 3 **WELCOME AND**  **INTRODUCTION** 

### 4 **DR. MIDDENDORF** : Well, good morning everybod y, H appy Valentine's Day. 

### 5 Welcome to the meeting of the World Trade Center Health Program's Scientific/ 

### 6 Technical Advisory Committee

. 

### 7 Hopefully everyone has w eathered the effects of Winter S torm Pax that's 

### 8 just gone through. It certainly caused us a fe w tense moments in the lead

- up to the 

### 9 meeting. I am Paul Middendorf and I'm the designated federal official for the 

### 10 committee. I do want to extend a warm welcome to each of the committee 

### 11 members and the members of the public who are on the phone with us. We very 

### 12 much appreciate your interest in these proceedings. 

### 13 Just to start out, I think it's very important for us to remember why we're 

### 14 here and set the appropriate tone for the meeting, so let's just spend a few 

### 15 moments i n silence to remember those who were killed in the attacks on 9/11 and 

### 16 also those responders and survivors who have since died because of those attacks. 

### 17 (Moment of silence.) 

### 18 **DR. MIDDENDORF** : Thank you. There are a number of administrative issues 

### 19 to deal with on the front of our meeting so let's work through those initially. First I 

### 20 need to point out that we announced openings for five seats on the STAC last 

### 21 summer. Final selections for those positions have not been made yet so five of our 

### 22 members have had their tenure on the committee extended an additional six 

### 23 months through March 30 th

. We anticipate announcing the selections for those 

### 24 positions in the very near future. 

### 25 We have also begun the process of soliciting nominations for six different 

### 26 seats on the committee, and those are sch eduled to open on September 30 th of this 

### 27 year. If you're interested in nominating someone, including yourself, please visit the 

### 28 committee's website to find the information on how to nominate someone. For 

### 29 those who are logged into the web portion of this conference, the committee's web 

### 30 address is on the screen. 

### 31 For those of you signed up to provide public comments, those are scheduled 

### 32 to begin at 11:30 this morning, and that's Eastern Standard T ime. Copies of the 

### 33 public comments that we received by yester day have been provided to each of the 

### 34 committee members and they will also be posted in NIOSH's docket number 248

-A, 

### 35 which is also available through the committee's website. 

### 36 Let's go ahead and do a quick roll call. For our roll call, I'll call out the nam e 

### 37 of each member and ask you to let me know that you're on the line. I'll ask you to 

### 38 state whether or not there have been any changes in your employment or interest 

### 39

### 9

that would affect your conflict of interest. If for some reason a member needs to 

### 1 leave t he call, please let me know when you leave and when you return so we can 

### 2 be sure that we have a quorum for the meeting. For the STAC a quorum is , is ten 

### 3 members. And also I'll repeat the roll call after each of the breaks and after the 

### 4 lunch period. 

### 5 So, Tom Aldrich? 

### 6 **DR. ALDRICH:** ...and I have received a grant from the NIOSH program but I 

### 7 don't believe that affects my conflict of interest situation. 

### 8 **DR. MIDDENDORF** : Okay. And Steven Cassidy and Valerie Dabas will not be 

### 9 participating in the meeting. 

### 10 John Dement? Okay, I don't hear John on the line. Kimberly Flynn? 

### 11 Kimberly announced herself earlier. Kimberly, are you there? 

### 12 **MS. FLYNN:** Hello? Paul? 

### 13 **DR. MIDDENDORF** : Yes? 

### 14 **MS. FLYNN:** Hi. Sorry, I couldn't get my mute off. My engagements have 

### 15 not changed. 

### 16 **DR. MIDDENDORF** : Okay. Bob Harrison? 

### 17 **D R. HARRISON:**  I'm here and I don't have any conflicts or issues. 

### 18 **DR. MIDDENDORF** : Okay. Catherine Hughes? 

### 19 **MS. HUGHES:** Nothing has changed. 

### 20 **DR. MIDDENDORF** : Okay. Steve Markowitz. 

### 21 **DR. MARKOWITZ:** Present. I don't think it's a conflict bu t we were a 

### 22 satellite

-- a site for Wisnivesky's asthma research project funded b y NIOSH. 

### 23 **DR. MIDDENDORF** : Okay. Is that new or different? 

### 24 **DR. MARKOWITZ:** No, no. It's be en going on for at least a year or so. 

### 25 **DR. MIDDENDOR F**  : Okay. So it's part of the evaluation for your conflict of 

### 26 interest already. 

### 27 **DR. MARKOWITZ:** Correct. 

### 28 **DR. MIDDENDORF** : Okay. Guille Mej i a? 

### 29 **MS. ME J**  **I A:**  I still have the same employer; however, I am now the director 

### 30 of the safety and health department a nd I'm also the PR for the cooperative 

### 31 agreement. 

### 32 **DR. MIDDENDORF** : Okay. And we 've addressed your conflict of interest 

### 33 issues already. 

### 34 **MS. ME J**  **I A:**  Yes. 

### 35 **DR. MIDDENDORF** : Okay. Carol North? 

### 36 **DR . NORT**  **H :**  I'm here. I don't think I have any change. 

### 37 **DR. MIDDEN DORF**  : Okay. Julia Quint? 

### 38 **DR . QUINT:**  I'm here. My status hasn't changed. 

### 39

### 10

**DR. MIDDENDORF** : Okay. Bi ll Rom? 

### 1 **D R. ROM:**  Present. No changes. 

### 2 **DR. MIDDENDORF** : Okay. Susan Sidel. 

### 3 **MS. SIDEL:** I'm here. Can you hear me? 

### 4 **DR. MIDDENDORF** : Yes, we can hear you

. 

### 5 **MS. SIDEL:** Okay, all good

. 

### 6 **DR. MIDDENDORF** : Okay. Glenn Talaska? 

### 7 **D R. TALASKA:**  Present. No changes. 

### 8 **DR. MIDDENDORF** : Okay. Leo Trasande? I believe h e'll be joining us this 

### 9 afternoon. He said he wouldn't be available this morning. Elizabeth Ward? 

### 10 **D R. WARD:**  I'm here. No changes. 

### 11 **DR. MIDDENDORF** : Okay. Virginia Weaver? 

### 12 **DR . WEAVER:**  Present and no changes. 

### 13 **DR. MIDDENDORF** : Okay. I guess there's 13 members who are present. I'll 

### 14 ask John Dement, have you joined us? 

### 15 **D R. DEMENT:**  Yes, Paul, I'm on the line. 

### 16 **DR. MIDDENDORF** : Okay. 

### 17 **D R. DEMENT:**  There are no changes. 

### 18 **DR. MIDDENDORF** : Okay, great. Okay, so that's 14 members; we do have a 

### 19 quorum. 

### 20 The focus of this meeting is on research needs for the World Trade Center 

### 21 Health Program . All the materials fo r this meeting including copies of our agenda 

### 22 and presentations can be got on the committee's website and, for those of you who 

### 23 are logged into the web portion of our meeting, the materials can also be 

### 24 downloaded by clicking on the right icon at the top of the screen that looks like 

### 25 three little pieces of paper. S o if you click on that, you should be able to get to the 

### 26 materials and download from there, if you don't get them from the website. 

### 27 Because the focus of this meeting is on the research needs of th e program, 

### 28 and some of our members are researchers who potentially have interest in doing 

### 29 research on World Trade Center

- related matters , i t is important that we manage the 

### 30 pote ntial for conflict of interest. So for each of those members, I believe, have been 

### 31 counseled on the limit s of their participation. If I happen to see that someone has 

### 32 strayed into areas that are of potential conflict of interest for them , I will point out 

### 33 to them

-- point that out to them , and then ask them to refrain from further 

### 34 discussion in that particular area. 

### 35 An issue we need to address for committee members is h ow to make sure 

### 36 each of you has the opportunity to voice your ideas. Obviously we can't see hands 

### 37 raised or name cards turned on end so we need to work out a way to be sure that 

### 38 each of you has the opportunity to contribute to the meeting. So after a speaker is 

### 39

### 11

finished and before the next speaker has been identified, if you would state that you 

### 1 have comments to make, Liz and I will both keep a sequential list of tho se who 

### 2 identified that they want to make comments, and then we'll recognize you in turn 

### 3 so you can have the floor. 

### 4 I also want to remind you that you really do need to identify yourself before 

### 5 speaking so our transcriptionist can accurately attribute your contributions to the 

### 6 meeting. 

### 7 The last things I need to review before turning this over to our Chair, Dr. Liz 

### 8 Ward , are the motions and voting procedures. When a member of the committee is 

### 9 developing a motion , I will type it so it's visible on the screen and each of you should 

### 10 be able to see it . When the Chair calls for a vote, I will have to do a roll call vote and 

### 11 will ask each of you in turn to say yes, meaning you are voting for the motion that 

### 12 has been put to the committee, or no, meaning you are vot ing against the motion 

### 13 that has been put to the committee, or abstain, meaning that you are not voting on 

### 14 the motion. If someone has been recused for a specific motion, I'll note that also. 

### 15 According to our bylaws a majority of those voting determines th e outcome. 

### 16 So with that, I will turn it over to Dr. Ward. 

### 17 **DR. WARD:** Well, I will just add my welcome to the committee members, 

### 18 presenters and members of the public who are joining us today. And also thank 

### 19 Paul and other CDC staff who have organized and s upported this meeting. 

### 20 I thin k we have a very full agenda, had a little bit of a late start , so I'd like to 

### 21 move directly to Dr. Howard for his charge to the committee. 

### 22 23 **CHARGE TO THE COMMITTEE** 

### 24 **DR. HOWARD:** Thank you, Liz. Good morning, advisory committee 

### 25 members and good morning to responders, survivors and members of the public. 

### 26 Welcome to the fourth meeting of the World Trade Center Health Program 

### 27 Scientific/Technical Advisory Committee . I especially want to thank each committee 

### 28 member for serving on the advisory committee. Your time and your advice to the 

### 29 Health Program are greatly appreciated. 

### 30 The advisory committee has an important role to play in the World Trade 

### 31 Center Health Program . The Zadroga 9/11 Health and Compensation Act of 2010 

### 32 specifies three areas of contributions of the advisory committ ee to the program. 

### 33 First, the A ct requires that the administrator consult with the advisory committee 

### 34 with regard to determining eligibility criteria for responder and survivor 

### 35 membershi p in the program . Second, the A ct provides that the administrator may 

### 36 seek a recommendation from the advisory committee regarding whether a 

### 37 particular health condition should be added to the list of World Trade 

### 38 Center

- related heal th conditions. And third, the A ct requir es the administrator to 

### 39

### 12

consult with the advisory committee with regard to identifying research needs for 

### 1 the program. 

### 2 It is th is third area, consulting the advisory committee with regard to 

### 3 identifying the research needs of the World Trade Center Health P rogram , that I 

### 4 asked you to meet today. 

### 5 Each year since 2011, NIOSH has solicited applications for scientifically 

### 6 rigorous research studies to help answer critical questions about the physical and 

### 7 mental health conditions related to the September 2001 te rrorist attacks. From 

### 8 2011 through 2013, 79 research proposals were reviewed , and 32 percent of them 

### 9 or 2 5 meritorious projects, including the renewal of the World Trade Center Health 

### 10 Registry, have been funded. 

### 11 The charge that I would respectfully give t o the advisory committee today is 

### 12 to: One, identify critical research gaps relative to our understanding of the effects 

### 13 of exposure to airborne toxins, any other hazard or any other adverse condition 

### 14 resulting from the September 11, 2001 terrorist attacks ; two, identify critical 

### 15 research knowledge gaps relative to the accurate diagnosis of World Trade 

### 16 Center

- related health conditions; three, identify critical research knowledge gaps 

### 17 relative to the effective treatment of World Trade Center

- related health c onditions; 

### 18 and most importantly, four, provide advice on the priority ordering of the critical 

### 19 research needs identified by the advisory committee. 

### 20 Thank you again for participating in the meeting today. I wish you a very 

### 21 productive meeting. Thank you fo r attending. 

### 22 **DR. WARD:** So I think we'll move directly to the next presentation by Jessica 

### 23 Bilics, who will give us a brief update on the World Trade Center Health Program

. 

### 24 25 **BRIEF UPDATE ON WTC HEALTH PROGRAM**  

### 26 **MS. BILICS:** He llo. This is Jessica Bilics. T his is the World Trade Center 

### 27 Health Program policies, staff and intergovernmental affairs. 

### 28 It's been almost two years since the STAC last convened in March 2012. In 

### 29 these two years, the World Trade Center Health Program has had many changes. 

### 30 Some of t hese changes include the addition of more than 50 types of

-- or categories 

### 31 of cancer, the addition of Pentagon , Shanksville,

-- Shanksville, Pennsylvania 

### 32 responders to our membership and the completion of a variety of policies and 

### 33 procedures to help progr am providers determine World Trade Center

- related and 

### 34 medically associated health conditions as well as policies and procedures for 

### 35 administrative requirements related to recoupment or reimbursements from 

### 36 workers' compensation or private health insurance. 

### 37 I will not spend the limited time we have today on the details of these 

### 38 policies and procedures or the regula tory activities of the program. H owever, I 

### 39

### 13

encourage everyone to spend some time on our website , specifically the policies 

### 1 and procedures page and the laws and regulations page , to learn more. You can 

### 2 access the website at: www.cdc.gov/wtc. 

### 3 What I'd like to spend my time doing this morning is going over some data 

### 4 on the World Trade Center Health Program that may be of interest to you and be 

### 5 deliber ated, as Dr. Howard requested, on research priorities for the future of the 

### 6 program. T he data I will cover should be on the screen if you are participating via 

### 7 Live Meeting and are also available in a two

- page document titled The World Trade 

### 8 Center Progra m Updates on the program's advisory committee web page. 

### 9 The first four tables provide break

- outs of the program's more than 66,500 

### 10 members by some basic demographics. The first table, table 1, breaks down the 

### 11 program's membership by four major member type s: FDNY responders, non

- FDNY 

### 12 responders, survivors and Pentagon/Shanksville responders. As you can see about 

### 13 two

-thirds or 64 percent of the program's membership is made up of non

- FDNY 

### 14 responders who responded to the disaster in New York City. Twenty

- fi ve percent 

### 15 are FDNY responders ; 11 percent are survivors from New York City disaster area; 

### 16 and less than one percent are responders from the Pentagon and Shanksville, 

### 17 Pennsylvania site s
. 

### 18 Table 2 breaks down the program's membership by member type s as well 

### 19 as gender. The program's members are about 83 percent male, 16 percent female 

### 20 and 1 percent unknown; h owever, the gender distribution varies within the member 

### 21 type. The three responder categories, the responders, FDNY and 

### 22 Pentagon/Shanksville in the tabl e , all have about 85 percent or more males , 

### 23 whereas the survivor population is split almost evenly between males and females. 

### 24 Table 3 provides the membership by member type as well as age categories. 

### 25 Now more than 12 years out from 9/11, about 70 percent of the program's 

### 26 members are between 40 and 59 years old. Some of you may have noticed and 

### 27 been surprised by the younger members in the program , particularly those in the 

### 28 responder and FDNY categor ies

. Table 3 reflects the statutory eligibility criteria 

### 29 which includes not only traditional first responders but volunteers who may have 

### 30 been young people providing support services at the site as well as family members 

### 31 of FDNY. 

### 32 Table 4 breaks down the member

-- the program's membership by the top 

### 33 ten places of residence. Not surprisingly, 87 percent of members live in either New 

### 34 York state or New Jersey. There are also significant numbers of members in Florida, 

### 35 Pennsylvania, North Carolina and California. Most of the members living outside the 

### 36 New York metro politan area are served by the program's nation

- wide provider 

### 37 network. 

### 38 As you all know , the World Trade Center Health Program provides 

### 39

### 14

treatment for certified members as a variety

-- for a variety of health conditions. 

### 1 The major categories of health condi tions include obstructive airway s diseases such 

### 2 as asthma, reactive airway dysfunction syndrome, World Trade Center

- related COPD 

### 3 and chronic cough, upper respiratory diseases, upper airway

-- such as upper airway 

### 4 hyperactivity, rhinosinusitis, nasal pharyn gitis and laryngitis as well as interstitial 

### 5 lung diseases, gastroesophageal reflux disease, certain types of cancers, mental 

### 6 health conditions and musculoskeletal disorders. 

### 7 Tables 5 and 6 show the number of certification categories per member. 

### 8 About 36, 000 , or 54 percent of the members , are not certified for any category of 

### 9 health condition s , which leaves 46 percent , or more tha n 30,000 members , certified 

### 10 for at least one health condition category. More than 30 percent of members are 

### 11 certified for three or more health condition categories. 

### 12 Tables 7 and 8 list the top ten health conditions certified for all conditions 

### 13 and then for cancer conditions only. The top three certified conditions of all health 

### 14 conditions are GERD, with more than 2,000 members ce rtified, sinusitis , with more 

### 15 than 1 , 500 members certified , and rhinitis with almost 15 members

-- 1 , 500 

### 16 members certified as well. 

### 17 Those top ten health conditions I just stated, the top condition is GERD, 

### 18 three are cancer conditions, three are mental heal th conditions, two are upper 

### 19 respiratory d iseases and one is an obstructive airways disease. 

### 20 Table 8 displays the top ten cancer s certified within the program. As of mid



### 21 J anuary, the World Trade Center Health Program had certified 1 , 930 cancers. Of 

### 22 this total, 320 , or 1 7 percent , are for prostate cancer, and just over 300 , or 

### 23 16 percent , are for non

- melanoma skin cancer. The top ten certified cancers make 

### 24 up 80 percent of all cancers certified within the program. 

### 25 That covers the eight tables provided in the document that I wanted to 

### 26 provide to the advisory committee for their discussion today. I'd be happy to try to 

### 27 answer any questions that any members may have. 

### 28 **MS. HUGHES:** Ye s , this is Catherine Hughes. Is this going to be posted on 

### 29 the website, this table? 

### 30 **MS. BILICS:** Yes, it is a document that contains all eight tables and it is 

### 31 available on the advisory committee web page. 

### 32 **MS. HUGHES:** So is it also available to the public is what I'm asking? 

### 33 **MS. BILICS:** Yes. It's already posted on the web page in the STAC ’s advisory. 

### 34 **MS. HUGHES:** Great, thank you. 

### 35 **MS. BILICS:** And it's titled World Trade Center Program Update

. 

### 36 **D R. HARRISON:**  This is Bob Harrison, thank you. Do you have a breakdown 

### 37 on the types of leukemia? 

### 38 **MS. BILICS:** I don't have them by coun t. The regulation like

-- I'm not sure I 

### 39

### 15

have the regulations in front of me. The regulations do break down

-- they include 

### 1 the tables of these cancers. I can probably find it

. 

### 2 **D R. HARRISON:**  Yeah, I'm just thinking of, you know, how many were AML, 

### 3 ALL, CML or

-- 

### 4 **MS. BILICS:** I don't have a specific breakdown for that level of detail right 

### 5 here. 

### 6 **D R. HARRISON:**  Okay. 

### 7 **MS. BILICS:** We can maybe get it up on the website later. 

### 8 **D R. HARRISON:**  Okay, thanks. 

### 9 **DR. MARKOWITZ:** Jessica, this is Steven Markowitz. I 'm looking at the 

### 10 Power

-- the transcript that was sent and looking through the tables that were 

### 11 numbered 1 through 8, and I can't see the reference to the chronic obstructive 

### 12 pulmonary disease that you mentioned. 

### 13 **MS. BILICS:** I was just saying that of the covered different major categories 

### 14 of health conditions included that was in the statute, and included is in the 

### 15 obstructive airways diseases catego ry is World Trade Center

- exacerbated COPD as 

### 16 an eligible condition for coverage. 

### 17 **DR. MARKOWITZ:** So in tabl e 7, was the top

-- was -- is the top ten covered 

### 18 health conditions

-- 

### 19 **MS. BILICS:** Yes. 

### 20 **DR. MARKOWITZ:**

-- which starts with GERD and then goes to sinusitis and 

### 21 then rhinitis, right? 

### 22 **MS. BILICS:** Yes. 

### 23 **DR. MARKOWITZ:** Okay. So I don't know what total the member count is 

### 24 beyond the top ten but, you know, in that table it looks like, you know, 8,000 total 

### 25 or so. But if you go to table 5, it looks like there are some 30,000 members who 

### 26 have at least one covered condition or if I'm reading that correctly, the y're certified 

### 27 for at least one covered condition. 

### 28 **MS. BILICS:** Correct. 

### 29 **DR. MARKOWITZ:** So I don't quite understand how it could be that 30,000 

### 30 members have a covered condition and we're looking at the top ten and the top ten 

### 31 seem to only include about 8, 000 members. 

### 32 **MS. BILICS:** I believe what's happening there is the 7 and 8 tables are 

### 33 actually those with claims since the program started so that's the ones that are in 

### 34 treatment. I believe that's the data. 

### 35 **DR. MARKOWITZ:** Okay. So okay. Table 5 is not necessarily in treatment; 

### 36 it's certified. 

### 37 **MS. BILICS:** No, it's for the whole program certified, yeah. 

### 38 **DR. MARKOWITZ:** Great , thank you. 

### 39

### 16

**MS. FLYNN:** Jessica, this is Kimberly. Thank you so much for this 

### 1 information. A follow

- up to Dr. Markowitz's questio n. Could you please clarify that 

### 2 the 35,966 members who are not

-- who have no certifications are all in the 

### 3 responder monitoring program and that the survivor program is different? 

### 4 **MS. BILICS:** Yeah, so the difference between the two categories, the 

### 5 resp onder and the survivor committees

-- or committees

-- populations, are that the 

### 6 responders are eligible to be in the program regardless of whether or not they have 

### 7 a health condition related to the World Trade Center. They are allowed to have 

### 8 monitoring w ithout being sick from any condition; whereas the survivor population 

### 9 statutorily has a requirement to

-- that the members have to be

-- they have to have 

### 10 a symptom initially to be sc reened to be determined if they a re eligible, the certified 

### 11 eligible surv ivors. So in order to be in the program they have to be sick from one of 

### 12 the conditions. 

### 13 **MS. FLYNN:** Thank you. 

### 14 **MS. MEJ I**  **A:** Jessica, this is Guille Mej i a. Can you tell me , do you have 

### 15 numbers in terms of the pending cases that need to be certified, how m any are still 

### 16 pending that would add to these numbers? 

### 17 **MS. BILICS:** I don't have those numbers. I don't know if I

-- anyone on our 

### 18 medical team

-- I'm looking at the pending cases for certification

-- a ny idea about 

### 19 how many they are? We can find out. 

### 20 **MS . MEJ**  **I A:**  Okay, and when was the

-- what's the date on these tables, in 

### 21 terms

-- do you have a cut

- off date for these numbers as of when? 

### 22 **MS. BILICS:** Tables 1 through 4 are through the 11 th of February and tables 

### 23 5 throug h 8 are all through mid

-January. I believe the date was the 8 th of January. 

### 24 **MS. ME J**  **I A:**  Okay, thank you. 

### 25 **DR. WARD:** Before we close, will you and members of the medical program 

### 26 staff be available during our later discussions in the event that there are some 

### 27 questions that come up from com mittee members about these diagnoses or the

-- 

### 28 for the medical program? 

### 29 **MS. BILICS:** Yes, there will be some of us here at any time and we can grab 

### 30 folks from down the hall. 

### 31 **DR. WARD:** Okay, great. 

### 32 **D R. HARRISON:**  This is Bob Harrison. I don't know whether we'll cover this 

### 33 later but one of the charges to the committee is the terms of research on effective 

### 34 treatment, and will we be covering that later or

-- I guess I'm just trying to get a 

### 35 sense of how the covered conditions and suggest anything about how pe ople have 

### 36 been treated or, you know, the numbers who remain in treatment, any questions or 

### 37 issues that have come up around treatment. 

### 38 **MS. BILICS:** There is a presentation from the clinical centers by Dr. Laura 

### 39

### 17

Crowley later that will speak, probably, to so me of your questions. 

### 1 **D R. HARRISON:**  Okay. Great, thanks. 

### 2 **DR. WARD:** Okay. So I think we should move on and to the presentation by 

### 3 Dr. Rob i son and Kubale on O verview of World Trade Center Health Research

. 

### 4 5 **OVERVIEW OF WTC HEALTH RESEARCH** 

### 6 **DR. KUBALE:** Goo d morning, this is Travis Kubale and I'm the program 

### 7 official from the Office of Extramural P rograms and assigned to the World Trade 

### 8 Center Health Program , and I'm here with Dr. Allen Robison who is the director of 

### 9 OEP. And Dr. Middendorf, as you know, ha s asked us to provide the committee with 

### 10 a brief overview describing the World Trade Center Health Program research 

### 11 portfolio, as Dr. Howard indicated, that was initiated in 2011. 

### 12 Dr. Robison and I will describe the current research solicitation 

### 13
announce ment and how STAC recommendations were incorporated. We will 

### 14 discuss the number of projects funded, and because this is a new and developing 

### 15 portfolio, we'll talk a bit about the publication status and estimated completion 

### 16 schedule. We will also briefly describe where the projects fit broadly within the 

### 17 primary research outcome and population focus areas that were discussed in the 

### 18 2011 STAC recommendation report. And finally we'll talk about where information 

### 19 concerning the current research , including th e principal investigator contact 

### 20 information, project descriptions and results , can be obtained. 

### 21 So Paul, the

-- if we move to the third slide, Allen will talk a little bit about 

### 22 the funding announcement. Allen? 

### 23 **DR. ROBISON:** Thank you, Travis. Can you hear me? 

### 24 **DR. KUBALE:** Yes. 

### 25 **DR. ROBISON:** Good morning, everyone. I just want to talk briefly about 

### 26 the World Trade Center Health Program research funding announcement that we 

### 27 developed in late 2011 and published in 2012. 

### 28 Our first application was publi shed in March 2012, and w e received our first 

### 29 round of applications in May of 2012. As Travis mentioned briefly, we incorporated 

### 30 input from a wide range of experts including the Scientific/Technical Advisory 

### 31 Committee , the World Trade Center Health Progra m and others. That input is 

### 32 reflected in the announcement by identifying major a reas of interest but not 

### 33 limiting the announcement to those six major areas of interest that are liste d. We 

### 34 also identified relevant diseases or conditions but we did not lim it applications to 

### 35 those nine or so diseases or conditions that are listed. We provided population 

### 36 focus, which is

-- which by that, I mean we specifically talked about responder 

### 37 populations and community members or survivor populations. 

### 38 We also listed contacts for the three data centers. And the reason for that 

### 39

### 18

was to help stimulate collaboration and encourage collaboration by the applicants 

### 1 as they submitted their

-- as they prepared their applications. 

### 2 And then also in the funding opportunity annou ncement we provided 

### 3 guidance t o reviewers on disaster science. A nd the way that's worded in the 

### 4 announcement, it's a l ittl e section called limitations of currently available data. We 

### 5 just advise the reviewers to be cognizant of the fact that research in this area is a 

### 6 type of research where there may not be a lot of pre

- event information, so we 

### 7 equate that to the area of the

-- the area that we call disaster science research. 

### 8 Our goals in preparing the announcement were to stimulate meritorious, or 

### 9 as Dr. Howard said, scientifically rigorous investigator

- initiated applications for 

### 10 research relevant to the World Trade Center Health Program , but we wanted to 

### 11 encourage collaboration , and we still pursue that

-- those two goals with each round 

### 12 of applications that we receive. 

### 13 We think it's been an effective and productive funding opportunity 

### 14 announcement based on the number and types

-- the number and types of p rojects 

### 15 that have been funded. 

### 16 A nd then before I close and turn it back over to Travis, I just want to say 

### 17 thank you to those committee members that are on the call , attending this meeting , 

### 18 who provided input and others who provided input. And I want to particularly 

### 19 thank the grantees on the phone and thank you for the great work that you're 

### 20 doing. So with that, I'll turn it back over to Travis. Thank you all. 

### 21 **DR. KUBALE:** Thank you, Allen. The next slide we want to go to, the current 

### 22 research portfolio projects, as has been stated, is the result of solicitations that 

### 23 were conducted in 2011,

- 12 and

- 13. A 2014 solicitation was just completed , and 

### 24 the submitted projects are scheduled for scientific and technical review this spring. 

### 25 A final solicitation is planned for '15, and that will be the last solicitation until the 

### 26 program is reauthorized. Cur rently, as has been stated, the portfolio has 25 projects 

### 27 including the World Trade Center Health Registry, which has multiple projects and 

### 28 focus areas , and will be discussed in detail by registry staff in the next presentation. 

### 29 In 2011 eight projects were funded , each with a three

-year duration. Now , 

### 30 four of these projects have published initial results and the other four are expected 

### 31 to have results published late in the current calendar year. There are currently a 

### 32 total of seven publications for those four projects. 

### 33 In 2012, 11 projects were funded, and like I said, the renewal of the World 

### 34 Trade Center Health Registry was included. Five of the 11 projects have two

- year 

### 35 duration periods and the initial results we expect possibly late this calendar year

. 

### 36 Now, as a note, since the renewal in 2012, the World Trade Center registry 

### 37 has produced 15 research publications. These published studies focus on cancer, 

### 38 mental health and physical comorbidity, respiratory effects among World Trade 

### 39

### 19

Center

- exposed chi ldren, 9/11 healthcare utilization, behavioral and structural 

### 1 barriers to evacuation and cardiovascular disease hospitalizations related to 9/11. 

### 2 In 2013, six projects were funded. Three of the projects have two

-year 

### 3 duration periods and three are for thr ee years. We are expecting and hoping that 

### 4 two of the two

- year projects may have early results in early 2015. 

### 5 The next slide is a listing of the eight studies by focus area funded in 2011. 

### 6 Three mental health studies were funded, and e ach of these studie s has a post



### 7 traumatic stress disorder emphasis. Dr. Adriana Feder's study identifies and 

### 8 describes the distinct course of World Trade Center

- related PTSD symptoms over 

### 9 time, and initial findings are published in two articles. 

### 10 Dr. Evelyn Bromet has two st udies, one examining post

- traumatic stress 

### 11 disorder and physical illness comorbidity, and this study will also include a 

### 12 comparison of PTSD treatment approaches among clinics. Dr. Bromet is also 

### 13 implementing and evaluating a s m oking cessation intervention program for 

### 14 individuals diagnosed with post

- traumatic stress disorders. 

### 15 As has been well publicized, respiratory disease conditions are prevalent at 

### 16 significant rates in both the responder and community populations. During the '11 

### 17 call, there was one res piratory disease study that Dr. Ken Berger is conducting to 

### 18 enhance the characterization of lung disease among individuals expos ed to World 

### 19 Trade Center dust. A nd this study does include rescue and recovery workers as well 

### 20 as area residents, and initial f indings have been published in three separate articles. 

### 21 During the first call in '11, two cancer incidence studies were funded. 

### 22 Dr. Paolo Bonfetta's (sic) study included non

- FDNY responders and a study by 

### 23 Dr. Prezant, David Prezant, included FDNY firefigh ters and emergency medical 

### 24 service workers. Initial findings for both of these studies have been published. 

### 25 In addition there were two studies with a cardiovascular disease focus. One 

### 26 by Dr. Morabia is examining the overall CVD risk among responders an d is also 

### 27 working to develop a specific World Trade Center heart disease risk score similar to 

### 28 that of the Framingham score for heart disease. Also Dr. Mary Ann McLaughlin is 

### 29 examining the long

- term effect of particulate matter on pulmonary and 

### 30 cardiovasc ular disease risk. 

### 31 Just as a note, females are included in all but one of these eight studies. 

### 32 The FDNY study has a low number of females but the seven other studies do include 

### 33 females. 

### 34 The next slide. The next two s l ides, beginning with this one, list 1 1 studies 

### 35 funded in 2012. This slide is a listing of the respiratory disease studies that were 

### 36 added to the portfolio during the 2012 call. 

### 37 As I said there were six of these studies. Dr. Tom Aldrich is examining the 

### 38 persistence over a ten

- year period o f bronchial hyper

- reactivity easily triggered 

### 39

### 20

airway narrowing among firefighters. The study will also assess the effectiveness of 

### 1 anti

- asthma medications at resolving bronchial hyper

- reactivity and a decline in lung 

### 2 function. 

### 3 Dr. Charlie Hall is investig ating the incidence of new obstructive airway 

### 4 disease cases over the first ten years following World Trade Center exposure , also 

### 5 among firefighters. Dr. Rafael de la Hoz is investigating how best to identify early 

### 6 indications of lung disease among World T rade Center's responders

-- responders, 

### 7 workers and volunteers. 

### 8 Dr. Sunderram is examining the role of nasal pathology or damage in World 

### 9 Trade Center responders and in the development of how it's related to the 

### 10 development of obstructive sleep apnea. H e's also looking at the impact of the 

### 11 nasal pathology on the use of continuous positive airway pressure machines or 

### 12 CPAP machines. 

### 13 Dr. Wisnivesky is studying the relationship between asthma morbidity and 

### 14 upper airway conditions among rescue and recovery workers. And Dr. Ben Luft is 

### 15 working to explain the poten tial mechanisms underlying post

- traumatic stress 

### 16 disorder and respiratory disease comorbidity, also among responders. 

### 17 Three of the six studies, Dr. Aldrich, Dr. Hall and Dr. Luft , are two

- year 

### 18 studi es and early results are possible by late in the calendar year. Four of the se six 

### 19 studies do include females. 

### 20 The next slide is a listing of the remaining five studies conducted in 2012. As 

### 21 you can see, there are three mental health studies. Dr. Adriana Feder is asse ssing 

### 22 the vulnerability to post

-traumatic stress disorder among police and respond ers. 

### 23 Dr. Christina Hoven is assessing the prevalence of mental health disorders and high 

### 24 risk behaviors among World Trade Center youth exposed to 9/11. A nd sh e also has 

### 25 a second study, also of World Trade Center youth to assess the mental health 

### 26 service need, use and barriers to service. That is a two

- year study and results are 

### 27 possible late this calendar year. 

### 28 In '12, we also added two studies that have a surveillance or a 

### 29 multi

- outcome focus. The registry, which we have talked about , was one. The 

### 30 second is a study by Dr. Kim which will describe the overall physical, mental and 

### 31 socioeconomic impact of the World Trade Center disaster on responders. All of 

### 32 th ese studies, all of these five studies, do include females. 

### 33 The next slide is a listing of the six studies that were funded in 2013. Two of 

### 34 these studies have what we've labeled as a biomarker development focus. 

### 35 Dr. Emanuela Taioli is working to generate data on biomarkers of prostate cancer 

### 36 aggressiveness. Her study population is rescue and recovery workers. 

### 37 And Dr. Michael Marmor is working on methods to determine if World 

### 38 Trade Center

- related trace elements can be identified in individual autopsy ti ssues. 

### 39

### 21

It's hoped that this work will provide a foundation for future development of 

### 1 biomarkers indicative of cumulative World Trade Center exposure. 

### 2 The remaining four studies that were funded in 2013 each have a distinct 

### 3 focus area. Dr. Leo Trasande is studying the physical health effects among 

### 4 adolescents who had early life exposure to the World Trade Center disaster. 

### 5 Dr. Joan Reibman is working to identify the mechanisms most responsible for 

### 6 uncontrolled lower respiratory disease among survivors and responders. And the 

### 7 study will also examine best treatment methods for patients with persistent lower 

### 8 respiratory symptoms. 

### 9 Dr. Ma y ris Webber is working to calculate the incidence of selected 

### 10 systemic autoimmune diseases in firefighters and emergency medi cal service 

### 11 workers. And Dr. Adam Gonzalez is comparing two met hods of mind

- body 

### 12 treatment for responders with PTSD, p ost

- traumatic stress disorders , and lower 

### 13 respiratory disease. 

### 14 All but one of these six studies include females. Three of them, Drs. Tai oli, 

### 15 Marmor and Webber are two

-year studies with initial results expected in mid

- 2015. 

### 16 The next slide is simply a summary of the study focus areas. There are just a 

### 17 couple of things that I want to call your attention to. There are currently three 

### 18 studies in the portfolio that focus on World Trade Center youth. Two are mental 

### 19 health and one, Dr. Trasande's, deals with physical health issues. 

### 20 The next slide gives a breakdown in the portfolio of the studies. Eighteen of 

### 21 the 25 focus primarily on responders ; three of the 25, which include World Trade 

### 22 Center youth that I just mentioned, are survivors only; and four of the 25 include 

### 23 populations that have both responders and survivors. 

### 24 And the next slide, I want to just point out that information about the 

### 25
res earch portfolio of projects can be accessed through the World Trade Center 

### 26 program website. On that site we will have updated, probably in the next several 

### 27 days, information about contact information for each of the PIs. We currently have 

### 28 study descripti ons that are available on the website, if

-- for people to see, and 

### 29 that's publicly available. 

### 30 We will also be adding into a database research articles as they are 

### 31 published, and that will be searchable as well. I also wanted to point out that we 

### 32 have t wo research grantee meetings each year. In the '14 meetings, we will begin 

### 33 discussions, as I said, on preliminary results. The researchers will also begin 

### 34 organizing findings and identifying research gaps as well and providing that 

### 35 information to the pro gram. The characterization or the categorizati o n scheme that 

### 36 I talked about wi ll also get a look at as well and I would imagine that there will be 

### 37 some modification there, too. 

### 38 Scientific publications, like I said, there are currently seven publications t hat 

### 39

### 22

are available from projects awarded in 2011. A nd currently the PIs will be 

### 1 presenting at several conferences in 2014, they include the American Thoracic 

### 2 Society C onference, the American

-- the World Congress of Epidemiology, the 

### 3 American Heart Associa tion and the American Association of Cancer Research. 

### 4 And finally I just want to thank, from the staff and the NIOSH Office of 

### 5 Extramural P rograms, the STAC committee members and also the very hard work 

### 6 that is being performed by the portfolio researchers. Thank you very much. 

### 7 **DR. WARD:** Thank you for that informative presentation. We have a few 

### 8 minutes for questions. 

### 9 **DR. MARKOWITZ:** This is Steven Markowitz; I have a question. I hope it's 

### 10 not an unfair question, but in Dr. Howard's charge to the committ ee, he listed 

### 11 several areas for us to look at. One was understanding the effects of exposure, 

### 12 secondly is research gaps on accurate diagnosis, a third is effective treatment, and 

### 13 I'm just wondering whether he's broken these projects down at all by those t hree 

### 14 factors, the extent to which they address m ore or less those three factors? 

### 15 **DR. KUBALE:** You know, Dr. Markowitz, we have some information about, 

### 16 you know, how these projects would relate to that. I, you know, I would have to 

### 17 probably get back to you on some of the specifics of that. And, you know, maybe 

### 18 some of the committee members, Dr. Aldrich or Dr. Trasande would, you know, 

### 19 want to weigh in on that as well. 

### 20 **DR. MARKOWITZ:** Actually, you know, let me just rephrase it. Do you think 

### 21 any of th ose t hree areas, the ideology of the diagnosis of treatment, i t seemed 

### 22 when you reviewed the projects that they seemed to be covered , more or less , in 

### 23 the various projects, t reatment, for instance, yo u mentioned a number of times. 

### 24 A nd from

-- is it your impres sion that any of tho se three areas are perhaps under

-- 

### 25
are underserved in terms of the research, from your point of view? 

### 26 **DR. KUBALE:** You know, I think the way that I would, you know, probably 

### 27 best answer that right now is that I think

-- I think that th ere are sev eral of the 

### 28 projects that we tried to point out that do have treatment relevance. I think that, 

### 29 because of the relative newnes s of the portfolio, it's hard for me to comment, you 

### 30 know, probably further on where the additional gaps would be, you know, at this 

### 31 particular time. 

### 32 **DR. MARKOWITZ:** Okay. Thank you. 

### 33 **DR. KUBALE:** I'm sorry. 

### 34 **DR. MARKOWITZ:** It's not a problem. 

### 35 **DR. HARRISON:** This is Bob Harrison. Could you just, Allen, just re



### 36 emphasize the current funding years for the projects that are already funded, when 

### 37 they're expected to end, when the new announcement goes out, and then when 

### 38 those would be expected to end? I'm just , just trying to get an overall perspective 

### 39

### 23

on the time frame of the current funding on the projects. 

### 1 **DR. KUBALE:** U m -- I'm sorry. 

### 2 **DR. ROBISON:** No, g o ahead, Travis, that's fine. 

### 3 **DR. KUBALE:** Dr. Harris (sic) , the projects that were funded in '13

-- or I'm 

### 4 sorry, in '11, there were eight of those, and they will end officially later this year. 

### 5 The projects that were f unded in '12, some will, the two

-year projects, will end in

-- 

### 6 at the end of '14 , and the four

- year projects will essentially be funded through the 

### 7 end of '15. 

### 8 The six projects that were funded in '13, two

-- like I said three of the 

### 9 two

-year projects

-- let's see, it will be FY '13 and '14, and the three

- year projects 

### 10 will go into '15. 

### 11 **DR. HARRISON:** The current projects that are funded end in 2015. 

### 12 **DR. KUBALE:** Yes. 

### 13 **DR. HARRISON:** And the new announcement that we're discussing in terms 

### 14 of recharge of pr iorities, that goes out this year and that

-- those would end in

-- 

### 15 **DR. KUBALE:** I'm sorry, I understand your question. That's a one

-- those 

### 16 will be the '15 call, if there is a call, which we're assuming there will be, will be for 

### 17
one - year projects. 

### 18 **DR. HARRISON:**  Okay, for one year. 

### 19 **DR. KUBALE:** Yes. 

### 20 **DR. HARRISON:** And those would start in

-- 

### 21 **DR. KUBALE:** The money would be allocated in '15. They would go into 

### 22 '16 but the money would be authorized and allocated for '15. 

### 23 **DR. HARRISON:** Okay, gotcha. Tha nk you very much. That helps me 'cause 

### 24 I just wanted to

-- and that would be, then, in terms of the

-- from 2001, those 

### 25 would be research projects that would then be out potentially 15 years, just in 

### 26 terms of any kind of longitudinal evaluation or

-- 

### 27 **DR. KUBALE:**  Yes, you're correct. That's correct. 

### 28 **DR. HARRISON:** We'd be talking 15 years. 

### 29 **DR. KUBALE:** That's correct. 

### 30 **DR. HARRISON:** Since 2001, okay. Thank you. 

### 31 **DR. ROBISON**  **:** And Bob, just to clarify, we've had one research funding 

### 32 announcement we've modi fied in each year to decrease the number of years, to line 

### 33 up with the projects. And then currently the next receipt date will be for one

-year 

### 34 projects. 

### 35 And then as we look ahead to another research funding opportunity 

### 36 announcement, we will incorporate input that we receive from the Scientific 

### 37 Advisory Committee members. We'll use information that we glean from the 

### 38 current projects that are funded , so we're , we're looking

-- we're looking ahead to 

### 39

### 24

that. Thanks. 

### 1 **DR. HARRISON:** So can I clarify that, jus t one quick question ? So then are

-- 

### 2 would you be asking us for our feedback and advice today on just the next 

### 3 announcement for one

-year projects or also for potential reauthorization and 

### 4 additional research in subsequent funding announcements that could go beyond 

### 5 one year? 

### 6 **DR. MIDDENDORF** : I think Dr. Howard is interested in getting information

-- 

### 7 this is Paul by the way -- is getting information and getting your advice extending 

### 8 out beyond the point of reauthorization. 

### 9 **DR. HARRISON:** Okay. Thank you. 

### 10 **DR . TALASKA:**  This is Glenn Talaska. One of the areas where there was a lot 

### 11 of uncertain ty was in the exposure and the ability to reconstruct the exposures from 

### 12 the , from the 9/11

-- the measurements that were done. Does that seem to be an 

### 13 area that's addr es sed? I realize that the Marmor study will be looking at the levels 

### 14 and autopsy samples , but still my thinking is there has been nothing that addressed 

### 15 strategies for doing monitoring under

-- when circumstances like this might arise 

### 16 again. 

### 17 **DR. KUBALE**  : Glenn, is that a question for us? We would agree with your 

### 18 assessment. 

### 19 **DR. TALASKA:** Okay, thank you. 

### 20 **DR. WARD:** If there are no further questions, we'll move on to the next 

### 21 presentation, which is by Drs. Farfel and Stellman about the World Trade Center 

### 22 Health Registry Research Program

. 

### 23 24 **WTC HEALTH REGISTRY RESEARCH** 

### 25 **DR. FARFEL:** Good morning. Thank you for the opportunity to provide an 

### 26 update on registry research. This is M ark Farfel, the registry director, and I'm going 

### 27 to begin with a very brief overv iew, a nd Dr. Steve Stellman, the registry's research 

### 28 director, is going to focus on registry research s ince our last update, which was at 

### 29 the November 2011 STAC meeting as well as our plans going forward. 

### 30 Next slide. Could I have the next slide, please? 

### 31 **D R. MIDDENDORF**  : Yeah, I'm working on it. 

### 32 **DR. FARFEL:** The registry has a cohort study of more than 71,000 people 

### 33 directly exposed to the 9/11 disaster. And it was designed to last 20

- plus years with 

### 34 periodic follow

- up health surveys. We do collect additi onal data by matching w ith 

### 35 administrative databases, to assess cancer, mortality and hospitalization , and by 

### 36 conducting in

- depth studies, such as our respiratory study, in collaboration with 

### 37 NYU

- Bellevue. The registry is also a platform for numerous 9/11

- related studies by 

### 38 external researchers, and Dr. Stellman will mention some of our active 

### 39

### 25

collaborations. 

### 1 One of the core registry aims is to respond to the health needs and concerns 

### 2 of enrollees and their families. Through our treatment referral project we do 

### 3 conduct extensive outreach to encourage enrollees to access monitoring and 

### 4 treatment through the World Trade Center Health Program

. 

### 5 Could I have the next slide , please? The registry has diverse populations of 

### 6 responders and non

- responder survivor s w ho were exposed to the disaster. We 

### 7 ha ve more than 30,000 rescue and recovery workers enrolled in the registry, 

### 8 including thousands of firefighters, police, out

- of

- state responder s, construction 

### 9 utility workers and volunteers. 

### 10 The largest group of survi vors is the building occupants and passers

- by 

### 11 group, followed by residents and school children and staff. Approximately one in 

### 12 four of our enrollees belong to more than one eligibility group, and that's why the 

### 13 numbers total more than 71,000. 

### 14 While most o f our enrollees live in New York City, we do have enrollees 

### 15 from all 50 states and more than 15 countries. 

### 16 And next slide , please. The registry was conceived here at DOHMH shortly 

### 17 after 9/11, and it became a collabo rative effort funded by FEMA, AT S DR, CDC 

### 18 beginning in 2002. Our Wave 1 survey was conducted in 03

- 04, and addressed new 

### 19 and worsening physical and mental health symptoms and conditions and exposures 

### 20 on and after 9/11. 

### 21 The first follow

- up survey was conducted in 06

- 07, and our Wave 3 survey 

### 22 pr ovided health updates approximately ten years post

- 9/11. These follow

- up 

### 23 surveys included questions on the course of symptoms and conditions, new 

### 24 conditions, unmet healthcare needs, quality of life and had separate adult and 

### 25 pediatric surveys. 

### 26 We collecte d data on Hurricane Sandy exposures and health outcomes six t o 

### 27 12 months after the events a mong 4 , 300 enrollees living in inundation zones and a 

### 28 sample of enrollees outside of inundation zones, and this effort demonstrated the 

### 29 registry's ability to mount a rapid response to another event and to obtain good 

### 30 survey response from enrollees. And our Wave 4 survey is currently under planning 

### 31 for a 2015 launch. 

### 32 Could I have the next slide? To date the registry has 43 publications in peer 

### 33 review journal s that re port on adverse health outcomes across all eligibility groups 

### 34 and subgroups, that address myriad conditions including som e that Travis 

### 35 mentioned earlier: PTSD, respiratory heart diseases, cancer, mortality, GERD, co



### 36
o c c urring conditions and other topics s uch as access to care and respiratory 

### 37 protection. 

### 38 We're also in continuous communication with scientific and clinical 

### 39

### 26

audiences through presentations at conferences and scientific meetings. We've also 

### 1 produced a number of technical reports as well as thre e sets of clinical guidelines 

### 2 developed with our colleagues at the clinical programs. 

### 3 Other outputs include our in

- dep th studies, doctoral and master s theses 

### 4 based on registry data and the public use data sets and data query tools that are 

### 5 posted on the re gistry's website. 

### 6 Could I have the next slide? The registry publications appear in a range of 

### 7 journals, and here in this slide I've grouped them by type of journal. So they include 

### 8 the clinical/medical journals, journals focused on occupation/environment al health 

### 9 as well as mental health, public health /epidemiology and disaster

- oriented journals. 

### 10 And our p ublications do include two papers, an editorial and two letters in JAMA as 

### 11 well as two papers in the Lancet

. 

### 12 Could I have the next slide? The publicat ions

-- the registry work is 

### 13 informing disaster response through the peer review literature contributions, the 

### 14 conference presentations, and studying the impact of exposure to multiple 

### 15 disasters. We also contribute through the facilitated external researc h that includes 

### 16 the studies of behavioral, organizational and structural aspects of evacuation of 

### 17 damaged and destroyed buildings at the World Trade Center site. 

### 18 Could I have the next slide, please? The treatment referral project at the 

### 19 registry is actual ly one of the four aims under our current NIOSH funding. And the 

### 20 project was launched in 2008 in collaboration with a health and hospital 

### 21 corporations World Trade Center of excellence for residents and area workers, and 

### 22 it's now been expanded to include r esponders and out

- of

- state enrollees. 

### 23 And we conduct what we deem personalized outreach to survivors who 

### 24 reported 9/11

- related public health

-- physical health and/or mental health 

### 25 symptoms as well as to responders with and without symptoms who did not r eport 

### 26 using 9/11 clinical services on the most recent survey. And our dedicated staff have 

### 27 social work and nursing backgrounds and are trained in motivational interviewing 

### 28 techniques so that they can encourage care seeking a ddr essing attitudinal and 

### 29
acces s barriers. 

### 30 There are many challenges to this project. We have hard to reach 

### 31 populations, for example, one of the subgroups with co morbid PTSD and depression 

### 32 and l o w social support. Others are concerned about mental health stigmatization or 

### 33 fail to con nect their symptoms with 9/11. 

### 34 And we have had some success motivating people either to make their first 

### 35 appointment, when we were linked to HHC's program. We're now applying to the 

### 36 World Trade Center Health Program , and we do continue to send applicati ons for 

### 37 the World Trade Center health application to interested enrollees and follow up to 

### 38 see if they have applied and to offer assistance if needed. 

### 39

### 27

And before I turn this over to Dr. Stellman, I just wanted to highlight some 

### 1 of the registry's strengths that I believe will enable the registry to remain an ongoing 

### 2 source for 9/11

- related long

- term health impacts research. 

### 3 Could I have the next slide? And these strengths include the diverse cohort, 

### 4 the large numbers that we have of both responders and su rvivors, the scope and 

### 5 depth of the scientific output that have had a role in informing 9/11 healthcare and 

### 6 providing lessons learned for future disasters. 

### 7 We also have dedicated staff for cor e registry functions in the areas of 

### 8 research, surveillance, c ohort maintenance and treatment referral. And we do have 

### 9
a strong commitment on the part of the enrollees, and for example, we have valid 

### 10 contact information for about 95 percent of our enrollees and relatively small 

### 11 numbers of withdrawals; it's just a li ttle bit more than 1 percent , and sma ll numbers 

### 12 of people currently lost to follow up. And lastly we do have increasing numbers of 

### 13 collaborations with distinguished external researchers. 

### 14 **DR. STELLMAN:** Good morning, this is Steve Stellman, the research d irector 

### 15 for the World Trade Center Health Registry . I want to thank you for this opportunity 

### 16 to acquaint the committee with highlights of registry published studies that have 

### 17 appeared in print since our previous appearance in 2011. I just have to emphasi ze 

### 18 that in the interest of time, I can only present the most salient features. All of these 

### 19 papers that I will discuss are in the open literature except for a new one by Dr. 

### 20 Brackbill on injury that was just accepted by American Journal of Epidemiology la st 

### 21 week. After I discuss the published studies, I'll give you an outline of the registry's 

### 22 current research program. 

### 23 As you can see we

-- the registry has now published 44 articles in the peer 

### 24 review literature and has five papers under review, and th ese sort into the thematic 

### 25 areas that are largely under discussi on this morning, physical and mental health. 

### 26 As you can see on the right

- hand panel, we have a number of other areas 

### 27 for which we have collected data and for which there is considerable amount of 

### 28 interest, and these are also the target of many of our studies, and I'll mention a few 

### 29 of these here. 

### 30 Next slide? Just as I mentioned, just as highlights of several studies, we had 

### 31 an article in collaboration with our colleagues at ATSDR, led by Vinicius Antao , on 

### 32 use of respiratory protective equipment. I'd like to point out, by the way, that this 

### 33 particular paper was one of a handful of nominees for the CD C's annual Charles C

. 

### 34 Shep a rd Award for S cience, so

-- for which there are usually about a thousand CDC 

### 35 coauthored papers under consideration, so we're very happy to have been among 

### 36 the finalists. 

### 37 But we studied almost 10,000 rescue/ recovery workers in that study. We 

### 38 found that protective equipment were used most often by construction utility 

### 39

### 28

workers, and that correct use of RPE was associated with between a 20 to 

### 1 50 percent reduced risk of respiratory illness, and that fit testing and training wer e 

### 2 key to effectiveness. And so, although these may seem somewhat obvious and are 

### 3 consistent with the guide lines that NIOSH and other organizations h ave been 

### 4 publishing for years, i t's really rather rare in the literature to find an actual 

### 5 evaluation of effectiveness. 

### 6 What you also see on the slide is the clinical study that was conducted by 

### 7 Dr. Friedman using innovative technology, impulse oscillometry, which is particularly 

### 8 sensitive to distal airway dysfunction. W e found that cases were more likely

-- cases 

### 9 of respiratory

-- lower respiratory distress were more likely to have abnormal 

### 10 spirometry than control but that a screening spiromet ry was relatively insensitive at 

### 11 distinguishing symptomatic or asymptomatic control, and that this oscillometry 

### 12 measurement was reflecting overall resistance to a irway flow was more likely to be 

### 13 elevated in cases than in contr ol. 

### 14 Next slide. We've now published three separate reports on coronary heart 

### 15 disease, o ne on mortality, one on incidence and one on hospitalization. The first 

### 16 bullet here refers to our inciden ce study in which we reported that dust exposure 

### 17 and PTSD inde pendently were predictors of elevated risk of nonfatal heart disease 

### 18 in our Wave 2 survey ; that is , two to six years post

- 9/11. 

### 19 The second bullet, this is our newly published study in the Journal of the 

### 20 American Heart Association based on linkage of resp ir atory data with the New York 

### 21 S tate SPARCS registry, which is a hospitalization database, which we found 

### 22 hospitalization for cardiovascular disease was 32 percent higher in women with 

### 23 PTSD and 82 percent higher in male responders with high exposure compared to 

### 24 low exposure. 

### 25 Then in the last bullet , where we've also had a number of analyses of data 

### 26 on GERD or symptoms of GERD, which we call GERS , or gastroesophageal reflux 

### 27 symptoms. We found an elevated rate of GERS in our

-- up to Wave 2 survey, and 

### 28 found t hat these were especially pronounced in peopl e who had comorbid PTSD, 

### 29 asthma or both . So this has extremely important clinical implications for clinicians 

### 30 who may be dealing with one or another of these outcomes, and may not realize 

### 31 that all three of them may be associated with serious pathology. 

### 32 Next slide? W e've done the major study on mortality in the registry based 

### 33 on linkage with the New York C ity vital records and with the N ational D eath I ndex of 

### 34 cancer base d on linkage with the New York S tate cance r registry and the registries 

### 35 of New Jersey, Connecticut and a number of other state s where the great majority 

### 36 of our enrollees live. The overall mortality in the registry population i s considerably 

### 37 below the population rate, which in fact is what you usu ally find in the early years of 

### 38 a cohort study based on volunteer enrollment. 

### 39

### 29

Cardiovascular mortality was in fact d ose related to a 9/11 intensity score , 

### 1 so that the people with the highest exposure among the survivors had a hazard ratio 

### 2 of about 1.6. 

### 3 In our cancer study we found overall no increased risk of cancer among 

### 4 people who did not perform rescue/recovery work. And among the 

### 5 rescue/recovery workers, although the overall death cancer incidence was not 

### 6 increased, we did report excess risk of three types of cancer, thyroid cancer, 

### 7 prostate cancer, multiple myeloma, and these were strikingly consistent with 

### 8 reports from two of the other reporting agenci es, the fire department and Mount 

### 9 Sinai

. 

### 10 Next slide. Some of our other recent findings. We recently reported on 

### 11 evacuation modes and time in people who evacuated the two World Trade Center 

### 12 towers. And building on a previous external researcher, the work of Robyn Gershon 

### 13 from Columbia University, we divided different types of various evacuation s 

### 14 accordi ng to structural and behavioral pattern. We found for example evacuation 

### 15 time was related to e ncountering smoke and poor lighting, structural barriers and 

### 16 behavioral barriers such as serious crowding and lack of communication. 

### 17 We have conducted three foll ow - ups -- or three rounds of data collection 

### 18 and two follow

- ups on our pediatric cohort . A nd in the younger children we 

### 19 reported our respiratory health associated with 9/11 exposures, which we found a 

### 20 prevalence of lower respiratory illness in 14 percent of the children , and the great 

### 21 majority of those reported a previous diagnosis of asthma among

-- with clinicians. 

### 22 We also have been looking at behavioral outcomes in children and 

### 23 adolescents as well , using some validated scales. And for example, in thi s study 

### 24 reported that, based on a question now known as the strengths and difficulties 

### 25 questionnaire, which taps into a number of emotional and behavioral domains, 

### 26 there was a three

- fold increased risk for an abnormal score

-- abnormal or 

### 27 borderline score on this outcome among children who also reported respiratory 

### 28 problems. 

### 29 T he third item on this slide refers to the study that I mentioned previously 

### 30 that has just been accepted for the American Journal of Epidemiology. There really 

### 31 has been very little res earch on the initial injuries that were sustained during the 

### 32 first hours and days of 9/11 exposure. And it turns out, at least in our study, we 

### 33 followed them forward now for a number of years, and that multiple injuries are 

### 34 strong predictors of subsequent

-- not only subsequent PTSD but subsequent 

### 35 development of chronic diseases including cardiovascular disease and diabetes, 

### 36 particularly cardiovascular disease. 

### 37 And finally, as Dr. Farfel mentioned before, the Hurricane Sandy 

### 38 phenomenon in New York City, wh ich hit us particularly hard during the last days of 

### 39

### 30

2011, raised the concerns that many people who already were dealing with 

### 1 9/11

- related problems may have been re

- traumatized, and so we sent out a survey 

### 2 to several thousand people in the registry, strati fied by whether they lived within or 

### 3 not within the official FEMA inundation zone. Those data are still under analysis 

### 4 now, and the only prel iminary finding that I'm able to report right now is that 

### 5 people with 9/11

- related PTSD are about seven times more likely to screen positive 

### 6 for a Hurricane Sandy

- related PTSD compared to people with no prior 9/11

- related 

### 7 PTSD. But just keep in mind this is preliminary, unpublished findings that we expect 

### 8 to be able to submit for publication very shortly. 

### 9 Next slide. To give you an idea of the manuscripts that are now in 

### 10 preparation, I've divided them into three areas here. We have two in

- depth studies, 

### 11 that is a nested clinical study of respiratory disease, which is in the field right now, 

### 12 which is progressing very nicely. And then the Hurricane Sandy study that I just, just 

### 13 mentioned. Below on the left, several studies in progress include one on mortality 

### 14 related to substance use and then another study of reproductive health and 

### 15 potentially adverse birth outco mes such as low birth weight at gestational age, 

### 16 which we

-- one study was -- which was done several years ago was only based on 

### 17 several years of data, and now we've linked the registry's data to New York City vital 

### 18 statistics for a 12

-year period. So we hav e a much longer period of follow

- up for 

### 19 those

. 

### 20 Over on the right we have a number of other studies in progress including 

### 21 the one on dia bet es, one on the long

- term time course of PTSD, which nowadays is 

### 22 popularly termed, trajectory study. We're also conc erned with comorbidity of 

### 23 both

-- as I mentioned before, comorbidity of physical and mental health outcomes, 

### 24 where we have one nearly completed manuscript on the comorbidity of PTSD and 

### 25 other mental health outcomes, particularly depression and anxiety. 

### 26 W e are working on one study on asthma control. We know asthma and 

### 27 other respiratory outcomes are a major 9/11

- related outcome, and we have data on 

### 28 the extent to which people are using standard or recommended types of control 

### 29 approaches. I mentioned before that we are continuing to follow up our population 

### 30 for GERD. We're also concerned with unmet healthcare needs for physical and 

### 31 mental health, and we have several studies on alcohol abuse that are in progress. 

### 32 Next slide. Research that is planned for the next two years the

-- or two 

### 33 operational activities are the updating of our cancer and mortal ity databases. 

### 34 Cancer incidence database that I mentioned derived largely from about a dozen 

### 35 state cancer registries including New York State, New Jersey and Con necticut. And 

### 36 our mortality assessment , which is based on our local vital statistics and N at ional 

### 37 Death I ndex. 

### 38 Then we have an active study of adolescent behavior that is from

-- goes 

### 39

### 31

into several domains inc luding internalizing behaviors, related to em otions, 

### 1 externalizing behaviors such as conduct and hyperactivity. 

### 2 As part of our mortality studies, we're specifically focusing o n PTSD and 

### 3 mortality, and then as we mentioned before our index study on rheumatoid arthritis 

### 4 and then there's a nested case - control study , which will unfold over the next year. 

### 5 I also mentioned before our study

-- we're looking at risk factors and one is 

### 6 smoking trajectories , and we're looking in particular at the impact of 9/11 on 

### 7 smoking habits , which a re some interest by themselves but which, of course , are 

### 8 indicators and predictors of subsequent chronic disease. 

### 9 Next slide. We are well along in our planning stage for Wave 4 survey. A nd 

### 10 I'm very pleased to note that many of the people on this committee have already 

### 11 made some valuable contributions to our

-- to the planning process and to our 

### 12 thinking about what will go into the survey. 

### 13 The objective for the survey will be to assess the course of conditions that 

### 14 we previously reported on, with a focus on chronic health, course of treatment for 

### 15 selected conditions, functional status of our enrollees and quality of life indicators, 

### 16 and then potentially new emerging conditions, which we're always looking out for. 

### 17 The survey population is all adult enrollees who will be at le ast 18 years of 

### 18 age in 2015, and that in effect is about 99 and a half percent of the entire registry. 

### 19 The methods that we will use will be a web and paper survey, which worked very 

### 20 well for Wave 3, and we use, as is our policy, we always send out surveys in three 

### 21 language: English, Spanish and Chinese. And our current plan is to launch the survey 

### 22 early in 2015. 

### 23 Next slide. Dr. Farfel also mentioned our linkages with external researchers, 

### 24 and this is something that we just simply can't do without, and we 're very pleased 

### 25 with our relationships. This is a magnificent way to leverage the skill set and the 

### 26 resources in the registry and effectively tap into the very rich talent pool of 

### 27 researchers in the New York metropolitan area and elsewhere. 

### 28 We have a

- - excuse me? We actively encourage external research projects 

### 29 and, as Dr. Kubale mentioned before, there are

-- have we lost our slide? Oh, okay. 

### 30 Dr. Kubale mentioned before that many of the external research

-- that the grant 

### 31 fund ed proposal s that NIOS H has funded are based on registry research. I'll just 

### 32 mention a few of those. We provide external researchers many different ways of 

### 33 collaborating with the registry : They can collaborate directly with us and just 

### 34 include us as if we were part of the re search team ; t hey can simply use our data as a 

### 35 public use database ; o r we have

-- for several of these studies t he registry can 

### 36 facilitate the recruitment of registry enrollees and once the recruitment is actually 

### 37 concluded, then the enrollees effectively are available to the external researchers 

### 38 for their approved projects. 

### 39

### 32

We have a review committee that reviews applications similar to the way 

### 1 that most grant app lications are reviewed. And to date we have approved 21 

### 2 studies from nine American and intern ational institutions. Not all of these studies 

### 3 are in fact go into effect because many of them are contingent on funding for the 

### 4 individual studies and some of the funding sources

-- sometimes investigators get 

### 5 funded and sometimes they don't. However, w e are open as we possib ly can with 

### 6 the making our data available. 

### 7 The next two slides will show the 11 active external research studies that we 

### 8 have. And I think I'm just simply going to go down the list and mention the type of 

### 9 study and the investigator, because many of these have already been covered by 

### 10 Dr. Kubale. 

### 11 So we h ave the first

-- the first three

-- first three bullet s here are pediatric 

### 12 studies: t he physical health study of Dr. Trasande at NYU and two mental health 

### 13 studies being done by Dr. Hove n at Columbia. The autopsy biomarker study by 

### 14 Dr. Marmor; the smoking cessation intervention by Dr. Kotov at Stony Brook; and a 

### 15 study of social i nt e gration a nd social support in police by Dr. Bowler at San Francisco 

### 16 State University. 

### 17 Next. We also have a collaboration with the Center for Aging at the CDC led 

### 18 by Dr. Valerie Edwards, lookin g at cognitive functioning; another PTSD study among 

### 19 police responders by

-- with Dr. Bowler at SFSU. A study with Dr. Berger, who is the 

### 20 oscillometry collaborator and i s interested in devel oping normative scales for 

### 21 oscillometry for comparative purposes. And then a very innovative GIS study of 

### 22 respiratory conditions and exposures based on proximity measures with Dr. Antao 

### 23 at ATSDR. And finally the study of upper respir atory symptomatology in responders 

### 24 by Dr. de la Hoz at Mount Sinai. 

### 25 Next. So with all of this activity going on, what are we actually doing? Well, 

### 26 we are continuing the analyses of registry data that I’ve outlined several of these 

### 27 slides already. As I m entioned we're working on the design and questionnaire for 

### 28 our Wave 4 data collection. We're working on the in

- depth respiratory health study 

### 29 and the rheumatoid arthritis case

- control study. We're updating cancer and 

### 30 mortality assessments. We will conti nue referrals to the World Trade Center Health 

### 31 Program that Dr. Farfel described. And of course, as we are doing now and we 

### 32 continue to do as we publish our findings in the

-- all the literature, we will share our 

### 33 findings with the public and with policy makers. 

### 34 Last slide. And o nce again, we gratefully acknowledge not only the funding 

### 35 but the advice and counsel of our agencies: NIOSH, ATSDR, the very talented and 

### 36 dedicated registry staff at the New York City Department of Health and Mental 

### 37 Hygiene and th e many members of our scientific community and labor advisory 

### 38 committees, many of whom are represented on the

-- this STAC as well. 

### 39

### 33

Thank you very much and we're happy to field questions , if you like. 

### 1 **DR. WARD:** Thank you. The floor is open for questions. 

### 2 **MS. FLYNN:** Liz? 

### 3 **DR. WARD:** Yes. 

### 4 **MS. FLYNN:** Hi, it's Kimberly. Thanks very much, Steve, for that 

### 5 acknowledgment of the collaborators and partners that the registry has worked 

### 6 with, and I just

-- following on that, I really do want to make a pitch to thi s 

### 7 committee for advocating a community

- base d participatory research process. A nd 

### 8 just to sort of name one example of how important that was, the paper that 

### 9 Dr. Friedman wrote, published in 2011 , on impulse oscillometry, at one point in the 

### 10 CBTR process, w here the registry was meeting with members of the community and 

### 11 also the medical director of the survivor program, Dr. Reibman, the registry was 

### 12 contemplating eliminating oscillometry from that study design. And were it not for 

### 13 the outcry among community members and Dr. Reibman, the registry may never 

### 14 have had these important results a n d this excellent paper. So it really

-- it really 

### 15 does matter that there is a collaborative process and that that process includes 

### 16 members of the affected community. 

### 17 **DR. FA RFEL:**  Are you expecting a response? All I can say is thank you again. 

### 18 We've got

-- the study actually was planned before I came to the registry but I

-- to 

### 19 this day, I do not understand why oscillometry is not a standard piece of equipment 

### 20 at every resp iratory pulmonologist 's arsenal

. It j ust seems to be so highly sensitive 

### 21 and useful. 

### 22 **MS. FLYNN:** Amen to that. 

### 23 **DR. WARD:** Other comments or questions? Then I guess we'll move on to 

### 24 the next speaker, wh ich is Laura Crowley, who will speak about the World Trade 

### 25 Center Clinical Centers of Excellence and the Data C enters ' Research N eeds. 

### 26 27 **WTC CLINICAL CENTERS OF EXCELLENCE /DATA CENTERS**  **RESEARCH NEEDS** 

### 28 **DR. CROWLEY:** Hi , good morning. First of all I woul d like to thank you for 

### 29 the invitation to present on topic s of interest for future research in the World Trade 

### 30 Center Health Program cohort s. And I'm affiliated with the responder program at 

### 31 the Mount Sinai clinical center but I have responsibility today to r eport on behalf of 

### 32 FDNY and survivor and responder pro gram s
. So I just wanted to start by describing 

### 33 the cohorts and a reminder of who each group is

. 

### 34 So as many of you know the FDNY program is a group of all active and 

### 35 retired fire department members who responded to the 9/11 attacks; t he responder 

### 36 program includes workers and volunteers who responded to the 9/11 attacks ; and 

### 37 the survivor program includes people who worked , lived or attended school, child 

### 38 care or adult s in the New York City disaster area. 

### 39

### 34

The characteristics

-- these are important character istics within the groups. 

### 1 C ertainly we provide medical monitoring and surveillance to each of our co horts. 

### 2 We provide specialized World Trade Center treatment services for exposure

- related 

### 3 diseases in upper airway, lower airway, GERD, mental health and s pecific 

### 4 musculoskeletal diseases and can cers. It's a unique group and a well

- characterized 

### 5 population at this point with high retention rates, and as everyone is well aware , 

### 6 this is an unprecedent ed exposure and we do not have a control for comparison. 

### 7 So a s a reminder the James Zadroga B ill on 9/11 intent was to support , in 

### 8 terms of research, research on physical and mental health conditions that may be 

### 9 related to the September 11, 2001 terrorist attacks; research on diagnosing World 

### 10 Trade Center

- related health conditions of such individuals in case of conditions for 

### 11 which there has been diagnostic uncertainty; research on treating World Trade 

### 12 Center

- related health conditions for individuals in the case of conditions for which 

### 13 there has been treatment unce rtai nty. And of course any emerging conditions. 

### 14 In moving forward, the World Trade Center Health Program responder and 

### 15 FDNY and survivor program s agree that research should pretty much follow a 

### 16 general direction, and think of it in kind of a three

- prong a pproach in thinking about 

### 17 each individual topic that needs to be explored moving forward. So we divided it 

### 18 based upon mechanism, outcome s and progression of disease. 

### 19 So number 1, mechanism. This is the concept of particular scientific areas of 

### 20 interest m ay be explained in terms of structure, interaction of their component 

### 21 parts. 

### 22 Number 2 with the outcomes. Evaluating clinical and population

- based 

### 23 research that seeks to study and optimize the end results of healthcare in patients. 

### 24 And number 3, progressio n of disease. Where we evaluate disease states 

### 25 and objective markers that place patients at risk for disease advancement. And 

### 26 certainly we'll allow for early intervention for treatment and may promote 

### 27 regression of disease. 

### 28 Let's move forward with mechan ism. I'm just gonna view a snapshot of a 

### 29 few published manuscripts, and you will see there are very many, that may fall into 

### 30 each of these categories, and then we' ll identify our thoughts moving forward for 

### 31 each category. 

### 32 So many of you are familiar wit h the FD NY study that was published in 

### 33 Chest

. This was inflammatory b iomarkers like GM

- CS, CSS and MDC , that were 

### 34 found to be elevated in the air flow

-- in air flow obstruction. 

### 35 The next paper was published in the Journal of Asthma by the survivor 

### 36 prog ram by Dr. Joan Reibman's team, where they found an elevated level of 

### 37 peripheral eosinophils in the World Trade Center patients found to have symptoms 

### 38 of wheeze and peripheral abnormalities with air flow obstruction. 

### 39

### 35

In the responder program, Dr. Land r i gan and Dr. L i oy found that World 

### 1 Trade Center dust was highly alkaline, and mice exposed to dust develop moderate 

### 2 inflammation and bronchial hyper

- reactivity . A nd that wa s published in the E H P 

### 3 that we’re on

. 

### 4 We have a mental health study , led by Dr. Pietrza k and Dr. Southwick , that 

### 5 evaluated basically the dimensional structure and course of post

- traumatic stress 

### 6 symptomatology in World Trade Center. And they found that the disaster

- related 

### 7 PTSD symptomatology in World Trade Center responders is best represe nted by five 

### 8 symptom dimensions. 

### 9 We also have a study which, unfortunately, I don't have a slide today on, but 

### 10 it's a study that's about to be published by Dr. Luft's team , a nd presented at the 

### 11 American Psycho pathology Association next month , in an abstr act form

. They 

### 12 provide d an epigenetic linkage between PTSD and respiratory disease. They found 

### 13 specific genes associated with respirato ry inflammatory cytokines , and this 

### 14 obviously could be very important in diagnostic and therapeutic impact s moving 

### 15 forw ard

. So what does this mean? So I propose future mechanism studies, there 

### 16 are probably many but I'm going to name just a few. 

### 17 So number 1, what may be the impact of World Trade Center exposure on 

### 18 responders ' DNA? Many are exper iencing chronic health dec line but the 

### 19 mechanisms remain unclear. It's critical for us to understand the relationship 

### 20 between exposure and changes to DNA and gene expression and further insight and 

### 21 development

-- insight into the development of disease and treatment options is 

### 22
ess ential. 

### 23 Another example that may be worth exploring is we know from the current 

### 24 list of World Trade Center covered conditions, there's in creased risk of sarcoidosis in 

### 25 hematological malignancy direct lymphoma. W e could argue that these diseases 

### 26
a re repres entative of a disruption in the immune system, suggesting maybe we 

### 27 could be taking a closer look at World Trade Center exposure in relation to diseases 

### 28 that alter the immune system, like hematologic disease, and seeing if there are any 

### 29 biomarkers to evalua te moving forward

. 

### 30 Let's look at our next prong, outcomes. So this manuscript is published in 

### 31 the American Journal of Industrial Medicine , by FDNY, and it highlighted the need to 

### 32 evaluate the relationship between symptoms, pulmonary function tests and 

### 33 dia gnosis and utilization of healthcare. In the Lancet, there is the publication by Dr. 

### 34 Juan Wisnivesky and Dr. Landrigan for the responder program s that evaluated the 

### 35 nine

- year cumulative incidence of asthma, sinusitis, GERD, depression and PTSD , 

### 36 and found there's a 27 percent incidence of asthma, 32 percent with sinusitis, 

### 37 39 percent with GERD, and 31 percent PTSD, and 27 percent in depression. And 

### 38 we're still seeing spirometry abnormalities to date. 

### 39

### 36

In the Journal of Occupational and Environmental Medicin e , Dr. Joan 

### 1 Reibman's team from the survivor program , five years out , on disaster residents and 

### 2 local workers are still seeing respiratory lung function abnormalities. And Dr. Luft's 

### 3 team for the responder program was able to identify a linkage between PTSD and 

### 4 respiratory symptoms in the Journal of Psychological Medicine

. 

### 5 In EHP, Dr. Southwick's team and Dr. Stellman looked at the responder 

### 6 group and found that working in 9/11 recovery operations was associated with 

### 7 chronic impairment of mental health and social functioning . P sychologic distress 

### 8 and psychop athology in World Trade Center w orkers greatly exceeded the 

### 9 population norm s
. 

### 10 So though ts on future of outcome studies. A couple thoughts came to 

### 11 mind , preliminary thoughts. Number 1, a need to assess overall health status and 

### 12 impact of World Trade Center exposure and how it's had on the individual s ’ 

### 13 occupation

-- economic s and psychologically, how they've been impacted , h ow their 

### 14 lives have changed. Very difficult end points to evaluate that we feel are definitely 

### 15 worth while . Thinking about and figure out a way to investigate. 

### 16 Number 2, how has exposure impacted cognition. Certainly that's an 

### 17 interesting question to answer, and may be considered in additional questions and 

### 18 adding additional questio ns to the monitoring program to explore further. 

### 19 Number 3, identify patient characteristics that maximize psycho therapeutic 

### 20 intervention for specific mental health conditions like PTSD. 

### 21 And Number 4, but definitely not lastly, utilize DC resource, that's a data 

### 22 center resource, to resume disease surveillance activities, to evaluate additional 

### 23 outcome measures, especially since the data's readily available for real

- time analysis 

### 24 and can analyze those conditions that have been certified and are currently unde r 

### 25 active treatment. 

### 26 Moving to the next prong: Progression of disease. In Chest, we saw in Dr. 

### 27 Prezant's study with FDNY, i t highlighted a relationship between pulmonary function 

### 28 test abnormality

-- pulmonary function test improvement and lower respiratory 

### 29 system improvement. And basically recommend ed w hat we need to continue to 

### 30 follow spirometry in our cohort

. 

### 31 In our survivor program, Dr. Reibman's team wa s able to confirm that PTSD 

### 32 high reversibility they were seeing in the population , but it reinforced the need for 

### 33 continued treatment. They were seeing improvements in populations but the

-- this 

### 34 reversibility reinforced the need to continue to follow them very closely. 

### 35 In the responder program, Dr. Gwen Skloot with Dr. Paul Enright noted 

### 36 increased rate s of spirometry even five years out post

- 9/11 , and again, 

### 37 recommended need for monitoring. 

### 38 I'm going to skip to our thought s on progression of disease , and skip the last 

### 39

### 37

two slides in the intere st of time. So advantage for the future. One example would 

### 1 b e responders who experienced b oth medical and psychologic sequelae are m or e 

### 2 impaired. This group requires further evaluation to determine best management 

### 3 strategy to optimize treatment. 

### 4 N umber 2 would be to investigate, and this is more in the physical health 

### 5 arena, these last two, investigate the impact of renal disease in the context of 

### 6 responders who no w have multiple co

- morbidities due to their exposure. 

### 7 And number 3, consider identifying and characterizing those patients who 

### 8 have had significant d ifficult health decline due to their World Trade Center 

### 9 exposure , especially those with severe asthma and interstitial lung disease. 

### 10 So, you know, we've mentioned studies that have been done, just a few , in 

### 11 each of the area s , general areas , of research tha t should be considered, and we've 

### 12 mentioned just a few of the studies that we think should be maybe considered in 

### 13 the future. Certainly this list is meant in no way to be comprehensive; it's only 

### 14 meant to give it a direction of future research, and we'd b e more than happy to 

### 15 return and expand on the list of details after discussion with our lead World Trade 

### 16 Center Health Program clinicians, researchers, (indiscernible) members. 

### 17 We would like to just round it off by saying a few things we'd like the group 

### 18 to consider is the time frame for any studies moving forward, the one

-year, 

### 19 obviously, versus the future, the longer time frame ; and addressing those 

### 20 populations that may be most vulnerable, like children ; and thirdly , that these 

### 21 populations may provide a nd translate to disaster, future disasters , or even non 

### 22 disaster populations in the public health arena. 

### 23 Thank you again for the opportunity to present our thoughts. 

### 24 **DR. WARD:** Thank you for your presentation. I noticed that we missed our 

### 25 11 :00 to 11:10 b reak. Paul, do you think we should just go ahead and take it now 

### 26 and then resume discussion with Dr. Crowley? 

### 27 **DR. MIDDENDORF** : Why don't we go ahead and ask Dr. Crowley any 

### 28 questions we might have , and then we'll take the break

. 

### 29 **DR. WARD:** Okay. Any ques tions for D r. Crowley? 

### 30 **DR. HARRISON:** This is Bob Harrison, thank you very much. It's just 

### 31 incredibly impressive. Did any of the research studies address the question whether 

### 32 early and aggressive treatment intervention make a difference in outcome? 

### 33 **DR. C ROWLEY:**  Yeah, I mean , that's an excellent question, and certainly 

### 34 something that is definitely worth exploring, based in the physical and mental 

### 35 health arena, and I think in context of some o f the potential proposals, certainly 

### 36 could be woven in, and I th ink that's an excellent suggestion. 

### 37 **DR. HARRISON:** I don't know whether it's too late to do that, looking 

### 38 backwards over 15 years , but it's certainly one of the questions that I always have as 

### 39

### 38

a public health, you know, official, is, you know, does getting people into early 

### 1 treatment for respiratory sympt oms or potential psychological sequelae make a 

### 2 difference, you know, so that we really have to have the systems and infrastructure 

### 3 in place. When

-- 

### 4 **DR. CROWLEY:** Right. I mean, we know from just a, from an asthma 

### 5 perspective , certainly folks who were left with prolonged disease without treatment 

### 6 are at risk for irreversibility. The Joan Reibman study that we mentioned early on 

### 7 about, you know, the reverse

-- potential for reversibility is an important po int 

### 8 because you have a chance to make an impact so that that doesn't become fixed 

### 9 airway obstruction. 

### 10 **DR. HARRISON:** Right. 

### 11 **DR. CROWLEY:** So I think there are ways to do it, and I think it's a good 

### 12 point. 

### 13 **DR. HARRISON:** Yeah. 

### 14 **DR. CROWLEY:** Thank you. 

### 15 **DR. T ALASKA:**  This is Glenn Talaska. I have a very closely related question. 

### 16 And I was wondering if there's been investigation as to which levels of either your 

### 17 biomarkers or your clinical measurements are

-- were n't associated with disease but 

### 18 were associate d with reversibility, so as we move on and try to prove which levels 

### 19 which may be preventative in the future, that could be extremely useful , when to 

### 20 remove people from an exposure when a marker is being made during the course of 

### 21 that exposure. 

### 22 **DR. CROWLEY :**  Yes, and absolutely we would very much like to investigate 

### 23 something like that. 

### 24 **MS. WALKER:** Dr. Crowley, this is Debra Walker from the World Trade 

### 25 Center Health Registry . I just had a question. You had mentioned about someone 

### 26 looking at patients who had severe chronic disease, that you were interested in 

### 27 looking at renal disease. Could you mention if you've seen patients who appear to 

### 28 be affected or an association with 9/11 exposure? 

### 29 **DR. CROWLEY:** It's too early to tell. I think it's a question that is definitely 

### 30 ring ing true in several of the investigators now. And I know Dr. Mary McLaughlin at 

### 31 Mount Sinai with her cardiovascular studies in looking at some of the laboratory 

### 32 markers felt like it was something worth investigating but it's too early for us to 

### 33 draw that correlation as of yet, but definitely wo rth investigating. 

### 34 **MS. WALKER:** All right. Thank you. 

### 35 **DR. WARD:** Okay, so if there are no further questions or comments from 

### 36 committee members, I thin k it would be wise to adjourn for our ten

- minu te break 

### 37 so that we can be reassembled and ready for the beginning of the public comment 

### 38 period at 11:30. Paul, do you want people to just leave their lines open? 

### 39

### 39

**DR. MIDDENDORF** : Yes. I think that would be best. 

### 1 **DR. WARD:** Okay. So my computer says it' s 11:15; we'll try to all be back by 

### 2 11:25 to reconvene for the public comment s
. 

### 3 **DR. MIDDENDORF** : Yes, and

-- 

### 4 **DR. HARRISON:** Liz, this is Bob Harrison; before we do that could

-- just 

### 5 moving ahead on the agenda, we're scheduled to take what your lunch brea k is 

### 6 really my breakfast break in a couple

-- in about an hour and a half or something like 

### 7 that? 

### 8 **DR. WARD:** Yes. 

### 9 **DR. MIDDENDORF** : So it would be 12:15 our time which is about in an hour 

### 10 from now. 

### 11 **DR. HARRISON:** About, about an hour from now, okay. 

### 12 **DR. MID DENDORF**  : Yes. So we have probably

-- four public commenters 

### 13 have signed up so we'll probably finish up around noon, and then Liz and the 

### 14 committee can decide whether or not they want to begin discussing the research 

### 15 needs at that point or if they want to just go ahead and break for lunch. 

### 16 **DR. WARD:** Thank you. 

### 17 **DR. MIDDENDORF** : Okay. So we're going to take ten minutes? 

### 18 **DR. WARD:** Yes. 

### 19 **DR. MIDDENDORF** : Okay. 

### 20 ( Meeting recessed from 11:15 to 11:30 a.m. ) 

### 21 **DR. MIDDENDORF** : We are now entering the public commen t port ion of 

### 22 our agenda. Each of our public commenters is signed up on a first

- com e, first



### 23 served basis . Each of them will have up to five minutes to present. I j ust remind 

### 24 everybody that it's surprising how quickly five minutes can go when you're talk ing 

### 25 on a subject of importance to you. So around the four

- minute mark, I'll just let the 

### 26 commenter know that they have one minute remaining to allow them to make their 

### 27 final point. If you haven't finished in five minutes, I'll have to rudely interrupt an d 

### 28 thank you for your comments, and I apologize to anybody that this happens to but 

### 29 we have to be fair to all our presenters and we also need to try and stay on time. 

### 30 I do want to point out that you do have the option of submitting written 

### 31 comments to the docket. The docket number is 24 8

- A. Information on how to 

### 32 submit those comments is on the NIOSH docket web page. 

### 33 The last thing I need to do before beginning the comments is to make sure 

### 34 the commenters are aware of the redaction policy for public commen ts . Tha t policy 

### 35 is in the Federal R egister notice for this meeting. It's on the committee's web page 

### 36 and it's in the material s available for downloading. So the policy outlines what 

### 37 information will be kept , what information will be redacted before it i s posted to the 

### 38 docket. 

### 39

### 40

So with that, I'll ask Dr. Melius, are you available? 

### 1 **UNIDENTIFIED :**  Did you say you have to do a roll call? 

### 2 **DR. MIDDENDORF** : Oh, yes, you're right. I do have to do a roll call, thank 

### 3 you. Let's do a roll

-- a quick roll call. To m Aldrich? 

### 4 **DR. ALDRICH:** Online. 

### 5 **DR. MIDDENDORF** : John Dement? 

### 6 **DR. DEMENT:** On line. 

### 7 **DR. MIDDENDORF** : Kimberly Flynn? 

### 8 **MS. FLYNN:** Online. 

### 9 **DR. MIDDENDORF** : Bob Harrison? 

### 10 **DR. HARRISON:** On line. 

### 11 **DR. MIDDENDORF** : Catherine Hughes? 

### 12 **MS. HUGHES:** ( indiscernible ). 

### 13 **DR. MIDDENDORF** : Steve Markowitz? 

### 14 **DR. MARKOWITZ:** Yeah, I'm here. 

### 15 **DR. MIDDENDORF** : Guil le Mej i a? 

### 16 **MS. ME J**  **I A:**  ( indiscernible ). 

### 17 **DR. MIDDENDORF** : Is that Guille? 

### 18 **MS. ME J**  **I A:**  Yes. 

### 19 **DR. MIDDENDORF** : Okay. Carol North? Carol, are you there? 

### 20 **DR. NORTH:** I'm her e. 

### 21 **DR. MIDDENDORF** : Okay. Julia Quint? 

### 22 **DR. QUINT:** Here. 

### 23 **DR. MIDDENDORF** : Bill Rom? 

### 24 **DR. ROM:** I'm present but I'm also Macintosh so I'm

-- I can only hear and 

### 25 cannot see. 

### 26 **DR. MIDDENDORF** : Okay. What I said earlier is that, for those that are on 

### 27 Mac, when w e have a motion, I will copy it and paste it into an email and send it on 

### 28 so you can see it. 

### 29 **DR. ROM:** Okay. 

### 30 **DR. MIDDENDORF** : Susan Sidel? 

### 31 **MS. SIDEL:** Here. 

### 32 **DR. MIDDENDORF** : Glenn Talaska? 

### 33 **DR. TALASKA:** Here. 

### 34 **DR. MIDDENDORF** : Leo Trasande? Okay, I expect he'll join us in a half an 

### 35 hour or so. Liz Ward? 

### 36 **DR. WARD:** Here. 

### 37 **DR. MIDDENDORF** : And Virginia Weaver? 

### 38 **DR . WEAVER:**  Present. 

### 39

### 41

**DR. MIDDENDORF** : Okay. Has your flight been canceled, just by the way? 

### 1 **DR . WEAVER:**  No, it hasn't, so I'm still hoping. 

### 2 **DR. MI DDENDORF**  : Okay. If you need to leave, just let me know. 

### 3 **DR . WEAVER:**  I will, thank you. 

### 4 **DR. MIDDENDORF** : So I'll ask Jim Melius, are you present? 

### 5 **DR. MELIUS:** I'm present. Can you hear me, Paul? 

### 6 **DR. MIDDENDORF** : Yes, we can hear you. 

### 7 8 **PUBLIC COMMENTS** 

### 9 **DR . MELIUS:**  Okay, good. It's hard to tell. Anyway, I would like to first 

### 10 thank the committee for your

-- certainly for your past efforts. I thought your 

### 11 assistance on the

-- with Dr. Howard on the cancer issues was very, very helpful and 

### 12 I thought came u p with a very good approach to dealing with a pretty difficult issue. 

### 13 So that's most appreciated by myself and many others involved here. 

### 14 I was very involved in developing the legislation that initiated this program, 

### 15 and I wanted to make sure it's clear t hat the research portion of this was probably 

### 16 one of the most difficult parts to get into the legislation. Given all the other federal 

### 17 funding for research, it

-- people were somewhat reluctant to

-- we -- I found an 

### 18 additional pool of research funding, a nd we made the case that it was important for 

### 19 this uni que population that I'm going , you know, medical research be done in a 

### 20 number of different areas and this needed to be supported o ver a period of time. I 

### 21 just think, given that difficulty , it's importa nt that we keep the research focused on 

### 22 the World Trade Center populations, and although it is sometimes tempting to think 

### 23 of some of the other areas where this research is pertinent to and what can be very 

### 24 necessary and important research, really has to b e funded, I think, through other 

### 25
sources
. 

### 26 Secondly, I'd like to particularly thank Dr. Crowley for her presentation. One 

### 27 of the things that disturbed me when I saw the initial agenda for this was there was 

### 28 no formal input from the clinical centers , who ar e the people essentially on the 

### 29 front line dealing with the many thousands of ill World Trade C enter responders and 

### 30 survivors. A lthough some of th os e people were represented on the lead advi sory 

### 31 committee, it seemed to me that there really needed to be fo rmal input on that, 

### 32
a nd I want to thank Laura for doing an excellent job on something that she, I think, 

### 33 only heard about earlier and late last week, early this week in terms of organizing 

### 34 that presentation. 

### 35 I think those items really are the heart of wh at needs to get done in this 

### 36 research, again, probably far too many questions given the amount of funding 

### 37 involved. But still, I think it's very important that we really start to focus on some of 

### 38 those i ssues that will provide the research that will, you know, hopefully yield a 

### 39

### 42

long

- term benefit to those thousands of responders and survivors who are ill. 

### 1 One important area that I've not h eard discussed today is a focus on what 

### 2 other conditions might be emerging in this population, and emerging conditions i s 

### 3 actually included in the legislation for this research. We have lots of data being 

### 4 collected but the research review process tends to make it, I think, difficult for that 

### 5 data to be evaluated and explored in some ways. We have many responde rs and 

### 6 survi vors who are ill who are concerned as to whether the conditions that they're 

### 7 now developing, whether it be kidney disease, autoimmune disease, others, might 

### 8 be related to their World Trade Center exposures and limited funding available 

### 9 through the clinics and to the data centers to evaluate that data. 

### 10 I already talked to Dr. Howard. I think direct funding to the data centers 

### 11 may be appropriate, b ut for doing some of those exploratory work but I also think 

### 12 that the research program may be able to take up so me of that slack , and I would 

### 13 hope that you would, you know, see what could be done within the research 

### 14 program to focus on that. 

### 15 Finally, I would like to echo something that I believe Steve Markowitz said 

### 16 earlier. I think one of the other important areas that I don't think is being addressed 

### 17 in this very important underlying probably ongoing research that has taken place 

### 18 and will take place in this population is a better a ssessment of their exposures. You 

### 19 know, i t's complicated , people did different task s , but I think the tendency is to 

### 20 assume it's too complicated to understand , and I think that's a disservice , given 

### 21 some of the differences in the types of jobs , time people worked there, and I think 

### 22 other factors that could be taken into account in terms of evaluating the long

- term 

### 23 impacts of this exposure and to identify higher risk groups. So I will end there. I 

### 24 think I'm under the five minutes so Paul didn't have to jump in. B ut thank you again 

### 25 for all your work on this. 

### 26 **DR. MIDDENDORF** : Thank you fo r your comments, Dr. Melius. Our next 

### 27 public commenter is Heidi Alexander. 

### 28 **MS. ALEXANDER:** Yes, I'm here. 

### 29 **DR. MIDDENDORF** : Okay. 

### 30 **MS. ALEXANDER:** Can you hear me? 

### 31 **DR. MIDDENDORF** : Yes, we can hear you fine. 

### 32 **MS. ALEXANDER:** Okay, great. First of all I want to thank you for all of your 

### 33 hard work in making the World Trade Center Health Program available, also to 

### 34 present my request , and then I'll give you some background of my situation. 

### 35 I ask that toxic encephalopathy ; that is, toxin induced brain damage, be 

### 36 added as physical injury to the list of illnesses treated by the World Trade Center 

### 37 Health Program . I recently came across a research paper presented by Dr. Grace 

### 38 Ziem, Z

- i

- e - m, at a conference in (indiscern ible) entitled Medical Evaluation 

### 39

### 43

Treatment Pati ent (in discerni ble). 

### 1 (extraneous interference from other participants ) 

### 2 And the treatment protocol for chemical injury, she testifies on her website, 

### 3 chemicalinjuries.net . (more extraneous interference) 

### 4 It's mcsbeaconofhope.com/ziem.html. It's the resea rch paper she 

### 5 presented. And her treatment protocol on her website , chemical injury. net, where 

### 6 she recommends SPECT brain scans to detect the toxic encephalopathy, t he brain 

### 7 damage, and (indiscern ible) for six to ten months as part of her treatment protoco l

. 

### 8 I'm impressed by her findings and I'm also mystified why this has been 

### 9 known for so many years and it's not be en put in place for people in my position. I’ll 

### 10 give you my facts for now. 

### 11 I lived across the street from the World Trade Center and was i n the toxic 

### 12 cloud. My apartment sustained considerable damage and contamination from the 

### 13 dust and smoke that infiltrated the entire area at the time of the tower s ’ collapse 

### 14 and for months afterward . The office where I worked is also a few blocks away, on 

### 15 Broad Street . I was a self

- employed computer programmer/technology consultant 

### 16 from 1985 up until the end of 2001. I was standing on the 14 th floor terrace of my 

### 17 building whe re I live d on Albany Street and South End Avenue. That's catty

- corner 

### 18 to the Tr ade Center site when the south tower imploded, and was blasted by a gust 

### 19 of vapor, and then immediately afterwards completely covered by the dust, and 

### 20 inhaled a significant amount of black ened air. 

### 21 I was in that environment for several hours until evacua ted by tug to Jersey 

### 22 City. I was very nauseous and ha d a severe headache at the time, and I went to a 

### 23 ( indiscernible ) house in New Jersey and I had difficulty breathing and burning lungs. 

### 24 I was taken to the emergency room at the local hospital and had c hest 

### 25
x - rays and was told to see a pulmonary specialist. Days later welts appeared on my 

### 26 face, arms and legs and skin that was exposed to the dust . I tried to continue 

### 27 working for my clients at the time but was so sick that I could no longer neglect the 

### 28 h ealth issues that developed. 

### 29 What I ingested from the dust and what was in the air that day circulated 

### 30 through my body causing extreme fatigue and affected various bodily functions for 

### 31 periods of time at random: the field of vision in both eyes went com pletely black 

### 32 only to return a few minutes later. Another time I lost h earing for several hours. I 

### 33 had difficulty breathing . M y brain function slowed down to the point where 

### 34 everyday tasks appeared as a slow

- moving slide show where I could see each step of 

### 35
a process , neglecting to perform the most important steps. 

### 36 This condition worsened over the next few years. I eventually lost the 

### 37 ability to speak full sentences so that I couldn't think of words. For a time I lost 

### 38 coordination of my hands. This b ecame evident when I tried to dial a phone where 

### 39

### 44

the phone number was in mind but I wasn't able to touch the corresponding 

### 1 number on the keypad. Another time the lymph nodes in my groin area grew to the 

### 2 size of golf balls. 

### 3 ( e xtraneous interference) 

### 4 S orry? 

### 5 **DR. MIDDENDORF** : Excuse me, would everybody except Ms. Alexander put 

### 6 your phones on mute, please? Thank you. 

### 7 **MS. ALEXANDER:** In 2005, I developed a chronic sore throat and 

### 8 hoarseness caus ed by a condition diagnosed as silent acid reflux which I cont inue to 

### 9 experience to date . After five to six years of following a self

- prescribed detoxifying 

### 10 practice, my brain function improved but not to the level I had prior 9/11. T o date I 

### 11 have persistent thinking problems and poor thought retention where I stru ggle to 

### 12 keep more than one concept in mind at a time. I also found that I have difficulty 

### 13 learning new things which wa s never something I had trouble with as an ardent 

### 14 technology professional. 

### 15 I have difficulty performing procedural tasks ; that is, anyt hing requir ing a 

### 16 systematic approach. My thoughts become disorganized , leaving me unable to 

### 17 perform the task correctly, requiring several attempts, especially when the process 

### 18 requir es the use of my hands. 

### 19 This is completely disabling for a computer progr ammer with a brain as a 

### 20 tool of the profession. I would like to rehabilitate th is part of my brain so that I can 

### 21 work again. I haven't been able to do so since 2001. 

### 22 I found out about this protocol online just last week. I stumbled across t he 

### 23 term tox ic encephalopathy. I looked it up and ran across Dr. Ziem's research paper, 

### 24 and am mystified why this isn't being implemented . This has been out there for 

### 25 years and you people are going about this as if this is all new and unfounded

. This is 

### 26 not new and t here are treatment protocols in place. 

### 27 I can't wait for your research to be gathered and analyzed. I'm sick now; I 

### 28 need help now. And then so I would like to add this toxic encephalopathy as 

### 29 physical damage. This is not post

- traumatic stress disorde r. This is quite physical. I 

### 30 had an MRI early on in 2003, and it showed that there was a

-- 

### 31 ( e xtraneous interference) 

### 32 **MS. ALEXANDER:**

-- ( indiscernible ) on the left side of my brain. 

### 33 **UNKNOWN SPEAKER:** This is a s moker, right? 

### 34 **MS. ALEXANDER:** I'm not a smoker. I was in good health before 9/11. I was 

### 35 a jogger, very active. Afterwards I can no longer jog. I can no longer exert myself 

### 36 because I can't breathe, all right? So that part I'm ( indiscernible ) just by avoiding 

### 37 those things. The brain damag e I need help with. I can't find anyone who knows 

### 38 how to treat this sort of thing. Dr. Ziem's paper and her protocol is the closest thing 

### 39

### 45

I'm finding to something that could be beneficial, and I urge you to take a good look 

### 1 at it and implement that as pa rt of the program. Thank you. 

### 2 **DR. MIDDENDORF** : Thank you very much, Ms. Alexander. 

### 3 **UNKNOWN SPEAKER:** I, I didn't have that calcium test. T hat would have 

### 4 been a standard, right? 

### 5 **DR. MIDDENDORF** : Excuse me, who is that speaking? Who is that 

### 6 speaking? Dur ing the public comment session, the only people who should be 

### 7 speaking are the public commenters themselves. Everyone else should be

-- have 

### 8 their phone muted. Thank you. 

### 9 Our next speaker is Mary Perillo. Mary, are you available? 

### 10 **MS. PERILLO:** Yes, I am . I'm he r e
. 

### 11 **DR. MIDDENDORF** : Okay, great. 

### 12 **MS. PERILLO:** Okay. My name is Mary Perillo. I just want to check that 

### 13 everyone can hear me? 

### 14 **DR. MIDDENDORF** : Yeah. 

### 15 **MS. PERILLO:** Okay. My name is Mary Perillo and I am a 9/11

- affected 

### 16 lower Manhattan resident. I'm reading comments by the WTC Health Program 

### 17 Survivor Steering Committee of which I'm a member. 

### 18 (extraneous interference) 

### 19 **MS. PERILLO:** Excuse me? 

### 20 **DR. MIDDENDORF** : Who is that speaking? Operator, could you find out 

### 21 who that is that's breaking in? 

### 22 **THE OPERATOR:** Absolutely. 

### 23 **DR. MIDDENDORF** : Thank you. 

### 24 **MS. PERILLO:** Okay. The Survivor Steering Committee is presently 

### 25 comprised of representatives of Manhattan Community Boards 1, 2 and 3, and a 

### 26 range of community, labor, environmental groups advocatin g on behalf of 

### 27 9/11

- affected individuals as well as residents, students and area workers. There's a 

### 28 wide range of knowledge gaps with respect to the science, biology and treat ment of 

### 29 WTC

- related illnesses. T herefore, NIOSH should approach closing these g aps by 

### 30 supporting a diverse portfolio of studies at different levels of funding including pilot 

### 31 studies, in

- depth clinical studies, studies of disease mechanism and epidemiological 

### 32 studies. 

### 33 It i s especially important that the STAC recognize that input from the WTC 

### 34 Centers of Excellence is critical to developing the World Trade Center Health 

### 35 Program 's research agenda since clinicians are likely to have the best sense of which 

### 36 conditions may be emerging as well as crucial perspectives on resolving diagnostic 

### 37 treatment and uncertainty. 

### 38 The SSC has a number of recommendations regarding the World Trade 

### 39

### 46

Center Health Program research priorities for the survival population. 

### 1 Given the increase

-- given children's increased susceptibility to harm, 

### 2 especially in cri tical periods of development, it is imperative that NIOSH continue to 

### 3 support

-- continue its support for research into 9/11 physical and ment al health 

### 4 impacts to those who we re exposed to the disaster a s childr en. Most important 

### 5 would be in

- depth studies of respiratory, developmental and endocrine health 

### 6 impacts, and studies that explore avenues for early identification and intervention. 

### 7 This cohort is rapidly disper sing so we urge NIOSH to double down on its support for 

### 8 pediatric studies now. 

### 9 Two, NIOSH should support longitudinal clinical research into the long

- term 

### 10 9/11 physical and mental health impacts for survivors as well as long

- term studies 

### 11 that explore the progression of the disease and treatment efficacy. 

### 12 Because of the known difficulties of performing epidemiologic studies on 

### 13 small populations with ongoing treatment, we would like to suggest that alternative 

### 14 approaches, studying cancer in diverse survivor populations be explored. Possible 

### 15 approaches include nested studies as well as a case s eries approach to 

### 16 understanding the possible role of exposures, differences in presentation and the 

### 17 effects of comorbid conditions or additional risks. 

### 18 Four, we recommend that blood samples be collected from WTC exposed 

### 19 survivors including those who were c hildren at the time of 9/11. Samples should be 

### 20 banked for later analysis including the freezing of live cells from which DNA, RNA 

### 21 and proteins can be recovered. We anticipate that these samples will provide useful 

### 22 in at least three ways: As potential so urce of long

- lived biomarkers of exposure to 

### 23 WTC toxins , useful in analyzing exposure

- related health conditions in this 

### 24 population ; a s a source of protein markers of disease with potential use in 

### 25 diagnosing and understanding WTC

- related disease; as a sourc e of genetic material, 

### 26 which can be analyzed for evidence of enduring genetic and epi gen et ic alterations 

### 27 relevant to disease that may be still detected many years after exposure. 

### 28 Five, because so little is known with respect to inflammation and other 

### 29 under lying mechanisms for WTC illnesses such as sarcoidosis , cancer and even 

### 30 asthma , i t is critical that NIOSH support studies of underlying disease mechanisms. 

### 31 This would include both physical and mental health disorders with potential final 

### 32 common pathways. Again, this research provides for building blocks, for more 

### 33 effective treatments and early intervention, excuse me. 

### 34 I would cite one final research need. The SSC believes that it is essential 

### 35 that NIOSH support research into the physical and mental healt h impacts to people 

### 36 exposed between Houston and 14 th Street s . This population had been eligible for 

### 37 treatment at the WTC E HC prior to th e passage of the Zadroga Act. 

### 38 EHC clinicians observed the same physical and mental health conditions in 

### 39

### 47

those who liv ed, worked or attended school in this geographic area as well as those 

### 1 in the current Zadroga cat chment

. 

### 2 We refer you to our written comments for the complete list. The SSC is 

### 3 grateful for this opportunity to provide comments and appreciates STAC's 

### 4
cons ideration. Thank you. 

### 5 **DR. MIDDENDORF** : Thank you, Ms. Perillo. Our next public commenter is 

### 6 Lila Nordstrom. 

### 7 **MS. NORDSTROM:** Hi. Can you hear me? 

### 8 **DR. MIDDENDORF** : Yes, you're coming through well. 

### 9 **MS. NORDSTROM:** Great. Thanks so much. So I'm Lila Nords trom. I run 

### 10 StuyHealth which is an organization that represents students who were impacted by 

### 11 9/11 and the 9/11 clean

- up. 

### 12 And I wanted to specifically urge NIOSH to fund studies of people that were 

### 13 exposed as children , like the people in my group and, y ou know, a lot of the children 

### 14 of survivors who lived in the area. We, you know, we don't really have a lot of 

### 15 information on what kinds of health issues are coming down the pike for people in 

### 16 our situation but we're going to be living with these health c onditions for a really 

### 17 long time. And to be

-- I think it's important that we

-- that NIOSH start to fund 

### 18 studies that are going to help us identify, you know, what the early

-- help us 

### 19 identify early what the health impacts are going to be on people in o ur -- of our 

### 20 generation, at Stuyvesa nt, specifically. 

### 21 Y ou know, we weren't even residents in the neighborhood but we

-- we 

### 22 returned to school on October 9 th when fires were still burning all around us, that 

### 23 barge that they took the debris to from the Wor ld Trade Center site was right next 

### 24 to our school building, and ther e were like more t han 200 truck loads a day of debris 

### 25 that came by. They weren't watered down or anything because it was too cold. 

### 26 Our vent system wasn't cleaned. It was used

-- you kno w, the school 

### 27 building was used as a center of

-- sorry, as a first responder base during the early 

### 28 days of the clean

- up. And so we, you know, were promised when we returned that 

### 29 there would be, you know, that the school would be adequately cleaned but it 

### 30 wasn't. The vents were still filled with 9/11 debris, the carpets in the theater were 

### 31 not taken up or anything like that. 

### 32 So we faced a sort of unique exposure but at a uniquely vulnerable time in 

### 33 our lives , and we're not the only school in the neighbo rhood that had a similar 

### 34 experience and, you know, specifically kids that lived in the neighborhood were 

### 35 down there a lot earlier than we were as well. 

### 36 But we, you know, we are trying to keep track of the health conditions that 

### 37 people in our group are fa cing. We've already received word of a number of 

### 38 unusual cancers and very high rates of conditions that people in their early 20s 

### 39

### 48

shouldn't really be facing, like very serious respiratory and acid reflux conditions and 

### 1 things like that. 

### 2 And so we, you k now, as people that are going to have to live with these 

### 3 conditions for, really, longer than any of the other survivors because

-- or, you 

### 4 know, hopefully longer than any of the other survivors. It, you know, we're sort of 

### 5 in a unique position where we ca n look at what these conditions are going to be, 

### 6 you know, and catch them early because we were exposed so early. 

### 7 So I want to ask that NIOSH start to, you know, look specifically at funding 

### 8 studies that focus on young people that were exposed as childre n. I understand 

### 9 there's already a study going on where something like 250 kids are being compared 

### 10 to a control group, and a study like that should really be expanded pretty rapidly 

### 11 because there were young people in a lot of different situations that were brought 

### 12 down to lower Manhattan after 9/11 for various reasons. I mean, there were four 

### 13 schools on our corner so it was a very student

- heavy population. There were 

### 14 obviously kids that liv ed in the neighborhood. So I just want to urge NIOSH to 

### 15 consider focusing on

-- or finding some focus for studies that focus on young adults 

### 16 that were exposed as children. 

### 17 That's all I n eeded to say, if you want to give the time to

-- 

### 18 **DR. MIDDENDORF** : Okay. Thank you very much, Ms. Nordstrom. 

### 19 **MS. NORDSTROM:** Okay. 

### 20 **DR. MIDDENDORF**  : I want to apologize to the public commenters. Early on 

### 21 in the process it sounded like somebody was breaking in to the line; I'm not sure 

### 22 who it was but I think our operator has been able to correct that for us. But I do 

### 23 apologize for that. 

### 24 L iz, I'll turn it over to you. Where do you want to go from here? 

### 25 **DR. WARD:** Well, we have a scheduled lunch break at 12:15. You know, I 

### 26 would suggest that we might want to talk about how we're going to approach the 

### 27 discussion of the research needs. I wo uld think that it might be good to think about 

### 28 them in each of the areas that Dr. Howard suggested we group them under and kind 

### 29 of get a list of the main ideas that committee members would like to advance 

### 30 before we actually go to the motions stage. 

### 31 I also wanted to say to the committee that we don't necessarily have a 

### 32 mandate to prioritize the suggested topics, you know, one by one. We can group 

### 33 them into grouping high, medium and low priority. And one question of 

### 34 clarification, Paul, when Dr. Howard aske d us to prioritize , did he basically ask us to 

### 35 prioritize across all of the four categories or within each category? 

### 36 **DR. MIDDENDORF** : He didn't specify. I think you could do it either way. I 

### 37 think it would be a little more helpful if you would categorize or group them into the 

### 38 high

- low

-- or high, medium, low, despite which category or type of research that 

### 39

### 49

they might interact. 

### 1 **DR. WARD:** Okay. So do the people on th e committee feel that it would b e 

### 2 helpful to try to first discuss these within each categ ory and get the major ideas 

### 3 down befo re we try to prioritize them o r does anyo ne have a suggestion for another 

### 4 way to approach the discussion? Okay, well , I would suggest that we proceed that 

### 5 way, then, and Paul, do you think it's reasonable that we break for lunch now and 

### 6 reconvene in 45 minutes? 

### 7 **DR. MIDDENDORF** : I think that would be fine. 

### 8 **DR. WARD:** Okay. So my clock has basically 11:59 or noon, so we'll plan on 

### 9 reconvening at 12:45. 

### 10 **DR. MIDDENDORF** : Okay. I will put that information up on the web so 

### 11 everybody can see it. 

### 12 **DR. WARD:** Thank you all. I look forwa rd to talking again at 12:45. 

### 13 ( Lunch recess from 12:00 to 12:45 p.m.) 

### 14 15 **DR. MIDDENDORF** : I think it’s time for us to get going again. We’ll start 

### 16 with the roll call. Tom Aldrich? 

### 17 **DR. ALDRICH:** I’ m here. 

### 18 **DR. MIDDENDORF** : Okay. John Dement? 

### 19 **DR. DEMENT:** Here. 

### 20 **DR. MIDDENDORF** : Kimberly Flynn? 

### 21 **MS. FLYNN:** Here. 

### 22 **DR. MIDDENDORF** : Bob Harrison? Bob back from his breakfast break? 

### 23 We’ll circle back for Bob. 

### 24 Catherine Hughes? 

### 25 (no response) 

### 26 **DR. MIDDENDORF** : Steve Markowitz? 

### 27 **DR. MARKOWITZ:** I’m here. 

### 28 **DR. MIDDENDORF** : Guille Mejia? 

### 29 **MS. MEJIA:** I’m here. 

### 30 **DR. MIDDENDORF** : Guille, am I pronouncing your name close to accurate? 

### 31 **MS. MEJIA** : It’s pretty close. 

### 32 **DR. MIDDENDORF** : Okay. Some day you’ll have to give me lessons on that. 

### 33 **MS. MEJIA** : Will do. 

### 34 **DR. MIDDENDORF** : Carol North? 

### 35 (no response) 

### 36 **DR. MIDDENDORF** : Julia Quint? 

### 37 (no response) 

### 38 **DR. MIDDENDORF** : Okay, well we’re missing a few people. I think we need 

### 39

### 50

to wait a few more minutes before

-- 

### 1 **DR. HARRISON:** P aul, did you hear that Bob Harrison is here? 

### 2 **DR. MIDDENDORF** : No, I didn’t. 

### 3 **DR. HARRISON:** Okay, I’m here. 

### 4 **DR. MIDDENDORF** : Okay. Back to Catherine Hughes? Carol North? 

### 5 (no response) 

### 6 **DR. MIDDENDORF** : I think we’re about 50 percent here. Let’s give it 

### 7 another minute or two and I’ll start all over again. 

### 8 I’m hearing a lot of noise, possibly from a printer in the background, from 

### 9 somebody. If somebody is typing and has something on in the background, so 

### 10 please mute if you’re not speaking. 

### 11 (paus e) 

### 12 **DR. MIDDENDORF** : Okay, let’s try this one more time. Tom Aldrich? 

### 13 **DR. ALDRICH:** I’m here. 

### 14 **DR. MIDDENDORF** : Okay. John Dement? 

### 15 **DR. DEMENT:** I’m here. 

### 16 **DR. MIDDENDORF** : Kimberly Flynn? 

### 17 **MS. FLYNN:** Here. 

### 18 **DR. MIDDENDORF** : Bob Harrison? 

### 19 **DR. HARRISON:** Bob ’s here. 

### 20 **DR. MIDDENDORF:** Catherine Hughes? 

### 21 (no response) 

### 22 **DR. MIDDENDORF** : Still not back. Steve Markowitz? 

### 23 **DR. MARKOWITZ:** Still here. 

### 24 **DR. MIDDENDORF** : Guille Mejia? 

### 25 **MS. MEJIA:** I’m here. 

### 26 **DR. MIDDENDORF** : Carol North? 

### 27 **DR. NORTH:** I’m back on now. 

### 28 **DR. MID DENDORF**  : Okay. Julia Quint? 

### 29 (no response) 

### 30 **DR. MIDDENDORF** : Bill Rom? 

### 31 (no response) 

### 32 **DR. MIDDENDORF:** Susan Sidel? 

### 33 **MS. SIDEL:** Here. 

### 34 **DR. MIDDENDORF:** Glenn Talaska? 

### 35 (no response) 

### 36 **DR. MIDDENDORF** : Leo Trasande? 

### 37 (no response) 

### 38 **DR. MIDDENDORF** : Liz W ard? 

### 39

### 51

**DR . WARD:**  Here. 

### 1 **DR. MIDDENDORF** : Virginia I think was leaving. Two, three, four, five, six, 

### 2 seven, eight. We only have nine; we don’t have a quorum yet. 

### 3 **DR. TALASKA:** Did you hear me? This is Glenn. 

### 4 **DR. MIDDENDORF** : Glenn, no, I did not hear you. 

### 5 **DR. TAL ASKA:**  Oh, okay, no, I’m here. 

### 6 **DR. MIDDENDORF** : Okay, that’s one, two, three, four, five, six, seven, eight, 

### 7 nine, ten. We have ten, Liz; we can proceed. 

### 8 9 **DISCUSSION OF RESEARCH NEEDS AND** 

### 10 **DEVELOPMENT OF RECOMMENDATIONS** 

### 11 **DR. WARD:** Okay, great. So as we d iscussed before lunch, I think what we'd 

### 12 like to do is get the major suggestions down under each of the four areas that 

### 13 Dr. Howard proposed we discuss. And under the first item, which is to identify critical 

### 14 research gaps relative to our understanding of the effects of exposure, I think we 

### 15 should also include suggestions related to characterizing the exposure because that is 

### 16 ( indiscernible due to extraneous input ). 

### 17 We are starting to hear some feedback from someone. We're having the same 

### 18 problem we had before. So Paul, could you ask the operator to check on that? 

### 19 **DR. MIDDENDORF:** Yes, I will. 

### 20 **MS. FLYNN:** Liz? 

### 21 **DR. WARD:** Yes. 

### 22 **MS. FLYNN:** This is, this is Kimberly. I don't know whether or not Dr. Crowley is 

### 23 back on the call but just speaking for myself, I would really benefit from an outline of 

### 24 some of the studies, you know, the, the kind of research needs and approaches that 

### 25 were not part of her PowerPoint presentation text but that she elaborated in her 

### 26 presentation. Would it be possible to request tha t? 

### 27 The other point that I think we could benefit from hearing her elaborate more 

### 28 fully is the need for research resources to do analysis of all of the data pouring into the 

### 29 responder and survivor data centers. 

### 30 **DR. WARD:** So, Paul, what's the situation wi th Dr. Crowley? Are you trying to 

### 31 reach her to see if she can rejoin us? 

### 32 **DR. MIDDENDORF:** I sent her an email. We had asked some speakers to stick 

### 33 around and join us in the afternoon, if it's at all possible, in case there were additional 

### 34 ques tions. Dr. Crowley, are you online? Are you available? 

### 35 **DR. ROM:** Dr. Rom just joined. 

### 36 **DR. MIDDENDORF:** Okay. Thank you. 

### 37 I'll ask again. Dr. Crowley, are you available? Okay, Kimberly, I think what we 

### 38 can do is we can ask again in a few minutes. 

### 39

### 52

**MS. FLYNN:** Sur e. Thank you very much. 

### 1 **DR. MIDDENDORF:** Okay. 

### 2 **DR. WARD:** I did try to take notes on Dr. Crowley's recommendations, and it's 

### 3 possible that, maybe between me and Ray, we could

-- or me, Ray and Paul and 

### 4 whoever else, we could at least try to capture some o f her major recommendations, if 

### 5 that would be helpful, and I think she did kind of divide them into the different areas 

### 6 that Dr. Howard mentioned. Maybe not; I don't know. But anyway, so the two things 

### 7 she

-- I mean, if it's agreeable I can kind of read through them, and then, Paul, are you 

### 8 going to be able to put them on the screen? 

### 9 **DR. MIDDENDORF:** Yeah, I will try to. 

### 10 **DR. WARD:** Okay. So the first thing she mentioned was im pact on DNA and 

### 11 gene expression . The second thing she mentioned was the increa sed occurrence of 

### 12 sarcoidosis and hematologic malignancies, and whether that

-- those both reflected a 

### 13 relationship of the World Trade Center exposures to immune system disorders and 

### 14 potential research looking at those mechanisms. 

### 15 She then, in her next s ection, talked about a more general assessment of 

### 16 overall health status and impact of World Trade Center exposures on occupational 

### 17 experience, income, economic and social well

- being as a separate topic. 

### 18 She mentioned the specific topic, which dovetails w ith one of our public 

### 19 presenters, on “ has exposure impact ed cognition ”?

. 

### 20 She mentioned a topic of examining patient characteristics that maximize the 

### 21 potential benefit of psychotherapeutic interventions. If I got any of these wrong, 

### 22 especially outside my subject matter or expertise, please correct them. 

### 23 **MS. SIDEL:** Liz, what does that last one mean? 

### 24 **DR. WARD:** I can tell you what I'm interpreting it to me an, but maybe one of 

### 25 our more psychologically experienced people could say it better. What I'm assu ming it 

### 26 to mean a r e what are the resulting characteristics of patients who seem to benefit 

### 27 most from known interventions. But it could easily be rephrased or broadened in 

### 28 different ways, and specifically related to what are the interventions that have bee n 

### 29 employed and how effective are they and what populations do they seem to work best 

### 30 in. So that one could definitely probably use a little bit of, you know, discussion and

-- 

### 31 **MS. SIDEL:** Right. 

### 32 **DR. WARD:** But that's how I interpreted it. 

### 33 And then the n ext one relates to how to better use data resources to

-- for 

### 34 surveillance of health conditions related to the health centers, and then I think that 

### 35 specifically referred to the data resource centers at the World Trade Center program 

### 36 site. 

### 37 I think there was -- the next topic I wrote down is pretty general, and she may 

### 38 have been more specific, but just was the whole question of understanding the 

### 39

### 53

progression of disease. I guess that also would relate to whether it progresses or 

### 1 whether it actually improves over time. 

### 2 So the next one, as I interpreted it, and this could be a little off, is looking at the 

### 3
me dical and psychological sequelae of exposure among the more impaired individuals. 

### 4 The next one is looking at the impact of renal disease in responders with 

### 5 multiple co

- morbidities. 

### 6 And then the next one, which may be related to one of the previous ones, 

### 7 characterize individuals with significant health impairment. 

### 8 **MS. SIDEL:** I'm sorry, characterize? 

### 9 **DR. WARD:** Characterize individuals with significant health impairment. But I 

### 10 don't think that

-- I don't think it really means characterize individuals but I guess it's 

### 11 more of a descriptive study to

-- of populations with significant health impairment. 

### 12 That could be clinical; it could be exposure stat us ; it could be specific demographic; it 

### 13 could be a lot of

-- kind of focus on the more impaired individuals and try to understand 

### 14 better who they are and what their needs are would be how I interpreted that. 

### 15 **MS. SIDEL:**  Okay. 

### 16 **DR. WARD:** Specific questio n, which could be applied in a lot of the

-- a lot of 

### 17 areas: Did early intervention make a difference in outcome? And there may be some 

### 18 specific areas where we would think that that would be most appropriate. There was a 

### 19 mention of a need for research to identify new conditions that may be arising in the 

### 20 population. Several people mentioned, including Dr. Crowley, the need for better 

### 21 exposure assessment or more exposure assessment studies . That was all

-- those were 

### 22 my notes from Dr. Crowley's presentati on. 

### 23 **MS. FLYNN:** Thank you very much, Liz. This is Kimberly. Your notes are better 

### 24 than mine; I really appreciate it. I do want to add in to this list that Dr. Crowley also 

### 25 mentioned research into the im pacts, the health impacts to vulnerable populations 

### 26 such as children. 

### 27 **DR. WARD:** So Paul, there ’s a -- I'm in a little bit of a pause because I was 

### 28 looking at my notes, and now I'm trying to get back into the website so that I can look 

### 29 at what you're typing. 

### 30 **DR. MIDDENDORF:** I'm sorry. I had mine on mute. 

### 31 **DR. WARD:** That's okay. No, no, I'm saying I'm trying to get back in

-- I 

### 32 somehow have lost the website where we can look at the documents you're looking at, 

### 33 so I have to find it again. 

### 34 **DR. MIDDENDORF:** Does everybody else, who is into the meeting, actua lly see 

### 35 where I've been typing? 

### 36 **DR. ALDRICH:** Yeah, I see it

. 

### 37 **DR. MIDDENDORF:** Okay. And a quick question for Catherine. Are you able to 

### 38 speak into the meeting now? I'm not hearing you so I'm assuming that you're not able 

### 39

### 54

to speak into the meeting. I n eed to check on that again. 

### 1 **DR. WARD:** So is everyone now able to see Paul's notes either through the 

### 2 website or through an email that Paul just sent? 

### 3 **MS. SIDEL:** Yes. Thank you, Paul. 

### 4 **MS. MEJIA :**  Thank you, Paul. 

### 5 **DR. WARD:** So Paul, if you would then add to that research on health impacts 

### 6 on vulnerable populations? 

### 7 **DR. MIDDENDORF:** I'm sorry, say that again? 

### 8 **DR. WARD:** A point that was just made on research on health impacts in 

### 9 vulnerable populations. 

### 10 **DR. ALDRICH:** This is Tom Aldrich. I wonder if I coul d mention another area? 

### 11 **DR. WARD:** Sure. That's, I think, what we should do now is look at the

-- you 

### 12 know, kind of add to the list and make s ure that

-- and keep

-- yeah, add to the list until 

### 13 we've gotten all of the major topics covered, and then go thr ough and try to refine and 

### 14 combine. So go ahead, Tom. 

### 15 **DR. ALDRICH:** Okay, well, I'm impressed with the

-- there's three large cancer 

### 16 studies have remarkably similar results. Not everything

-- not all the cancers have 

### 17 statistically significant increases b ut each of the three large studies showed significant 

### 18 increases over expected in at least some cancers. And all of them were only up to 

### 19 seven years post

- 9/11. 

### 20 And I think in general we believe that cancer latency averages longer than that, 

### 21 something in the range of 20 years, so what we may be seeing is a leading tail of a 

### 22 bell

- shaped curve. And if that's the case, then we're in for very large increases in 

### 23 cancer in the future. That may or may not be true but we should be thinking about that 

### 24 possibility

. 

### 25 And so I think that it's reasonable to expect, because of the inhalational route 

### 26 of exposure for most of these toxins, that head and neck, lung, esophageal cancers 

### 27 might be

-- might emerge next. And those of course are extremely deadly and hard to 

### 28 tre at, so early diagnosis is really important. 

### 29 I think we should solicit proposals to evaluate biomarkers or other early 

### 30 detection techniques to detect free cancerous lesions or early cancers in order to treat 

### 31 them when they're potentially curable. 

### 32 **MS. HUGH ES:**  That sounds really good. Catherine here. Can you hear me yet? 

### 33 **DR. MIDDENDORF:** Yes, we can hear you now. 

### 34 **MS. HUGHES:** Great. I liked the last comment. Thank you. 

### 35 **DR. ROM:** I might add to Tom Aldrich's recommendation for biomarkers for 

### 36 early cancer detection. NIOSH could actually interact with NCI, who has a program on 

### 37 early

-- called the early detection research network that funds about 35 PIs around the 

### 38 country for studying biomarkers in high

- risk populations for early detection of lung 

### 39

### 55

cancer, p rostate cancer, GI or women's cancer. And that program is very collaborative 

### 1 and would probably be interested in the WTC registry. So that's a second for 

### 2 biomarkers for early detection of cancer recommendation. 

### 3 I would add to that

-- this is Bill Rom s peaking

-- that it would be very nice to 

### 4 develop biomarkers for asthma since we've gone from about 9 or 10 percent at 

### 5 baseline up to 27 percent in the Lancet article that Dr. Crowley cited, that there must 

### 6 be markers spilling over into the blood or other s ources that could be looked at to 

### 7 correlate to these symptoms and meet the physic al findings. And it may help u s 

### 8 understand the etiology of asthma. 

### 9 And I might add to that that microbio me might have something to do with that, 

### 10 and we haven't even discuss ed microbio me , but that might be something that's altered 

### 11 by World Trade Center dust and the GERD, asthma and sinusitis populations. And I'm 

### 12 not sure we've had any applications to look at that, but that might be another altered 

### 13 background setting that pre disposes to these illnesses. 

### 14 **DR. WARD:** That's great, and thank you. And I just wanted to interject a 

### 15 procedural thing

-- this is Liz again

-- that, as each of the speakers talks, I'm assuming 

### 16 that you're going to double

- check what

-- how Paul has capture d your suggestions and 

### 17 make sure that they're

-- I think Paul's doing a great job of condensing them, but make 

### 18 sure that they are captured accurately and that all the points are captured. 

### 19 **DR. MIDDENDORF:** Yeah, I'm going to have to circle back with some of the 

### 20 folks, like Bill Rom, who I

-- is not able to get into the website. So I'm going to have to 

### 21 email this out real quick. 

### 22 **DR. WARD:** Okay, yeah, it is helpful for those who can to follow along on the 

### 23 website. I just

-- I somehow had gotten myself out o f it but got myself back into it, and 

### 24 so it's really helpful to follow along the suggestions. 

### 25 So would anyone else like to add something to the list? I think Paul is sending it 

### 26 out again. 

### 27 **MS. SIDEL:** I would. I'd like to add something to the list. It' s Susan Sidel. 

### 28 **DR. WARD:** Okay. 

### 29 **MS. SIDEL:** Something that I think Dr. Melius mentioned earlier and that I've 

### 30 raised a few times is autoimmune diseases. There has been, I think, very little research 

### 31 on autoimmune diseases, and it's interesting because I

- - I mean, obviously I'm not a 

### 32 doctor but I do know that it's accepted among hematologists that environmental toxins 

### 33 cause some autoimmune diseases or if you have a genetic predisposition to it, it'll make 

### 34 the autoimmune disease, you know, happen when it ma y not have otherwise, if you are 

### 35 exposed to something. 

### 36 Now, and this is something that would have been interesting to ask 

### 37 Dr. Crowley. I wonder if part of the reason why something like autoimmune diseases 

### 38 are not covered is because the kind of doctors t hat would study it, I think, would be a 

### 39

### 56

rheumatologist, and there aren't any rheumatologists that are involved in the program. 

### 1 I mean, that's not the kind of doctor s that we have. And if tha t's the reason why, then 

### 2 do we reach out , you know, to specialis ts? I mean, how does that work? So it's like a 

### 3 two

- part question because, I think it

-- 

### 4 **DR. ALDRICH:** Tom Aldrich. 

### 5 **MS. SIDEL:** I'm sorry, what? 

### 6 **DR. ALDRICH:** I would just mention that one of the funded research projects is 

### 7 specifically to look at inciden ce of autoimmune diseases, and one of the cohorts 

### 8 relative to that would be expected in the population. So it's being addressed at least in 

### 9
one area . I thi n k I saw something about rheumatoid arthritis in another study also. 

### 10 **DR. WARD:** And who wa s speakin g just then? 

### 11 **DR. ALDRICH:** I beg your pardon, Tom Aldrich. 

### 12 **MS. SIDEL:** Right, but the document that , you know, well, I mean, that's really 

### 13 good but is that enough? Because I mean, there was something that I was reading 

### 14 about asbestos out in Libby, Montana and how

-- it's Montana

-- and how exposure to 

### 15 asbestos, they're seeing a lot of lupus, which is usually something that affects women, 

### 16 you know, that are of child

- bearing ages, and it's happening in a lot of men that are in 

### 17 their 40s. So I mean, it's jus t something that's a really broad subject, and the whole 

### 18 inflammation

- cancer connection from the

-- you know, from the fire department 

### 19 article, I just think that it's something that really needs to be looked into. 

### 20 And also I have to say that, because I h ave one and I've just been fighting for it 

### 21 for years, a nd there's so much resistance at the program to even considering that what 

### 22 was going on with me could possibly have anything to do with my exposure. And, you 

### 23 know, it wasn't until I got a specialist i nvolved to definitely say that it was, you know, 

### 24 before I could take that information back to the

-- you know, back to the program and 

### 25 have it be taken seriously. 

### 26 **DR. WARD:** So

-- 

### 27 **MS. SIDEL:** So. 

### 28 **DR. WARD:** Yeah, I think one thing we could do is, as we get the new 

### 29 suggestions in, is see if they really fit

-- if they dovetail well with something that's 

### 30 already on the list. So I would say that this autoimmune diseases, we could combine 

### 31 that with the second suggestion on the list, to look at sarcoidosis and m alignancy. But 

### 32 maybe the broader topic is immune system disorders, and that would include 

### 33 autoimmune diseases, malignancy

-- 

### 34 **MS. SIDEL:** Oh, that’s a good idea

. 

### 35 **DR. WARD:** Yeah. 

### 36 **MS. SIDEL:** The other thing that to me, you know, talking with my doctor, 

### 37 esp ecially since that woman was talking about it earlier, but a lot of people

-- I've 

### 38 known a lot of people that have cognitive issues in the program, and it's usually 

### 39

### 57

t hought , you know, the doctors will say, well, it's because of PTSD. And it isn't. It's

- - 

### 1 something definitely happens to your brain from exposure to toxins. And I thought 

### 2 that that's something that would be really interesting to look into as well as the fact 

### 3 that we're not using EMDR to treat post

- traumatic stress disorder. I mean, it's li ke 

### 4 there's so many

-- there are so ma ny techniques to deal with post

- traumatic stress 

### 5 disorder and we're using, you know, like old

- fashioned psychotherapy when there 

### 6
are -- 

### 7 **DR. ALDRICH:** What is EMDR? 

### 8 **MS. SIDEL:** I forget exactly what it stands for but, yo u know, you sort of relive 

### 9 the

-- it's like left

- brain/right

- brain, you kind of see

-- they put little clickers in your 

### 10 hands and you kind of relive, you know, the painful experience, and you just kind of 

### 11 keep

-- you know, you're going to do this with a th erapist, and you kind of work 

### 12 through it until it doesn't

-- you know, it's not as troubling. I'll look up the initials. 

### 13 Actually, let me just Google it. 

### 14 **MS. FLYNN:** Hello? Can you hear me? 

### 15 **MS. SIDEL:** Yeah. 

### 16 **MS. FLYNN:** This is Kimberly. Hi. EMDR is e ye movement desensitization and 

### 17 reprocessing. And at least one clinician in the Bellevue responder program has used it. 

### 18 I, you know, was lucky to catch a presentation a couple of years ago. So I'm not saying 

### 19 there shouldn't be research on it but, you kn ow, it is a recognized modality. 

### 20 **MS. SIDEL:** And there's another

-- there's something else that they do at Mass 

### 21 General that's like the next step up from EMDR. I don't remember what it's called but 

### 22 maybe, Dr. North, maybe you might have more information a bout this. But I think 

### 23 we're using techniques that are kind of like old

- fashioned and take a long time. And 

### 24 there's like there's shorter ways to deal with, you know, the trauma. 

### 25 **DR. WARD:** Is Dr. North on the call yet? 

### 26 **MS. SIDEL:** I guess not. 

### 27 **DR. HARRIS ON:**  This is Bob Harrison. I would like to add an idea or concept to 

### 28 the list, and that is research that focuses on practice or, you know, what NIOSH has 

### 29 called R

- to

- P , research to practice. Sometimes we call it applied epidemiology or 

### 30 applied public hea lth. One of the things that has struck me, maybe coming out here 

### 31 from the west coast perspective but also as an occupational medicine provider, is that 

### 32 there's a huge amount of research that's incredibly valuable from these studies that

-- 

### 33 and there's bee n a lot written, you know, and really good summary articles, but I guess 

### 34 thinking it now, it's going to be, you know, almost 15 years out from this experience. 

### 35 You know, is there a way to integrate or apply the research fin dings and think about 

### 36 how it's a ffected the population that's in the registries or other potential worker 

### 37 populations. You know, this

-- I see the research not only divided up into three 

### 38 categories that we're charged with, but there is, you know, basic biological 

### 39

### 58

biomonitoring, etiologi cal, epidemiological, but, you know, but I guess this other 

### 1 element is, you know, practice or public health impact. I don't know how that would 

### 2 be translated into research proposals but I would j ust throw that into the mix as , if 

### 3 there was an announcement that was put out that would encourage, you know, 

### 4 innovative proposals along that line. 

### 5 **DR. MIDDENDORF:** I just want to interrupt for just a second. Dr. North is on 

### 6 the line but she's having trouble speaking. We're trying to get her access. 

### 7 **DR. NORTH:** C an you hear me? 

### 8 **DR. MIDDENDORF:** Yes, we can hear you now. 

### 9 **DR. NORTH:** Oh, excellent. I've been trying six or eight times to interject and 

### 10 nobody heard me. 

### 11 So regarding the mental health discussion, I had a couple of things that I 

### 12 wanted to add to the l ist, if that would be okay at this time. 

### 13 **DR. WARD:** That would be great. 

### 14 **DR. NORTH:** Great. Okay, well, the first thing relates to something other 

### 15 people have talked some about, which is the exposure issue. And 9/11 really was a 

### 16 different disaster from m ost past disasters in

-- because of its scope and magnitude, the 

### 17 exposures may have gone a lot further than previous disasters. But I don't think we can 

### 18 necessarily assume the exposure zones for mental health problems will be the same as 

### 19 for other disease s. And so I think it's critical that that be further studied. That's my 

### 20 first item. 

### 21 My second item is that often, for lack of a better method, diagnoses are not 

### 22 made and instead mental health problems are discussed in terms of symptoms, and, 

### 23 you know, we don't study cancer symptoms; we study cancer. And it would be good if 

### 24 we could

-- if research could figure out a better way to assess full psychiatric disorders. 

### 25 'Cause it's not clear what these symptoms mean outside of disorders. They can be very 

### 26
no nspecific, so I'd like to see the field improve its ability in research there. 

### 27 Hello? Did you hear me? 

### 28 **DR. MIDDENDORF:** Yes. 

### 29 **DR. WARD:** Yes. 

### 30 **MS. SIDEL:** I didn't hear her. She cut out. 

### 31 **DR. MIDDENDORF:** I think she finished, and then she was waiting for a 

### 32 response and didn't hear anything; is that correct? 

### 33 **DR. NORTH:** Yes. 

### 34 **MS. SIDEL:** Oh. 

### 35 **DR. WARD:** And so this is Liz. I'm trying to figure out what the best way to kind 

### 36 of collate this information is since only Paul really has direct access to the document

. 

### 37 So I guess, Paul, if maybe periodically, when you mail this out

-- I think you're mailing it 

### 38 out to everyone regardless of whether they have access t o the web version or not. 

### 39

### 59

**DR. MIDDENDORF:** Correct. 

### 1 **DR. WARD:** And so Carol, if you would go into the te xt that Paul just 

### 2 transcribed and kind of edit your comments, that would probably be helpful, and in fact 

### 3 if everyone could do that, because I think Paul's capturing the bare essence but I think 

### 4 we will want to have a version of the document that has these points more clearly 

### 5 articulated. And then one of the things we'll probably want to do is take the email 

### 6 version of the document and start grouping things and collapsing and organizing. I do 

### 7 think that we may have gotten off

-track a little bit with our p lan to focus first o n John's 

### 8 area 1 and then area 2. I'm actually having a little trouble sorting out which of the 

### 9 things in our list fall into the different categories. But I do think it would be important 

### 10 that we have some interactive mechanism for peo ple to go in and edit their comments 

### 11 so that we can get this list to be as clear as possible. 

### 12 **DR. NORTH:** Can we do it by email? 'Cause I can't get on the web. 

### 13 **DR. WARD:** That's what I'm thinking. Probably the easiest thing is if 

### 14 everybody

-- Paul, if th is doesn't sound good to you, let me know. Let's say, if I made a 

### 15 point, I could take that point from the latest version of your document, rephrase it, if 

### 16 necessary, and send it back to you, and then you could insert it in the master 

### 17 document? Would that

-- 

### 18 **DR. MIDDENDORF:** That sounds fine. 

### 19 **DR. WARD:** Okay. 

### 20 **DR. ALDRICH:** This is Tom Aldrich. I was struck by something Dr. North said 

### 21 and I think it's something that we should follow up on. The remote or the different 

### 22 geography that might apply to mental h ealth issues as compared to, for the want of a 

### 23 better word, physical health issues, one example of that, that I think was very 

### 24 interesting, was the 9/11 dispatchers who were not within the footprint of the World 

### 25 Trade Center nor the original geographic bou ndaries but had significant PTSD issues. I 

### 26 don't remember any details about it but that's an interest ing aspect of this that's got a 

### 27 little attention. 

### 28 **DR. NORTH:** This is Carol North. That's a very interesting twist on the exposure 

### 29 issue. Because this d isaster was so big, we've never even really thought about these 

### 30 things before. 

### 31 **DR. WARD:** So it does sound to me

-- this is Liz

-- that we will want to coalesce 

### 32 around at least one research priority topic related to mental health issues and maybe 

### 33 fold in t he issue of cognitive impairment? Dr. North, do you have a sense of how those 

### 34 might be

-- if those should be combined, and if so, how, or if they should be separate? 

### 35 **DR. NORTH:** Well, some of cognitive impairment is truly a psychiatric issue. 

### 36 Other cogni tive impairment, depending on the situation, could be neurological or 

### 37 metabolic or otherwise medical, so it touches on both. 

### 38 **MS. SIDEL:** The issue I'm concerned about with the cognitive is if it's thought of 

### 39

### 60

as being part of like PTSD, it sort of diminishe s the impact of it. Because there's 

### 1 therapy, like cognitive remediation, that people can do, and if it's not thought of as its 

### 2
own -- you know, as its own thing and it's like kind of wrapped up PTSD, then people 

### 3 aren't going to have access to the kind of therapy that's really going to help them 

### 4 function. 

### 5 **MS. FLYNN:** This is Kimberly, and this issue of cognitive impairment came up 

### 6 recently in the survivor steering committee, because apparently lots of patients at the 

### 7 World Trade Center of our mental health center are complaining about cognitive 

### 8 issues: memory, attention, thinking, et cetera. And what the mental health director at 

### 9 the EHC who was present said to us, that made a great deal of sense, is that there 

### 10 should be a preliminary study. There needs to be, sort of as a first step, a full 

### 11 characterization of the problem, because indeed we don't know how much of this 

### 12 problem is a result of environmental exposures and how much of this problem is a 

### 13 result of psychological exposures to the disaster. So I do n't know if I'm, if I'm, you 

### 14 know, capturing her expertise adequately but that was the point that emerged from 

### 15 our meeting. 

### 16 **DR. NORTH:** I agree. I agree with you. 

### 17 **DR. MIDDENDORF:** I just want to let everybody know that all of the emails that 

### 18 I send out an d anything I get back in terms of an email will be compiled into a 

### 19 document and it will be posted on the website so that all this is public information. 

### 20 **MS. HUGHES:** I have a question

-- Catherine Hughes here. Are we checking 

### 21 that the treatments, such as for cancer, is effective or not or there may be more 

### 22 effective modes to treat the cancer? Would this be a study topic? 

### 23 **DR. ALDRICH:** This is Tom Aldrich. The problem with that approach is that 

### 24 there are so few cases, that there's not going to be enough p ower in the study to 

### 25 determine different treatments. So I think we have to leave treatment differences for 

### 26 cancers to the cancer experts who are treating large numbers. 

### 27 **DR. MARKOWITZ:** This is Steve Markowitz. I think there is a related topic, 

### 28 though, th at probably is germane, which is that this is a big

-- the World Trade Center 

### 29 Health Program is now a pretty big system, and someone should be looking at the 

### 30 healthcare utilization in the group and perhaps comparing it to the World Trade Center



### 31 exposed peo ple who are not participating in the health program, to understand the 

### 32 patterns of how people are using this care, thinking ahead to the future disasters' 

### 33 problems, whether it makes sense to set up a new segregated health program or 

### 34 whether it makes sense to pursue a different kind of way of treating people. And 

### 35 related to that, not just on the treatment side but on the monitoring side, I think some 

### 36 research needs to be done on the utility and effectiveness of the current monitoring 

### 37 program. On the health

-- on the WTC Health Registry side, we have, you know, a 

### 38 questionnaire

- based approach; on the Health Program side, we have a physical 

### 39

### 61

examination, an annual

-- at least an annual offer of an encounter, although most 

### 1 people don't show up a nnually. And the question is, d oes -- what are the pros and cons 

### 2 of both sides, but specifically in the World Trade Center Health Program, what's the 

### 3 utility actually providing hand s - on monitoring? That's not to speak in favor or against 

### 4 it, just we need to understand wh at we're getting out of it. So I would say that the 

### 5 research area would be both healthcare utilization on the treatment side and also, on 

### 6 the monitoring side, utility and effectiveness of the monitoring program as it's set up 

### 7
now. 

### 8 **MS. SIDEL:** Well, one of the issues also with the monitoring program is that 

### 9 you're telling everything to a nurse, and she's interpreting what you're saying and 

### 10 putting it into your file, and if you don't

-- there's a lot of times that information is like 

### 11 incorrect, it's sort of her version of what you're telling her. And so I've always 

### 12 wondered if it would be better to have some sort of a system where there was like an 

### 13 internet or people just had an iPad and they filled out all that information themselves, 

### 14 because at times it be comes congested when someone else is ( indiscernible ). 

### 15 **DR. MARKOWITZ:** That would be a

-- this is Steve Markowitz

-- yeah, that 

### 16 would be the kind of question that could be looked at in this research area. 

### 17 **MS. SIDEL:** Yeah. 

### 18 **MS. MEJIA:** Liz, this is Guille Mejia. I just wanted to bring up something that 

### 19 Jim Melius had mentioned in his presentation which was that he was looking at 

### 20 focusing on emerging conditions. And so I think one area that we might want to look at 

### 21 is what are the non

- covered conditions that are being reported by participants in the 

### 22 Health Program, and is there, you know, a pattern or trend or anything that can lead to 

### 23 maybe adding more conditions? 

### 24 **DR. WARD:** Yeah, I think that's very well stated, and it's connected with one of 

### 25 the topic s we' ve already captured . I think it's stated more clearly. I think we said 

### 26 something about new conditions, I think. But I think this really captures what we're 

### 27 trying to say. So Paul, if you could get that down. 

### 28 **MS. FLYNN:** Liz, this is Kimberly with a fol low

- up comment, which is that it 

### 29 does appear that research resources are needed to do analysis of any emerging 

### 30 conditions that are, you know, in the database. My sense right now is that the data 

### 31 center has this information and does not have the wherewitha l to conduct the 

### 32 analyses. 

### 33 **MS. SIDEL:** This is a little bit far out , but I'm going to take a risk and bring it up 

### 34 anyway, is that, you know, because of the victims' compensation fund, attorneys are 

### 35 compiling tons of information on each of their clients' he alth condition s that are 

### 36 related to the World Trade Center, and that information is definitely out there. It's 

### 37 either going to go to the justice department or it co uld be compiled , you know, 

### 38 individually. But it's a lot of information because each person

-- e ach client goes and, 

### 39

### 62

you know, tells every condition that's related to World Trade Center ( indiscernible ) and 

### 1 it's pretty simple. 

### 2 **DR. WARD:** Good. I think, I think one way to help reframe the discussion so 

### 3 that we're as responsive as possible to Dr. Howard's questions is to look again at his 

### 4 questions. And I think what he's asking us to do is to identify critical research 

### 5 knowledge gaps in each of these areas. So while I think it's tempting to look at specific 

### 6 courses of data or specific ways to do research, I think what we really should try to do is 

### 7 articulate as clearly as possible what the knowledge gap is that we're trying to address. 

### 8 **DR. ALDRICH:** This is Tom Aldrich again. It seems to me that that that's been 

### 9 presented today is pretty good ove rview of the knowledge gap. My view is that

-- I 

### 10 mean, there's only so much money for research, and there are gaps. To me the best 

### 11 way to approach this is to provide some guidance to areas that are

-- that NIOSH or 

### 12 whoever thinks is important, but yet ma ke the determination of funding dependent on 

### 13 the best quality research. So if it turns out that the best quality research does not 

### 14 match exactly with our list of needs, I don't think that's necessarily a problem. We 

### 15 should be supporting the best research that we can. 

### 16 **DR. WARD:** Well, I think it's real

-- you're addressing two areas of the process, 

### 17 and maybe someone at NIOSH would like to chime in. So I think our function as the 

### 18 scientific advisory committee is to suggest the priority

-- or you know, the priority 

### 19 knowledge gap. And then there's a separate process that evaluate s the quality of the 

### 20 proposal. So I think our recommendations might be used to help draft better requests 

### 21 for proposals. But I think there's a separate process that's going to eval uate the quality 

### 22 of the proposals, and so we're not in any way dictating which proposals will be funded. 

### 23 Paul, or someone else from the NIOSH grants program, would you like to step in? 

### 24 **DR. KUBALE:** Dr. Ward, this is Travis Kubale. I would just agree that , there is a 

### 25 separate, you know, scientific and technical review process, you know, for that 

### 26 purpose. You're exactly right. 

### 27 **DR. ROBISON:** This is Alle n Robison. I would just add that the ideas and input 

### 28 that you come up with today, we will take that and use that as we move forward with 

### 29 subsequent funding opportunity announcement s . Thanks. 

### 30 **DR. WARD:** So with respect to the first area, maybe we should kind of review 

### 31 what, at least what I think are the major themes that are emerging, and then we can 

### 32 see wha t is missing. So I think one major theme that's emerging, that there seems to 

### 33 be a lot of interest in, is the question of the newly emerging conditions, that are not 

### 34 currently covered conditions but may be emerging in the population and could be 

### 35 identifie d by research, either usin g existing data, specifically using existing data 

### 36 sources. So that seems like, you know, something that the committee would want to 

### 37 recommend. 

### 38 A second important area is doing research on mental health conditions related 

### 39

### 63

to

-- or doing more research on mental health conditions related to exposure and also 

### 1 the

-- and one thing that came across very strongly there was the idea that the way 

### 2 we've been categorizing exposure in terms of chemical and physical toxins may not be 

### 3 appropria te for the exposures that impact mental health outcomes. 

### 4 And also I guess the question that Dr. North raised about research, is there a 

### 5 way to do research, population

- based research, where we would be looking at actual 

### 6 psychiatric diagnoses rather than sym ptoms. So that could all be

-- those could be 

### 7 combined into one research topic on mental health outcomes related to World Trade 

### 8 Center exposures. 

### 9 **MS. SIDEL:** What about the techniques they use for

-- to treat mental health. 

### 10 You know, for example us e the things like EMDR for post

- traumatic stress disorder 

### 11 rather than just psychotherapy? 

### 12 **DR. WARD:** Well, I think that might be more appropriate conceivably under the 

### 13 third, the third research area, which is critical research knowledge gaps relative to 

### 14 effectiv e treatment of World Trade Center

- related conditions. 

### 15 **MS. SIDEL:** I see. Okay, thank you. 

### 16 **DR. WARD:** And then the third area, I think, is

-- was related to biomarkers of, 

### 17 specifically cancer but other potentially other chronic conditions related to World 

### 18 Trade Center exposures. And that captures a specific suggestion that Dr. Crowley made 

### 19 related to DNA and epigenetic effect. It captures a

-- it captures what Dr. Rom talked 

### 20 about in terms of biomarkers related to asthma, potentially. 

### 21 And the last

-- th e fourth kind of major area that I'm trying to

-- you know, I'm 

### 22 trying to distill these into a smaller number of larger points, would be the whole 

### 23 question of immune system disorders, which would include autoimmune diseases and 

### 24 cancers of the

-- relating t o the immune system, like sarcoidosis. 

### 25 So does anyone think that's a good synthesis of the four major topics we might 

### 26 want to identify under the first point? 

### 27 **DR. TRASANDE:** Hi. Can I

-- sorry to interrupt. This is Leo Trasande. I just 

### 28 joined. 

### 29 **DR. WARD :**  Hi, Leo. 

### 30 **DR. TRASANDE:** Hi, how are you? 

### 31 **DR. WARD:** Good. 

### 32 **DR. MIDDENDORF:** Welcome, Leo. 

### 33 **MS. FLYNN:** Liz? 

### 34 **DR. WARD:** Excuse me, go ahead. 

### 35 **MS. FLYNN:** I'm sorry. This is Kimberly, and Leo arrived just in time. I would 

### 36 suggest that we add health impacts , particularly physical health impacts, to the 

### 37 pediatric population. 

### 38 **DR. WARD:** Good. And I would suggest maybe we broaden it a little bit to say 

### 39

### 64

vulnerable populations, and that would be pediatric and also potentially the groups 

### 1 that

-- well, I guess tha t could be pediatric but the study of children and young adults or 

### 2 people who were exposed to the World Trade Center at a relatively early age. There 

### 3 may be other vulnerable populations as well. 

### 4 **MS. HUGHES:** Hi, this is Catherine Hughes. I think I'm the only residential mom 

### 5 on the committee. I think it can't

-- it has to deal with the physical health, 'cause, you 

### 6 know, when they say they studied

-- that there's been studies on the population, a lot 

### 7 of it has been mental, and there's been really a deficie ncy on the physical health for 

### 8 children. And I mentioned this at the last survivors' meeting. You know, we had the 

### 9 clinical guidelines, first for adults, went through iteration 1, iteration 2. Finally after 

### 10 much fighting, they got guidelines for childre n. I mean, it's been a battle to get children 

### 11 recognized in this entire process, and we've really done them a disservice over the 

### 12 years. So children have

-- you know, they have to be there in terms of the physical 

### 13 health as well. That's all. 

### 14 **DR. WARD:** Good. Good. 

### 15 **MS. SIDEL:** You know, in the children's category, babies that were born during 

### 16 that time, I know of a few people that have concerns about, you know, their children 

### 17 that were conceived while one of the parents was working at the World Trade Cen ter 

### 18 after the attacks. They ha ve, you know, different issues that affect children that they 

### 19 had as well before, you know, 9/11 , don't have. 

### 20 **DR. WARD:** Okay, so that

-- but I think in terms of, Paul, where you noted 

### 21 pediatric disease and other, I think wha t we want to do is maybe make that one little 

### 22 more broadly as effects

-- health effects of exposure, World Trade Center, during 

### 23 gestation or early life, something like that. Then in parentheses, childhood and 

### 24 adolescence or something like that, so we're k ind of broadening it. 

### 25 And looking at the, at the web version, it looks like you have most of the points 

### 26 we've

-- so under item

-- under point 1, we really

-- I mean, like the overall subhead is 

### 27 Dr. Howard's question, and then each of these areas is a sep arate kind of research 

### 28 recommendation. So newly emerging uncovered conditions is one research 

### 29 recommendation, and then more research on mental health conditions is the second 

### 30 recommendation. And they're all under item 1. Or they're all under, you know, his 

### 31 subhead 1. 

### 32 **DR. MIDDENDORF:** Okay, I don't have that up, so. 

### 33 **DR. WARD:** Well, I see it. Oh, you don't have the

-- well, that's okay. You can 

### 34 just put a header like subhead 1 or something or... 

### 35 **DR. MIDDENDORF:** Okay. So all of these go under his? 

### 36 **DR. WARD:**  His item 1, I think. Yeah. 

### 37 **DR. MIDDENDORF:** Okay. 

### 38 **DR. WARD:** What I'm thinking is maybe we should just

-- we should see if 

### 39

### 65

there's

-- if this captures the major themes that we want to prioritize or if

-- so and 

### 1 maybe what we could do is

-- well, I guess you'll send these out, after you finish 

### 2 reformatting them, and then we can maybe look at them and see if we've captured 

### 3 everything and if we've got the wording close to correct. 

### 4 **DR. ALDRICH:** This is Tom Aldrich again. I think one thing that isn't included in 

### 5 that list is exposure assessment. 

### 6 **DR. WARD:** Okay. 

### 7 **DR. ALDRICH:** I forget how that's based but the quantification of exposure. 

### 8 **DR. DEMENT:** This is John Dement. I really second that one. It came about in a 

### 9 number of different discussions. It seems that early on we had a lot of exposure 

### 10 assessment that was really innovative, but later on it seems that we've sort of settled in 

### 11 on what was done before and not really looked at some issues of differences in the 

### 12 particularly higher

- risk populations not yet identified. So I think that's really narrow 

### 13 and it really still needs to be up on this list. It really deals with etiology as well. 

### 14 **DR. MIDDENDORF:** So how would you suggest I word this? 

### 15 **DR. DEMENT:** Well, I think: expanded and integrated expos ure assessment. 

### 16 And I really like the comments about the fact that we've principally looked at physical 

### 17 exposures and largely respiratory, but it really needs to be

-- that concept needs to 

### 18 be

-- needs to be broadened out. And I think it has some validat ion at least of some of 

### 19 the exposure assessment. It seems to be validated by the results that we've seen, 

### 20 particularly respiratory. But the network needs to be expanded out to some of the 

### 21 other health conditions. 

### 22 **DR. WARD:** And I think what I would do is I would take that verbiage, that John 

### 23 just suggested, and make that a major bullet, and take cognition out of it. I think

-- I'm 

### 24 not sure what

-- you know, I think, I think we still

-- I mean, I'm not

-- I'm not sure if

-- 

### 25 well, I guess we can list cogni tion as a separate research topic, 'cause it sounds like we 

### 26 don't really

-- I mean, we could, we could kind of group it under newly emerging 

### 27 uncovered conditions or under mental health conditions, even though Dr. North 

### 28 pointed out that the causes of proble ms with cognition could be either physical or 

### 29 psychological, or we could keep it as a separate topic. I'm not sure, you know, where 

### 30 it's

-- maybe to me it makes the most sense to kind of group it as

-- under the newly 

### 31 emerging for

-- because it's

-- I don 't know how strongly it will stand alone as

-- 

### 32 **DR. DEMENT:** Right. 

### 33 **DR. WARD:**

-- a major research theme. 

### 34 **DR. DEMENT:** Right. 

### 35 **DR. WARD:** But we can, we can talk about that. But I definitely don't

-- I don't 

### 36 think it should be under the

-- I think the expo sure assessment is a very strong theme 

### 37 and it should stand

-- I think it should stand alone. 

### 38 **MS. FLYNN:** Liz, this is Kimberly. I'd like to just jump in on exposure 

### 39

### 66

assessment. I just

-- I guess I just want to reemphasize the point that, particularly for 

### 1 the survivor community, there is no reliable data set of environmental measurements. 

### 2 So I'm assuming that one would come at exposure assessment for that community 

### 3 differently. One suggestion is biomarkers of long

- lived exposures, which I know is 

### 4 being d one in the World Trade Center adolescent study by Dr. Trasande. So I don't 

### 5 know if you want to put

-- okay, that makes sense, put it under biomarkers, but that 

### 6 would be a marker of exposure and not a marker of disease. 

### 7 **DR. MIDDENDORF:** I'm going to try an d send this out to everybody now so 

### 8 people have a chance to look at it. (pause) I sent it out. Hopefully people are receiving 

### 9 it. And what I sent out was the major themes and the grouping, one through six, under 

### 10 Dr. Howard's charge number 1. 

### 11 **DR. WARD:** Well, it hasn't come into my in

- box yet. 

### 12 **DR. MIDDENDORF:** Okay. 

### 13 **DR. WARD:** Has anyone else received it? 

### 14 **MS. MEJIA :**  Still waiting. 

### 15 **DR. ALDRICH:** Not yet. 

### 16 **DR. MIDDENDORF:** I re

- sent it just to see

-- make sure it wasn't caught off 

### 17 somewhere. 

### 18 **DR. WARD:** I g uess, Paul, in the worst case, if we can't receive it, maybe we 

### 19 can jus t read through them one by one, and those people who have

-- I don't know why 

### 20 it's not coming in. 

### 21 **DR. MIDDENDORF:** Yeah, Dr. North is again trying to get in but she's not able 

### 22 to be hea rd. 

### 23 **MS. SIDEL:** I just got my email. 

### 24 **DR. MARKOWITZ:** Yeah, I just got the email too. 

### 25 **DR. MIDDENDORF:** Dr. North says: I'm trying to say that the exposure 

### 26 measurement should be specifically annotated to include a unique line of study for 

### 27 mental health. 

### 28 **UNI DENTIFIED SPEAKER:**  I agree; I think it's really interesting. 

### 29 **DR. WARD:** Okay, so

-- 

### 30 **DR. MIDDENDORF:** Okay, we're having some difficulties here. Both Dr. North 

### 31 and Dr. Talaska are having difficulty being heard. If the operator is on the line, please 

### 32 make sure that Glenn Talaska and Carol North are added to the speaking line. 

### 33 **THE OPERATOR:** They have open lines, sir. 

### 34 **DR. MIDDENDORF:** They do have open lines. Can you hear me? 

### 35 **DR. NORTH:** Hi, this is Carol; can you hear me? 

### 36 **DR. MIDDENDORF:** Yes. 

### 37 **DR. TALASKA :**  Can you hear Glenn? 

### 38 **DR. MIDDENDORF:** Yes, we can hear you, Glenn. 

### 39

### 67

**DR. TALASKA:** Oh, good, finally. God, I was yelling. I wanted to add that

-- 

### 1 **DR. NORTH:** This is Carol; can you hear me? 

### 2 **DR. TALASKA:** May I talk? 

### 3 **DR. MIDDENDORF:** Yes, Carol, we hear y ou , too. 

### 4 **DR. NORTH:** Thank you. 

### 5 **DR. TALASKA:** This is Glenn Talaska. I wanted to just reinforce what Paul was 

### 6 saying about exposure assessment and the strategies that need to be developed as a 

### 7 result of the exposure assessment that was done after 9/11. 

### 8 I think if everyone remembers, you know, one of the

-- the exposure 

### 9 assessment that was done on

-- during 9/11 was amazingly poor. And one of the things 

### 10 that would just be

-- we really do need to develop a strategy coming out of what 

### 11 markers were measured and a critical review of what was done for the exposure 

### 12 assessment during 9/11. 

### 13 John and I did that to a limited extent with the papers that we had but we did 

### 14 that in a period of a week. And a research study, which would look at that and try to 

### 15 integra te and make suggestions about which markers for which types of exposures, 

### 16 would be very useful, I think. It would be very

-- well, it would be very useful if 

### 17
s omething like this ever happens again. 

### 18 It certainly has been rolled in from the deep water hor izon or the other 

### 19 disasters that we have, including hurricanes. We don't really have a strategy for doing 

### 20 that yet, and I think that's important. And it would include using or developing which 

### 21 long

- term markers, which could be gotten from the autopsy stu dies that are being 

### 22 done currently, could predict or could be used to indicate which sort of shorter

-term 

### 23 markers might be used to tell people when they've reached a critical level of exposure 

### 24 and should be removed from doing particular work. And that way , we could prevent 

### 25 the need. Thank you. 

### 26 **DR. WARD:** I guess the question I have is

-- I mean, I mean, I'm not sure, Glenn, 

### 27 that the way you phrased that, it kind of lends itself to a research funding proposal. I 

### 28 mean, it relates to a lot of these differen t areas, but it seems like it's more like writing a 

### 29 paper or a review. And I think what we're trying to do is come up with topics that really 

### 30 will benefit this population rather than the broader

-- not that it's not important to use 

### 31 the information that w e learned at the World Trade Center to benefit the broader 

### 32 fields but I think we're talking

-- we're talking about doing research within the World 

### 33 Trade Center population. So I mean, I think what you're talking about fits in one of 

### 34 these broad categories but I'm not sure it would be a stand

- alone priority. 

### 35 **DR. TALASKA:** Well, no, I was really seconding what you

-- what we were 

### 36 talking about. I could hear you; I couldn't talk. But what John Dement said

-- 

### 37 **DR. WARD:** Okay. Okay, yeah, okay. And so one su ggestion, just in the 

### 38 interest of trying to move, you know, to a

-- unfortunately we have this one meeting 

### 39

### 68

and we want to come up with final recommendations, and it's, you know, it's

-- I want 

### 1 to make sure that we get to look at all of the four topics. So if we look at the email that 

### 2 Paul sent out, maybe what we should start doing

-- one thing

-- I mean, we could make 

### 3 a motion that these general topics would be the six priority areas we want to make 

### 4 recommendations on or we could make a motion that a speci fic additional area be 

### 5 added before we word

- smith the final product, and maybe move on to the second 

### 6 area, because I think we'll want to do the prioritization after we've gone through all of 

### 7 the

-- all of the four charge areas. 

### 8 **MS. HUGHES:** I have a questi on -- Catherine Hughes. Should we also put them 

### 9 in priority order, like

-- 'cause right now they're in order 1 through 6, and people might 

### 10 think that it's based on priority. 

### 11 **DR. WARD:** Well, I guess we can. We could prioritize within each area, and 

### 12 then prioritize across the different areas, if the group would like to do that. 

### 13 **MS. HUGHES:** 'Cause right now it's

-- you know, it looks like biomarkers is 

### 14 number 3 but biomarkers is really important that it should

-- you know, it looks like it 

### 15 should probably be moved up. 

### 16 **DR. MIDDENDORF:** I'm going to suggest that at this point you just get out your 

### 17 ideas and what you think the specific, specific wording for each of these would be. And 

### 18 then at the very end, when you have all of the ideas or all of the specific topics that you 

### 19 want to address, then prioritize across all of the groups rather than just looking at each 

### 20 individual group. So at this point, let's just make sure that we get the wording in 

### 21 numbers 1, 2, 3, the way you want it, and then at the very end, go through and look at 

### 22 all of the topics and then prioritize. 

### 23 **MS. MEJIA:** Liz, this is Guille. I'm looking at number 2 in terms of the research 

### 24 for mental health conditions, and you list two exposures, physical and chemical 

### 25 exposures. And obviously not being a researcher, is there any way to include the

-- 

### 26 maybe the visual and audio exposures that were experienced be different populations, 

### 27 in particular I'm thinking about our, as someone else mentioned earlier, the 911 

### 28 operators who didn't

-- weren't phy sically at Ground Zero but certainly had to handle 

### 29 hundreds of calls coming in, and it would be interesting to see the impact that it has on 

### 30 this population. 

### 31 **DR. WARD:** Yeah, and I think this one probably needs to be rephrased, and I 

### 32 would love it if someb ody

-- I mean, if somebody would make a recommendation for a 

### 33 rephrasing of this one that, you know, better captures the intent. I don't know if, Carol, 

### 34 you're on and can talk but you might be the best person to do that. 

### 35 **DR. NORTH:** Well, I tried to write something. I'd sent it. 

### 36 **DR. MIDDENDORF:** Yeah, the problem is I can't listen to what everybody is 

### 37 saying and type that in, and then go back and look at what you're sending back in 

### 38 emails; it just isn't working very well. 

### 39

### 69

**DR. NORTH:** Now that I can talk, w ould you like me to read it? 

### 1 **DR. MIDDENDORF:** Yes. 

### 2 **DR. NORTH:** Okay. I got to find it here. Okay, exposures. That's what we're 

### 3 talking about, right? 

### 4 **DR. WARD:** It's number 2, the more research on mental health conditions in 

### 5 relation to exposure. 

### 6 **DR. NOR TH:**  Right. So you can't necessarily assume the exposures for mental 

### 7 health are the same as those for medical illnesses, so we need research to characterize 

### 8 disaster

- related exposures

-- 

### 9 **DR. MIDDENDORF:** Wait, wait. Go slowly. Research to what? 

### 10 **DR. NORT H:**  Characterize disaster

- related exposures in relation to specific

-- 

### 11 **DR. MIDDENDORF:** Wait, wait, wait. I'm trying to type. I'm not that good a 

### 12 typist. Research to characterize disaster

- related

-- 

### 13 **DR. NORTH:** Exposures. 

### 14 **DR. MIDDENDORF:** Okay. 

### 15 **DR. NORT H:**  In relation to specific psychiatric disorders such as

-- 

### 16 **DR. MIDDENDORF:** Whoa, whoa, whoa. Okay. 

### 17 **DR. NORTH:** PTSD. 

### 18 **DR. MIDDENDORF:** Say it again, PTSD? 

### 19 **DR. NORTH:** PTSD, major depressive disorder, recognizing that exposures 

### 20 may -- 

### 21 **DR. MIDDENDORF:** W ait a minute. Major depressive disorder. Okay. 

### 22 **DR. NORTH:** Recognizing that exposures may be different for different 

### 23 psychiatric disorders. 

### 24 **DR. MIDDENDORF:** Recognizing that exposures may be different? 

### 25 **DR. NORTH:** For different psychiatric disorders. 

### 26 **DR. MIDDENDORF:**  I missed a for. 

### 27 **DR. NORTH:** So the bottom line, the knowledge gap is that we don't know how 

### 28 disaster

- related exposures relate to psychopathology. 

### 29 **DR. ALDRICH:** This is Tom Aldrich. Doesn't that belong under item 6? 

### 30 **DR. WARD:** Tom, it could b ut I think the original intent was also to call for 

### 31 more research on mental health disorders in general, including the

-- including the 

### 32 context of looking at both diagnoses and symptoms. 

### 33 **DR. ALDRICH:** Yes. 

### 34 **DR. WARD:** So and there will inherently be some ov erlap between some of 

### 35 these. I mean, there's going to be overlap between biomarkers and exposure 

### 36 assessment, but I think what we want to do is really identify where we see that a gap 

### 37 exists. And what I was sensing is that there's a gap

-- there's a resea rch gap in the 

### 38 understanding of the impact of the exposure on mental health disorders in general, and 

### 39

### 70

then more specifically, there's a need to better characterize exposures in relation to 

### 1 risk of developing mental health disorders. And so

-- 

### 2 **DR. ALDRICH:** I agree but I think those are separate topics. And right now in 

### 3 the document it looks like that whole issue of increased attention to mental health 

### 4 disorders has been eliminated and just gone down to potential to mental health 

### 5 disorder exposure or menta l health

-- exposure -- 

### 6 **DR. WARD:** Right. 

### 7 **DR. ALDRICH:**

-- as it relates to mental health. There are two separate issues, 

### 8 and I think the exposure part of it belongs as part of number 6. 

### 9 **DR. NORTH:** Yes. 

### 10 **DR. ALDRICH:** And yes, there will be overlap but th at's okay. 

### 11 **DR. NORTH:** And then the research on mental health conditions would include 

### 12 the point I made about symptoms versus diagnosis. 

### 13 **DR. WARD:** Right, so I guess what we need is a separate

-- we need a draft of a 

### 14 separate point on the mental health con ditions research. And then we need to see 

### 15 how well the point we've already draft ed on the exposure assessment for mental 

### 16 health

- related exposures can be captured under exposure assessment. 

### 17 **DR. ALDRICH:** I'd like to make a suggestion about item 1, okay? 

### 18 **DR . WARD:**  Okay. 

### 19 **DR. MIDDENDORF:** Well, can we finish up on 2 and 3

-- on -- in the mental 

### 20 health? 

### 21 **DR. WARD:** Yeah, 'cause I do think what we want to do is when we make the 

### 22 suggestions, we really want to make it framed as close as possible to how you'd like to 

### 23 see the sentence written. 

### 24 **DR. ALDRICH:** I have that for item 1. 

### 25 **DR. WARD:** Okay, but we want to finish up on

-- I think Paul wants to finish on 

### 26 item 2 before we move on to item 1. Okay, to finish on item 2, I think we need a 

### 27 sentence from Carol on ment al health research. 

### 28 **DR. MIDDENDORF:** Do you want this to be like item number 3 , or do you want 

### 29 it to be included in number 2? 

### 30 **DR. WARD:** I guess at this point I would make the mental health research 

### 31 number 2, and then it sounds like the exposure assessment related to mental health is 

### 32 going to be a sub

- bullet under the expanded integrated exposure assessment. 

### 33 **DR. NORTH:** That would be fine. 

### 34 **DR. WARD:** But

-- 

### 35 **MS. SIDEL:** Can I just ask like why you wouldn't be more specific in 2, and just 

### 36 say like some of the m -- you know, mental health conditions such as cognitive 

### 37 disorders? 

### 38 **DR. ALDRICH:** I thought the concern about that was that cognitive disorders 

### 39

### 71

may be mental health, may not be mental health. I mean, it's all about whether it's, 

### 1 whether it's a psychologi cal injury or a physical injury. 

### 2 **DR. NORTH:** Yes. 

### 3 **DR. WARD:** That was the concern. 

### 4 **MS. SIDEL:** But then maybe it should be just broken up into its own separate 

### 5 set, because that is a concern. But the way this is it's like they don't have to look at 

### 6 cogni tive. 

### 7 **DR. ALDRICH:** I was going to suggest that as part of number 1. 

### 8 **DR. WARD:** That's where I was seeing it, and we can see it

-- 

### 9 **MS. SIDEL:** Okay, that's good. 

### 10 **DR. WARD:**

-- more specific. I mean, it sounds like renal disease is another one 

### 11 that's

-- 

### 12 **DR . ALDRICH:**  Right, so look, under number 1, get rid of the second uncovered, 

### 13 because that's ambiguous. 

### 14 **MS. SIDEL:** Yes. 

### 15 **DR. ALDRICH:** Then we'll leave that one but the second one. No, leave that 

### 16 one. Newly emerging uncovered conditions that could be prov en or disproven by 

### 17 research or existing data sources, for example, cognitive disorders, autoimmune 

### 18 diseases, renal diseases

-- 

### 19 **DR. MIDDENDORF:** Okay, wait a minute. 

### 20 **MS. SIDEL:** Excellent. 

### 21 **DR. MIDDENDORF:** Such as

-- 

### 22 **DR. ALDRICH:** Cognitive disorders, autoi mmune disorders, renal diseases and I 

### 23 don't know, want to add in endocrine disorders? I mean, things that haven't been 

### 24 studied. 

### 25 **DR. WARD:** That sounds good to me. 

### 26 **MS. SIDEL**  **:** That sounds really good. 

### 27 **MS. FLYNN:** This is Kimberly, I'm not sure I can be hea rd, but

-- 

### 28 **DR. WARD:** You can be heard. 

### 29 **MS. FLYNN:** Thank you. I'm not entirely sure that these conditions can be 

### 30 proven or disproven by research on existing data sources. I think there would be, for 

### 31 some of these addition

-- I mean, I know I've been pip ing up about the need to do 

### 32 analysis using existing data sources but cognitive diso rders, we're not going to prove or 

### 33 disprove based on existing data sources. 

### 34 **DR. WARD:** Yeah, so I think the current wording, unless it's changed, is 

### 35 research or existing dat a sources. 

### 36 **MS. FLYNN:** Yeah, let's go with that. 

### 37 **DR. MIDDENDORF:** Okay, so

-- 

### 38 **MS. FLYNN:** Analysis or analysis of existing data sources? 

### 39

### 72

**DR. WARD:** Yeah. 

### 1 **MS. FLYNN:** And the other thing I just wanted to roll in here , I am not sure of 

### 2 the extent to which Dr

. North's excellent point about diagnostic terminology applies to 

### 3 children, number 1, for those who experienced the disaster as children, I guess; and in 

### 4 addition, I would say that there has been a lot of mental health research on children 

### 5 exposed to the d isaster. I'm not saying there shouldn't be more. There should be more 

### 6 but the gaps, as Catherine has stated, are largely on: well, let's get this with the most 

### 7 critical gaps or on the physical health end. So maybe using the word adult in the 

### 8 mental heal th

-- in Dr. North's point, you know, which would also cover potentially, 

### 9 young adults, but major depressive disorders, as I understand, it's not something that 

### 10 you would use as a child diagnosis. Please correct me if I'm wrong. 

### 11 **DR. NORTH:** Sure you would

. 

### 12 **MS. FLYNN:** You would? 

### 13 **DR. NORTH:** I'm not sure I understand the point. I think that both of my points 

### 14 would pertain to both adults and children. 

### 15 **MS. FLYNN:** Really? Okay. But there has

-- Dr. North, there has been a fair 

### 16 amount of mental health resea rch on the impact of 9/11 to children. So I would 

### 17 obviously defer to your, you know, expert judgment on this but

-- 

### 18 **DR. NORTH:** Well my, my points are not about whether there's been mental 

### 19 health research on adults or children. 

### 20 **MS. FLYNN:** Okay. 

### 21 **DR. NORTH :**  Mine is specifically about the insufficient research on the meaning 

### 22 of exposures and on assessment of full diagnosis as opposed to symptoms. 

### 23 **MS. FLYNN:** Okay. I, I understand what you're saying. I'm less familiar with 

### 24 the application of these very, ve ry serious diagnoses, like major depressive disorder, to 

### 25 children, but, you know, I defer. And also we're talking about people who are 

### 26 adolescents now so maybe that makes more sense. 

### 27 **DR. MIDDENDORF:** Okay, I'll give the people with Macs the opportunity to see 

### 28 what we're talking about. I sent out an email with the current wording. It's on the 

### 29 screen so we might want to give them a minute or two to get their email so they can 

### 30 weigh in. 

### 31 **DR. WARD:** And I think, Paul, one thing that didn't get captured in thi s version 

### 32 is the objection to proven or disproven, and I would propose t hat maybe we could say : 

### 33 that should be further investigated or could be further investigated. Because I agree 

### 34 that most of the time we never really prove or disp rove things

. 

### 35 **DR. MIDDE NDORF:**  I was going to bring that up. 

### 36 **DR. WARD:** But I think other than that, it seems like this bullet is capturing 

### 37 something that we think is important. 

### 38 **DR. ALDRICH:** I'm the one who suggested proven or disproven, and I think it's 

### 39

### 73

being kind of wishy

- was hy to say it's going to be investigated. I mean, the goal is to 

### 1 prove or disprove something. We may fall short of that goal but I don't think we should 

### 2 hesitate to state that goal. 

### 3 **DR. WARD:** What do other committee members think? 

### 4 **DR. NORTH:** I agree. 

### 5 **MS . SIDEL:**  Yeah, I don't like being wishy

- washy. 

### 6 **DR. WARD:** Okay, so, so are we at the point where we want to go ahead and 

### 7 make a motion on the final wording for point 1, and then have a vote? 

### 8 **MS. FLYNN:** Can I just

-- 

### 9 **DR. MIDDENDORF:** Has everyone received their email? I think that's the first 

### 10 question. 

### 11 **DR. ALDRICH:** Well, and add in endocrine diseases. 

### 12 **MS. FLYNN:** This is Kimberly, what about the word discovered? I just feel that, 

### 13 you know, we need a little more wiggle room here than absolute proof. I o ffer that as 

### 14 an alternative. You may or may not like it. 

### 15 **DR. ALDRICH:** I don't like it because it's

-- it suggests that it's there to be found, 

### 16 and it might not be there to be found. That's why we need to include the possibility 

### 17 that we're going to find something in the negative. 

### 18 **MS. MEJIA:** This is Guille, in terms of item number 1, I just want to make sure 

### 19 that what I had raised earlier in terms of ensuring that the non

- covered conditions that 

### 20 are being reported by the participants in the health program are also captured in this as 

### 21 part of the emerging conditions? 

### 22 **MS. FLYNN :**  Yes, that's good. 

### 23 **DR. WARD:** All right, so it should read newly emerging non

- covered conditions. 

### 24 **DR. MIDDENDORF:** Well, I was

-- 

### 25 **MS. MEJIA:** But are reported by people in the progra m. That's the really 

### 26 important part 'cause it gives it credence. 

### 27 **DR. MIDDENDORF:** Just tell me what words you want and where you want 

### 28 them. 

### 29 **DR. ALDRICH:** Tom Aldrich again. I have a problem with that because the fact 

### 30 that people are reporting something d oesn't mean it's World Trade Center

- related, and 

### 31 to phrase it that way suggests that it is. 

### 32 **MS. FLYNN:** I agree. 

### 33 **DR. ALDRICH:** I mean, our purpose here is science so we should

-- we 

### 34 shouldn't

-- we should be critical. 

### 35 **MS. SIDEL:** Okay, what about brought t o the attention as, you know, as 

### 36 potentially World Trade Center

- related? 

### 37 **DR. ALDRICH:** I'd have to see how you phrase it. 

### 38 **MS. SIDEL:** Okay, I have to

-- I have to write it for a minute. 

### 39

### 74

**DR. WARD:** Well, I mean, maybe we should back it up a little bit and s ay 

### 1 something like investigate whether World Trade Center

- exposed populations have an 

### 2 increased prevalence of conditions not previously recognized covered by the World 

### 3 Trade Center Health Program. Have an increased

-- because I think that's really the 

### 4
sens e, is that we want to know if, you know, by focusing on the things that emerged as 

### 5 World Trade Center

- related conditions early in the course of studying what might occur 

### 6 in the population, we might be missing things

-- diseases or conditions that have a 

### 7 lo nger latency. We could say investigate whether there are newly emerging conditions 

### 8 among World Trade Center

- exposed populations. 

### 9 **MS. SIDEL:** I think that works and that's really what we're trying to do is 

### 10 investigate, and say, you know, just the word of a nd, you know, m ake the list of 

### 11 autoimmune disorders, cognitive disorders, renal diseases. 

### 12 **DR. WARD:** And it could be that that list is really including some conditions 

### 13 that have been raised as concerns but not adequately investigated. 

### 14 **MS. FLYNN:** Yeah. 

### 15 **MS. SIDEL:**  Well, investigated by the World Trade Center because (multiple 

### 16 speakers ) have them say that it's World Trade Center

- related. 

### 17 **DR. WARD:** (Indiscern ible) adequate

-- you know, have not been fully 

### 18 investigated in World Trade Center

- exposed population s? 

### 19 **THE COURT REPORTER:** Excuse me, was that Ms. Sidel speaking? 

### 20 **MS. SIDEL:** Yes. 

### 21 **DR. WARD:** And then it was Liz. 

### 22 **THE COURT REPORTER:** Right, yeah. 

### 23 **DR. MARKOWITZ:** This is Steve Markowitz. I actually don't think we should 

### 24 provide examples of conditions. I think the general category of newly emerging 

### 25 conditions would be sufficient. I don't know

-- I mean, I think the hunches on these 

### 26 named conditions are hunches, and I don't

-- to mention them seems like we're 

### 27 endorsing them as areas that need study more t han other conditions that we haven't 

### 28 named. And I don't thin k that the researchers or that NIOSH need these examples. 

### 29 **MS. SIDEL:** Okay, the point of it was, though, that there are certain conditions 

### 30 that have been brought to our attention this morning, li ke Dr. Melius brought up 

### 31 autoimmune disorders. I think the fire department complained about autoimmune 

### 32 disorders. The woman that wrote the letter about her cognitive issues. So those are 

### 33 two specific areas that were thought of that, you know, I certainl y would like to see 

### 34 them researched to see if they are in fact related to the World Trade Center. The rest 

### 35 ( indiscernible ) explore, you know, research cognitive, you know, problems and 

### 36 cognitive issues and autoimmune diseases and renal as possible World T rade 

### 37 Center

- related. 

### 38 **DR. WARD:** This is Liz. I think maybe what we could do that might, and this 

### 39

### 75

makes sense to me, is in this bullet really capture the broad theme of: make sure we're 

### 1 conducting research and surveillance to capture any newly emerging dis eases, but then 

### 2 where we really as a committee feel that the re needs to be more research, like if 

### 3 there's a specific area, like autoimmune diseases and immune system dysfunction, we 

### 4 could call that out as a separate bullet point or a separate point, but af ter due 

### 5 consideration that we really do think that particular area is more important than a 

### 6 variety of other areas that we could also highlight. 'Cause I do agree with Steve's point, 

### 7 that if we just make this look based on things that really have been men tioned during 

### 8 this call without kind of, you know, a more reasoned rationale for why we're 

### 9 mentioning these and not others, it's not really very helpful in setting the research 

### 10 direction. 

### 11 **MS. FLYNN:** Yes, I agree. 

### 12 **MS. SIDEL:** I agree. 

### 13 **DR. WARD:** So, Steve, would you like t o make a motion with final wording of 

### 14 this bullet number 1? 

### 15 **DR. MARKOWITZ:** Well, the

-- so Paul just sent around number 6. 

### 16 **DR. WARD:** Okay. I haven't seen it. 

### 17 **DR. MARKOWITZ:** Number 6. 

### 18 **DR. MIDDENDORF:** Yeah, and it shows the two alternat ives. One and two are 

### 19 the two versions that

-- I guess the originating version, and then the one that it 

### 20 morphed into. 

### 21 **MS. SIDEL:** Yeah, I would take out

-- I would definitely take out cognitive 

### 22 disorders, autoimmune disorders, renal diseases. I would de finitely undo number 1, 

### 23 because it's, you know, we don't have the research on those things because if we did 

### 24 have the research it wouldn't be an issue now. But it's an issue because it's affecting 

### 25 people, and there's no World Trade Center research on it. 

### 26 **DR. MARKOWITZ:** Yeah, so that's

-- this is Steve Markowitz. The number 1, if 

### 27 you just take out the examples, number 1 probably captures better what we mean. 

### 28 Uncovered

-- you might want to specify that, you know, conditions that are currently 

### 29 not covered by the WTC program. And investigated by research or analysis, well, 

### 30 actually that's not either/or. 

### 31 **DR. MIDDENDORF:** Are you suggesting an and, slash or? 

### 32 **DR. ALDRICH:** Why not just go with number 2, adding the word uncovered 

### 33 before conditions? And leaving out everything after populations? 

### 34 **DR. MARKOWITZ:** Yeah, that's fine. 

### 35 **DR. MIDDENDORF:** Emerging conditions. 

### 36 **DR. ALDRICH:** Uncovered conditions. 

### 37 **DR. MIDDENDORF:** Well, one of the suggestions was to use the term not 

### 38 covered by the WTCHP. 

### 39

### 76

**DR. MARKOWITZ:** Th at's better. 

### 1 **DR. MIDDENDORF:** Okay. And what else goes away, just after populations? 

### 2 **DR. MARKOWITZ:** Right, yeah. 

### 3 **DR. MIDDENDORF:** Investigate

-- so it would read: Investigate whether there 

### 4 are newly emerging conditions not covered by the WTCHP among WTC population. 

### 5 **DR. ALDRICH :**  I like it. It's vague, it's broad, that's good. 

### 6 **DR. MIDDENDORF:** I want to send this out to everybody so they know exactly 

### 7 what it is. Is this the motion you're making? Is this the motion? 

### 8 **DR. MARKOWITZ:** Sure, yes. This is Steve Markowitz. Yes, I'd make that 

### 9 motion. 

### 10 **DR. ALDRICH:** Okay, this is Tom Aldrich, I second. 

### 11 **DR. MIDDENDORF:** All right. 

### 12 **DR. WARD:** And we have to vote. 

### 13 **DR. MIDDENDORF:** I'm going to send it out to everybody so they can see 

### 14 exactly what it says. This i s number 7 coming your way. I'm just going to point out that 

### 15 we have about two and a half hours left, and that includes time for a little break, here, 

### 16 fairly soon. 

### 17 **DR. WARD:** Well, hopefully we're shaking out the process a little bit so we'll be 

### 18 faster on the others, hopefully. So let's see, everybody has 7. 

### 19 **DR. MIDDENDORF:** Yeah, well, that's the question. Is there someone w ho has 

### 20 not received number 7 yet ? 

### 21 **MS. SIDEL:** I received it. Number 1 is so vague that like what are we

-- what 

### 22 are we really sayi ng? We're not saying anything, kind of. I mean

-- 

### 23 **DR. MARKOWITZ:** No, actually

-- this is Steve Markowitz

-- I would disa gree, 

### 24 actually, because if NIOSH were to set this as a research area and, you know, it would 

### 25 invite proposals that are going to have to plausibly address certain emerging conditions 

### 26 by way of methods or

-- 

### 27 **MS. SIDEL:** Right, but the problem that we have with our proposal, and this is 

### 28 what I was talking about earlier, like for example with something like autoimmune 

### 29 disease, it's highly u nlikely that any of the people that do these World Trade Center 

### 30 research projects is going to tackle autoimmune diseases because they're not, they're 

### 31 not rheumatologists. So that's why

-- 

### 32 **DR. MARKOWITZ:** No, no, that's

-- 

### 33 **DR. WARD:** I think we have

-- we still have the options of calling out certain 

### 34 disease characters or certain diseases or groupings of diseases in another priority. 

### 35 **DR. ALDRICH:** It's also

-- it's just not true that they exist

-- groups are not 

### 36 studying those things because they don't have expertise. There is an ongoing study of 

### 37 autoimmune disease in the FDNY cohort, and it's being run by epidemiologists with 

### 38 consultation from rheumatologists. And they are doing a really fine job. 

### 39

### 77

**MS. SIDEL:** I would

-- okay, well, that's good. I'm reall y glad to hear that but I 

### 1 just meant like

-- and you know, I'm not in the FDNY program; I'm in the, you know, the 

### 2 responder program, so I just know that people that have been really frustrated because 

### 3 they have had problems that are very likely World Trade Center

- related, that they 

### 4 haven't been able to either get treated for it or even get a referral for it because it's not 

### 5 part of the program. And, you know, my thought is that the reason that some of these 

### 6 things aren't part of the program is because it's above the first level of ( indiscernible )

. 

### 7 It’s not necessarily their area of expertise

. 

### 8 **DR. ALDRICH:** But my point is but the system, the system has worked. The 

### 9 prior

-- the prior request for proposals was adequate to elicit that proposal even 

### 10 though th ere were no rheu matologists on any of the research staffs. And so this type 

### 11 of process is working. 

### 12 **MS. SIDEL:** Okay, but people

-- 

### 13 **DR. WARD:** Okay. I think we have a motion. 

### 14 **DR. MIDDENDORF:** Okay, first off, I need to ask, Julia, can you be heard now? 

### 15 J ulia's been trying to say something and hasn't been able to get through. 

### 16 **DR. WARD:** I mean, I would say that we should call for a vote on this motion 

### 17 'cause I think we've heard a lot of the perspectives that we were expressing before, and 

### 18 it's really a que stion of whether the

-- you know, this is

-- I don't think further 

### 19 discussion is necessarily going to be productive. I think it's really a question of whether 

### 20 the majority of

-- or you know, the committee, how the committee as a whole feels 

### 21 about this. I guess if we get a really divided vote, then we could have more discussion. 

### 22 But if there's, if there's ( indiscernible ) on it , we may need to

-- we should move on to 

### 23 other points that may be equally or more important. 

### 24 **DR. MIDDENDORF:** Yeah, before we have a vote, though, I need to make sure 

### 25 that everybody has had a chance to be heard. 

### 26 **DR. WARD:** Right, right. 

### 27 **DR. MIDDENDORF:** And Julia is not into the meeting as yet. I'm assuming she 

### 28 can hear but she can't be heard. 

### 29 **DR. WARD :**  Right. 

### 30 **DR. TRASANDE:** Paul , t his is Leo. I'm just confirming I received 7. 

### 31 **DR. MIDDENDORF:** Okay, great. Is there anybody who has not received 

### 32 number 7? 

### 33 **DR. QUINT:** I've received 7 but I can't be

-- can you hear me? 

### 34 **DR. MIDDENDORF:** Yes. 

### 35 **DR. QUINT:** Oh, can you hear me now? 

### 36 **DR. MIDD ENDORF:**  Yeah. 

### 37 **DR. QUINT:** Okay, it's Julia. 

### 38 **DR. MIDDENDORF:** Okay, great. 

### 39

### 78

**DR. QUINT:** The question I have is whether or not the uncovered conditions or 

### 1 the newly emerging conditions are being systematically captured. All I heard was that, 

### 2 you know, just discuss

-- some things were discussed at meeting s but I haven't

-- is 

### 3 there a method now for capturing these uncovered conditions? Otherwise, you know, 

### 4 there's no

-- what are we investigating? 

### 5 **DR. MARKOWITZ:** This is Steve Markowitz. You know, one of the ideas

-- the 

### 6 proposal for a priority area that Dr. Melius made was to improve the surveillance

-- the 

### 7 performance of the current

-- the systems, the Registry and the Health Program. So I 

### 8 think that would, if done properly, that would address that issue. If there were more 

### 9 sensitive surveillance, then the signals from the populations would be appropriately 

### 10 detected, and that would provide some data for newly emerging conditions, which 

### 11 ones, which ones to pick. 

### 12 **DR. QUINT:** I agree, and so maybe we should a dd systematically document and 

### 13 investigate, because, you know, it's not clear that the surveillance systems are working 

### 14 adequately now, so the investigate newly emerging diseases doesn't have much 

### 15
me aning. And there's not a good feed in the system for tha t. 

### 16 **DR. WARD:** I think yes and no. I think the original intent was both to capture 

### 17 the opportunity of surveillance and the opportunity of research. So for example, you 

### 18 may not approach

-- you may appr oach this in a surveillance way or you may actually 

### 19 pro pose to do a study looking at biomarkers that would reflect some ne wly emerging 

### 20 condition that you hypothesize for other reasons. So I, I think the

-- what we want to 

### 21 do is

-- I mean, to me the key

-- the essence is the question of whether there are newly 

### 22 emerging conditions, and we don't necessarily need to be more specific about it being 

### 23 surveillance or other types of research. 

### 24 **DR. QUINT:** Okay. 

### 25 **DR. ALDRICH:** I agree with that. I think that if we make it too specific, that 

### 26 leaves out some innovative pro posal that somebody's been thinking about, and if it 

### 27 doesn't happen to include surveillance, they will think they won't be able to get funded 

### 28 through this mechanism. 

### 29 **DR. QUINT:** Well, I guess I was concerned about how they identify them as 

### 30 emerging. What' s the, what's the source of

-- you know, anybody can say something is 

### 31 emerging but, you know, what is the source of that information? But okay, I won't 

### 32 pursue that. 

### 33 **DR. MARKOWITZ:** This is Steve Markowitz. I think that's a really good point, 

### 34 but I do thi nk it's

-- if there's a

-- somewhere we're going to get to another 

### 35 recommendation about surveill

-- improved surveillance. 

### 36 **DR. QUINT:** Oh, okay. 

### 37 **DR. MARKOWITZ:** And I think that would be

-- that would answer, at least 

### 38 partly answer, tha t, you know, detecti on of emerge nts. 

### 39

### 79

**DR. QUINT:** Okay. Great, thanks. 

### 1 **DR. TRASANDE:** This is Leo. Can I ask a clarifying question, because I cut in and 

### 2 out for the past 45 minutes. 

### 3 **DR. MIDDENDORF:** Please do. 

### 4 **DR. TRASANDE:** Numbers 1 through 7 in various emails you sent, I assume 

### 5 number 7 is the

-- is what we' re debating now, and the other six have been voted on? 

### 6 **DR. WARD:** No. We still need to vote on the others. 

### 7 **DR. MIDDENDORF:** Wishful, wishful thinking, Leo. 

### 8 **DR. TRASANDE:** Okay. 

### 9 **DR. MIDDENDORF:** This will be the first v ote we take. 

### 10 **DR. TRASANDE:** Okay. Thank you. 

### 11 **DR. MIDDENDORF:** The other emails were just trying to develop thoughts and 

### 12 ideas. And because there are numerous people who cannot see the, the web, because 

### 13 they have Macs and it's just not working, for them I 'm just sending it out in an email so 

### 14 people can see exactly what the wording is, and also to try to keep them up to speed 

### 15 with summarizing the information that has been discussed. So , Liz? 

### 16 **DR. WARD:** Yes. 

### 17 **DR. MIDDENDORF:** Did you want to call for the vot e? I think we had a motion 

### 18 and a second. 

### 19 **DR. WARD:** Well, I mean, you know, I did

-- I was prefacing the point that they 

### 20 may not be newly emerging but I think NIOSH probably will get the, the sense of what 

### 21 we're talking about. They don't necessarily have to be newly emerging. They could be, 

### 22 you know, just previously unrecognized or

-- 

### 23 **MS. SIDEL:** That's a good way to put it. 

### 24 **DR. NORTH:** Yeah. 

### 25 **MS. SIDEL:** That would be more accurate because a lot of things, you know, 

### 26 has been around forever but it's just that nobody was talking about it or recognizing it 

### 27 or getting treated for it. 

### 28 **DR. WARD:** All right, ( indiscernible ) unrecognized conditions associated with 

### 29 World Trade Center ex posures that are not covered by

-- 

### 30 (Interference ) 

### 31 **DR. WARD:** Okay, somebody's n ot muted and we're hearing their background 

### 32 noise. Hello? Okay. 

### 33 **DR. MIDDENDORF:** So you're changing the motion; is that

-- 

### 34 **DR. MARKOWITZ :**  Yeah. 

### 35 **DR. MIDDENDORF:** Okay. It was either Steve or Tom that

-- 

### 36 **DR. MARKOWITZ:** That friendly amendment is accept ed by the proposer. 

### 37 **DR. MIDDENDORF:** Okay, so how does it read? 

### 38 **DR. MARKOWITZ:** Can someone read it ? 

### 39

### 80

**DR. WARD:** Investigate ( indiscernible ) that are previously unrecognized 

### 1 conditions associated with World Trade Center exposures but are not

-- that are not 

### 2 listed as covered conditions. 

### 3 **DR. MARKOWITZ:** Yeah, they're not currently identified

-- 

### 4 **DR. NORTH:** Currently. 

### 5 **DR. MARKOWITZ:**

-- identified as WTC

- covered conditions. 

### 6 **DR. WARD:** Yeah. 

### 7 **DR. ALDRICH:** Could you make it previously unrecognized or newly emer ging? 

### 8 **DR. QUINT:** You don't have to have newly emerging. 

### 9 **DR. MIDDENDORF:** Okay, so I didn't catch, quite, the tail end of the

-- 

### 10 **DR. WARD:** Steve, you're the original motion proposer, so why don't you 

### 11 propose the final language? 

### 12 **DR. MARKOWITZ:** Let's see, working still off what Paul sent as number 7, 

### 13 right? 

### 14 **DR. MIDDENDORF:** Yes. 

### 15 **DR. WARD:** Right

-- 

### 16 **DR. MARKOWITZ:** Okay, so

-- 

### 17 **DR. WARD:** So I think the part that’s not that we're

-- somebody proposed 

### 18 adding

-- we were -- I think we were at investigating wheth er there are previously 

### 19
un recognized conditions not currently

-- 

### 20 **DR. MARKOWITZ:** Right, right, okay. Set up an investigation

-- 

### 21 **DR. WARD:** But then someone else said, maybe we should say, and newly 

### 22 emerging, and somebody else said we don't need it. So I' m giving you the final call. 

### 23 **DR. MARKOWITZ:** So w hy don't we say: Investigate whether there are newly 

### 24 emerging or previously unrecognized conditions, health conditions, that are not 

### 25 covered by the WTCHP among WTC populations? 

### 26 **MS. SIDEL:** I think that's go od. 

### 27 **DR. MIDDENDORF:** I need to hear it again. Investigate

-- 

### 28 **DR. MARKOWITZ:** Whether there are newly emerging conditions or previously 

### 29 unrecognized conditions. 

### 30 **DR. MIDDENDORF:** Okay, at one point

-- last time you said health conditions. 

### 31 **DR. MARKOWITZ:** Ye ah, I'm sorry, health conditions, that's right. 

### 32 **DR. MIDDENDORF:** Okay. 

### 33 **DR. MARKOWITZ:** Yeah. That are not covered by WTCHP among WTC 

### 34 populations. 

### 35 **DR. MIDDENDORF:** Okay. There was also a term

-- somebody at one point 

### 36 suggested adding: previously unrecogni zed health conditions associated with WTC 

### 37 exposures not covered by the WTCHP among WTC populations. 

### 38 **DR. MARKOWITZ:** No, I think that's just

-- that just obfuscates it. 

### 39

### 81

**DR. MIDDENDORF:** Okay, you want to take out associated with WTC 

### 1 exposures. 

### 2 **DR. WARD:** I' m fine with that. I suggested it and I'm fine with taking it out. 

### 3 **DR. MIDDENDORF:** Okay. So here's, here's what I have: Investigate whether 

### 4 there are newly emerging health conditions or previously unrecognized health 

### 5 conditions not covered by the WTCHP among WTC populations. 

### 6 I'm going to send this out in an email for those

-- this will be number 8. 

### 7 **MS. SIDEL:** Poor Paul. 

### 8 **DR. WARD:** Poor us because we still have

-- this is still on number 1. 

### 9 **DR. MIDDENDORF:** Yeah. 

### 10 **DR. A**  **LDRICH :**  You guys are doing great. Hang in there. 

### 11 **DR. MIDDENDORF:** Has anybody received number 8 yet? 

### 12 **DR. WARD:** I have not. 

### 13 **DR. MIDDENDORF:** Okay. 

### 14 **DR. QUINT:** Are your electronics frozen out east? 

### 15 **DR. MIDDENDORF:** We're in a nice spot here in Atlanta, so I don't think that's 

### 16 our problem. I am going to re send 8. 

### 17 **UNIDENTIFIED SPEAKER:** I just got it, Paul. 

### 18 **DR. MIDDENDORF:** Has everyone received it? 

### 19 **MS. FLYNN:** Not quite yet. This is Kimberly. I haven't received it but I've heard 

### 20 the language, and I think we should move forward on it. 

### 21 **D R. MIDDENDORF:**  Is there anyone who feels like they want to wait until they 

### 22 have the email? 

### 23 **DR. TRASANDE:** I suggest we vote. 

### 24 **DR. MIDDENDORF:** Okay, Liz? 

### 25 **DR. WARD:** I think we should vote. So Paul, are you going to do the roll call 

### 26 vote? 

### 27 **DR. MIDDENDORF:** Yes, I will. 

### 28 **DR. WARD:** Okay. 

### 29 **DR. MIDDENDORF:** Okay. Tom Aldrich? You can vote yes, no or abstain. 

### 30 **DR. ALDRICH:** I vote yes. 

### 31 **DR. MIDDENDORF:** Okay, John Dement. (pause) Okay, I'm going to pass on 

### 32 John at the moment. 

### 33 **DR. DEMENT:** Hello? 

### 34 **DR. MIDDENDORF:** Hello, John? 

### 35 **DR. DEMENT:** Yes. I voted yes. 

### 36 **DR. MIDDENDORF:** Oh, okay. We just couldn't hear you. Kimberly Flynn. 

### 37 **MS. FLYNN:** Yes. 

### 38 **DR. MIDDENDORF:** Bob Harrison. 

### 39

### 82

**DR. HARRISON:** Yes. 

### 1 **DR. MIDDENDORF:** Catherine Hughes. 

### 2 **MS. HUGHES:** Yes. 

### 3 **DR. MIDDENDORF:** S teve Markowitz? 

### 4 **DR. MARKOWITZ:** Yes. 

### 5 **DR. MIDDENDORF:** Guille? 

### 6 **MS. MEJIA:** Yes. 

### 7 **DR. MIDDENDORF:** Carol. 

### 8 **DR. NORTH:** Yes. 

### 9 **DR. MIDDENDORF:** Julia. 

### 10 **DR. QUINT:** Yes. 

### 11 **DR. MIDDENDORF:** Bill. 

### 12 **DR. ROM:** Yes. 

### 13 **DR. MIDDENDORF:** Susan. Susan? 

### 14 **MS. SIDEL:** Yes, sorry. 

### 15 **DR. MIDDENDORF:** Okay. Glenn? 

### 16 **DR. TALASKA:** Yes. 

### 17 **DR. MIDDENDORF:** Leo? 

### 18 **DR. TRASANDE:** Yes. 

### 19 **DR. MIDDENDORF:** Liz? 

### 20 **DR. WARD:** Yes. 

### 21 **DR. MIDDENDORF:** And I don't think Virginia's with us anymore. Okay one, 

### 22 two, three, four, five, six, seven, eight, nine, te n, 11, 12, 13, 14 yeses. Zero no e s, zero 

### 23 abstain. Okay. Motion passes. 

### 24 **DR. WARD:** So I would propose that the next one we talk about is mental 

### 25 health research, and hopefully we have some suggested new language on that from 

### 26 Dr. North that we can

-- that Paul can email? 

### 27 **DR. MIDDENDORF:** Okay, well, do you want to take a quick break or do you 

### 28 want me to help out if we get the wording and I'll email it out, and then we'll take a 

### 29 short break? 

### 30 **DR. NORTH:** Good. 

### 31 **DR. MIDDENDORF:** Yeah, we're set up for a break a t 2:30 ; it’s already after 

### 32 2:30. Does that sound like a good plan, Liz? 

### 33 **DR. WARD:** That sound s fine. 

### 34 **DR. MIDDENDORF:** Okay. So we'll try to hammer out the language. Carol, do 

### 35 you have some suggestions? 

### 36 **DR. NORTH:** I would probably

-- thought was wh at I sent you before. Is that 

### 37 what we’re on ? I'm lost as to which document we're on. 

### 38 **DR. WARD:** Okay, we're on

-- I went back to the version 5 that Paul previously 

### 39

### 83

sent. 

### 1 **DR. NORTH:** Okay. 

### 2 **DR. WARD:** Where we have the list of all the general suggested topics. And I 

### 3 was going to try to consider them in order. So if anybody has time during the break to 

### 4 look at any of them and suggest

-- some of them

-- cl early several of them need word



### 5
s mi th ing. So if anyone wants to send any suggestions to Paul, they should. 

### 6 **DR. MIDDENDORF:** I would prefer that they not email anything to me. I think 

### 7 that the suggestions need to be made verbally. 

### 8 **DR. WARD:** Okay. Okay. So write them down so that you can read them off 

### 9 when we're back on the phone. 

### 10 Okay, so we'll go ahead an d take a ten

- minute break. 

### 11 **DR. MIDDENDORF:** Okay, and Carol is going to be thinking about wording for 

### 12 the mental health. 

### 13 **DR. NORTH:** I'm working on it. 

### 14 **DR. MIDDENDORF:** Okay, great. So what time are we returning? 

### 15 **DR. WARD:** My clock says now 2:38 , so I gu ess at 2:58, which is

-- no, that's 20 

### 16 minutes. 

### 17 **DR. MIDDENDORF:** Yeah, just do it 2:48? 

### 18 **DR. WARD:** Yeah, so yeah. 

### 19 **DR. MIDDENDORF:** Okay, 2:50. 

### 20 **DR. WARD:** Okay. Thanks. 

### 21 (R ecess in proceeding s, 2:38 until 2:50 p.m. ) 

### 22 23 **DR. MIDDENDORF** : Let’s begin. I’ve go t 2:50, and we have just a little over 

### 24 two hours left. Tom Aldrich, are you there? 

### 25 **DR. ALDRICH:** Yes. 

### 26 **DR. MIDDENDORF** : Okay. John Dement? 

### 27 **DR. DEMENT:** Yes. 

### 28 **DR. MIDDENDORF** : Kimberly Flynn? 

### 29 **MS. FLYNN:** Yes. 

### 30 **DR. MIDDENDORF** : Bob Harrison? 

### 31 **DR. HARRISON:** Ye s. 

### 32 **DR. MIDDENDORF** : Catherine Hughes? 

### 33 **MS. HUGHES:** Yes. 

### 34 **DR. MIDDENDORF** : Steve Markowitz? 

### 35 **DR. MARKOWITZ:** Yes. 

### 36 **DR. MIDDENDORF** : Guille Mejia? 

### 37 **MS. MEJ I**  **A:** Present. 

### 38 **DR. MIDDENDORF** : Carol North? 

### 39

### 84

**DR. NORTH:** Yes. 

### 1 **DR. MIDDENDORF** : Julia Quint? 

### 2 **DR. QUINT:** Yes. 

### 3 **DR. MIDDENDORF** : Bill Rom? (pause) Come back to Bill. Susan Sidel? 

### 4 **MS. SIDEL:** Here

. 

### 5 **DR. MIDDENDORF** : Glenn Talaska? 

### 6 **DR. TALASKA:** Present. 

### 7 **DR. MIDDENDORF** : Leo Trasande? 

### 8 **DR. TRASANDE:** Yes. 

### 9 **DR. MIDDENDORF** : Liz W ard? 

### 10 **DR. WARD:** Here

. 

### 11 **DR. MIDDENDORF** : And Virginia is gone, so one, two, three, four... W e 

### 12 have 13, and Bill, are you there? Okay. Well, we have 13, and so we have a 

### 13 quorum; we can continue on. 

### 14 15 **DISCUSSION OF RESEARCH NEEDS AND DEVELOPMENT OF** 

### 16 **RECOMMENDATIONS (continued)**  

### 17 **DR. WARD:** Okay. So Carol, did you have a proposed wording for item 

### 18 number 2? 

### 19 **DR. NORTH:** I'm ready. That's an (a) and a (b); (a) relates to exposure. 

### 20 Characterize the disaster

- related exposures that are associated with the 

### 21 development of specific psychiatric disorders. Y ou want me to proceed to (b)? 

### 22 **DR. WARD:** I think it would be good to do that. 

### 23 **DR. NORTH:** (b) is diagnosis. Differ entiate psychiatric disorders from 

### 24 symptoms and distress in relation to disaster exposures, comma. 

### 25 **DR. MIDDENDORF** : Okay, wait a minute . I g ot a little slow there

. 

### 26 Differ entiate psychiatric disorders... 

### 27 **DR. NORTH:** From symptoms and distress in relation to disaster exposure, 

### 28 comma, and develop efficient and effective methods

-- 

### 29 **DR. MIDDENDORF** : I'm sorry, develop what? 

### 30 **DR. NORTH:** Efficient a nd effective methods for diagnosis of 

### 31 disaster

- related psychopathology in populations and individuals. 

### 32 **DR. MIDDENDORF** : Okay. Do you want that as one motion or do you want 

### 33 these as separate motions? 

### 34 **DR. NORTH:** I don't care. 

### 35 **DR. WARD:** I think one thing w e could do is we could combine

-- I mean, we 

### 36 could have them as one motion and just have a, you know, a subhead such as 

### 37 research on mental health

-- World Trade Center

- related mental health disorders, 

### 38 and then we could have the two items included in that. And once an yone has

-- I 

### 39

### 85

think it would be better to combine it into one research area unless someone has a 

### 1 strong objection to doing that. 

### 2 **DR. NORTH:** I separated them simply because they were

-- responded to 

### 3 two different separate areas in the tasks tha t we were given in the original letter. 

### 4 **DR. WARD:** Which

-- what were the areas , then? The

-- accurate diagnosis 

### 5
was -- o kay

-- 

### 6 **DR. NORTH:** The first was identify gaps on understanding the effects of 

### 7 exposure, and the second

-- these are the charges. The second was , I guess , relative 

### 8 to accurate diagnosis. 

### 9 **DR. WARD:** Okay. Very good point . So let's do that, then. Let's includ e the 

### 10

-- only the one on item 1, and the voting and listing now, and then when we move 

### 11 on to Dr. Howard's item 2, we can include the other one. 

### 12 **DR. NORTH:** All right. Then I might mention that I didn't include anything 

### 13 on treatment because I didn't have strong feelings about it but other members may 

### 14 have some. 

### 15 **DR. WARD:** Right. No, we haven't even started on two yet. And you're 

### 16
r ight, it probably better belong there. 

### 17 Okay, so let's wrap up on the mental health research items for this list

. 

### 18 Paul, do you want to read it over one more time? 

### 19 **DR. MIDDENDORF** : Sure. What I have now is : Characterize the 

### 20 disaster

- related exposures tha t are associated with the development of specific 

### 21 psychiatric disorders. 

### 22 **DR. WARD:** My opinion would be that it might be better to keep that as a 

### 23 separate priority than to subsume it under exposure assessment , because it really is 

### 24 kind of a very unique obs ervation that Carol i s making , and she's also kind of saying 

### 25 that you may need to do a different exposure assessment, look at different 

### 26 psychiatric disorders, which it seems to me that that's enough of a unique concept 

### 27 to stand on its own as a research pri ority. 

### 28 **MS. SIDEL:** Coul d I ask a question? This is Susan . I don't know really 

### 29 understand this because , because they think it's better

-- I mean, we're asking them 

### 30 to look at other things

. But they don't see that there’ s a reason to look at other 

### 31 things. And so I don't understand how this would change that. 

### 32 **DR. WARD:** Well, this is a separate research priority. It's completely 

### 33 different from what we just discussed under item 1. 

### 34 **MS. SIDEL:** Yeah, I know. I mean, I know that but it came out of the whole 

### 35 thing of cognitive, you know, dealing with cognitive issues. 

### 36 **DR. WARD:** No, it didn’t . I think it came out of

-- I mean, I think I created

-- I 

### 37 said that maybe they were interrelated but I think this is a

-- this is a separate point 

### 38 that Dr. North was rai sing as a research priority. 

### 39

### 86

**DR. NORTH:** Yeah, certainly I didn't intend it for cognitive issues; I intended 

### 1 it for psychiatric illness. 

### 2 **MS. SIDEL :**  Okay. All right. Then, then I, I just

-- I just didn't understand it. 

### 3 'Cause we were talking about the c ognitive thing. And I thought that that's what

-- 

### 4 **DR. NORTH:** No, I thought it diverged from that. 

### 5 **MS**
**. SIDEL**  **:** I'm sorry; I couldn't understand you. What ? 

### 6 **DR. NORTH:** I diverged from that. 

### 7 **MS. SIDEL :**  Oh, I see, okay. So where is that going to go ? 

### 8 **DR. N ORTH:**  Either under exposures related to mental health or under 

### 9 mental health related to exposure s
. 

### 10 **MS. SIDEL :**  So is it gonna be

-- would that be part of 2? 

### 11 **DR. NORTH:** It could be. 

### 12 **MS. SIDEL :**  Wait. I think it should be separate , then , because I think t hat 

### 13 the problem is that it's not being recognized, and so it's gonna have to be spelled 

### 14 out

. Not as in, like somewhat

-- something's gonna, you know

-- if you ’re not 

### 15 schooled in that, it has to be pointed out. 

### 16 **DR. NORTH:** So I'm not sure I understand the question. Where are you 

### 17 suggesting we put it? Hello? 

### 18 **MS. SIDEL :**  I think it should be separate. 

### 19 **DR. NORTH:** Okay. Other number ? 

### 20 **MS. SIDEL :**  It should be

-- it should be raised as an issue. I mean, t he issue 

### 21
was that they 're not looking at cognitive iss ues that are not caused by PTSD; they 

### 22 were actually caused because something happened to your brain as a result of being 

### 23 exposed to toxins. That would

-- I thought that the cognitive

-- the woman that 

### 24 spoke today, that's what she was talking about , and I thought that we would be 

### 25 addressing that , that issue. 

### 26 **DR. NORTH:** Well, it’s probably going to be more relevant to certain 

### 27 medical conditions. My point earlier was there are different kinds of exposures that 

### 28 would be pertinent to mental health conditions. 

### 29 **DR. WARD:** Can I say

-- I mean, my sugges tion would be that Dr. North 

### 30 mak e the motion

-- at this point I don't think we can continue to

-- I mean, I think 

### 31 we have to take these one by one, agree that they are a research priority, and then 

### 32
move on to the n ext research priority. B ecause otherwi se we're not going to get 

### 33 past the first item in the agenda. So I think if Dr. North wants to make that as a 

### 34 motion, and then we have a second, then we could

-- the committee could vote on 

### 35 it as whether we see it ove rall as a research priority, not necessarily ranking it as the 

### 36 most important but that it is one of the research priorities that this committee 

### 37 recommends as a critical gap in knowledge

. 

### 38 **MS. SIDEL :**  So you're basically saying that we're going to have like a laundry 

### 39

### 87

list of things that are possible things that should be looked into, you know. 

### 1 **DR. WARD:** Well, I don't think it's going to be a laundry list, 'cause I think 

### 2 we already have

-- I mean , we're going back to version number 6 that Paul sent 

### 3 around , wh ich has somewhere between six and seven teams. Now, the cognitive, 

### 4 cognitive health effects, I think, was originally subsumed as an example under bullet 

### 5 1, which we've already voted on , with taking out the bullets. 

### 6 So I guess we still will need to discu ss -- it's clear that Dr. North does not feel 

### 7 that cognitive issues belongs in the same priority area as the mental health 

### 8 research. 

### 9 **DR. NORTH** : It might sometimes. 

### 10 **MS. SIDEL** : But what mental health are they doing right now? I just don’t 

### 11 understand it. 

### 12 **DR. WARD:** It might sometimes but it might not sometimes so Carol, you 

### 13 have to decide if you want it in

-- write a broader bullet that includes the cognitive 

### 14 research or, if not, then we have to handle the cognitive research as a separate 

### 15 bullet. 

### 16 I don' t know how many committee members feel strongly that that belongs 

### 17 on the list but I think we are going to need to take specific propo sals for research 

### 18 gap areas one by one, but recognize that, you know, I was assuming that we were 

### 19 down to six or seven, tha t we were word

- smithing. 

### 20 **DR. NORTH :**  We can't subsume all cognitive disorders in psychiatric 

### 21 disorders. 

### 22 **DR. WARD:** We can't but we could

-- I mean, if we wanted to

-- 

### 23 **MS. SIDEL :**  She's talking about a very specific thing. She's talking people 

### 24 that are act ually found of having been exposed to toxins , that they're having 

### 25 cognitive issues

. 

### 26 **DR. WARD:** Because one person on a -- because one person in the public 

### 27 has testimony suggested that it's a research priority does not mean that the 

### 28 committee, as a whole, i s going to

-- 

### 29 **MS. SIDEL :**  Okay, I

-- 

### 30 **DR. WARD:**

-- request it as a research priority. So I don't know how we get 

### 31 to the point where we have a substantive discussion on that but I do recognize that 

### 32 that was what the public

-- the participant from the publi c was advocating for. I just 

### 33

-- 

### 34 **MS. SIDEL :**  Right. I don't think it's just one person . I know a lot of people 

### 35 that have those issues. And I think it's very common and I think that usually people 

### 36 are told that it's part of post

- traumatic stress disorder, and maybe it's not. And then 

### 37 it just doesn't get treated. 

### 38 **DR. NORTH:**  This is Carol, can I

-- 

### 39

### 88

**MS. SIDEL** : It's a cognitive issue. 

### 1 **DR. NORTH:** Can I respond to that? I'm thinking of psychiatric disorders in 

### 2 terms of exposure to trauma. I think that c ognitive disorder s in relation to exposure 

### 3 to toxins is a different set of condition s
. 

### 4 **MS. SIDEL :**  Right. I think that's what she's talking about , is as associated to 

### 5 toxins, not as being exposed to trauma. 

### 6 **DR. NORTH:** Right. That would not relate to m y point. 

### 7 **MS. SIDEL** : -- and you know, she's probably had a neuropsych test. I know a 

### 8 lot of people that have had neuropsych tests. I know the NYPD does them. And , 

### 9 you know, the results are that people are damaged. They don't have the same 

### 10 brains that they went in

-- that they went into, you know, they went to the World 

### 11 Trade Center with. 

### 12 **DR. NORTH:** Right. I don't conceptualize that as part of the psychiatric 

### 13 disorder s I'm talking about. 

### 14 **DR. WARD:** Right , so what I'm saying is let's start on

-- let's let Carol make a 

### 15 motion on the ones she's talking about , and maybe Carol can help us phrase one 

### 16 that Susan's talking about in more

-- you know, in the appropriate technical 

### 17 language . A nd then we can take a vote on whether the committee feels that that

-- 

### 18 that it wants to recommend that as a research gap of priority. 

### 19 **DR. NORTH :**  I'll be glad to help with that. 

### 20 **DR. WARD:** Okay. 

### 21 **DR. NORTH:** May I move that we vote on , I guess, acceptance of number 9 

### 22 as it is worded ? Do I need to repeat it? 

### 23 **DR. MIDDENDORF** : Okay, it's actually motion number 2 , and the wording I 

### 24 have is: Characterize the disaster

- related exposures that are associated with the 

### 25 development of specific psychiatric disorders. 

### 26 **DR. NORTH:** That's it . Thank you. 

### 27 **DR. WARD:** Do I have a second? 

### 28 **MS. ME**  **J I**  **A:** Second. This is Guille. 

### 29 **DR. WARD:** So let's call for a vote. 

### 30 **DR. MIDDENDORF** : Okay. Tom Aldrich on motion number 2? 

### 31 **DR. ALDRICH:** Vote yes. 

### 32 **DR. MIDDENDORF** : John Dement? 

### 33 **DR. DEMENT:** Yes. 

### 34 **DR. MIDDENDORF** : Kimberly Flynn? 

### 35 **MS. FLYNN:** Yes. 

### 36 **DR. MIDD ENDORF**  : Bob Harrison? Bob, did you say something? I'll come 

### 37 back to you, Bob. Catherine Hughes? 

### 38 **MS. HUGHES:** Yes. 

### 39

### 89

**DR. MIDDENDORF** : Steve Markowitz? 

### 1 **DR. MARKOWITZ:** Yes. 

### 2 **DR. MIDDENDORF** : Guille Mej i a? 

### 3 **MS. ME J**  **I A:**  Yes. 

### 4 **DR. MIDDENDORF** : Carol North? 

### 5 **DR. NORTH:**  Yes. 

### 6 **DR. MIDDENDORF** : Julia Quint? 

### 7 **DR. QUINT:** Yes. 

### 8 **DR. MIDDENDORF** : Bill Rom? 

### 9 **DR. ROM:** Yes. 

### 10 **DR. MIDDENDORF** : Susan Sidel? 

### 11 **MS. SIDEL:** Yes. 

### 12 **DR. MIDDENDORF** : Glenn Talaska? 

### 13 **DR. TALASKA:** Yes. 

### 14 **DR. MIDDENDORF** : Leo Trasande? 

### 15 **DR. TRASANDE:** Yes. 

### 16 **DR. M IDDENDORF**  : And Liz W ard? 

### 17 **DR. WARD:** Yes. 

### 18 **DR. MIDDENDORF** : Okay. I'm assuming Virginia's still not with us. There 

### 19
were 1, 2, 3, 4, 5, 6, 7, 8, 9, 10

-- Bob Harrison, are you still there? I'm not hearing 

### 20 Bob. We have 13 yeses, zero noes and zero abstent ions. Okay. 

### 21 **DR. WARD:** Okay, so then, I think the next order of business would be to 

### 22 articulate a motion or a statement that we can vote on regarding research on 

### 23 cognitive disorders related to toxic exposures in World Trade Center populations. 

### 24 **DR. ALDRICH :**  This is Tom Aldrich. I still think that's part of number 1, and if 

### 25 a researcher identifies cognitive disorders as an issue to study, they'll study it. 

### 26 **DR. WARD:** Well, I guess what we need to do is figure out a way to get a 

### 27
sense -- overall sense of t he committee. So we've heard Susan advocating that it is 

### 28 an important priority on its own. And I think the way

-- and we've also heard a 

### 29 number of people saying that, you know, it rightly belongs as a

-- you know, 

### 30 something that could be under item 1 . B ut I guess at this point we need a motion 

### 31 and a vote , because we have different viewpoints having been expressed on the 

### 32 committee, so I was thinking if we could have a motion to include it, then we can 

### 33 take a vote as to whether we want to include it. We c an have a discussion and a 

### 34 vote as to whether we want to include it as a separate research priority. 

### 35 **DR. NORTH**  **:** This is Carol. I would vote to put it as part of number 1 , as part 

### 36 of the medical conditions, and I would like to make that motion. 

### 37 **DR. WARD:** And just to clarify, we won't call it out specifically but it will be 

### 38 understood that it would be one of the conditions that we include under item 1. 

### 39

### 90

**MS. SIDEL:** All right. This is Susan. I don't understand how it would be 

### 1 understood if it's not spelled out. Hello? Can you hear me ? 

### 2 **DR. ALDRICH**  : I don't think it has to be spelled out. 

### 3 **MS. SIDEL:** I'm, I'm confused. I mean are you saying that we need to have 

### 4 number 1 , and then it'll say something about you're going to use the word cognitive 

### 5 disorders a s caused by toxins? Or

-- 

### 6 **DR. ALDRICH**  : Number 1 stands as number 1 , and i t’ s one of many 

### 7 potentially previously unrecognized health conditions. 

### 8 **DR. MIDDENDORF :**  Allen stated that one of the things that will happen is 

### 9 that when they go to put together the funding announcements, they will look at the 

### 10 specific motions and then they'll also look at the transcript to try and get a sense of 

### 11 what the committee was intending with that. 

### 12 **MS. SIDEL:** You know, I just give up. I mean... 

### 13 **DR. WARD:** Okay, well, Carol has made a motion

-- essentially it's kind of

-- I 

### 14 guess it's hard to make a motion. I'm not sure the motion is actually vote

- able i n 

### 15 the way it was made. So I think maybe it is easier to just say, Susan makes a motion 

### 16 to include it as a separate priorit y area , and the, and the assumption we're voting on 

### 17 is that if it's not

-- if that, if that does not get voted by the majority on the 

### 18 committee, then the sense of the committee is that it is included as one of the 

### 19 potential diseases to be studied under rec ommendation 1. 

### 20 **MS. SIDEL :**  So nobody on the committee thinks that something could 

### 21 happen to your brain from being exposed to toxins, so that the reason people are 

### 22 having cognitive issues is because of PTSD or because they're depressed? 

### 23 **DR. NORTH:** This is Carol. No, I think that that's the reason to include it 

### 24 under number 1 , to separate it from the psychiatric disorders

-- 

### 25 **MS. SIDEL:** But I don't understand how you're going to include it. I mean, if 

### 26 you're not going to say it. If you're not going to say

-- I mean, I don't understand

-- I 

### 27 guess what I'm saying is like, what do you mean by include it? You're going to say 

### 28 the words cognitive , you know, issues as

-- 

### 29 **DR. WARD:** No

. I think that's not

-- we're not

-- 

### 30 **MS. SIDEL :**  I mean, that sounds very vagu e because that's not inclu

-- you 

### 31 know, not saying anything is not including it. That's like

-- nobody reads the notes of 

### 32 what the committee meant

. 

### 33 **DR. WARD:** But I don't think aside from

-- I mean, they're

-- what we're 

### 34 trying to do is capture things tha t the majority of the people on the committee think 

### 35 are important , critical research knowledge gap s . And so far the only person who, 

### 36 who has advanced the viewpoint that that particular topic should be on the list of 

### 37 critical research knowledge gaps is you

. 

### 38 **MS. SIDEL :**  All right, so then let's move on

-- 

### 39

### 91

**DR. WARD:** Is there an yone else who supports that or if not, w e probably 

### 1 should move on. 

### 2 **DR. MARKOWITZ:** This is Steven Markowitz. Actually I would argue against 

### 3 any -- naming any particular condition at this point, given what we know. So it's not 

### 4 just cognition but I would make the same statement for renal diseases or whatever. 

### 5 They are subsumed under newly emerging conditions. 

### 6 **DR. NORTH:** I agree. 

### 7 **DR. MARK O**  **WITZ:** What we need is a sensitive enough su rveillance system 

### 8 to be able to pick up concerns like Susan's. If, if

-- 

### 9 **MS. SIDEL:** You know what, they're not really emerging conditions, though. 

### 10 They've been here for a long time and it's just been ignored. So there's a lot of 

### 11 people that have been s uffering for a lot of years, and unless they have the money 

### 12 to go be treated by outside doctors, they're not being treated . O r I know people 

### 13 that are in the volunteer program as, you know, like that's the committee. I got a 

### 14 connect iv e tissues disease cov ered as related to, you know, World Trade Center 

### 15 exposure s, because I had the medical, you know, the medical s support it. And, you 

### 16 know, workers' comp, when all of them were in New York, they sent me to five 

### 17 different doc

-- you know, rheumatologists. I couldn't find one to say that, you 

### 18 know, to disagree with my doctor who said that this is a result of my exposure. And 

### 19 I know a lot of other people that are -- have similar situations to mine

. They just 

### 20 have finances to go on their own to a rheumatologis t to be treated. And then when 

### 21 the

-- when the volunteer program ends, in 2016, because they're gonna, you know, 

### 22 be out of money, then, you know, somebody like me, I'm not gonna have treatment. 

### 23 And i t's not fair because it's, you know, the issue and

-- a t my very first appointment 

### 24 in 2002

. 

### 25 **DR. WARD:** You know, t he other point for everyone is a lot of the other 

### 26 bullet points

-- or the other recommendations that we haven't gotten to talk about , 

### 27 there was one related to biomarkers; there was one related very broadly to immune 

### 28 system disorders, which would include autoimmune diseases, which , you know, I 

### 29 think there's a

-- there's more support in the

-- there may be more support in the 

### 30 community that that is a category of diseases that we really do need to call out as a 

### 31 research priority. There's one on vulnerable populations including those exposed 

### 32 during gestation, childhood and adolescence. And then there's one on exposure 

### 33 assessment. 

### 34 So I mean, from a viewpoint of efficiently doing our jobs, I would sugg est 

### 35 that we table the discussion of cognitive disorders for now and move on to immune 

### 36 system disorders, and that

-- well, we could move on to biomarkers

-- 

### 37 **DR. NORTH:** What about the other mental health issues? 

### 38 **DR. WARD:** Well, we need to take a vote on th at, right. 

### 39

### 92

**DR. NORTH:** The diagnosis statement that we haven't discussed yet? 

### 1 **DR. WARD:** That one, I think, we want to

-- we want to vote on when we're 

### 2 down to the second. You pointed out correctly that that's related to the accurate 

### 3 diagnosis, which is u nder the second

-- 

### 4 **DR. NORTH:** Okay, that's the other thing. 

### 5 **DR. WARD:** Yeah, no, I've been lost but I think that's where it belongs and 

### 6 I'm more

-- you know, but I think, you know, our immediate order of business 

### 7 should be to finalize our recommendations in relation to area 1, and then move on 

### 8 to area 2 and hope that, that we've learned enough through this process that we 

### 9 can really narrow down the

-- the second, third and fourth area more quickly , and 

### 10 come to consensus. 

### 11 **DR. NORTH :**  Good, I got it. I'm fo llowing that, thank you. 

### 12 **DR. WARD:** It's also an

-- you know, we also do have the option easily of 

### 13 saying, you know, putting in the committee recommendations that there was 

### 14 debate about whether research on cognitive disorders related to toxins should be 

### 15 in cluded on the list. And you know, we can include those topics that we discussed 

### 16 but didn't come to consensus on for the sake of completeness. 

### 17 But I suggest we move on and take a vote on the proposal for the second 

### 18 recommendation under category 1. If Paul will read it to us one more time. We 

### 19 have a

-- we did have a second on that motion, I think. 

### 20 **DR. MIDDENDORF** : On which motion? Oh, you mean the differentiate 

### 21 psychiatric disorders? 

### 22 **DR. WARD:** No, no. We're

-- I don't think we vot ed on the motion by Car ol 

### 23 that belongs in this section. 

### 24 **DR. MIDDENDORF** : Characterize the disaster

- related exposures? 

### 25 **DR. WARD:** Right. 

### 26 **DR. MIDDENDORF** : Yeah, we have a vote, 13

- 0

- 0

. 

### 27 **DR. WARD:** We have? Okay, good, we're done with that one, okay. 

### 28 Moving on, we're tabl ing cogni tive discussion for now, and we're moving on to 

### 29 biomarkers. 

### 30 **MS. FLYNN:** Liz? 

### 31 **DR. WARD:** Yes. 

### 32 **MS. FLYNN:** This is Kimberly. I don't know if this helps or not but would it 

### 33 be possible, before we move on to biomarkers, for perhaps Dr. Markowitz to frame 

### 34 a pr oposal around symptom surveillance? 

### 35 **DR. MARKOWITZ:** This is Steve Markowitz. No, l et's do biomarkers. We'll 

### 36 get to surveillance. 

### 37 **MS. FLYNN:** Okay. So we gotta come back to symptom surveillance 

### 38 because that is at the bottom of many a complaint from survi vors and responders. 

### 39

### 93

**MS. SIDEL:** It was supposed to be strengthened , I thought, like three years 

### 1 ago. 

### 2 **DR. WARD:** Okay, so on biomarkers , has anyone had time to try to frame

-- 

### 3 **DR. ALDRICH:**

-- s uggested word ing for biomarkers

-- this is Tom Aldrich. 

### 4 **DR. W ARD:**  Okay. Go ahead. 

### 5 **DR. ALDRICH:** This is possibly only a part of it because it doesn't include the 

### 6 issue about long

- lived biomarkers as a measure of exposure, which, I think, maybe 

### 7 ought to be a separate thing because it's not

-- it's more about exposu re than about 

### 8 biomarkers so this is excluding that. 

### 9 What I suggest is : Determine the value of biomarkers for early detection of 

### 10 precancerous conditions, comma

-- 

### 11 **DR. MIDDENDORF** : Wait a minute. Early detection

-- 

### 12 **DR. ALDRICH:**

-- of precancerous condition s, comma, early cancers, comma, 

### 13 or other World Trade Center

-- or other WTC

- associated diseases. 

### 14 **DR. MIDDENDORF** : You said associated, not related, okay. 

### 15 **DR. ALDRICH:** Either one, it doesn't matter. 

### 16 **DR. MIDDENDORF** : Well, t hese are your words. 

### 17 **DR. ALDRICH:** Yeah, that's it. 

### 18 **DR. WARD:** Okay, do we have a second on that motion? 

### 19 **MS. SIDEL :**  I 'll second. 

### 20 **DR. TALASKA:** Second. 

### 21 **DR. WARD:** Any discussion? 

### 22 **MS. SIDEL:** No. 

### 23 **DR. WARD:** Okay. I guess we'll move to a vote? 

### 24 **THE COURT REPORTER:** I'm sorry, could I get w ho seconded, please? 

### 25 **DR. WARD:** Who seconded it? 

### 26 **DR. TALASKA:** Glenn Talaska. 

### 27 **THE COURT REPORTER:** Thank you. 

### 28 **MS. SIDEL:** Oh, I

-- whatever. 

### 29 **DR. MIDDENDORF:** And Susan. Both of them seconded it, so. 

### 30 **THE COURT REPORTER:** Okay, thank you. 

### 31 **DR. MIDDENDORF** : S o, are we r eady for a vote? Okay, the wording on the 

### 32 motion is: Determine the value of biomarkers for early detection of precancerous 

### 33 conditions, early cancers, or other WTC

- associated diseases. Is e verybody ready for 

### 34 the vote? 

### 35 **DR. WARD:** Yes. 

### 36 **DR. MIDDE NDORF**  : Tom Aldrich? Tom, did you say something? 

### 37 **DR. ALDRICH:** Oh, I vote yes. 

### 38 **DR. MIDDENDORF** : Okay. John Dement? 

### 39

### 94

**DR. DEMENT:** Yes. 

### 1 **DR. MIDDENDORF** : Kimberly Flynn? 

### 2 **MS. FLYNN:** Yes. 

### 3 **DR. MIDDENDORF** : Bob Harrison? Okay, Catherine Hughes? 

### 4 **MS. HUGHES:** Ye s. 

### 5 **DR. MIDDENDORF** : Steve Markowitz? 

### 6 **DR. MARKOWITZ:** Yes. 

### 7 **DR. MIDDENDORF** : Guille Mej i a? 

### 8 **MS. ME J**  **I A:**  Yes. 

### 9 **DR. MIDDENDORF** : Carol North? 

### 10 **DR. NORTH:** Yes. 

### 11 **DR. MIDDENDORF** : Julia Quint? 

### 12 **DR. QUINT:** Yes. 

### 13 **DR. MIDDENDORF** : Bill Rom? 

### 14 **DR. ROM:** Yes. 

### 15 **DR. MIDDENDORF** : Susan Sidel? 

### 16 **MS. SIDEL:** Yes. 

### 17 **DR. MIDDENDORF** : Glenn Talaska? 

### 18 **DR. TALASKA:** Yes. 

### 19 **DR. MIDDENDORF** : Leo Trasande? 

### 20 **DR. TRASANDE:** Yes. 

### 21 **DR. MIDDENDORF** : Liz Ward? 

### 22 **DR. WARD:** Yes. 

### 23 **DR. MIDDENDORF** : Okay, 1, 2, 3, 4, 5, 6, 7, 8, 9... 13 yes, zero no, zero 

### 24 ab stain. 

### 25 **DR. WARD:** Okay, so the next one on the list is immune system disorders 

### 26 that cover sarcoidosis, malignancy, auto immune diseases as a broad category. Has 

### 27 anyone come up with better wording for that? 

### 28 **DR. ALDRICH:** Let me ask, does the long

- lived biom arkers, which I really like 

### 29 that concept, but that's going to be a part of number 7, right, or the last one on the 

### 30 list, the exposure assessment? 

### 31 **DR. WARD:** I think that's what was proposed. 

### 32 **DR. ALDRICH:** Good. 

### 33 **DR. WARD:** So I mean, there is the question of whether we want to 

### 34 highlight any specific disease category in these recommendations. We did highlight 

### 35 mental health condition s
. So I had a feeling that there wa s support from a number 

### 36 of people on the immune system disorders; is that correct? 

### 37 **DR. A**  **LDR ICH**  **:** I personally think, to be consistent , w e should say this is all 

### 38 part of 1 , and not talk about it separately. 

### 39

### 95

**DR. WARD:** Okay, so i s there anyone who disagrees with that perspective? 

### 1 **MS. SIDEL:** I don't

-- I don't understand what you mean by that. Wh at do

-- 

### 2 what do you mean that it's all part of 1? 

### 3 **DR. A**  **LDRICH :**  This w ould be one of those newly emerging health conditions 

### 4 that refer to in motion 1

. 

### 5 **MS. SIDEL:** But you're not going to say what it is? 

### 6 **DR. A**  **LDRICH :**  No , because I think it's up to the res earcher s to focus on 

### 7 what they think are important , and convince us or convince the

-- 

### 8 **MS. SIDEL:** Okay. 

### 9 **DR. A**  **LDRICH :**  -- the review committee, whoever's going to be reviewing 

### 10 the applications, that they made a good case for it. And if it

-- if someone ma kes a 

### 11 really, really good case that hang nails are associated with the World Trade Center, 

### 12 they should be funded. It's a matter of who can make a good case for something, 

### 13 not some preconceived idea about what's important. 

### 14 **MS. SIDEL:** Well, there we re prec onceived ideas about what was important 

### 15 from the very beginning of the program, when they decided what they were gonna 

### 16 cover and what they weren't gonna cover . And just because something like 

### 17 autoimmune diseases wasn't on that list it wasn't because they didn't exist or 

### 18 because people didn't have them , it was because it wasn't something that was being 

### 19 checked and it wasn't being recorded

. 

### 20 **DR. A**  **LDRICH :**  But I just

-- it was

-- 

### 21 **MS. SIDEL:** And so it

-- okay, but ( indiscernible )

-- 

### 22 **DR. A**  **LDRICH :**  -- ( indiscern ible ) emerging

-- newly emerging disease s. 

### 23 **MS. SIDEL:** But it's not newly emerging; it's been there, and all I'm saying is 

### 24 that, with 13 years out and nobody has come close to dealing with this. The first 

### 25 time that it was

-- that anything was ever like re mo tely close was the discussion of 

### 26 inflammation in the Dr. Prezant ’s article. And that was like, you know, when you 

### 27 discuss inflammation, you know, the underlying, underlying

-- all of the 

### 28 ( indiscernible ) things that we had and, you know, that are associa ted with cancer, 

### 29 and it's, you know, it's a big part of autoimmune diseases. So

-- 

### 30 **DR. AL**  **DRICH :**  Yeah, I think that, that work is being done. It's being done 

### 31 with the, the autoimmune surveillance program at the FDNY that 's funded by NIOSH 

### 32 last year, and it is a late

- emerging disease. It wasn't one of the early emerging 

### 33 things. Yes, there were some people who had polymyositis as a related condition

-- 

### 34 **MS. SIDEL:** It was late because it wasn't recognized. 

### 35 **DR. A**  **LDRICH :**  But a few cases out of many thousand s is not something you 

### 36 can study. Now there are many cases and now they can be studied but it's not

-- it's 

### 37 not a neglect that led them not to be studied. It's that they were

-- they had not 

### 38 emerged in enough volume to be studied back then. 

### 39

### 96

A nd now the y are being studied. And I don't think that we should

-- you 

### 1 know, that's why I

-- I kind of feel like cognitive issues are more -- are less 

### 2 recognized than autoimmune. Maybe that's because they're not related to World 

### 3 Trade Center but they're not

-- aut oimmune diseases are being recognized. They're 

### 4 not recognized to the point that they can be included in the Health Program . But 

### 5 the whole point of this research is to find out if they

-- if they should or should not 

### 6 be included. And that's

-- and resear ch is being done. The research will be 

### 7 encouraged by item 1, research into cognitive issues , research into autoimmune 

### 8 diseases, research into all kinds of new areas, so

-- 

### 9 **MS. SIDEL:** But the thing is that we haven't had any new areas for a long 

### 10 time, a l ong, long time. 

### 11 **DR. WARD:** Let me just cut in, so we're

-- we're just having a debate 

### 12 between two people in this and I guess I'd like to hear what other people think . At 

### 13 this point

-- 

### 14 **DR. MARKOWITZ:** This is Steve Markowitz

-- 

### 15 **DR. WARD:** Yeah. 

### 16 **DR. MARKOWI TZ:**  So, I think it's sort of a Catch

- 22, right? Some of these 

### 17 aren't looked at until it provides a strong enough signal but it doesn't provide a 

### 18 signal until it's looked at. So I think what we

-- I think between the, the first priority 

### 19 we discussed, whi ch was newly emerging and previously unrecognized. And then I 

### 20 think when we get to something, a proposal on a more sensitive surveillance 

### 21 system, so that it's more likely that problems will be picked up, like Susan's 

### 22 discussing. Between those, I think, t hen, it'll cover this issue. 

### 23 **DR. A**  **LDRICH :**  But won’t there be a preamble to the list of priorities? 

### 24 **DR. WARD:** Here's the thing, a ny text that we want to convey has to be 

### 25 discussed and approved during this meeting. So if we want to talk about a 

### 26 preamble, we have to come up with draft text for the preamble. 

### 27 Now, I apologize 'cause I feel like we're not

-- I mean, I don't think we , for 

### 28 various reasons including technical circumstances, I don't feel like we're in the 

### 29 most

-- I think this meeting is n’t the mos t conducive way to come up with the best 

### 30 set of recommendations , but within the technology constraints that we have , p retty 

### 31 much we have to agree on final text in the cour se of this meeting. So if any body 

### 32 wants to propose a preamble, they should probably think about how they would 

### 33 want to word it while we're talking so that w e can consider it as a committee and 

### 34 vote on it. 

### 35 **MS. SIDEL:** I just feel like it's redundant. We just, we just

-- we're asking 

### 36 people to do what they're supposed to do. They're suppo sed to research new and 

### 37 emergent

-- emerging things. It doesn't have to be said, but it's not being done. 

### 38 **DR. A**  **LDRICH :**  Yes, but we cannot

-- 

### 39

### 97

**MS. SIDEL:** And it could be done

. 

### 1 **DR. A**  **LDRICH :**  We cannot point out things for study for which there is no 

### 2 eviden ce. 

### 3 **DR. MARKOWITZ:** You know, I think actually we just have a

-- this is Steve 

### 4 Markowitz

-- we have a disagreement here. And I don't think we're gonna actually 

### 5 breach this. I don't think we're gonna solve this disagreement. So

-- because the 

### 6 same points of view

-- and I don't mean any disrespect here

-- but are being 

### 7 repeatedly expressed. So I think either we formulate a specific proposal that can be, 

### 8 you know, we accept it or reject it or we move on. 

### 9 **DR. WARD:** This is Liz; I agree. 

### 10 **MS. SIDEL:** Well, i s this a court for suggesting that more research needs to 

### 11 be done in the area of autoimmune diseases related to the World Trade Center? 

### 12 **DR. NORTH:** I don't think we ought to single it out. This is Carol. 

### 13 **DR. DEMENT:** This is John Dement. I think it's und er item 1 in surveillance , 

### 14 as Steve has talked about as well. 

### 15 **MS. ME J**  **I A:**  This is Guille . I also agree that it's covered under item 1. 

### 16 **DR. TALASKA:** Glenn Talaska, the same. 

### 17 **DR. WARD:** Okay, so, so unless , you know, unless Susan, you want to make 

### 18 a speci fic, you know, motion, and then we have a

-- see if we have a second, and 

### 19 take a vote , I think we can table the issue ' cause it

-- at least to me it doesn't seem 

### 20 like there's a great deal of support for calling this out as a priority research area. 

### 21 **MS. SID EL:**  I don't think it's worth it for me to come up with a motion 

### 22 because it's not gonna get passed, so

... 

### 23 **DR. WARD:** Okay, thank you . So the next general area we have on the list is 

### 24 health effects of exposure to vulnerable populations with specific emphas is on 

### 25 children exposed during gestation, people exposed during childhood and 

### 26 adolescence. Does someone want to make a motion for the wording on that? 

### 27 **DR. ALDRICH:** I think the wording

-- the most recent wording is reall y, really 

### 28 good: Assess health e ffec ts of exposure on gestation and early life , paren, 

### 29 childhood and adolescence , end paren . I think that's perfect. 

### 30 **MS. FLYNN:** And

-- this is Kimberly. Would we include the biomarkers of 

### 31 exposure point here? 

### 32 **DR. ALDRICH:** My view is that belongs after the next one. 

### 33 **MS. FLYNN:** Okay. 

### 34 **DR. ALDRICH:** T he next one. 

### 35 **MS. FLYNN:** Okay. 

### 36 **DR. WARD:** I think that was the viewpoint I heard earlier from most people, 

### 37 that

-- or from several people, that we should include it under the exposure 

### 38 assessment. So d o we have a second on the motion for the item number 6? 

### 39

### 98

**DR. NORTH:** I ’ll second it. This is Carol. 

### 1 **DR. WARD:** Okay. Paul, should we go to a vote? 

### 2 **DR. MIDDENDORF** : Yeah, this is motion number 4. It is: Assess health 

### 3
e ffect s of exposure on ge station and early life , in parentheses, childhood and 

### 4 adolescence. 

### 5 I'll give people a second to think about that. And then I'll get to Tom 

### 6 Aldrich? 

### 7 **DR. ALDRICH:** Is it WTC exposure or just exposure? 

### 8 **DR. MIDDENDORF** : The wording only says exposure at this point. 

### 9 **MS. FLYNN :**  I a ccept the friendly amendment of World Trade Center 

### 10 expo sure 'cause this is what this i s all about

. 

### 11 **DR. WARD:** Yes. 

### 12 **DR. ALDRICH:** With that amendment, I vote yes. 

### 13 **DR. MIDDENDORF** : Was that amendment seconded? 

### 14 **DR. NORTH:** I 'll second, Carol. 

### 15 **DR. MIDDENDORF** : Okay. So Tom Aldrich? 

### 16 **DR. ALDRICH:** Yes. 

### 17 **DR. MIDDENDORF** : John Dement? 

### 18 **DR. DEMENT:** Yes. 

### 19 **DR. MIDDENDORF** : Kimberly Flynn? 

### 20 **MS. FLYNN:** Yes. 

### 21 **DR. MIDDENDORF** : Bob Harrison? Catherine Hughes? 

### 22 **MS. HUGHES:** Yes. 

### 23 **DR. MIDDENDORF** : Steve Markowitz? 

### 24 **DR. MARKOWI TZ:**  Yes. 

### 25 **DR. MIDDENDORF** : Guille Mej i a? 

### 26 **MS. MEJ I**  **A:** Yes. 

### 27 **DR. MIDDENDORF** : Carol North? 

### 28 **DR. NORTH:** Yes. 

### 29 **DR. MIDDENDORF** : Julia Quint? 

### 30 **DR. QUINT:** Yes. 

### 31 **DR. MIDDENDORF** : Bill Rom? 

### 32 **DR. ROM:** Yes. 

### 33 **DR. MIDDENDORF** : Susan Sidel? 

### 34 **MS. SIDEL:** I'm sorry, yes. 

### 35 **DR. MIDDENDORF**  : Glenn Talaska? Leo Trasande? Liz Ward? 

### 36 **DR. WARD:** Yes. 

### 37 **DR. MIDDENDORF** : Okay. I'm gonna go back and check to see whether or 

### 38 not

-- Bob Harrison, are you there? I'm hoping this isn't a problem with just not 

### 39

### 99

being able to speak. Glenn Talas ka? 

### 1 **DR. TALASKA:** I voted yes. 

### 2 **DR. MIDDENDORF** : Leo Trasande? Okay, I didn't hear anything from Leo or 

### 3 Bob. 

### 4 **DR. TALASKA:** You got mine, though, right? 

### 5 **DR. MIDDENDORF** : T hat was Glenn? 

### 6 **DR. TALASKA:** Yes. 

### 7 **DR. MIDDENDORF** : Yes, I got your yes. 

### 8 **DR. WARD:** S o Paul, maybe you should ask if Leo or Bob are having trouble 

### 9 speaking, they should email you or something? 

### 10 **DR. MIDDENDORF** : Yeah, they

-- usually they do. 

### 11 **DR. WARD:** Okay. 

### 12 **DR. MIDDENDORF** : So that's one of the things I've been monitoring. 

### 13 **DR. WARD:** Okay, s o we have the last bullet or the last item on the list is 

### 14 related to exposure assessment. And I'm hoping that someone has some draft 

### 15 language. 

### 16 **DR. A**  **LDRICH :**  I have a s uggestion for that. Unfortunately I don't think it's 

### 17 quite complete because it doesn't address the special issues or separate psychiatric 

### 18 exposures and i t doesn't address the long

- term, long

- lasting b iomarker issue, and I 

### 19 think thos e should be addressed. But aside from that, if we say: improved WTC 

### 20 exposure quant ification : inhaled, topical , ingested, psychological or other. 

### 21 **DR. MIDDENDORF** : Okay, I'm gonna ask you to repeat all that. 

### 22 **DR. A**  **LDRICH :**  Improved WTC exposure quantification, colon, inhaled, 

### 23 topical, ingested, psychological or other. 

### 24 **DR. MIDDENDORF** : Okay. 

### 25 **DR. NORTH:** Could I make a suggestion

-- this is Carol. We've got the 

### 26 mental health stuff separately. Could we take it out of this? Because psychological 

### 27 exposure is an odd conflict. 

### 28 **DR. ALDRICH**  : Yeah, let's take it out and let's do a motion

-- motion 6 that 

### 29 says something abou t the separate qua nti fication of physical and nonphysical 

### 30 exposures. 

### 31 **MS. FLYNN:** This is Kimberly. Can I just

-- can I please ask what's entailed by 

### 32 quantification in this instance ? 

### 33 **DR. A**  **LDRICH :**  My view is that it's been extremely murky to understand how 

### 34 to quantify an individual's exposure, and that the only

-- the only techniques have 

### 35 been extremely crude, and if some smart people can come up with better ways of 

### 36 doing it, that would be very valuable. This may be an impossible goal. 

### 37 **DR. WARD:** Yeah, thi s is Liz. I would suggest maybe we should substitute 

### 38 estimation. 

### 39

### 100

**DR. DEMENT:** I would say assessment. This is John Dement. 

### 1 **DR. WARD:** Yeah, yeah. 

### 2 **DR. ALDRICH :**  Assessment or metrics. 

### 3 **DR. DEMENT :**  Yeah, or metrics, whatever. That's true because 

### 4 quantific ation has a connotation that you can actually put a numeric value to it and 

### 5 in a lot of cases you really can't. 

### 6 **DR. TALASKA:** That's right. And I think metrics or -- 

### 7 **DR. DEMENT:** Yeah. 

### 8 **DR. TALASKA:**

-- assessment would be better. 

### 9 **DR. ALDRICH :**  Well, you k now what? I'm thinking that since those last four 

### 10 words, and we're gonna get rid of psychological on that, the last three words refer 

### 11 to the word just before it. S omehow the word exposure should be just before it. So 

### 12 it should be improved assessment of WTC exposure, colon. 

### 13 **DR. MIDDENDORF** : I'm sorry, say that again? 

### 14 **DR . ALDRICH**  **:** Improved asse ssment of WTC exposure, colon. Or estimate, 

### 15 if you prefer, and then get rid of psychological. 

### 16 **DR. WARD:** Yeah, and I'm not sure that we really need to specify the long



### 17 live biomarkers 'cause again, that's something that

-- I mean, the investigators could 

### 18 propose to do to satisfy this knowledge gap. 

### 19 **DR. DEMENT:** Great point. It's a very cool idea though

. 

### 20 **DR. NORTH:** Question. Exposure to what is implied here ? 

### 21 **DR. M ARKOWITZ**  **:** Just about any agent. Just about any agent is what's 

### 22 implied

. 

### 23 **DR. DEMENT :**  Yeah. 

### 24 **DR. WARD:** So the three words

-- just to repeat, the three words you have 

### 25 after the colon are? 

### 26 **DR. ALDRICH**  : Inhaled, topical, ingested or other. 

### 27 **DR. WARD:** Okay. 

### 28 **DR. ALDRICH**  : I don't think there wa s any intravenous. 

### 29 **UNIDENTIFIED SPEAKER:** There may have been some IM though

. 

### 30 **DR. WARD:** Okay, so do we have a second for that motion? 

### 31 **DR. TALASKA:** I 'll second it. 

### 32 **THE COURT REPORTER:** Who seconded? 

### 33 **DR. MIDDENDORF** : The question on the table is assessment of WTC 

### 34 exposure, colon, inhaled, topical, ingested or other. 

### 35 **MS. SIDEL:** Is this written down someplace ? 

### 36 **DR. MIDDENDORF** : Sorry? 

### 37 **MS. SIDEL:** Is this

-- did we

-- is this written down ? 

### 38 **DR. MIDDENDORF** : Yeah, you need me to send it ? 

### 39

### 101

**MS. SIDEL** : Yeah

. I'm confused; I can't figure out which one it is. 

### 1 **DR. MIDDENDORF** : Okay. 

### 2 **THE COURT REPORTER:** I'm sorry, who seconded the motion, please? 

### 3 **DR. TALASKA**  : Glenn Talaska. 

### 4 **THE COURT REPORTER:** Thank you. 

### 5 **DR. WARD:** Okay, so Paul i s sending out the, the task, and then once 

### 6 everyone has it, we can go ahead and have a vote. 

### 7 **DR. MIDDENDORF** : And while we're waiting I will just point out that we 

### 8 have about an hour and 15 minutes, maybe an hour and 20 minutes , left. 

### 9 **DR. A**  **LDRICH :**  While w e're waiting , could somebody try to figure out how to 

### 10 phrase that next point, about the difference between exposure to physical agents 

### 11 and exposure to images or whatever it is that causes PTSD in people who weren't 

### 12 actually on the scene? 

### 13 **DR. WARD:** I thoug ht that was already covered in bullet 2, and we don't 

### 14 need to point it out

. 

### 15 **UN IDENTIFIED**  **SPEAKER:** Yes. 

### 16 **DR. A**  **LDRICH :**  Okay, cool. So no motion 6. 

### 17 **DR. WARD:** Right. So that would enable us to move on to the second area 

### 18 that Dr. Howard asked us to comment on. 

### 19 **DR. MARKOWITZ:** Liz? It's Steve Markowitz; I'm sorry to interrupt you but I 

### 20 do have a surveillance proposal. 

### 21 **DR. WARD:** Oh, I'm sorry, Steve

. 

### 22 **DR. MARKOWITZ:** It wasn't on Paul's previous list. 

### 23 **DR. WARD:** I know; that's why I forgot but it's still

-- n o, I still knew it , so 

### 24 yes , please

. 

### 25 **DR. MARKOWITZ:** But Paul, I sent it to you. 

### 26 **DR. MIDDENDORF** : Okay, I just copied it in. 

### 27 **DR. MARKOWITZ:** Okay. 

### 28 **DR. MIDDENDORF** : If you want to read it off. 

### 29 **DR. MARKOWITZ:** This is, you know, I welcome changes to the langu age 

### 30 here. Evaluate and improve the utility and use of current WTC data and activities 

### 31 for the purpose of access surveillance of health conditions in WTC exposed 

### 32 population. 

### 33 **DR. ALDRICH :**  That assumes it's all current data and not new data? 

### 34 **DR. MARKOWITZ:** Well, n o, we can, we can take out the word current. It's 

### 35 current

-- yeah, current would be

-- I mean, data that already exists, not future data. 

### 36 But since the question was raised, let's just take out that

-- so it would, it would say : 

### 37 Evaluate and impr ove the utility and use of WTC data and activities for the purpose 

### 38 of access surveillance of health conditions in WTC exposed populations. 

### 39

### 102

**DR. MIDDENDORF** : Okay, before we move any further on that one, let me 

### 1 ask if everybody has received the previous emai l? The improved assessment of WTC 

### 2 exposure, colon, inhaled, topical, ingested or other. 

### 3 **DR. WARD:** Yes. 

### 4 **MS. SIDEL:** And that's it? That's the whole thing? 

### 5 **DR. MIDDENDORF:** That's it. That's everything. 

### 6 **MS. SIDEL :**  And what about

-- I'm sorry, what's th e point? 

### 7 **DR. MARKOWITZ:** I'm sorry, is the question about the

-- is the question 

### 8 here

-- this is Steve Markowitz

-- about the surveillance proposal? 

### 9 **DR. MIDDENDORF** : We a re back on the improved assessment of WTC 

### 10 exposure. 

### 11 **DR. MARKOWITZ:** Okay, was that vot ed on already? 

### 12 **MS. SIDEL :**  No. 

### 13 **DR. MIDDENDORF** : No. 

### 14 **DR. MARKOWITZ:** Oh, okay. I apologize. I apologize. 

### 15 **MS. SIDEL :**  Sorry

. 

### 16 **DR. M ARKOWITZ**  : Go ahead. 

### 17 **MS. SIDEL :**  I'm sorry, Steve, I couldn't hear you

. 

### 18 **DR. MARKOWITZ**  : No, no, no. We're back on the exposur e, fine. So just 

### 19 strike the surveillance; we'll get to that. 

### 20 **DR. MIDDENDORF:** Susan, you had a question about improved assessment? 

### 21 **MS. SIDEL:** Yeah. Like what is that information going to do ? 

### 22 **DR. DEMENT:** This is John

-- this is John

-- 

### 23 **MS. SIDEL:** I m ean, if you have that information, like what, what will that 

### 24 help do? 

### 25 **DR. WARD:** John, I think you were trying to speak. 

### 26 **DR. DEMENT:** Yeah, I, I think the idea here is that some innovative 

### 27 integration that some of these exp osure assessment tools could give us a better

-- a 

### 28 linkage perhaps even with the surveillance data to generate hypotheses. 

### 29 Exposure

-- a better exposure assessment could definitely improve our abilit y to 

### 30 make causal links in this ideological research area so that was, I think, the core i dea 

### 31 behind it. 

### 32 **MS. SIDEL :**  Okay, thanks

. 

### 33 **DR. TALASKA :**  This is Glenn Talaska. I like that a lot because it's vague 

### 34 enough to include all the things we mentioned earlier. And it allows researchers to 

### 35 be innovative in addressing the weaknesses of the past exposure assessment that 

### 36 was previously done at 9/11

. 

### 37 **DR. WARD:** Okay, so are we ready to take a vote? 

### 38 **DR. MIDDENDORF** : Did we have a -- I think this is the motion . We need a 

### 39

### 103

second on it. 

### 1 **DR. TALASKA:** It's already been seconded. I did it last time. 

### 2 **DR. MIDDENDORF**  : Okay, sorry. So yes, we're ready for a vote. And the 

### 3 vote is on the improved assessment of WTC exposure, colon, inhaled, topical, 

### 4 ingested or other. Bob Aldrich? 

### 5 **DR. ALDRICH:** Yes. 

### 6 **DR. MIDDENDORF** : John Dement? 

### 7 **DR. DEMENT:** Yes. 

### 8 **DR. MIDDEN DORF**  : Kimberly Flynn? 

### 9 **MS. FLYNN:** Yes. 

### 10 **DR. MIDDENDORF** : Bob Harrison? Catherine Hughes? 

### 11 **MS. HUGHES:** Yes. 

### 12 **DR. MIDDENDORF** : Steve Markowitz? 

### 13 **DR. MARKOWITZ:** Yes. 

### 14 **DR. MIDDENDORF** : Guille Mej i a? 

### 15 **MS. MEJ I**  **A:** Yes. 

### 16 **DR. MIDDENDORF** : Carol North? 

### 17 **DR. NORTH:** Yes

. 

### 18 **DR. MIDDENDORF** : Julia Quint? 

### 19 **DR. QUINT:** Yes. 

### 20 **DR. MIDDENDORF** : Bill Rom? 

### 21 **DR. ROM:** Yes. 

### 22 **DR. MIDDENDORF** : Susan Sidel? 

### 23 **MS. SIDEL:** Yes. 

### 24 **DR. MIDDENDORF** : Glenn Talaska? 

### 25 **DR. TALASKA:** Yes. 

### 26 **DR. MIDDENDORF** : Leo Trasande? Liz Ward? 

### 27 **DR. WARD:** Yes. 

### 28 **DR. MIDDE NDORF**  : Twelve yes, zero no, zero abstentions. Motion passes. 

### 29 **DR. WARD:** Steve, I have a question on the proposed language

-- this is Liz. 

### 30 When you say WTC data, are you really referring to WTC Health Program and 

### 31 registry data or

-- it just seems a littl e bit broad, and I wondered if you wa nted to be 

### 32 more specific or not? 

### 33 **DR. MARKOWITZ:** I'm sorry, it would refer to both the health registry and 

### 34 the health program data. 

### 35 **DR. WARD:** Well, I just have this one -- I mean, is it confined to that data or 

### 36 is it a ny data or is it new research data or

-- I mean, I guess I was thinking it needed 

### 37 a little clarification. World Trade Center data is

-- doesn't mean anything if you 

### 38 don't define it further. 

### 39

### 104

**DR. MARKOWITZ:** Okay. Yeah, so this

-- so what I'm really after here would 

### 1 be more apparent with the World Trade Center Health Program and the clinics is the 

### 2 like, is that

-- because the health

-- the World Trade Center health registry at the 

### 3 health department actually

-- surveillance is what it's doing already. But t he clinical 

### 4 data or the data collected in the clinical program is underutilized for the purposes of 

### 5 surveillance. This was what, I think, Dr. Melius was striving at. And so the purpose 

### 6 here is to draw attention to it and to find ways of improving its use

. 

### 7 **DR. WARD:** So then the friendly amendment would be , well, WTCHP data? 

### 8 **DR. MARKOWITZ:** Right, okay. That's fine. 

### 9 **MS. SIDEL :**  But are you confident in the way that it's collected? 

### 10 **DR. MARKOWITZ:** I'm sorry, I couldn't hear that. 

### 11 **MS. SIDEL :**  Are you confid ent in the methodology that's being used to 

### 12 collect it, that it's accurate? 

### 13 **DR. MARKOWITZ:** No, you know, I'm agnostic on that, actually, but I think 

### 14 that would be one of the things to look at is the quality of the data, how accurate it 

### 15 is. 

### 16 **DR. ALDRICH:** W hy limit the investigator to Health Program data ? Why 

### 17 shouldn't the investigator be free to use data of good quality from any source? 

### 18 **MS. SIDEL :**  I'm just saying that this is your opportunity, maybe, to improve 

### 19 the methodology for collecting it. You know , like the things I was talking about in 

### 20 monitoring where you're talking to a nurse who's sitting there putting

-- you know, 

### 21 in putting the information into a computer

. And then a year later, when you go 

### 22 back, you have to think about that information becau se it wasn't put in correctly. In 

### 23 other words, if you did it yourself, it would be correct. So if

-- 

### 24 **DR. ALDRICH:** But that seems like that would be handled by this

-- but what 

### 25 wouldn't be handled by this would be if some researcher had some innovative w ay 

### 26 to get to link the World Trade Center registry data with the Health Program data , 

### 27 and come up with something new by doing that , that would be concluded if we limit 

### 28 this to just Health Program data. 

### 29 **DR. WARD:** I have an idea. Could we leave the text as it is but then add: 

### 30 and/or develop additional surveillance methods or surveillance resources ? 

### 31 **DR. ALDRICH:** I like it. 

### 32 **DR. WARD:** Like that? That could be an and, or an or, and/or develop. 

### 33 **DR. MIDDENDORF** : Where would that go? 

### 34 **DR. WARD:** It would just go at the end of this sentence. 

### 35 **DR. MIDDENDORF** : And/or develop

-- 

### 36 **DR. WARD:** Additional surveillance resources or data sources . That would 

### 37 include linking or other

-- other data sets. 

### 38 **DR. MIDDENDORF** : So w hat is your wording again? 

### 39

### 105

**DR. WARD:** I think tha t' s good, and/or develop

-- 

### 1 **DR. MIDDENDORF** : Surveillance data sources

-- 

### 2 **DR. WARD:** Additional

-- 

### 3 **DR. MIDDENDORF** : Additional? 

### 4 **MS. MEJIA :**  Or how about improve d surveillance? 

### 5 **DR. WARD:** Improved surveillance data methods or sources? I think just 

### 6 improved s urveillance methods would be fine. 

### 7 **DR. MIDDENDORF** : So the wording that we're looking at at the moment is: 

### 8 Evaluate and improve the utility and use of World Trade Center Health Program 

### 9 data and activities for the purpose of active surveillance and health conditions in 

### 10 WTC

- exposed populations and/or develop improved surveillance methods. 

### 11 **DR. WARD:** I s there somebody who want s to make a motion that that 

### 12 language be adopted? 

### 13 **DR. MARKOWITZ:** Steve Markowitz. I would propose that. 

### 14 **DR. ALDRICH:** I'll second tha t. Tom Aldrich. 

### 15 **DR. WARD:** So I think we can go ahead and move to a vote. 

### 16 **DR. MIDDENDORF** : Do people feel like they need to see the wording on this 

### 17 before they can vote? 

### 18 **MS. FLYNN :**  Do you think

-- c an you make sure that by the end of this 

### 19 meeting, we get a copy of all the wording that was approved ? 

### 20 **DR. MIDDENDORF** : Yes, I can

. 

### 21 **MS. FLYNN :**  That would be really helpful. Thanks a lot, Paul. 

### 22 **DR. MIDDENDORF** : I just sent this out, s o you should be able to see it in a 

### 23 minute or so, hopefully a little less

. 

### 24 **MS. FLYNN**  **:** I just got surveillance, thanks. 

### 25 **DR. MIDDENDORF** : Okay. 

### 26 **MS. FLYNN :**  But like a cumulative list of all the things we've voted on. 

### 27 Great. 

### 28 **DR. MIDDENDORF** : Yeah, it's actually

-- I've got that cumulative list here in 

### 29 a document that I'm gonna be sha ring on the web. Unfortunately, you're not able 

### 30 to see it. B ut yes, I will send this document out. 

### 31 Okay, I guess we're proceeding to a vote. Tom Aldrich? 

### 32 **DR. ALDRICH:** Yes. 

### 33 **DR. MIDDENDORF** : John Dement? 

### 34 **DR. DEMENT:** Yes. 

### 35 **DR. MIDDENDORF** : Kimberly Flyn n? 

### 36 **MS. FLYNN:** Yes. 

### 37 **DR. MIDDENDORF** : Bob Harrison? Catherine Hughes? 

### 38 **MS. HUGHES:** Yes. 

### 39

### 106

**DR. MIDDENDORF** : Steve Markowitz? 

### 1 **DR. MARKOWITZ:** Yes. 

### 2 **DR. MIDDENDORF** : Guille Mej i a? 

### 3 **MS. ME J**  **I A:**  Yes. 

### 4 **DR. MIDDENDORF** : Carol North? 

### 5 **DR. NORTH:** Yes. 

### 6 **DR. MIDDENDORF** : J ulia Quint? 

### 7 **DR. QUINT:** Yes. 

### 8 **DR. MIDDENDORF** : Bill Rom? 

### 9 **DR. ROM:** Yes. 

### 10 **DR. MIDDENDORF** : Susan Sidel? 

### 11 **MS. SIDEL:** Yes. 

### 12 **DR. MIDDENDORF** : Susan, if you're responding, it's not coming through. 

### 13 **MS. SIDEL:** Oh, yes. 

### 14 **DR. MIDDENDORF** : Glenn Talaska? 

### 15 **DR. TALASKA:** Yes. 

### 16 **DR. MIDDENDORF** : Leo Trasande? Leo, if you responded, I didn't hear you. 

### 17 I'm still not hearing anything from Leo. Liz Ward? 

### 18 **DR. WARD:** Yes. 

### 19 **DR. MIDDENDORF** : Okay. That's 12 yes, zero noes, and zero abstentions. 

### 20 Motion passes. 

### 21 **DR. WARD:** Okay, so I think we're ready to move on to the critical research 

### 22 knowledge gap relative to the accurate diagnosis of WTC

- related health conditions

. 

### 23 And what I 'd like to do, as much as possible, is for people to, you know, really try to 

### 24 propose topics that they th ink really are of significant and broad importance, and to 

### 25 try to propose them in words kind of along the same lines as the ones we've voted 

### 26 on. So if you can propose the final lang

-- something close to the final language that 

### 27 we can move forward. 

### 28 So I t hink the first one that we should consider is the one that was already 

### 29 proposed by Carol North related to the psychiatric diagnoses. And Paul, I think you 

### 30 have that while you were putting it in the

-- 

### 31 **DR. MIDDENDORF** : Yes. The wording is: Differentiate psychiatric diso rders 

### 32 from symptoms and distress in relation to disaster exposure a nd develop efficient 

### 33 and effective methods for diagnosis of disaster

- related p sychopathology in 

### 34 populations and individuals. 

### 35 And I am going to send that out 'cause it's lo ng and complicated. 

### 36 **DR. WARD:** Okay, do we have a second? I assume that we can assume -- I 

### 37 assume that Carol has put that forward as a motion, and is there a second? 

### 38 **DR. MIDDENDORF** : Okay, I've just

-- I've sent it out. 

### 39

### 107

**DR. WARD:** Okay, people need a minu te to look at it and then we'll ask for 

### 1 a second. 

### 2 **MS. SIDEL:** My message has no content . Paul? 

### 3 **DR. MIDDENDORF** : Yeah, let me look

. 

### 4 **MS. SIDEL:** Weird

. 

### 5 **DR. MIDDENDORF** : The one I sent has content

. Let me resend. 

### 6 **DR. A**  **LDRICH :**  I just got it. 

### 7 **MS. SIDEL:** Yea h, I got it. I have it, thank you. 

### 8 **DR. MIDDENDORF** : Okay. 

### 9 **DR. WARD:** Okay, and so do we have a second for that motion? 

### 10 **DR. HARRISON:** This is Bob Harrison, second. 

### 11 **DR. WARD:** Okay. Is there any further discussion on the motion? 

### 12 **DR. MARKOWITZ:** This is St eve Markowitz. Carol, could you just succinctly 

### 13 describe again the importance of this differentiating disorders from symptoms of 

### 14 distress? 

### 15 **DR. NORTH:** I'm glad you asked that because I wasn't sure that everything 

### 16 that I intend for this is getting across. And basically we know a lot about symptoms 

### 17 but we don't know enough about psychiatric disorders. Most of the studies have 

### 18 looked at symptoms and it's not cle ar what symptoms mean. They’ve used 

### 19 symptoms screeners rather than assess psychiatric disorder s
. And I think that it's in 

### 20 parallel to study of cancer. We don't study cancer symptoms; we study cancer. And 

### 21 I don't think we want to give psychiatric illness the short, short shrift . That's what I 

### 22 meant. 

### 23 **DR. MARKOWITZ:** So, I wonder whether you're disc ussing evaluating the 

### 24 clinical significance of symptoms and distress. 

### 25 **DR. NORTH:** Well, that could be a side sheet. But right now we don't have 

### 26 enough data about properly measured psychiatric disorders. Most of our data is 

### 27 about symptoms that we don't kn ow what they really mean an d we don't have the 

### 28 data on disorders to , to know what symptoms outside of that context mean s
. 

### 29 **DR. MARKOWITZ:** How about evaluating the

-- rather than symptoms and 

### 30 distress in relation to psychiatric disorders, to differentiate t hat

-- I mean, I don't 

### 31 want to take much time here

-- but

-- 

### 32 **DR. NORTH:** No , I understand what you're saying

. We have way too many 

### 33 symptoms outside of diagnosi s, a nd I think in the end what we're gonna care about 

### 34 is diagnosis. 

### 35 **DR. MARKOWITZ:** Right. 

### 36 **DR. N ORTH:**  We know that people are distress ed ; that's a given. But what 

### 37
we want to do is identify people with disorders that need treatment , a nd then give 

### 38 general interventions to the distressed population s
. 

### 39

### 108

**DR. MARKOWITZ:** S o you want to understand the relat ionship between 

### 1 symptoms and distress on the one hand, and the development of psychiatric 

### 2 disorders? 

### 3 **DR. NORTH:** Well, we, we want to differentiate them because right now the 

### 4 literature doesn't. 

### 5 **DR. MARKOWITZ:** Okay. 

### 6 **DR. NORTH:** And that's a mistake. 

### 7 **DR. M ARKOWITZ:**  Okay, I understand. 

### 8 **MS. SIDEL:** I don't understand. Could you, could you explain that part again 

### 9 to me ? 

### 10 **DR. NORTH:** Okay, most of the literature we have is about symptoms of 

### 11 PTSD

. 

### 12 **MS. SIDEL:** Right. 

### 13 **DR. NORTH:** Symptoms of this and that

. 

### 14 **MS. SI**  **DEL:** Right, right, right. 

### 15 **DR. NORTH:** And it's just hard to know what that means or what to do with 

### 16 it. You don't have enough research that it's taking the effort to accurately diagnose 

### 17 and identify disorders for specific treatment. 

### 18 **MS. SIDEL:** But how

- - but I don't, I don't see where the

-- how does it get to 

### 19 a disorder? I mean, is that

-- 

### 20 **DR. NORTH:** Well, we have carefully defined criteria. 

### 21 **MS. SIDEL:** Oh. 

### 22 **DR. NORTH:** We just haven't used them. 

### 23 **MS. SIDEL:** So they're not like calling it by a name. 

### 24 **DR . NORTH:**  Well, sometimes they mistakenly call it by name. They 

### 25 measure symptoms and they call it PTSD or depression when really it's not. 

### 26 **MS. SIDEL:** But what else would it be? 

### 27 **DR. NORTH:** What's that? 

### 28 **MS. SIDEL:** What would be symptoms

-- like what wou ld be

-- what would 

### 29 be

-- what would be a correct dia gnosis? 

### 30 **DR. NORTH:** Well, PTSD or major depression. Those are the common ones 

### 31 that develop after disaster s
. 

### 32 **MS. SIDEL:** Right , and why wouldn't they b e that? 

### 33 **DR. NORTH:** They don't

. It's labor intensiv e; they haven't develop ed the 

### 34 efficient method s to do that , and so we often settle for symptoms of thus and such , 

### 35 and I think that's about as satisfying as measuring symptoms of cancer. I'd like to 

### 36 study cancer, not symptoms of cancer. These are difficul t concept s but they're very 

### 37 important. 

### 38 **MS. SIDEL:** No, I, I understand the concepts, but I just don't see why they 

### 39

### 109

don't think that they're already doing that because I think they

-- I think that they 

### 1 think that they're doing that

. 

### 2 **DR. NORTH:** It could be. I'd like to see things be done differently so that we 

### 3
can advance knowledge. 

### 4 **DR. WARD:** Does anyone else have any thoughts on this point or any 

### 5 questions about it? I'll tell you my point of view is that I don't feel that I fully grasp 

### 6 it but I think it' s probably an important question, and it might result in some 

### 7 proposal s that would be really able to address it, and it may not. I mean, it, you 

### 8 know, really is going to require people who both understand the nature

-- and who 

### 9 understand the nature and im portance of the question and can think of ways to 

### 10 address it. 

### 11 But, you know, I don't

-- I think we

-- very few of us have expertise in 

### 12 psychiatric disorders, and I

-- so I tend to want to defer to Dr. North's expertise on 

### 13 this. And again , I don't think it's really going to generate a lot of proposals but w e 

### 14 might

-- it might bring forth a really good and important proposal if we include it in 

### 15 the list

. 

### 16 **DR. NORTH:** I think because we have psychiatric expertise will

-- many of 

### 17 them will understand it enoug h to generate proposals, and if judging the proposals, 

### 18 many of them will unde rstand this enough to judge it well

. 

### 19 **MS. SIDEL:** Okay

. 

### 20 **DR. WARD:** I think that the proposal's been made and seconded. Am I 

### 21 correct, Paul? 

### 22 **DR. MIDDENDORF** : Yes. 

### 23 **DR. WARD:** So perh aps we should move to the vote so that we can consider 

### 24 the ideas in this topic

-- in this area that we haven't even put on the table yet. 

### 25 **DR. MIDDENDORF** : Okay. Motion on the table is: Differentiate psychiatric 

### 26 disorders from symptoms of distress in rela tion to disaster exposure a nd develop 

### 27 efficient and effective methods for diagnosis of disaster

- related psychopathology in 

### 28 populations and individuals. So going to the vote, Dr. Aldrich? 

### 29 **DR. ALDRICH:** Yes. 

### 30 **DR. MIDDENDORF** : John Dement? 

### 31 **DR. DEMENT:** Yes. 

### 32 **D R. MIDDENDORF**  : Kimberly Flynn? 

### 33 **MS. FLYNN:** Yes. 

### 34 **DR. MIDDENDORF** : Bob Harrison? 

### 35 **DR. HARRISON:** Yes. 

### 36 **DR. MIDDENDORF** : Catherine Hughes? 

### 37 **MS. HUGHES:** Yes. 

### 38 **DR. MIDDENDORF** : Steve Markowitz? 

### 39

### 110

**DR. MARKOWITZ:** Yes. 

### 1 **DR. MIDDENDORF** : Guille Meji a? 

### 2 **MS. ME J**  **IA:** Yes. 

### 3 **DR. MIDDENDORF** : Carol North? 

### 4 **DR. NORTH:** Yes. 

### 5 **DR. MIDDENDORF** : Julia Quint? 

### 6 **DR. QUINT:** Yes. 

### 7 **DR. MIDDENDORF** : Bill Rom? 

### 8 **DR. ROM:** Yes. 

### 9 **DR. MIDDENDORF** : Susan Sidel? 

### 10 **MS. SIDEL:** Yes. 

### 11 **DR. MIDDENDORF** : Glenn Talaska? 

### 12 **DR. TALASKA:** Yes. 

### 13 **DR. MIDDENDORF** : Leo T rasande? Liz Ward? 

### 14 **DR. WARD:** Yes. 

### 15 **DR. MIDDENDORF:** Thirteen yes, zero noes, zero abstentions. Motion 

### 16 passes. 

### 17 **DR. WARD:** So the floor is now open for additional proposals in relation to 

### 18 critical research gaps relative to accurate diagnosis of World Tra de Center

- related 

### 19 health conditions. 

### 20 And maybe on this one we should try to get indication of who, who has one 

### 21 that they would like to propose. How many people

-- who would like to propose a 

### 22 specific point? 

### 23 **DR. MARKOWITZ:** This is Steve Markowitz. I'd like to propose something. 

### 24 **DR. WARD:** Is there anyone else who has something in mind that they'd like 

### 25 to propose? Okay. Steve, go ahead. 

### 26 **DR. MARKOWITZ:** This

-- I mentioned this before. It actually pertains to 

### 27 diagnosis and treatment. But it would be t o examine the patterns of healthcare 

### 28 utilization in the World Trade Center Health Program and the utility of the medical 

### 29 monitoring activities of

-- also of the World Trade Center Health Program

. 

### 30 The purpose of this is to encourage -- 

### 31 **MS. FLYNN :**  Can you s peak up louder, please? I can't hear you very well. 

### 32 **DR. MARKOWITZ:** Sure. So the purpose of this is to

-- is to take a rigorous 

### 33 look at actually what the World Trade Center Health Program is doing in terms of 

### 34 the treatment and also in terms of the medica l monitoring so that we can learn, 

### 35 learn about these programs, maybe how they can be improved but also how they 

### 36 can be designed for the future. 

### 37 **DR. WARD:** So Paul, have you been able to capture that ? 

### 38 **DR. MIDDENDORF** : Sorry, I was on mute. I only got the first part: Examine 

### 39

### 111

the patterns of healthcare utilization

-- 

### 1 **DR. MARKOWITZ:** Yeah, I just sen t it to you, Paul. I don't know how quickly 

### 2 it'll come. 

### 3 **DR. MIDDENDORF** : Okay. Yep, it's here. Okay. 

### 4 **DR. MARKOWITZ:** And I welcome , you know, language which i s more 

### 5 complete or more refined. 

### 6 **DR. ALDRICH**  : I think what's missing in this is your point that doing this will 

### 7 lead to improve ment in design of future programs. But somehow that point has to 

### 8 get into this

. 

### 9 **MS. SIDEL :**  Well, wait. Don't you mean how, ho w to improve this program 

### 10 like right now? 

### 11 **DR. MARKOWITZ:** Yeah, for both purposes, actually. 

### 12 **DR. ALDRICH**  : Yeah, but I mean, you want to propose more than just an 

### 13 examination. An examination

-- 

### 14 **DR. MARKOWITZ:** Right, right. 

### 15 **DR. ALDRICH**  : -- leading to the design of better. 

### 16 **MS. SIDEL :**  Well, monitoring the problem, because it takes so long , you 

### 17 know, you're in there for the whole day . Is that the kind of thing you 're talking 

### 18 about? 

### 19 **DR. MARKOWITZ:** That would be one aspect, sure. 

### 20 **MS. SIDEL :**  Because I think that more people would come if it was a more 

### 21 streamlined process. I think that's really good. 

### 22 **DR. MARKOWITZ:** But, Tom, so what other verbs should be added to this? 

### 23 **DR. ALDRICH**  : Maybe after the, after the examine, examine the value and 

### 24 efficacy or somet hing? 

### 25 **MS. SIDEL :**  Why don't you just say improve the efficacy of the monitoring 

### 26 program and

-- 

### 27 **DR. ALDRICH**  **:** Yeah, but you know what, the scientist doesn't have the 

### 28 opportunity to improve ; he has the opportunity to suggest improvements. 

### 29 **MS. SIDEL :**  Right. Well, right. So that would be good. 

### 30 **DR. ALDRICH**  **:** Well, I agree but I mean, so what t he scientist will actually do 

### 31 will be examine the value or examine the use or exam ine the quality or something. 

### 32 **MS. FLYNN:** This is Kimberly. Would there be a possibili ty also of including 

### 33 language about barriers to care? Or i s that already included in the n otion of 

### 34 healthcare utilization? 

### 35 **DR. MARKOWITZ:** Well, I think it would be

-- that would be included in 

### 36 patterns actually. 

### 37 **MS. FLYNN:** Okay. In patterns? 

### 38 **DR. MARKOW ITZ:**  Yeah. 

### 39

### 112

**MS. FLYNN:** Okay, so then we should keep the word pattern s
. 

### 1 **DR. WARD:** So Paul, I think the way you're capturing it is not quite the way 

### 2 it's intended

. 

### 3 **DR. MIDDENDORF** : Okay. 

### 4 **DR. WARD:** Steve, can you see the screen? 

### 5 **DR. MARKOWITZ:** Hold on. 

### 6 **DR . WARD:**  I think the value and efficacy was the, was the replacement for 

### 7 utility. So I think it was examine the patterns of healthcare utilization in the WTCHP 

### 8 and the value and efficacy of medical monitoring activity. I think that's what was 

### 9 intended. 

### 10 **D R. MARKOWITZ:**  Yeah, I'm sorry. I'm not seeing what Paul's written. So 

### 11 Paul, if you could read it, then I can get it. 

### 12 **DR. MIDDENDORF** : Yeah, let me read it out . Examine the value and efficacy 

### 13 of patterns of healthcare utilization in the World Trade Cent er Health Program and 

### 14 the value and efficacy of the medical monitoring activities of the WTCHP. 

### 15 **DR. MARKOWITZ:** Oh, that's fine. 

### 16 **DR. WARD:** And I guess the thing that doesn't make sense to me is the 

### 17 value and efficacy of patterns of healthcare utilization. I mean, you don't look at the 

### 18 value and efficacy of a pattern. 

### 19 **DR. MARKOWITZ:** Right, right. 

### 20 **DR. WARD:** So I'm suggesting taking that out of there and just looking at 

### 21 examin e patterns of healthcare utilization and the value and efficacy of the medical 

### 22 monitoring activities ? 

### 23 **DR. MARKOWITZ:** Yeah, that makes more sense actually, because we 

### 24 don't

-- we're not getting into evaluating the efficacy of treatment ; that would be a 

### 25
m istake. So I think the pattern s in the first half and the efficacy in the second is fine. 

### 26 **DR. MIDDENDORF** : I think I

-- what I

-- I copied value and efficacy from the 

### 27 first part into the second part. So the way it reads is: Examine patterns of 

### 28 healthcare utilization in the WTCHP and the value and efficacy of the medical 

### 29 monitoring a ctivities of the WTCHP. 

### 30 **DR. MARKOWITZ:** All right. That's good. 

### 31 **MS. MEJ I**  **A:** This is Guille. I have a little friendly amendment to that. Is it 

### 32 possible for it to read: Examine patterns of healthcare utilization and delivery in the 

### 33 World Trade Center Hea lth Program ? So we're looking at the delivery of the 

### 34 healthcare as well as the utilization of it. 

### 35 **DR. MARKOWITZ:** That's fine. 

### 36 **DR. MIDDENDORF** : And delivery of what? 

### 37 **DR. WARD:** Don't need the , of. I think you can just get rid of the , of. 

### 38 Healthcare util ization and delivery i n
. 

### 39

### 113

**DR. MIDDENDORF** : Delivery of what? 

### 1 **DR. MARKOWITZ:** No, it's the delivery of healthcare

. But if you just put 

### 2 utilization and delivery, it's fine. 

### 3 **MS. MEJ I**  **A** : Right. 

### 4 **DR. MIDDENDORF** : So the wording is: Examine patterns of healthcar e 

### 5 utilization and delivery in the World Trade Center Health Program and the value and 

### 6 efficacy of the medical monitoring activities of the WTCHP. 

### 7 **DR. MARKOWITZ:** Yeah, that's good. 

### 8 **DR. MIDDENDORF** : Okay, so that 's the mo tion ; is it seconded? 

### 9 **MS. HUGHES:** Y es. Catherine here

. 

### 10 **DR. MIDDENDORF** : Okay. 

### 11 **DR. WARD:** We're ready for a vote. 

### 12 **DR. MIDDENDORF** : Okay. Tom Aldrich? 

### 13 **DR. ALDRICH:** Yes. 

### 14 **DR. MIDDENDORF** : John Dement? 

### 15 **DR. DEMENT:** Yes. 

### 16 **DR. MIDDENDORF** : Kimberly Flynn? 

### 17 **MS. FLYNN:** Yes. 

### 18 **DR. MIDDENDORF** : Bob Ha rrison? 

### 19 **DR. HARRISON:** Yes. 

### 20 **DR. MIDDENDORF** : Catherine Hughes? 

### 21 **MS. HUGHES:** Yes. 

### 22 **DR. MIDDENDORF** : Steve Markowitz? 

### 23 **DR. MARKOWITZ:** Yes. 

### 24 **DR. MIDDENDORF** : Guille Mej i a? 

### 25 **MS. MEJ I**  **A:** Yes. 

### 26 **DR. MIDDENDORF** : Carol North? 

### 27 **DR. NORTH:** Yes. 

### 28 **DR. MIDDENDORF** : Julia Qu int? 

### 29 **DR. QUINT:** Yes. 

### 30 **DR. MIDDENDORF** : Bill Rom? 

### 31 **DR. ROM:** Yes. 

### 32 **DR. MIDDENDORF** : Susan Sidel? 

### 33 **MS. SIDEL:** Sorry, yes. 

### 34 **DR. MIDDENDORF** : Glenn Talaska? 

### 35 **DR. TALASKA:** Yes. 

### 36 **DR. MIDDENDORF** : Leo Trasande? Liz Ward? 

### 37 **DR. WARD:** Yes. 

### 38 **DR. MIDDENDORF** : That's 13 ye s, zero noes and zero abstentions. Motion 

### 39

### 114

passes. 

### 1 **DR. WARD:** So is there anyone else who'd like to propose a research gap 

### 2 relative to accurate diagnosis of World Trade Center

- related health conditions? 

### 3 **MS. FLYNN:** This is Kimberly, and I'm afraid I'm not the ideal person to 

### 4 phrase this , but wouldn't examining epi genetic alterations relevant to disease play 

### 5 an important role in diagnosis? 

### 6 **DR. MARKOWITZ:** Not really in diagnosis. 

### 7 **MS. FLYNN:** Okay. 

### 8 **DR. MARKOWITZ:** I mean, you know, in mechanism of the disease , sure, 

### 9 but not, to my knowledge, not in diagnosis. 

### 10 **MS. FLYNN:** Okay. 

### 11 **DR. WARD:** Okay, so I just looked back at Dr. Crowley's

-- my notes from Dr. 

### 12 Crowley, and I didn't see any of the topics that she mentioned that specifically 

### 13 would fall in to this category. I think one of the important points that she made , tha t 

### 14
we still need to capture but it may be falls better under 3 , is did early intervention 

### 15 make a difference in outcome. 

### 16 **MS. SIDEL :**  E arly intervention does make a difference in outcome , but if 

### 17 you're not paying attention to something because you're just not paying attention 

### 18 to it, t hen you're gonna have a bad outcome, and that was the point of asking for 

### 19 research. 

### 20 **DR. WARD:** I guess one of the things

-- I mean, one of the things that 

### 21 people can propose to look at in the World Trade Center

-- in the previous priority 

### 22
area is whether the

-- these

-- the selection of things that are being monitored for is 

### 23 appropriate or might be too defined to detect other conditions

. I mean, that, that 

### 24 could be a topic u nder that last priority area. 

### 25 **MS. SIDEL:** I think they've become so limited in air as digested, that other 

### 26 things are not considered. And they're not

-- it's not a matter of that there are n’t so 

### 27 many of them that they're being hit over the head with it. I mean, there's a lot of 

### 28 cancer but cancer happens because there's a lot of press about it. 

### 29 **DR. WARD:** Well, I think that this

-- 

### 30 **MS. SIDEL:** Like there are a lot of political factors that go into a lot of these, 

### 31 you know, decision s , and having

-- you know , early detection i s critical but it 

### 32 doesn't

-- it's not going to happen unless you 're recogniz ing things and you're 

### 33 looking for new things actively. And that's been my, my comment. And I said this in 

### 34 2011, and I think we 're just, you know, going in circ les, like we're just studying you 

### 35 know more parts of the same issues

. 

### 36 **DR. WARD:** I thi nk we

-- I think we think we covered that under the first 

### 37 priority under topic 1. So I guess, unless anyone has something additional to 

### 38 propose with regard to accurate d iagnosis of WTC

- related health conditions, we 

### 39

### 115

should m ove on to research gaps relative to effective treatment of WTC

- related 

### 1 health conditions. 

### 2 **MS. FLYNN:** Well, Liz, I have one

-- this is Kimberly

-- I have one additional 

### 3 question , and again, it's not onl y you see a need for me to separate out the 

### 4 diagnostic and the treatment part, so forgive me if this is not relevant, but t he 

### 5 whole issue of comorbidity, particularly between sev ere respiratory conditions and 

### 6 PTSD, doe s that

-- I guess, my question is wher e in this scheme would that fall? 

### 7 Because this is something that has been raised by World Trade Center Health 

### 8 Program clinicians. 

### 9 **DR. WARD:** I'm hoping some of our clinicians

-- 

### 10 **DR. ALDRICH:** T hat's on the topic of several of the r esearch grant s , and 

### 11 ther e are a number of papers about comorbidity

. T here's lots more to be done. But 

### 12 it's not really a research gap, right? Hasn't that already been identified as a 

### 13 problem? 

### 14 **MS. FLYNN:** It certainly has been identified as a problem. I think, and 

### 15 forgive me; I don't have this handy, but we ha d some language from, from survivor 

### 16 program mental health folks that talked about the effects of comorbid conditions 

### 17 and additional risks that talked about final common pathways. I don't know 

### 18 whether folks feel that this h as received adequate attention or... Again, yes, if it's 

### 19 not

-- if it's not a pressing gap, you know, I understand that as the standard for 

### 20 inclusion on this list. But it's not for me to say whether it's a pressing gap. 

### 21 **DR. WARD:** I mean, I think

-- I'm not sure where it would belong but I guess, 

### 22 if I was to try to articulate it, it would be , as a research gap, it would be 

### 23 understanding mechanisms underlying

-- 

### 24 **MS. FLYNN:** Yeah, that makes sense. 

### 25 **DR. WARD:**

-- app arent

-- 

### 26 **MS. FLYNN:** That makes sense. 

### 27 **DR. WARD:** 

-- associations between, you know, underlying common 

### 28 pathway s for certain

-- for WTC

- related conditions or something. Does any

-- does 

### 29 anyone else feel strongly that that should be included somewhere? 

### 30 **DR. MIDDENDORF** : Could you just repeat, repeat what the idea is again? 

### 31 **DR. WARD:** I ’m think ing that what we 're trying to capture is underly

-- 

### 32
un derstand mechanisms underlying associations between WTC

- related co



### 33 morbidities such as PTSD and respiratory disease . Understanding why these two 

### 34 conditions

-- I mean, i s it purely exposure

- mediated or are there other

-- is it 

### 35 something related to the mechanism or patho physiology of these conditions that 

### 36 make them more likely to occur together. I think that's what Kimberly is getting at. 

### 37 **MS. FLYNN:** Yeah, tha nk you. 

### 38 **DR. WARD:** And you've got another

-- I mean, do you get what she meant 

### 39

### 116

and could you say it in another way, Steve ? 

### 1 **DR. MARKOWITZ:** No, no, no. I wasn't

-- my concern about that, it's not 

### 2 that it doesn't have value but my concern about that is that it doesn't really 

### 3 contribute in a short

- term way to the welfare of the World Trade Center exposed 

### 4 population. It doesn't kind of help us understand the c lin ical expression or the 

### 5
e pi demiologic expression or early intervention in a way that I can see in t he near 

### 6 future as helping people. That's, that's my problem with that. 

### 7 **DR. WARD:** Okay, so does, does anyone else want to spend time working 

### 8 on this some more or should we just table it, put it in the parking lot as something 

### 9 that we don't have time to fu lly develop during this meeting ? 

### 10 Okay. I guess I haven't heard any sentiments that we should go forward 

### 11 with it. So the one thing that seems clear to me in terms of critical knowledge gap s 

### 12 relative to effective treatment of WTC

- related health condition s is the concept of 

### 13 more research to determine whether early intervention makes a difference in 

### 14 certain outcomes. 

### 15 **DR. A**  **LDRICH :**  It's hard to talk about early intervention when we're now 12 

### 16 and a half years out. 

### 17 **MS. FLYNN :**  Yeah. 

### 18 **DR. WARD:** Well, it would have to be

-- well, I mean, I guess it would have 

### 19 to be retrospective. I mean, it would have to be some kind of a retrospective study 

### 20 concerning people. I mean , people may have been diagnosed at one or two years 

### 21 post

- exposure and some of them may have r eceived an intervention . I don't

-- 

### 22 **MS. SIDEL:** There's a, there's a gap between diagnosis and actual 

### 23 treatment. You know, you could be diagnosed when it was just a

-- when it was just 

### 24
a -- you know, they were just doing diagnostic stuff and then it was a year or two 

### 25 before they opened up the treatment program. So for some people they

-- if they 

### 26 didn't go to their private doctors to follow up on whatever happen ed in their, in 

### 27 their, I think it was called help for heroes appointment, there would be a big gap i n 

### 28 treatment. 

### 29 **DR. WARD:** Well, I guess, I mean, there may not

-- may or may not be 

### 30 opportunities to look at it 'cause it's true, early intervention could require early 

### 31 diagnosis. 

### 32 **MS. FLYNN:** This is Kimberly, and I guess the one example that I feel mee ts 

### 33 that standard is that Dr. Trasande is looking at cardiometabolic in disease in people 

### 34 exposed as children. A nd certainly if, if those start to show up, and one of the 

### 35 things he's seen in a pilot study is kids wh o have

-- exposed kids wh o have high 

### 36 bloo d pressure but don't have, you know, the usual overweight

-- you know, their, 

### 37 their weight is normal, they have high blood pressure. S o he's looking at something 

### 38 like that , and certainly, you know, if this shows up in his study of, what , 250 exposed 

### 39

### 117

kids, then that would provide a basis for early intervention to prevent, you know, 

### 1 chronic heart disease, et cetera, if I'm not mistaken. 

### 2 **DR. WARD:** Yes. I think, though, the question is you want to

-- I mean, I 

### 3 think where this might be most common is, is peo ple who did or did not receive 

### 4 certain interventions for respiratory medicines or

-- I mean, it does seem like it 

### 5 would be an important question to answer but it would require framing what, what 

### 6 the specific intervention was. And seeing whether the

-- you know, the

-- if 

### 7 everyone got treat

-- if everyone who was diagnosed was treated pretty similarly, 

### 8 then I'm not sure you could study it. But if there are opportunities to compare 

### 9 people who were

-- had similar conditions and some were diagnosed early and 

### 10 aggressively treated and others were maybe diagnosed but not aggressively treated. 

### 11 I mean, should we throw this open as a topic of research or do people think it's not 

### 12 likely enough to be approved and we don't want to put it on the list? 

### 13 **MS. SIDEL**  **:** The o ther thing is that even if you did get treated, it's not like 

### 14 you can be cured. It doesn't

-- you know, it doesn't go away. It's just sort of 

### 15 managing symptoms. 

### 16 **DR. WARD:** Clinicians ? World Trade Center P rogram, what do you think? 

### 17 Do you want this in o r do you want this not in? 

### 18 **DR. ALDRICH:** This is Tom Aldrich. I favor not doing this just because we 

### 19 have more pressing issues about current treatments than about, about looking back 

### 20 at what happened 12 and a half years ago. 

### 21 **DR. WARD:** Okay. So anyone st rongly disagree with that? Okay. So then 

### 22 the question is

-- 

### 23 **DR. MIDDENDORF** : I just do want to point out that you have the option of 

### 24 including it on the list and then giving it a low priority. That is one of your options. 

### 25 **DR. ALDRICH:** Is this list excl usive ; that is, no grant that addresses 

### 26 something that's not on this list will be considered? 

### 27 **MS. SIDEL :**  That's a g ood question. 

### 28 **DR. MIDDENDORF** : No . What, what you provide to the, to the 

### 29 administrator will

-- all of these things will be considered as p art of a larger 

### 30 consideration. Information will be gathered from other sources as well. So this is 

### 31 just one avenue of gathering information about what the research needs are. 

### 32 **DR. ALDRICH:** Okay. 

### 33 **MS. SIDEL**  **:** Can I raise something that's a new gap of knowl edge or that ’s 

### 34 something that should be researched? Is that all right or are we past that? 

### 35 **DR. WARD:** No, we're still o n it. Ideally it’s things related to types of 

### 36 treatment of WTC

- related health conditions 'cause that's the

-- that's the area of 

### 37
resear ch gaps that we're, we're trying to fl e sh out now. 

### 38 **MS. SIDEL**  **:** Well, one thing that I'm concerned about, and I think it's gonna 

### 39

### 118

get worse with cancer because the treatment is that side effects

-- sorry about my 

### 1 dog

-- side effects from medications. And I don't, you know, know if those things 

### 2 should get certified or if you can get treated for those or how that's going to work. 

### 3 For example, Nexium causes

-- hang on one second, sorry. You know, 

### 4 Nexium, which a lot of us take a couple times a day, you know, it causes 

### 5 osteoporosis; so do all the inhalers. I don't know if that's being monitored or 

### 6 tracked but it's something that can come up for people. It's a lot of side effects 

### 7 from a lot of medications, and I think, with the cancer drugs, that that's even more 

### 8
severe. 

### 9 **DR. ALDRICH:** I think that's a really interesting concept because with

-- 

### 10 we've got a lot of things on the list of conditions associated with the World Trade 

### 11 Center, and maybe with all the drugs, we're bringing in a lot more conditions. 

### 12 **MS. SI**  **DEL :**  Yeah, I don't think there's a way around it. I think that you 

### 13 create the conditions just because it just happens. But it's also interesting 'cause it's 

### 14 not something that, you know, when you're told

-- when you're on Nexium

-- note 

### 15 by the way, this could cause osteoporosis. You know, I found out about it on the TV 

### 16 commercial about Nexium. You know, 'cause i t's just

-- you just wouldn't think 

### 17 about it. 

### 18 There's a lot of issues like that, and I think a lot of these medications , and 

### 19 especially for m any of us who are on like multiple medications, it just compounds 

### 20 the initial effect s of like one medication. And it's

-- I mean, it's kind of like modern 

### 21 medicine but I think it, it's concerning. 

### 22 **DR. ALDRICH:** Yeah, so that's all about risk benefit, righ t? So it's

-- I mean, I 

### 23 think it would be very interesting to examine the risks versus benefit

-- or the 

### 24 benefits versus drawbacks of taking World Trade Center

- related medication. 

### 25 **MS. SIDEL**  **:** Well, and like what the options are because , if you're not taki ng 

### 26 Nexium and you can't do inhalers or you take nose spray that has, that has steroids 

### 27 in it, it's going to be bad for your glands, what are your

-- what are your choices? 

### 28 There's not

-- I mean, there are not very many other choices out there. 

### 29 **MS. FLYNN :**  So let's come up with the wording for this 'cause it seems to be 

### 30 a good idea. Can someone put

-- articulate it well? 

### 31 **MS. SIDEL**  **:** Not me. I have cognitive issues. Let's see. 

### 32 **MS. FLYNN :**  How about study ing the side effects of drugs that were 

### 33 administered to World Trade Center diseases? Of drugs administered t o treat 

### 34 World Trade Center

-- 

### 35 **MS. SIDEL**  **:** Right. 

### 36 **DR. ALDRICH:** I like it. Simple, the, the researcher can make with it

-- make 

### 37 of it what he or she chooses. 

### 38 **MS. HUGHES :**  Yeah, and I remember some of the first responders also 

### 39

### 119

complaining about

-- in , in Washington. 

### 1 **DR. WARD:** Okay, so do we have a motion for this? 

### 2 **DR. MIDDENDORF** : Yeah, let me read it so that everybody is sure of what it 

### 3 is. Study the side effects of drugs administered for treatment of World Trade 

### 4 Center

- related diseases. 

### 5 **MS. FLYNN**  **:** I like it. 

### 6 **DR. MIDDENDORF** : So we need a motion and a second. 

### 7 **MS. HUGHES**  **:** Yes. 

### 8 **DR. MIDDENDORF** : Yeah. Yes, you're submitting this as a motion? 

### 9 **MS. HUGHES:** Yes, Catherine is. 

### 10 **DR. MIDDENDORF** : Okay. 

### 11 **DR. WARD:**  And who is the second? 

### 12 **DR. ALDRICH:** I'll second it. Tom Aldrich. 

### 13 **DR. MIDDENDORF** : Okay. Are we ready for a vote, then ? Tom Aldrich? 

### 14 **DR. ALDRICH:** Yes. 

### 15 **DR. MIDDENDORF** : John Dement? 

### 16 **DR. DEMENT:** Yes. 

### 17 **DR. MIDDENDORF** : Kimberly Flynn? 

### 18 **MS. FLYNN:** Yes. 

### 19 **DR. MIDDENDORF** : Bob Harrison? 

### 20 **DR. HARRISON:** Yes. 

### 21 **DR. MIDDENDORF** : Catherine Hughes? 

### 22 **MS. HUGHES:** Yes. 

### 23 **DR. MIDDENDORF** : Steve Markowitz? 

### 24 **DR. MARKOWITZ:** No. 

### 25 **DR. MIDDENDORF** : Guille Mej i a? 

### 26 **MS. ME J**  **I A:**  Yes. 

### 27 **DR. MIDDENDORF** : Carol North? 

### 28 **DR. NORTH:** Yes

. 

### 29 **DR. MIDDENDORF** : Julia Quint? 

### 30 **DR. QUINT:** Yes. 

### 31 **DR. MIDDENDORF** : Bill Rom? 

### 32 **DR. ROM:** No. 

### 33 **DR. MIDDENDORF** : Susan Sidel? Susan? Okay, I'm going to move on. 

### 34 Glenn Talaska? 

### 35 **DR. TALASKA:** No. 

### 36 **DR. MIDDENDORF** : Leo Trasande? Liz Ward? 

### 37 **DR. WARD:** No. 

### 38 **DR. MIDD ENDORF**  : Eight yes, four noes, zero abstentions. Okay, the 

### 39

### 120

motion passes. 

### 1 Okay, Susan said you guys g o t disconnected? 

### 2 **MS. SIDEL:** Yeah, I got disconnected, sorry. 

### 3 **DR. MIDDENDORF** : Okay, did you want to vote on that motion? 

### 4 **MS. SIDEL:** Yeah, what's the m otion? How is it worded? 

### 5 **DR. MIDDENDORF** : The motion says: Study the side effects of drugs 

### 6 administered for treatment of WTC

- related diseases. 

### 7 **MS. SIDEL:** Perfect. Yes. 

### 8 **DR. MIDDENDORF** : Okay. Change that to nine yes and four noes. Motion 

### 9 passes. 

### 10 **DR. W ARD:**  Okay, so let me just ask a question. Is the reason that we're not 

### 11 getting more ideas here in relation to treatment of respiratory diseases the fact that 

### 12 that's already the topic of a lot of research? Or is it just that the committee is 

### 13 getting tire d? 

### 14 **MS. SIDEL :**  No, I think that it's been

-- you know, I th ink it's, it's been a focus 

### 15 for, for all these years. 

### 16 **DR. WARD:** Okay. 

### 17 **MS. SIDEL :**  I'm not

-- not that there's probably not new things that are 

### 18 coming out but there's just so much work done on it, and I mean, it 'll probably 

### 19 always continue but that's

-- but that's one reason why we 're not seeing any, 

### 20 anything new is because it's just

-- there just keeps this focus going back on the stuff 

### 21 that's already been done, like some other nuance of it. 

### 22 **DR. WA RD:**  Yeah, and I was probably being a little facetious but I think it is 

### 23 important that if, you know, we're really not coming up with a lot of 

### 24 recommendations on items 2 and 3, and I just want to make sure that the 

### 25 committee is, is considering these recomm endations as thoroughly as they should 

### 26 because this is, this is our opportunity to influence the research agenda. And if 

### 27
we -- if there really are some topics that we haven't considered in the area of 

### 28 effective treatment of World Trade Center

- related dise ases, we should really take 

### 29 the time to think about them. 

### 30 **MS. SIDEL:** Well, I brought up, you know, using EMDR to treat 

### 31 post

- traumatic stress d isorder, and then somehow that got t urned into something 

### 32 else; I don't know what. But that's a really g ood treat ment for PTSD, that they 're 

### 33 not using it in the mental health feature at Mount Sinai anyway
. I think that 

### 34 Kimberly said that they haven't ( indiscernible ) at Bellevue. 

### 35 **DR. ALDRICH:** I do hear t hat there's a lot of controversy about what's 

### 36 effective and wha t isn't effective in treating PTSD, and shouldn't that be a focus? 

### 37 **MS. SIDEL :**  I just think that it's something that , that's out there and it's 

### 38 being used at

-- you know, if it's being used at like other hospitals that are credible 

### 39

### 121

and other credible progr ams, that maybe we should be able to use it. I know that a 

### 1 lot of volunteers, because they were

-- because we were allowed to choose our own 

### 2 doctors, a lot of volunteers are seeing doctors that do EMDR, and the rate of

-- just 

### 3 the success that they've had with, you know, coping with their PTSD has been, you 

### 4 know, tremendous, to the extent that you can see the change in people's 

### 5 personalities. You know, they go from being really angry all the time to being 

### 6 pleasant and sort of at peace. It's dramatic, dra matic changes, whereas

-- 

### 7 **DR. ALDRICH:** If that is so dramatic, why isn't that the standard of care? 

### 8 And so, so shouldn't we be encouraging people to find out if it's really better than 

### 9 other treatments? 

### 10 **MS. HUGHES :**  This is Catherine. I may have a sugge stion. I would

-- I think 

### 11 this is important but I think it's broader than this. And I would say that there are an 

### 12 awful lot of treatments that are being explored for PTSD in various trauma settings 

### 13 but not enough work that is specific to disaster setting s, and so I would like to 

### 14 broaden this to treatment s in general for specific use in disaster populations. 

### 15 And a second item that I think might be appropriate to include in this is 

### 16 better utilization of treatment in general , specifically for mental health . And that's 

### 17 it. 

### 18 **MS. SIDEL :**  Part of the p roblem with the mental health p rogram is that 

### 19 there aren't a lot of people there that are really, really experienced. I mean, the one 

### 20 at Mount Sinai anyway. 

### 21 You know, the first psychiatrist came to us straight out of school. And she 

### 22 was, she was wonderful. Our second psychiatrist came to us st raight out of school. 

### 23 So they haven 't ha d like a lot of like clinical practical experience. They don't have a 

### 24 lot of, you know, peers that have been practicing for a zi llion years that can offer 

### 25 advice. It's just the way it is. 

### 26 And I think that there's another

-- a lot of volunteers because there wasn't

-- 

### 27 we were allowed to choose our own doctors. We, we have some different 

### 28 experiences , and I think that i t' s worth l ooking at, those experiences. It's not like 

### 29 everybody went to the same person that did EMDR, but a lot of people, you know, it 

### 30 definitely got around that it worked . And so

-- 

### 31 **DR. NORTH:** So it’s like (indiscernible) b ecause there are o ther potential 

### 32 trea tments like virtual exposure -- 

### 33 **MS. SIDEL:** Absolutely. 

### 34 **DR. NORTH:**

-- ( indiscernible ). I wouldn’t want to single out one. 

### 35 **MS. SIDEL:** Absolutely. Absolutely. I think you're right. I think absolutely. 

### 36 And I'm not saying that I know the best one but I 'm just saying that there's definitely 

### 37
more out there than do ing tradition al like , you know, psychoanalysis and talking 

### 38 about your mommy. You know what I mean? It just

-- that just t akes forever and 

### 39

### 122

doing it

-- in the time that it's taking so long, you k now, your life is ticking by. 

### 1 **DR. NORTH**  **:** Well , I don't think people generally

-- that's not the state of 

### 2 the field, to use psychoanalysis for disaster

- related PTSD. 

### 3 **MS. SIDEL:** Well, that's what they're

-- well, that's what they're doing. 

### 4 They've

-- they have social workers who are talking to you about, you know, your -- 

### 5 it's just like

-- it's like traditional therapy, and I don't think it i s effective. 

### 6 **DR. WARD:** Well, Carol, could you give us some wording and propose a 

### 7 motion? Wording that Paul can get down? 

### 8 **DR. NORTH:** Something to the effect of : To specifically investigate the 

### 9 effectiveness and utility of treatments for PTSD, specifically in disaster affected 

### 10 groups or individuals. 

### 11 **DR. MIDDENDORF** : Okay, so what I have is: Specifically investigate t he 

### 12 effectiveness and utility of

-- wait, that's not right. 

### 13 **DR. NORTH:** To investigate the effectiveness and utility of specific PTSD 

### 14 treatments in disaster

- related settings. 

### 15 **DR. MIDDENDORF** : Okay, you said, specific PTSD treatmen ts? Are you sure 

### 16 you want that? 

### 17 **DR. NORTH:** Well,

-- 

### 18 **MS. SIDEL** : I think that's what it's about. 

### 19 **DR**

. **NORTH** : I don't want to

-- I don't want to single any one out , but we 

### 20 want to test specific ones like, you know, if somebody has an interest in EMDR , if 

### 21 somebody has an interest in prolonged exposure, those specific therapies should be 

### 22 tested in disaster settings. They've been tested in more broad PTSD settings but not 

### 23 in disaster. 

### 24 **DR. ALDRICH**  : So get rid of the first specifically. 

### 25 **DR. NORTH:** Yeah, it was overly long on specifi cs. 

### 26 **DR. MIDDENDORF** : So the current wording is: Investigate the effectiveness 

### 27 and utility of specific PTSD treatments in disaster

- affected groups or individuals. 

### 28 **DR. A**  **LDRICH :**  Why not in WTC

- affected groups or individuals? 

### 29 **MS. SIDEL :**  Right. That would b e good. 

### 30 **DR. NORTH:** Sure. 

### 31 **DR. MARKOWITZ :**  My only question with this one is, are we

-- would it be 

### 32 setting investigators up to fail? Will there, will there be enough cases and will there 

### 33 be so that they'll be able to make, you know, significant

-- or are we just planning on 

### 34 leaving it up to them? 

### 35 **DR. NORTH:** I agree , and this is a problem because by now people are going 

### 36 to be really chronic and it's going to be much, much harder to treat. It would be far 

### 37 more interesting if we could be treating early on a fter. And this is why I was not 

### 38 enthusiastic about developing items specifically for treatment. 

### 39

### 123

**MS. SIDEL:** Well, you could continue the people that have had

-- that have 

### 1 had EMDR , that went through the same disaster that got EMDR treatment. 

### 2 **DR. NORTH:** T his is really not as strong of a research design as we would 

### 3 like

. 

### 4 **MS. SIDEL:** Well, I mean, you can 't

-- it's like, you know, 13 years later so it's 

### 5 hard to be perfect but it would just show that

-- it would maybe give some impetus 

### 6 for trying some EMDR or trying some other, you know, creative kinds of therapies at 

### 7 Mount Sinai ’s mental health

. 

### 8 **DR. NORTH:** I would be far more enthusiastic about trying to get people to 

### 9 treatment , who haven’t come to treatment. So many people don't go

-- 

### 10 **MS. SIDEL:** ‘Cause th ey're not going to go to treatment because it doesn't 

### 11 work. This is what I'm telling you; it doesn't work. You know, you're sitting there 

### 12 with a social worker

-- 

### 13 **DR. NORTH:** But there are people who have used the EMDR treatment that 

### 14 they could go to , and they haven't. 

### 15 **MS. SIDEL:** Because maybe they can't afford it; they would have to pay for 

### 16 it. We don't offer EMDR treatment in the program. So they'd have to know about it 

### 17 and they'd have to have the resources to go pay for it. 

### 18 **DR. NORTH:** But that's a utility issue , that the chance that people would go , 

### 19 is more interesting, scientifically. 

### 20 **DR. ALDRICH :**  Wouldn't that

-- wouldn't investigators who want ed to 

### 21 investigate that be able to apply under this priority? 

### 22 **MS. SIDEL :**  You mean like have a grant that would pay for people to go? 

### 23 **DR. ALDRICH :**  No. I'm just saying this, this is one of the priorities, and an 

### 24 investigator who wants to do that study will look at this as a possible funding 

### 25 opportunity and have them compete for it. And if it's a good applic ation, it might 

### 26 prevail. If it's not a good application, it's not gonna get funded. 

### 27 **DR. NORTH:** That makes sense. 

### 28 **MS. SIDEL:** All right, but still, all these people in the program that doesn't 

### 29 work an d they're not getting anywhere with their lives 'cause they're just depressed 

### 30 and spinning. So well, they

-- 

### 31 **DR. ALDRICH**  **:** Look, w e're all trying to

-- we're all trying to help people, and 

### 32 some people don't get help and some people do. We do the best we can. 

### 33 **MS. SIDEL:** Right, but if we have

-- but if there' s other ways to treat people 

### 34 that are stronger and better, that have more successful results, but

-- 

### 35 **DR. ALDRICH**  **:** And I don't

-- 

### 36 **MS. SIDEL:**

-- we should research it

-- 

### 37 **DR. ALDRICH:** And I don't

-- do not

-- 

### 38 **MS. SIDEL:**

-- well, we should be researching w hether or not that's 

### 39

### 124

something that would be better for people. 

### 1 **DR. ALDRICH**  **:** That's why, that's why a priority like this should be in here. 

### 2 But it shouldn't be

-- we shouldn't go in with the idea that one specific treatment's 

### 3 better than another, a speci fic unproven treatment

. 

### 4 **MS. SIDEL:** I didn't say that. I said any of the treatments ; there’s other 

### 5 treatments that they use , there's like cognitive something. There's another one that 

### 6 they use at Mass General that's like more advanced than EMDR ; I don't remember 

### 7 the name of it

. I'm not an expert at this stuff, b ut I'm just saying that there are 

### 8 other things that work and that I, I don't think that what's going on now will

-- 

### 9 **DR. WARD:** Well, I mean

-- 

### 10 **MS. SIDEL :**  -- I mean, it 's worth it to explore some things that could be an 

### 11 alternative. 

### 12 **DR. ALDRICH:** I think we're all talking about the same thing. So this, this 

### 13 phraseology covers what we want to do, doesn't it? Can't we just accept this and 

### 14 move on? 

### 15 **MS. SIDEL :**  W ell, w hat's the phraseology? 

### 16 **DR. ALDRI**  **CH** : Investigate the effectiveness and utility of specific PTSD 

### 17 treatments in World Trade Center

- affected groups or individuals. 

### 18 **MS. SIDEL :**  Well, I guess it's really vague. They could come up with 

### 19 anything. Like they could come up and say that what they ’re doing works

. 

### 20 **DR. ALDRICH:** That's the point. And if the science is good, then it will get 

### 21 funded. If the science is not good, it will not get funded. 

### 22 **MS. SIDEL :**  Okay. 

### 23 **DR. WARD:** So I think we have the motion to

-- who will propose the 

### 24 motion? 

### 25 **DR. NO RTH:**  This is Ca rol. I guess I'm the one that proposed the wording so 

### 26 I'll move that we vote on the wording. 

### 27 **DR. WARD:** Okay, and then do we have a second? 

### 28 **DR. ALDRICH:** I'll second it

. 

### 29 **DR. MIDDENDORF** : Okay, so the motion on the table is: Investigate th e 

### 30 effectiveness and utility of specific PTSD treatments in World Trade Center

- affected 

### 31 groups or individuals. And going to the vote, Tom Aldrich? 

### 32 **DR. ALDRICH:** Yes. 

### 33 **DR. MIDDENDORF** : John Dement? 

### 34 **DR. DEMENT:** Yes. 

### 35 **DR. MIDDENDORF** : Kimberly Flynn? Kimberly, are you with us? I'm not 

### 36 hearing you so we'll move on to Bob Harrison? Bob, are y ou there? Not hearing 

### 37 anything. Catherine Hughes? 

### 38 **MS. HUGHES:** Yes. 

### 39

### 125

**DR. MIDDENDORF** : Steve Markowitz? 

### 1 **DR. MARKOWITZ:** Yes. 

### 2 **DR. MIDDENDORF** : Guille Mej i a? 

### 3 **MS. ME J**  **I A:**  Ye s. 

### 4 **DR. MIDDENDORF** : Carol North? 

### 5 **DR. NORTH:** Yes. 

### 6 **DR. MIDDENDORF** : Julia Quint? 

### 7 **DR. QUINT:** Yes. 

### 8 **DR. MIDDENDORF** : Bill Rom? 

### 9 **DR. ROM:** Yes. 

### 10 **DR. MIDDENDORF** : Susan Sidel? 

### 11 **MS. SIDEL:** Yes. 

### 12 **DR. MIDDENDORF** : Glenn Talaska? 

### 13 **DR. TALASKA:** Yes. 

### 14 **DR. MIDDENDORF** : Le o Trasande? Liz Ward? 

### 15 **DR. WARD:** Yes. 

### 16 **MS. FLYNN:** Paul ? It's Kimberly, I'm sorry. Yes. 

### 17 **DR. MIDDENDORF** : Yes, okay. So that goes to 12 yes, zero noes and zero 

### 18 abstentions. 

### 19 And I'll point out that we have about ten minutes left. 

### 20 **DR. WARD:** Okay, so I w ould propose that we move from the generation of 

### 21 ideas under these three c at e gories to see if there's any sort of priority setting that 

### 22 we can do at this point in time. 

### 23 **DR. A**  **LDRICH :**  I think it's very clear that number 9 goes to the bottom

. 

### 24 **DR. WARD:** All right. I'm g etting back into the site so that I can see what 

### 25 number 9 is. 

### 26 **DR. ALDRICH:** It's the one that wasn't unanimous. 

### 27 **DR. MIDDENDORF** : Number 9 is : Study the side effects of dru gs 

### 28 administered for treatment of World Trade Center

- related diseases. 

### 29 **D R. WARD:**  So is that the only differentiation we want to make at this 

### 30 point? Or do we want to indicate that some of these are

-- the committee feels are 

### 31 especially high priorities? 

### 32 **MS. FLYNN:** This is Kimberly. I feel that assess the health e ffects of WT C 

### 33 exposures on gestation and early life has to be a very high priority. 

### 34 There are approximately 35,000 children who were exposed to WTC, and 

### 35 very little is known about the physical health effects on those children. In fact the 

### 36 first actual clinical stud y of physical health effects was not funded until 2013. So 

### 37 they are, you know, a vulnerable population and they are in fact the least studied of 

### 38 any WTC disaster population. 

### 39

### 126

Also I would point out that this is a rapidly dispersing population , s o really, 

### 1 certainly those of us in the survivor community feel that NIOSH has to make up for 

### 2 lost time and double down on this research. 

### 3 **D R. ALDRICH**  **:** One and three should be high priorit y
. 

### 4 **DR. WARD:** Okay, that

-- 

### 5 **DR. MIDDENDORF** : Wait. Say that again? 

### 6 **D R. ALDRIC**  **H :**  I think 1 and 3 ( indiscernible ). 

### 7 **DR. WARD:** So that could be a limited ( indiscernible ). We're getting some 

### 8 interference from background noise. Could whoever has it go on mute? 

### 9 Okay, so why don't you put that in the form of a motion? 

### 10 **MS. FLYNN:** I s th at directed at me? 

### 11 **DR. WARD:** I think, I think one person said, said

-- let's see, one person said 

### 12 1 and 3 and then

-- actually that's true . One person said 1 and 3, and another 

### 13 person said 4. So we could have one person make a motion to have all three b e to p 

### 14 priority or we could vote one by one. 

### 15 **DR. NORTH:** This is Carol. I would like to add the exposure in mental health 

### 16 item as priority. 

### 17 **UNIDENTIFIED SPEAKER :**  [expletive deleted] you, no. 

### 18 **DR. WARD:** Okay. So we

-- 

### 19 **DR. MARKOWITZ**  **:** Could we just vote as we go through each one and have 

### 20 each person say whether they think it's high, medium or low? 

### 21 **MS. FLYNN :**  Can you email the list around about where we currently

-- 

### 22 **DR. MIDDENDORF** : I did that about two minutes ago. 

### 23 **DR. WARD:** That might be the best thing t o do given the limited time. 

### 24 Maybe we can just

-- is it possible to just go through each of them and have each 

### 25 person say whether they think it's high, medium and

-- or low and tabulate the 

### 26 results? 

### 27 **DR. MIDDENDORF** : We can do that. How do you propose tha t we then 

### 28 consolidate that information? 

### 29 **DR. WARD:** Well, we just make a table that says X number

-- for, for item 1. 

### 30 **DR. MIDDENDORF** : Okay, so all we're doing is we're identifying , say for 

### 31 motion number 1, five people thought it was high, two people though t it was 

### 32 medium and one person thought it was low. Is that what you're suggesting? 

### 33 **DR. WARD:** Yeah, 'cause I can't see any other way to use the last nine 

### 34 minutes. 

### 35 **DR. MIDDENDORF** : All right. 

### 36 **DR. MARKOWITZ**  **:** That would be my suggestion, yeah. 

### 37 **DR. WARD:** Or if we need to make it simpler, we could just ask, you know, 

### 38 people whether they think it's high or not , and just do it high versus not high. 

### 39

### 127

**MS. FLYNN:** That might be quicker i n the time remaining. 

### 1 **DR. WARD:** Yeah. 

### 2 **DR. MARKOWITZ**  **:** Yeah, I think high vers us not high makes sense. 

### 3 **DR. MIDDENDORF** : Okay. How about if we just do it this way so that we 

### 4 get a

-- kind of a yes or no vote. Just do motion number 1 , and then how many 

### 5 people think it's a high priority; motion number 2, how many people think it's a high 

### 6 priority. 

### 7 **DR. WARD:** Okay. 

### 8 **DR. MIDDENDORF:** Then we get the same information that way. 

### 9 **DR. WARD:** But you still have to go through all the names for each one, I 

### 10 think. 

### 11 **DR. MIDDENDORF** : I'll do a roll call on each one for its priority. 

### 12 **DR. ALDRICH:** Y o u're gonna have to do that real quick. 

### 13 **DR. MIDDENDORF** : Yeah. Okay. Motion 1, is this a high priority, Tom 

### 14 Aldrich? 

### 15 **DR. ALDRICH:** Yes. 

### 16 **DR. MIDDENDORF** : John Dement? 

### 17 **DR. DEMENT:** Yes. 

### 18 **DR. MIDDENDORF** : Kimberly? 

### 19 **MS. FLYNN:** Yes. 

### 20 **DR. MIDDENDORF** : Bob? Cath erine? 

### 21 **MS. HUGHES:** Yes. 

### 22 **DR. MIDDENDORF** : Steve? 

### 23 **DR. MARKOWITZ:** Yes. 

### 24 **DR. MIDDENDORF** : Guille? 

### 25 **MS. ME J**  **I A:**  Yes. 

### 26 **DR. MIDDENDORF** : Carol? 

### 27 **DR. NORTH:** Yes. 

### 28 **DR. MIDDENDORF** : Julia? 

### 29 **DR. QUINT:** Yes. 

### 30 **DR. MIDDENDORF** : Bill? 

### 31 **DR. ROM:** Yes. 

### 32 **DR. MIDDENDORF** : Susan? 

### 33 **MS. SIDEL:** Yes. 

### 34 **DR. MIDDENDORF** : Glenn? 

### 35 **DR. TALASKA:** Yes. 

### 36 **DR. MIDDENDORF** : Leo? Liz? 

### 37 **DR. WARD:** Yes. 

### 38 **DR. MIDDENDORF** : One, two, three, four, five, six, seven, eight, nine, ten, 

### 39

### 128

eleven, t welve yeses. So the motion w as - - motion 1 is a high priority. And we had, 

### 1 what was the number, 12? Okay. Okay. 

### 2 Motion 2 is a high priority. Characterize the disaster

- related exposures that 

### 3 are associated with the development of specific psychiatric disorders. 

### 4 Tom, is that a high priority? 

### 5 **DR. ALDRICH:** No. 

### 6 **DR. MID DENDORF**  : I'm sorry? 

### 7 **DR. ALDRICH:** No. 

### 8 **DR. MIDDENDORF** : No, I'm

-- okay, thank you. John? 

### 9 **DR. DEMENT:** No. 

### 10 **DR. MIDDENDORF** : Kimberly. 

### 11 **MS. FLYNN:** No. 

### 12 **DR. MIDDENDORF** : Bob? Catherine. 

### 13 **MS. HUGHES:** No. 

### 14 **DR. MIDDENDORF** : Steve? 

### 15 **DR. MARKOWITZ:** No. 

### 16 **DR. MIDDEN DORF**  : Guille? 

### 17 **MS. ME J**  **I A:**  No. 

### 18 **DR. MIDDENDORF** : Carol? 

### 19 **DR. NORTH:** I'll stick with my yes. 

### 20 **DR. MIDDENDORF** : Julia? 

### 21 **DR. QUINT:** No. 

### 22 **DR. MIDDENDORF** : Bill? 

### 23 **DR. ROM:** No. 

### 24 **DR. MIDDENDORF** : Susan? 

### 25 **MS. SIDEL:** No. 

### 26 **DR. MIDDENDORF** : Glenn? Glenn? I'm sorry, what ? Glenn? 

### 27 **DR. TALASKA:** No. 

### 28 **DR. MIDDENDORF** : Thank you. Leo? Liz? 

### 29 **DR. WARD:** Yes

-- oh, no. Sorry, no. 

### 30 **DR. MIDDENDORF** : Okay. One yes, 11 no, zero abstentions. 

### 31 Motion 3 : Determine the value of biomarkers for early detect ion of 

### 32 precancerous condition s, early cancers or other WTC

- associated diseases. Is this a 

### 33 high priority? Tom? 

### 34 **DR. ALDRICH:** Yes. 

### 35 **DR. MIDDENDORF** : John? 

### 36 **DR. DEMENT:** Yes. 

### 37 **DR. MIDDENDORF** : Kimberly? 

### 38 **MS. FLYNN:** Yes. 

### 39

### 129

**DR. MIDDENDORF** : Bob? Catherine? 

### 1 **MS. HUGHES:** Yes. 

### 2 **DR. MIDDENDORF** : Steve? 

### 3 **DR. MARKOWITZ:** No. 

### 4 **DR. MIDDENDORF** : Guille? 

### 5 **MS. ME J**  **I A:**  I'm going to abstain. 

### 6 **DR. MIDDENDORF** : Carol? 

### 7 **DR. NORTH:** Yes. 

### 8 **DR. MIDDENDORF** : Julia? 

### 9 **DR. QUINT:** Yes. 

### 10 **DR. MIDDENDORF** : Bill? 

### 11 **DR. ROM:** Yes. 

### 12 **DR. MIDDENDORF** : Susan? 

### 13 **MS. SIDEL:** Yes. 

### 14 **DR. MIDDE NDORF**  : Glenn? 

### 15 **DR. TALASKA:** Yes. 

### 16 **DR. MIDDENDORF** : Leo? Liz? 

### 17 **DR. WARD:** Yes. 

### 18 **DR. MIDDENDORF** : Okay, one, two, three, four, five, six, seven, eight, nine, 

### 19 ten yes; one no, one abstention. Okay, motion passes. That was motion 3. 

### 20 Motion 4: Assess health e ffects of WTC exposure on gestation and early life, 

### 21 childhood and adolescence. So Tom , is this a high priority? 

### 22 **DR. ALDRICH:** Yes. 

### 23 **DR. MIDDENDORF** : John? 

### 24 **DR. DEMENT:** Yes. 

### 25 **DR. MIDDENDORF** : Kimberly? 

### 26 **MS. FLYNN:** Yes. 

### 27 **DR. MIDDENDORF** : Bob? Catherine? 

### 28 **MS. HUGHES:**  Yes. 

### 29 **DR. MIDDENDORF** : Steve? 

### 30 **DR. MARKOWITZ:** Yes. 

### 31 **DR. MIDDENDORF** : Guille? 

### 32 **MS. ME J**  **I A:**  Yes. 

### 33 **DR. MIDDENDORF** : Carol? 

### 34 **DR. NORTH:** Yes. 

### 35 **DR. MIDDENDORF** : Julia? 

### 36 **DR. QUINT:** Yes. 

### 37 **DR. MIDDENDORF** : Bill? 

### 38 **DR. ROM:** Yes. 

### 39

### 130

**DR. MIDDENDORF** : Susan? 

### 1 **MS. SIDEL:** Yes. 

### 2 **DR. MIDDENDORF** : Glenn? 

### 3 **DR. TALASKA:** Yes. 

### 4 **DR. MIDDENDORF** : Leo? Liz? 

### 5 **DR. WARD:** Yes. 

### 6 **DR. MIDDENDORF** : Okay. That's 12 yes, zero no, zero abstentions. That 

### 7 motion passes. 

### 8 Okay, motion 5 is a high priority. Motion 5 is : Improved assessment of WTC 

### 9 exposure : inhaled, topical, ingested or other. Okay. Tom Aldrich? 

### 10 **DR. ALDRICH:** No. 

### 11 **DR. MIDDENDORF** : John Dement? 

### 12 **DR. DEMENT:** Yes. 

### 13 **DR. MIDDENDORF** : Kimberly? 

### 14 **MS. FLYNN:** No. 

### 15 **DR. MIDDENDORF** : Bob? Catherine? 

### 16 **MS. HUGHES:** Medium. 

### 17 **DR. MIDDENDORF** : Ye s or no. 

### 18 **MS. HUGHES:** No. 

### 19 **DR. MIDDENDORF** : Steve? 

### 20 **DR. MARKOWITZ:** Yes. 

### 21 **DR. MIDDENDORF** : Guille? 

### 22 **MS. ME J**  **I A:**  Yes. 

### 23 **DR. MIDDENDORF** : Carol? 

### 24 **DR. NORTH:** Yes. 

### 25 **DR. MIDDENDORF** : Julia? 

### 26 **DR. QUINT:** Yes. 

### 27 **DR. MIDDENDORF** : Bill? 

### 28 **DR. ROM:** No. 

### 29 **DR. MIDDENDORF** : Susan? 

### 30 **MS. SIDEL:** Not sure. I guess I'll say no. 

### 31 **DR. MIDDENDORF** : Glenn? 

### 32 **DR. TALASKA:** Yes. 

### 33 **DR. MIDDENDORF** : Leo? Liz? 

### 34 **DR. WARD:** No. 

### 35 **DR. MIDDENDORF** : Okay. One, two, three, four, five, s ix yes, six no. 

### 36 Motion 6. I'm assuming everybody is okay with the s horthand way of doing 

### 37 our motions? 

### 38 **UNIDENTIFIED SPEAKER:** Yes. 

### 39

### 131

**DR. MIDDENDORF** : Okay. 

### 1 **UNIDENTIFIED SPEAKER:** Yes. 

### 2 **DR. MIDDENDORF** : Okay. Motion 6 is: Evaluate and improve the utility and 

### 3 use of WTCHP data and activities for the purpose of active surveill a nce of health 

### 4 conditions in WTC

- exposed populations and/or develop improved surveillance 

### 5 methods. 

### 6 Okay, so Tom Aldrich, is this a high priority? 

### 7 **DR. ALDRICH:** Yes. 

### 8 **DR. MIDDENDORF** : John? 

### 9 **DR. DEMENT:** Yes. 

### 10 **DR. MIDDENDORF** : Kimberly? 

### 11 **MS. FLYNN:** Yes. 

### 12 **DR. MIDDENDORF**  : Bob? Catherine? 

### 13 **MS. HUGHES:** Yes. 

### 14 **DR. MIDDENDORF** : Steven? 

### 15 **DR. MARKOWITZ:** Yes. 

### 16 **DR. MIDDENDORF** : Guille? 

### 17 **MS. ME J**  **I A:**  Yes. 

### 18 **DR. MIDDENDORF** : Carol? 

### 19 **DR. NORTH:** Yes. 

### 20 **DR. MIDDENDORF** : Julia? 

### 21 **DR. QUINT:** Yes. 

### 22 **DR. MIDDENDORF** : Bill? 

### 23 **DR. ROM:** Yes. 

### 24 **DR. MIDDENDORF** : Susan? 

### 25 **MS. SIDEL:** Yes. 

### 26 **DR. MIDDENDORF** : Glenn? 

### 27 **DR. TALASKA:** Yes. 

### 28 **DR. MIDDENDORF** : Leo? Liz? 

### 29 **DR. WARD:** Yes. 

### 30 **DR. MIDDENDORF** : So that's 12 yes, zero no, zero abstentions. 

### 31 Motion 7. Seven is: Differentiate psychiatric disorders from sy mptoms and 

### 32 distress in relation to disaster exposure and develop efficient and effective methods 

### 33 for diagnosis of disaster

- related psychopathology in populations and individuals

. 

### 34 Tom, is this a high priority? 

### 35 **DR. ALDRICH:** Yes. 

### 36 **DR. MIDDENDORF** : John? 

### 37 **DR. D EMENT:**  No. 

### 38 **DR. MIDDENDORF** : Kimberly? 

### 39

### 132

**MS. FLYNN:** Yes. 

### 1 **DR. MIDDENDORF** : Bob? Catherine? 

### 2 **MS. HUGHES:** No. 

### 3 **DR. MIDDENDORF** : Steve? 

### 4 **DR. MARKOWITZ:** Yes. 

### 5 **DR. MIDDENDORF** : Guille? 

### 6 **MS. MEJ I**  **A:** Yes. 

### 7 **DR. MIDDENDORF** : Carol? 

### 8 **DR. NORTH:** Yes. 

### 9 **DR. MIDDENDORF** : Juli a? 

### 10 **DR. QUINT:** Yes. 

### 11 **DR. MIDDENDORF** : Bill? 

### 12 **DR. ROM:** No. 

### 13 **DR. MIDDENDORF** : Susan? 

### 14 **MS. SIDEL:** No. 

### 15 **DR. MIDDENDORF** : Glenn? 

### 16 **DR. TALASKA:** Yes. 

### 17 **DR. MIDDENDORF** : Leo? Liz? 

### 18 **DR. WARD:** Yes. 

### 19 **DR. MIDDENDORF** : Okay. Nine yes, three noes, zero abstentions. 

### 20 Motion 8 was or is: Examine the patterns of healthcare utilization and 

### 21 delivery in the World Trade Center Health Program and the value and efficacy of 

### 22 medical monitoring activities of the World Trade Center Health Program

. 

### 23 Is this a high priority, Tom? 

### 24 **DR. ALDRIC H:**  No. 

### 25 **DR. MIDDENDORF** : John? 

### 26 **DR. DEMENT:** Yes. 

### 27 **DR. MIDDENDORF** : Kimberly? 

### 28 **MS. FLYNN:** Yes. 

### 29 **DR. MIDDENDORF** : Bob? Catherine? 

### 30 **MS. HUGHES:** Yes. 

### 31 **DR. MIDDENDORF** : Steve? 

### 32 **DR. MARKOWITZ:** Yes. 

### 33 **DR. MIDDENDORF** : Guille? 

### 34 **MS. ME J**  **IA:** Yes. 

### 35 **DR. MIDDENDORF** : Carol? 

### 36 **DR. NORTH:** Yes. 

### 37 **DR. MIDDENDORF** : Julia? 

### 38 **DR. QUINT:** Yes. 

### 39

### 133

**DR. MIDDENDORF** : Bill? 

### 1 **DR. ROM:** Yes. 

### 2 **DR. MIDDENDORF** : Susan? 

### 3 **MS. SIDEL:** Yes. 

### 4 **DR. MIDDENDORF** : Glenn? 

### 5 **DR. TALASKA:** Yes. 

### 6 **DR. MIDDENDORF** : Leo? Liz? 

### 7 **DR. WARD:** Yes. 

### 8 **DR. MIDDENDORF** : Okay. One no and 11 yes. No abstentions. 

### 9 Motion 9: Study the side effects of drugs administered for treatment of 

### 10 WTC

- related diseases. 

### 11 Tom, is this a high priority? 

### 12 **DR. ALDRICH:** No. 

### 13 **DR. MIDDENDORF** : John? 

### 14 **DR. DEMENT:** No. 

### 15 **DR. MIDDENDORF** : Kimberly? 

### 16 **MS. FLYNN:** No. 

### 17 **D R. MIDDENDORF**  : Bob? Catherine? 

### 18 **MS. HUGHES:** No. 

### 19 **DR. MIDDENDORF** : Steven? 

### 20 **DR. MARKOWITZ:** No. 

### 21 **DR. MIDDENDORF** : Guille? 

### 22 **MS. ME J**  **I A:**  No. 

### 23 **DR. MIDDENDORF** : Carol? 

### 24 **DR. NORTH:** No. 

### 25 **DR. MIDDENDORF** : Julia. 

### 26 **DR. QUINT:** No. 

### 27 **DR. MIDDENDORF** : Bill? 

### 28 **DR. ROM:** No. 

### 29 **DR. MIDDENDORF**  : Susan? 

### 30 **MS. SIDEL:** Yes. 

### 31 **DR. MIDDENDORF** : Glenn? 

### 32 **DR. TALASKA:** No. 

### 33 **DR. MIDDENDORF** : Leo? Liz? 

### 34 **DR. WARD:** No. 

### 35 **DR. MIDDENDORF** : Okay. One yes and 11 no. Okay. 

### 36 And motion 10 was : Investigate the effectiveness and utility of specific 

### 37 PTSD tr eatments in WTC

- a ffected groups or individuals. 

### 38 Okay, Tom, is this a high priority? 

### 39

### 134

**DR. ALDRICH:** No. 

### 1 **DR. MIDDENDORF** : John? 

### 2 **DR. DEMENT:** No. 

### 3 **DR. MIDDENDORF** : Kimberly? 

### 4 **MS. FLYNN:** Yes. 

### 5 **DR. MIDDENDORF** : Bob? Catherine? 

### 6 **MS. HUGHES:** Yes. 

### 7 **DR. MIDDENDORF** : S teven? 

### 8 **DR. MARKOWITZ:** No. 

### 9 **DR. MIDDENDORF** : Guille? 

### 10 **MS. ME J**  **I A:**  Yes. 

### 11 **DR. MIDDENDORF** : Carol? 

### 12 **DR. NORTH:** No. 

### 13 **DR. MIDDENDORF** : Julia? 

### 14 **DR. QUINT:** Yes. 

### 15 **DR. MIDDENDORF** : Bill? 

### 16 **DR. ROM:** No. 

### 17 **DR. MIDDENDORF** : Susan? 

### 18 **MS. SIDEL:** Yes. 

### 19 **DR. MIDDENDORF** : Glenn? 

### 20 **DR. TALASKA:**  No. 

### 21 **DR. MIDDENDORF** : Leo? Liz? 

### 22 **DR. WARD:** Yes. 

### 23 **DR. MIDDENDORF** : Okay. One, two, three, four, five, six, s even yes, five no. 

### 24 **DR. WARD:** I think that is a helpful metric that we can use. I think Dr. 

### 25 Howard will find that helpful. Paul? 

### 26 **DR. MIDD ENDORF**  : Yes, I'm, I'm here. 

### 27 **DR. WARD:** Okay. 

### 28 **DR. MIDDENDORF** : Sorry. Trying to do some quick cleaning here. 

### 29 **DR. WARD:** Good. 

### 30 **DR. TALASKA:** You're doing a great job, Paul. 

### 31 32 **ADMINISTRATIVE ISSUES AND ADJOURN** 

### 33 **DR. MIDDENDORF** : Well, okay. So what is the com mittee going to do? 

### 34 What, what are you plann ing to do with this or how do you want to present this 

### 35 information to Dr. Howard? 

### 36 **DR. WARD:** Well, Paul, I mean, we could either draft a cover letter or you 

### 37 could just

-- I mean, you could circulate the list and the tabulations. And then unles s 

### 38 anyone has any questions, we could just provide that to Dr. Howard? 

### 39

### 135

**DR. MIDDENDORF** : Yeah, I think even if I sen d it out to folks, if they 

### 1 disagree with something that's on it, there's nothing that, that can be done about it. 

### 2 **DR. WARD:** Yeah. So I would say let's just send it to Dr. Howard. We really 

### 3 don't have time to talk about

-- and then first, there'll be the transcript , and 

### 4 certainly NIOSH staff could look at the transcript and, and help Dr. Howard identify 

### 5 the dis cussion points that are most relevant to his decision

- making. 

### 6 **DR. MIDDENDORF** : Yeah, and I will let you know that we have combed 

### 7 mightily through in great detail through the previous transcripts as we 've been 

### 8 writing regulations. So the

-- n ot just the in formation but what people say and how 

### 9 they say it are used to a considerable extent. So what you say in the meetings is 

### 10 valuable and is considered to be important. 

### 11 **DR. WARD:** Good. 

### 12 **DR. MIDDENDORF** : So

-- 

### 13 **DR. WARD:** And it's interesting, I have read throug h the transcript s , 'cause 

### 14 it's one of my roles as the Chair to say that I believe they're accurate, a nd it is 

### 15 remarkable , s ometimes it's embarrassing how you make, you know, you don't use 

### 16 the English language as well as you wish you did, but there really a re some very 

### 17 useful discussions in those, in those transcripts. 

### 18 **DR. MIDDENDORF** : Very much so. So the disposition from the

-- what the 

### 19 committee intends to do, then, is for me to provide this document to Dr. Howard as 

### 20 the

-- their report

. Is that what yo u’re telling me? 

### 21 **DR. WARD:** I think so. That would be my recommendation. 

### 22 **DR. MIDDENDORF** : How do people feel about that? 

### 23 **MS. FLYNN:** Well, it sounds good. 

### 24 **DR. MIDDENDORF** : Any dissensions? 

### 25 **DR. TALASKA:** It's the product of our day. 

### 26 **DR. MIDDENDORF:** Sorry ? 

### 27 **DR. TALASKA:** It's the product of our day. 

### 28 **DR. MIDDENDORF** : Yeah. Okay. Well, since that is what I'm h earing from 

### 29 the committee, that is what I will do, and I will send a copy of this out to everyone 

### 30 so you know what it is and how it all turned out, ex actly what happened. 

### 31 Transcripts will be available in a number of weeks. 

### 32 I also want to thank each of you for mu sc ling through this very difficult 

### 33 meeting. The promise of technology often doesn't measure up to what is really 

### 34 needed. And we struggled thr ough, and I very much appreciate your hanging in 

### 35 there and mu sc ling through it with me. 

### 36 **MS. SIDEL:** Thank you for doing it. 

### 37 **DR. WARD:** Thank you, Paul 

### 38 **UNIDENTIFIED SPEAKER** : Thank you. 

### 39

### 136

**MS. HUGHES:** Thank you, Paul. Thank you, Liz. 

### 1 **D R. ROBISON**  **:** Hey, Paul, this is Allen. I would second that. And I've been 

### 2 listening , and Travis has been listening. I t's very helpful to us to l isten to the 

### 3 discussions and the sort of the struggles and chal lenges that you wrestle with in the 

### 4 time that you have to do this, so thank you. 

### 5 **DR. WARD:** Thank you. 

### 6 **DR. MIDDENDORF** : Well, with that, I guess we're closing the meeting? 

### 7 **MS. SIDEL:** So i f I'm unhappy about something, could I write a separate 

### 8 letter? 

### 9 **DR. MIDDENDORF** : You can write something to the administrator at any 

### 10 time

. 

### 11 **MS. SIDEL:** Okay. Thank you. 

### 12 **DR. MIDDENDORF** : Thank you , everybody. 

### 13 **DR. WARD:** Have a good weekend every one . Take care. Bye

- bye. 

### 14 (Whereupon, the meeting was adjourned , 5:10 p.m. ) 

### 15 16

### 137

**CERTIFICATE OF COURT REPORTER** 

### 1

**STATE OF GEORGIA**

**COUNTY OF FULTON**
I, Steven Ray Green, Certified Merit Court Reporter, do hereby certify that I reported the above and foregoing on the day of February 14 , 201 4 ; and it is a true and accurate transcript of the proceedings captioned herein. I further certify that I am neither relation nor counsel to any of the parties herein, nor have any interest in the cause named herein. WITNESS my h and and official seal this the 9 t h day of March , 201 4

.

___________________________________ **STEVEN RAY GREEN, CCR, CVR**
**- CM, PNSC**  **C ERTIFIED MERIT COURT REPORTER**  **CERTIFICATE NUMBER: A**
**- 2102**