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 ADVISORY

COMMITTEE (STAC) MEETING

February 14, 2014

The verbatim transcript of the

Meeting of the Scientific/Technical Advisory

Committee Meeting held telephonically on February

14, 2014, 9:30 a.m.
2

C O N T E N T S

February 14, 2014

WELCOME AND INTRODUCTION 8

DR. PAUL J. MIDDENDORF and DR. ELIZABETH WARD 

CHARGE TO THE COMMITTEE 11

DR. JOHN HOWARD

BRIEF UPDATE ON WTC HEALTH PROGRAM 12

JESSICA BILICS

OVERVIEW OF WTC HEALTH RESEARCH 17

DR. ALLEN ROBISON and DR. TRAVIS KUBALE

WTC HEALTH REGISTRY RESEARCH 24

DR. MARK FARFEL and DR. STEVEN STELLMAN

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 51

DEVELOPMENT OF RECOMMENDATIONS

DR. ELIZABETH WARD

ADMINISTRATIVE ISSUES AND ADJOURN 134

DR. ELIZABETH WARD and DR. PAUL J. MIDDENDORF

COURT REPORTER’S CERTIFICATE 137
3

TRANSCRIPT LEGEND

The following transcript contains quoted material. Such material is reproduced as read or 

spoken.

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 affirmative 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 - NIOSH OFFICE OF EXTRAMURAL PROGRAMS

STEVEN MARKOWITZ, COMMITTEE MEMBER

GUILLE MEJIA, COMMITTEE MEMBER

JIM MELIUS, PUBLIC COMMENTER

PAUL J. MIDDENDORF, PhD - DESIGNATED FEDERAL OFFICIAL

LILA NORDSTROM, PUBLIC COMMENTER

CAROL NORTH, COMMITTEE MEMBER

MARY PERILLO, 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

LEO TRASANDE, COMMITTEE MEMBER

ELIZABETH WARD, PhD - CHAIR
5

Committee Members

1

2 Occupational Physicians with Experience in Treating WTC Rescue and Recovery 

3 Workers:

4

5 Steven Markowitz, M.D.

6 Professor of Environmental Sciences and Director of The Center for The Biology of Natural 

7 Systems at Queens College, City University of New York, New York City.

8 William Rom, M.D., M.P.H.

9 Professor of Medicine and Environmental Medicine, New York University School of Medicine 

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

11 University, New York City.

12

13 Occupational Physicians:

14

15 Robert Harrison, M.D., M.P.H.

16 Clinical Professor of Medicine, University of California, San Francisco; 

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

18 Health, San Francisco.

19 Virginia Weaver, M.D., M.P.H.

20 Director, Occupational and Environmental Medicine Residency, Bloomberg School of Public 

21 Health, Johns Hopkins University, Baltimore.

22

23 Physician with Pulmonary Medicine Expertise:

24 Thomas K. Aldrich, M.D.

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

26 of Medicine, Yeshiva University, New York City.

27 Representatives of WTC Responders:

28

29 Stephen Cassidy

30 President, Uniformed Firefighters Association of Greater New York, Local 94 I.A.F.F. AFL-CIO 
6

1 Valerie Dabas

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

3 New York City.

4 Guillermina Mejia, M.P.H

5 Certified Health Education Specialist, Principal Program Coordinator, Safety and Health 

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

7 37, New York City.

8

9 Representative of Certified-Eligible WTC Survivors:

10

11 Kimberly Flynn,

12 Co-Founder, Director, 9/11 Environmental Action

13 Catherine McVay Hughes

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

15 Manhattan World Trade Center Redevelopment, New York City.

16 Susan Sidel, J.D.

17 Resident of New York City and volunteer WTC responder.

18

19 Industrial Hygienist:

20 John Dement, Ph.D.

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

22

23 Toxicologist:

24 Julia Quint, Ph.D.

25 Research Scientist Supervisor II and Chief, Hazard Evaluation System and Information Service 

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

27 Epidemiologist:

28 Elizabeth Ward, Ph.D. (Advisory Committee Chair-Person)

29 National Vice-President for Intramural Research, American Cancer Society, Atlanta.

30

31
7

1 Mental Health Professional:

2 Carol S. North, M.D. M.P.E.

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

4

5 Environmental Health Specialists:

6 Glenn Talaska, Ph.D.

7 Certified Industrial Hygienist, Professor, Department of Environmental Health, University of 

8 Cincinnati, Cincinnati.

9 Leonardo Trasande, M.D., M.P.P.

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

11 University; Associate Attending in Pediatrics, Bellevue Hospital Center, New York City.

12

13

14 Designated Federal Official:

15 Paul J. Middendorf, Ph.D., CIH

16 Senior Scientist

17 CDC/NIOSH/Office of the Director

18 Cincinnati, Ohio

19

20
8

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

2 (9:35 a.m.)

3

4 WELCOME AND INTRODUCTION

5 DR. MIDDENDORF: Well, good morning everybody, Happy Valentine's Day. 

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

7 Technical Advisory Committee. 

8 Hopefully everyone has weathered the effects of Winter Storm Pax that's 

9 just gone through. It certainly caused us a few tense moments in the lead-up to the 

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

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

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

13 much appreciate your interest in these proceedings.

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

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

16 moments in silence to remember those who were killed in the attacks on 9/11 and 

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

18 (Moment of silence.)

19 DR. MIDDENDORF: Thank you. There are a number of administrative issues 

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

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

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

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

months through March 30th 24 . We anticipate announcing the selections for those 

25 positions in the very near future.

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

seats on the committee, and those are scheduled to open on September 30th 27 of this 

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

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

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

31 address is on the screen.

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

33 to begin at 11:30 this morning, and that's Eastern Standard Time. Copies of the 

34 public comments that we received by yesterday have been provided to each of the 

35 committee members and they will also be posted in NIOSH's docket number 248-A, 

36 which is also available through the committee's website.

37 Let's go ahead and do a quick roll call. For our roll call, I'll call out the name 

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

39 state whether or not there have been any changes in your employment or interest 
9

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

2 leave the call, please let me know when you leave and when you return so we can 

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

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

5 lunch period.

6 So, Tom Aldrich? 

7 DR. ALDRICH: ...and I have received a grant from the NIOSH program but I 

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

9 DR. MIDDENDORF: Okay. And Steven Cassidy and Valerie Dabas will not be 

10 participating in the meeting. 

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

12 Kimberly announced herself earlier. Kimberly, are you there?

13 MS. FLYNN: Hello? Paul?

14 DR. MIDDENDORF: Yes?

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

16 not changed.

17 DR. MIDDENDORF: Okay. Bob Harrison?

18 DR. HARRISON: I'm here and I don't have any conflicts or issues.

19 DR. MIDDENDORF: Okay. Catherine Hughes?

20 MS. HUGHES: Nothing has changed.

21 DR. MIDDENDORF: Okay. Steve Markowitz.

22 DR. MARKOWITZ: Present. I don't think it's a conflict but we were a 

23 satellite -- a site for Wisnivesky's asthma research project funded by NIOSH.

24 DR. MIDDENDORF: Okay. Is that new or different?

25 DR. MARKOWITZ: No, no. It's been going on for at least a year or so.

26 DR. MIDDENDORF: Okay. So it's part of the evaluation for your conflict of 

27 interest already.

28 DR. MARKOWITZ: Correct.

29 DR. MIDDENDORF: Okay. Guille Mejia?

30 MS. MEJIA: I still have the same employer; however, I am now the director 

31 of the safety and health department and I'm also the PR for the cooperative 

32 agreement.

33 DR. MIDDENDORF: Okay. And we've addressed your conflict of interest 

34 issues already.

35 MS. MEJIA: Yes.

36 DR. MIDDENDORF: Okay. Carol North?

37 DR. NORTH: I'm here. I don't think I have any change.

38 DR. MIDDENDORF: Okay. Julia Quint?

39 DR. QUINT: I'm here. My status hasn't changed.
10

1 DR. MIDDENDORF: Okay. Bill Rom?

2 DR. ROM: Present. No changes.

3 DR. MIDDENDORF: Okay. Susan Sidel.

4 MS. SIDEL: I'm here. Can you hear me?

5 DR. MIDDENDORF: Yes, we can hear you.

6 MS. SIDEL: Okay, all good.

7 DR. MIDDENDORF: Okay. Glenn Talaska?

8 DR. TALASKA: Present. No changes.

9 DR. MIDDENDORF: Okay. Leo Trasande? I believe he'll be joining us this 

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

11 DR. WARD: I'm here. No changes.

12 DR. MIDDENDORF: Okay. Virginia Weaver?

13 DR. WEAVER: Present and no changes.

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

15 ask John Dement, have you joined us?

16 DR. DEMENT: Yes, Paul, I'm on the line.

17 DR. MIDDENDORF: Okay.

18 DR. DEMENT: There are no changes.

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

20 quorum.

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

22 Health Program. All the materials for this meeting including copies of our agenda 

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

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

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

26 three little pieces of paper. So if you click on that, you should be able to get to the 

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

28 Because the focus of this meeting is on the research needs of the program, 

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

30 research on World Trade Center-related matters, it is important that we manage the 

31 potential for conflict of interest. So for each of those members, I believe, have been 

32 counseled on the limits of their participation. If I happen to see that someone has 

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

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

35 discussion in that particular area.

36 An issue we need to address for committee members is how to make sure 

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

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

39 each of you has the opportunity to contribute to the meeting. So after a speaker is 
11

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

2 have comments to make, Liz and I will both keep a sequential list of those who 

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

4 so you can have the floor.

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

6 speaking so our transcriptionist can accurately attribute your contributions to the 

7 meeting.

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

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

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

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

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

13 has been put to the committee, or no, meaning you are voting against the motion 

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

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

16 According to our bylaws a majority of those voting determines the outcome.

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

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

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

20 Paul and other CDC staff who have organized and supported this meeting.

21 I think we have a very full agenda, had a little bit of a late start, so I'd like to 

22 move directly to Dr. Howard for his charge to the committee.

23

24 CHARGE TO THE COMMITTEE

25 DR. HOWARD: Thank you, Liz. Good morning, advisory committee

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

27 Welcome to the fourth meeting of the World Trade Center Health Program

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

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

30 Health Program are greatly appreciated.

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

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

33 specifies three areas of contributions of the advisory committee to the program. 

34 First, the Act requires that the administrator consult with the advisory committee 

35 with regard to determining eligibility criteria for responder and survivor 

36 membership in the program. Second, the Act provides that the administrator may 

37 seek a recommendation from the advisory committee regarding whether a 

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

39 Center-related health conditions. And third, the Act requires the administrator to 
12

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

2 the program.

3 It is this third area, consulting the advisory committee with regard to 

4 identifying the research needs of the World Trade Center Health Program, that I 

5 asked you to meet today. 

6 Each year since 2011, NIOSH has solicited applications for scientifically 

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

8 mental health conditions related to the September 2001 terrorist attacks. From 

9 2011 through 2013, 79 research proposals were reviewed, and 32 percent of them 

10 or 25 meritorious projects, including the renewal of the World Trade Center Health 

11 Registry, have been funded.

12 The charge that I would respectfully give to the advisory committee today is 

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

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

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

16 research knowledge gaps relative to the accurate diagnosis of World Trade 

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

18 relative to the effective treatment of World Trade Center-related health conditions; 

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

20 research needs identified by the advisory committee.

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

22 productive meeting. Thank you for attending.

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

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

25

26 BRIEF UPDATE ON WTC HEALTH PROGRAM

27 MS. BILICS: Hello. This is Jessica Bilics. This is the World Trade Center 

28 Health Program policies, staff and intergovernmental affairs. 

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

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

31 Some of these changes include the addition of more than 50 types of -- or categories 

32 of cancer, the addition of Pentagon, Shanksville, -- Shanksville, Pennsylvania 

33 responders to our membership and the completion of a variety of policies and 

34 procedures to help program providers determine World Trade Center-related and 

35 medically associated health conditions as well as policies and procedures for 

36 administrative requirements related to recoupment or reimbursements from 

37 workers' compensation or private health insurance.

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

39 policies and procedures or the regulatory activities of the program. However, I 
13

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

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

3 access the website at: www.cdc.gov/wtc.

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

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

6 deliberated, as Dr. Howard requested, on research priorities for the future of the 

7 program. The data I will cover should be on the screen if you are participating via 

8 Live Meeting and are also available in a two-page document titled The World Trade 

9 Center Program Updates on the program's advisory committee web page.

10 The first four tables provide break-outs of the program's more than 66,500 

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

12 program's membership by four major member types: FDNY responders, non-FDNY 

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

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

15 responders who responded to the disaster in New York City. Twenty-five percent 

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

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

18 Pennsylvania sites.

19 Table 2 breaks down the program's membership by member types as well 

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

21 and 1 percent unknown; however, the gender distribution varies within the member 

22 type. The three responder categories, the responders, FDNY and 

23 Pentagon/Shanksville in the table, all have about 85 percent or more males,

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

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

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

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

28 been surprised by the younger members in the program, particularly those in the 

29 responder and FDNY categories. Table 3 reflects the statutory eligibility criteria 

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

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

32 of FDNY.

33 Table 4 breaks down the member -- the program's membership by the top 

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

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

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

37 New York metropolitan area are served by the program's nation-wide provider 

38 network.

39 As you all know, the World Trade Center Health Program provides 
14

1 treatment for certified members as a variety -- for a variety of health conditions. 

2 The major categories of health conditions include obstructive airways diseases such 

3 as asthma, reactive airway dysfunction syndrome, World Trade Center-related COPD 

4 and chronic cough, upper respiratory diseases, upper airway -- such as upper airway 

5 hyperactivity, rhinosinusitis, nasal pharyngitis and laryngitis as well as interstitial 

6 lung diseases, gastroesophageal reflux disease, certain types of cancers, mental 

7 health conditions and musculoskeletal disorders.

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

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

10 health conditions, which leaves 46 percent, or more than 30,000 members, certified 

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

12 certified for three or more health condition categories.

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

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

15 conditions are GERD, with more than 2,000 members certified, sinusitis, with more 

16 than 1,500 members certified, and rhinitis with almost 15 members -- 1,500 

17 members certified as well.

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

19 three are cancer conditions, three are mental health conditions, two are upper 

20 respiratory diseases and one is an obstructive airways disease.

21 Table 8 displays the top ten cancers certified within the program. As of mid22 January, the World Trade Center Health Program had certified 1,930 cancers. Of 

23 this total, 320, or 17 percent, are for prostate cancer, and just over 300, or 

24 16 percent, are for non-melanoma skin cancer. The top ten certified cancers make 

25 up 80 percent of all cancers certified within the program.

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

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

28 answer any questions that any members may have.

29 MS. HUGHES: Yes, this is Catherine Hughes. Is this going to be posted on 

30 the website, this table?

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

32 available on the advisory committee web page.

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

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

35 MS. HUGHES: Great, thank you.

36 MS. BILICS: And it's titled World Trade Center Program Update.

37 DR. HARRISON: This is Bob Harrison, thank you. Do you have a breakdown 

38 on the types of leukemia?

39 MS. BILICS: I don't have them by count. The regulation like -- I'm not sure I 
15

1 have the regulations in front of me. The regulations do break down -- they include 

2 the tables of these cancers. I can probably find it.

3 DR. HARRISON: Yeah, I'm just thinking of, you know, how many were AML, 

4 ALL, CML or --

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

6 here.

7 DR. HARRISON: Okay.

8 MS. BILICS: We can maybe get it up on the website later.

9 DR. HARRISON: Okay, thanks.

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

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

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

13 pulmonary disease that you mentioned.

14 MS. BILICS: I was just saying that of the covered different major categories 

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

16 obstructive airways diseases category is World Trade Center-exacerbated COPD as 

17 an eligible condition for coverage.

18 DR. MARKOWITZ: So in table 7, was the top -- was -- is the top ten covered 

19 health conditions --

20 MS. BILICS: Yes.

21 DR. MARKOWITZ: -- which starts with GERD and then goes to sinusitis and 

22 then rhinitis, right?

23 MS. BILICS: Yes.

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

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

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

27 have at least one covered condition or if I'm reading that correctly, they're certified 

28 for at least one covered condition.

29 MS. BILICS: Correct.

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

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

32 seem to only include about 8,000 members.

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

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

35 treatment. I believe that's the data.

36 DR. MARKOWITZ: Okay. So okay. Table 5 is not necessarily in treatment; 

37 it's certified.

38 MS. BILICS: No, it's for the whole program certified, yeah.

39 DR. MARKOWITZ: Great, thank you.
16

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

2 information. A follow-up to Dr. Markowitz's question. Could you please clarify that 

3 the 35,966 members who are not -- who have no certifications are all in the 

4 responder monitoring program and that the survivor program is different?

5 MS. BILICS: Yeah, so the difference between the two categories, the 

6 responder and the survivor committees -- or committees -- populations, are that the 

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

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

9 monitoring without being sick from any condition; whereas the survivor population 

10 statutorily has a requirement to -- that the members have to be -- they have to have 

11 a symptom initially to be screened to be determined if they are eligible, the certified 

12 eligible survivors. So in order to be in the program they have to be sick from one of 

13 the conditions.

14 MS. FLYNN: Thank you.

15 MS. MEJIA: Jessica, this is Guille Mejia. Can you tell me, do you have 

16 numbers in terms of the pending cases that need to be certified, how many are still 

17 pending that would add to these numbers?

18 MS. BILICS: I don't have those numbers. I don't know if I -- anyone on our 

19 medical team -- I'm looking at the pending cases for certification -- any idea about 

20 how many they are? We can find out.

21 MS. MEJIA: Okay, and when was the -- what's the date on these tables, in 

22 terms -- do you have a cut-off date for these numbers as of when?

MS. BILICS: Tables 1 through 4 are through the 11th 23 of February and tables 

5 through 8 are all through mid-January. I believe the date was the 8th 24 of January.

25 MS. MEJIA: Okay, thank you.

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

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

28 questions that come up from committee members about these diagnoses or the --

29 for the medical program?

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

31 folks from down the hall.

32 DR. WARD: Okay, great.

33 DR. HARRISON: This is Bob Harrison. I don't know whether we'll cover this 

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

35 treatment, and will we be covering that later or -- I guess I'm just trying to get a 

36 sense of how the covered conditions and suggest anything about how people have 

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

38 issues that have come up around treatment.

39 MS. BILICS: There is a presentation from the clinical centers by Dr. Laura 
17

1 Crowley later that will speak, probably, to some of your questions.

2 DR. HARRISON: Okay. Great, thanks.

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

4 Dr. Robison and Kubale on Overview of World Trade Center Health Research.

5

6 OVERVIEW OF WTC HEALTH RESEARCH

7 DR. KUBALE: Good morning, this is Travis Kubale and I'm the program 

8 official from the Office of Extramural Programs and assigned to the World Trade 

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

10 OEP. And Dr. Middendorf, as you know, has asked us to provide the committee with 

11 a brief overview describing the World Trade Center Health Program research 

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

13 Dr. Robison and I will describe the current research solicitation 

14 announcement and how STAC recommendations were incorporated. We will 

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

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

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

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

19 2011 STAC recommendation report. And finally we'll talk about where information 

20 concerning the current research, including the principal investigator contact 

21 information, project descriptions and results, can be obtained. 

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

23 the funding announcement. Allen?

24 DR. ROBISON: Thank you, Travis. Can you hear me? 

25 DR. KUBALE: Yes.

26 DR. ROBISON: Good morning, everyone. I just want to talk briefly about 

27 the World Trade Center Health Program research funding announcement that we 

28 developed in late 2011 and published in 2012.

29 Our first application was published in March 2012, and we received our first 

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

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

32 Committee, the World Trade Center Health Program and others. That input is 

33 reflected in the announcement by identifying major areas of interest but not 

34 limiting the announcement to those six major areas of interest that are listed. We 

35 also identified relevant diseases or conditions but we did not limit applications to 

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

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

38 populations and community members or survivor populations. 

39 We also listed contacts for the three data centers. And the reason for that 
18

1 was to help stimulate collaboration and encourage collaboration by the applicants 

2 as they submitted their -- as they prepared their applications. 

3 And then also in the funding opportunity announcement we provided 

4 guidance to reviewers on disaster science. And the way that's worded in the

5 announcement, it's a little section called limitations of currently available data. We 

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

7 type of research where there may not be a lot of pre-event information, so we 

8 equate that to the area of the -- the area that we call disaster science research.

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

10 as Dr. Howard said, scientifically rigorous investigator-initiated applications for 

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

12 encourage collaboration, and we still pursue that -- those two goals with each round 

13 of applications that we receive.

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

15 announcement based on the number and types -- the number and types of projects 

16 that have been funded. 

17 And then before I close and turn it back over to Travis, I just want to say 

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

19 who provided input and others who provided input. And I want to particularly 

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

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

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

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

24 were conducted in 2011, -12 and -13. A 2014 solicitation was just completed, and 

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

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

27 program is reauthorized. Currently, as has been stated, the portfolio has 25 projects 

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

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

30 In 2011 eight projects were funded, each with a three-year duration. Now,

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

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

33 total of seven publications for those four projects.

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

35 Trade Center Health Registry was included. Five of the 11 projects have two-year 

36 duration periods and the initial results we expect possibly late this calendar year. 

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

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

39 mental health and physical comorbidity, respiratory effects among World Trade 
19

1 Center-exposed children, 9/11 healthcare utilization, behavioral and structural 

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

3 In 2013, six projects were funded. Three of the projects have two-year 

4 duration periods and three are for three years. We are expecting and hoping that 

5 two of the two-year projects may have early results in early 2015.

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

7 Three mental health studies were funded, and each of these studies has a post8 traumatic stress disorder emphasis. Dr. Adriana Feder's study identifies and 

9 describes the distinct course of World Trade Center-related PTSD symptoms over 

10 time, and initial findings are published in two articles.

11 Dr. Evelyn Bromet has two studies, one examining post-traumatic stress 

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

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

14 implementing and evaluating a smoking cessation intervention program for 

15 individuals diagnosed with post-traumatic stress disorders.

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

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

18 call, there was one respiratory disease study that Dr. Ken Berger is conducting to 

19 enhance the characterization of lung disease among individuals exposed to World 

20 Trade Center dust. And this study does include rescue and recovery workers as well 

21 as area residents, and initial findings have been published in three separate articles.

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

23 Dr. Paolo Bonfetta's (sic) study included non-FDNY responders and a study by 

24 Dr. Prezant, David Prezant, included FDNY firefighters and emergency medical 

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

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

27 by Dr. Morabia is examining the overall CVD risk among responders and is also 

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

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

30 examining the long-term effect of particulate matter on pulmonary and 

31 cardiovascular disease risk.

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

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

34 females.

35 The next slide. The next two slides, beginning with this one, list 11 studies 

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

37 added to the portfolio during the 2012 call. 

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

39 persistence over a ten-year period of bronchial hyper-reactivity easily triggered 
20

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

2 anti-asthma medications at resolving bronchial hyper-reactivity and a decline in lung 

3 function.

4 Dr. Charlie Hall is investigating the incidence of new obstructive airway 

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

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

7 indications of lung disease among World Trade Center's responders -- responders, 

8 workers and volunteers. 

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

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

11 development of obstructive sleep apnea. He's also looking at the impact of the 

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

13 CPAP machines. 

14 Dr. Wisnivesky is studying the relationship between asthma morbidity and 

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

16 working to explain the potential mechanisms underlying post-traumatic stress 

17 disorder and respiratory disease comorbidity, also among responders.

18 Three of the six studies, Dr. Aldrich, Dr. Hall and Dr. Luft, are two-year 

19 studies and early results are possible by late in the calendar year. Four of these six 

20 studies do include females.

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

22 you can see, there are three mental health studies. Dr. Adriana Feder is assessing 

23 the vulnerability to post-traumatic stress disorder among police and responders. 

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

25 risk behaviors among World Trade Center youth exposed to 9/11. And she also has 

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

27 service need, use and barriers to service. That is a two-year study and results are 

28 possible late this calendar year.

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

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

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

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

33 these studies, all of these five studies, do include females.

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

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

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

37 aggressiveness. Her study population is rescue and recovery workers. 

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

39 Trade Center-related trace elements can be identified in individual autopsy tissues. 
21

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

2 biomarkers indicative of cumulative World Trade Center exposure.

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

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

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

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

7 uncontrolled lower respiratory disease among survivors and responders. And the 

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

9 respiratory symptoms.

10 Dr. Mayris Webber is working to calculate the incidence of selected 

11 systemic autoimmune diseases in firefighters and emergency medical service 

12 workers. And Dr. Adam Gonzalez is comparing two methods of mind-body 

13 treatment for responders with PTSD, post-traumatic stress disorders, and lower 

14 respiratory disease.

15 All but one of these six studies include females. Three of them, Drs. Taioli, 

16 Marmor and Webber are two-year studies with initial results expected in mid-2015.

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

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

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

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

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

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

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

24 populations that have both responders and survivors.

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

26 research portfolio of projects can be accessed through the World Trade Center 

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

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

29 study descriptions that are available on the website, if -- for people to see, and 

30 that's publicly available. 

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

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

33 have two research grantee meetings each year. In the '14 meetings, we will begin 

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

35 organizing findings and identifying research gaps as well and providing that 

36 information to the program. The characterization or the categorization scheme that 

37 I talked about will also get a look at as well and I would imagine that there will be 

38 some modification there, too.

39 Scientific publications, like I said, there are currently seven publications that 
22

1 are available from projects awarded in 2011. And currently the PIs will be 

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

3 Society Conference, the American -- the World Congress of Epidemiology, the 

4 American Heart Association and the American Association of Cancer Research.

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

6 Extramural Programs, the STAC committee members and also the very hard work 

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

8 DR. WARD: Thank you for that informative presentation. We have a few 

9 minutes for questions.

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

11 not an unfair question, but in Dr. Howard's charge to the committee, he listed 

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

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

14 I'm just wondering whether he's broken these projects down at all by those three 

15 factors, the extent to which they address more or less those three factors?

16 DR. KUBALE: You know, Dr. Markowitz, we have some information about, 

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

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

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

20 want to weigh in on that as well.

21 DR. MARKOWITZ: Actually, you know, let me just rephrase it. Do you think 

22 any of those three areas, the ideology of the diagnosis of treatment, it seemed 

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

24 the various projects, treatment, for instance, you mentioned a number of times. 

25 And from -- is it your impression that any of those three areas are perhaps under --

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

27 DR. KUBALE: You know, I think the way that I would, you know, probably 

28 best answer that right now is that I think -- I think that there are several of the 

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

30 because of the relative newness of the portfolio, it's hard for me to comment, you 

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

32 particular time.

33 DR. MARKOWITZ: Okay. Thank you.

34 DR. KUBALE: I'm sorry.

35 DR. MARKOWITZ: It's not a problem.

36 DR. HARRISON: This is Bob Harrison. Could you just, Allen, just re37 emphasize the current funding years for the projects that are already funded, when 

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

39 those would be expected to end? I'm just, just trying to get an overall perspective 
23

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

2 DR. KUBALE: Um -- I'm sorry.

3 DR. ROBISON: No, go ahead, Travis, that's fine.

4 DR. KUBALE: Dr. Harris (sic), the projects that were funded in '13 -- or I'm 

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

6 The projects that were funded in '12, some will, the two-year projects, will end in --

7 at the end of '14, and the four-year projects will essentially be funded through the 

8 end of '15. 

9 The six projects that were funded in '13, two -- like I said three of the 

10 two-year projects -- let's see, it will be FY '13 and '14, and the three-year projects 

11 will go into '15.

12 DR. HARRISON: The current projects that are funded end in 2015.

13 DR. KUBALE: Yes.

14 DR. HARRISON: And the new announcement that we're discussing in terms 

15 of recharge of priorities, that goes out this year and that -- those would end in --

16 DR. KUBALE: I'm sorry, I understand your question. That's a one -- those 

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

18 one-year projects.

19 DR. HARRISON: Okay, for one year.

20 DR. KUBALE: Yes.

21 DR. HARRISON: And those would start in --

22 DR. KUBALE: The money would be allocated in '15. They would go into 

23 '16 but the money would be authorized and allocated for '15.

24 DR. HARRISON: Okay, gotcha. Thank you very much. That helps me 'cause 

25 I just wanted to -- and that would be, then, in terms of the -- from 2001, those 

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

27 terms of any kind of longitudinal evaluation or --

28 DR. KUBALE: Yes, you're correct. That's correct.

29 DR. HARRISON: We'd be talking 15 years.

30 DR. KUBALE: That's correct.

31 DR. HARRISON: Since 2001, okay. Thank you.

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

33 announcement we've modified in each year to decrease the number of years, to line 

34 up with the projects. And then currently the next receipt date will be for one-year 

35 projects. 

36 And then as we look ahead to another research funding opportunity 

37 announcement, we will incorporate input that we receive from the Scientific 

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

39 current projects that are funded, so we're, we're looking -- we're looking ahead to 
24

1 that. Thanks.

2 DR. HARRISON: So can I clarify that, just one quick question? So then are --

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

4 announcement for one-year projects or also for potential reauthorization and 

5 additional research in subsequent funding announcements that could go beyond 

6 one year?

7 DR. MIDDENDORF: I think Dr. Howard is interested in getting information --

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

9 out beyond the point of reauthorization.

10 DR. HARRISON: Okay. Thank you.

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

12 of uncertainty was in the exposure and the ability to reconstruct the exposures from 

13 the, from the 9/11 -- the measurements that were done. Does that seem to be an 

14 area that's addressed? I realize that the Marmor study will be looking at the levels 

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

16 strategies for doing monitoring under -- when circumstances like this might arise 

17 again. 

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

19 assessment.

20 DR. TALASKA: Okay, thank you.

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

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

23 Health Registry Research Program.

24

25 WTC HEALTH REGISTRY RESEARCH

26 DR. FARFEL: Good morning. Thank you for the opportunity to provide an 

27 update on registry research. This is Mark Farfel, the registry director, and I'm going 

28 to begin with a very brief overview, and Dr. Steve Stellman, the registry's research 

29 director, is going to focus on registry research since our last update, which was at 

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

31 Next slide. Could I have the next slide, please?

32 DR. MIDDENDORF: Yeah, I'm working on it.

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

34 directly exposed to the 9/11 disaster. And it was designed to last 20-plus years with 

35 periodic follow-up health surveys. We do collect additional data by matching with 

36 administrative databases, to assess cancer, mortality and hospitalization, and by 

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

38 NYU-Bellevue. The registry is also a platform for numerous 9/11-related studies by 

39 external researchers, and Dr. Stellman will mention some of our active 
25

1 collaborations.

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

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

4 conduct extensive outreach to encourage enrollees to access monitoring and 

5 treatment through the World Trade Center Health Program.

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

7 responders and non-responder survivors who were exposed to the disaster. We 

8 have more than 30,000 rescue and recovery workers enrolled in the registry,

9 including thousands of firefighters, police, out-of-state responders, construction

10 utility workers and volunteers. 

11 The largest group of survivors is the building occupants and passers-by 

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

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

14 numbers total more than 71,000.

15 While most of our enrollees live in New York City, we do have enrollees 

16 from all 50 states and more than 15 countries.

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

18 after 9/11, and it became a collaborative effort funded by FEMA, ATSDR, CDC

19 beginning in 2002. Our Wave 1 survey was conducted in 03-04, and addressed new 

20 and worsening physical and mental health symptoms and conditions and exposures 

21 on and after 9/11. 

22 The first follow-up survey was conducted in 06-07, and our Wave 3 survey 

23 provided health updates approximately ten years post-9/11. These follow-up 

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

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

26 pediatric surveys.

27 We collected data on Hurricane Sandy exposures and health outcomes six to 

28 12 months after the events among 4,300 enrollees living in inundation zones and a 

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

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

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

32 for a 2015 launch.

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

34 review journals that report on adverse health outcomes across all eligibility groups 

35 and subgroups, that address myriad conditions including some that Travis 

36 mentioned earlier: PTSD, respiratory heart diseases, cancer, mortality, GERD, co37 occurring conditions and other topics such as access to care and respiratory 

38 protection.

39 We're also in continuous communication with scientific and clinical 
26

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

2 produced a number of technical reports as well as three sets of clinical guidelines 

3 developed with our colleagues at the clinical programs.

4 Other outputs include our in-depth studies, doctoral and masters theses 

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

6 posted on the registry's website.

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

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

9 the clinical/medical journals, journals focused on occupation/environmental health 

10 as well as mental health, public health/epidemiology and disaster-oriented journals. 

11 And our publications do include two papers, an editorial and two letters in JAMA as 

12 well as two papers in the Lancet.

13 Could I have the next slide? The publications -- the registry work is 

14 informing disaster response through the peer review literature contributions, the 

15 conference presentations, and studying the impact of exposure to multiple 

16 disasters. We also contribute through the facilitated external research that includes 

17 the studies of behavioral, organizational and structural aspects of evacuation of 

18 damaged and destroyed buildings at the World Trade Center site.

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

20 registry is actually one of the four aims under our current NIOSH funding. And the 

21 project was launched in 2008 in collaboration with a health and hospital 

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

23 it's now been expanded to include responders and out-of-state enrollees. 

24 And we conduct what we deem personalized outreach to survivors who 

25 reported 9/11-related public health -- physical health and/or mental health 

26 symptoms as well as to responders with and without symptoms who did not report 

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

28 social work and nursing backgrounds and are trained in motivational interviewing 

29 techniques so that they can encourage care seeking addressing attitudinal and 

30 access barriers. 

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

32 populations, for example, one of the subgroups with comorbid PTSD and depression 

33 and low social support. Others are concerned about mental health stigmatization or 

34 fail to connect their symptoms with 9/11. 

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

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

37 World Trade Center Health Program, and we do continue to send applications for 

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

39 see if they have applied and to offer assistance if needed.
27

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

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

3 source for 9/11-related long-term health impacts research. 

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

5 the large numbers that we have of both responders and survivors, the scope and 

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

7 providing lessons learned for future disasters. 

8 We also have dedicated staff for core registry functions in the areas of 

9 research, surveillance, cohort maintenance and treatment referral. And we do have 

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

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

12 numbers of withdrawals; it's just a little bit more than 1 percent, and small numbers 

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

14 collaborations with distinguished external researchers. 

15 DR. STELLMAN: Good morning, this is Steve Stellman, the research director 

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

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

18 appeared in print since our previous appearance in 2011. I just have to emphasize 

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

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

21 Brackbill on injury that was just accepted by American Journal of Epidemiology last 

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

23 current research program.

24 As you can see we -- the registry has now published 44 articles in the peer 

25 review literature and has five papers under review, and these sort into the thematic 

26 areas that are largely under discussion this morning, physical and mental health.

27 As you can see on the right-hand panel, we have a number of other areas 

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

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

30 of these here.

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

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

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

34 particular paper was one of a handful of nominees for the CDC's annual Charles C. 

35 Shepard Award for Science, so -- for which there are usually about a thousand CDC 

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

37 the finalists.

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

39 found that protective equipment were used most often by construction utility 
28

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

2 50 percent reduced risk of respiratory illness, and that fit testing and training were 

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

4 consistent with the guidelines that NIOSH and other organizations have been 

5 publishing for years, it's really rather rare in the literature to find an actual 

6 evaluation of effectiveness.

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

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

9 sensitive to distal airway dysfunction. We found that cases were more likely -- cases 

10 of respiratory -- lower respiratory distress were more likely to have abnormal 

11 spirometry than control but that a screening spirometry was relatively insensitive at

12 distinguishing symptomatic or asymptomatic control, and that this oscillometry 

13 measurement was reflecting overall resistance to airway flow was more likely to be 

14 elevated in cases than in control.

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

16 disease, one on mortality, one on incidence and one on hospitalization. The first 

17 bullet here refers to our incidence study in which we reported that dust exposure 

18 and PTSD independently were predictors of elevated risk of nonfatal heart disease 

19 in our Wave 2 survey; that is, two to six years post-9/11.

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

21 American Heart Association based on linkage of respiratory data with the New York 

22 State SPARCS registry, which is a hospitalization database, which we found 

23 hospitalization for cardiovascular disease was 32 percent higher in women with 

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

25 low exposure.

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

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

28 symptoms. We found an elevated rate of GERS in our -- up to Wave 2 survey, and 

29 found that these were especially pronounced in people who had comorbid PTSD, 

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

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

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

33 Next slide? We've done the major study on mortality in the registry based 

34 on linkage with the New York City vital records and with the National Death Index of 

35 cancer based on linkage with the New York State cancer registry and the registries 

36 of New Jersey, Connecticut and a number of other states where the great majority 

37 of our enrollees live. The overall mortality in the registry population is considerably 

38 below the population rate, which in fact is what you usually find in the early years of 

39 a cohort study based on volunteer enrollment.
29

1 Cardiovascular mortality was in fact dose related to a 9/11 intensity score,

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

3 of about 1.6.

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

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

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

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

8 prostate cancer, multiple myeloma, and these were strikingly consistent with 

9 reports from two of the other reporting agencies, the fire department and Mount 

10 Sinai.

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

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

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

14 from Columbia University, we divided different types of various evacuations

15 according to structural and behavioral pattern. We found for example evacuation 

16 time was related to encountering smoke and poor lighting, structural barriers and 

17 behavioral barriers such as serious crowding and lack of communication.

18 We have conducted three follow-ups -- or three rounds of data collection

19 and two follow-ups on our pediatric cohort. And in the younger children we 

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

21 prevalence of lower respiratory illness in 14 percent of the children, and the great 

22 majority of those reported a previous diagnosis of asthma among -- with clinicians. 

23 We also have been looking at behavioral outcomes in children and 

24 adolescents as well, using some validated scales. And for example, in this study 

25 reported that, based on a question now known as the strengths and difficulties 

26 questionnaire, which taps into a number of emotional and behavioral domains, 

27 there was a three-fold increased risk for an abnormal score -- abnormal or 

28 borderline score on this outcome among children who also reported respiratory 

29 problems.

30 The third item on this slide refers to the study that I mentioned previously 

31 that has just been accepted for the American Journal of Epidemiology. There really 

32 has been very little research on the initial injuries that were sustained during the 

33 first hours and days of 9/11 exposure. And it turns out, at least in our study, we 

34 followed them forward now for a number of years, and that multiple injuries are 

35 strong predictors of subsequent -- not only subsequent PTSD but subsequent 

36 development of chronic diseases including cardiovascular disease and diabetes, 

37 particularly cardiovascular disease.

38 And finally, as Dr. Farfel mentioned before, the Hurricane Sandy 

39 phenomenon in New York City, which hit us particularly hard during the last days of 
30

1 2011, raised the concerns that many people who already were dealing with 

2 9/11-related problems may have been re-traumatized, and so we sent out a survey 

3 to several thousand people in the registry, stratified by whether they lived within or 

4 not within the official FEMA inundation zone. Those data are still under analysis 

5 now, and the only preliminary finding that I'm able to report right now is that 

6 people with 9/11-related PTSD are about seven times more likely to screen positive 

7 for a Hurricane Sandy-related PTSD compared to people with no prior 9/11-related 

8 PTSD. But just keep in mind this is preliminary, unpublished findings that we expect 

9 to be able to submit for publication very shortly.

10 Next slide. To give you an idea of the manuscripts that are now in 

11 preparation, I've divided them into three areas here. We have two in-depth studies, 

12 that is a nested clinical study of respiratory disease, which is in the field right now, 

13 which is progressing very nicely. And then the Hurricane Sandy study that I just, just 

14 mentioned. Below on the left, several studies in progress include one on mortality 

15 related to substance use and then another study of reproductive health and 

16 potentially adverse birth outcomes such as low birth weight at gestational age, 

17 which we -- one study was -- which was done several years ago was only based on 

18 several years of data, and now we've linked the registry's data to New York City vital 

19 statistics for a 12-year period. So we have a much longer period of follow-up for 

20 those. 

21 Over on the right we have a number of other studies in progress including 

22 the one on diabetes, one on the long-term time course of PTSD, which nowadays is 

23 popularly termed, trajectory study. We're also concerned with comorbidity of 

24 both -- as I mentioned before, comorbidity of physical and mental health outcomes, 

25 where we have one nearly completed manuscript on the comorbidity of PTSD and 

26 other mental health outcomes, particularly depression and anxiety. 

27 We are working on one study on asthma control. We know asthma and 

28 other respiratory outcomes are a major 9/11-related outcome, and we have data on 

29 the extent to which people are using standard or recommended types of control 

30 approaches. I mentioned before that we are continuing to follow up our population 

31 for GERD. We're also concerned with unmet healthcare needs for physical and 

32 mental health, and we have several studies on alcohol abuse that are in progress.

33 Next slide. Research that is planned for the next two years the -- or two 

34 operational activities are the updating of our cancer and mortality databases. 

35 Cancer incidence database that I mentioned derived largely from about a dozen 

36 state cancer registries including New York State, New Jersey and Connecticut. And 

37 our mortality assessment, which is based on our local vital statistics and National 

38 Death Index. 

39 Then we have an active study of adolescent behavior that is from -- goes
31

1 into several domains including internalizing behaviors, related to emotions, 

2 externalizing behaviors such as conduct and hyperactivity. 

3 As part of our mortality studies, we're specifically focusing on PTSD and 

4 mortality, and then as we mentioned before our index study on rheumatoid arthritis 

5 and then there's a nested case-control study, which will unfold over the next year. 

6 I also mentioned before our study -- we're looking at risk factors and one is 

7 smoking trajectories, and we're looking in particular at the impact of 9/11 on 

8 smoking habits, which are some interest by themselves but which, of course, are 

9 indicators and predictors of subsequent chronic disease.

10 Next slide. We are well along in our planning stage for Wave 4 survey. And 

11 I'm very pleased to note that many of the people on this committee have already 

12 made some valuable contributions to our -- to the planning process and to our 

13 thinking about what will go into the survey. 

14 The objective for the survey will be to assess the course of conditions that 

15 we previously reported on, with a focus on chronic health, course of treatment for 

16 selected conditions, functional status of our enrollees and quality of life indicators, 

17 and then potentially new emerging conditions, which we're always looking out for.

18 The survey population is all adult enrollees who will be at least 18 years of 

19 age in 2015, and that in effect is about 99 and a half percent of the entire registry. 

20 The methods that we will use will be a web and paper survey, which worked very 

21 well for Wave 3, and we use, as is our policy, we always send out surveys in three 

22 language: English, Spanish and Chinese. And our current plan is to launch the survey 

23 early in 2015.

24 Next slide. Dr. Farfel also mentioned our linkages with external researchers, 

25 and this is something that we just simply can't do without, and we're very pleased 

26 with our relationships. This is a magnificent way to leverage the skill set and the 

27 resources in the registry and effectively tap into the very rich talent pool of 

28 researchers in the New York metropolitan area and elsewhere. 

29 We have a -- excuse me? We actively encourage external research projects 

30 and, as Dr. Kubale mentioned before, there are -- have we lost our slide? Oh, okay. 

31 Dr. Kubale mentioned before that many of the external research -- that the grant 

32 funded proposals that NIOSH has funded are based on registry research. I'll just 

33 mention a few of those. We provide external researchers many different ways of 

34 collaborating with the registry: They can collaborate directly with us and just 

35 include us as if we were part of the research team; they can simply use our data as a

36 public use database; or we have -- for several of these studies the registry can 

37 facilitate the recruitment of registry enrollees and once the recruitment is actually 

38 concluded, then the enrollees effectively are available to the external researchers 

39 for their approved projects.
32

1 We have a review committee that reviews applications similar to the way 

2 that most grant applications are reviewed. And to date we have approved 21 

3 studies from nine American and international institutions. Not all of these studies 

4 are in fact go into effect because many of them are contingent on funding for the 

5 individual studies and some of the funding sources -- sometimes investigators get 

6 funded and sometimes they don't. However, we are open as we possibly can with 

7 the making our data available.

8 The next two slides will show the 11 active external research studies that we 

9 have. And I think I'm just simply going to go down the list and mention the type of 

10 study and the investigator, because many of these have already been covered by 

11 Dr. Kubale.

12 So we have the first -- the first three -- first three bullets here are pediatric 

13 studies: the physical health study of Dr. Trasande at NYU and two mental health 

14 studies being done by Dr. Hoven at Columbia. The autopsy biomarker study by 

15 Dr. Marmor; the smoking cessation intervention by Dr. Kotov at Stony Brook; and a 

16 study of social integration and social support in police by Dr. Bowler at San Francisco 

17 State University.

18 Next. We also have a collaboration with the Center for Aging at the CDC led 

19 by Dr. Valerie Edwards, looking at cognitive functioning; another PTSD study among 

20 police responders by -- with Dr. Bowler at SFSU. A study with Dr. Berger, who is the 

21 oscillometry collaborator and is interested in developing normative scales for 

22 oscillometry for comparative purposes. And then a very innovative GIS study of 

23 respiratory conditions and exposures based on proximity measures with Dr. Antao

24 at ATSDR. And finally the study of upper respiratory symptomatology in responders 

25 by Dr. de la Hoz at Mount Sinai.

26 Next. So with all of this activity going on, what are we actually doing? Well, 

27 we are continuing the analyses of registry data that I’ve outlined several of these 

28 slides already. As I mentioned we're working on the design and questionnaire for 

29 our Wave 4 data collection. We're working on the in-depth respiratory health study 

30 and the rheumatoid arthritis case-control study. We're updating cancer and 

31 mortality assessments. We will continue referrals to the World Trade Center Health 

32 Program that Dr. Farfel described. And of course, as we are doing now and we 

33 continue to do as we publish our findings in the -- all the literature, we will share our 

34 findings with the public and with policy makers.

35 Last slide. And once again, we gratefully acknowledge not only the funding 

36 but the advice and counsel of our agencies: NIOSH, ATSDR, the very talented and 

37 dedicated registry staff at the New York City Department of Health and Mental 

38 Hygiene and the many members of our scientific community and labor advisory 

39 committees, many of whom are represented on the -- this STAC as well.
33

1 Thank you very much and we're happy to field questions, if you like.

2 DR. WARD: Thank you. The floor is open for questions.

3 MS. FLYNN: Liz?

4 DR. WARD: Yes.

5 MS. FLYNN: Hi, it's Kimberly. Thanks very much, Steve, for that 

6 acknowledgment of the collaborators and partners that the registry has worked 

7 with, and I just -- following on that, I really do want to make a pitch to this 

8 committee for advocating a community-based participatory research process. And 

9 just to sort of name one example of how important that was, the paper that 

10 Dr. Friedman wrote, published in 2011, on impulse oscillometry, at one point in the 

11 CBTR process, where the registry was meeting with members of the community and 

12 also the medical director of the survivor program, Dr. Reibman, the registry was 

13 contemplating eliminating oscillometry from that study design. And were it not for 

14 the outcry among community members and Dr. Reibman, the registry may never 

15 have had these important results and this excellent paper. So it really -- it really

16 does matter that there is a collaborative process and that that process includes 

17 members of the affected community.

18 DR. FARFEL: Are you expecting a response? All I can say is thank you again. 

19 We've got -- the study actually was planned before I came to the registry but I -- to 

20 this day, I do not understand why oscillometry is not a standard piece of equipment 

21 at every respiratory pulmonologist's arsenal. It just seems to be so highly sensitive 

22 and useful.

23 MS. FLYNN: Amen to that.

24 DR. WARD: Other comments or questions? Then I guess we'll move on to 

25 the next speaker, which is Laura Crowley, who will speak about the World Trade 

26 Center Clinical Centers of Excellence and the Data Centers' Research Needs.

27

28 WTC CLINICAL CENTERS OF EXCELLENCE/DATA CENTERS RESEARCH NEEDS

29 DR. CROWLEY: Hi, good morning. First of all I would like to thank you for 

30 the invitation to present on topics of interest for future research in the World Trade 

31 Center Health Program cohorts. And I'm affiliated with the responder program at 

32 the Mount Sinai clinical center but I have responsibility today to report on behalf of 

33 FDNY and survivor and responder programs. So I just wanted to start by describing 

34 the cohorts and a reminder of who each group is. 

35 So as many of you know the FDNY program is a group of all active and 

36 retired fire department members who responded to the 9/11 attacks; the responder 

37 program includes workers and volunteers who responded to the 9/11 attacks; and 

38 the survivor program includes people who worked, lived or attended school, child 

39 care or adults in the New York City disaster area.
34

1 The characteristics -- these are important characteristics within the groups. 

2 Certainly we provide medical monitoring and surveillance to each of our cohorts. 

3 We provide specialized World Trade Center treatment services for exposure-related 

4 diseases in upper airway, lower airway, GERD, mental health and specific 

5 musculoskeletal diseases and cancers. It's a unique group and a well-characterized 

6 population at this point with high retention rates, and as everyone is well aware,

7 this is an unprecedented exposure and we do not have a control for comparison.

8 So as a reminder the James Zadroga Bill on 9/11 intent was to support, in 

9 terms of research, research on physical and mental health conditions that may be 

10 related to the September 11, 2001 terrorist attacks; research on diagnosing World 

11 Trade Center-related health conditions of such individuals in case of conditions for 

12 which there has been diagnostic uncertainty; research on treating World Trade 

13 Center-related health conditions for individuals in the case of conditions for which 

14 there has been treatment uncertainty. And of course any emerging conditions.

15 In moving forward, the World Trade Center Health Program responder and

16 FDNY and survivor programs agree that research should pretty much follow a 

17 general direction, and think of it in kind of a three-prong approach in thinking about 

18 each individual topic that needs to be explored moving forward. So we divided it 

19 based upon mechanism, outcomes and progression of disease.

20 So number 1, mechanism. This is the concept of particular scientific areas of 

21 interest may be explained in terms of structure, interaction of their component 

22 parts.

23 Number 2 with the outcomes. Evaluating clinical and population-based 

24 research that seeks to study and optimize the end results of healthcare in patients.

25 And number 3, progression of disease. Where we evaluate disease states 

26 and objective markers that place patients at risk for disease advancement. And 

27 certainly we'll allow for early intervention for treatment and may promote 

28 regression of disease.

29 Let's move forward with mechanism. I'm just gonna view a snapshot of a 

30 few published manuscripts, and you will see there are very many, that may fall into 

31 each of these categories, and then we'll identify our thoughts moving forward for 

32 each category. 

33 So many of you are familiar with the FDNY study that was published in 

34 Chest. This was inflammatory biomarkers like GM-CS, CSS and MDC, that were 

35 found to be elevated in the air flow -- in air flow obstruction. 

36 The next paper was published in the Journal of Asthma by the survivor 

37 program by Dr. Joan Reibman's team, where they found an elevated level of 

38 peripheral eosinophils in the World Trade Center patients found to have symptoms 

39 of wheeze and peripheral abnormalities with air flow obstruction.
35

1 In the responder program, Dr. Landrigan and Dr. Lioy found that World 

2 Trade Center dust was highly alkaline, and mice exposed to dust develop moderate 

3 inflammation and bronchial hyper-reactivity. And that was published in the EHP 

4 that we’re on.

5 We have a mental health study, led by Dr. Pietrzak and Dr. Southwick, that 

6 evaluated basically the dimensional structure and course of post-traumatic stress 

7 symptomatology in World Trade Center. And they found that the disaster-related 

8 PTSD symptomatology in World Trade Center responders is best represented by five 

9 symptom dimensions. 

10 We also have a study which, unfortunately, I don't have a slide today on, but 

11 it's a study that's about to be published by Dr. Luft's team, and presented at the 

12 American Psychopathology Association next month, in an abstract form. They 

13 provided an epigenetic linkage between PTSD and respiratory disease. They found 

14 specific genes associated with respiratory inflammatory cytokines, and this 

15 obviously could be very important in diagnostic and therapeutic impacts moving 

16 forward. So what does this mean? So I propose future mechanism studies, there 

17 are probably many but I'm going to name just a few.

18 So number 1, what may be the impact of World Trade Center exposure on 

19 responders' DNA? Many are experiencing chronic health decline but the 

20 mechanisms remain unclear. It's critical for us to understand the relationship 

21 between exposure and changes to DNA and gene expression and further insight and 

22 development -- insight into the development of disease and treatment options is 

23 essential.

24 Another example that may be worth exploring is we know from the current 

25 list of World Trade Center covered conditions, there's increased risk of sarcoidosis in 

26 hematological malignancy direct lymphoma. We could argue that these diseases 

27 are representative of a disruption in the immune system, suggesting maybe we 

28 could be taking a closer look at World Trade Center exposure in relation to diseases 

29 that alter the immune system, like hematologic disease, and seeing if there are any 

30 biomarkers to evaluate moving forward.

31 Let's look at our next prong, outcomes. So this manuscript is published in 

32 the American Journal of Industrial Medicine, by FDNY, and it highlighted the need to 

33 evaluate the relationship between symptoms, pulmonary function tests and 

34 diagnosis and utilization of healthcare. In the Lancet, there is the publication by Dr. 

35 Juan Wisnivesky and Dr. Landrigan for the responder programs that evaluated the

36 nine-year cumulative incidence of asthma, sinusitis, GERD, depression and PTSD,

37 and found there's a 27 percent incidence of asthma, 32 percent with sinusitis, 

38 39 percent with GERD, and 31 percent PTSD, and 27 percent in depression. And 

39 we're still seeing spirometry abnormalities to date.
36

1 In the Journal of Occupational and Environmental Medicine, Dr. Joan 

2 Reibman's team from the survivor program, five years out, on disaster residents and 

3 local workers are still seeing respiratory lung function abnormalities. And Dr. Luft's 

4 team for the responder program was able to identify a linkage between PTSD and 

5 respiratory symptoms in the Journal of Psychological Medicine.

6 In EHP, Dr. Southwick's team and Dr. Stellman looked at the responder 

7 group and found that working in 9/11 recovery operations was associated with 

8 chronic impairment of mental health and social functioning. Psychologic distress 

9 and psychopathology in World Trade Center workers greatly exceeded the 

10 population norms.

11 So thoughts on future of outcome studies. A couple thoughts came to 

12 mind, preliminary thoughts. Number 1, a need to assess overall health status and 

13 impact of World Trade Center exposure and how it's had on the individuals’

14 occupation -- economics and psychologically, how they've been impacted, how their 

15 lives have changed. Very difficult end points to evaluate that we feel are definitely 

16 worth while. Thinking about and figure out a way to investigate.

17 Number 2, how has exposure impacted cognition. Certainly that's an 

18 interesting question to answer, and may be considered in additional questions and 

19 adding additional questions to the monitoring program to explore further.

20 Number 3, identify patient characteristics that maximize psychotherapeutic 

21 intervention for specific mental health conditions like PTSD.

22 And Number 4, but definitely not lastly, utilize DC resource, that's a data 

23 center resource, to resume disease surveillance activities, to evaluate additional 

24 outcome measures, especially since the data's readily available for real-time analysis 

25 and can analyze those conditions that have been certified and are currently under 

26 active treatment.

27 Moving to the next prong: Progression of disease. In Chest, we saw in Dr. 

28 Prezant's study with FDNY, it highlighted a relationship between pulmonary function 

29 test abnormality -- pulmonary function test improvement and lower respiratory 

30 system improvement. And basically recommended what we need to continue to 

31 follow spirometry in our cohort.

32 In our survivor program, Dr. Reibman's team was able to confirm that PTSD 

33 high reversibility they were seeing in the population, but it reinforced the need for 

34 continued treatment. They were seeing improvements in populations but the -- this 

35 reversibility reinforced the need to continue to follow them very closely.

36 In the responder program, Dr. Gwen Skloot with Dr. Paul Enright noted 

37 increased rates of spirometry even five years out post-9/11, and again, 

38 recommended need for monitoring.

39 I'm going to skip to our thoughts on progression of disease, and skip the last 
37

1 two slides in the interest of time. So advantage for the future. One example would 

2 be responders who experienced both medical and psychologic sequelae are more

3 impaired. This group requires further evaluation to determine best management 

4 strategy to optimize treatment. 

5 Number 2 would be to investigate, and this is more in the physical health 

6 arena, these last two, investigate the impact of renal disease in the context of 

7 responders who now have multiple co-morbidities due to their exposure. 

8 And number 3, consider identifying and characterizing those patients who 

9 have had significant difficult health decline due to their World Trade Center 

10 exposure, especially those with severe asthma and interstitial lung disease.

11 So, you know, we've mentioned studies that have been done, just a few, in

12 each of the areas, general areas, of research that should be considered, and we've 

13 mentioned just a few of the studies that we think should be maybe considered in 

14 the future. Certainly this list is meant in no way to be comprehensive; it's only 

15 meant to give it a direction of future research, and we'd be more than happy to 

16 return and expand on the list of details after discussion with our lead World Trade 

17 Center Health Program clinicians, researchers, (indiscernible) members. 

18 We would like to just round it off by saying a few things we'd like the group

19 to consider is the time frame for any studies moving forward, the one-year, 

20 obviously, versus the future, the longer time frame; and addressing those 

21 populations that may be most vulnerable, like children; and thirdly, that these 

22 populations may provide and translate to disaster, future disasters, or even non23 disaster populations in the public health arena.

24 Thank you again for the opportunity to present our thoughts.

25 DR. WARD: Thank you for your presentation. I noticed that we missed our 

26 11:00 to 11:10 break. Paul, do you think we should just go ahead and take it now 

27 and then resume discussion with Dr. Crowley?

28 DR. MIDDENDORF: Why don't we go ahead and ask Dr. Crowley any 

29 questions we might have, and then we'll take the break.

30 DR. WARD: Okay. Any questions for Dr. Crowley?

31 DR. HARRISON: This is Bob Harrison, thank you very much. It's just 

32 incredibly impressive. Did any of the research studies address the question whether 

33 early and aggressive treatment intervention make a difference in outcome?

34 DR. CROWLEY: Yeah, I mean, that's an excellent question, and certainly 

35 something that is definitely worth exploring, based in the physical and mental 

36 health arena, and I think in context of some of the potential proposals, certainly 

37 could be woven in, and I think that's an excellent suggestion.

38 DR. HARRISON: I don't know whether it's too late to do that, looking 

39 backwards over 15 years, but it's certainly one of the questions that I always have as 
38

1 a public health, you know, official, is, you know, does getting people into early 

2 treatment for respiratory symptoms or potential psychological sequelae make a 

3 difference, you know, so that we really have to have the systems and infrastructure 

4 in place. When --

5 DR. CROWLEY: Right. I mean, we know from just a, from an asthma 

6 perspective, certainly folks who were left with prolonged disease without treatment 

7 are at risk for irreversibility. The Joan Reibman study that we mentioned early on 

8 about, you know, the reverse -- potential for reversibility is an important point

9 because you have a chance to make an impact so that that doesn't become fixed 

10 airway obstruction.

11 DR. HARRISON: Right.

12 DR. CROWLEY: So I think there are ways to do it, and I think it's a good 

13 point.

14 DR. HARRISON: Yeah.

15 DR. CROWLEY: Thank you.

16 DR. TALASKA: This is Glenn Talaska. I have a very closely related question. 

17 And I was wondering if there's been investigation as to which levels of either your 

18 biomarkers or your clinical measurements are -- weren't associated with disease but 

19 were associated with reversibility, so as we move on and try to prove which levels 

20 which may be preventative in the future, that could be extremely useful, when to 

21 remove people from an exposure when a marker is being made during the course of 

22 that exposure.

23 DR. CROWLEY: Yes, and absolutely we would very much like to investigate 

24 something like that.

25 MS. WALKER: Dr. Crowley, this is Debra Walker from the World Trade 

26 Center Health Registry. I just had a question. You had mentioned about someone 

27 looking at patients who had severe chronic disease, that you were interested in 

28 looking at renal disease. Could you mention if you've seen patients who appear to 

29 be affected or an association with 9/11 exposure?

30 DR. CROWLEY: It's too early to tell. I think it's a question that is definitely 

31 ringing true in several of the investigators now. And I know Dr. Mary McLaughlin at 

32 Mount Sinai with her cardiovascular studies in looking at some of the laboratory

33 markers felt like it was something worth investigating but it's too early for us to 

34 draw that correlation as of yet, but definitely worth investigating.

35 MS. WALKER: All right. Thank you.

36 DR. WARD: Okay, so if there are no further questions or comments from 

37 committee members, I think it would be wise to adjourn for our ten-minute break 

38 so that we can be reassembled and ready for the beginning of the public comment 

39 period at 11:30. Paul, do you want people to just leave their lines open?
39

1 DR. MIDDENDORF: Yes. I think that would be best.

2 DR. WARD: Okay. So my computer says it's 11:15; we'll try to all be back by 

3 11:25 to reconvene for the public comments.

4 DR. MIDDENDORF: Yes, and --

5 DR. HARRISON: Liz, this is Bob Harrison; before we do that could -- just 

6 moving ahead on the agenda, we're scheduled to take what your lunch break is 

7 really my breakfast break in a couple -- in about an hour and a half or something like 

8 that?

9 DR. WARD: Yes.

10 DR. MIDDENDORF: So it would be 12:15 our time which is about in an hour 

11 from now.

12 DR. HARRISON: About, about an hour from now, okay.

13 DR. MIDDENDORF: Yes. So we have probably -- four public commenters 

14 have signed up so we'll probably finish up around noon, and then Liz and the 

15 committee can decide whether or not they want to begin discussing the research 

16 needs at that point or if they want to just go ahead and break for lunch.

17 DR. WARD: Thank you.

18 DR. MIDDENDORF: Okay. So we're going to take ten minutes?

19 DR. WARD: Yes.

20 DR. MIDDENDORF: Okay. 

21 (Meeting recessed from 11:15 to 11:30 a.m.)

22 DR. MIDDENDORF: We are now entering the public comment portion of 

23 our agenda. Each of our public commenters is signed up on a first-come, first24 served basis. Each of them will have up to five minutes to present. I just remind 

25 everybody that it's surprising how quickly five minutes can go when you're talking 

26 on a subject of importance to you. So around the four-minute mark, I'll just let the 

27 commenter know that they have one minute remaining to allow them to make their 

28 final point. If you haven't finished in five minutes, I'll have to rudely interrupt and 

29 thank you for your comments, and I apologize to anybody that this happens to but 

30 we have to be fair to all our presenters and we also need to try and stay on time. 

31 I do want to point out that you do have the option of submitting written 

32 comments to the docket. The docket number is 248-A. Information on how to 

33 submit those comments is on the NIOSH docket web page.

34 The last thing I need to do before beginning the comments is to make sure 

35 the commenters are aware of the redaction policy for public comments. That policy 

36 is in the Federal Register notice for this meeting. It's on the committee's web page 

37 and it's in the materials available for downloading. So the policy outlines what 

38 information will be kept, what information will be redacted before it is posted to the 

39 docket.
40

1 So with that, I'll ask Dr. Melius, are you available?

2 UNIDENTIFIED: Did you say you have to do a roll call?

3 DR. MIDDENDORF: Oh, yes, you're right. I do have to do a roll call, thank 

4 you. Let's do a roll -- a quick roll call. Tom Aldrich?

5 DR. ALDRICH: Online.

6 DR. MIDDENDORF: John Dement?

7 DR. DEMENT: Online.

8 DR. MIDDENDORF: Kimberly Flynn?

9 MS. FLYNN: Online.

10 DR. MIDDENDORF: Bob Harrison?

11 DR. HARRISON: On line.

12 DR. MIDDENDORF: Catherine Hughes?

13 MS. HUGHES: (indiscernible).

14 DR. MIDDENDORF: Steve Markowitz?

15 DR. MARKOWITZ: Yeah, I'm here.

16 DR. MIDDENDORF: Guille Mejia?

17 MS. MEJIA: (indiscernible).

18 DR. MIDDENDORF: Is that Guille?

19 MS. MEJIA: Yes.

20 DR. MIDDENDORF: Okay. Carol North? Carol, are you there?

21 DR. NORTH: I'm here.

22 DR. MIDDENDORF: Okay. Julia Quint?

23 DR. QUINT: Here.

24 DR. MIDDENDORF: Bill Rom?

25 DR. ROM: I'm present but I'm also Macintosh so I'm -- I can only hear and 

26 cannot see.

27 DR. MIDDENDORF: Okay. What I said earlier is that, for those that are on 

28 Mac, when we have a motion, I will copy it and paste it into an email and send it on 

29 so you can see it.

30 DR. ROM: Okay.

31 DR. MIDDENDORF: Susan Sidel?

32 MS. SIDEL: Here.

33 DR. MIDDENDORF: Glenn Talaska?

34 DR. TALASKA: Here.

35 DR. MIDDENDORF: Leo Trasande? Okay, I expect he'll join us in a half an 

36 hour or so. Liz Ward?

37 DR. WARD: Here.

38 DR. MIDDENDORF: And Virginia Weaver?

39 DR. WEAVER: Present.
41

1 DR. MIDDENDORF: Okay. Has your flight been canceled, just by the way?

2 DR. WEAVER: No, it hasn't, so I'm still hoping.

3 DR. MIDDENDORF: Okay. If you need to leave, just let me know.

4 DR. WEAVER: I will, thank you.

5 DR. MIDDENDORF: So I'll ask Jim Melius, are you present?

6 DR. MELIUS: I'm present. Can you hear me, Paul?

7 DR. MIDDENDORF: Yes, we can hear you.

8

9 PUBLIC COMMENTS

10 DR. MELIUS: Okay, good. It's hard to tell. Anyway, I would like to first 

11 thank the committee for your -- certainly for your past efforts. I thought your 

12 assistance on the -- with Dr. Howard on the cancer issues was very, very helpful and 

13 I thought came up with a very good approach to dealing with a pretty difficult issue. 

14 So that's most appreciated by myself and many others involved here.

15 I was very involved in developing the legislation that initiated this program, 

16 and I wanted to make sure it's clear that the research portion of this was probably 

17 one of the most difficult parts to get into the legislation. Given all the other federal 

18 funding for research, it -- people were somewhat reluctant to -- we -- I found an 

19 additional pool of research funding, and we made the case that it was important for 

20 this unique population that I'm going, you know, medical research be done in a 

21 number of different areas and this needed to be supported over a period of time. I 

22 just think, given that difficulty, it's important that we keep the research focused on 

23 the World Trade Center populations, and although it is sometimes tempting to think 

24 of some of the other areas where this research is pertinent to and what can be very 

25 necessary and important research, really has to be funded, I think, through other 

26 sources.

27 Secondly, I'd like to particularly thank Dr. Crowley for her presentation. One 

28 of the things that disturbed me when I saw the initial agenda for this was there was 

29 no formal input from the clinical centers, who are the people essentially on the 

30 front line dealing with the many thousands of ill World Trade Center responders and 

31 survivors. Although some of those people were represented on the lead advisory 

32 committee, it seemed to me that there really needed to be formal input on that, 

33 and I want to thank Laura for doing an excellent job on something that she, I think, 

34 only heard about earlier and late last week, early this week in terms of organizing 

35 that presentation. 

36 I think those items really are the heart of what needs to get done in this 

37 research, again, probably far too many questions given the amount of funding 

38 involved. But still, I think it's very important that we really start to focus on some of 

39 those issues that will provide the research that will, you know, hopefully yield a 
42

1 long-term benefit to those thousands of responders and survivors who are ill.

2 One important area that I've not heard discussed today is a focus on what 

3 other conditions might be emerging in this population, and emerging conditions is 

4 actually included in the legislation for this research. We have lots of data being 

5 collected but the research review process tends to make it, I think, difficult for that 

6 data to be evaluated and explored in some ways. We have many responders and 

7 survivors who are ill who are concerned as to whether the conditions that they're 

8 now developing, whether it be kidney disease, autoimmune disease, others, might 

9 be related to their World Trade Center exposures and limited funding available 

10 through the clinics and to the data centers to evaluate that data.

11 I already talked to Dr. Howard. I think direct funding to the data centers 

12 may be appropriate, but for doing some of those exploratory work but I also think 

13 that the research program may be able to take up some of that slack, and I would 

14 hope that you would, you know, see what could be done within the research 

15 program to focus on that.

16 Finally, I would like to echo something that I believe Steve Markowitz said 

17 earlier. I think one of the other important areas that I don't think is being addressed 

18 in this very important underlying probably ongoing research that has taken place 

19 and will take place in this population is a better assessment of their exposures. You 

20 know, it's complicated, people did different tasks, but I think the tendency is to 

21 assume it's too complicated to understand, and I think that's a disservice, given 

22 some of the differences in the types of jobs, time people worked there, and I think 

23 other factors that could be taken into account in terms of evaluating the long-term 

24 impacts of this exposure and to identify higher risk groups. So I will end there. I 

25 think I'm under the five minutes so Paul didn't have to jump in. But thank you again 

26 for all your work on this.

27 DR. MIDDENDORF: Thank you for your comments, Dr. Melius. Our next 

28 public commenter is Heidi Alexander.

29 MS. ALEXANDER: Yes, I'm here.

30 DR. MIDDENDORF: Okay.

31 MS. ALEXANDER: Can you hear me?

32 DR. MIDDENDORF: Yes, we can hear you fine.

33 MS. ALEXANDER: Okay, great. First of all I want to thank you for all of your 

34 hard work in making the World Trade Center Health Program available, also to 

35 present my request, and then I'll give you some background of my situation.

36 I ask that toxic encephalopathy; that is, toxin induced brain damage, be 

37 added as physical injury to the list of illnesses treated by the World Trade Center 

38 Health Program. I recently came across a research paper presented by Dr. Grace 

39 Ziem, Z-i-e-m, at a conference in (indiscernible) entitled Medical Evaluation 
43

1 Treatment Patient (indiscernible). 

2 (extraneous interference from other participants)

3 And the treatment protocol for chemical injury, she testifies on her website,

4 chemicalinjuries.net. (more extraneous interference)

5 It's mcsbeaconofhope.com/ziem.html. It's the research paper she 

6 presented. And her treatment protocol on her website, chemicalinjury.net, where 

7 she recommends SPECT brain scans to detect the toxic encephalopathy, the brain 

8 damage, and (indiscernible) for six to ten months as part of her treatment protocol. 

9 I'm impressed by her findings and I'm also mystified why this has been 

10 known for so many years and it's not been put in place for people in my position. I’ll 

11 give you my facts for now. 

12 I lived across the street from the World Trade Center and was in the toxic 

13 cloud. My apartment sustained considerable damage and contamination from the 

14 dust and smoke that infiltrated the entire area at the time of the towers’ collapse

15 and for months afterward. The office where I worked is also a few blocks away, on

16 Broad Street. I was a self-employed computer programmer/technology consultant 

from 1985 up until the end of 2001. I was standing on the 14th 17 floor terrace of my 

18 building where I lived on Albany Street and South End Avenue. That's catty-corner 

19 to the Trade Center site when the south tower imploded, and was blasted by a gust 

20 of vapor, and then immediately afterwards completely covered by the dust, and 

21 inhaled a significant amount of blackened air. 

22 I was in that environment for several hours until evacuated by tug to Jersey 

23 City. I was very nauseous and had a severe headache at the time, and I went to a 

24 (indiscernible) house in New Jersey and I had difficulty breathing and burning lungs. 

25 I was taken to the emergency room at the local hospital and had chest 

26 x-rays and was told to see a pulmonary specialist. Days later welts appeared on my 

27 face, arms and legs and skin that was exposed to the dust. I tried to continue 

28 working for my clients at the time but was so sick that I could no longer neglect the 

29 health issues that developed. 

30 What I ingested from the dust and what was in the air that day circulated 

31 through my body causing extreme fatigue and affected various bodily functions for 

32 periods of time at random: the field of vision in both eyes went completely black 

33 only to return a few minutes later. Another time I lost hearing for several hours. I 

34 had difficulty breathing. My brain function slowed down to the point where 

35 everyday tasks appeared as a slow-moving slide show where I could see each step of 

36 a process, neglecting to perform the most important steps. 

37 This condition worsened over the next few years. I eventually lost the 

38 ability to speak full sentences so that I couldn't think of words. For a time I lost 

39 coordination of my hands. This became evident when I tried to dial a phone where 
44

1 the phone number was in mind but I wasn't able to touch the corresponding 

2 number on the keypad. Another time the lymph nodes in my groin area grew to the 

3 size of golf balls.

4 (extraneous interference)

5 Sorry?

6 DR. MIDDENDORF: Excuse me, would everybody except Ms. Alexander put 

7 your phones on mute, please? Thank you.

8 MS. ALEXANDER: In 2005, I developed a chronic sore throat and 

9 hoarseness caused by a condition diagnosed as silent acid reflux which I continue to 

10 experience to date. After five to six years of following a self-prescribed detoxifying 

11 practice, my brain function improved but not to the level I had prior 9/11. To date I 

12 have persistent thinking problems and poor thought retention where I struggle to 

13 keep more than one concept in mind at a time. I also found that I have difficulty 

14 learning new things which was never something I had trouble with as an ardent 

15 technology professional. 

16 I have difficulty performing procedural tasks; that is, anything requiring a

17 systematic approach. My thoughts become disorganized, leaving me unable to 

18 perform the task correctly, requiring several attempts, especially when the process 

19 requires the use of my hands.

20 This is completely disabling for a computer programmer with a brain as a 

21 tool of the profession. I would like to rehabilitate this part of my brain so that I can 

22 work again. I haven't been able to do so since 2001. 

23 I found out about this protocol online just last week. I stumbled across the

24 term toxic encephalopathy. I looked it up and ran across Dr. Ziem's research paper,

25 and am mystified why this isn't being implemented. This has been out there for 

26 years and you people are going about this as if this is all new and unfounded. This is 

27 not new and there are treatment protocols in place. 

28 I can't wait for your research to be gathered and analyzed. I'm sick now; I 

29 need help now. And then so I would like to add this toxic encephalopathy as 

30 physical damage. This is not post-traumatic stress disorder. This is quite physical. I

31 had an MRI early on in 2003, and it showed that there was a --

32 (extraneous interference)

33 MS. ALEXANDER: -- (indiscernible) on the left side of my brain.

34 UNKNOWN SPEAKER: This is a smoker, right?

35 MS. ALEXANDER: I'm not a smoker. I was in good health before 9/11. I was 

36 a jogger, very active. Afterwards I can no longer jog. I can no longer exert myself 

37 because I can't breathe, all right? So that part I'm (indiscernible) just by avoiding 

38 those things. The brain damage I need help with. I can't find anyone who knows 

39 how to treat this sort of thing. Dr. Ziem's paper and her protocol is the closest thing 
45

1 I'm finding to something that could be beneficial, and I urge you to take a good look 

2 at it and implement that as part of the program. Thank you.

3 DR. MIDDENDORF: Thank you very much, Ms. Alexander.

4 UNKNOWN SPEAKER: I, I didn't have that calcium test. That would have 

5 been a standard, right?

6 DR. MIDDENDORF: Excuse me, who is that speaking? Who is that 

7 speaking? During the public comment session, the only people who should be 

8 speaking are the public commenters themselves. Everyone else should be -- have 

9 their phone muted. Thank you.

10 Our next speaker is Mary Perillo. Mary, are you available?

11 MS. PERILLO: Yes, I am. I'm here.

12 DR. MIDDENDORF: Okay, great.

13 MS. PERILLO: Okay. My name is Mary Perillo. I just want to check that 

14 everyone can hear me?

15 DR. MIDDENDORF: Yeah.

16 MS. PERILLO: Okay. My name is Mary Perillo and I am a 9/11-affected 

17 lower Manhattan resident. I'm reading comments by the WTC Health Program

18 Survivor Steering Committee of which I'm a member.

19 (extraneous interference)

20 MS. PERILLO: Excuse me?

21 DR. MIDDENDORF: Who is that speaking? Operator, could you find out 

22 who that is that's breaking in?

23 THE OPERATOR: Absolutely.

24 DR. MIDDENDORF: Thank you.

25 MS. PERILLO: Okay. The Survivor Steering Committee is presently 

26 comprised of representatives of Manhattan Community Boards 1, 2 and 3, and a 

27 range of community, labor, environmental groups advocating on behalf of 

28 9/11-affected individuals as well as residents, students and area workers. There's a 

29 wide range of knowledge gaps with respect to the science, biology and treatment of 

30 WTC-related illnesses. Therefore, NIOSH should approach closing these gaps by 

31 supporting a diverse portfolio of studies at different levels of funding including pilot 

32 studies, in-depth clinical studies, studies of disease mechanism and epidemiological 

33 studies.

34 It is especially important that the STAC recognize that input from the WTC 

35 Centers of Excellence is critical to developing the World Trade Center Health 

36 Program's research agenda since clinicians are likely to have the best sense of which 

37 conditions may be emerging as well as crucial perspectives on resolving diagnostic 

38 treatment and uncertainty.

39 The SSC has a number of recommendations regarding the World Trade 
46

1 Center Health Program research priorities for the survival population. 

2 Given the increase -- given children's increased susceptibility to harm, 

3 especially in critical periods of development, it is imperative that NIOSH continue to 

4 support -- continue its support for research into 9/11 physical and mental health 

5 impacts to those who were exposed to the disaster as children. Most important 

6 would be in-depth studies of respiratory, developmental and endocrine health 

7 impacts, and studies that explore avenues for early identification and intervention. 

8 This cohort is rapidly dispersing so we urge NIOSH to double down on its support for 

9 pediatric studies now.

10 Two, NIOSH should support longitudinal clinical research into the long-term 

11 9/11 physical and mental health impacts for survivors as well as long-term studies 

12 that explore the progression of the disease and treatment efficacy. 

13 Because of the known difficulties of performing epidemiologic studies on 

14 small populations with ongoing treatment, we would like to suggest that alternative 

15 approaches, studying cancer in diverse survivor populations be explored. Possible 

16 approaches include nested studies as well as a case series approach to 

17 understanding the possible role of exposures, differences in presentation and the 

18 effects of comorbid conditions or additional risks.

19 Four, we recommend that blood samples be collected from WTC exposed 

20 survivors including those who were children at the time of 9/11. Samples should be 

21 banked for later analysis including the freezing of live cells from which DNA, RNA 

22 and proteins can be recovered. We anticipate that these samples will provide useful 

23 in at least three ways: As potential source of long-lived biomarkers of exposure to 

24 WTC toxins, useful in analyzing exposure-related health conditions in this 

25 population; as a source of protein markers of disease with potential use in 

26 diagnosing and understanding WTC-related disease; as a source of genetic material, 

27 which can be analyzed for evidence of enduring genetic and epigenetic alterations 

28 relevant to disease that may be still detected many years after exposure.

29 Five, because so little is known with respect to inflammation and other 

30 underlying mechanisms for WTC illnesses such as sarcoidosis, cancer and even 

31 asthma, it is critical that NIOSH support studies of underlying disease mechanisms. 

32 This would include both physical and mental health disorders with potential final 

33 common pathways. Again, this research provides for building blocks, for more 

34 effective treatments and early intervention, excuse me.

35 I would cite one final research need. The SSC believes that it is essential 

36 that NIOSH support research into the physical and mental health impacts to people 

exposed between Houston and 14th 37 Streets. This population had been eligible for 

38 treatment at the WTC EHC prior to the passage of the Zadroga Act. 

39 EHC clinicians observed the same physical and mental health conditions in 
47

1 those who lived, worked or attended school in this geographic area as well as those 

2 in the current Zadroga catchment. 

3 We refer you to our written comments for the complete list. The SSC is 

4 grateful for this opportunity to provide comments and appreciates STAC's 

5 consideration. Thank you.

6 DR. MIDDENDORF: Thank you, Ms. Perillo. Our next public commenter is 

7 Lila Nordstrom.

8 MS. NORDSTROM: Hi. Can you hear me?

9 DR. MIDDENDORF: Yes, you're coming through well.

10 MS. NORDSTROM: Great. Thanks so much. So I'm Lila Nordstrom. I run 

11 StuyHealth which is an organization that represents students who were impacted by 

12 9/11 and the 9/11 clean-up. 

13 And I wanted to specifically urge NIOSH to fund studies of people that were 

14 exposed as children, like the people in my group and, you know, a lot of the children 

15 of survivors who lived in the area. We, you know, we don't really have a lot of 

16 information on what kinds of health issues are coming down the pike for people in 

17 our situation but we're going to be living with these health conditions for a really 

18 long time. And to be -- I think it's important that we -- that NIOSH start to fund 

19 studies that are going to help us identify, you know, what the early -- help us 

20 identify early what the health impacts are going to be on people in our -- of our 

21 generation, at Stuyvesant, specifically. 

22 You know, we weren't even residents in the neighborhood but we -- we 

returned to school on October 9

th 23 when fires were still burning all around us, that 

24 barge that they took the debris to from the World Trade Center site was right next 

25 to our school building, and there were like more than 200 truckloads a day of debris 

26 that came by. They weren't watered down or anything because it was too cold. 

27 Our vent system wasn't cleaned. It was used -- you know, the school 

28 building was used as a center of -- sorry, as a first responder base during the early 

29 days of the clean-up. And so we, you know, were promised when we returned that 

30 there would be, you know, that the school would be adequately cleaned but it

31 wasn't. The vents were still filled with 9/11 debris, the carpets in the theater were 

32 not taken up or anything like that. 

33 So we faced a sort of unique exposure but at a uniquely vulnerable time in 

34 our lives, and we're not the only school in the neighborhood that had a similar 

35 experience and, you know, specifically kids that lived in the neighborhood were 

36 down there a lot earlier than we were as well. 

37 But we, you know, we are trying to keep track of the health conditions that 

38 people in our group are facing. We've already received word of a number of 

39 unusual cancers and very high rates of conditions that people in their early 20s 
48

1 shouldn't really be facing, like very serious respiratory and acid reflux conditions and 

2 things like that. 

3 And so we, you know, as people that are going to have to live with these 

4 conditions for, really, longer than any of the other survivors because -- or, you 

5 know, hopefully longer than any of the other survivors. It, you know, we're sort of 

6 in a unique position where we can look at what these conditions are going to be, 

7 you know, and catch them early because we were exposed so early. 

8 So I want to ask that NIOSH start to, you know, look specifically at funding 

9 studies that focus on young people that were exposed as children. I understand 

10 there's already a study going on where something like 250 kids are being compared 

11 to a control group, and a study like that should really be expanded pretty rapidly 

12 because there were young people in a lot of different situations that were brought 

13 down to lower Manhattan after 9/11 for various reasons. I mean, there were four 

14 schools on our corner so it was a very student-heavy population. There were 

15 obviously kids that lived in the neighborhood. So I just want to urge NIOSH to 

16 consider focusing on -- or finding some focus for studies that focus on young adults 

17 that were exposed as children.

18 That's all I needed to say, if you want to give the time to --

19 DR. MIDDENDORF: Okay. Thank you very much, Ms. Nordstrom. 

20 MS. NORDSTROM: Okay.

21 DR. MIDDENDORF: I want to apologize to the public commenters. Early on 

22 in the process it sounded like somebody was breaking into the line; I'm not sure 

23 who it was but I think our operator has been able to correct that for us. But I do 

24 apologize for that.

25 Liz, I'll turn it over to you. Where do you want to go from here?

26 DR. WARD: Well, we have a scheduled lunch break at 12:15. You know, I 

27 would suggest that we might want to talk about how we're going to approach the 

28 discussion of the research needs. I would think that it might be good to think about 

29 them in each of the areas that Dr. Howard suggested we group them under and kind 

30 of get a list of the main ideas that committee members would like to advance 

31 before we actually go to the motions stage.

32 I also wanted to say to the committee that we don't necessarily have a 

33 mandate to prioritize the suggested topics, you know, one by one. We can group 

34 them into grouping high, medium and low priority. And one question of

35 clarification, Paul, when Dr. Howard asked us to prioritize, did he basically ask us to 

36 prioritize across all of the four categories or within each category?

37 DR. MIDDENDORF: He didn't specify. I think you could do it either way. I 

38 think it would be a little more helpful if you would categorize or group them into the 

39 high-low -- or high, medium, low, despite which category or type of research that 
49

1 they might interact.

2 DR. WARD: Okay. So do the people on the committee feel that it would be 

3 helpful to try to first discuss these within each category and get the major ideas 

4 down before we try to prioritize them or does anyone have a suggestion for another 

5 way to approach the discussion? Okay, well, I would suggest that we proceed that 

6 way, then, and Paul, do you think it's reasonable that we break for lunch now and 

7 reconvene in 45 minutes?

8 DR. MIDDENDORF: I think that would be fine.

9 DR. WARD: Okay. So my clock has basically 11:59 or noon, so we'll plan on 

10 reconvening at 12:45.

11 DR. MIDDENDORF: Okay. I will put that information up on the web so 

12 everybody can see it.

13 DR. WARD: Thank you all. I look forward to talking again at 12:45.

14 (Lunch recess from 12:00 to 12:45 p.m.)

15

16 DR. MIDDENDORF: I think it’s time for us to get going again. We’ll start 

17 with the roll call. Tom Aldrich?

18 DR. ALDRICH: I’m here.

19 DR. MIDDENDORF: Okay. John Dement?

20 DR. DEMENT: Here.

21 DR. MIDDENDORF: Kimberly Flynn?

22 MS. FLYNN: Here.

23 DR. MIDDENDORF: Bob Harrison? Bob back from his breakfast break? 

24 We’ll circle back for Bob.

25 Catherine Hughes?

26 (no response)

27 DR. MIDDENDORF: Steve Markowitz?

28 DR. MARKOWITZ: I’m here.

29 DR. MIDDENDORF: Guille Mejia?

30 MS. MEJIA: I’m here.

31 DR. MIDDENDORF: Guille, am I pronouncing your name close to accurate?

32 MS. MEJIA: It’s pretty close.

33 DR. MIDDENDORF: Okay. Some day you’ll have to give me lessons on that.

34 MS. MEJIA: Will do.

35 DR. MIDDENDORF: Carol North?

36 (no response)

37 DR. MIDDENDORF: Julia Quint?

38 (no response)

39 DR. MIDDENDORF: Okay, well we’re missing a few people. I think we need 
50

1 to wait a few more minutes before -- 

2 DR. HARRISON: Paul, did you hear that Bob Harrison is here?

3 DR. MIDDENDORF: No, I didn’t.

4 DR. HARRISON: Okay, I’m here.

5 DR. MIDDENDORF: Okay. Back to Catherine Hughes? Carol North?

6 (no response)

7 DR. MIDDENDORF: I think we’re about 50 percent here. Let’s give it 

8 another minute or two and I’ll start all over again. 

9 I’m hearing a lot of noise, possibly from a printer in the background, from 

10 somebody. If somebody is typing and has something on in the background, so 

11 please mute if you’re not speaking.

12 (pause)

13 DR. MIDDENDORF: Okay, let’s try this one more time. Tom Aldrich?

14 DR. ALDRICH: I’m here.

15 DR. MIDDENDORF: Okay. John Dement?

16 DR. DEMENT: I’m here.

17 DR. MIDDENDORF: Kimberly Flynn?

18 MS. FLYNN: Here.

19 DR. MIDDENDORF: Bob Harrison? 

20 DR. HARRISON: Bob’s here.

21 DR. MIDDENDORF: Catherine Hughes?

22 (no response)

23 DR. MIDDENDORF: Still not back. Steve Markowitz?

24 DR. MARKOWITZ: Still here.

25 DR. MIDDENDORF: Guille Mejia?

26 MS. MEJIA: I’m here.

27 DR. MIDDENDORF: Carol North?

28 DR. NORTH: I’m back on now.

29 DR. MIDDENDORF: Okay. Julia Quint?

30 (no response)

31 DR. MIDDENDORF: Bill Rom? 

32 (no response)

33 DR. MIDDENDORF: Susan Sidel?

34 MS. SIDEL: Here.

35 DR. MIDDENDORF: Glenn Talaska?

36 (no response)

37 DR. MIDDENDORF: Leo Trasande?

38 (no response)

39 DR. MIDDENDORF: Liz Ward?
51

1 DR. WARD: Here.

2 DR. MIDDENDORF: Virginia I think was leaving. Two, three, four, five, six, 

3 seven, eight. We only have nine; we don’t have a quorum yet.

4 DR. TALASKA: Did you hear me? This is Glenn.

5 DR. MIDDENDORF: Glenn, no, I did not hear you.

6 DR. TALASKA: Oh, okay, no, I’m here.

7 DR. MIDDENDORF: Okay, that’s one, two, three, four, five, six, seven, eight, 

8 nine, ten. We have ten, Liz; we can proceed.

9

10 DISCUSSION OF RESEARCH NEEDS AND 

11 DEVELOPMENT OF RECOMMENDATIONS

12 DR. WARD: Okay, great. So as we discussed before lunch, I think what we'd 

13 like to do is get the major suggestions down under each of the four areas that 

14 Dr. Howard proposed we discuss. And under the first item, which is to identify critical 

15 research gaps relative to our understanding of the effects of exposure, I think we 

16 should also include suggestions related to characterizing the exposure because that is 

17 (indiscernible due to extraneous input). 

18 We are starting to hear some feedback from someone. We're having the same 

19 problem we had before. So Paul, could you ask the operator to check on that?

20 DR. MIDDENDORF: Yes, I will.

21 MS. FLYNN: Liz?

22 DR. WARD: Yes.

23 MS. FLYNN: This is, this is Kimberly. I don't know whether or not Dr. Crowley is 

24 back on the call but just speaking for myself, I would really benefit from an outline of 

25 some of the studies, you know, the, the kind of research needs and approaches that 

26 were not part of her PowerPoint presentation text but that she elaborated in her 

27 presentation. Would it be possible to request that? 

28 The other point that I think we could benefit from hearing her elaborate more 

29 fully is the need for research resources to do analysis of all of the data pouring into the 

30 responder and survivor data centers.

31 DR. WARD: So, Paul, what's the situation with Dr. Crowley? Are you trying to 

32 reach her to see if she can rejoin us?

33 DR. MIDDENDORF: I sent her an email. We had asked some speakers to stick 

34 around and join us in the afternoon, if it's at all possible, in case there were additional 

35 questions. Dr. Crowley, are you online? Are you available?

36 DR. ROM: Dr. Rom just joined.

37 DR. MIDDENDORF: Okay. Thank you. 

38 I'll ask again. Dr. Crowley, are you available? Okay, Kimberly, I think what we 

39 can do is we can ask again in a few minutes.
52

1 MS. FLYNN: Sure. Thank you very much.

2 DR. MIDDENDORF: Okay.

3 DR. WARD: I did try to take notes on Dr. Crowley's recommendations, and it's 

4 possible that, maybe between me and Ray, we could -- or me, Ray and Paul and 

5 whoever else, we could at least try to capture some of her major recommendations, if 

6 that would be helpful, and I think she did kind of divide them into the different areas 

7 that Dr. Howard mentioned. Maybe not; I don't know. But anyway, so the two things 

8 she -- I mean, if it's agreeable I can kind of read through them, and then, Paul, are you 

9 going to be able to put them on the screen?

10 DR. MIDDENDORF: Yeah, I will try to.

11 DR. WARD: Okay. So the first thing she mentioned was impact on DNA and 

12 gene expression. The second thing she mentioned was the increased occurrence of 

13 sarcoidosis and hematologic malignancies, and whether that -- those both reflected a 

14 relationship of the World Trade Center exposures to immune system disorders and 

15 potential research looking at those mechanisms. 

16 She then, in her next section, talked about a more general assessment of 

17 overall health status and impact of World Trade Center exposures on occupational 

18 experience, income, economic and social well-being as a separate topic. 

19 She mentioned the specific topic, which dovetails with one of our public

20 presenters, on “ has exposure impacted cognition”?. 

21 She mentioned a topic of examining patient characteristics that maximize the 

22 potential benefit of psychotherapeutic interventions. If I got any of these wrong, 

23 especially outside my subject matter or expertise, please correct them.

24 MS. SIDEL: Liz, what does that last one mean?

25 DR. WARD: I can tell you what I'm interpreting it to mean, but maybe one of 

26 our more psychologically experienced people could say it better. What I'm assuming it 

27 to mean are what are the resulting characteristics of patients who seem to benefit 

28 most from known interventions. But it could easily be rephrased or broadened in 

29 different ways, and specifically related to what are the interventions that have been 

30 employed and how effective are they and what populations do they seem to work best 

31 in. So that one could definitely probably use a little bit of, you know, discussion and --

32 MS. SIDEL: Right.

33 DR. WARD: But that's how I interpreted it. 

34 And then the next one relates to how to better use data resources to -- for 

35 surveillance of health conditions related to the health centers, and then I think that 

36 specifically referred to the data resource centers at the World Trade Center program 

37 site. 

38 I think there was -- the next topic I wrote down is pretty general, and she may 

39 have been more specific, but just was the whole question of understanding the 
53

1 progression of disease. I guess that also would relate to whether it progresses or 

2 whether it actually improves over time. 

3 So the next one, as I interpreted it, and this could be a little off, is looking at the 

4 medical and psychological sequelae of exposure among the more impaired individuals. 

5 The next one is looking at the impact of renal disease in responders with 

6 multiple co-morbidities. 

7 And then the next one, which may be related to one of the previous ones, 

8 characterize individuals with significant health impairment.

9 MS. SIDEL: I'm sorry, characterize?

10 DR. WARD: Characterize individuals with significant health impairment. But I 

11 don't think that -- I don't think it really means characterize individuals but I guess it's 

12 more of a descriptive study to -- of populations with significant health impairment. 

13 That could be clinical; it could be exposure status; it could be specific demographic; it 

14 could be a lot of -- kind of focus on the more impaired individuals and try to understand 

15 better who they are and what their needs are would be how I interpreted that. 

16 MS. SIDEL: Okay.

17 DR. WARD: Specific question, which could be applied in a lot of the -- a lot of 

18 areas: Did early intervention make a difference in outcome? And there may be some 

19 specific areas where we would think that that would be most appropriate. There was a 

20 mention of a need for research to identify new conditions that may be arising in the 

21 population. Several people mentioned, including Dr. Crowley, the need for better 

22 exposure assessment or more exposure assessment studies. That was all -- those were 

23 my notes from Dr. Crowley's presentation.

24 MS. FLYNN: Thank you very much, Liz. This is Kimberly. Your notes are better 

25 than mine; I really appreciate it. I do want to add in to this list that Dr. Crowley also 

26 mentioned research into the impacts, the health impacts to vulnerable populations

27 such as children.

28 DR. WARD: So Paul, there’s a -- I'm in a little bit of a pause because I was 

29 looking at my notes, and now I'm trying to get back into the website so that I can look 

30 at what you're typing.

31 DR. MIDDENDORF: I'm sorry. I had mine on mute.

32 DR. WARD: That's okay. No, no, I'm saying I'm trying to get back in -- I 

33 somehow have lost the website where we can look at the documents you're looking at, 

34 so I have to find it again.

35 DR. MIDDENDORF: Does everybody else, who is into the meeting, actually see 

36 where I've been typing?

37 DR. ALDRICH: Yeah, I see it.

38 DR. MIDDENDORF: Okay. And a quick question for Catherine. Are you able to 

39 speak into the meeting now? I'm not hearing you so I'm assuming that you're not able 
54

1 to speak into the meeting. I need to check on that again.

2 DR. WARD: So is everyone now able to see Paul's notes either through the 

3 website or through an email that Paul just sent?

4 MS. SIDEL: Yes. Thank you, Paul.

5 MS. MEJIA: Thank you, Paul.

6 DR. WARD: So Paul, if you would then add to that research on health impacts 

7 on vulnerable populations?

8 DR. MIDDENDORF: I'm sorry, say that again?

9 DR. WARD: A point that was just made on research on health impacts in 

10 vulnerable populations.

11 DR. ALDRICH: This is Tom Aldrich. I wonder if I could mention another area?

12 DR. WARD: Sure. That's, I think, what we should do now is look at the -- you 

13 know, kind of add to the list and make sure that -- and keep -- yeah, add to the list until 

14 we've gotten all of the major topics covered, and then go through and try to refine and 

15 combine. So go ahead, Tom.

16 DR. ALDRICH: Okay, well, I'm impressed with the -- there's three large cancer 

17 studies have remarkably similar results. Not everything -- not all the cancers have 

18 statistically significant increases but each of the three large studies showed significant 

19 increases over expected in at least some cancers. And all of them were only up to 

20 seven years post-9/11. 

21 And I think in general we believe that cancer latency averages longer than that, 

22 something in the range of 20 years, so what we may be seeing is a leading tail of a 

23 bell-shaped curve. And if that's the case, then we're in for very large increases in 

24 cancer in the future. That may or may not be true but we should be thinking about that 

25 possibility. 

26 And so I think that it's reasonable to expect, because of the inhalational route 

27 of exposure for most of these toxins, that head and neck, lung, esophageal cancers 

28 might be -- might emerge next. And those of course are extremely deadly and hard to 

29 treat, so early diagnosis is really important. 

30 I think we should solicit proposals to evaluate biomarkers or other early 

31 detection techniques to detect free cancerous lesions or early cancers in order to treat 

32 them when they're potentially curable.

33 MS. HUGHES: That sounds really good. Catherine here. Can you hear me yet?

34 DR. MIDDENDORF: Yes, we can hear you now.

35 MS. HUGHES: Great. I liked the last comment. Thank you.

36 DR. ROM: I might add to Tom Aldrich's recommendation for biomarkers for 

37 early cancer detection. NIOSH could actually interact with NCI, who has a program on 

38 early -- called the early detection research network that funds about 35 PIs around the 

39 country for studying biomarkers in high-risk populations for early detection of lung 
55

1 cancer, prostate cancer, GI or women's cancer. And that program is very collaborative 

2 and would probably be interested in the WTC registry. So that's a second for 

3 biomarkers for early detection of cancer recommendation. 

4 I would add to that -- this is Bill Rom speaking -- that it would be very nice to 

5 develop biomarkers for asthma since we've gone from about 9 or 10 percent at 

6 baseline up to 27 percent in the Lancet article that Dr. Crowley cited, that there must 

7 be markers spilling over into the blood or other sources that could be looked at to 

8 correlate to these symptoms and meet the physical findings. And it may help us

9 understand the etiology of asthma. 

10 And I might add to that that microbiome might have something to do with that, 

11 and we haven't even discussed microbiome, but that might be something that's altered 

12 by World Trade Center dust and the GERD, asthma and sinusitis populations. And I'm 

13 not sure we've had any applications to look at that, but that might be another altered 

14 background setting that predisposes to these illnesses.

15 DR. WARD: That's great, and thank you. And I just wanted to interject a 

16 procedural thing -- this is Liz again -- that, as each of the speakers talks, I'm assuming 

17 that you're going to double-check what -- how Paul has captured your suggestions and 

18 make sure that they're -- I think Paul's doing a great job of condensing them, but make 

19 sure that they are captured accurately and that all the points are captured.

20 DR. MIDDENDORF: Yeah, I'm going to have to circle back with some of the 

21 folks, like Bill Rom, who I -- is not able to get into the website. So I'm going to have to 

22 email this out real quick.

23 DR. WARD: Okay, yeah, it is helpful for those who can to follow along on the 

24 website. I just -- I somehow had gotten myself out of it but got myself back into it, and 

25 so it's really helpful to follow along the suggestions. 

26 So would anyone else like to add something to the list? I think Paul is sending it 

27 out again.

28 MS. SIDEL: I would. I'd like to add something to the list. It's Susan Sidel.

29 DR. WARD: Okay.

30 MS. SIDEL: Something that I think Dr. Melius mentioned earlier and that I've 

31 raised a few times is autoimmune diseases. There has been, I think, very little research 

32 on autoimmune diseases, and it's interesting because I -- I mean, obviously I'm not a 

33 doctor but I do know that it's accepted among hematologists that environmental toxins 

34 cause some autoimmune diseases or if you have a genetic predisposition to it, it'll make 

35 the autoimmune disease, you know, happen when it may not have otherwise, if you are 

36 exposed to something. 

37 Now, and this is something that would have been interesting to ask 

38 Dr. Crowley. I wonder if part of the reason why something like autoimmune diseases 

39 are not covered is because the kind of doctors that would study it, I think, would be a 
56

1 rheumatologist, and there aren't any rheumatologists that are involved in the program. 

2 I mean, that's not the kind of doctors that we have. And if that's the reason why, then 

3 do we reach out, you know, to specialists? I mean, how does that work? So it's like a 

4 two-part question because, I think it --

5 DR. ALDRICH: Tom Aldrich.

6 MS. SIDEL: I'm sorry, what?

7 DR. ALDRICH: I would just mention that one of the funded research projects is 

8 specifically to look at incidence of autoimmune diseases, and one of the cohorts 

9 relative to that would be expected in the population. So it's being addressed at least in 

10 one area. I think I saw something about rheumatoid arthritis in another study also.

11 DR. WARD: And who was speaking just then?

12 DR. ALDRICH: I beg your pardon, Tom Aldrich.

13 MS. SIDEL: Right, but the document that, you know, well, I mean, that's really 

14 good but is that enough? Because I mean, there was something that I was reading 

15 about asbestos out in Libby, Montana and how -- it's Montana -- and how exposure to 

16 asbestos, they're seeing a lot of lupus, which is usually something that affects women, 

17 you know, that are of child-bearing ages, and it's happening in a lot of men that are in 

18 their 40s. So I mean, it's just something that's a really broad subject, and the whole 

19 inflammation-cancer connection from the -- you know, from the fire department 

20 article, I just think that it's something that really needs to be looked into. 

21 And also I have to say that, because I have one and I've just been fighting for it 

22 for years, and there's so much resistance at the program to even considering that what 

23 was going on with me could possibly have anything to do with my exposure. And, you 

24 know, it wasn't until I got a specialist involved to definitely say that it was, you know, 

25 before I could take that information back to the -- you know, back to the program and 

26 have it be taken seriously.

27 DR. WARD: So --

28 MS. SIDEL: So.

29 DR. WARD: Yeah, I think one thing we could do is, as we get the new 

30 suggestions in, is see if they really fit -- if they dovetail well with something that's 

31 already on the list. So I would say that this autoimmune diseases, we could combine 

32 that with the second suggestion on the list, to look at sarcoidosis and malignancy. But 

33 maybe the broader topic is immune system disorders, and that would include 

34 autoimmune diseases, malignancy --

35 MS. SIDEL: Oh, that’s a good idea.

36 DR. WARD: Yeah.

37 MS. SIDEL: The other thing that to me, you know, talking with my doctor, 

38 especially since that woman was talking about it earlier, but a lot of people -- I've 

39 known a lot of people that have cognitive issues in the program, and it's usually 
57

1 thought, you know, the doctors will say, well, it's because of PTSD. And it isn't. It's --

2 something definitely happens to your brain from exposure to toxins. And I thought 

3 that that's something that would be really interesting to look into as well as the fact 

4 that we're not using EMDR to treat post-traumatic stress disorder. I mean, it's like 

5 there's so many -- there are so many techniques to deal with post-traumatic stress 

6 disorder and we're using, you know, like old-fashioned psychotherapy when there 

7 are --

8 DR. ALDRICH: What is EMDR?

9 MS. SIDEL: I forget exactly what it stands for but, you know, you sort of relive 

10 the -- it's like left-brain/right-brain, you kind of see -- they put little clickers in your 

11 hands and you kind of relive, you know, the painful experience, and you just kind of 

12 keep -- you know, you're going to do this with a therapist, and you kind of work 

13 through it until it doesn't -- you know, it's not as troubling. I'll look up the initials. 

14 Actually, let me just Google it.

15 MS. FLYNN: Hello? Can you hear me?

16 MS. SIDEL: Yeah.

17 MS. FLYNN: This is Kimberly. Hi. EMDR is eye movement desensitization and 

18 reprocessing. And at least one clinician in the Bellevue responder program has used it. 

19 I, you know, was lucky to catch a presentation a couple of years ago. So I'm not saying 

20 there shouldn't be research on it but, you know, it is a recognized modality.

21 MS. SIDEL: And there's another -- there's something else that they do at Mass 

22 General that's like the next step up from EMDR. I don't remember what it's called but 

23 maybe, Dr. North, maybe you might have more information about this. But I think 

24 we're using techniques that are kind of like old-fashioned and take a long time. And 

25 there's like there's shorter ways to deal with, you know, the trauma.

26 DR. WARD: Is Dr. North on the call yet?

27 MS. SIDEL: I guess not.

28 DR. HARRISON: This is Bob Harrison. I would like to add an idea or concept to 

29 the list, and that is research that focuses on practice or, you know, what NIOSH has 

30 called R-to-P, research to practice. Sometimes we call it applied epidemiology or 

31 applied public health. One of the things that has struck me, maybe coming out here 

32 from the west coast perspective but also as an occupational medicine provider, is that 

33 there's a huge amount of research that's incredibly valuable from these studies that --

34 and there's been a lot written, you know, and really good summary articles, but I guess 

35 thinking it now, it's going to be, you know, almost 15 years out from this experience. 

36 You know, is there a way to integrate or apply the research findings and think about 

37 how it's affected the population that's in the registries or other potential worker 

38 populations. You know, this -- I see the research not only divided up into three 

39 categories that we're charged with, but there is, you know, basic biological 
58

1 biomonitoring, etiological, epidemiological, but, you know, but I guess this other 

2 element is, you know, practice or public health impact. I don't know how that would 

3 be translated into research proposals but I would just throw that into the mix as, if 

4 there was an announcement that was put out that would encourage, you know, 

5 innovative proposals along that line.

6 DR. MIDDENDORF: I just want to interrupt for just a second. Dr. North is on 

7 the line but she's having trouble speaking. We're trying to get her access.

8 DR. NORTH: Can you hear me?

9 DR. MIDDENDORF: Yes, we can hear you now.

10 DR. NORTH: Oh, excellent. I've been trying six or eight times to interject and 

11 nobody heard me. 

12 So regarding the mental health discussion, I had a couple of things that I 

13 wanted to add to the list, if that would be okay at this time.

14 DR. WARD: That would be great.

15 DR. NORTH: Great. Okay, well, the first thing relates to something other 

16 people have talked some about, which is the exposure issue. And 9/11 really was a 

17 different disaster from most past disasters in -- because of its scope and magnitude, the 

18 exposures may have gone a lot further than previous disasters. But I don't think we can 

19 necessarily assume the exposure zones for mental health problems will be the same as 

20 for other diseases. And so I think it's critical that that be further studied. That's my 

21 first item. 

22 My second item is that often, for lack of a better method, diagnoses are not 

23 made and instead mental health problems are discussed in terms of symptoms, and, 

24 you know, we don't study cancer symptoms; we study cancer. And it would be good if 

25 we could -- if research could figure out a better way to assess full psychiatric disorders. 

26 'Cause it's not clear what these symptoms mean outside of disorders. They can be very 

27 nonspecific, so I'd like to see the field improve its ability in research there.

28 Hello? Did you hear me?

29 DR. MIDDENDORF: Yes.

30 DR. WARD: Yes.

31 MS. SIDEL: I didn't hear her. She cut out.

32 DR. MIDDENDORF: I think she finished, and then she was waiting for a

33 response and didn't hear anything; is that correct?

34 DR. NORTH: Yes.

35 MS. SIDEL: Oh.

36 DR. WARD: And so this is Liz. I'm trying to figure out what the best way to kind 

37 of collate this information is since only Paul really has direct access to the document. 

38 So I guess, Paul, if maybe periodically, when you mail this out -- I think you're mailing it 

39 out to everyone regardless of whether they have access to the web version or not.
59

1 DR. MIDDENDORF: Correct.

2 DR. WARD: And so Carol, if you would go into the text that Paul just 

3 transcribed and kind of edit your comments, that would probably be helpful, and in fact 

4 if everyone could do that, because I think Paul's capturing the bare essence but I think 

5 we will want to have a version of the document that has these points more clearly 

6 articulated. And then one of the things we'll probably want to do is take the email 

7 version of the document and start grouping things and collapsing and organizing. I do 

8 think that we may have gotten off-track a little bit with our plan to focus first on John's 

9 area 1 and then area 2. I'm actually having a little trouble sorting out which of the 

10 things in our list fall into the different categories. But I do think it would be important 

11 that we have some interactive mechanism for people to go in and edit their comments 

12 so that we can get this list to be as clear as possible.

13 DR. NORTH: Can we do it by email? 'Cause I can't get on the web.

14 DR. WARD: That's what I'm thinking. Probably the easiest thing is if 

15 everybody -- Paul, if this doesn't sound good to you, let me know. Let's say, if I made a 

16 point, I could take that point from the latest version of your document, rephrase it, if 

17 necessary, and send it back to you, and then you could insert it in the master 

18 document? Would that --

19 DR. MIDDENDORF: That sounds fine.

20 DR. WARD: Okay.

21 DR. ALDRICH: This is Tom Aldrich. I was struck by something Dr. North said 

22 and I think it's something that we should follow up on. The remote or the different 

23 geography that might apply to mental health issues as compared to, for the want of a 

24 better word, physical health issues, one example of that, that I think was very 

25 interesting, was the 9/11 dispatchers who were not within the footprint of the World 

26 Trade Center nor the original geographic boundaries but had significant PTSD issues. I 

27 don't remember any details about it but that's an interesting aspect of this that's got a 

28 little attention.

29 DR. NORTH: This is Carol North. That's a very interesting twist on the exposure 

30 issue. Because this disaster was so big, we've never even really thought about these 

31 things before.

32 DR. WARD: So it does sound to me -- this is Liz -- that we will want to coalesce 

33 around at least one research priority topic related to mental health issues and maybe 

34 fold in the issue of cognitive impairment? Dr. North, do you have a sense of how those 

35 might be -- if those should be combined, and if so, how, or if they should be separate?

36 DR. NORTH: Well, some of cognitive impairment is truly a psychiatric issue. 

37 Other cognitive impairment, depending on the situation, could be neurological or 

38 metabolic or otherwise medical, so it touches on both.

39 MS. SIDEL: The issue I'm concerned about with the cognitive is if it's thought of 
60

1 as being part of like PTSD, it sort of diminishes the impact of it. Because there's 

2 therapy, like cognitive remediation, that people can do, and if it's not thought of as its 

3 own -- you know, as its own thing and it's like kind of wrapped up PTSD, then people 

4 aren't going to have access to the kind of therapy that's really going to help them 

5 function.

6 MS. FLYNN: This is Kimberly, and this issue of cognitive impairment came up 

7 recently in the survivor steering committee, because apparently lots of patients at the 

8 World Trade Center of our mental health center are complaining about cognitive 

9 issues: memory, attention, thinking, et cetera. And what the mental health director at 

10 the EHC who was present said to us, that made a great deal of sense, is that there 

11 should be a preliminary study. There needs to be, sort of as a first step, a full 

12 characterization of the problem, because indeed we don't know how much of this 

13 problem is a result of environmental exposures and how much of this problem is a 

14 result of psychological exposures to the disaster. So I don't know if I'm, if I'm, you 

15 know, capturing her expertise adequately but that was the point that emerged from 

16 our meeting.

17 DR. NORTH: I agree. I agree with you.

18 DR. MIDDENDORF: I just want to let everybody know that all of the emails that 

19 I send out and anything I get back in terms of an email will be compiled into a 

20 document and it will be posted on the website so that all this is public information.

21 MS. HUGHES: I have a question -- Catherine Hughes here. Are we checking 

22 that the treatments, such as for cancer, is effective or not or there may be more 

23 effective modes to treat the cancer? Would this be a study topic?

24 DR. ALDRICH: This is Tom Aldrich. The problem with that approach is that 

25 there are so few cases, that there's not going to be enough power in the study to 

26 determine different treatments. So I think we have to leave treatment differences for 

27 cancers to the cancer experts who are treating large numbers.

28 DR. MARKOWITZ: This is Steve Markowitz. I think there is a related topic, 

29 though, that probably is germane, which is that this is a big -- the World Trade Center 

30 Health Program is now a pretty big system, and someone should be looking at the 

31 healthcare utilization in the group and perhaps comparing it to the World Trade Center32 exposed people who are not participating in the health program, to understand the 

33 patterns of how people are using this care, thinking ahead to the future disasters' 

34 problems, whether it makes sense to set up a new segregated health program or 

35 whether it makes sense to pursue a different kind of way of treating people. And 

36 related to that, not just on the treatment side but on the monitoring side, I think some 

37 research needs to be done on the utility and effectiveness of the current monitoring 

38 program. On the health -- on the WTC Health Registry side, we have, you know, a 

39 questionnaire-based approach; on the Health Program side, we have a physical 
61

1 examination, an annual -- at least an annual offer of an encounter, although most 

2 people don't show up annually. And the question is, does -- what are the pros and cons 

3 of both sides, but specifically in the World Trade Center Health Program, what's the 

4 utility actually providing hands-on monitoring? That's not to speak in favor or against 

5 it, just we need to understand what we're getting out of it. So I would say that the 

6 research area would be both healthcare utilization on the treatment side and also, on 

7 the monitoring side, utility and effectiveness of the monitoring program as it's set up 

8 now.

9 MS. SIDEL: Well, one of the issues also with the monitoring program is that 

10 you're telling everything to a nurse, and she's interpreting what you're saying and 

11 putting it into your file, and if you don't -- there's a lot of times that information is like 

12 incorrect, it's sort of her version of what you're telling her. And so I've always 

13 wondered if it would be better to have some sort of a system where there was like an 

14 internet or people just had an iPad and they filled out all that information themselves, 

15 because at times it becomes congested when someone else is (indiscernible).

16 DR. MARKOWITZ: That would be a -- this is Steve Markowitz -- yeah, that 

17 would be the kind of question that could be looked at in this research area.

18 MS. SIDEL: Yeah.

19 MS. MEJIA: Liz, this is Guille Mejia. I just wanted to bring up something that 

20 Jim Melius had mentioned in his presentation which was that he was looking at 

21 focusing on emerging conditions. And so I think one area that we might want to look at 

22 is what are the non-covered conditions that are being reported by participants in the 

23 Health Program, and is there, you know, a pattern or trend or anything that can lead to 

24 maybe adding more conditions?

25 DR. WARD: Yeah, I think that's very well stated, and it's connected with one of 

26 the topics we've already captured. I think it's stated more clearly. I think we said 

27 something about new conditions, I think. But I think this really captures what we're 

28 trying to say. So Paul, if you could get that down.

29 MS. FLYNN: Liz, this is Kimberly with a follow-up comment, which is that it 

30 does appear that research resources are needed to do analysis of any emerging 

31 conditions that are, you know, in the database. My sense right now is that the data 

32 center has this information and does not have the wherewithal to conduct the 

33 analyses.

34 MS. SIDEL: This is a little bit far out, but I'm going to take a risk and bring it up 

35 anyway, is that, you know, because of the victims' compensation fund, attorneys are 

36 compiling tons of information on each of their clients' health conditions that are 

37 related to the World Trade Center, and that information is definitely out there. It's 

38 either going to go to the justice department or it could be compiled, you know, 

39 individually. But it's a lot of information because each person -- each client goes and, 
62

1 you know, tells every condition that's related to World Trade Center (indiscernible) and 

2 it's pretty simple.

3 DR. WARD: Good. I think, I think one way to help reframe the discussion so 

4 that we're as responsive as possible to Dr. Howard's questions is to look again at his 

5 questions. And I think what he's asking us to do is to identify critical research 

6 knowledge gaps in each of these areas. So while I think it's tempting to look at specific 

7 courses of data or specific ways to do research, I think what we really should try to do is 

8 articulate as clearly as possible what the knowledge gap is that we're trying to address.

9 DR. ALDRICH: This is Tom Aldrich again. It seems to me that that that's been 

10 presented today is pretty good overview of the knowledge gap. My view is that -- I 

11 mean, there's only so much money for research, and there are gaps. To me the best 

12 way to approach this is to provide some guidance to areas that are -- that NIOSH or 

13 whoever thinks is important, but yet make the determination of funding dependent on 

14 the best quality research. So if it turns out that the best quality research does not 

15 match exactly with our list of needs, I don't think that's necessarily a problem. We 

16 should be supporting the best research that we can.

17 DR. WARD: Well, I think it's real -- you're addressing two areas of the process, 

18 and maybe someone at NIOSH would like to chime in. So I think our function as the 

19 scientific advisory committee is to suggest the priority -- or you know, the priority 

20 knowledge gap. And then there's a separate process that evaluates the quality of the 

21 proposal. So I think our recommendations might be used to help draft better requests 

22 for proposals. But I think there's a separate process that's going to evaluate the quality 

23 of the proposals, and so we're not in any way dictating which proposals will be funded. 

24 Paul, or someone else from the NIOSH grants program, would you like to step in?

25 DR. KUBALE: Dr. Ward, this is Travis Kubale. I would just agree that, there is a 

26 separate, you know, scientific and technical review process, you know, for that 

27 purpose. You're exactly right.

28 DR. ROBISON: This is Allen Robison. I would just add that the ideas and input 

29 that you come up with today, we will take that and use that as we move forward with 

30 subsequent funding opportunity announcements. Thanks.

31 DR. WARD: So with respect to the first area, maybe we should kind of review 

32 what, at least what I think are the major themes that are emerging, and then we can 

33 see what is missing. So I think one major theme that's emerging, that there seems to 

34 be a lot of interest in, is the question of the newly emerging conditions, that are not 

35 currently covered conditions but may be emerging in the population and could be 

36 identified by research, either using existing data, specifically using existing data 

37 sources. So that seems like, you know, something that the committee would want to 

38 recommend.

39 A second important area is doing research on mental health conditions related 
63

1 to -- or doing more research on mental health conditions related to exposure and also 

2 the -- and one thing that came across very strongly there was the idea that the way 

3 we've been categorizing exposure in terms of chemical and physical toxins may not be 

4 appropriate for the exposures that impact mental health outcomes.

5 And also I guess the question that Dr. North raised about research, is there a 

6 way to do research, population-based research, where we would be looking at actual 

7 psychiatric diagnoses rather than symptoms. So that could all be -- those could be 

8 combined into one research topic on mental health outcomes related to World Trade 

9 Center exposures.

10 MS. SIDEL: What about the techniques they use for -- to treat mental health. 

11 You know, for example use the things like EMDR for post-traumatic stress disorder 

12 rather than just psychotherapy?

13 DR. WARD: Well, I think that might be more appropriate conceivably under the 

14 third, the third research area, which is critical research knowledge gaps relative to 

15 effective treatment of World Trade Center-related conditions.

16 MS. SIDEL: I see. Okay, thank you.

17 DR. WARD: And then the third area, I think, is -- was related to biomarkers of, 

18 specifically cancer but other potentially other chronic conditions related to World 

19 Trade Center exposures. And that captures a specific suggestion that Dr. Crowley made 

20 related to DNA and epigenetic effect. It captures a -- it captures what Dr. Rom talked 

21 about in terms of biomarkers related to asthma, potentially. 

22 And the last -- the fourth kind of major area that I'm trying to -- you know, I'm 

23 trying to distill these into a smaller number of larger points, would be the whole 

24 question of immune system disorders, which would include autoimmune diseases and 

25 cancers of the -- relating to the immune system, like sarcoidosis. 

26 So does anyone think that's a good synthesis of the four major topics we might 

27 want to identify under the first point?

28 DR. TRASANDE: Hi. Can I -- sorry to interrupt. This is Leo Trasande. I just 

29 joined.

30 DR. WARD: Hi, Leo.

31 DR. TRASANDE: Hi, how are you?

32 DR. WARD: Good.

33 DR. MIDDENDORF: Welcome, Leo.

34 MS. FLYNN: Liz?

35 DR. WARD: Excuse me, go ahead.

36 MS. FLYNN: I'm sorry. This is Kimberly, and Leo arrived just in time. I would 

37 suggest that we add health impacts, particularly physical health impacts, to the 

38 pediatric population.

39 DR. WARD: Good. And I would suggest maybe we broaden it a little bit to say 
64

1 vulnerable populations, and that would be pediatric and also potentially the groups 

2 that -- well, I guess that could be pediatric but the study of children and young adults or 

3 people who were exposed to the World Trade Center at a relatively early age. There 

4 may be other vulnerable populations as well.

5 MS. HUGHES: Hi, this is Catherine Hughes. I think I'm the only residential mom 

6 on the committee. I think it can't -- it has to deal with the physical health, 'cause, you 

7 know, when they say they studied -- that there's been studies on the population, a lot 

8 of it has been mental, and there's been really a deficiency on the physical health for 

9 children. And I mentioned this at the last survivors' meeting. You know, we had the 

10 clinical guidelines, first for adults, went through iteration 1, iteration 2. Finally after 

11 much fighting, they got guidelines for children. I mean, it's been a battle to get children 

12 recognized in this entire process, and we've really done them a disservice over the 

13 years. So children have -- you know, they have to be there in terms of the physical 

14 health as well. That's all.

15 DR. WARD: Good. Good.

16 MS. SIDEL: You know, in the children's category, babies that were born during 

17 that time, I know of a few people that have concerns about, you know, their children 

18 that were conceived while one of the parents was working at the World Trade Center 

19 after the attacks. They have, you know, different issues that affect children that they 

20 had as well before, you know, 9/11, don't have.

21 DR. WARD: Okay, so that -- but I think in terms of, Paul, where you noted 

22 pediatric disease and other, I think what we want to do is maybe make that one little 

23 more broadly as effects -- health effects of exposure, World Trade Center, during 

24 gestation or early life, something like that. Then in parentheses, childhood and 

25 adolescence or something like that, so we're kind of broadening it. 

26 And looking at the, at the web version, it looks like you have most of the points 

27 we've -- so under item -- under point 1, we really -- I mean, like the overall subhead is 

28 Dr. Howard's question, and then each of these areas is a separate kind of research 

29 recommendation. So newly emerging uncovered conditions is one research 

30 recommendation, and then more research on mental health conditions is the second 

31 recommendation. And they're all under item 1. Or they're all under, you know, his 

32 subhead 1.

33 DR. MIDDENDORF: Okay, I don't have that up, so.

34 DR. WARD: Well, I see it. Oh, you don't have the -- well, that's okay. You can 

35 just put a header like subhead 1 or something or...

36 DR. MIDDENDORF: Okay. So all of these go under his?

37 DR. WARD: His item 1, I think. Yeah.

38 DR. MIDDENDORF: Okay.

39 DR. WARD: What I'm thinking is maybe we should just -- we should see if 
65

1 there's -- if this captures the major themes that we want to prioritize or if -- so and 

2 maybe what we could do is -- well, I guess you'll send these out, after you finish 

3 reformatting them, and then we can maybe look at them and see if we've captured 

4 everything and if we've got the wording close to correct. 

5 DR. ALDRICH: This is Tom Aldrich again. I think one thing that isn't included in 

6 that list is exposure assessment.

7 DR. WARD: Okay.

8 DR. ALDRICH: I forget how that's based but the quantification of exposure.

9 DR. DEMENT: This is John Dement. I really second that one. It came about in a 

10 number of different discussions. It seems that early on we had a lot of exposure 

11 assessment that was really innovative, but later on it seems that we've sort of settled in 

12 on what was done before and not really looked at some issues of differences in the 

13 particularly higher-risk populations not yet identified. So I think that's really narrow 

14 and it really still needs to be up on this list. It really deals with etiology as well. 

15 DR. MIDDENDORF: So how would you suggest I word this?

16 DR. DEMENT: Well, I think: expanded and integrated exposure assessment. 

17 And I really like the comments about the fact that we've principally looked at physical 

18 exposures and largely respiratory, but it really needs to be -- that concept needs to 

19 be -- needs to be broadened out. And I think it has some validation at least of some of 

20 the exposure assessment. It seems to be validated by the results that we've seen, 

21 particularly respiratory. But the network needs to be expanded out to some of the 

22 other health conditions.

23 DR. WARD: And I think what I would do is I would take that verbiage, that John 

24 just suggested, and make that a major bullet, and take cognition out of it. I think -- I'm 

25 not sure what -- you know, I think, I think we still -- I mean, I'm not -- I'm not sure if --

26 well, I guess we can list cognition as a separate research topic, 'cause it sounds like we 

27 don't really -- I mean, we could, we could kind of group it under newly emerging 

28 uncovered conditions or under mental health conditions, even though Dr. North 

29 pointed out that the causes of problems with cognition could be either physical or 

30 psychological, or we could keep it as a separate topic. I'm not sure, you know, where 

31 it's -- maybe to me it makes the most sense to kind of group it as -- under the newly 

32 emerging for -- because it's -- I don't know how strongly it will stand alone as --

33 DR. DEMENT: Right.

34 DR. WARD: -- a major research theme.

35 DR. DEMENT: Right.

36 DR. WARD: But we can, we can talk about that. But I definitely don't -- I don't 

37 think it should be under the -- I think the exposure assessment is a very strong theme 

38 and it should stand -- I think it should stand alone.

39 MS. FLYNN: Liz, this is Kimberly. I'd like to just jump in on exposure 
66

1 assessment. I just -- I guess I just want to reemphasize the point that, particularly for

2 the survivor community, there is no reliable data set of environmental measurements. 

3 So I'm assuming that one would come at exposure assessment for that community 

4 differently. One suggestion is biomarkers of long-lived exposures, which I know is 

5 being done in the World Trade Center adolescent study by Dr. Trasande. So I don't 

6 know if you want to put -- okay, that makes sense, put it under biomarkers, but that 

7 would be a marker of exposure and not a marker of disease.

8 DR. MIDDENDORF: I'm going to try and send this out to everybody now so 

9 people have a chance to look at it. (pause) I sent it out. Hopefully people are receiving 

10 it. And what I sent out was the major themes and the grouping, one through six, under 

11 Dr. Howard's charge number 1.

12 DR. WARD: Well, it hasn't come into my in-box yet.

13 DR. MIDDENDORF: Okay.

14 DR. WARD: Has anyone else received it?

15 MS. MEJIA: Still waiting.

16 DR. ALDRICH: Not yet.

17 DR. MIDDENDORF: I re-sent it just to see -- make sure it wasn't caught off 

18 somewhere.

19 DR. WARD: I guess, Paul, in the worst case, if we can't receive it, maybe we 

20 can just read through them one by one, and those people who have -- I don't know why 

21 it's not coming in.

22 DR. MIDDENDORF: Yeah, Dr. North is again trying to get in but she's not able 

23 to be heard.

24 MS. SIDEL: I just got my email.

25 DR. MARKOWITZ: Yeah, I just got the email too.

26 DR. MIDDENDORF: Dr. North says: I'm trying to say that the exposure 

27 measurement should be specifically annotated to include a unique line of study for 

28 mental health.

29 UNIDENTIFIED SPEAKER: I agree; I think it's really interesting.

30 DR. WARD: Okay, so --

31 DR. MIDDENDORF: Okay, we're having some difficulties here. Both Dr. North 

32 and Dr. Talaska are having difficulty being heard. If the operator is on the line, please 

33 make sure that Glenn Talaska and Carol North are added to the speaking line.

34 THE OPERATOR: They have open lines, sir.

35 DR. MIDDENDORF: They do have open lines. Can you hear me?

36 DR. NORTH: Hi, this is Carol; can you hear me?

37 DR. MIDDENDORF: Yes.

38 DR. TALASKA: Can you hear Glenn?

39 DR. MIDDENDORF: Yes, we can hear you, Glenn.
67

1 DR. TALASKA: Oh, good, finally. God, I was yelling. I wanted to add that --

2 DR. NORTH: This is Carol; can you hear me?

3 DR. TALASKA: May I talk?

4 DR. MIDDENDORF: Yes, Carol, we hear you, too.

5 DR. NORTH: Thank you.

6 DR. TALASKA: This is Glenn Talaska. I wanted to just reinforce what Paul was 

7 saying about exposure assessment and the strategies that need to be developed as a 

8 result of the exposure assessment that was done after 9/11. 

9 I think if everyone remembers, you know, one of the -- the exposure 

10 assessment that was done on -- during 9/11 was amazingly poor. And one of the things 

11 that would just be -- we really do need to develop a strategy coming out of what 

12 markers were measured and a critical review of what was done for the exposure 

13 assessment during 9/11. 

14 John and I did that to a limited extent with the papers that we had but we did 

15 that in a period of a week. And a research study, which would look at that and try to 

16 integrate and make suggestions about which markers for which types of exposures, 

17 would be very useful, I think. It would be very -- well, it would be very useful if 

18 something like this ever happens again. 

19 It certainly has been rolled in from the deep water horizon or the other 

20 disasters that we have, including hurricanes. We don't really have a strategy for doing 

21 that yet, and I think that's important. And it would include using or developing which 

22 long-term markers, which could be gotten from the autopsy studies that are being 

23 done currently, could predict or could be used to indicate which sort of shorter-term 

24 markers might be used to tell people when they've reached a critical level of exposure 

25 and should be removed from doing particular work. And that way, we could prevent 

26 the need. Thank you.

27 DR. WARD: I guess the question I have is -- I mean, I mean, I'm not sure, Glenn, 

28 that the way you phrased that, it kind of lends itself to a research funding proposal. I 

29 mean, it relates to a lot of these different areas, but it seems like it's more like writing a 

30 paper or a review. And I think what we're trying to do is come up with topics that really 

31 will benefit this population rather than the broader -- not that it's not important to use 

32 the information that we learned at the World Trade Center to benefit the broader 

33 fields but I think we're talking -- we're talking about doing research within the World 

34 Trade Center population. So I mean, I think what you're talking about fits in one of 

35 these broad categories but I'm not sure it would be a stand-alone priority.

36 DR. TALASKA: Well, no, I was really seconding what you -- what we were 

37 talking about. I could hear you; I couldn't talk. But what John Dement said --

38 DR. WARD: Okay. Okay, yeah, okay. And so one suggestion, just in the 

39 interest of trying to move, you know, to a -- unfortunately we have this one meeting 
68

1 and we want to come up with final recommendations, and it's, you know, it's -- I want 

2 to make sure that we get to look at all of the four topics. So if we look at the email that 

3 Paul sent out, maybe what we should start doing -- one thing -- I mean, we could make 

4 a motion that these general topics would be the six priority areas we want to make 

5 recommendations on or we could make a motion that a specific additional area be 

6 added before we word-smith the final product, and maybe move on to the second 

7 area, because I think we'll want to do the prioritization after we've gone through all of 

8 the -- all of the four charge areas.

9 MS. HUGHES: I have a question -- Catherine Hughes. Should we also put them 

10 in priority order, like -- 'cause right now they're in order 1 through 6, and people might 

11 think that it's based on priority.

12 DR. WARD: Well, I guess we can. We could prioritize within each area, and 

13 then prioritize across the different areas, if the group would like to do that.

14 MS. HUGHES: 'Cause right now it's -- you know, it looks like biomarkers is 

15 number 3 but biomarkers is really important that it should -- you know, it looks like it 

16 should probably be moved up.

17 DR. MIDDENDORF: I'm going to suggest that at this point you just get out your 

18 ideas and what you think the specific, specific wording for each of these would be. And 

19 then at the very end, when you have all of the ideas or all of the specific topics that you 

20 want to address, then prioritize across all of the groups rather than just looking at each 

21 individual group. So at this point, let's just make sure that we get the wording in 

22 numbers 1, 2, 3, the way you want it, and then at the very end, go through and look at 

23 all of the topics and then prioritize.

24 MS. MEJIA: Liz, this is Guille. I'm looking at number 2 in terms of the research 

25 for mental health conditions, and you list two exposures, physical and chemical 

26 exposures. And obviously not being a researcher, is there any way to include the --

27 maybe the visual and audio exposures that were experienced be different populations, 

28 in particular I'm thinking about our, as someone else mentioned earlier, the 911 

29 operators who didn't -- weren't physically at Ground Zero but certainly had to handle 

30 hundreds of calls coming in, and it would be interesting to see the impact that it has on 

31 this population.

32 DR. WARD: Yeah, and I think this one probably needs to be rephrased, and I 

33 would love it if somebody -- I mean, if somebody would make a recommendation for a 

34 rephrasing of this one that, you know, better captures the intent. I don't know if, Carol, 

35 you're on and can talk but you might be the best person to do that.

36 DR. NORTH: Well, I tried to write something. I'd sent it.

37 DR. MIDDENDORF: Yeah, the problem is I can't listen to what everybody is 

38 saying and type that in, and then go back and look at what you're sending back in 

39 emails; it just isn't working very well.
69

1 DR. NORTH: Now that I can talk, would you like me to read it?

2 DR. MIDDENDORF: Yes.

3 DR. NORTH: Okay. I got to find it here. Okay, exposures. That's what we're 

4 talking about, right?

5 DR. WARD: It's number 2, the more research on mental health conditions in 

6 relation to exposure.

7 DR. NORTH: Right. So you can't necessarily assume the exposures for mental 

8 health are the same as those for medical illnesses, so we need research to characterize 

9 disaster-related exposures --

10 DR. MIDDENDORF: Wait, wait. Go slowly. Research to what?

11 DR. NORTH: Characterize disaster-related exposures in relation to specific --

12 DR. MIDDENDORF: Wait, wait, wait. I'm trying to type. I'm not that good a 

13 typist. Research to characterize disaster-related --

14 DR. NORTH: Exposures.

15 DR. MIDDENDORF: Okay.

16 DR. NORTH: In relation to specific psychiatric disorders such as --

17 DR. MIDDENDORF: Whoa, whoa, whoa. Okay.

18 DR. NORTH: PTSD. 

19 DR. MIDDENDORF: Say it again, PTSD?

20 DR. NORTH: PTSD, major depressive disorder, recognizing that exposures 

21 may --

22 DR. MIDDENDORF: Wait a minute. Major depressive disorder. Okay.

23 DR. NORTH: Recognizing that exposures may be different for different 

24 psychiatric disorders.

25 DR. MIDDENDORF: Recognizing that exposures may be different?

26 DR. NORTH: For different psychiatric disorders.

27 DR. MIDDENDORF: I missed a for.

28 DR. NORTH: So the bottom line, the knowledge gap is that we don't know how 

29 disaster-related exposures relate to psychopathology.

30 DR. ALDRICH: This is Tom Aldrich. Doesn't that belong under item 6?

31 DR. WARD: Tom, it could but I think the original intent was also to call for 

32 more research on mental health disorders in general, including the -- including the 

33 context of looking at both diagnoses and symptoms.

34 DR. ALDRICH: Yes.

35 DR. WARD: So and there will inherently be some overlap between some of 

36 these. I mean, there's going to be overlap between biomarkers and exposure 

37 assessment, but I think what we want to do is really identify where we see that a gap 

38 exists. And what I was sensing is that there's a gap -- there's a research gap in the 

39 understanding of the impact of the exposure on mental health disorders in general, and 
70

1 then more specifically, there's a need to better characterize exposures in relation to 

2 risk of developing mental health disorders. And so --

3 DR. ALDRICH: I agree but I think those are separate topics. And right now in 

4 the document it looks like that whole issue of increased attention to mental health 

5 disorders has been eliminated and just gone down to potential to mental health 

6 disorder exposure or mental health -- exposure --

7 DR. WARD: Right.

8 DR. ALDRICH: -- as it relates to mental health. There are two separate issues, 

9 and I think the exposure part of it belongs as part of number 6.

10 DR. NORTH: Yes.

11 DR. ALDRICH: And yes, there will be overlap but that's okay.

12 DR. NORTH: And then the research on mental health conditions would include 

13 the point I made about symptoms versus diagnosis.

14 DR. WARD: Right, so I guess what we need is a separate -- we need a draft of a 

15 separate point on the mental health conditions research. And then we need to see 

16 how well the point we've already drafted on the exposure assessment for mental 

17 health-related exposures can be captured under exposure assessment.

18 DR. ALDRICH: I'd like to make a suggestion about item 1, okay?

19 DR. WARD: Okay.

20 DR. MIDDENDORF: Well, can we finish up on 2 and 3 -- on -- in the mental 

21 health?

22 DR. WARD: Yeah, 'cause I do think what we want to do is when we make the 

23 suggestions, we really want to make it framed as close as possible to how you'd like to 

24 see the sentence written.

25 DR. ALDRICH: I have that for item 1.

26 DR. WARD: Okay, but we want to finish up on -- I think Paul wants to finish on 

27 item 2 before we move on to item 1. Okay, to finish on item 2, I think we need a 

28 sentence from Carol on mental health research.

29 DR. MIDDENDORF: Do you want this to be like item number 3, or do you want 

30 it to be included in number 2?

31 DR. WARD: I guess at this point I would make the mental health research 

32 number 2, and then it sounds like the exposure assessment related to mental health is 

33 going to be a sub-bullet under the expanded integrated exposure assessment.

34 DR. NORTH: That would be fine.

35 DR. WARD: But --

36 MS. SIDEL: Can I just ask like why you wouldn't be more specific in 2, and just 

37 say like some of them -- you know, mental health conditions such as cognitive 

38 disorders?

39 DR. ALDRICH: I thought the concern about that was that cognitive disorders 
71

1 may be mental health, may not be mental health. I mean, it's all about whether it's, 

2 whether it's a psychological injury or a physical injury. 

3 DR. NORTH: Yes.

4 DR. WARD: That was the concern.

5 MS. SIDEL: But then maybe it should be just broken up into its own separate 

6 set, because that is a concern. But the way this is it's like they don't have to look at 

7 cognitive.

8 DR. ALDRICH: I was going to suggest that as part of number 1.

9 DR. WARD: That's where I was seeing it, and we can see it --

10 MS. SIDEL: Okay, that's good.

11 DR. WARD: -- more specific. I mean, it sounds like renal disease is another one 

12 that's --

13 DR. ALDRICH: Right, so look, under number 1, get rid of the second uncovered, 

14 because that's ambiguous.

15 MS. SIDEL: Yes.

16 DR. ALDRICH: Then we'll leave that one but the second one. No, leave that 

17 one. Newly emerging uncovered conditions that could be proven or disproven by 

18 research or existing data sources, for example, cognitive disorders, autoimmune 

19 diseases, renal diseases --

20 DR. MIDDENDORF: Okay, wait a minute.

21 MS. SIDEL: Excellent.

22 DR. MIDDENDORF: Such as --

23 DR. ALDRICH: Cognitive disorders, autoimmune disorders, renal diseases and I 

24 don't know, want to add in endocrine disorders? I mean, things that haven't been 

25 studied.

26 DR. WARD: That sounds good to me.

27 MS. SIDEL: That sounds really good.

28 MS. FLYNN: This is Kimberly, I'm not sure I can be heard, but --

29 DR. WARD: You can be heard.

30 MS. FLYNN: Thank you. I'm not entirely sure that these conditions can be 

31 proven or disproven by research on existing data sources. I think there would be, for 

32 some of these addition -- I mean, I know I've been piping up about the need to do 

33 analysis using existing data sources but cognitive disorders, we're not going to prove or 

34 disprove based on existing data sources.

35 DR. WARD: Yeah, so I think the current wording, unless it's changed, is 

36 research or existing data sources.

37 MS. FLYNN: Yeah, let's go with that.

38 DR. MIDDENDORF: Okay, so --

39 MS. FLYNN: Analysis or analysis of existing data sources?
72

1 DR. WARD: Yeah.

2 MS. FLYNN: And the other thing I just wanted to roll in here, I am not sure of 

3 the extent to which Dr. North's excellent point about diagnostic terminology applies to 

4 children, number 1, for those who experienced the disaster as children, I guess; and in 

5 addition, I would say that there has been a lot of mental health research on children 

6 exposed to the disaster. I'm not saying there shouldn't be more. There should be more 

7 but the gaps, as Catherine has stated, are largely on: well, let's get this with the most 

8 critical gaps or on the physical health end. So maybe using the word adult in the 

9 mental health -- in Dr. North's point, you know, which would also cover potentially, 

10 young adults, but major depressive disorders, as I understand, it's not something that 

11 you would use as a child diagnosis. Please correct me if I'm wrong.

12 DR. NORTH: Sure you would.

13 MS. FLYNN: You would?

14 DR. NORTH: I'm not sure I understand the point. I think that both of my points 

15 would pertain to both adults and children.

16 MS. FLYNN: Really? Okay. But there has -- Dr. North, there has been a fair 

17 amount of mental health research on the impact of 9/11 to children. So I would 

18 obviously defer to your, you know, expert judgment on this but --

19 DR. NORTH: Well my, my points are not about whether there's been mental 

20 health research on adults or children.

21 MS. FLYNN: Okay.

22 DR. NORTH: Mine is specifically about the insufficient research on the meaning 

23 of exposures and on assessment of full diagnosis as opposed to symptoms.

24 MS. FLYNN: Okay. I, I understand what you're saying. I'm less familiar with 

25 the application of these very, very serious diagnoses, like major depressive disorder, to 

26 children, but, you know, I defer. And also we're talking about people who are 

27 adolescents now so maybe that makes more sense.

28 DR. MIDDENDORF: Okay, I'll give the people with Macs the opportunity to see 

29 what we're talking about. I sent out an email with the current wording. It's on the 

30 screen so we might want to give them a minute or two to get their email so they can 

31 weigh in.

32 DR. WARD: And I think, Paul, one thing that didn't get captured in this version 

33 is the objection to proven or disproven, and I would propose that maybe we could say: 

34 that should be further investigated or could be further investigated. Because I agree 

35 that most of the time we never really prove or disprove things.

36 DR. MIDDENDORF: I was going to bring that up.

37 DR. WARD: But I think other than that, it seems like this bullet is capturing 

38 something that we think is important.

39 DR. ALDRICH: I'm the one who suggested proven or disproven, and I think it's 
73

1 being kind of wishy-washy to say it's going to be investigated. I mean, the goal is to 

2 prove or disprove something. We may fall short of that goal but I don't think we should 

3 hesitate to state that goal.

4 DR. WARD: What do other committee members think?

5 DR. NORTH: I agree.

6 MS. SIDEL: Yeah, I don't like being wishy-washy.

7 DR. WARD: Okay, so, so are we at the point where we want to go ahead and 

8 make a motion on the final wording for point 1, and then have a vote?

9 MS. FLYNN: Can I just --

10 DR. MIDDENDORF: Has everyone received their email? I think that's the first 

11 question.

12 DR. ALDRICH: Well, and add in endocrine diseases.

13 MS. FLYNN: This is Kimberly, what about the word discovered? I just feel that, 

14 you know, we need a little more wiggle room here than absolute proof. I offer that as 

15 an alternative. You may or may not like it.

16 DR. ALDRICH: I don't like it because it's -- it suggests that it's there to be found, 

17 and it might not be there to be found. That's why we need to include the possibility 

18 that we're going to find something in the negative.

19 MS. MEJIA: This is Guille, in terms of item number 1, I just want to make sure 

20 that what I had raised earlier in terms of ensuring that the non-covered conditions that 

21 are being reported by the participants in the health program are also captured in this as 

22 part of the emerging conditions?

23 MS. FLYNN: Yes, that's good.

24 DR. WARD: All right, so it should read newly emerging non-covered conditions.

25 DR. MIDDENDORF: Well, I was --

26 MS. MEJIA: But are reported by people in the program. That's the really 

27 important part 'cause it gives it credence.

28 DR. MIDDENDORF: Just tell me what words you want and where you want 

29 them.

30 DR. ALDRICH: Tom Aldrich again. I have a problem with that because the fact 

31 that people are reporting something doesn't mean it's World Trade Center-related, and 

32 to phrase it that way suggests that it is.

33 MS. FLYNN: I agree.

34 DR. ALDRICH: I mean, our purpose here is science so we should -- we 

35 shouldn't -- we should be critical.

36 MS. SIDEL: Okay, what about brought to the attention as, you know, as 

37 potentially World Trade Center-related?

38 DR. ALDRICH: I'd have to see how you phrase it.

39 MS. SIDEL: Okay, I have to -- I have to write it for a minute.
74

1 DR. WARD: Well, I mean, maybe we should back it up a little bit and say 

2 something like investigate whether World Trade Center-exposed populations have an 

3 increased prevalence of conditions not previously recognized covered by the World 

4 Trade Center Health Program. Have an increased -- because I think that's really the 

5 sense, is that we want to know if, you know, by focusing on the things that emerged as 

6 World Trade Center-related conditions early in the course of studying what might occur 

7 in the population, we might be missing things -- diseases or conditions that have a 

8 longer latency. We could say investigate whether there are newly emerging conditions 

9 among World Trade Center-exposed populations.

10 MS. SIDEL: I think that works and that's really what we're trying to do is 

11 investigate, and say, you know, just the word of and, you know, make the list of 

12 autoimmune disorders, cognitive disorders, renal diseases.

13 DR. WARD: And it could be that that list is really including some conditions 

14 that have been raised as concerns but not adequately investigated.

15 MS. FLYNN: Yeah.

16 MS. SIDEL: Well, investigated by the World Trade Center because (multiple 

17 speakers) have them say that it's World Trade Center-related.

18 DR. WARD: (Indiscernible) adequate -- you know, have not been fully 

19 investigated in World Trade Center-exposed populations?

20 THE COURT REPORTER: Excuse me, was that Ms. Sidel speaking?

21 MS. SIDEL: Yes.

22 DR. WARD: And then it was Liz.

23 THE COURT REPORTER: Right, yeah.

24 DR. MARKOWITZ: This is Steve Markowitz. I actually don't think we should 

25 provide examples of conditions. I think the general category of newly emerging 

26 conditions would be sufficient. I don't know -- I mean, I think the hunches on these 

27 named conditions are hunches, and I don't -- to mention them seems like we're 

28 endorsing them as areas that need study more than other conditions that we haven't 

29 named. And I don't think that the researchers or that NIOSH need these examples.

30 MS. SIDEL: Okay, the point of it was, though, that there are certain conditions 

31 that have been brought to our attention this morning, like Dr. Melius brought up 

32 autoimmune disorders. I think the fire department complained about autoimmune 

33 disorders. The woman that wrote the letter about her cognitive issues. So those are 

34 two specific areas that were thought of that, you know, I certainly would like to see 

35 them researched to see if they are in fact related to the World Trade Center. The rest 

36 (indiscernible) explore, you know, research cognitive, you know, problems and 

37 cognitive issues and autoimmune diseases and renal as possible World Trade 

38 Center-related.

39 DR. WARD: This is Liz. I think maybe what we could do that might, and this 
75

1 makes sense to me, is in this bullet really capture the broad theme of: make sure we're 

2 conducting research and surveillance to capture any newly emerging diseases, but then 

3 where we really as a committee feel that there needs to be more research, like if 

4 there's a specific area, like autoimmune diseases and immune system dysfunction, we 

5 could call that out as a separate bullet point or a separate point, but after due 

6 consideration that we really do think that particular area is more important than a 

7 variety of other areas that we could also highlight. 'Cause I do agree with Steve's point, 

8 that if we just make this look based on things that really have been mentioned during 

9 this call without kind of, you know, a more reasoned rationale for why we're 

10 mentioning these and not others, it's not really very helpful in setting the research 

11 direction.

12 MS. FLYNN: Yes, I agree.

13 MS. SIDEL: I agree.

14 DR. WARD: So, Steve, would you like to make a motion with final wording of 

15 this bullet number 1?

16 DR. MARKOWITZ: Well, the -- so Paul just sent around number 6.

17 DR. WARD: Okay. I haven't seen it.

18 DR. MARKOWITZ: Number 6.

19 DR. MIDDENDORF: Yeah, and it shows the two alternatives. One and two are 

20 the two versions that -- I guess the originating version, and then the one that it 

21 morphed into.

22 MS. SIDEL: Yeah, I would take out -- I would definitely take out cognitive 

23 disorders, autoimmune disorders, renal diseases. I would definitely undo number 1, 

24 because it's, you know, we don't have the research on those things because if we did 

25 have the research it wouldn't be an issue now. But it's an issue because it's affecting 

26 people, and there's no World Trade Center research on it.

27 DR. MARKOWITZ: Yeah, so that's -- this is Steve Markowitz. The number 1, if 

28 you just take out the examples, number 1 probably captures better what we mean. 

29 Uncovered -- you might want to specify that, you know, conditions that are currently 

30 not covered by the WTC program. And investigated by research or analysis, well, 

31 actually that's not either/or.

32 DR. MIDDENDORF: Are you suggesting an and, slash or?

33 DR. ALDRICH: Why not just go with number 2, adding the word uncovered 

34 before conditions? And leaving out everything after populations?

35 DR. MARKOWITZ: Yeah, that's fine.

36 DR. MIDDENDORF: Emerging conditions.

37 DR. ALDRICH: Uncovered conditions. 

38 DR. MIDDENDORF: Well, one of the suggestions was to use the term not 

39 covered by the WTCHP.
76

1 DR. MARKOWITZ: That's better.

2 DR. MIDDENDORF: Okay. And what else goes away, just after populations?

3 DR. MARKOWITZ: Right, yeah.

4 DR. MIDDENDORF: Investigate -- so it would read: Investigate whether there 

5 are newly emerging conditions not covered by the WTCHP among WTC population.

6 DR. ALDRICH: I like it. It's vague, it's broad, that's good.

7 DR. MIDDENDORF: I want to send this out to everybody so they know exactly 

8 what it is. Is this the motion you're making? Is this the motion?

9 DR. MARKOWITZ: Sure, yes. This is Steve Markowitz. Yes, I'd make that 

10 motion.

11 DR. ALDRICH: Okay, this is Tom Aldrich, I second.

12 DR. MIDDENDORF: All right.

13 DR. WARD: And we have to vote. 

14 DR. MIDDENDORF: I'm going to send it out to everybody so they can see 

15 exactly what it says. This is number 7 coming your way. I'm just going to point out that 

16 we have about two and a half hours left, and that includes time for a little break, here, 

17 fairly soon.

18 DR. WARD: Well, hopefully we're shaking out the process a little bit so we'll be 

19 faster on the others, hopefully. So let's see, everybody has 7.

20 DR. MIDDENDORF: Yeah, well, that's the question. Is there someone who has 

21 not received number 7 yet?

22 MS. SIDEL: I received it. Number 1 is so vague that like what are we -- what 

23 are we really saying? We're not saying anything, kind of. I mean --

24 DR. MARKOWITZ: No, actually -- this is Steve Markowitz -- I would disagree, 

25 actually, because if NIOSH were to set this as a research area and, you know, it would 

26 invite proposals that are going to have to plausibly address certain emerging conditions 

27 by way of methods or --

28 MS. SIDEL: Right, but the problem that we have with our proposal, and this is 

29 what I was talking about earlier, like for example with something like autoimmune 

30 disease, it's highly unlikely that any of the people that do these World Trade Center 

31 research projects is going to tackle autoimmune diseases because they're not, they're 

32 not rheumatologists. So that's why --

33 DR. MARKOWITZ: No, no, that's --

34 DR. WARD: I think we have -- we still have the options of calling out certain 

35 disease characters or certain diseases or groupings of diseases in another priority.

36 DR. ALDRICH: It's also -- it's just not true that they exist -- groups are not 

37 studying those things because they don't have expertise. There is an ongoing study of 

38 autoimmune disease in the FDNY cohort, and it's being run by epidemiologists with 

39 consultation from rheumatologists. And they are doing a really fine job.
77

1 MS. SIDEL: I would -- okay, well, that's good. I'm really glad to hear that but I 

2 just meant like -- and you know, I'm not in the FDNY program; I'm in the, you know, the 

3 responder program, so I just know that people that have been really frustrated because 

4 they have had problems that are very likely World Trade Center-related, that they 

5 haven't been able to either get treated for it or even get a referral for it because it's not 

6 part of the program. And, you know, my thought is that the reason that some of these 

7 things aren't part of the program is because it's above the first level of (indiscernible). 

8 It’s not necessarily their area of expertise.

9 DR. ALDRICH: But my point is but the system, the system has worked. The 

10 prior -- the prior request for proposals was adequate to elicit that proposal even 

11 though there were no rheumatologists on any of the research staffs. And so this type 

12 of process is working.

13 MS. SIDEL: Okay, but people --

14 DR. WARD: Okay. I think we have a motion.

15 DR. MIDDENDORF: Okay, first off, I need to ask, Julia, can you be heard now? 

16 Julia's been trying to say something and hasn't been able to get through.

17 DR. WARD: I mean, I would say that we should call for a vote on this motion 

18 'cause I think we've heard a lot of the perspectives that we were expressing before, and 

19 it's really a question of whether the -- you know, this is -- I don't think further 

20 discussion is necessarily going to be productive. I think it's really a question of whether 

21 the majority of -- or you know, the committee, how the committee as a whole feels 

22 about this. I guess if we get a really divided vote, then we could have more discussion. 

23 But if there's, if there's (indiscernible) on it, we may need to -- we should move on to 

24 other points that may be equally or more important.

25 DR. MIDDENDORF: Yeah, before we have a vote, though, I need to make sure 

26 that everybody has had a chance to be heard.

27 DR. WARD: Right, right.

28 DR. MIDDENDORF: And Julia is not into the meeting as yet. I'm assuming she 

29 can hear but she can't be heard.

30 DR. WARD: Right.

31 DR. TRASANDE: Paul, this is Leo. I'm just confirming I received 7.

32 DR. MIDDENDORF: Okay, great. Is there anybody who has not received 

33 number 7?

34 DR. QUINT: I've received 7 but I can't be -- can you hear me?

35 DR. MIDDENDORF: Yes.

36 DR. QUINT: Oh, can you hear me now?

37 DR. MIDDENDORF: Yeah.

38 DR. QUINT: Okay, it's Julia.

39 DR. MIDDENDORF: Okay, great.
78

1 DR. QUINT: The question I have is whether or not the uncovered conditions or 

2 the newly emerging conditions are being systematically captured. All I heard was that, 

3 you know, just discuss -- some things were discussed at meetings but I haven't -- is 

4 there a method now for capturing these uncovered conditions? Otherwise, you know, 

5 there's no -- what are we investigating?

6 DR. MARKOWITZ: This is Steve Markowitz. You know, one of the ideas -- the 

7 proposal for a priority area that Dr. Melius made was to improve the surveillance -- the 

8 performance of the current -- the systems, the Registry and the Health Program. So I 

9 think that would, if done properly, that would address that issue. If there were more 

10 sensitive surveillance, then the signals from the populations would be appropriately 

11 detected, and that would provide some data for newly emerging conditions, which 

12 ones, which ones to pick.

13 DR. QUINT: I agree, and so maybe we should add systematically document and 

14 investigate, because, you know, it's not clear that the surveillance systems are working 

15 adequately now, so the investigate newly emerging diseases doesn't have much 

16 meaning. And there's not a good feed in the system for that.

17 DR. WARD: I think yes and no. I think the original intent was both to capture 

18 the opportunity of surveillance and the opportunity of research. So for example, you 

19 may not approach -- you may approach this in a surveillance way or you may actually 

20 propose to do a study looking at biomarkers that would reflect some newly emerging 

21 condition that you hypothesize for other reasons. So I, I think the -- what we want to 

22 do is -- I mean, to me the key -- the essence is the question of whether there are newly

23 emerging conditions, and we don't necessarily need to be more specific about it being 

24 surveillance or other types of research.

25 DR. QUINT: Okay.

26 DR. ALDRICH: I agree with that. I think that if we make it too specific, that 

27 leaves out some innovative proposal that somebody's been thinking about, and if it 

28 doesn't happen to include surveillance, they will think they won't be able to get funded 

29 through this mechanism.

30 DR. QUINT: Well, I guess I was concerned about how they identify them as 

31 emerging. What's the, what's the source of -- you know, anybody can say something is 

32 emerging but, you know, what is the source of that information? But okay, I won't 

33 pursue that.

34 DR. MARKOWITZ: This is Steve Markowitz. I think that's a really good point, 

35 but I do think it's -- if there's a -- somewhere we're going to get to another 

36 recommendation about surveill -- improved surveillance.

37 DR. QUINT: Oh, okay.

38 DR. MARKOWITZ: And I think that would be -- that would answer, at least 

39 partly answer, that, you know, detection of emergents.
79

1 DR. QUINT: Okay. Great, thanks.

2 DR. TRASANDE: This is Leo. Can I ask a clarifying question, because I cut in and 

3 out for the past 45 minutes.

4 DR. MIDDENDORF: Please do.

5 DR. TRASANDE: Numbers 1 through 7 in various emails you sent, I assume 

6 number 7 is the -- is what we're debating now, and the other six have been voted on?

7 DR. WARD: No. We still need to vote on the others.

8 DR. MIDDENDORF: Wishful, wishful thinking, Leo.

9 DR. TRASANDE: Okay.

10 DR. MIDDENDORF: This will be the first vote we take.

11 DR. TRASANDE: Okay. Thank you.

12 DR. MIDDENDORF: The other emails were just trying to develop thoughts and 

13 ideas. And because there are numerous people who cannot see the, the web, because 

14 they have Macs and it's just not working, for them I'm just sending it out in an email so 

15 people can see exactly what the wording is, and also to try to keep them up to speed 

16 with summarizing the information that has been discussed. So, Liz?

17 DR. WARD: Yes.

18 DR. MIDDENDORF: Did you want to call for the vote? I think we had a motion 

19 and a second.

20 DR. WARD: Well, I mean, you know, I did -- I was prefacing the point that they 

21 may not be newly emerging but I think NIOSH probably will get the, the sense of what 

22 we're talking about. They don't necessarily have to be newly emerging. They could be, 

23 you know, just previously unrecognized or --

24 MS. SIDEL: That's a good way to put it.

25 DR. NORTH: Yeah.

26 MS. SIDEL: That would be more accurate because a lot of things, you know, 

27 has been around forever but it's just that nobody was talking about it or recognizing it 

28 or getting treated for it.

29 DR. WARD: All right, (indiscernible) unrecognized conditions associated with 

30 World Trade Center exposures that are not covered by --

31 (Interference)

32 DR. WARD: Okay, somebody's not muted and we're hearing their background 

33 noise. Hello? Okay.

34 DR. MIDDENDORF: So you're changing the motion; is that --

35 DR. MARKOWITZ: Yeah.

36 DR. MIDDENDORF: Okay. It was either Steve or Tom that --

37 DR. MARKOWITZ: That friendly amendment is accepted by the proposer.

38 DR. MIDDENDORF: Okay, so how does it read?

39 DR. MARKOWITZ: Can someone read it?
80

1 DR. WARD: Investigate (indiscernible) that are previously unrecognized 

2 conditions associated with World Trade Center exposures but are not -- that are not

3 listed as covered conditions.

4 DR. MARKOWITZ: Yeah, they're not currently identified --

5 DR. NORTH: Currently.

6 DR. MARKOWITZ: -- identified as WTC-covered conditions. 

7 DR. WARD: Yeah.

8 DR. ALDRICH: Could you make it previously unrecognized or newly emerging?

9 DR. QUINT: You don't have to have newly emerging.

10 DR. MIDDENDORF: Okay, so I didn't catch, quite, the tail end of the --

11 DR. WARD: Steve, you're the original motion proposer, so why don't you 

12 propose the final language?

13 DR. MARKOWITZ: Let's see, working still off what Paul sent as number 7, 

14 right?

15 DR. MIDDENDORF: Yes.

16 DR. WARD: Right --

17 DR. MARKOWITZ: Okay, so --

18 DR. WARD: So I think the part that’s not that we're -- somebody proposed 

19 adding -- we were -- I think we were at investigating whether there are previously 

20 unrecognized conditions not currently --

21 DR. MARKOWITZ: Right, right, okay. Set up an investigation --

22 DR. WARD: But then someone else said, maybe we should say, and newly 

23 emerging, and somebody else said we don't need it. So I'm giving you the final call.

24 DR. MARKOWITZ: So why don't we say: Investigate whether there are newly 

25 emerging or previously unrecognized conditions, health conditions, that are not 

26 covered by the WTCHP among WTC populations?

27 MS. SIDEL: I think that's good.

28 DR. MIDDENDORF: I need to hear it again. Investigate --

29 DR. MARKOWITZ: Whether there are newly emerging conditions or previously 

30 unrecognized conditions.

31 DR. MIDDENDORF: Okay, at one point -- last time you said health conditions.

32 DR. MARKOWITZ: Yeah, I'm sorry, health conditions, that's right.

33 DR. MIDDENDORF: Okay.

34 DR. MARKOWITZ: Yeah. That are not covered by WTCHP among WTC 

35 populations.

36 DR. MIDDENDORF: Okay. There was also a term -- somebody at one point 

37 suggested adding: previously unrecognized health conditions associated with WTC 

38 exposures not covered by the WTCHP among WTC populations.

39 DR. MARKOWITZ: No, I think that's just -- that just obfuscates it.
81

1 DR. MIDDENDORF: Okay, you want to take out associated with WTC 

2 exposures.

3 DR. WARD: I'm fine with that. I suggested it and I'm fine with taking it out.

4 DR. MIDDENDORF: Okay. So here's, here's what I have: Investigate whether 

5 there are newly emerging health conditions or previously unrecognized health 

6 conditions not covered by the WTCHP among WTC populations. 

7 I'm going to send this out in an email for those -- this will be number 8.

8 MS. SIDEL: Poor Paul.

9 DR. WARD: Poor us because we still have -- this is still on number 1.

10 DR. MIDDENDORF: Yeah.

11 DR. ALDRICH: You guys are doing great. Hang in there.

12 DR. MIDDENDORF: Has anybody received number 8 yet?

13 DR. WARD: I have not.

14 DR. MIDDENDORF: Okay.

15 DR. QUINT: Are your electronics frozen out east?

16 DR. MIDDENDORF: We're in a nice spot here in Atlanta, so I don't think that's

17 our problem. I am going to resend 8. 

18 UNIDENTIFIED SPEAKER: I just got it, Paul.

19 DR. MIDDENDORF: Has everyone received it?

20 MS. FLYNN: Not quite yet. This is Kimberly. I haven't received it but I've heard 

21 the language, and I think we should move forward on it.

22 DR. MIDDENDORF: Is there anyone who feels like they want to wait until they 

23 have the email?

24 DR. TRASANDE: I suggest we vote.

25 DR. MIDDENDORF: Okay, Liz?

26 DR. WARD: I think we should vote. So Paul, are you going to do the roll call 

27 vote?

28 DR. MIDDENDORF: Yes, I will.

29 DR. WARD: Okay.

30 DR. MIDDENDORF: Okay. Tom Aldrich? You can vote yes, no or abstain.

31 DR. ALDRICH: I vote yes.

32 DR. MIDDENDORF: Okay, John Dement. (pause) Okay, I'm going to pass on 

33 John at the moment.

34 DR. DEMENT: Hello?

35 DR. MIDDENDORF: Hello, John?

36 DR. DEMENT: Yes. I voted yes.

37 DR. MIDDENDORF: Oh, okay. We just couldn't hear you. Kimberly Flynn.

38 MS. FLYNN: Yes.

39 DR. MIDDENDORF: Bob Harrison.
82

1 DR. HARRISON: Yes.

2 DR. MIDDENDORF: Catherine Hughes.

3 MS. HUGHES: Yes.

4 DR. MIDDENDORF: Steve Markowitz?

5 DR. MARKOWITZ: Yes.

6 DR. MIDDENDORF: Guille?

7 MS. MEJIA: Yes.

8 DR. MIDDENDORF: Carol.

9 DR. NORTH: Yes. 

10 DR. MIDDENDORF: Julia.

11 DR. QUINT: Yes.

12 DR. MIDDENDORF: Bill.

13 DR. ROM: Yes.

14 DR. MIDDENDORF: Susan. Susan?

15 MS. SIDEL: Yes, sorry.

16 DR. MIDDENDORF: Okay. Glenn?

17 DR. TALASKA: Yes.

18 DR. MIDDENDORF: Leo?

19 DR. TRASANDE: Yes.

20 DR. MIDDENDORF: Liz?

21 DR. WARD: Yes.

22 DR. MIDDENDORF: And I don't think Virginia's with us anymore. Okay one, 

23 two, three, four, five, six, seven, eight, nine, ten, 11, 12, 13, 14 yeses. Zero noes, zero 

24 abstain. Okay. Motion passes.

25 DR. WARD: So I would propose that the next one we talk about is mental 

26 health research, and hopefully we have some suggested new language on that from 

27 Dr. North that we can -- that Paul can email?

28 DR. MIDDENDORF: Okay, well, do you want to take a quick break or do you 

29 want me to help out if we get the wording and I'll email it out, and then we'll take a 

30 short break?

31 DR. NORTH: Good.

32 DR. MIDDENDORF: Yeah, we're set up for a break at 2:30; it’s already after 

33 2:30. Does that sound like a good plan, Liz?

34 DR. WARD: That sounds fine.

35 DR. MIDDENDORF: Okay. So we'll try to hammer out the language. Carol, do 

36 you have some suggestions?

37 DR. NORTH: I would probably -- thought was what I sent you before. Is that 

38 what we’re on? I'm lost as to which document we're on.

39 DR. WARD: Okay, we're on -- I went back to the version 5 that Paul previously 
83

1 sent.

2 DR. NORTH: Okay.

3 DR. WARD: Where we have the list of all the general suggested topics. And I 

4 was going to try to consider them in order. So if anybody has time during the break to 

5 look at any of them and suggest -- some of them -- clearly several of them need word6 smithing. So if anyone wants to send any suggestions to Paul, they should.

7 DR. MIDDENDORF: I would prefer that they not email anything to me. I think 

8 that the suggestions need to be made verbally.

9 DR. WARD: Okay. Okay. So write them down so that you can read them off 

10 when we're back on the phone. 

11 Okay, so we'll go ahead and take a ten-minute break.

12 DR. MIDDENDORF: Okay, and Carol is going to be thinking about wording for 

13 the mental health.

14 DR. NORTH: I'm working on it.

15 DR. MIDDENDORF: Okay, great. So what time are we returning?

16 DR. WARD: My clock says now 2:38, so I guess at 2:58, which is -- no, that's 20 

17 minutes.

18 DR. MIDDENDORF: Yeah, just do it 2:48?

19 DR. WARD: Yeah, so yeah.

20 DR. MIDDENDORF: Okay, 2:50.

21 DR. WARD: Okay. Thanks.

22 (Recess in proceedings, 2:38 until 2:50 p.m.) 

23

24 DR. MIDDENDORF: Let’s begin. I’ve got 2:50, and we have just a little over 

25 two hours left. Tom Aldrich, are you there?

26 DR. ALDRICH: Yes.

27 DR. MIDDENDORF: Okay. John Dement?

28 DR. DEMENT: Yes.

29 DR. MIDDENDORF: Kimberly Flynn?

30 MS. FLYNN: Yes.

31 DR. MIDDENDORF: Bob Harrison?

32 DR. HARRISON: Yes.

33 DR. MIDDENDORF: Catherine Hughes?

34 MS. HUGHES: Yes.

35 DR. MIDDENDORF: Steve Markowitz?

36 DR. MARKOWITZ: Yes.

37 DR. MIDDENDORF: Guille Mejia?

38 MS. MEJIA: Present.

39 DR. MIDDENDORF: Carol North?
84

1 DR. NORTH: Yes.

2 DR. MIDDENDORF: Julia Quint?

3 DR. QUINT: Yes.

4 DR. MIDDENDORF: Bill Rom? (pause) Come back to Bill. Susan Sidel?

5 MS. SIDEL: Here.

6 DR. MIDDENDORF: Glenn Talaska?

7 DR. TALASKA: Present.

8 DR. MIDDENDORF: Leo Trasande?

9 DR. TRASANDE: Yes.

10 DR. MIDDENDORF: Liz Ward?

11 DR. WARD: Here.

12 DR. MIDDENDORF: And Virginia is gone, so one, two, three, four... We 

13 have 13, and Bill, are you there? Okay. Well, we have 13, and so we have a 

14 quorum; we can continue on.

15

16 DISCUSSION OF RESEARCH NEEDS AND DEVELOPMENT OF 

17 RECOMMENDATIONS (continued)

18 DR. WARD: Okay. So Carol, did you have a proposed wording for item 

19 number 2?

20 DR. NORTH: I'm ready. That's an (a) and a (b); (a) relates to exposure. 

21 Characterize the disaster-related exposures that are associated with the 

22 development of specific psychiatric disorders. You want me to proceed to (b)?

23 DR. WARD: I think it would be good to do that.

24 DR. NORTH: (b) is diagnosis. Differentiate psychiatric disorders from

25 symptoms and distress in relation to disaster exposures, comma.

26 DR. MIDDENDORF: Okay, wait a minute. I got a little slow there. 

27 Differentiate psychiatric disorders...

28 DR. NORTH: From symptoms and distress in relation to disaster exposure, 

29 comma, and develop efficient and effective methods --

30 DR. MIDDENDORF: I'm sorry, develop what?

31 DR. NORTH: Efficient and effective methods for diagnosis of 

32 disaster-related psychopathology in populations and individuals.

33 DR. MIDDENDORF: Okay. Do you want that as one motion or do you want 

34 these as separate motions?

35 DR. NORTH: I don't care.

36 DR. WARD: I think one thing we could do is we could combine -- I mean, we 

37 could have them as one motion and just have a, you know, a subhead such as 

38 research on mental health -- World Trade Center-related mental health disorders, 

39 and then we could have the two items included in that. And once anyone has -- I 
85

1 think it would be better to combine it into one research area unless someone has a 

2 strong objection to doing that.

3 DR. NORTH: I separated them simply because they were -- responded to

4 two different separate areas in the tasks that we were given in the original letter.

5 DR. WARD: Which -- what were the areas, then? The -- accurate diagnosis

6 was -- okay --

7 DR. NORTH: The first was identify gaps on understanding the effects of 

8 exposure, and the second -- these are the charges. The second was, I guess, relative 

9 to accurate diagnosis.

10 DR. WARD: Okay. Very good point. So let's do that, then. Let's include the 

11 -- only the one on item 1, and the voting and listing now, and then when we move 

12 on to Dr. Howard's item 2, we can include the other one.

13 DR. NORTH: All right. Then I might mention that I didn't include anything 

14 on treatment because I didn't have strong feelings about it but other members may 

15 have some.

16 DR. WARD: Right. No, we haven't even started on two yet. And you're 

17 right, it probably better belong there. 

18 Okay, so let's wrap up on the mental health research items for this list. 

19 Paul, do you want to read it over one more time?

20 DR. MIDDENDORF: Sure. What I have now is: Characterize the 

21 disaster-related exposures that are associated with the development of specific 

22 psychiatric disorders.

23 DR. WARD: My opinion would be that it might be better to keep that as a 

24 separate priority than to subsume it under exposure assessment, because it really is 

25 kind of a very unique observation that Carol is making, and she's also kind of saying 

26 that you may need to do a different exposure assessment, look at different 

27 psychiatric disorders, which it seems to me that that's enough of a unique concept 

28 to stand on its own as a research priority.

29 MS. SIDEL: Could I ask a question? This is Susan. I don't know really 

30 understand this because, because they think it's better -- I mean, we're asking them 

31 to look at other things. But they don't see that there’s a reason to look at other 

32 things. And so I don't understand how this would change that.

33 DR. WARD: Well, this is a separate research priority. It's completely 

34 different from what we just discussed under item 1.

35 MS. SIDEL: Yeah, I know. I mean, I know that but it came out of the whole 

36 thing of cognitive, you know, dealing with cognitive issues.

37 DR. WARD: No, it didn’t. I think it came out of -- I mean, I think I created -- I 

38 said that maybe they were interrelated but I think this is a -- this is a separate point 

39 that Dr. North was raising as a research priority.
86

1 DR. NORTH: Yeah, certainly I didn't intend it for cognitive issues; I intended 

2 it for psychiatric illness.

3 MS. SIDEL: Okay. All right. Then, then I, I just -- I just didn't understand it. 

4 'Cause we were talking about the cognitive thing. And I thought that that's what --

5 DR. NORTH: No, I thought it diverged from that.

6 MS. SIDEL: I'm sorry; I couldn't understand you. What?

7 DR. NORTH: I diverged from that.

8 MS. SIDEL: Oh, I see, okay. So where is that going to go?

9 DR. NORTH: Either under exposures related to mental health or under 

10 mental health related to exposures.

11 MS. SIDEL: So is it gonna be -- would that be part of 2?

12 DR. NORTH: It could be.

13 MS. SIDEL: Wait. I think it should be separate, then, because I think that 

14 the problem is that it's not being recognized, and so it's gonna have to be spelled 

15 out. Not as in, like somewhat -- something's gonna, you know -- if you’re not 

16 schooled in that, it has to be pointed out.

17 DR. NORTH: So I'm not sure I understand the question. Where are you 

18 suggesting we put it? Hello?

19 MS. SIDEL: I think it should be separate.

20 DR. NORTH: Okay. Other number?

21 MS. SIDEL: It should be -- it should be raised as an issue. I mean, the issue 

22 was that they're not looking at cognitive issues that are not caused by PTSD; they 

23 were actually caused because something happened to your brain as a result of being 

24 exposed to toxins. That would -- I thought that the cognitive -- the woman that 

25 spoke today, that's what she was talking about, and I thought that we would be 

26 addressing that, that issue.

27 DR. NORTH: Well, it’s probably going to be more relevant to certain 

28 medical conditions. My point earlier was there are different kinds of exposures that 

29 would be pertinent to mental health conditions.

30 DR. WARD: Can I say -- I mean, my suggestion would be that Dr. North 

31 make the motion -- at this point I don't think we can continue to -- I mean, I think 

32 we have to take these one by one, agree that they are a research priority, and then 

33 move on to the next research priority. Because otherwise we're not going to get 

34 past the first item in the agenda. So I think if Dr. North wants to make that as a 

35 motion, and then we have a second, then we could -- the committee could vote on 

36 it as whether we see it overall as a research priority, not necessarily ranking it as the 

37 most important but that it is one of the research priorities that this committee 

38 recommends as a critical gap in knowledge.

39 MS. SIDEL: So you're basically saying that we're going to have like a laundry 
87

1 list of things that are possible things that should be looked into, you know.

2 DR. WARD: Well, I don't think it's going to be a laundry list, 'cause I think 

3 we already have -- I mean, we're going back to version number 6 that Paul sent 

4 around, which has somewhere between six and seven teams. Now, the cognitive, 

5 cognitive health effects, I think, was originally subsumed as an example under bullet 

6 1, which we've already voted on, with taking out the bullets. 

7 So I guess we still will need to discuss -- it's clear that Dr. North does not feel 

8 that cognitive issues belongs in the same priority area as the mental health 

9 research.

10 DR. NORTH: It might sometimes. 

11 MS. SIDEL: But what mental health are they doing right now? I just don’t 

12 understand it.

13 DR. WARD: It might sometimes but it might not sometimes so Carol, you 

14 have to decide if you want it in -- write a broader bullet that includes the cognitive 

15 research or, if not, then we have to handle the cognitive research as a separate 

16 bullet. 

17 I don't know how many committee members feel strongly that that belongs 

18 on the list but I think we are going to need to take specific proposals for research 

19 gap areas one by one, but recognize that, you know, I was assuming that we were 

20 down to six or seven, that we were word-smithing.

21 DR. NORTH: We can't subsume all cognitive disorders in psychiatric 

22 disorders.

23 DR. WARD: We can't but we could -- I mean, if we wanted to --

24 MS. SIDEL: She's talking about a very specific thing. She's talking people 

25 that are actually found of having been exposed to toxins, that they're having 

26 cognitive issues.

27 DR. WARD: Because one person on a -- because one person in the public 

28 has testimony suggested that it's a research priority does not mean that the 

29 committee, as a whole, is going to --

30 MS. SIDEL: Okay, I --

31 DR. WARD: -- request it as a research priority. So I don't know how we get 

32 to the point where we have a substantive discussion on that but I do recognize that 

33 that was what the public -- the participant from the public was advocating for. I just 

34 --

35 MS. SIDEL: Right. I don't think it's just one person. I know a lot of people 

36 that have those issues. And I think it's very common and I think that usually people 

37 are told that it's part of post-traumatic stress disorder, and maybe it's not. And then 

38 it just doesn't get treated. 

39 DR. NORTH: This is Carol, can I --
88

1 MS. SIDEL: It's a cognitive issue.

2 DR. NORTH: Can I respond to that? I'm thinking of psychiatric disorders in 

3 terms of exposure to trauma. I think that cognitive disorders in relation to exposure 

4 to toxins is a different set of conditions.

5 MS. SIDEL: Right. I think that's what she's talking about, is as associated to 

6 toxins, not as being exposed to trauma. 

7 DR. NORTH: Right. That would not relate to my point. 

8 MS. SIDEL: -- and you know, she's probably had a neuropsych test. I know a 

9 lot of people that have had neuropsych tests. I know the NYPD does them. And, 

10 you know, the results are that people are damaged. They don't have the same 

11 brains that they went in -- that they went into, you know, they went to the World 

12 Trade Center with.

13 DR. NORTH: Right. I don't conceptualize that as part of the psychiatric 

14 disorders I'm talking about.

15 DR. WARD: Right, so what I'm saying is let's start on -- let's let Carol make a 

16 motion on the ones she's talking about, and maybe Carol can help us phrase one 

17 that Susan's talking about in more -- you know, in the appropriate technical 

18 language. And then we can take a vote on whether the committee feels that that --

19 that it wants to recommend that as a research gap of priority.

20 DR. NORTH: I'll be glad to help with that.

21 DR. WARD: Okay.

22 DR. NORTH: May I move that we vote on, I guess, acceptance of number 9

23 as it is worded? Do I need to repeat it?

24 DR. MIDDENDORF: Okay, it's actually motion number 2, and the wording I 

25 have is: Characterize the disaster-related exposures that are associated with the 

26 development of specific psychiatric disorders.

27 DR. NORTH: That's it. Thank you.

28 DR. WARD: Do I have a second? 

29 MS. MEJIA: Second. This is Guille.

30 DR. WARD: So let's call for a vote.

31 DR. MIDDENDORF: Okay. Tom Aldrich on motion number 2?

32 DR. ALDRICH: Vote yes.

33 DR. MIDDENDORF: John Dement?

34 DR. DEMENT: Yes.

35 DR. MIDDENDORF: Kimberly Flynn?

36 MS. FLYNN: Yes.

37 DR. MIDDENDORF: Bob Harrison? Bob, did you say something? I'll come 

38 back to you, Bob. Catherine Hughes?

39 MS. HUGHES: Yes.
89

1 DR. MIDDENDORF: Steve Markowitz?

2 DR. MARKOWITZ: Yes.

3 DR. MIDDENDORF: Guille Mejia?

4 MS. MEJIA: Yes. 

5 DR. MIDDENDORF: Carol North?

6 DR. NORTH: Yes.

7 DR. MIDDENDORF: Julia Quint?

8 DR. QUINT: Yes.

9 DR. MIDDENDORF: Bill Rom?

10 DR. ROM: Yes.

11 DR. MIDDENDORF: Susan Sidel?

12 MS. SIDEL: Yes.

13 DR. MIDDENDORF: Glenn Talaska?

14 DR. TALASKA: Yes.

15 DR. MIDDENDORF: Leo Trasande?

16 DR. TRASANDE: Yes.

17 DR. MIDDENDORF: And Liz Ward?

18 DR. WARD: Yes.

19 DR. MIDDENDORF: Okay. I'm assuming Virginia's still not with us. There 

20 were 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 -- Bob Harrison, are you still there? I'm not hearing 

21 Bob. We have 13 yeses, zero noes and zero abstentions. Okay.

22 DR. WARD: Okay, so then, I think the next order of business would be to 

23 articulate a motion or a statement that we can vote on regarding research on 

24 cognitive disorders related to toxic exposures in World Trade Center populations.

25 DR. ALDRICH: This is Tom Aldrich. I still think that's part of number 1, and if 

26 a researcher identifies cognitive disorders as an issue to study, they'll study it.

27 DR. WARD: Well, I guess what we need to do is figure out a way to get a 

28 sense -- overall sense of the committee. So we've heard Susan advocating that it is 

29 an important priority on its own. And I think the way -- and we've also heard a

30 number of people saying that, you know, it rightly belongs as a -- you know, 

31 something that could be under item 1. But I guess at this point we need a motion 

32 and a vote, because we have different viewpoints having been expressed on the 

33 committee, so I was thinking if we could have a motion to include it, then we can 

34 take a vote as to whether we want to include it. We can have a discussion and a 

35 vote as to whether we want to include it as a separate research priority.

36 DR. NORTH: This is Carol. I would vote to put it as part of number 1, as part 

37 of the medical conditions, and I would like to make that motion.

38 DR. WARD: And just to clarify, we won't call it out specifically but it will be 

39 understood that it would be one of the conditions that we include under item 1.
90

1 MS. SIDEL: All right. This is Susan. I don't understand how it would be 

2 understood if it's not spelled out. Hello? Can you hear me?

3 DR. ALDRICH: I don't think it has to be spelled out.

4 MS. SIDEL: I'm, I'm confused. I mean are you saying that we need to have 

5 number 1, and then it'll say something about you're going to use the word cognitive

6 disorders as caused by toxins? Or --

7 DR. ALDRICH: Number 1 stands as number 1, and it’s one of many 

8 potentially previously unrecognized health conditions.

9 DR. MIDDENDORF: Allen stated that one of the things that will happen is 

10 that when they go to put together the funding announcements, they will look at the 

11 specific motions and then they'll also look at the transcript to try and get a sense of 

12 what the committee was intending with that.

13 MS. SIDEL: You know, I just give up. I mean...

14 DR. WARD: Okay, well, Carol has made a motion -- essentially it's kind of -- I 

15 guess it's hard to make a motion. I'm not sure the motion is actually vote-able in 

16 the way it was made. So I think maybe it is easier to just say, Susan makes a motion 

17 to include it as a separate priority area, and the, and the assumption we're voting on 

18 is that if it's not -- if that, if that does not get voted by the majority on the 

19 committee, then the sense of the committee is that it is included as one of the 

20 potential diseases to be studied under recommendation 1.

21 MS. SIDEL: So nobody on the committee thinks that something could 

22 happen to your brain from being exposed to toxins, so that the reason people are 

23 having cognitive issues is because of PTSD or because they're depressed?

24 DR. NORTH: This is Carol. No, I think that that's the reason to include it 

25 under number 1, to separate it from the psychiatric disorders --

26 MS. SIDEL: But I don't understand how you're going to include it. I mean, if 

27 you're not going to say it. If you're not going to say -- I mean, I don't understand -- I 

28 guess what I'm saying is like, what do you mean by include it? You're going to say 

29 the words cognitive, you know, issues as --

30 DR. WARD: No. I think that's not -- we're not --

31 MS. SIDEL: I mean, that sounds very vague because that's not inclu -- you 

32 know, not saying anything is not including it. That's like -- nobody reads the notes of 

33 what the committee meant.

34 DR. WARD: But I don't think aside from -- I mean, they're -- what we're 

35 trying to do is capture things that the majority of the people on the committee think 

36 are important, critical research knowledge gaps. And so far the only person who, 

37 who has advanced the viewpoint that that particular topic should be on the list of 

38 critical research knowledge gaps is you.

39 MS. SIDEL: All right, so then let's move on --
91

1 DR. WARD: Is there anyone else who supports that or if not, we probably 

2 should move on.

3 DR. MARKOWITZ: This is Steven Markowitz. Actually I would argue against 

4 any -- naming any particular condition at this point, given what we know. So it's not 

5 just cognition but I would make the same statement for renal diseases or whatever. 

6 They are subsumed under newly emerging conditions. 

7 DR. NORTH: I agree.

8 DR. MARKOWITZ: What we need is a sensitive enough surveillance system 

9 to be able to pick up concerns like Susan's. If, if --

10 MS. SIDEL: You know what, they're not really emerging conditions, though. 

11 They've been here for a long time and it's just been ignored. So there's a lot of 

12 people that have been suffering for a lot of years, and unless they have the money 

13 to go be treated by outside doctors, they're not being treated. Or I know people 

14 that are in the volunteer program as, you know, like that's the committee. I got a 

15 connective tissues disease covered as related to, you know, World Trade Center 

16 exposures, because I had the medical, you know, the medicals support it. And, you 

17 know, workers' comp, when all of them were in New York, they sent me to five 

18 different doc -- you know, rheumatologists. I couldn't find one to say that, you 

19 know, to disagree with my doctor who said that this is a result of my exposure. And 

20 I know a lot of other people that are -- have similar situations to mine. They just 

21 have finances to go on their own to a rheumatologist to be treated. And then when 

22 the -- when the volunteer program ends, in 2016, because they're gonna, you know, 

23 be out of money, then, you know, somebody like me, I'm not gonna have treatment. 

24 And it's not fair because it's, you know, the issue and -- at my very first appointment 

25 in 2002.

26 DR. WARD: You know, the other point for everyone is a lot of the other 

27 bullet points -- or the other recommendations that we haven't gotten to talk about,

28 there was one related to biomarkers; there was one related very broadly to immune 

29 system disorders, which would include autoimmune diseases, which, you know, I 

30 think there's a -- there's more support in the -- there may be more support in the 

31 community that that is a category of diseases that we really do need to call out as a 

32 research priority. There's one on vulnerable populations including those exposed 

33 during gestation, childhood and adolescence. And then there's one on exposure 

34 assessment. 

35 So I mean, from a viewpoint of efficiently doing our jobs, I would suggest 

36 that we table the discussion of cognitive disorders for now and move on to immune 

37 system disorders, and that -- well, we could move on to biomarkers --

38 DR. NORTH: What about the other mental health issues?

39 DR. WARD: Well, we need to take a vote on that, right.
92

1 DR. NORTH: The diagnosis statement that we haven't discussed yet?

2 DR. WARD: That one, I think, we want to -- we want to vote on when we're 

3 down to the second. You pointed out correctly that that's related to the accurate 

4 diagnosis, which is under the second --

5 DR. NORTH: Okay, that's the other thing.

6 DR. WARD: Yeah, no, I've been lost but I think that's where it belongs and 

7 I'm more -- you know, but I think, you know, our immediate order of business 

8 should be to finalize our recommendations in relation to area 1, and then move on 

9 to area 2 and hope that, that we've learned enough through this process that we 

10 can really narrow down the -- the second, third and fourth area more quickly, and 

11 come to consensus.

12 DR. NORTH: Good, I got it. I'm following that, thank you.

13 DR. WARD: It's also an -- you know, we also do have the option easily of 

14 saying, you know, putting in the committee recommendations that there was 

15 debate about whether research on cognitive disorders related to toxins should be 

16 included on the list. And you know, we can include those topics that we discussed 

17 but didn't come to consensus on for the sake of completeness.

18 But I suggest we move on and take a vote on the proposal for the second 

19 recommendation under category 1. If Paul will read it to us one more time. We 

20 have a -- we did have a second on that motion, I think.

21 DR. MIDDENDORF: On which motion? Oh, you mean the differentiate 

22 psychiatric disorders?

23 DR. WARD: No, no. We're -- I don't think we voted on the motion by Carol 

24 that belongs in this section.

25 DR. MIDDENDORF: Characterize the disaster-related exposures?

26 DR. WARD: Right.

27 DR. MIDDENDORF: Yeah, we have a vote, 13-0-0.

28 DR. WARD: We have? Okay, good, we're done with that one, okay. 

29 Moving on, we're tabling cognitive discussion for now, and we're moving on to 

30 biomarkers.

31 MS. FLYNN: Liz?

32 DR. WARD: Yes.

33 MS. FLYNN: This is Kimberly. I don't know if this helps or not but would it 

34 be possible, before we move on to biomarkers, for perhaps Dr. Markowitz to frame 

35 a proposal around symptom surveillance?

36 DR. MARKOWITZ: This is Steve Markowitz. No, let's do biomarkers. We'll 

37 get to surveillance.

38 MS. FLYNN: Okay. So we gotta come back to symptom surveillance 

39 because that is at the bottom of many a complaint from survivors and responders.
93

1 MS. SIDEL: It was supposed to be strengthened, I thought, like three years 

2 ago.

3 DR. WARD: Okay, so on biomarkers, has anyone had time to try to frame --

4 DR. ALDRICH: -- suggested wording for biomarkers -- this is Tom Aldrich.

5 DR. WARD: Okay. Go ahead.

6 DR. ALDRICH: This is possibly only a part of it because it doesn't include the 

7 issue about long-lived biomarkers as a measure of exposure, which, I think, maybe 

8 ought to be a separate thing because it's not -- it's more about exposure than about 

9 biomarkers so this is excluding that.

10 What I suggest is: Determine the value of biomarkers for early detection of 

11 precancerous conditions, comma --

12 DR. MIDDENDORF: Wait a minute. Early detection --

13 DR. ALDRICH: -- of precancerous conditions, comma, early cancers, comma, 

14 or other World Trade Center -- or other WTC-associated diseases.

15 DR. MIDDENDORF: You said associated, not related, okay.

16 DR. ALDRICH: Either one, it doesn't matter.

17 DR. MIDDENDORF: Well, these are your words.

18 DR. ALDRICH: Yeah, that's it.

19 DR. WARD: Okay, do we have a second on that motion?

20 MS. SIDEL: I'll second. 

21 DR. TALASKA: Second.

22 DR. WARD: Any discussion?

23 MS. SIDEL: No.

24 DR. WARD: Okay. I guess we'll move to a vote?

25 THE COURT REPORTER: I'm sorry, could I get who seconded, please?

26 DR. WARD: Who seconded it?

27 DR. TALASKA: Glenn Talaska.

28 THE COURT REPORTER: Thank you.

29 MS. SIDEL: Oh, I -- whatever.

30 DR. MIDDENDORF: And Susan. Both of them seconded it, so.

31 THE COURT REPORTER: Okay, thank you.

32 DR. MIDDENDORF: So, are we ready for a vote? Okay, the wording on the 

33 motion is: Determine the value of biomarkers for early detection of precancerous 

34 conditions, early cancers, or other WTC-associated diseases. Is everybody ready for 

35 the vote?

36 DR. WARD: Yes.

37 DR. MIDDENDORF: Tom Aldrich? Tom, did you say something?

38 DR. ALDRICH: Oh, I vote yes.

39 DR. MIDDENDORF: Okay. John Dement?
94

1 DR. DEMENT: Yes.

2 DR. MIDDENDORF: Kimberly Flynn?

3 MS. FLYNN: Yes.

4 DR. MIDDENDORF: Bob Harrison? Okay, Catherine Hughes?

5 MS. HUGHES: Yes.

6 DR. MIDDENDORF: Steve Markowitz?

7 DR. MARKOWITZ: Yes.

8 DR. MIDDENDORF: Guille Mejia?

9 MS. MEJIA: Yes.

10 DR. MIDDENDORF: Carol North?

11 DR. NORTH: Yes.

12 DR. MIDDENDORF: Julia Quint?

13 DR. QUINT: Yes.

14 DR. MIDDENDORF: Bill Rom?

15 DR. ROM: Yes.

16 DR. MIDDENDORF: Susan Sidel?

17 MS. SIDEL: Yes. 

18 DR. MIDDENDORF: Glenn Talaska?

19 DR. TALASKA: Yes.

20 DR. MIDDENDORF: Leo Trasande?

21 DR. TRASANDE: Yes.

22 DR. MIDDENDORF: Liz Ward?

23 DR. WARD: Yes.

24 DR. MIDDENDORF: Okay, 1, 2, 3, 4, 5, 6, 7, 8, 9... 13 yes, zero no, zero 

25 abstain.

26 DR. WARD: Okay, so the next one on the list is immune system disorders 

27 that cover sarcoidosis, malignancy, autoimmune diseases as a broad category. Has 

28 anyone come up with better wording for that?

29 DR. ALDRICH: Let me ask, does the long-lived biomarkers, which I really like 

30 that concept, but that's going to be a part of number 7, right, or the last one on the 

31 list, the exposure assessment?

32 DR. WARD: I think that's what was proposed. 

33 DR. ALDRICH: Good.

34 DR. WARD: So I mean, there is the question of whether we want to 

35 highlight any specific disease category in these recommendations. We did highlight 

36 mental health conditions. So I had a feeling that there was support from a number 

37 of people on the immune system disorders; is that correct?

38 DR. ALDRICH: I personally think, to be consistent, we should say this is all 

39 part of 1, and not talk about it separately.
95

1 DR. WARD: Okay, so is there anyone who disagrees with that perspective?

2 MS. SIDEL: I don't -- I don't understand what you mean by that. What do --

3 what do you mean that it's all part of 1?

4 DR. ALDRICH: This would be one of those newly emerging health conditions 

5 that refer to in motion 1.

6 MS. SIDEL: But you're not going to say what it is?

7 DR. ALDRICH: No, because I think it's up to the researchers to focus on 

8 what they think are important, and convince us or convince the --

9 MS. SIDEL: Okay.

10 DR. ALDRICH: -- the review committee, whoever's going to be reviewing 

11 the applications, that they made a good case for it. And if it -- if someone makes a 

12 really, really good case that hang nails are associated with the World Trade Center, 

13 they should be funded. It's a matter of who can make a good case for something, 

14 not some preconceived idea about what's important.

15 MS. SIDEL: Well, there were preconceived ideas about what was important 

16 from the very beginning of the program, when they decided what they were gonna 

17 cover and what they weren't gonna cover. And just because something like 

18 autoimmune diseases wasn't on that list it wasn't because they didn't exist or 

19 because people didn't have them, it was because it wasn't something that was being 

20 checked and it wasn't being recorded.

21 DR. ALDRICH: But I just -- it was --

22 MS. SIDEL: And so it -- okay, but (indiscernible) --

23 DR. ALDRICH: -- (indiscernible) emerging -- newly emerging diseases.

24 MS. SIDEL: But it's not newly emerging; it's been there, and all I'm saying is 

25 that, with 13 years out and nobody has come close to dealing with this. The first 

26 time that it was -- that anything was ever like remotely close was the discussion of

27 inflammation in the Dr. Prezant’s article. And that was like, you know, when you 

28 discuss inflammation, you know, the underlying, underlying -- all of the 

29 (indiscernible) things that we had and, you know, that are associated with cancer, 

30 and it's, you know, it's a big part of autoimmune diseases. So --

31 DR. ALDRICH: Yeah, I think that, that work is being done. It's being done 

32 with the, the autoimmune surveillance program at the FDNY that's funded by NIOSH 

33 last year, and it is a late-emerging disease. It wasn't one of the early emerging 

34 things. Yes, there were some people who had polymyositis as a related condition --

35 MS. SIDEL: It was late because it wasn't recognized.

36 DR. ALDRICH: But a few cases out of many thousands is not something you 

37 can study. Now there are many cases and now they can be studied but it's not -- it's 

38 not a neglect that led them not to be studied. It's that they were -- they had not 

39 emerged in enough volume to be studied back then. 
96

1 And now they are being studied. And I don't think that we should -- you 

2 know, that's why I -- I kind of feel like cognitive issues are more -- are less 

3 recognized than autoimmune. Maybe that's because they're not related to World 

4 Trade Center but they're not -- autoimmune diseases are being recognized. They're 

5 not recognized to the point that they can be included in the Health Program. But 

6 the whole point of this research is to find out if they -- if they should or should not 

7 be included. And that's -- and research is being done. The research will be 

8 encouraged by item 1, research into cognitive issues, research into autoimmune 

9 diseases, research into all kinds of new areas, so --

10 MS. SIDEL: But the thing is that we haven't had any new areas for a long 

11 time, a long, long time.

12 DR. WARD: Let me just cut in, so we're -- we're just having a debate 

13 between two people in this and I guess I'd like to hear what other people think. At 

14 this point --

15 DR. MARKOWITZ: This is Steve Markowitz --

16 DR. WARD: Yeah.

17 DR. MARKOWITZ: So, I think it's sort of a Catch-22, right? Some of these 

18 aren't looked at until it provides a strong enough signal but it doesn't provide a 

19 signal until it's looked at. So I think what we -- I think between the, the first priority 

20 we discussed, which was newly emerging and previously unrecognized. And then I 

21 think when we get to something, a proposal on a more sensitive surveillance 

22 system, so that it's more likely that problems will be picked up, like Susan's 

23 discussing. Between those, I think, then, it'll cover this issue.

24 DR. ALDRICH: But won’t there be a preamble to the list of priorities?

25 DR. WARD: Here's the thing, any text that we want to convey has to be 

26 discussed and approved during this meeting. So if we want to talk about a 

27 preamble, we have to come up with draft text for the preamble.

28 Now, I apologize 'cause I feel like we're not -- I mean, I don't think we, for 

29 various reasons including technical circumstances, I don't feel like we're in the 

30 most -- I think this meeting isn’t the most conducive way to come up with the best 

31 set of recommendations, but within the technology constraints that we have, pretty 

32 much we have to agree on final text in the course of this meeting. So if anybody 

33 wants to propose a preamble, they should probably think about how they would 

34 want to word it while we're talking so that we can consider it as a committee and 

35 vote on it.

36 MS. SIDEL: I just feel like it's redundant. We just, we just -- we're asking 

37 people to do what they're supposed to do. They're supposed to research new and 

38 emergent -- emerging things. It doesn't have to be said, but it's not being done.

39 DR. ALDRICH: Yes, but we cannot --
97

1 MS. SIDEL: And it could be done.

2 DR. ALDRICH: We cannot point out things for study for which there is no 

3 evidence.

4 DR. MARKOWITZ: You know, I think actually we just have a -- this is Steve 

5 Markowitz -- we have a disagreement here. And I don't think we're gonna actually 

6 breach this. I don't think we're gonna solve this disagreement. So -- because the 

7 same points of view -- and I don't mean any disrespect here -- but are being 

8 repeatedly expressed. So I think either we formulate a specific proposal that can be, 

9 you know, we accept it or reject it or we move on.

10 DR. WARD: This is Liz; I agree.

11 MS. SIDEL: Well, is this a court for suggesting that more research needs to 

12 be done in the area of autoimmune diseases related to the World Trade Center?

13 DR. NORTH: I don't think we ought to single it out. This is Carol.

14 DR. DEMENT: This is John Dement. I think it's under item 1 in surveillance,

15 as Steve has talked about as well.

16 MS. MEJIA: This is Guille. I also agree that it's covered under item 1.

17 DR. TALASKA: Glenn Talaska, the same.

18 DR. WARD: Okay, so, so unless, you know, unless Susan, you want to make 

19 a specific, you know, motion, and then we have a -- see if we have a second, and

20 take a vote, I think we can table the issue 'cause it -- at least to me it doesn't seem 

21 like there's a great deal of support for calling this out as a priority research area.

22 MS. SIDEL: I don't think it's worth it for me to come up with a motion 

23 because it's not gonna get passed, so...

24 DR. WARD: Okay, thank you. So the next general area we have on the list is 

25 health effects of exposure to vulnerable populations with specific emphasis on 

26 children exposed during gestation, people exposed during childhood and 

27 adolescence. Does someone want to make a motion for the wording on that?

28 DR. ALDRICH: I think the wording -- the most recent wording is really, really 

29 good: Assess health effects of exposure on gestation and early life, paren, 

30 childhood and adolescence, end paren. I think that's perfect.

31 MS. FLYNN: And -- this is Kimberly. Would we include the biomarkers of 

32 exposure point here?

33 DR. ALDRICH: My view is that belongs after the next one. 

34 MS. FLYNN: Okay.

35 DR. ALDRICH: The next one.

36 MS. FLYNN: Okay.

37 DR. WARD: I think that was the viewpoint I heard earlier from most people, 

38 that -- or from several people, that we should include it under the exposure 

39 assessment. So do we have a second on the motion for the item number 6?
98

1 DR. NORTH: I’ll second it. This is Carol.

2 DR. WARD: Okay. Paul, should we go to a vote?

3 DR. MIDDENDORF: Yeah, this is motion number 4. It is: Assess health 

4 effects of exposure on gestation and early life, in parentheses, childhood and 

5 adolescence. 

6 I'll give people a second to think about that. And then I'll get to Tom 

7 Aldrich?

8 DR. ALDRICH: Is it WTC exposure or just exposure?

9 DR. MIDDENDORF: The wording only says exposure at this point.

10 MS. FLYNN: I accept the friendly amendment of World Trade Center 

11 exposure 'cause this is what this is all about.

12 DR. WARD: Yes.

13 DR. ALDRICH: With that amendment, I vote yes.

14 DR. MIDDENDORF: Was that amendment seconded?

15 DR. NORTH: I'll second, Carol.

16 DR. MIDDENDORF: Okay. So Tom Aldrich?

17 DR. ALDRICH: Yes.

18 DR. MIDDENDORF: John Dement?

19 DR. DEMENT: Yes.

20 DR. MIDDENDORF: Kimberly Flynn?

21 MS. FLYNN: Yes.

22 DR. MIDDENDORF: Bob Harrison? Catherine Hughes?

23 MS. HUGHES: Yes.

24 DR. MIDDENDORF: Steve Markowitz?

25 DR. MARKOWITZ: Yes.

26 DR. MIDDENDORF: Guille Mejia?

27 MS. MEJIA: Yes.

28 DR. MIDDENDORF: Carol North?

29 DR. NORTH: Yes.

30 DR. MIDDENDORF: Julia Quint?

31 DR. QUINT: Yes.

32 DR. MIDDENDORF: Bill Rom?

33 DR. ROM: Yes.

34 DR. MIDDENDORF: Susan Sidel?

35 MS. SIDEL: I'm sorry, yes.

36 DR. MIDDENDORF: Glenn Talaska? Leo Trasande? Liz Ward?

37 DR. WARD: Yes.

38 DR. MIDDENDORF: Okay. I'm gonna go back and check to see whether or 

39 not -- Bob Harrison, are you there? I'm hoping this isn't a problem with just not 
99

1 being able to speak. Glenn Talaska?

2 DR. TALASKA: I voted yes.

3 DR. MIDDENDORF: Leo Trasande? Okay, I didn't hear anything from Leo or 

4 Bob.

5 DR. TALASKA: You got mine, though, right?

6 DR. MIDDENDORF: That was Glenn?

7 DR. TALASKA: Yes.

8 DR. MIDDENDORF: Yes, I got your yes.

9 DR. WARD: So Paul, maybe you should ask if Leo or Bob are having trouble 

10 speaking, they should email you or something?

11 DR. MIDDENDORF: Yeah, they -- usually they do.

12 DR. WARD: Okay.

13 DR. MIDDENDORF: So that's one of the things I've been monitoring.

14 DR. WARD: Okay, so we have the last bullet or the last item on the list is 

15 related to exposure assessment. And I'm hoping that someone has some draft 

16 language.

17 DR. ALDRICH: I have a suggestion for that. Unfortunately I don't think it's 

18 quite complete because it doesn't address the special issues or separate psychiatric 

19 exposures and it doesn't address the long-term, long-lasting biomarker issue, and I 

20 think those should be addressed. But aside from that, if we say: improved WTC 

21 exposure quantification: inhaled, topical, ingested, psychological or other.

22 DR. MIDDENDORF: Okay, I'm gonna ask you to repeat all that.

23 DR. ALDRICH: Improved WTC exposure quantification, colon, inhaled,

24 topical, ingested, psychological or other.

25 DR. MIDDENDORF: Okay.

26 DR. NORTH: Could I make a suggestion -- this is Carol. We've got the 

27 mental health stuff separately. Could we take it out of this? Because psychological 

28 exposure is an odd conflict.

29 DR. ALDRICH: Yeah, let's take it out and let's do a motion -- motion 6 that 

30 says something about the separate quantification of physical and nonphysical 

31 exposures.

32 MS. FLYNN: This is Kimberly. Can I just -- can I please ask what's entailed by 

33 quantification in this instance?

34 DR. ALDRICH: My view is that it's been extremely murky to understand how

35 to quantify an individual's exposure, and that the only -- the only techniques have 

36 been extremely crude, and if some smart people can come up with better ways of 

37 doing it, that would be very valuable. This may be an impossible goal.

38 DR. WARD: Yeah, this is Liz. I would suggest maybe we should substitute 

39 estimation.
100

1 DR. DEMENT: I would say assessment. This is John Dement.

2 DR. WARD: Yeah, yeah.

3 DR. ALDRICH: Assessment or metrics.

4 DR. DEMENT: Yeah, or metrics, whatever. That's true because 

5 quantification has a connotation that you can actually put a numeric value to it and 

6 in a lot of cases you really can't.

7 DR. TALASKA: That's right. And I think metrics or --

8 DR. DEMENT: Yeah.

9 DR. TALASKA: -- assessment would be better.

10 DR. ALDRICH: Well, you know what? I'm thinking that since those last four 

11 words, and we're gonna get rid of psychological on that, the last three words refer 

12 to the word just before it. Somehow the word exposure should be just before it. So 

13 it should be improved assessment of WTC exposure, colon.

14 DR. MIDDENDORF: I'm sorry, say that again?

15 DR. ALDRICH: Improved assessment of WTC exposure, colon. Or estimate, 

16 if you prefer, and then get rid of psychological.

17 DR. WARD: Yeah, and I'm not sure that we really need to specify the long18 live biomarkers 'cause again, that's something that -- I mean, the investigators could 

19 propose to do to satisfy this knowledge gap.

20 DR. DEMENT: Great point. It's a very cool idea though.

21 DR. NORTH: Question. Exposure to what is implied here?

22 DR. MARKOWITZ: Just about any agent. Just about any agent is what's 

23 implied.

24 DR. DEMENT: Yeah.

25 DR. WARD: So the three words -- just to repeat, the three words you have 

26 after the colon are?

27 DR. ALDRICH: Inhaled, topical, ingested or other.

28 DR. WARD: Okay.

29 DR. ALDRICH: I don't think there was any intravenous.

30 UNIDENTIFIED SPEAKER: There may have been some IM though.

31 DR. WARD: Okay, so do we have a second for that motion?

32 DR. TALASKA: I'll second it.

33 THE COURT REPORTER: Who seconded?

34 DR. MIDDENDORF: The question on the table is assessment of WTC 

35 exposure, colon, inhaled, topical, ingested or other.

36 MS. SIDEL: Is this written down someplace?

37 DR. MIDDENDORF: Sorry?

38 MS. SIDEL: Is this -- did we -- is this written down?

39 DR. MIDDENDORF: Yeah, you need me to send it?
101

1 MS. SIDEL: Yeah. I'm confused; I can't figure out which one it is.

2 DR. MIDDENDORF: Okay.

3 THE COURT REPORTER: I'm sorry, who seconded the motion, please?

4 DR. TALASKA: Glenn Talaska.

5 THE COURT REPORTER: Thank you.

6 DR. WARD: Okay, so Paul is sending out the, the task, and then once 

7 everyone has it, we can go ahead and have a vote.

8 DR. MIDDENDORF: And while we're waiting I will just point out that we 

9 have about an hour and 15 minutes, maybe an hour and 20 minutes, left.

10 DR. ALDRICH: While we're waiting, could somebody try to figure out how to 

11 phrase that next point, about the difference between exposure to physical agents 

12 and exposure to images or whatever it is that causes PTSD in people who weren't 

13 actually on the scene?

14 DR. WARD: I thought that was already covered in bullet 2, and we don't 

15 need to point it out.

16 UNIDENTIFIED SPEAKER: Yes.

17 DR. ALDRICH: Okay, cool. So no motion 6.

18 DR. WARD: Right. So that would enable us to move on to the second area 

19 that Dr. Howard asked us to comment on.

20 DR. MARKOWITZ: Liz? It's Steve Markowitz; I'm sorry to interrupt you but I 

21 do have a surveillance proposal.

22 DR. WARD: Oh, I'm sorry, Steve.

23 DR. MARKOWITZ: It wasn't on Paul's previous list.

24 DR. WARD: I know; that's why I forgot but it's still -- no, I still knew it, so 

25 yes, please.

26 DR. MARKOWITZ: But Paul, I sent it to you.

27 DR. MIDDENDORF: Okay, I just copied it in.

28 DR. MARKOWITZ: Okay.

29 DR. MIDDENDORF: If you want to read it off.

30 DR. MARKOWITZ: This is, you know, I welcome changes to the language 

31 here. Evaluate and improve the utility and use of current WTC data and activities 

32 for the purpose of access surveillance of health conditions in WTC exposed 

33 population.

34 DR. ALDRICH: That assumes it's all current data and not new data?

35 DR. MARKOWITZ: Well, no, we can, we can take out the word current. It's 

36 current -- yeah, current would be -- I mean, data that already exists, not future data. 

37 But since the question was raised, let's just take out that -- so it would, it would say:

38 Evaluate and improve the utility and use of WTC data and activities for the purpose 

39 of access surveillance of health conditions in WTC exposed populations.
102

1 DR. MIDDENDORF: Okay, before we move any further on that one, let me 

2 ask if everybody has received the previous email? The improved assessment of WTC 

3 exposure, colon, inhaled, topical, ingested or other.

4 DR. WARD: Yes. 

5 MS. SIDEL: And that's it? That's the whole thing?

6 DR. MIDDENDORF: That's it. That's everything.

7 MS. SIDEL: And what about -- I'm sorry, what's the point?

8 DR. MARKOWITZ: I'm sorry, is the question about the -- is the question 

9 here -- this is Steve Markowitz -- about the surveillance proposal?

10 DR. MIDDENDORF: We are back on the improved assessment of WTC 

11 exposure.

12 DR. MARKOWITZ: Okay, was that voted on already?

13 MS. SIDEL: No.

14 DR. MIDDENDORF: No.

15 DR. MARKOWITZ: Oh, okay. I apologize. I apologize.

16 MS. SIDEL: Sorry.

17 DR. MARKOWITZ: Go ahead.

18 MS. SIDEL: I'm sorry, Steve, I couldn't hear you.

19 DR. MARKOWITZ: No, no, no. We're back on the exposure, fine. So just 

20 strike the surveillance; we'll get to that. 

21 DR. MIDDENDORF: Susan, you had a question about improved assessment?

22 MS. SIDEL: Yeah. Like what is that information going to do?

23 DR. DEMENT: This is John -- this is John --

24 MS. SIDEL: I mean, if you have that information, like what, what will that 

25 help do?

26 DR. WARD: John, I think you were trying to speak.

27 DR. DEMENT: Yeah, I, I think the idea here is that some innovative 

28 integration that some of these exposure assessment tools could give us a better -- a

29 linkage perhaps even with the surveillance data to generate hypotheses. 

30 Exposure -- a better exposure assessment could definitely improve our ability to 

31 make causal links in this ideological research area so that was, I think, the core idea 

32 behind it.

33 MS. SIDEL: Okay, thanks.

34 DR. TALASKA: This is Glenn Talaska. I like that a lot because it's vague

35 enough to include all the things we mentioned earlier. And it allows researchers to 

36 be innovative in addressing the weaknesses of the past exposure assessment that 

37 was previously done at 9/11.

38 DR. WARD: Okay, so are we ready to take a vote?

39 DR. MIDDENDORF: Did we have a -- I think this is the motion. We need a 
103

1 second on it.

2 DR. TALASKA: It's already been seconded. I did it last time.

3 DR. MIDDENDORF: Okay, sorry. So yes, we're ready for a vote. And the 

4 vote is on the improved assessment of WTC exposure, colon, inhaled, topical, 

5 ingested or other. Bob Aldrich?

6 DR. ALDRICH: Yes.

7 DR. MIDDENDORF: John Dement?

8 DR. DEMENT: Yes.

9 DR. MIDDENDORF: Kimberly Flynn?

10 MS. FLYNN: Yes.

11 DR. MIDDENDORF: Bob Harrison? Catherine Hughes?

12 MS. HUGHES: Yes.

13 DR. MIDDENDORF: Steve Markowitz?

14 DR. MARKOWITZ: Yes.

15 DR. MIDDENDORF: Guille Mejia?

16 MS. MEJIA: Yes.

17 DR. MIDDENDORF: Carol North?

18 DR. NORTH: Yes.

19 DR. MIDDENDORF: Julia Quint?

20 DR. QUINT: Yes.

21 DR. MIDDENDORF: Bill Rom?

22 DR. ROM: Yes.

23 DR. MIDDENDORF: Susan Sidel?

24 MS. SIDEL: Yes.

25 DR. MIDDENDORF: Glenn Talaska?

26 DR. TALASKA: Yes.

27 DR. MIDDENDORF: Leo Trasande? Liz Ward?

28 DR. WARD: Yes.

29 DR. MIDDENDORF: Twelve yes, zero no, zero abstentions. Motion passes.

30 DR. WARD: Steve, I have a question on the proposed language -- this is Liz. 

31 When you say WTC data, are you really referring to WTC Health Program and 

32 registry data or -- it just seems a little bit broad, and I wondered if you wanted to be 

33 more specific or not?

34 DR. MARKOWITZ: I'm sorry, it would refer to both the health registry and 

35 the health program data.

36 DR. WARD: Well, I just have this one -- I mean, is it confined to that data or 

37 is it any data or is it new research data or -- I mean, I guess I was thinking it needed 

38 a little clarification. World Trade Center data is -- doesn't mean anything if you 

39 don't define it further.
104

1 DR. MARKOWITZ: Okay. Yeah, so this -- so what I'm really after here would 

2 be more apparent with the World Trade Center Health Program and the clinics is the 

3 like, is that -- because the health -- the World Trade Center health registry at the 

4 health department actually -- surveillance is what it's doing already. But the clinical 

5 data or the data collected in the clinical program is underutilized for the purposes of 

6 surveillance. This was what, I think, Dr. Melius was striving at. And so the purpose 

7 here is to draw attention to it and to find ways of improving its use.

8 DR. WARD: So then the friendly amendment would be, well, WTCHP data?

9 DR. MARKOWITZ: Right, okay. That's fine.

10 MS. SIDEL: But are you confident in the way that it's collected?

11 DR. MARKOWITZ: I'm sorry, I couldn't hear that.

12 MS. SIDEL: Are you confident in the methodology that's being used to 

13 collect it, that it's accurate?

14 DR. MARKOWITZ: No, you know, I'm agnostic on that, actually, but I think 

15 that would be one of the things to look at is the quality of the data, how accurate it 

16 is.

17 DR. ALDRICH: Why limit the investigator to Health Program data? Why 

18 shouldn't the investigator be free to use data of good quality from any source?

19 MS. SIDEL: I'm just saying that this is your opportunity, maybe, to improve 

20 the methodology for collecting it. You know, like the things I was talking about in 

21 monitoring where you're talking to a nurse who's sitting there putting -- you know, 

22 inputting the information into a computer. And then a year later, when you go 

23 back, you have to think about that information because it wasn't put in correctly. In 

24 other words, if you did it yourself, it would be correct. So if --

25 DR. ALDRICH: But that seems like that would be handled by this -- but what 

26 wouldn't be handled by this would be if some researcher had some innovative way 

27 to get to link the World Trade Center registry data with the Health Program data,

28 and come up with something new by doing that, that would be concluded if we limit 

29 this to just Health Program data. 

30 DR. WARD: I have an idea. Could we leave the text as it is but then add: 

31 and/or develop additional surveillance methods or surveillance resources?

32 DR. ALDRICH: I like it.

33 DR. WARD: Like that? That could be an and, or an or, and/or develop.

34 DR. MIDDENDORF: Where would that go?

35 DR. WARD: It would just go at the end of this sentence.

36 DR. MIDDENDORF: And/or develop --

37 DR. WARD: Additional surveillance resources or data sources. That would 

38 include linking or other -- other data sets.

39 DR. MIDDENDORF: So what is your wording again?
105

1 DR. WARD: I think that's good, and/or develop --

2 DR. MIDDENDORF: Surveillance data sources --

3 DR. WARD: Additional --

4 DR. MIDDENDORF: Additional?

5 MS. MEJIA: Or how about improved surveillance?

6 DR. WARD: Improved surveillance data methods or sources? I think just 

7 improved surveillance methods would be fine.

8 DR. MIDDENDORF: So the wording that we're looking at at the moment is: 

9 Evaluate and improve the utility and use of World Trade Center Health Program

10 data and activities for the purpose of active surveillance and health conditions in 

11 WTC-exposed populations and/or develop improved surveillance methods.

12 DR. WARD: Is there somebody who wants to make a motion that that 

13 language be adopted?

14 DR. MARKOWITZ: Steve Markowitz. I would propose that.

15 DR. ALDRICH: I'll second that. Tom Aldrich.

16 DR. WARD: So I think we can go ahead and move to a vote.

17 DR. MIDDENDORF: Do people feel like they need to see the wording on this 

18 before they can vote?

19 MS. FLYNN: Do you think -- can you make sure that by the end of this 

20 meeting, we get a copy of all the wording that was approved?

21 DR. MIDDENDORF: Yes, I can.

22 MS. FLYNN: That would be really helpful. Thanks a lot, Paul.

23 DR. MIDDENDORF: I just sent this out, so you should be able to see it in a 

24 minute or so, hopefully a little less.

25 MS. FLYNN: I just got surveillance, thanks.

26 DR. MIDDENDORF: Okay.

27 MS. FLYNN: But like a cumulative list of all the things we've voted on. 

28 Great.

29 DR. MIDDENDORF: Yeah, it's actually -- I've got that cumulative list here in 

30 a document that I'm gonna be sharing on the web. Unfortunately, you're not able 

31 to see it. But yes, I will send this document out. 

32 Okay, I guess we're proceeding to a vote. Tom Aldrich?

33 DR. ALDRICH: Yes.

34 DR. MIDDENDORF: John Dement?

35 DR. DEMENT: Yes.

36 DR. MIDDENDORF: Kimberly Flynn?

37 MS. FLYNN: Yes.

38 DR. MIDDENDORF: Bob Harrison? Catherine Hughes?

39 MS. HUGHES: Yes.
106

1 DR. MIDDENDORF: Steve Markowitz?

2 DR. MARKOWITZ: Yes.

3 DR. MIDDENDORF: Guille Mejia?

4 MS. MEJIA: Yes.

5 DR. MIDDENDORF: Carol North?

6 DR. NORTH: Yes.

7 DR. MIDDENDORF: Julia Quint?

8 DR. QUINT: Yes.

9 DR. MIDDENDORF: Bill Rom?

10 DR. ROM: Yes.

11 DR. MIDDENDORF: Susan Sidel?

12 MS. SIDEL: Yes. 

13 DR. MIDDENDORF: Susan, if you're responding, it's not coming through.

14 MS. SIDEL: Oh, yes.

15 DR. MIDDENDORF: Glenn Talaska?

16 DR. TALASKA: Yes.

17 DR. MIDDENDORF: Leo Trasande? Leo, if you responded, I didn't hear you. 

18 I'm still not hearing anything from Leo. Liz Ward?

19 DR. WARD: Yes.

20 DR. MIDDENDORF: Okay. That's 12 yes, zero noes, and zero abstentions. 

21 Motion passes.

22 DR. WARD: Okay, so I think we're ready to move on to the critical research 

23 knowledge gap relative to the accurate diagnosis of WTC-related health conditions. 

24 And what I'd like to do, as much as possible, is for people to, you know, really try to 

25 propose topics that they think really are of significant and broad importance, and to 

26 try to propose them in words kind of along the same lines as the ones we've voted 

27 on. So if you can propose the final lang -- something close to the final language that 

28 we can move forward.

29 So I think the first one that we should consider is the one that was already 

30 proposed by Carol North related to the psychiatric diagnoses. And Paul, I think you 

31 have that while you were putting it in the --

32 DR. MIDDENDORF: Yes. The wording is: Differentiate psychiatric disorders 

33 from symptoms and distress in relation to disaster exposure and develop efficient 

34 and effective methods for diagnosis of disaster-related psychopathology in 

35 populations and individuals. 

36 And I am going to send that out 'cause it's long and complicated.

37 DR. WARD: Okay, do we have a second? I assume that we can assume -- I 

38 assume that Carol has put that forward as a motion, and is there a second?

39 DR. MIDDENDORF: Okay, I've just -- I've sent it out.
107

1 DR. WARD: Okay, people need a minute to look at it and then we'll ask for 

2 a second.

3 MS. SIDEL: My message has no content. Paul?

4 DR. MIDDENDORF: Yeah, let me look.

5 MS. SIDEL: Weird.

6 DR. MIDDENDORF: The one I sent has content. Let me resend.

7 DR. ALDRICH: I just got it.

8 MS. SIDEL: Yeah, I got it. I have it, thank you.

9 DR. MIDDENDORF: Okay.

10 DR. WARD: Okay, and so do we have a second for that motion?

11 DR. HARRISON: This is Bob Harrison, second.

12 DR. WARD: Okay. Is there any further discussion on the motion?

13 DR. MARKOWITZ: This is Steve Markowitz. Carol, could you just succinctly 

14 describe again the importance of this differentiating disorders from symptoms of 

15 distress?

16 DR. NORTH: I'm glad you asked that because I wasn't sure that everything 

17 that I intend for this is getting across. And basically we know a lot about symptoms 

18 but we don't know enough about psychiatric disorders. Most of the studies have 

19 looked at symptoms and it's not clear what symptoms mean. They’ve used 

20 symptoms screeners rather than assess psychiatric disorders. And I think that it's in 

21 parallel to study of cancer. We don't study cancer symptoms; we study cancer. And 

22 I don't think we want to give psychiatric illness the short, short shrift. That's what I 

23 meant.

24 DR. MARKOWITZ: So, I wonder whether you're discussing evaluating the 

25 clinical significance of symptoms and distress.

26 DR. NORTH: Well, that could be a side sheet. But right now we don't have 

27 enough data about properly measured psychiatric disorders. Most of our data is 

28 about symptoms that we don't know what they really mean and we don't have the 

29 data on disorders to, to know what symptoms outside of that context means.

30 DR. MARKOWITZ: How about evaluating the -- rather than symptoms and 

31 distress in relation to psychiatric disorders, to differentiate that -- I mean, I don't 

32 want to take much time here -- but --

33 DR. NORTH: No, I understand what you're saying. We have way too many 

34 symptoms outside of diagnosis, and I think in the end what we're gonna care about 

35 is diagnosis.

36 DR. MARKOWITZ: Right.

37 DR. NORTH: We know that people are distressed; that's a given. But what 

38 we want to do is identify people with disorders that need treatment, and then give 

39 general interventions to the distressed populations.
108

1 DR. MARKOWITZ: So you want to understand the relationship between 

2 symptoms and distress on the one hand, and the development of psychiatric 

3 disorders?

4 DR. NORTH: Well, we, we want to differentiate them because right now the 

5 literature doesn't.

6 DR. MARKOWITZ: Okay.

7 DR. NORTH: And that's a mistake.

8 DR. MARKOWITZ: Okay, I understand.

9 MS. SIDEL: I don't understand. Could you, could you explain that part again 

10 to me?

11 DR. NORTH: Okay, most of the literature we have is about symptoms of

12 PTSD.

13 MS. SIDEL: Right.

14 DR. NORTH: Symptoms of this and that.

15 MS. SIDEL: Right, right, right.

16 DR. NORTH: And it's just hard to know what that means or what to do with 

17 it. You don't have enough research that it's taking the effort to accurately diagnose 

18 and identify disorders for specific treatment.

19 MS. SIDEL: But how -- but I don't, I don't see where the -- how does it get to 

20 a disorder? I mean, is that --

21 DR. NORTH: Well, we have carefully defined criteria.

22 MS. SIDEL: Oh.

23 DR. NORTH: We just haven't used them.

24 MS. SIDEL: So they're not like calling it by a name.

25 DR. NORTH: Well, sometimes they mistakenly call it by name. They 

26 measure symptoms and they call it PTSD or depression when really it's not. 

27 MS. SIDEL: But what else would it be?

28 DR. NORTH: What's that?

29 MS. SIDEL: What would be symptoms -- like what would be -- what would 

30 be -- what would be a correct diagnosis?

31 DR. NORTH: Well, PTSD or major depression. Those are the common ones 

32 that develop after disasters.

33 MS. SIDEL: Right, and why wouldn't they be that?

34 DR. NORTH: They don't. It's labor intensive; they haven't developed the

35 efficient methods to do that, and so we often settle for symptoms of thus and such, 

36 and I think that's about as satisfying as measuring symptoms of cancer. I'd like to 

37 study cancer, not symptoms of cancer. These are difficult concepts but they're very 

38 important.

39 MS. SIDEL: No, I, I understand the concepts, but I just don't see why they 
109

1 don't think that they're already doing that because I think they -- I think that they 

2 think that they're doing that.

3 DR. NORTH: It could be. I'd like to see things be done differently so that we 

4 can advance knowledge.

5 DR. WARD: Does anyone else have any thoughts on this point or any 

6 questions about it? I'll tell you my point of view is that I don't feel that I fully grasp 

7 it but I think it's probably an important question, and it might result in some 

8 proposals that would be really able to address it, and it may not. I mean, it, you 

9 know, really is going to require people who both understand the nature -- and who 

10 understand the nature and importance of the question and can think of ways to 

11 address it. 

12 But, you know, I don't -- I think we -- very few of us have expertise in 

13 psychiatric disorders, and I -- so I tend to want to defer to Dr. North's expertise on 

14 this. And again, I don't think it's really going to generate a lot of proposals but we 

15 might -- it might bring forth a really good and important proposal if we include it in 

16 the list.

17 DR. NORTH: I think because we have psychiatric expertise will -- many of 

18 them will understand it enough to generate proposals, and if judging the proposals, 

19 many of them will understand this enough to judge it well.

20 MS. SIDEL: Okay.

21 DR. WARD: I think that the proposal's been made and seconded. Am I 

22 correct, Paul?

23 DR. MIDDENDORF: Yes.

24 DR. WARD: So perhaps we should move to the vote so that we can consider 

25 the ideas in this topic -- in this area that we haven't even put on the table yet.

26 DR. MIDDENDORF: Okay. Motion on the table is: Differentiate psychiatric 

27 disorders from symptoms of distress in relation to disaster exposure and develop 

28 efficient and effective methods for diagnosis of disaster-related psychopathology in 

29 populations and individuals. So going to the vote, Dr. Aldrich?

30 DR. ALDRICH: Yes.

31 DR. MIDDENDORF: John Dement?

32 DR. DEMENT: Yes.

33 DR. MIDDENDORF: Kimberly Flynn?

34 MS. FLYNN: Yes.

35 DR. MIDDENDORF: Bob Harrison?

36 DR. HARRISON: Yes.

37 DR. MIDDENDORF: Catherine Hughes?

38 MS. HUGHES: Yes.

39 DR. MIDDENDORF: Steve Markowitz?
110

1 DR. MARKOWITZ: Yes.

2 DR. MIDDENDORF: Guille Mejia?

3 MS. MEJIA: 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? Liz Ward?

15 DR. WARD: Yes. 

16 DR. MIDDENDORF: Thirteen yes, zero noes, zero abstentions. Motion 

17 passes.

18 DR. WARD: So the floor is now open for additional proposals in relation to 

19 critical research gaps relative to accurate diagnosis of World Trade Center-related 

20 health conditions. 

21 And maybe on this one we should try to get indication of who, who has one 

22 that they would like to propose. How many people -- who would like to propose a 

23 specific point?

24 DR. MARKOWITZ: This is Steve Markowitz. I'd like to propose something.

25 DR. WARD: Is there anyone else who has something in mind that they'd like 

26 to propose? Okay. Steve, go ahead.

27 DR. MARKOWITZ: This -- I mentioned this before. It actually pertains to 

28 diagnosis and treatment. But it would be to examine the patterns of healthcare 

29 utilization in the World Trade Center Health Program and the utility of the medical 

30 monitoring activities of -- also of the World Trade Center Health Program.

31 The purpose of this is to encourage --

32 MS. FLYNN: Can you speak up louder, please? I can't hear you very well.

33 DR. MARKOWITZ: Sure. So the purpose of this is to -- is to take a rigorous 

34 look at actually what the World Trade Center Health Program is doing in terms of 

35 the treatment and also in terms of the medical monitoring so that we can learn, 

36 learn about these programs, maybe how they can be improved but also how they 

37 can be designed for the future.

38 DR. WARD: So Paul, have you been able to capture that? 

39 DR. MIDDENDORF: Sorry, I was on mute. I only got the first part: Examine 
111

1 the patterns of healthcare utilization --

2 DR. MARKOWITZ: Yeah, I just sent it to you, Paul. I don't know how quickly 

3 it'll come.

4 DR. MIDDENDORF: Okay. Yep, it's here. Okay.

5 DR. MARKOWITZ: And I welcome, you know, language which is more 

6 complete or more refined.

7 DR. ALDRICH: I think what's missing in this is your point that doing this will 

8 lead to improvement in design of future programs. But somehow that point has to 

9 get into this.

10 MS. SIDEL: Well, wait. Don't you mean how, how to improve this program 

11 like right now?

12 DR. MARKOWITZ: Yeah, for both purposes, actually.

13 DR. ALDRICH: Yeah, but I mean, you want to propose more than just an 

14 examination. An examination --

15 DR. MARKOWITZ: Right, right.

16 DR. ALDRICH: -- leading to the design of better.

17 MS. SIDEL: Well, monitoring the problem, because it takes so long, you 

18 know, you're in there for the whole day. Is that the kind of thing you're talking 

19 about?

20 DR. MARKOWITZ: That would be one aspect, sure.

21 MS. SIDEL: Because I think that more people would come if it was a more 

22 streamlined process. I think that's really good.

23 DR. MARKOWITZ: But, Tom, so what other verbs should be added to this?

24 DR. ALDRICH: Maybe after the, after the examine, examine the value and 

25 efficacy or something?

26 MS. SIDEL: Why don't you just say improve the efficacy of the monitoring 

27 program and --

28 DR. ALDRICH: Yeah, but you know what, the scientist doesn't have the 

29 opportunity to improve; he has the opportunity to suggest improvements.

30 MS. SIDEL: Right. Well, right. So that would be good.

31 DR. ALDRICH: Well, I agree but I mean, so what the scientist will actually do 

32 will be examine the value or examine the use or examine the quality or something.

33 MS. FLYNN: This is Kimberly. Would there be a possibility also of including 

34 language about barriers to care? Or is that already included in the notion of 

35 healthcare utilization?

36 DR. MARKOWITZ: Well, I think it would be -- that would be included in 

37 patterns actually.

38 MS. FLYNN: Okay. In patterns?

39 DR. MARKOWITZ: Yeah.
112

1 MS. FLYNN: Okay, so then we should keep the word patterns.

2 DR. WARD: So Paul, I think the way you're capturing it is not quite the way 

3 it's intended.

4 DR. MIDDENDORF: Okay.

5 DR. WARD: Steve, can you see the screen?

6 DR. MARKOWITZ: Hold on.

7 DR. WARD: I think the value and efficacy was the, was the replacement for 

8 utility. So I think it was examine the patterns of healthcare utilization in the WTCHP 

9 and the value and efficacy of medical monitoring activity. I think that's what was 

10 intended.

11 DR. MARKOWITZ: Yeah, I'm sorry. I'm not seeing what Paul's written. So 

12 Paul, if you could read it, then I can get it.

13 DR. MIDDENDORF: Yeah, let me read it out. Examine the value and efficacy 

14 of patterns of healthcare utilization in the World Trade Center Health Program and 

15 the value and efficacy of the medical monitoring activities of the WTCHP.

16 DR. MARKOWITZ: Oh, that's fine.

17 DR. WARD: And I guess the thing that doesn't make sense to me is the 

18 value and efficacy of patterns of healthcare utilization. I mean, you don't look at the 

19 value and efficacy of a pattern. 

20 DR. MARKOWITZ: Right, right.

21 DR. WARD: So I'm suggesting taking that out of there and just looking at 

22 examine patterns of healthcare utilization and the value and efficacy of the medical 

23 monitoring activities?

24 DR. MARKOWITZ: Yeah, that makes more sense actually, because we 

25 don't -- we're not getting into evaluating the efficacy of treatment; that would be a 

26 mistake. So I think the patterns in the first half and the efficacy in the second is fine.

27 DR. MIDDENDORF: I think I -- what I -- I copied value and efficacy from the 

28 first part into the second part. So the way it reads is: Examine patterns of 

29 healthcare utilization in the WTCHP and the value and efficacy of the medical 

30 monitoring activities of the WTCHP.

31 DR. MARKOWITZ: All right. That's good.

32 MS. MEJIA: This is Guille. I have a little friendly amendment to that. Is it 

33 possible for it to read: Examine patterns of healthcare utilization and delivery in the 

34 World Trade Center Health Program? So we're looking at the delivery of the 

35 healthcare as well as the utilization of it.

36 DR. MARKOWITZ: That's fine.

37 DR. MIDDENDORF: And delivery of what?

38 DR. WARD: Don't need the, of. I think you can just get rid of the, of. 

39 Healthcare utilization and delivery in.
113

1 DR. MIDDENDORF: Delivery of what?

2 DR. MARKOWITZ: No, it's the delivery of healthcare. But if you just put 

3 utilization and delivery, it's fine.

4 MS. MEJIA: Right.

5 DR. MIDDENDORF: So the wording is: Examine patterns of healthcare 

6 utilization and delivery in the World Trade Center Health Program and the value and 

7 efficacy of the medical monitoring activities of the WTCHP.

8 DR. MARKOWITZ: Yeah, that's good.

9 DR. MIDDENDORF: Okay, so that's the motion; is it seconded?

10 MS. HUGHES: Yes. Catherine here.

11 DR. MIDDENDORF: Okay.

12 DR. WARD: We're ready for a vote.

13 DR. MIDDENDORF: Okay. 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: Yes.

25 DR. MIDDENDORF: Guille Mejia?

26 MS. MEJIA: 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: Sorry, yes.

35 DR. MIDDENDORF: Glenn Talaska?

36 DR. TALASKA: Yes.

37 DR. MIDDENDORF: Leo Trasande? Liz Ward?

38 DR. WARD: Yes.

39 DR. MIDDENDORF: That's 13 yes, zero noes and zero abstentions. Motion 
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1 passes.

2 DR. WARD: So is there anyone else who'd like to propose a research gap 

3 relative to accurate diagnosis of World Trade Center-related health conditions?

4 MS. FLYNN: This is Kimberly, and I'm afraid I'm not the ideal person to 

5 phrase this, but wouldn't examining epigenetic alterations relevant to disease play 

6 an important role in diagnosis?

7 DR. MARKOWITZ: Not really in diagnosis.

8 MS. FLYNN: Okay.

9 DR. MARKOWITZ: I mean, you know, in mechanism of the disease, sure, 

10 but not, to my knowledge, not in diagnosis.

11 MS. FLYNN: Okay.

12 DR. WARD: Okay, so I just looked back at Dr. Crowley's -- my notes from Dr. 

13 Crowley, and I didn't see any of the topics that she mentioned that specifically 

14 would fall into this category. I think one of the important points that she made, that 

15 we still need to capture but it maybe falls better under 3, is did early intervention 

16 make a difference in outcome.

17 MS. SIDEL: Early intervention does make a difference in outcome, but if 

18 you're not paying attention to something because you're just not paying attention 

19 to it, then you're gonna have a bad outcome, and that was the point of asking for 

20 research.

21 DR. WARD: I guess one of the things -- I mean, one of the things that 

22 people can propose to look at in the World Trade Center -- in the previous priority

23 area is whether the -- these -- the selection of things that are being monitored for is

24 appropriate or might be too defined to detect other conditions. I mean, that, that

25 could be a topic under that last priority area.

26 MS. SIDEL: I think they've become so limited in air as digested, that other 

27 things are not considered. And they're not -- it's not a matter of that there aren’t so 

28 many of them that they're being hit over the head with it. I mean, there's a lot of 

29 cancer but cancer happens because there's a lot of press about it.

30 DR. WARD: Well, I think that this --

31 MS. SIDEL: Like there are a lot of political factors that go into a lot of these, 

32 you know, decisions, and having -- you know, early detection is critical but it 

33 doesn't -- it's not going to happen unless you're recognizing things and you're 

34 looking for new things actively. And that's been my, my comment. And I said this in 

35 2011, and I think we're just, you know, going in circles, like we're just studying you 

36 know more parts of the same issues.

37 DR. WARD: I think we -- I think we think we covered that under the first 

38 priority under topic 1. So I guess, unless anyone has something additional to 

39 propose with regard to accurate diagnosis of WTC-related health conditions, we 
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1 should move on to research gaps relative to effective treatment of WTC-related 

2 health conditions.

3 MS. FLYNN: Well, Liz, I have one -- this is Kimberly -- I have one additional 

4 question, and again, it's not only you see a need for me to separate out the 

5 diagnostic and the treatment part, so forgive me if this is not relevant, but the 

6 whole issue of comorbidity, particularly between severe respiratory conditions and 

7 PTSD, does that -- I guess, my question is where in this scheme would that fall? 

8 Because this is something that has been raised by World Trade Center Health 

9 Program clinicians.

10 DR. WARD: I'm hoping some of our clinicians --

11 DR. ALDRICH: That's on the topic of several of the research grants, and 

12 there are a number of papers about comorbidity. There's lots more to be done. But 

13 it's not really a research gap, right? Hasn't that already been identified as a 

14 problem?

15 MS. FLYNN: It certainly has been identified as a problem. I think, and 

16 forgive me; I don't have this handy, but we had some language from, from survivor 

17 program mental health folks that talked about the effects of comorbid conditions 

18 and additional risks that talked about final common pathways. I don't know 

19 whether folks feel that this has received adequate attention or... Again, yes, if it's 

20 not -- if it's not a pressing gap, you know, I understand that as the standard for 

21 inclusion on this list. But it's not for me to say whether it's a pressing gap.

22 DR. WARD: I mean, I think -- I'm not sure where it would belong but I guess, 

23 if I was to try to articulate it, it would be, as a research gap, it would be 

24 understanding mechanisms underlying --

25 MS. FLYNN: Yeah, that makes sense.

26 DR. WARD: -- apparent --

27 MS. FLYNN: That makes sense.

28 DR. WARD: -- associations between, you know, underlying common 

29 pathways for certain -- for WTC-related conditions or something. Does any -- does 

30 anyone else feel strongly that that should be included somewhere?

31 DR. MIDDENDORF: Could you just repeat, repeat what the idea is again?

32 DR. WARD: I’m thinking that what we're trying to capture is underly --

33 understand mechanisms underlying associations between WTC-related co34 morbidities such as PTSD and respiratory disease. Understanding why these two 

35 conditions -- I mean, is it purely exposure-mediated or are there other -- is it 

36 something related to the mechanism or pathophysiology of these conditions that 

37 make them more likely to occur together. I think that's what Kimberly is getting at.

38 MS. FLYNN: Yeah, thank you.

39 DR. WARD: And you've got another -- I mean, do you get what she meant 
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1 and could you say it in another way, Steve?

2 DR. MARKOWITZ: No, no, no. I wasn't -- my concern about that, it's not 

3 that it doesn't have value but my concern about that is that it doesn't really 

4 contribute in a short-term way to the welfare of the World Trade Center exposed 

5 population. It doesn't kind of help us understand the clinical expression or the 

6 epidemiologic expression or early intervention in a way that I can see in the near 

7 future as helping people. That's, that's my problem with that.

8 DR. WARD: Okay, so does, does anyone else want to spend time working 

9 on this some more or should we just table it, put it in the parking lot as something 

10 that we don't have time to fully develop during this meeting? 

11 Okay. I guess I haven't heard any sentiments that we should go forward 

12 with it. So the one thing that seems clear to me in terms of critical knowledge gaps

13 relative to effective treatment of WTC-related health conditions is the concept of 

14 more research to determine whether early intervention makes a difference in 

15 certain outcomes.

16 DR. ALDRICH: It's hard to talk about early intervention when we're now 12 

17 and a half years out.

18 MS. FLYNN: Yeah. 

19 DR. WARD: Well, it would have to be -- well, I mean, I guess it would have 

20 to be retrospective. I mean, it would have to be some kind of a retrospective study 

21 concerning people. I mean, people may have been diagnosed at one or two years 

22 post-exposure and some of them may have received an intervention. I don't --

23 MS. SIDEL: There's a, there's a gap between diagnosis and actual 

24 treatment. You know, you could be diagnosed when it was just a -- when it was just 

25 a -- you know, they were just doing diagnostic stuff and then it was a year or two 

26 before they opened up the treatment program. So for some people they -- if they 

27 didn't go to their private doctors to follow up on whatever happened in their, in 

28 their, I think it was called help for heroes appointment, there would be a big gap in 

29 treatment.

30 DR. WARD: Well, I guess, I mean, there may not -- may or may not be 

31 opportunities to look at it 'cause it's true, early intervention could require early 

32 diagnosis.

33 MS. FLYNN: This is Kimberly, and I guess the one example that I feel meets 

34 that standard is that Dr. Trasande is looking at cardiometabolic in disease in people 

35 exposed as children. And certainly if, if those start to show up, and one of the 

36 things he's seen in a pilot study is kids who have -- exposed kids who have high 

37 blood pressure but don't have, you know, the usual overweight -- you know, their, 

38 their weight is normal, they have high blood pressure. So he's looking at something 

39 like that, and certainly, you know, if this shows up in his study of, what, 250 exposed 
117

1 kids, then that would provide a basis for early intervention to prevent, you know, 

2 chronic heart disease, et cetera, if I'm not mistaken.

3 DR. WARD: Yes. I think, though, the question is you want to -- I mean, I 

4 think where this might be most common is, is people who did or did not receive 

5 certain interventions for respiratory medicines or -- I mean, it does seem like it 

6 would be an important question to answer but it would require framing what, what 

7 the specific intervention was. And seeing whether the -- you know, the -- if 

8 everyone got treat -- if everyone who was diagnosed was treated pretty similarly, 

9 then I'm not sure you could study it. But if there are opportunities to compare 

10 people who were -- had similar conditions and some were diagnosed early and 

11 aggressively treated and others were maybe diagnosed but not aggressively treated. 

12 I mean, should we throw this open as a topic of research or do people think it's not 

13 likely enough to be approved and we don't want to put it on the list?

14 MS. SIDEL: The other thing is that even if you did get treated, it's not like 

15 you can be cured. It doesn't -- you know, it doesn't go away. It's just sort of 

16 managing symptoms.

17 DR. WARD: Clinicians? World Trade Center Program, what do you think? 

18 Do you want this in or do you want this not in?

19 DR. ALDRICH: This is Tom Aldrich. I favor not doing this just because we 

20 have more pressing issues about current treatments than about, about looking back 

21 at what happened 12 and a half years ago.

22 DR. WARD: Okay. So anyone strongly disagree with that? Okay. So then 

23 the question is --

24 DR. MIDDENDORF: I just do want to point out that you have the option of 

25 including it on the list and then giving it a low priority. That is one of your options.

26 DR. ALDRICH: Is this list exclusive; that is, no grant that addresses 

27 something that's not on this list will be considered?

28 MS. SIDEL: That's a good question. 

29 DR. MIDDENDORF: No. What, what you provide to the, to the 

30 administrator will -- all of these things will be considered as part of a larger 

31 consideration. Information will be gathered from other sources as well. So this is 

32 just one avenue of gathering information about what the research needs are.

33 DR. ALDRICH: Okay.

34 MS. SIDEL: Can I raise something that's a new gap of knowledge or that’s

35 something that should be researched? Is that all right or are we past that?

36 DR. WARD: No, we're still on it. Ideally it’s things related to types of 

37 treatment of WTC-related health conditions 'cause that's the -- that's the area of 

38 research gaps that we're, we're trying to flesh out now.

39 MS. SIDEL: Well, one thing that I'm concerned about, and I think it's gonna
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1 get worse with cancer because the treatment is that side effects -- sorry about my 

2 dog -- side effects from medications. And I don't, you know, know if those things 

3 should get certified or if you can get treated for those or how that's going to work. 

4 For example, Nexium causes -- hang on one second, sorry. You know, 

5 Nexium, which a lot of us take a couple times a day, you know, it causes 

6 osteoporosis; so do all the inhalers. I don't know if that's being monitored or 

7 tracked but it's something that can come up for people. It's a lot of side effects 

8 from a lot of medications, and I think, with the cancer drugs, that that's even more 

9 severe.

10 DR. ALDRICH: I think that's a really interesting concept because with --

11 we've got a lot of things on the list of conditions associated with the World Trade 

12 Center, and maybe with all the drugs, we're bringing in a lot more conditions.

13 MS. SIDEL: Yeah, I don't think there's a way around it. I think that you 

14 create the conditions just because it just happens. But it's also interesting 'cause it's 

15 not something that, you know, when you're told -- when you're on Nexium -- note

16 by the way, this could cause osteoporosis. You know, I found out about it on the TV 

17 commercial about Nexium. You know, 'cause it's just -- you just wouldn't think 

18 about it. 

19 There's a lot of issues like that, and I think a lot of these medications, and 

20 especially for many of us who are on like multiple medications, it just compounds 

21 the initial effects of like one medication. And it's -- I mean, it's kind of like modern 

22 medicine but I think it, it's concerning.

23 DR. ALDRICH: Yeah, so that's all about risk benefit, right? So it's -- I mean, I 

24 think it would be very interesting to examine the risks versus benefit -- or the 

25 benefits versus drawbacks of taking World Trade Center-related medication.

26 MS. SIDEL: Well, and like what the options are because, if you're not taking 

27 Nexium and you can't do inhalers or you take nose spray that has, that has steroids 

28 in it, it's going to be bad for your glands, what are your -- what are your choices? 

29 There's not -- I mean, there are not very many other choices out there.

30 MS. FLYNN: So let's come up with the wording for this 'cause it seems to be 

31 a good idea. Can someone put -- articulate it well?

32 MS. SIDEL: Not me. I have cognitive issues. Let's see.

33 MS. FLYNN: How about studying the side effects of drugs that were 

34 administered to World Trade Center diseases? Of drugs administered to treat 

35 World Trade Center --

36 MS. SIDEL: Right.

37 DR. ALDRICH: I like it. Simple, the, the researcher can make with it -- make 

38 of it what he or she chooses.

39 MS. HUGHES: Yeah, and I remember some of the first responders also 
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1 complaining about -- in, in Washington.

2 DR. WARD: Okay, so do we have a motion for this?

3 DR. MIDDENDORF: Yeah, let me read it so that everybody is sure of what it 

4 is. Study the side effects of drugs administered for treatment of World Trade 

5 Center-related diseases.

6 MS. FLYNN: I like it.

7 DR. MIDDENDORF: So we need a motion and a second.

8 MS. HUGHES: Yes.

9 DR. MIDDENDORF: Yeah. Yes, you're submitting this as a motion?

10 MS. HUGHES: Yes, Catherine is.

11 DR. MIDDENDORF: Okay.

12 DR. WARD: And who is the second?

13 DR. ALDRICH: I'll second it. Tom Aldrich.

14 DR. MIDDENDORF: Okay. Are we ready for a vote, then? Tom Aldrich?

15 DR. ALDRICH: Yes.

16 DR. MIDDENDORF: John Dement?

17 DR. DEMENT: Yes. 

18 DR. MIDDENDORF: Kimberly Flynn?

19 MS. FLYNN: Yes.

20 DR. MIDDENDORF: Bob Harrison?

21 DR. HARRISON: Yes.

22 DR. MIDDENDORF: Catherine Hughes?

23 MS. HUGHES: Yes.

24 DR. MIDDENDORF: Steve Markowitz?

25 DR. MARKOWITZ: No.

26 DR. MIDDENDORF: Guille Mejia?

27 MS. MEJIA: Yes.

28 DR. MIDDENDORF: Carol North?

29 DR. NORTH: Yes.

30 DR. MIDDENDORF: Julia Quint?

31 DR. QUINT: Yes.

32 DR. MIDDENDORF: Bill Rom?

33 DR. ROM: No.

34 DR. MIDDENDORF: Susan Sidel? Susan? Okay, I'm going to move on. 

35 Glenn Talaska?

36 DR. TALASKA: No.

37 DR. MIDDENDORF: Leo Trasande? Liz Ward?

38 DR. WARD: No.

39 DR. MIDDENDORF: Eight yes, four noes, zero abstentions. Okay, the 
120

1 motion passes. 

2 Okay, Susan said you guys got disconnected?

3 MS. SIDEL: Yeah, I got disconnected, sorry.

4 DR. MIDDENDORF: Okay, did you want to vote on that motion?

5 MS. SIDEL: Yeah, what's the motion? How is it worded?

6 DR. MIDDENDORF: The motion says: Study the side effects of drugs 

7 administered for treatment of WTC-related diseases.

8 MS. SIDEL: Perfect. Yes.

9 DR. MIDDENDORF: Okay. Change that to nine yes and four noes. Motion 

10 passes.

11 DR. WARD: Okay, so let me just ask a question. Is the reason that we're not 

12 getting more ideas here in relation to treatment of respiratory diseases the fact that 

13 that's already the topic of a lot of research? Or is it just that the committee is 

14 getting tired?

15 MS. SIDEL: No, I think that it's been -- you know, I think it's, it's been a focus 

16 for, for all these years.

17 DR. WARD: Okay.

18 MS. SIDEL: I'm not -- not that there's probably not new things that are 

19 coming out but there's just so much work done on it, and I mean, it'll probably 

20 always continue but that's -- but that's one reason why we're not seeing any, 

21 anything new is because it's just -- there just keeps this focus going back on the stuff 

22 that's already been done, like some other nuance of it.

23 DR. WARD: Yeah, and I was probably being a little facetious but I think it is 

24 important that if, you know, we're really not coming up with a lot of 

25 recommendations on items 2 and 3, and I just want to make sure that the 

26 committee is, is considering these recommendations as thoroughly as they should 

27 because this is, this is our opportunity to influence the research agenda. And if 

28 we -- if there really are some topics that we haven't considered in the area of 

29 effective treatment of World Trade Center-related diseases, we should really take 

30 the time to think about them.

31 MS. SIDEL: Well, I brought up, you know, using EMDR to treat 

32 post-traumatic stress disorder, and then somehow that got turned into something 

33 else; I don't know what. But that's a really good treatment for PTSD, that they're 

34 not using it in the mental health feature at Mount Sinai anyway. I think that 

35 Kimberly said that they haven't (indiscernible) at Bellevue.

36 DR. ALDRICH: I do hear that there's a lot of controversy about what's 

37 effective and what isn't effective in treating PTSD, and shouldn't that be a focus?

38 MS. SIDEL: I just think that it's something that, that's out there and it's 

39 being used at -- you know, if it's being used at like other hospitals that are credible 
121

1 and other credible programs, that maybe we should be able to use it. I know that a 

2 lot of volunteers, because they were -- because we were allowed to choose our own 

3 doctors, a lot of volunteers are seeing doctors that do EMDR, and the rate of -- just 

4 the success that they've had with, you know, coping with their PTSD has been, you 

5 know, tremendous, to the extent that you can see the change in people's 

6 personalities. You know, they go from being really angry all the time to being 

7 pleasant and sort of at peace. It's dramatic, dramatic changes, whereas --

8 DR. ALDRICH: If that is so dramatic, why isn't that the standard of care? 

9 And so, so shouldn't we be encouraging people to find out if it's really better than 

10 other treatments?

11 MS. HUGHES: This is Catherine. I may have a suggestion. I would -- I think 

12 this is important but I think it's broader than this. And I would say that there are an 

13 awful lot of treatments that are being explored for PTSD in various trauma settings 

14 but not enough work that is specific to disaster settings, and so I would like to 

15 broaden this to treatments in general for specific use in disaster populations. 

16 And a second item that I think might be appropriate to include in this is 

17 better utilization of treatment in general, specifically for mental health. And that's 

18 it.

19 MS. SIDEL: Part of the problem with the mental health program is that 

20 there aren't a lot of people there that are really, really experienced. I mean, the one

21 at Mount Sinai anyway. 

22 You know, the first psychiatrist came to us straight out of school. And she 

23 was, she was wonderful. Our second psychiatrist came to us straight out of school. 

24 So they haven't had like a lot of like clinical practical experience. They don't have a 

25 lot of, you know, peers that have been practicing for a zillion years that can offer 

26 advice. It's just the way it is. 

27 And I think that there's another -- a lot of volunteers because there wasn't --

28 we were allowed to choose our own doctors. We, we have some different 

29 experiences, and I think that it's worth looking at, those experiences. It's not like 

30 everybody went to the same person that did EMDR, but a lot of people, you know, it 

31 definitely got around that it worked. And so --

32 DR. NORTH: So it’s like (indiscernible) because there are other potential 

33 treatments like virtual exposure --

34 MS. SIDEL: Absolutely.

35 DR. NORTH: -- (indiscernible). I wouldn’t want to single out one.

36 MS. SIDEL: Absolutely. Absolutely. I think you're right. I think absolutely. 

37 And I'm not saying that I know the best one but I'm just saying that there's definitely 

38 more out there than doing traditional like, you know, psychoanalysis and talking 

39 about your mommy. You know what I mean? It just -- that just takes forever and 
122

1 doing it -- in the time that it's taking so long, you know, your life is ticking by.

2 DR. NORTH: Well, I don't think people generally -- that's not the state of 

3 the field, to use psychoanalysis for disaster-related PTSD.

4 MS. SIDEL: Well, that's what they're -- well, that's what they're doing. 

5 They've -- they have social workers who are talking to you about, you know, your --

6 it's just like -- it's like traditional therapy, and I don't think it is effective.

7 DR. WARD: Well, Carol, could you give us some wording and propose a

8 motion? Wording that Paul can get down?

9 DR. NORTH: Something to the effect of: To specifically investigate the 

10 effectiveness and utility of treatments for PTSD, specifically in disaster affected 

11 groups or individuals.

12 DR. MIDDENDORF: Okay, so what I have is: Specifically investigate the 

13 effectiveness and utility of -- wait, that's not right.

14 DR. NORTH: To investigate the effectiveness and utility of specific PTSD 

15 treatments in disaster-related settings.

16 DR. MIDDENDORF: Okay, you said, specific PTSD treatments? Are you sure 

17 you want that?

18 DR. NORTH: Well, -- 

19 MS. SIDEL: I think that's what it's about.

20 DR. NORTH: I don't want to -- I don't want to single any one out, but we 

21 want to test specific ones like, you know, if somebody has an interest in EMDR, if 

22 somebody has an interest in prolonged exposure, those specific therapies should be 

23 tested in disaster settings. They've been tested in more broad PTSD settings but not 

24 in disaster.

25 DR. ALDRICH: So get rid of the first specifically.

26 DR. NORTH: Yeah, it was overly long on specifics.

27 DR. MIDDENDORF: So the current wording is: Investigate the effectiveness 

28 and utility of specific PTSD treatments in disaster-affected groups or individuals.

29 DR. ALDRICH: Why not in WTC-affected groups or individuals?

30 MS. SIDEL: Right. That would be good.

31 DR. NORTH: Sure.

32 DR. MARKOWITZ: My only question with this one is, are we -- would it be 

33 setting investigators up to fail? Will there, will there be enough cases and will there 

34 be so that they'll be able to make, you know, significant -- or are we just planning on 

35 leaving it up to them?

36 DR. NORTH: I agree, and this is a problem because by now people are going 

37 to be really chronic and it's going to be much, much harder to treat. It would be far 

38 more interesting if we could be treating early on after. And this is why I was not 

39 enthusiastic about developing items specifically for treatment.
123

1 MS. SIDEL: Well, you could continue the people that have had -- that have 

2 had EMDR, that went through the same disaster that got EMDR treatment.

3 DR. NORTH: This is really not as strong of a research design as we would 

4 like.

5 MS. SIDEL: Well, I mean, you can't -- it's like, you know, 13 years later so it's 

6 hard to be perfect but it would just show that -- it would maybe give some impetus 

7 for trying some EMDR or trying some other, you know, creative kinds of therapies at 

8 Mount Sinai’s mental health.

9 DR. NORTH: I would be far more enthusiastic about trying to get people to 

10 treatment, who haven’t come to treatment. So many people don't go --

11 MS. SIDEL: ‘Cause they're not going to go to treatment because it doesn't 

12 work. This is what I'm telling you; it doesn't work. You know, you're sitting there 

13 with a social worker --

14 DR. NORTH: But there are people who have used the EMDR treatment that 

15 they could go to, and they haven't.

16 MS. SIDEL: Because maybe they can't afford it; they would have to pay for 

17 it. We don't offer EMDR treatment in the program. So they'd have to know about it 

18 and they'd have to have the resources to go pay for it.

19 DR. NORTH: But that's a utility issue, that the chance that people would go,

20 is more interesting, scientifically.

21 DR. ALDRICH: Wouldn't that -- wouldn't investigators who wanted to 

22 investigate that be able to apply under this priority?

23 MS. SIDEL: You mean like have a grant that would pay for people to go?

24 DR. ALDRICH: No. I'm just saying this, this is one of the priorities, and an 

25 investigator who wants to do that study will look at this as a possible funding 

26 opportunity and have them compete for it. And if it's a good application, it might 

27 prevail. If it's not a good application, it's not gonna get funded.

28 DR. NORTH: That makes sense.

29 MS. SIDEL: All right, but still, all these people in the program that doesn't 

30 work and they're not getting anywhere with their lives 'cause they're just depressed 

31 and spinning. So well, they --

32 DR. ALDRICH: Look, we're all trying to -- we're all trying to help people, and 

33 some people don't get help and some people do. We do the best we can.

34 MS. SIDEL: Right, but if we have -- but if there's other ways to treat people 

35 that are stronger and better, that have more successful results, but --

36 DR. ALDRICH: And I don't --

37 MS. SIDEL: -- we should research it --

38 DR. ALDRICH: And I don't -- do not --

39 MS. SIDEL: -- well, we should be researching whether or not that's 
124

1 something that would be better for people.

2 DR. ALDRICH: That's why, that's why a priority like this should be in here. 

3 But it shouldn't be -- we shouldn't go in with the idea that one specific treatment's 

4 better than another, a specific unproven treatment.

5 MS. SIDEL: I didn't say that. I said any of the treatments; there’s other 

6 treatments that they use, there's like cognitive something. There's another one that 

7 they use at Mass General that's like more advanced than EMDR; I don't remember 

8 the name of it. I'm not an expert at this stuff, but I'm just saying that there are 

9 other things that work and that I, I don't think that what's going on now will --

10 DR. WARD: Well, I mean --

11 MS. SIDEL: -- I mean, it's worth it to explore some things that could be an 

12 alternative.

13 DR. ALDRICH: I think we're all talking about the same thing. So this, this 

14 phraseology covers what we want to do, doesn't it? Can't we just accept this and 

15 move on?

16 MS. SIDEL: Well, what's the phraseology?

17 DR. ALDRICH: Investigate the effectiveness and utility of specific PTSD 

18 treatments in World Trade Center-affected groups or individuals.

19 MS. SIDEL: Well, I guess it's really vague. They could come up with 

20 anything. Like they could come up and say that what they’re doing works.

21 DR. ALDRICH: That's the point. And if the science is good, then it will get 

22 funded. If the science is not good, it will not get funded.

23 MS. SIDEL: Okay.

24 DR. WARD: So I think we have the motion to -- who will propose the 

25 motion?

26 DR. NORTH: This is Carol. I guess I'm the one that proposed the wording so 

27 I'll move that we vote on the wording.

28 DR. WARD: Okay, and then do we have a second?

29 DR. ALDRICH: I'll second it.

30 DR. MIDDENDORF: Okay, so the motion on the table is: Investigate the 

31 effectiveness and utility of specific PTSD treatments in World Trade Center-affected 

32 groups or individuals. And going to the vote, Tom Aldrich?

33 DR. ALDRICH: Yes.

34 DR. MIDDENDORF: John Dement?

35 DR. DEMENT: Yes.

36 DR. MIDDENDORF: Kimberly Flynn? Kimberly, are you with us? I'm not 

37 hearing you so we'll move on to Bob Harrison? Bob, are you there? Not hearing 

38 anything. Catherine Hughes?

39 MS. HUGHES: Yes. 
125

1 DR. MIDDENDORF: Steve Markowitz?

2 DR. MARKOWITZ: Yes.

3 DR. MIDDENDORF: Guille Mejia?

4 MS. MEJIA: Yes.

5 DR. MIDDENDORF: Carol North?

6 DR. NORTH: Yes.

7 DR. MIDDENDORF: Julia Quint?

8 DR. QUINT: Yes.

9 DR. MIDDENDORF: Bill Rom?

10 DR. ROM: Yes.

11 DR. MIDDENDORF: Susan Sidel?

12 MS. SIDEL: Yes.

13 DR. MIDDENDORF: Glenn Talaska?

14 DR. TALASKA: Yes.

15 DR. MIDDENDORF: Leo Trasande? Liz Ward?

16 DR. WARD: Yes.

17 MS. FLYNN: Paul? It's Kimberly, I'm sorry. Yes.

18 DR. MIDDENDORF: Yes, okay. So that goes to 12 yes, zero noes and zero 

19 abstentions. 

20 And I'll point out that we have about ten minutes left.

21 DR. WARD: Okay, so I would propose that we move from the generation of 

22 ideas under these three categories to see if there's any sort of priority setting that 

23 we can do at this point in time.

24 DR. ALDRICH: I think it's very clear that number 9 goes to the bottom.

25 DR. WARD: All right. I'm getting back into the site so that I can see what 

26 number 9 is.

27 DR. ALDRICH: It's the one that wasn't unanimous.

28 DR. MIDDENDORF: Number 9 is: Study the side effects of drugs 

29 administered for treatment of World Trade Center-related diseases.

30 DR. WARD: So is that the only differentiation we want to make at this 

31 point? Or do we want to indicate that some of these are -- the committee feels are 

32 especially high priorities?

33 MS. FLYNN: This is Kimberly. I feel that assess the health effects of WTC 

34 exposures on gestation and early life has to be a very high priority. 

35 There are approximately 35,000 children who were exposed to WTC, and 

36 very little is known about the physical health effects on those children. In fact the 

37 first actual clinical study of physical health effects was not funded until 2013. So 

38 they are, you know, a vulnerable population and they are in fact the least studied of 

39 any WTC disaster population. 
126

1 Also I would point out that this is a rapidly dispersing population, so really,

2 certainly those of us in the survivor community feel that NIOSH has to make up for 

3 lost time and double down on this research.

4 DR. ALDRICH: One and three should be high priority.

5 DR. WARD: Okay, that --

6 DR. MIDDENDORF: Wait. Say that again?

7 DR. ALDRICH: I think 1 and 3 (indiscernible).

8 DR. WARD: So that could be a limited (indiscernible). We're getting some 

9 interference from background noise. Could whoever has it go on mute?

10 Okay, so why don't you put that in the form of a motion?

11 MS. FLYNN: Is that directed at me?

12 DR. WARD: I think, I think one person said, said -- let's see, one person said 

13 1 and 3 and then -- actually that's true. One person said 1 and 3, and another 

14 person said 4. So we could have one person make a motion to have all three be top 

15 priority or we could vote one by one.

16 DR. NORTH: This is Carol. I would like to add the exposure in mental health 

17 item as priority.

18 UNIDENTIFIED SPEAKER: [expletive deleted] you, no.

19 DR. WARD: Okay. So we --

20 DR. MARKOWITZ: Could we just vote as we go through each one and have 

21 each person say whether they think it's high, medium or low?

22 MS. FLYNN: Can you email the list around about where we currently --

23 DR. MIDDENDORF: I did that about two minutes ago.

24 DR. WARD: That might be the best thing to do given the limited time. 

25 Maybe we can just -- is it possible to just go through each of them and have each 

26 person say whether they think it's high, medium and -- or low and tabulate the 

27 results?

28 DR. MIDDENDORF: We can do that. How do you propose that we then 

29 consolidate that information?

30 DR. WARD: Well, we just make a table that says X number -- for, for item 1.

31 DR. MIDDENDORF: Okay, so all we're doing is we're identifying, say for 

32 motion number 1, five people thought it was high, two people thought it was 

33 medium and one person thought it was low. Is that what you're suggesting?

34 DR. WARD: Yeah, 'cause I can't see any other way to use the last nine 

35 minutes.

36 DR. MIDDENDORF: All right.

37 DR. MARKOWITZ: That would be my suggestion, yeah.

38 DR. WARD: Or if we need to make it simpler, we could just ask, you know, 

39 people whether they think it's high or not, and just do it high versus not high.
127

1 MS. FLYNN: That might be quicker in the time remaining.

2 DR. WARD: Yeah. 

3 DR. MARKOWITZ: Yeah, I think high versus not high makes sense.

4 DR. MIDDENDORF: Okay. How about if we just do it this way so that we 

5 get a -- kind of a yes or no vote. Just do motion number 1, and then how many 

6 people think it's a high priority; motion number 2, how many people think it's a high 

7 priority.

8 DR. WARD: Okay.

9 DR. MIDDENDORF: Then we get the same information that way.

10 DR. WARD: But you still have to go through all the names for each one, I 

11 think.

12 DR. MIDDENDORF: I'll do a roll call on each one for its priority.

13 DR. ALDRICH: You're gonna have to do that real quick.

14 DR. MIDDENDORF: Yeah. Okay. Motion 1, is this a high priority, Tom 

15 Aldrich?

16 DR. ALDRICH: Yes.

17 DR. MIDDENDORF: John Dement?

18 DR. DEMENT: Yes.

19 DR. MIDDENDORF: Kimberly?

20 MS. FLYNN: Yes.

21 DR. MIDDENDORF: Bob? Catherine?

22 MS. HUGHES: Yes.

23 DR. MIDDENDORF: Steve?

24 DR. MARKOWITZ: Yes. 

25 DR. MIDDENDORF: Guille?

26 MS. MEJIA: Yes.

27 DR. MIDDENDORF: Carol?

28 DR. NORTH: Yes.

29 DR. MIDDENDORF: Julia?

30 DR. QUINT: Yes.

31 DR. MIDDENDORF: Bill?

32 DR. ROM: Yes.

33 DR. MIDDENDORF: Susan?

34 MS. SIDEL: Yes. 

35 DR. MIDDENDORF: Glenn?

36 DR. TALASKA: Yes.

37 DR. MIDDENDORF: Leo? Liz?

38 DR. WARD: Yes.

39 DR. MIDDENDORF: One, two, three, four, five, six, seven, eight, nine, ten, 
128

1 eleven, twelve yeses. So the motion was -- motion 1 is a high priority. And we had, 

2 what was the number, 12? Okay. Okay.

3 Motion 2 is a high priority. Characterize the disaster-related exposures that 

4 are associated with the development of specific psychiatric disorders.

5 Tom, is that a high priority?

6 DR. ALDRICH: No.

7 DR. MIDDENDORF: I'm sorry?

8 DR. ALDRICH: No.

9 DR. MIDDENDORF: No, I'm -- okay, thank you. John?

10 DR. DEMENT: No.

11 DR. MIDDENDORF: Kimberly.

12 MS. FLYNN: No.

13 DR. MIDDENDORF: Bob? Catherine.

14 MS. HUGHES: No.

15 DR. MIDDENDORF: Steve?

16 DR. MARKOWITZ: No.

17 DR. MIDDENDORF: Guille?

18 MS. MEJIA: No.

19 DR. MIDDENDORF: Carol?

20 DR. NORTH: I'll stick with my yes.

21 DR. MIDDENDORF: Julia?

22 DR. QUINT: No.

23 DR. MIDDENDORF: Bill?

24 DR. ROM: No.

25 DR. MIDDENDORF: Susan?

26 MS. SIDEL: No.

27 DR. MIDDENDORF: Glenn? Glenn? I'm sorry, what? Glenn?

28 DR. TALASKA: No.

29 DR. MIDDENDORF: Thank you. Leo? Liz?

30 DR. WARD: Yes -- oh, no. Sorry, no.

31 DR. MIDDENDORF: Okay. One yes, 11 no, zero abstentions. 

32 Motion 3: Determine the value of biomarkers for early detection of 

33 precancerous conditions, early cancers or other WTC-associated diseases. Is this a 

34 high priority? Tom?

35 DR. ALDRICH: Yes.

36 DR. MIDDENDORF: John?

37 DR. DEMENT: Yes.

38 DR. MIDDENDORF: Kimberly?

39 MS. FLYNN: Yes.
129

1 DR. MIDDENDORF: Bob? Catherine?

2 MS. HUGHES: Yes.

3 DR. MIDDENDORF: Steve?

4 DR. MARKOWITZ: No.

5 DR. MIDDENDORF: Guille?

6 MS. MEJIA: I'm going to abstain.

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?

14 MS. SIDEL: Yes.

15 DR. MIDDENDORF: Glenn?

16 DR. TALASKA: Yes.

17 DR. MIDDENDORF: Leo? Liz?

18 DR. WARD: Yes.

19 DR. MIDDENDORF: Okay, one, two, three, four, five, six, seven, eight, nine, 

20 ten yes; one no, one abstention. Okay, motion passes. That was motion 3. 

21 Motion 4: Assess health effects of WTC exposure on gestation and early life, 

22 childhood and adolescence. So Tom, is this a high priority?

23 DR. ALDRICH: Yes.

24 DR. MIDDENDORF: John?

25 DR. DEMENT: Yes.

26 DR. MIDDENDORF: Kimberly?

27 MS. FLYNN: Yes.

28 DR. MIDDENDORF: Bob? Catherine?

29 MS. HUGHES: Yes.

30 DR. MIDDENDORF: Steve?

31 DR. MARKOWITZ: Yes.

32 DR. MIDDENDORF: Guille?

33 MS. MEJIA: Yes.

34 DR. MIDDENDORF: Carol?

35 DR. NORTH: Yes.

36 DR. MIDDENDORF: Julia?

37 DR. QUINT: Yes.

38 DR. MIDDENDORF: Bill?

39 DR. ROM: Yes.
130

1 DR. MIDDENDORF: Susan?

2 MS. SIDEL: Yes.

3 DR. MIDDENDORF: Glenn?

4 DR. TALASKA: Yes.

5 DR. MIDDENDORF: Leo? Liz?

6 DR. WARD: Yes.

7 DR. MIDDENDORF: Okay. That's 12 yes, zero no, zero abstentions. That 

8 motion passes. 

9 Okay, motion 5 is a high priority. Motion 5 is: Improved assessment of WTC 

10 exposure: inhaled, topical, ingested or other. Okay. Tom Aldrich?

11 DR. ALDRICH: No.

12 DR. MIDDENDORF: John Dement?

13 DR. DEMENT: Yes.

14 DR. MIDDENDORF: Kimberly?

15 MS. FLYNN: No.

16 DR. MIDDENDORF: Bob? Catherine?

17 MS. HUGHES: Medium. 

18 DR. MIDDENDORF: Yes or no.

19 MS. HUGHES: No.

20 DR. MIDDENDORF: Steve?

21 DR. MARKOWITZ: Yes.

22 DR. MIDDENDORF: Guille?

23 MS. MEJIA: Yes.

24 DR. MIDDENDORF: Carol?

25 DR. NORTH: Yes. 

26 DR. MIDDENDORF: Julia?

27 DR. QUINT: Yes.

28 DR. MIDDENDORF: Bill?

29 DR. ROM: No.

30 DR. MIDDENDORF: Susan?

31 MS. SIDEL: Not sure. I guess I'll say no. 

32 DR. MIDDENDORF: Glenn?

33 DR. TALASKA: Yes.

34 DR. MIDDENDORF: Leo? Liz?

35 DR. WARD: No.

36 DR. MIDDENDORF: Okay. One, two, three, four, five, six yes, six no. 

37 Motion 6. I'm assuming everybody is okay with the shorthand way of doing 

38 our motions?

39 UNIDENTIFIED SPEAKER: Yes.
131

1 DR. MIDDENDORF: Okay.

2 UNIDENTIFIED SPEAKER: Yes.

3 DR. MIDDENDORF: Okay. Motion 6 is: Evaluate and improve the utility and 

4 use of WTCHP data and activities for the purpose of active surveillance of health 

5 conditions in WTC-exposed populations and/or develop improved surveillance 

6 methods. 

7 Okay, so Tom Aldrich, is this a high priority?

8 DR. ALDRICH: Yes.

9 DR. MIDDENDORF: John?

10 DR. DEMENT: Yes.

11 DR. MIDDENDORF: Kimberly?

12 MS. FLYNN: Yes. 

13 DR. MIDDENDORF: Bob? Catherine?

14 MS. HUGHES: Yes.

15 DR. MIDDENDORF: Steven?

16 DR. MARKOWITZ: Yes.

17 DR. MIDDENDORF: Guille?

18 MS. MEJIA: Yes.

19 DR. MIDDENDORF: Carol?

20 DR. NORTH: Yes.

21 DR. MIDDENDORF: Julia?

22 DR. QUINT: Yes.

23 DR. MIDDENDORF: Bill?

24 DR. ROM: Yes.

25 DR. MIDDENDORF: Susan?

26 MS. SIDEL: Yes.

27 DR. MIDDENDORF: Glenn?

28 DR. TALASKA: Yes.

29 DR. MIDDENDORF: Leo? Liz?

30 DR. WARD: Yes.

31 DR. MIDDENDORF: So that's 12 yes, zero no, zero abstentions.

32 Motion 7. Seven is: Differentiate psychiatric disorders from symptoms and 

33 distress in relation to disaster exposure and develop efficient and effective methods 

34 for diagnosis of disaster-related psychopathology in populations and individuals.

35 Tom, is this a high priority?

36 DR. ALDRICH: Yes.

37 DR. MIDDENDORF: John?

38 DR. DEMENT: No.

39 DR. MIDDENDORF: Kimberly?
132

1 MS. FLYNN: Yes.

2 DR. MIDDENDORF: Bob? Catherine?

3 MS. HUGHES: No.

4 DR. MIDDENDORF: Steve?

5 DR. MARKOWITZ: Yes.

6 DR. MIDDENDORF: Guille?

7 MS. MEJIA: Yes.

8 DR. MIDDENDORF: Carol?

9 DR. NORTH: Yes.

10 DR. MIDDENDORF: Julia?

11 DR. QUINT: Yes.

12 DR. MIDDENDORF: Bill?

13 DR. ROM: No.

14 DR. MIDDENDORF: Susan?

15 MS. SIDEL: No.

16 DR. MIDDENDORF: Glenn?

17 DR. TALASKA: Yes.

18 DR. MIDDENDORF: Leo? Liz?

19 DR. WARD: Yes.

20 DR. MIDDENDORF: Okay. Nine yes, three noes, zero abstentions.

21 Motion 8 was or is: Examine the patterns of healthcare utilization and 

22 delivery in the World Trade Center Health Program and the value and efficacy of 

23 medical monitoring activities of the World Trade Center Health Program.

24 Is this a high priority, Tom?

25 DR. ALDRICH: No.

26 DR. MIDDENDORF: John?

27 DR. DEMENT: Yes.

28 DR. MIDDENDORF: Kimberly?

29 MS. FLYNN: Yes.

30 DR. MIDDENDORF: Bob? Catherine?

31 MS. HUGHES: Yes.

32 DR. MIDDENDORF: Steve?

33 DR. MARKOWITZ: Yes. 

34 DR. MIDDENDORF: Guille?

35 MS. MEJIA: Yes.

36 DR. MIDDENDORF: Carol?

37 DR. NORTH: Yes.

38 DR. MIDDENDORF: Julia?

39 DR. QUINT: Yes.
133

1 DR. MIDDENDORF: Bill?

2 DR. ROM: Yes.

3 DR. MIDDENDORF: Susan?

4 MS. SIDEL: Yes.

5 DR. MIDDENDORF: Glenn?

6 DR. TALASKA: Yes.

7 DR. MIDDENDORF: Leo? Liz?

8 DR. WARD: Yes.

9 DR. MIDDENDORF: Okay. One no and 11 yes. No abstentions.

10 Motion 9: Study the side effects of drugs administered for treatment of 

11 WTC-related diseases.

12 Tom, is this a high priority?

13 DR. ALDRICH: No.

14 DR. MIDDENDORF: John?

15 DR. DEMENT: No.

16 DR. MIDDENDORF: Kimberly?

17 MS. FLYNN: No.

18 DR. MIDDENDORF: Bob? Catherine?

19 MS. HUGHES: No.

20 DR. MIDDENDORF: Steven?

21 DR. MARKOWITZ: No.

22 DR. MIDDENDORF: Guille?

23 MS. MEJIA: No.

24 DR. MIDDENDORF: Carol?

25 DR. NORTH: No.

26 DR. MIDDENDORF: Julia.

27 DR. QUINT: No.

28 DR. MIDDENDORF: Bill?

29 DR. ROM: No.

30 DR. MIDDENDORF: Susan?

31 MS. SIDEL: Yes.

32 DR. MIDDENDORF: Glenn?

33 DR. TALASKA: No.

34 DR. MIDDENDORF: Leo? Liz?

35 DR. WARD: No.

36 DR. MIDDENDORF: Okay. One yes and 11 no. Okay. 

37 And motion 10 was: Investigate the effectiveness and utility of specific 

38 PTSD treatments in WTC-affected groups or individuals.

39 Okay, Tom, is this a high priority?
134

1 DR. ALDRICH: No.

2 DR. MIDDENDORF: John?

3 DR. DEMENT: No.

4 DR. MIDDENDORF: Kimberly?

5 MS. FLYNN: Yes.

6 DR. MIDDENDORF: Bob? Catherine?

7 MS. HUGHES: Yes.

8 DR. MIDDENDORF: Steven?

9 DR. MARKOWITZ: No.

10 DR. MIDDENDORF: Guille?

11 MS. MEJIA: Yes.

12 DR. MIDDENDORF: Carol?

13 DR. NORTH: No.

14 DR. MIDDENDORF: Julia?

15 DR. QUINT: Yes.

16 DR. MIDDENDORF: Bill?

17 DR. ROM: No.

18 DR. MIDDENDORF: Susan?

19 MS. SIDEL: Yes.

20 DR. MIDDENDORF: Glenn?

21 DR. TALASKA: No.

22 DR. MIDDENDORF: Leo? Liz?

23 DR. WARD: Yes.

24 DR. MIDDENDORF: Okay. One, two, three, four, five, six, seven yes, five no.

25 DR. WARD: I think that is a helpful metric that we can use. I think Dr. 

26 Howard will find that helpful. Paul?

27 DR. MIDDENDORF: Yes, I'm, I'm here.

28 DR. WARD: Okay.

29 DR. MIDDENDORF: Sorry. Trying to do some quick cleaning here.

30 DR. WARD: Good.

31 DR. TALASKA: You're doing a great job, Paul.

32

33 ADMINISTRATIVE ISSUES AND ADJOURN

34 DR. MIDDENDORF: Well, okay. So what is the committee going to do? 

35 What, what are you planning to do with this or how do you want to present this 

36 information to Dr. Howard?

37 DR. WARD: Well, Paul, I mean, we could either draft a cover letter or you 

38 could just -- I mean, you could circulate the list and the tabulations. And then unless 

39 anyone has any questions, we could just provide that to Dr. Howard?
135

1 DR. MIDDENDORF: Yeah, I think even if I send it out to folks, if they 

2 disagree with something that's on it, there's nothing that, that can be done about it.

3 DR. WARD: Yeah. So I would say let's just send it to Dr. Howard. We really 

4 don't have time to talk about -- and then first, there'll be the transcript, and 

5 certainly NIOSH staff could look at the transcript and, and help Dr. Howard identify 

6 the discussion points that are most relevant to his decision-making.

7 DR. MIDDENDORF: Yeah, and I will let you know that we have combed 

8 mightily through in great detail through the previous transcripts as we've been 

9 writing regulations. So the -- not just the information but what people say and how 

10 they say it are used to a considerable extent. So what you say in the meetings is 

11 valuable and is considered to be important.

12 DR. WARD: Good.

13 DR. MIDDENDORF: So --

14 DR. WARD: And it's interesting, I have read through the transcripts, 'cause 

15 it's one of my roles as the Chair to say that I believe they're accurate, and it is 

16 remarkable, sometimes it's embarrassing how you make, you know, you don't use 

17 the English language as well as you wish you did, but there really are some very 

18 useful discussions in those, in those transcripts.

19 DR. MIDDENDORF: Very much so. So the disposition from the -- what the 

20 committee intends to do, then, is for me to provide this document to Dr. Howard as 

21 the -- their report. Is that what you’re telling me?

22 DR. WARD: I think so. That would be my recommendation.

23 DR. MIDDENDORF: How do people feel about that?

24 MS. FLYNN: Well, it sounds good.

25 DR. MIDDENDORF: Any dissensions? 

26 DR. TALASKA: It's the product of our day.

27 DR. MIDDENDORF: Sorry?

28 DR. TALASKA: It's the product of our day.

29 DR. MIDDENDORF: Yeah. Okay. Well, since that is what I'm hearing from 

30 the committee, that is what I will do, and I will send a copy of this out to everyone 

31 so you know what it is and how it all turned out, exactly what happened. 

32 Transcripts will be available in a number of weeks.

33 I also want to thank each of you for muscling through this very difficult 

34 meeting. The promise of technology often doesn't measure up to what is really 

35 needed. And we struggled through, and I very much appreciate your hanging in 

36 there and muscling through it with me.

37 MS. SIDEL: Thank you for doing it.

38 DR. WARD: Thank you, Paul

39 UNIDENTIFIED SPEAKER: Thank you.
136

1 MS. HUGHES: Thank you, Paul. Thank you, Liz.

2 DR. ROBISON: Hey, Paul, this is Allen. I would second that. And I've been 

3 listening, and Travis has been listening. It's very helpful to us to listen to the 

4 discussions and the sort of the struggles and challenges that you wrestle with in the 

5 time that you have to do this, so thank you.

6 DR. WARD: Thank you.

7 DR. MIDDENDORF: Well, with that, I guess we're closing the meeting?

8 MS. SIDEL: So if I'm unhappy about something, could I write a separate 

9 letter?

10 DR. MIDDENDORF: You can write something to the administrator at any 

11 time.

12 MS. SIDEL: Okay. Thank you.

13 DR. MIDDENDORF: Thank you, everybody.

14 DR. WARD: Have a good weekend everyone. Take care. Bye-bye. 

15 (Whereupon, the meeting was adjourned, 5:10 p.m.)

16
137

1 CERTIFICATE OF COURT REPORTER

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, 2014; 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 hand and official seal this the 9th day of March, 2014.

___________________________________

STEVEN RAY GREEN, CCR, CVR-CM, PNSC

CERTIFIED MERIT COURT REPORTER

CERTIFICATE NUMBER: A-2102