59

Dr. Jonas. The National Library of Medicine is the No. 1 source
of information for all medical information, including complemen-
tary and alternative medicine.

Mr. MILLER. Thank you. Thank you for the job you’re doing. I'm
proud of you.

Mr. Horn. Could I ask one question?

Mr. BurTON. Yes, Mr. Horn.

What we're going to—after you ask your question, we’re going to
bring another panel up. Dr. Jonas and Dr. Klausner have kindly
agreed to wait until after the next apanel, because we may have
some additional questions for them we hear from some other
doctors. So, with that, go ahead and ask your question.

Mr. Horn. Mr. Miller reminded me that there has been a very
excellent program in the Department of Defense that was founded
by Jack Murtha, who is on Defense Appropriations. And one of the
reasons it was founded, and that’s before our time in coming here,
was that a very distinguished researcher on cancer was turned
down by the National Cancer Institute, because he never had a
grant from the National Cancer Institute. And he was funded
under—and was at a very distinguished university. He was funded
by the military money, and there’s some great results that have re-
sulted from that.

Now, on that business of, gee, you’ve never had a grant from the
NCI, so we can’t fund you. I mean, this is a catch-22 if I ever
heard it.

Dr. KLAUSNER. That does not happen. In fact, just the opposite.
We set aside money to bring new people in to give their first
grants. It’s actually a special set-aside to make sure that we can
attract those people in. And, actually, the NCI doesn’t make that
sort of decision. The grants come in, his proposal came in and peers
come together and they review it and they rate it and then deter-
mine its rating.

And it’s often viewed that then NCI decides not to fund it. That’s
not true. We make an up-front decision that we will stand by the
recommendation of independent peer review and then fund what
reaches a certain level.

Mr. Horn. Do you try to get anybody from the alternative medi-
cine side on some of those peer review committees?

Dr. KLAUSNER. Well, yes. When the NCI is doing its own review
and it’s relevant to complementary alternative medicine, we then
will seek out expertise for those particular reviews. And one of the
places we turn to is turn to the Office of Alternative Medicine. 1
think that works very well.

One thing to remember is that most review that goes on of
grants that come in, while the Institute funds that, they don’t re-
view them. There’s a separate Center for Scientific Review. So it’s
actually separated from us to give the peer review system an inde-

ndence. 'e simply get the results of those and then provide the
‘unding.

Mr. Horn. I learned long ago that sometimes it’s helpful to have
a gadfly on review committees of any kind who are asking the
tough questions, and nobody wants to be laughed at or something,
but maybe they ought to be asked. Do you have that kind of person
on one of these panels?


“LQ

OPENING STATEMENT OF REP. CHRISTOPHER COX
‘VICE-CHAIRMAN, COMMITTEE ON
GOVERNMENT REFORM AND OVERSIGHT

JULY 31, 1998

HEARING ON NCI RESPONSE TO ALTERNATIVE TREATMENTS FOR CANCER

Mr. Chairman, thank you for holding this hearing

today.

The question before us today is: what is the
National Cancer Institute doing to advance research in

the area of complementary and alternative medicine?

An increasing number of severely-ill patients are
turning to alternative forms of medical treatment,
after finding more traditional medicine to be
unsuccessful. In fact, the New England Journal of
Medicine has reported that more than one out of every
three Americans have at some time relied on an

alternative form of medical treatment.

At this Subcommittee’s hearing in February of this
year, Rep. DeFazio discussed H.R. 746, the Access to
Treatment Act, legislation he has introduced and of

which I am an original sponsor.


COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT
DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

J. DENNIS HASTERT, Illinois

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

CHRISTOPHER COX, California

ILEANA ROS-LEHTINEN, Florida

JOHN M. McHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. McINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

JOHN B. SHADEGG, ‘Arizona

STEVEN C. LATOURETTE, Ohio

MARSHALL “MARK” SANFORD, South
Carolina

JOHN E. SUNUNU, New Hampshire

PETE SESSIONS, Texas

MICHAEL PAPPAS, New Jersey

VINCE SNOWBARGER, Kansas

BOB BARR, Georgia

DAN MILLER, Florida

RON LEWIS, Kentucky

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, Jr., West Virginia
MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

GARY A. CONDIT, California

CAROLYN B. MALONEY, New York
THOMAS M. BARRETT, Wisconsin
ELEANOR HOLMES NORTON, Washington,

DC
CHAKA FATTAH, Pennsylvania
ELIJAH E. CUMMINGS, Maryland
DENNIS J. KUCINICH, Ohio
ROD R. BLAGOJEVICH, Illinois
DANNY K. DAVIS, Illinois
JOHN F. TIERNEY, Massachusetts
JIM TURNER, Texas
THOMAS H. ALLEN, Maine
HAROLD E. FORD, Jr., Tennessee
BERNARD SANDERS, Vermont
(Independent)

KEVIN BINGER, Staff Director
DanlEL R. MOLL, Deputy Staff Director
Dawip A. Kass, Deputy Counsel and Parliamentarian
Juorr McCoy, Chief Clerk
Putt SCHILIRO, Minority Staff Director

aD


68

THE CHEESE IS ALWAYS FREE IN A MOUSETRAP

AFTER SIX CHEMO SESSIONS ON MOPP I AM REEVALUATED. THIS
MEANS A BONE MARROW SAMPLE WILL BE OBTAINED. THIS
CONSISTS OF "DRILLING" INTO THE SACRUM (THE BONE AT THE END
OF YOUR SPINE) IN ORDER TO COLLECT THE CELLS NEEDED TO
MONITOR MY CANCER. THIS PROCEDURE CAUSES BEADS OF SWEAT
TO POP OUT ON MY FOREHEAD. THIS IS BECAUSE IT REALLY HURTS.
1 AM A TOUGH GUVY...BUT IT REALLY HURTS, THE RESULTS ARE IN.
THEY FIND ONE CANCER CELL ON THE FORTIETH SLIDE OF FORTY
SAMPLES. I AM THIRTY-FIVE YEARS OLD, I WEIGH ONE HUNDRED
AND TWENTY-SEVEN POUNDS (DOWN FROM ONE HUNDRED AND
EIGHTY-FIVE POUNDS NINE MONTHS PRIOR) AND, I AM STILL DYING
OF CANCER. I FINISH THE LAST SIX MONTHS OF MEDICAL SCHOOL
WHILE ON CHEMOTHERAPY. I WILL NOT GIVE UP.

A LITTLE KNOWLEDGE IS A GOOD THING

I TRAVEL TO THE CLEVELAND CLINIC TO BE EVALUATED. THEY
TREAT ME WELL. I AM A DOCTOR. A NEW DOCTOR BUT, A DOCTOR
NONE THE LESS. THE NEWS IS THE SAME...STAGE IV-B HODGKIN'S.
LYMPHOMA LOCATED IN MY BONES...A SOMEWHAT RARE
PRESENTATION...NOT A GOOD CELL TYPE...BUT, IF YOU HAVE TO
HAVE A CANCER, THIS IS THE ONE TO HAVE, I AM TAKEN TO
SURGERY AND HAVE AN INFUS-A-PORT PLACED UNDER THE SKIN OF
MY LEFT UPPER CHEST. THE PORT IS CONNECTED TO A TUBE THAT
GOES DIRECTLY INTO MY VENOUS SYSTEM. IT ALLOWS CHEMO TO
BE ADMINISTERED I.V. WITHOUT HAVING TO FIND A VEIN. WHEN I
AWAKEN FROM SURGERY THE CHEMO THERAPY IS ALREADY BEING
ADMINISTERED THROUGH MY NEW INFUS-A-PORT. I START
THROWING UP IN THE CAR ON MY WAY HOME FROM THE HOSPITAL.
THIS HAS BEEN A SAME-DAY-SURGERY OUTPATIENT PROCEDURE. MY
NEW THERAPY IS ABVD (ADRIAMYCIN - CARDIOTOXIC, BLEOMYCIN -
DAMAGES YOUR LUNGS, VINBLASTINE - SIDE EFFECT: CANCER, AND
DOXORUBICIN - MAKES YOUR URINE RED). I START MY MEDICAL
INTERNSHIP. THE WORK IS GRUELING--TWELVE DAYS ON...TWO
DAYS OFF... TWELVE HOURS A DAY OR UNTIL YOUR DUTIES ARE
DONE. I ONLY MISS ON THE DAYS I HAVE CHEMO...I PUKE FOR
SEVENTEEN HOURS AND GET UP AND GO BACK TO WORK. I PRAY
FOR WHITE COUNTS LESS THAN ONE. TAKING CHEMO HITS EVERY
TWO WEEKS IS MAKING A TOUGH YEAR OF INTERNSHIP EVEN
HARDER. AFTER MY FIFTH HIT OF CHEMO(I AM SUPPOSED TO HAVE A
TOTAL OF SIX)...1 QUIT TAKING IT. IF I AM GOING TO DIE...

SO BE IT, I CANNOT TAKE ANY MORE CHEMO. NEVER
AGAIN...NEVER AGAIN...NO MORE "RAT POISON"...NEVER AGAIN.

-6-


79

Congressman Burton, distinguished members of the Committee, I thank you for inviting
me to give testimony here today.

| graduated from New York Medical College 40 years ago and have had a broad practice
experience. I was an Air Force Flight Surgeon, a Medical Missionary in Malawi, Central Affica, a
General Internist, a Medical Oncologist, and for the past 15 years, a practitioner of altemative
medicine. 1 was the founding president of the Virginia Oncology Group and the member of the
Eastern Cooperative Oncology Group and the Mid Atlantic Oncology Program.

After 13 years of using FDA approved Chemotherapy protocols, I concluded that such
therapies were extremely toxic, poorly tolerated, and not effective in prolonging survival in most
solid tumors of adults. Over a 10 year period, I signed 170 death certificates per year by using
chemotherapy. It was obvious to me that I was not treating the essential issues in the
‘management of patients with cancer.

In 1983, my patients began to request therapies other than chemotherapy. I agreed, and
without even knowing it, 1 became an “alternative medicine practitioner” and was “red flagged”
by opponents to this form of therapy

Being a classical oncologist and a clinical investigator, I was pleasantly surprised by the
clinical responses that I saw. I gave Urea to one patient with breast cancer. She had a complete
response of tumor in her hung and liver and had no bone marrow toxicity, no hair loss, and no
heart damage. Her quality of life was excellent. She was seen traveling on her husband’s Harley-

Davidson motorcycle 10 years later.


15

‘The OAM has six functional areas. The following paragraphs describe the
activities within those areas.

Extramural Affairs (Grants)

Sponsored Research

‘The Office issued its first Request for Applications (RFA) in 1993, for grants
of up to $30,000 each to fund expioratory pilot projects to identify promising
areas of future research. The RFA was unusual in allowing any practitioner,
with or without the backing of a conventional research institution, to apply.

Collaboration between orthodox research investigators and altemative
‘medical practitioners was encouraged. More than 800 letters of intent were
received, and 452 applications were reviewed — the largest response to a
single RFA in NIH history. Thirty awards were made in September 1993 and
another 12 in September 1996.

The OAM continues to co-fund research grants as appropriate applications
for research into complementary and alternative medicine are received and
reviewed through the NIH peer review process. Please contact the OAM
Clearinghouse to obtain the Research Information Package for more
information

Altemative Medicine Specialty
Research Center Grants

The OAM has funded 10 Specially Research Centers to study
complementary and alternative treatments for specific health conditions.

The Centers form the foundation for conducting ongoing complementary and
alternative medical research through the NIH.

The Centers will develop a prioritized research agenda, provide technical
assistance, provide mechanisms for research development, and conduct
collaborative research. Average funding for each Center is approximately
$850,000 aver 3 years, The OAM Specialty Research Centers are located
at

Bastyr University
Seattle, WA
‘Specialty: HIV/AIDS

Beth Israel Hospital, Harvard Medical Schoo!
Boston, MA

fon,
‘Specialty: General Medical Conditions

Columbia University College of Physicians and Surgeons
New York, NY.
‘Specialty: Women's Health Issues
Co-unding: The Otfice of Research on Women's Health, NIH

Kessler institute for Rehabilitation
fest Orange, NJ
The University of Medicine & Dentistry, Newark, NJ
‘Specialty: Stroke and Neurological Conditions
‘Co-funding: The National institute of Child Health and Human
Development, NIH

Hennepin County Medical Center/University of Minnesota

Medical Schoot
Minneapolis, MN
‘Specialty: Addictions



14

ALL WORK AND NO PLAY MAKES JACK A DEAD BOV...IF HE
HAS CANCER

IT WORKED TOO HARD. SIXTY TO SEVENTY HOUR A WEEK WAS TOO
MUCH FOR MY BODY BUT, I LOVED IT. I WAS AN ADRENALINE JUNKY
..-A "CODE BLUE RANGER"...AN EMERGENCY MEDICINE MAVEN. IT
WAS KILLING ME. DR. GONZALEZ WAS THE FIRST PHYSICIAN TO
TELL ME WHAT WE ALL KNOW...ALL FEEL...TOO MUCH MENTAL AND
PHYSICAL STRESS IMPAIRS THE IMMUNE SYSTEM. I MADE A MENTAL
NOTE TO RELAX...AFTER YEARS DRIVING THE LEAD CAR IN THE RACE
"PIT STOPS" WERE NOT IN MY CREED.

SAUNAS, SWEDES, AND SWITCHES: SKIN DETOX

INITIALLY, WHEN I HAD A LARGER TUMOR LOAD, I BECAME MORE
TOXIC AFTER TAKING THE ENZYMES. MY MENTAL MEASURE WAS TO
LOOK FOR GOUT. CHEMOTHERAPY KILLS ALL SORTS OF CELLS.
WHEN THE CELLS DIE, THEIR CONTENTS (INCLUDING URIC ACID)
ARE DUMPED INTO THE BLOOD STREAM. THE INCREASE IN URIC
ACID MEANS GOUT. GOUT IS A NIFTY LITTLE DISEASE WHICH
MAKES YOUR BIG TOE FEEL LIKE SOMEONE RAMMED A PHILLIPS.
HEAD SCREWDRIVER THROUGH IT. IT HURTS. TWO WEEKS AFTER I
STARTED TAKING THE ENZYMES I HAD GOUT. LABORATORY TESTS
SUPPORTED THE FACT THAT I HAD AN INCREASE IN URIC ACID. THE
GOUT PASSED. I CONTINUED MY ENEMAS AND ENZYMES. THE
ORGANIC FOOD DIET, THE CARROT JUICE...ALL BECAME PART OF A
DAILY ROUTINE. SLOWLY, I WAS GETTING BETTER. WHENEVER I
FELT SILLY PERFORMING ANY PROTOCOL I WOULD SEARCH FOR THE
ANATOMIC AND PHYSIOLOGIC REASONS WHY IT WORKED. FOR
INSTANCE, COFFEE (CAFFEINE-A XANTHINE) WHILE A STIMULANT
WHEN TAKEN ORALLY, WORKS IN A DIFFERENT FASHION WHEN
ABSORBED THROUGH THE G.I. MUCOSA. APPARENTLY IT IS
MEDIATED VIA THE PARASYMPATHETIC NERVOUS SYSTEM ALLOWING
SMOOTH MUSCLE RELAXATION AND, THEREFORE, RELAXATION OF
THE DUCT SYSTEM OF THE LIVER. THIS LETS THE LIVER DUMP
TOXINS MORE RAPIDLY THAN IT NORMALLY WOULD. IT WORKS.
THAT IS ALL I CAN SAY...IT WORKS. SKIN BRUSHING WAS A LITTLE
TOUGHER. USING A BRUSH TO BRUSH MY SKIN (ALWAYS DISTAL TO.
PROXIMAL -- TOWARD THE CENTER OF THE BODY) SEEMED A LITTLE
HOKEY. THAT WAS UNTIL I LOOKED A LITTLE CLOSER. THE SKIN IS
THE BODY'S SECOND LARGEST DETOXIFYING ORGAN. A
MICROSCOPIC VIEW REVEALS ARTERIOLES CONNECTED TO VENULES
WITH A LYMPH CAPILLARY BETWEEN. INCREASE BLOOD FLOW
(BRUSHING) INCREASE LYMPHATIC DRAINAGE, INCREASE
DETOXIFICATION. NO MAGIC...JUST STRUCTURE AND FUNCTION.

-12-


32

detection is to be useful and successful. Our interventions, despite their success, have, by and
large, been the result of guesswork. But now, we are at a point where we can transform our
approach to cancer.

We also are learning to understand the causes of cancer. Research on cancer risk — the
probability that the disease will occur in a given population — is identifying populations with a
significant probability of developing cancer. Because cancer is a multistage process, analysis
of risk factors leads to the development of prevention and control strategies, as well as early
detection methods, and in some cases more precise treatments. Epidemiologic research has
identified many factors that increase cancer risk. Most of these are related to environment and
lifestyle, while others are part of a person's genetic makeup. With the exception of a few
genetic conditions, however, it is still not possible to predict with any degree of certainty that a
person having one or more of these factors will develop cancer. ‘This uncertainty is related to
the very nature of cancer and the need for many specific alterations to accumulate in a single
cell for that normal cell to be transformed into a cancer cell.

‘NCL Support of Complementary Treatments for Cancer - Links to CAM cancer research

Let me emphasize at the start that the basic tenet of the NIH is to employ rigorous
methodologies to reach conclusions based on evidence and not on belief. It is through such
‘methodologies that the intersection between ‘so-called! traditional medicine and “so-called”
complementary and alternative medicine will be sought. Standards of evidence cannot be
compromised and I am pleased that, on this crucial point, { and many colleagues in the
complementary and alternative medicine community agree, By employing rigorous
methodologies to studies in complementary and alternative medicine, NCI has awarded and
continues to support many high quality CAM-related research projects, including projects
examining the effects of dietary interventions in cancer treatment, projects examining the
therapeutic value of vitamins and minerals in cancer treatment and prevention, studies in stress
and pain management to enhance the quality of life for cancer patients, and studies examining
the effect of natural inhibitors of carcinogenesis.

Before I describe what the NCI is doing to alter both our approach to the evaluation of
complementary and alternative therapies and our relationship with the complementary and
alternative medicine communities, let me make a few underlying points. First, why is there so
much complementary and alternative medicine in cancer? Let me propose two reasons:

First, is the near universal and quite ancient desire both to explain observations about
health and disease and to contribute by turning those observations, beliefs and theories into
interventions. Whether capturing folk traditions or individual contributions, these activities
offer an often confusing but potentially rich storehouse of information.

Second, is the frustration that all of us have with the inadequacy of so many of our
current therapies, especially for certain cancers and especially for far advanced cancer.

2


103

testimonies before me, and I know that you have the experience
and the expertise, and we are hoping to look at the safety and effi-
cacy of other issues.

Also I wanted to comment, Mr. Chairman, that I am pleased also
that you have from NIH Dr. Richard Klausner, from the National
Cancer Institute, who has testified and also Dr. Wayne Jonas who
testified. You chose to have some good experts here.

Dr. Speckhart, from what I understand, you have been practic-
ing, by many doctors’ views, sort of unconventional medicine. Does
this put you in peril as a practitioner in any way?

Dr. SPECKHART. No. en all these issues came up in 1992, my
practice went up by leaps and bounds. It was like wearing a purple
heart. I never advertise; I have no radio broadcast, and I have no
newsletter. I just wanted to do what I thought was best for my pa-
tients.

Mrs. MorRELLA. I also heard that you had cancer yourself?

Dr. SPECKHaRT. Yes, cancer of my nose.

Mrs. MorELLA. Did having cancer effect the way that you looked
at the disease?

Dr. SPECKHART. Absolutely. There was nobody to give me advice
as to what I should do, and I looked into my own self, and I found
that dental problems were the biggest issue, metals and infections
underneath crowns and things like that. So I set about to have all
of the metal removed and all of the diseased teeth taken out. I see
this routinely, that dental metals are a big issue. And patients
waiting to come to my office, based on the data that I have from
the data base, I recommend, while you are waiting around, to have
the metal taken out of your mouth. It is a big barrier. If the metal
is taken out, I find that the cases go to completion a lot more rap-
idly.

Now, this is a big area and I know it is a politically hot issue
to say heavy dental metals ought to be looked at. I don’t know of
any trial which has been done to address this issue, and we ought
to do it in a dispassionate way, based on the data that I have, but
that is the type of thing that we can integrate with the National
Cancer Institute.

It would be easy, for example, if I can say with reasonable cer-
tainty from my data that there is a relationship between, let’s say,
mercury amalgam and breast cancer. It would be easy to do stand-
ard therapy in one protocol and in the other arm take the metal
out and look at the outcome. It would be fairly straightforward.

Now, I think there would have to be a lot more comfort on the
part of those designing such a trial to say that at least that is the
case, and the responsibility I have with this early data is to show
outcomes. And I think that can be done, but the limitation that I
have is that I am working out in the marketplace. I have to make
a living. I have a staff to keep up. And all the work that I have
done in research has been out of my own private pocket, and I
haven’t had any outside help, and I am constrained by time. At the
end of the day, I am pretty tired.

I am 68, and I can’t sit down and do innovative work on re-
search. I will do that on weekends. Now that the board action is
over, I have a little more vigor coming back. I think I have enough
energy to do that, and I want to disseminate. I have given lectures


39

1_OPENING STATEMENT

Good nuoming. It is my pleasure to come before you today to summarize the activities of
the Office of Alternative Medicine (OAM) of the National Institutes of Health (NIH) regarding
research and public information on unconventional cancer therapies. Cancer is one of the most
devastating afflictions faced by Americans. Unconventional approaches to cancer abound and
are extensively used by the public. There is little research on unconventional cancer treatments
and so there are few guides for the public for making informed and evidence-based choices. Itis
the purpose of the OAM to facilitate research for discovering what is safe and effective in

unconventional medicine and provide that information to the public.

IL_BACKGROUND

‘The Office of Altemative Medicine (OAM) was established by statute in 1993 (P.L.103-
43) to “facilitate the evaluation of alternative medical treatment modalities...” The Office
developed its mission statement based upon this to facilitate research and evaluation of
unconventional medical practices and disseminate these results to the public.

Within this broad scope, the OAM is interested in all clinical conditions and diseases that
potentially lend themselves to treatment with complementary and altemative medicine (CAM)
interventions. Cancer is one of the major diseases for which the OAM has concentrated
resources. Over 60% of public inquiries that come into the OAM clearinghouse are related to

cancer, and cancer patients frequently seek out and use unconventional therapies.


64

IRONICALLY, ONE OF THE ONLY TIMES IN YOUR LIFE THAT YOU CAN
CLEARLY IDENTIFY WHAT YOU PRIZE MOST IS WRAPPED IN THE FACT
THAT YOU HAVE A TERRIBLE DISEASE. WITH A SORT OF "ZEN OF
BEING", A GESTALT OF IMPORTANCE, A PROLONGED FLASH OF
INSIGHT YOU RECOGNIZE THE OVERWHELMING SIGNIFICANCE OF SO
MANY SMALL THINGS...SO MANY NEW TREASURES. THE PEOPLE YOU
LOVE, THE NATURAL WORLD SURROUNDING YOU, YOUR FIVE
SENSES, THE EMOTIONAL SATISFACTION OF WORK...IT IS LIKE
BEING REBORN AND POSSESSING THAT ELUSIVE "SIXTH" SENSE.

THE WORST THING ABOUT HAVING CANCER IS NEVER BEING ABLE TO
TAKE ANYTHING FOR GRANTED.

WE CAN GLIDE THROUGH OUR DAYS BECAUSE WE CAN IGNORE
MOST OF THE INPUT OUR MIND IS FED. WE DO NOT HAVE TO
"ACKNOWLEDGE" WHAT WE TAKE IN BECAUSE OUR PERCEPTION IS
THAT IT JUST DOES NOT MATTER...WE CANNOT BE BOTHERED BY IT.
YOU MAY NOT REALIZE WHAT A LUXURY THIS CLOUDED VISION IS;
UNTIL IT IS TAKEN FROM YOU. ITS LOSS LEAVES YOU STUNNED...
INTROSPECTIVE...NUMB.

THE MEDICAL COMMUNITY
IT HAVE WHAT?

AFTER THE INITIAL SHOCK, THERE IS A WHIMSICAL FREEDOM THAT
COMES WITH BEING TOLD YOU HAVE CANCER...WHAT ELSE CAN LIFE
DO TO YOU?...YOU HAVE "THE BIG C"! HIT ME WITH YOUR BEST
SHOT! I CAN RELAX NOW--I'M OUT OF THE GAME...DOWN THE
CRAPPER...DONE FOR. GOD!...THE REALITY FRIGHTENS YOU!

A CANCER BY ANY OTHER NAME...

STAGE IV-B MIXED CELLULARITY HODGKIN'S LYMPHOMA, FIBRO-
SARCOMA, EWING'S TUMOR, LYMPHOCYTIC LEUKEMIA, BASAL CELL
CARCINOMA, RENAL CELL CARCINOMA, WILM'S TUMOR, SMALL CELL
CARCINOMA OF THE LUNG, KAPOSI'S SARCOMA, CUTANEOUS
MALIGNANT MELANOMA...THE LITANY GOES ON AND ON AND ON...
A LISTING OF EFFICIENT PREDATORS SILENTLY STALKING.

IF YOU HAVE TO HAVE ONE...THIS IS THE ONE TO HAVE.
NOT ALL CANCERS KILL YOU RIGHT AWAY. SOME TAKE WEEKS,
SOME MONTHS, AND, IF YOU ARE LUCKY...SOME TAKE YEARS. THERE
IS NO SUCH THING AS A GOOD CANCER. THEY ARE ALL BAD,

-2-


35

‘Of considerable importance to all of us is the public availability of accurate, up-to-date

information about CAM therapies. NCI has taken steps to assure that this information receives
the same consideration as conventional approaches in our evaluation and dissemination efforts.

Detailed CAM summaries are being prepared for cancer therapies identified by our
Cancer Information Service and the OAM Clearinghouse as being of public interest.
‘The development of these summaries will follow the same model as those for
conventional therapies and include specific trial results and references to the published
literature. They will be reviewed by the appropriate Physicians Data Query (PDQ)
Editorial Board depending on whether the intervention is for the treatment or
prevention of cancer or used as a supportive care intervention, In addition, these
summaries will be sent to experts in the CAM community for review and comment
before they are made available on the NCI web site.

Reviews are in progress for shark cartilage and hydrazine sulfate; summaries for
lactrile, Essaic, and antineoplastins will be drafted in the near future.

Several months ago, as a result of our own concerns and the constructive input from the
CAM community, we removed from the NCI web site all previous CAM information
and are creating new information that treats CAM dispassionately and fairly. We are in
the process of completely rewriting all the NCI fact sheets that deal with CAM , with
hydrazine sulfate and antineoplastons being the first therapies newly available on the
web site.

We shall establish eeu in CAM atthe NCI as part ofthe medical grand rounds
series in our Division of Clinical Sciences and open to all members of the NIH
‘community interested in CAM approaches.

We are discussing with Dr. Barnett Kramer, the Editor of the Journal of the National
Cancer Institute, the possibility of instituting a regular feature on CAM and cancer.
This would, in my view, be a very useful thing to do; the ultimate decision on how this
ought to be implemented will rest with Dr. Kramer and his Editorial Board.

As Director of NCI, I have a strong commitment to improving relations and eliminating

as best as possible the tension between the two research communities. Both communities share
a common and admirable goal - to cure cancer. It is vital that we work together to that end.

I will be happy to answer any questions.


67

WHY I CHOSE AN ALTERNATIVE THERAPY
" A MAN'S GOT TO KNOW HIS LIMITATIONS."
- ACLINT EASTWOOD CHARACTER

MY INITIAL DIAGNOSIS OF LYMPHOMA IN 1986 WAS FOLLOWED BY
A YEAR OF CHEMOTHERAPY. MOPP, AS IT IS CALLED, CONSISTED OF
MUSTARD NITROGEN (USED DURING W.W.I BY THE GERMANS TO
GAS ALLIED TROOPS), ONCOVIN (CAUSES YOUR HANDS AND FEET TO
GO NUMB), PREDNISONE (GIVES YOU A BIZARRE MENTATION AND
CAUSES YOUR FACE TO BLOAT), AND PROCARBAZINE (MAY CAUSE
LEUKEMIA -- MAKES YOU STERILE). MUSTARD NITROGEN AND
ONCOVIN WERE ADMINISTERED VIA I.V.. THESE DRUGS, LIKE MOST
CHEMOTHERAPEUTIC AGENTS, DAMAGE YOUR VEINS MAKING
SUBSEQUENT I.V. STARTS MORE AND MORE DIFFICULT. CHEMO
NURSES START TO HAWK FOR ANY GOOD VEIN. THE BACKS OF YOUR
HANDS, YOUR FOREARMS...ANY PLACE AN I.V. NEEDLE CAN BE
INSERTED IS OPEN FOR SPECULATION AND PENETRATION.

PENNY LOAFERS AND CHEMO BAGS MAKE ME PUKE...

TT IS A WELL KNOWN FACT THAT MOPP HAS A REMARKABLE
PROPENSITY TOWARD MAKING YOU PUKE YOUR GUTS OUT. IT DOES
NOT MAKE YOU VOMIT...IT MAKES YOU PUKE. HOSPITAL AT EIGHT
O'CLOCK...CHEMO AT NINE O'CLOCK...HOME AT TEN O'CLOCK...
PUKING STARTS AT ELEVEN FORTY-FIVE. ONCE EVERY TWENTY
MINUTE FOR SEVENTEEN HOURS YOU HUG THE COMMODE AND “DRY
HEAVE". IT IS EXHAUSTING! THE ANTI-EMETIC DRUGS YOU HAVE
TAKEN ARE OVERPOWERED BY THE BODY'S URGE TO PURGE ITSELF
FROM THIS POISON. THE MIND MAKES ASSOCIATIONS WHICH ARE
NOT EASILY CONTROLLED. HEARING THE SOUND OF PENNY LOAFERS
(MY ONCOLOGIST'S FAVORITE SHOE) COMING DOWN THE
HALL--EVOKES WAVES OF NAUSEA. JUST SEEING THE BROWN BAGS
(COLORED TO PREVENT LIGHT FROM ALTERING THE CHEMO DRUGS)
REQUIRES A WASTE BASKET BE AT THE READY. THE WINDING STEM
OF YOUR WRISTWATCH FEELS LIKE AN I.V. START--YOU STOP.
WEARING THE WATCH. EVERY TWO WEEKS YOU HAVE YOUR BLOOD
DRAWN TO FOLLOW YOUR WHITE BLOOD CELL COUNT. IF THE
CHEMO HAS NOT DESTROYED TOO MANY OF YOUR WHITE BLOOD
CELLS...IF YOUR "COUNT" IS NOT BELOW 1.0 (NORMAL 4.6 - 10.8),
YOU CAN TAKE ANOTHER HIT OF CHEMO. YOU LIVE AND DIE BY THE
COUNT. YOU PRAY FOR A COUNT LESS THAN 1.0 SO YOU WILL NOT
HAVE TO TAKE ANOTHER "HIT". WITH A COUNT LESS THAN 1.0 YOU
COULD DIE FROM INFECTION...WHO CARES...OAMN CHEMO!

5.


104

and things like that. But I need help. I need somebody with exper-
tise that can say, I can take your data and this is valid and this
is not and put it into a package and have it go up to another level.
I am not covetous of it; I just want to get it out there.

Mrs. MoRELLA. Do you think that the treatments that you do
could be clinically tested?

Dr. SPECKHART. Everything that I do works off a voltmeter. It is
three-dimensional space time. It is very analytical. And it should
be fairly straightforward. After all, I think we have to do research
into biophysics. That is a large area that has to be developed.

Look what happened with geology after the invention of the seis-
mograph. We really began to understand what was going on under-
neath the surface. With electroacupuncture, you can get signals
from the skin and see what is going on with various organ systems.
It is nontoxic and noninvasive, and you can work your case.

I can iterate. I can go over a patient one time and see what I
have as energy blocks and do the same thing again. You keep
working the case until you don’t get any more iterations and then
observe as a trained physician to see the clinical response. It really
works nice for somebody that is analytical in nature.

Mrs. MORELLA. Dr. Key, let me ask you a question about conven-
tional oncologists. Do you think that they are doing the best for
their patients; and, if not, what would you suggest?

Dr. Key. I don’t believe that I have ever met a clinical oncologist
or physician personally that would do anything but the best for
their patients. I think the problem is in how you look at what you

lo.

When I was first given the tape of Dr. Gonzalez’s program, I hon-
estly looked at it and said, here is what I need, is a hippy-dippy
approach to cancer. I tossed it in a box, took the traditional ther-
apy. Eight years later I relapsed and was given the opportunity to
have a bone marrow transparent or salvage chemotherapy. I knew
I had about a 24 percent chance of living, which is a 76 percent
chance of dying. I found that tape when I was cleaning out a box
and put it in on the way to a track meet to watch my girls run.
I was doing it just as something to do.

What this gentleman was saying made a great deal of anatomic
and physiologic sense. What happened, as a physician and cancer
patient, my view changed. If any one of you sitting here has cancer,
you know taking an alternative approach is not outside the bounds
of normalcy. In fact, it may be the best way for you to go.

No, I don’t think that oncologists are trying to do their patients
in. I think when my lymphoma specialist looked at me and said,
do this bone marrow transplant, knowing that I had a 24 percent
chance of living through it and I would have a miserable existence,
he told me to do it because that is what he is trained to do. He
is not allowed to look at alternative treatment by others in his pro-
fession. So that is the answer. I don’t think that they are out after
us. 1 think they need to change the way that they look at what

ey do.

Mrs. MoRELLA. Dr. Klausner testified earlier, he talked about
collaborative efforts that are being made to develop the CAM infor-
mation and the research opportunities expansion. Would you like


45

interviews. This study was jointly funded by OAM and NCI. Finally, also in 1998, the
University of Southem California SEER contract was also modified to include a “Special Study
of Use of Complementary/Alternative Medicine by Cancer Patients for Selected Cancers and
Population Subgroups.” This is supported entirely by the NCI.

Future plans may include a study of the effectiveness of specific CAM cancer
interventions over long periods of use as they relate to cancer outcomes, quality of life and
mortality.

Current Clinical Trials, Because of the existing clinical trials infrastructure of the NCI, including
cancer centers and cooperative groups, and the willingness of NCI to contribute the use of these
centers, clinical studies will require minimal start up time. It is the aim of the OAM to perform
more definitive clinical trials and make any results available to the public. There are two
currently planned studies to be implemented with the NCI, using the recommendations of
POMES and through NCI clinical trial mechanisms.

‘Shark Cartilage. The first is the use of shark cartilage for the treatment of some solid
tumors. Protocols to conduct a rigorous test of shark cartilage on cancer through NCI supported
cancer centers are currently under review by the NCI. A process for solicitation and selection of
an appropriate product to test is also underway. Funds have been transferred to the NCI for this
project.

Diet and Supplement Therapy. A second project is the use of diet and nutritional
supplements for the treatment of pancreatic cancer (using a program developed by Dr. Nick
Gonzales). This project is an example of how CAM cancer practices can go through a
progressive series of research steps starting with a best case series, to practice outcome

evaluation, to a controlled trial. The OAM has been providing technical assistance throughout


87

be confused with those who use nutritional support, exercise. stress reduction, group
support acupuncture, herbs and spirituality to provide demonstrable benefit to cancer

patients.

Chairman Burton has correctly pointed out the very word “cancer” is so terrifying and the
umpact on the individual so uncertain, thet faced with the die gnosis an individual seeks
‘elp and trestment from whatever source he or she can find. The facts that the alternative
medicine “business” has grown from 13 billion in 1990 to an estimated 50 billion in 1997
and that more people visit altemafive medicine practitioners than primary care physicians
in the United States speak to the attractiveness as these approuches to consumers.

Lastly, the critics of complementary and altemative medicite (CAM) bemnoan the lack of
scientific studies documenting efficacy. This criticism is vilid but the lack of evidence
based medicine is not unique to CAM but exists in traditional medicine as well. Consider
the use of autologous bone marrow transplant for women with metastatic breast cancer.
In the 5-year period between 1989-1994 there was a 6-fold increase in the use of bone
marrow transplantation despite the lack of demonstrable su vival advantage using their
expensive, morbid and occasionally fatal intervention. In contrast, a landmark study by
Spiegel and colleagues at Stanford University demonstrate! a doubling of survival in
breast cancer patients receiving a single 1 % hour session of group support for | year. As
expected the median survival in the control group was 18 monihs versus 36 months in
those receiving group support. Ladics and gentlemen, I sulmt that if these figures were

the result of a new drug or expensive interventional procedare that would allow an


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SOLVING THE CANCER CRISIS: COMPREHEN-
SIVE RESEARCH, COORDINATION AND CARE

FRIDAY, JULY 31, 1998

HOUSE OF REPRESENTATIVES,
COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT,
Washington, DC.

The committee met, pursuant to notice, at 10:05 a.m., in room
2154, Rayburn House Office Building, Hon. Dan Burton (chairman
of the committee) presiding.

Present: Representatives Burton, Gilman, Morella, Miller, Wax-
man, Maloney, and Kucinich.

Staff present: Kevin Binger, staff director; Daniel R. Moll, deputy
staff director; David A. Kass, deputy counsel and parliamentarian;
Laurie Taylor, professional staff member/counsel; Judith McCoy,
chief clerk; Teresa Austin, assistant clerk/calendar clerk; Will
Dwyer, director of communications; Bill Hanka, deputy director of
communications; John Williams, press secretary; Robin Butler, of-
fice manager; Phil Schiliro, minority staff director; Phil Barnett,
minority chief counsel; Cherri Branson, minority counsel; Earley
Green, minority staff assistant; and Ellen Rayner, minority chief
clerk.

Mr. BURTON. The committee will come to order.

Before we start our hearing today, I would like to make mention
of Officer Chestnut, who lost his life last Friday, along with Detec-
tive Gibson, who was buried yesterday at Arlington. We would
have deferred the hearing today except that people were already on
their way and had made plans, and so we do not want this to be
seen as any disrespect whatsoever for Mr. Chestnut, whose funeral
process will be starting shortly.

So I would like for everyone to bow their head for a moment of
silent prayer in remembrance of these two great officers.

you.

Today, we will continue a series of hearings begun earlier this
year focusing on improving access to alternative medical treat-
ments for millions of desperately ill Americans. Today, we will
focus on a disease that we know will kill half a million Americans
this year and will afflict many more Americans. That is cancer.
Cancer is not choosy. It strikes people of all ages, races, and eco-
nomic backgrounds. Cancer now strikes one in three and kills one
in four, and that is up from an incidence on one in four and mortal-
ity of one in five in the 1950's. So the increase has been substantial
since the 1950’s.

It is with regret that I say again that more than 25 years have
passed since President Richard Nixon first declared war on cancer.

c60)


42

solicited the CAM community for preliminary research information, such as “Best Case Series,”
(a procedure for presenting cases successfully treated), conducted workshops and technical
assistance to hundreds of CAM practitioners on how to collect research information, and issued
several contracts to obtain scientific summaries of CAM cancer areas.

‘Also during this time, the OAM funded a grant to the University of Texas Health
Sciences Center in Houston to begin collecting and developing research projects in CAM and
developing links between the CAM and research communities. This center is administered
through the NCI and is dedicated solely to cancer. The Texas center is now in their fourth and
final year of award. Preliminary information coming from the Texas center has identified
possible promising interventions in cancer such as the use of mistletoe extracts for the treatment

of several types of cancer. In addition, the center has summarized the current research on over

25 of the main CAM cancer therapies and made this information available to the public over their
website and at conferences and meetings.

In 1993, the OAM transferred funds to the NCI to conduet a study of anti-neoplastons, a
controversial cancer therapy developed by a practitioner in Houston. This study failed to obtain
sufficient recruitment and was stopped in 1995 after disagreements over protocol design. After
evaluating the issues around this attempted trial, and on advice from the OAM advisory council,
the OAM sought to increase advisory input and develop opportunities for more dialogue between
the CAM and conventional communities.

Obtaining Advisory Input

In the summer and fall of 1995 and spring of 1996, the OAM and NCI held a series of

meetings both internally and with outside consultants to examine how to execute research

Projects more effectively in CAM cancer areas and build better collaborative bridges between the


73

SQUAD C-10 - DISTRICT OF COLUMBIA JOINT FUGITIVE TASK FORCE
(DCIFTF)

SQUAD C-10, CONSISTING OF 13 FBI AGENTS, 15 MPD OFFICERS, 8
DEPUTY U.S. MARSHALS AND 12 ADDITIONAL FEDERAL AND LOCAL LAW
ENFORCEMENT OFFICERS, FOCUSES EXCLUSIVELY ON THE APPREHENSION OF
VIOLENT FUGITIVES. SINCE ITS INCEPTION IN AUGUST, 1989, THE
DCJFTF HAS BEEN RESPONSIBLE FOR THE ARREST OF OVER 6,000 VIOLENT
FUGITIVES. THE CONCEPT OF SQUAD C~10 HAS BEEN SO SUCCESSFUL THAT
IT HAS BEEN EXPANDED INTO NORTHERN VIRGINIA THROUGH A PARTNERSHIP
WITH THE FAIRFAX COUNTY POLICE DEPARTMENT AND THE FAIRFAX COUNTY

SHERIFF'S DEPARTMENT.

SQUAD C-21 - FBI/MPD MAJOR CASE TEAM

SQUAD C-21 INCLUDES 11 FBI AGENTS AND 10 MPD OFFICERS. THE
MISSION OF SQUAD C-21 IS TO INVESTIGATE HOMICIDES WHICH ARE GANG
OR NARCOTICS RELATED OR INCLUDE SUBSTANTIAL INSTANCES OF
OBSTRUCTION OF JUSTICE. SQUAD C-21'S MISSION ALSO INCLUDES THE
INVESTIGATION OF SERIAL KILLERS, HIGH PROFILE CASES, SUCH AS THE
BALLOU HIGH SCHOOL FEMALE STUDENT HOMICIDES AND THE STARBUCKS
MURDERS, AND CERTAIN ASSAULT WITH INTENT TO KILL (AWIK) OR
HOMICIDE CASES WHERE POLICE OFFICERS ARE THE VICTIMS. IT IS A
SPECIFIC GOAL OF SQUAD C-21 TO CAUSE A MEASURABLE REDUCTION IN
THE NUMBER OF VIOLENT CRIMES IN WASHINGTON, D.C. AND REDUCING THE
EXISTING HOMICIDE RATE. SINCE ITS INCEPTION IN JUNE, 1992, SQUAD

©-21 HAS SOLVED A TOTAL OF 212 HOMICIDES. CURRENTLY, SQUAD C-21


the outcome

Physicians must be free to prescribe safe and effective therapies from whatever school of
thought in which they are trained Remember both medicine and law engage in “practice”. There
is no guarantee of outcome. Simply using alternative therapies should not be a cause for license
revocation or probation.

J encourage you to provide funding for both basic research and for clinical trials in
alternative medicine through the National Institute of Health and the Office of Alternative

Medicine.

Vincent J Speckhart, M.D., MD(H)


SOLVING THE CANCER CRISIS: COMPREHENSIVE
RESEARCH, COORDINATION AND CARE

HEARING

BEFORE THE

COMMITTEE ON
GOVERNMENT REFORM
AND OVERSIGHT
HOUSE OF REPRESENTATIVES

ONE HUNDRED FIFTH CONGRESS
SECOND SESSION

JULY 31, 1998

Serial No. 105-156

Printed for the use of the Committee on Government Reform and Oversight

oe

U.S. GOVERNMENT PRINTING OFFICE
50-588 CC WASHINGTON : 1998

For sale by the U.S. Government Printing Office
‘Superintendent of Documents, Congressional Sales Office, Washington, DC 20402

ISBN 0-16-057488-9
3



110

problem is the disease. It is not just attitude. I think it is very im-
portant to maintain that perspective.

We need to make more progress. That is what we are about. The
NCI wouldn’t be there if that disease wasn’t there, but I think it
is very important not to send the message that there are some
therapies that predictably and reproducibly cure people.

I think Dr. Gonzalez would not recommend people not receive
chemotherapy for Hodgkin’s disease, but I want to be careful that
we not leave a message that sends a message to the American peo-
ple misinformation about cancer and chemotherapy.

Mr. Burton. Thank you. I hope with the great strides that have
been made that the information that we are getting from other
sources, from other doctors in other fields, that we are able to in-
corporate that and maybe add to and give every doctor in this
country more tools with which to fight this disease.

Did you have any final comments, Dr. Jonas?

Dr. Jonas. Yes, sir. I appreciate your having this hearing and
talking to us about the progress. Of the presentations that were
made, we are integrally involved in a number of them that were
actually discussed. The Gonzalez therapy, the NCI and we are in-
volved in supporting a clinical trial this year.

We have made practice visits to almost all of the therapies men-
tioned here today. I have personally made visits to Dr. Gonzalez’s
practice, Dr. Speckhart’s practice, to the vaccine practice that your
wife currently undergoes and other diet therapy practices currently
around the world, including some mentioned in China.

We provided a grant to study this electrical therapy in rats in
China which showed some remarkable results in rat sarcoma, and
we have requested this researcher out at the University of Califor-
nia apply for a larger grant.

I think you have heard today the exact issues we are trying to
address, promoting dialog in these areas so there is an increased
exchange between CAM practitioners and the researchers that can
take it forward, and also the need to have another view, a view
which recognizes health supporting activities as having a major im-
pact on cancer and going forward with research in those areas.
Thank you.

Mr. BurTON. Mrs. Morella, do you have any other comments?

Mrs. MorELLA. NIH is, of course, one of my favorites, not only
because it happens to be in the district that I represent but the fact
that it is a premier international front of research. And it was 22
years ago when my sister died of cancer, and she was on chemo-
therapy. I have found out that if she were alive today her cancer
would be cured, because we have made those kinds of strides. This
is why we in Congress have funded handsomely the National Insti-
tutes of Health, because we know of the quality of life and the tre-
mendous savings that we have made.

I am pleased that you do have the OAM, that you are involved
in alternative therapies. People are looking for hope and they are
looking for other ways, and they know that maybe something can
come about. So I compliment you on that, and I think that we are
in no way demeaning the research that is being done, which we en-
courage and want to encourage you to fund.




107

Mr. BurTON. He said, no one dies from the disease, they die from

the treatment?

Dr. KEy. Basically, yes. In fact, that is almost a verbatim quote.

What happened was, after a literature search and computer

searches and cutting through the jargon of all of the journals and
cancer-free period, survival time, I came up with the fact that I
have about a 24 percent chance of living. After analyzing that, I
was evaluated by everyone he asked me to be evaluated by. When
I came back and sat down with him, I said, thank you very much
for all of your efforts. I appreciate your efforts, but I am not going
to do anything.

I said, how do I die? And he looked at me and he said, what do
ou mean? I said, how do I die? He said, metastatic disease. But
e said that they don’t die from your disease, they die from its

treatment. I said, my point exactly. He was being honest and not

ip.

And I invited him, after I chose to see Dr. Gonzalez, please follow
me, do a scan, do a blood test; and he didn’t want to have any part
of it. Yet I work with this man, both my oncologist and his partner,
Who >is my good friend, and they always look at me and shake their

eads,

One other anecdote, his partner oncologist was walking into the
office to report to a parent of a 21-year-old man that he was going
to die from Hodgkin’s lymphoma. He had had the bone marrow
transplants and so on. The physician walking in met a nurse who
happened to know me also, and they were chatting about how well
I was doing, and the parent heard this. And so when Dr. Gulick
walked in, who was trained at Cleveland Clinic, said there is noth-
ing else we can do, we can continue to feed you the chemo-
therapies, he said, I don’t mean to be rude, what about this other

iy?

Yes, why don’t you give him a call?

This young man applied to get into Dr. Gonzalez’s program and
wasn’t taken in. I called Dr. Gonzalez more as a friend and a plea.
This young man was my son’s age; you can’t let him die. Dr. Gon-
zalez looked at me. He said, Larry, I get over 125 calls a day. I can
take three people. I have to take the three people that I am going
to be most helpful with. This young man has massive chemo-
therapy, and previous bone marrow transplants just about preclude
him from having a good outcome.

Now, I didn’t read that as he is only taking people he can cure.
He took me. He almost didn’t want to take me because I had so
much chemotherapy. I looked at it, how can Dr. Gonzalez live turn-
ing people away? How do you do this?

So, yes, my oncologist did look at me and say you don’t die of the
cancer, you die of the treatment. On the other hand, he did it with-
out blinking.

Mr. BuRTON. You know, I don’t know how you change the mind-
set. When Dr. Marshall cured me with just some antibiotics and
bismuth of a disease that everybody else thought was caused by
nerves, stomach ulcers—I was at a party, and I told him about my
experience with Dr. Marshall, and he became visibly angry. His
mind-set was that stuff doesn’t work.


30

There has been a lot of progress. Much of that progress has been
hard to see because we have had to invest in understanding these
diseases which are so complex. And I would be delighted to answer
questions about that and how we are moving forward.

Thank you very much.

Mr. Burton. Thank you, Dr. Klausner.

[The prepared statement of Dr. Klausner follows:]


89

believe that we need to continues the search for a cure for cancer but despite the
prodigious advances in molecular biology, immunology, genetics and other areas, the
cure will not come easily. To increase funding which will allow adequate research trials
of complementary techniques aimed at slowing disease prog ession and improving life
quality should be viewed as part of our overall strategy in th war against cancer.

‘We have heard the impressive statistics conveying just how ::portant complementary
and alternative medicine is to the average American. Despits the staggering amount
spent out of pocket by Americans, the NIH expenditures for research in this area is
miniscule and should be greatly augmented.

In conclusion, as an academic physician involved in cancer research, teaching and clinical
core, and as an individual afflicted with the scourge of cancer, I believe we, in American
medicine, are falling far short of what is needed to maximize: cancer care for our citizens.
My recommendations to the committee to stimulate more research is this most important

area are as follows:

1.) The recent establishment of a Cancer Advisory Panel to the office of altemative
‘medicare (OAM) is a step in the right direction but not neatly enough. The panel may
make recoramendations to the OAM, but the rea! fate of any grant proposal will be
decided by the study section to which the grant is assigned by the NCL Initially, there
‘will not be enough CAM grant proposals to warrant the establishment of a separate study

section; Tam dubious that any of the existing study sections will look with a great deal of


84

Last, the critics of CAM bemoan the lack of scientific studies doc-
umenting efficacy. This criticism is valid, but the lack of evidence-
based medicine is not unique to CAM and exists in traditional med-
icine as well. We need to continue the search for a cure for cancer.
But cures should not be the only goal. To increase funding which
will allow adequate research trials of complementary techniques
aimed at slowing disease progression, such as has been dem-
onstrated in AIDS therapy, and improving life quality should be
viewed as part of our overall strategy in the war against cancer.

Despite the staggering amount spent out-of-pocket by Americans,
the NIH expenditures for research in this area is minuscule and
should be greatly augmented. As an academic physician involved in
cancer research, teaching and clinical care and as an individual af-
flicted with the scourge of cancer, I believe we and American medi-
cine are falling far short of what is needed to maximize cancer care
for our citizens.

My recommendation to the committee to stimulate more research
in this most important area is as follows: The recent establishment
of a Cancer Advisory Panel to the Office of Alternative Medicine is
a step in the right direction but not nearly enough. The panel may
make recommendations to the OAM, but the real fate of any grant
proposal will be decided by the study section to which the grant is
assigned,

Initially, there will not be enough CAM grant proposals to war-
rant the establishment of a separate study section, but I am dubi-
ous that any of the existing study sections will look with a great
deal of favor on the complementary medicine grants competing
with the other grants submitted to the NCI. I believe the only way
to ensure adequate oversight of these grants is to have someone
sympathetic to the CAM community appointed to the National
Cancer Advisory Board. An individual with a true interest and
commitment to CAM sitting on this committee could exert a power-
ful influence in assuring that complementary medicine grants are
given an adequate review and, equally important, that information

e disseminated from the National Cancer Advisory Board to the
CAM community concerning strategies to increase the likelihood of
success of grant applications.

A representative on the NCAB, chosen because of research expe-
rience and knowledge of the role of complementary and alternative
medicine and cancer management, would assure the CAM commu-
nity and the American voter that our government is aware of the
growing demand for CAM services and is determined to evaluate
these modalities in an impartial, scientific and carefully scrutinized
manner.

Thank you very much for the opportunity to address this commit-
tee.

Mr. BurTON. Thank you, Dr. Fair.

[The prepared statement of Dr. Fair follows:]


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HIN fopsn2 save pur coum ot Papuan am CaRy Sonu ote
204 Soa Bes aq andro popes fou am suonepuranaenn ero


54

Mr. KucinicH. Thank you very much, Mr. Chairman; and I
thank you very much for your leadership in this area. Because cer-
tainly People all over the country are looking for assistance and a
means of dealing with cancer and Chairman Burton's leadership in
raising the possibility of looking at alternative therapies as a
means of assuring that people have a better chance to live is, I
think, a major contribution; and I want to salute you for that, Mr.
Chairman.

What we know is that the American people are already moving
ahead in search of a cure for cancer, because that’s what I think
you could attribute to—to what you can attribute the amazing pop-
ularity of the use of alternative therapies. The thing that occurs to
me is that we hear that there’s a lack of scientific studies docu-
menting the efficacy of alternative therapies. Dr. Jonas, could you
tell us, is perhaps one reason because of the resistance of tradi-
tional medicine to funding alternative research?

Dr. Jonas. Well, traditionally, there has not been an investment
by the conventional community which has the bulk of the resources
in these areas. That’s largely why they’re classified as unconven-
tional medicine. And so there has not been a large investment in
these areas.

Mr. KucINICcH. There’s been a great amount of anecdotal infor-
mation available. Is there a central data base for that information?

Dr. JONAS. No, there isn’t. Anecdotal information or stories can
be useful. In fact, it’s the foundation for collecting research that
then goes into comparative trials, also. But it must be collected in
very systematic and complete ways. And most of the information
that is collected out in practices is not collected in order to be ana-
lyzed in a way to decide whether it works or not works, and so
often that information is not very useful for making decisions about
the amount of evidence that exists.

Mr. KucInicu. You know, it may be, in listening to medical prac-
titioners speak on this subject, that the lack of a centralized data
base on this is a major obstacle toward being able to evaluate this
almost folkloric need which people have for alternative therapies.
But it goes beyond folklore. ‘Alternative therapies do work.

What can be done to establish a centralized data base and even
a web site? I mean, we're in an era of technological leaps. If we had
a web site where people who have experienced the benefits of alter-
native therapies could literally tell their story and then the profes-
sional practitioners could perhaps see if there’s some common
links. So how would you respond to that?

Dr. Jonas. Well, theoretically, that’s possible; practically, it’s ex-
tremely difficult. And I will give you an example.

We have a process that NCI developed calls the best-case series,
which is essentially doing what you're requesting, collecting evi-
dence that certain cases actually were cured by a therapy and actu-
ally did have cancer. And frequently, when that evidence is pro-
vided, it’s found that there were errors in what has been reported.
So, for example, the individual did not have cancer or the cancer
diagnosis was incorrect or they only reported part of the therapies
that they were getting and didn’t report all types of therapies
which could be effective.


96

Testimony to the Committee on Government
Reform and Oversight

James S. Gordon, MD
Director, Center for Mind-Body Medicine

Six weeks ago, the Center for Mind-Body Medicine, with the collaboration of the NIH’s
Office of Alternative Medicine and the University of Texas Health Sciences Center,
held the first annual conference on Comprehensive Cancer Care: Integrating
Complementary and Alternative Therapies. (See attached articles from USA Today and
the Journal of the National Cancer Institute.)

This conference brought together for the first time those who are doing the most
interesting research and clinical work with complementary and alternative therapies
with leaders of the American cancer establishment, including David Rosenthal, MD,
President of the American Society, Robert Wittes, MD, Deputy Director of the National
Cancer Institute, and Robert Temple, MD, Deputy Director of the Food and Drug
Administration. Some 115 clinicians, researchers, and patient advocates from around

the world presented their work, and more than 1000 people attended.

The conference grew out of obvious and pressing needs that many of us have
recognized and that I have experienced in several of my professional roles ~ as Director
of the Center for Mind-Body Medicine, an organization that provides support groups
and referrals for hundreds of people with cancer each month; as the first Chair of the
Program Advisory Council for NIH's Office of Alternative Medicine; and as a clinician
in private practice, who receives calls every day from people with cancer and their

families.


15

EVERYTHING NEW ISN'T NECESSARILY GOOD, AND
EVERYTHING OLD ISN'T NECESSARILY BAD

I HAVE BEEN ON THIS METABOLIC / NUTRITIONAL TREATMENT
PROGRAM FOR OVER THREE YEARS. I HAVE HAD TRADITIONAL
LABORATORY TEST AND A VARIETY OF SCANS PERFORMED. FOR THE
MOST PART MY RESULTS RANGE FORM NORMAL TO SLIGHTLY
IRREGULAR. MY TUMOR LOAD HAS SHRUNK DOWN. RESIDUAL
REACTIVE LYMPH NODES REMAIN IN MY LUNGS (NOT UNUSUAL FOR
THIS TYPE OF CANCER) BUT DO NOT HINDER MY RESPIRATORY
EFFORT. MOST HAVE SHRUNK, THE OTHERS ARE NOT ENLARGING.
THE ONCE, GOLF-BALL SIZED LYMPH NODE LOCATED AT THE BASE OF
MY NECK -- (AN INDICATION OF MY ABDOMINAL PERIAORTIC
ADENOPATHY) IS NOW BARELY PALPABLE. A FORMER BODY BUILDER,
I WEIGH TWO HUNDRED AND TWENTY-FIVE POUNDS. I TRY TO
EXERCISE AT LEAST THREE TIMES A WEEK. AFTER NOT WORKING
FOR TWO YEARS, I NOW WORK THIRTY-SIX HOURS A WEEK AS AN
URGENT CARE PHYSICIAN AT MICHIGAN STATE UNIVERSITY'S
STUDENT HEALTH CENTER. SOMETIMES I GET FATIGUED -- A LITTLE
REMINDER TO KEEP IT SLOW. I AM A PRODUCTIVE MEMBER OF
SOCIETY. I AM A GOOD FATHER, A GOOD HUSBAND, A GOOD
DOCTOR....BUT MOST OF ALL...[ AM HERE! I WORK WITH A
PHYSICIAN WHO LOST HER HUSBAND TO HODGKIN'S LYMPHOMA. A
CHEMIST, HE WAS EXPOSED TO THE SAME BENZENE PRODUCTS THAT
GAVE ME MY CANCER (I WAS EXPOSED AT AGE FOURTEEN WHILE
WORKING IN A DRY CLEANERS). SHE IS AMAZED AT MY HEALTH.
ANOTHER CO-WORKER'S HUSBAND HAS MY DISEASE. HE OPTED FOR
THE MORE ORTHODOX ROUTE OF SALVAGE CHEMOTHERAPY AND
BONE MARROW TRANSPLANT. HE IS MISERABLE. HE WEIGHS
NINETY POUNDS "WET WITH A ROCK IN HIS POCKET”. HIS SKIN IS
THE COLOR OF AGED PARCHMENT. HE LIVES IN A PRIVATE HELL.
ALIENATION FROM HIS WIFE, CHILDREN, AND SOCIETY ARE A WAY
OF LIFE. HE IS ANGRY. AN ENGINEER, AN INTELLIGENT MAN, HE IS
WAITING TO DIE, FOR HIM, CANCER'S MANTRA IS A DRONE...DEATH
WILL BE INEVITABLE AND WELCOMED.

TELL A LIE LONG ENOUGH AND IT BECOMES THE TRUTH

MY FINAL THOUGHTS FOR YOU INCLUDE A DISCLAIMER. I WILL
TELL YOU THAT I DO NOT HATE OR DISAVOW THE WORK OF
ORTHODOX ONCOLOGY. BY A QUIRK OF FATE, CHEMOTHERAPY KEPT
ME ALIVE LONG ENOUGH TO TAKE PART IN MY PRESENT PROGRAM.
HOWEVER, IF I CAN PREVENT ONE OTHER HUMAN BEING FROM
SUFFERING THROUGH, NOT JUST THE CANCER BUT THE TREATMENTS.
OF THIS DISEASE--I WILL DO SO. I WILL DEVOTE MY LIFE TO IT.

-13-


36

Mr. Burton. Dr. Jonas.

STATEMENT OF WAYNE JONAS, M.D., DIRECTOR, OFFICE OF
ALTERNATIVE MEDICINE, NIH

Dr. JoNAS. Thank you. Good morning.

It is my pleasure to come before the committee today to summa-
rize the activities of the Office of Alternative Medicine at the Na-
tional Institutes of Health regarding unconventional cancer thera-
pies.

As has been mentioned, cancer is one of the most devastating
conditions faced by Americans today. Unconventional approaches
abound and are extensively used by the public; and yet, at the
same time, there is very little research on these treatments so that
there are few guidelines to help the public make informed and evi-
dence-based choices about their use. It is the purpose of the OAM
to facilitate research for discovering what is safe and effective in
unconventional medicine and provide that information to the pub-
ic.

There are three main challenges that must be addressed in pur-
suing research and CAM cancer therapies. The first is the need for
resources and an infrastructure that is committed to rigorous re-
search in CAM cancer therapies. I agree wholeheartedly that
choices in health care must be based on evidence and not simply

lief.

The second is the need to develop trust and collaborative rela-
tionships between the cancer researchers and those practitioners
who are providing CAM cancer therapies; and the third, to help the
prioritization process that Dr. Klausner mentioned, is to obtain ex-
pert advisory input in deciding on which projects can and should
be researched first. The OAM is moving forward in all of these
areas.

In order to address the first issue, rigorous research, we recog-
nized very early that we would need cooperation and collaboration
with the NCI. The reason is very simple. The NCI has all the req-
uisite resources to execute appropriate research, including in-house
expertise for conducting clinical trials, conducting preclinical re-
search, reviewing protocols, working with the Food and Drug Ad-
ministration for investigation on new drug applications. The NCI
is also able to provide linkages to non-NIH researchers with de-
tailed knowledge about specific cancers.

The OAM is successfully using this model in a number of other
areas with other institutes. For example, we have a large clinical
trial on the treatment of depression with St. John’s Wort with the
National Institute of Mental Health. We have a trial that is going
to start soon on acupuncture and osteoarthritis with the Arthritis
Institute; and we are going to fund some studies in nutritional
therapy for heart disease through the centers that are supported
by the National Heart, Lung, and Blood Institute.

By working closely with the NCI, the OAM is developing similar
projects for CAM cancer therapies.

To address the second issue, building collaboration and trust, we
have begun a series of activities to bridge CAM practitioners with
the conventional research community. is includes funding ex-
ploratory grants, a number of them on cancer; conducting over 40


48

This database is continually updated and maintained, The goal is to eventually catalogue
most of the world’s useful scientific information on CAM and make it available to researchers,

practitioners and the lay public.

FUTU iS

For the future, the OAM plans to continue current activities and relationships. Activities
may intensify in basic research, clinical trials, data evaluation and information retrieval and
distribution. The basic groundwork for all of these activities is already in place and there is a
demonstrated mutually beneficial synergy developing between the CAM and conventional
‘communities in cancer research.

The Office of Alternative Medicine and the National Institutes of Health have a strong
commitment to seeing that complementary and alternative medicine practices are evaluated in a
scientifically rigorous manner. In addition, the topics selected and research methods used in such
investigations must provide the public with information that is useful for making reliable
decisions in health care. It is essential that all communities work together to assist the public in

making informed choices about the best options available for the treatment of cancer.

This concludes my statement. I will be happy to answer any questions.


53

will agree up front on the markers, such as quality-of-life meas-
ures.

So the collaboration is very intense and I think works very well.

On the other hand, we keep a separation because we are not a
regulatory agency. We do not determine and should not determine
who has access. Our goal is to be separate and to fairly evaluate,
to do research, to discover new things and to evaluate what works
or does not work.

Mr. Horn. Let me move to alternative therapies and alternative
pharmaceuticals, so forth.

How is money allocated within the National Institutes of Health
as a whole and all of your many specialized institutes? How do you
deal with that if you have in each of those let’s say something that
would be described as an alternative therapy because it is not tra-
ditional? So how is that handled to make sure they get such fund-
ing or is that all run through the alternative program?

Dr. Jonas. A number of the institutes fund on their own a num-
ber of complementary and alternative types of therapies. And, in
fact, Dr. Klausner mentioned that the NCI this last year has put
$16 million, for example. The OAM has provided over its entire ex-
istence about $3 million into the cancer area for research.

We meet regularly with the Institutes, the Institute Directors
and their staff. We have a trans-Federal CAM coordinating com-
mittee that Dr. Varmus put together last year and discuss what
are the best research opportunities that currently exist for the com-
ing year with each of the Institutes; and, depending upon the other
commitments they have, the resources we have, we then develop

ose.

Mr. Horn. Now does some of your budget come directly ear-
marked by Congress or do you have to beg, borrow and steal from
the NIH Institute in order to have a viable program?

Dr. Jonas. Well, we do both. We usually have an earmarked
budget specifically for our office, and we use that with the other
Institutes to develop collaborative projects. And when outstanding
applications or research Projects come in, we work with each of the
Institutes and often will co-fund so that there is money coming
from both sides into that, and this way we leverage the money.

As I discussed in my testimony, by using the infrastructures that
exist, many of the Institutes are already paying for the research in-
frastructure that we will then use and add onto to conduct re-
search.

Dr. KLAUSNER. Not to disagree with Dr. Jonas, but he’s never
been known to steal from any institute.

Dr. Jonas. That’s true. No institute has ever given us money.

Mr. Horn. I’m talking about bureaucratic stealing.

Mr. Burton. Mr. Kucinich—before I yield to Mr. Kucinich, real
briefly, what percentage of funds do you get compared to what the
National Cancer Institute gets?

Dr. JONAS. Well, our budget this year was $20 million.

Mr. BurToN. And what’s the National Cancer Institute’s budget?

Dr. KLAUSNER. $2.5 billion.

Mr. Burton. $2.5 billion.

Mr. Kucinich.


49

Mr. BURTON. You may recall from our previous hearings we had
some horror stories from people who had cancer and had children
that had cancer and there were alternative treatments that they
wanted to utilize and they were denied those alternative treat-
ments even though it was a life-or-death situation, and that was
very disturbing to me and to some of my colleagues.

We are not really trying to pick on you, Dr. Klausner or Dr.
Jonas and your offices. It appears to me as a nondoctor, a layman,
that there has always been an institutional bias against new sci-
entific change. Louis Pasteur was vilified and yet later proven to
be one of the great scientists.

Barry Marshall, who is a friend of mine, he is a friend of mine
because he cured me of a stomach problem that I got when I was
in Africa. Barry Marshall went before a symposium of stomach doc-
tors, experts, in Belgium and he told them that he thought that ul-
cers in most people was caused by a bacteria and they literally
laughed him off the stage. He went home and drank the bacteria
and cured himself and proved it. It is kind of like what Louis Pas-
teur did, and it is kind of sad that doctors have to risk their lives
to prove their point sometimes. But, nevertheless, now millions and
millions of people are going to be able to be helped by Barry Mar-
shall’s procedure; and fthink the guy ought to get the Nobel Prize.
But that is the problem we have. There is an institutional bias.

Dr. Linus Pauling. When I was a State legislator, I called him
about Laetrile. Dr. Linus Pauling got two Nobel Prizes for scientific
research. He was not some guy from the backwoods. He knew what
he was talking about. And Dr. Pauling told me that he thought
there was some promise with Laetrile. And then he went off on a
tirade about Vitamin C and said, you should take at least 4,000 or
5,000 milligrams a day, which I do. Because I think he must know
something or must have known something.

And then we come to my wife. I read an article in Life magazine
about a fellow who was having some remarkable results with
breast cancer tumors, Dr. Springer, who just passed away recently
up in Highland Park, IL. And I called him up and was able to get
my wife in the program. She has been almost 5 years cancer free,
and her prognosis was not good. And we attribute that in large
part to Dr. Springer and his program. But FDA tried to close it

jown.

Those are the kinds of things that really bother people. Because
if they feel they are in a life-and-death situation, they want to have
every opportunity to save their lives or their loved ones’ lives. And
you and I have talked about this in my office privately; and I think
it is really incumbent upon the medical profession, NIH, Alter-
native Medicine Office to do everything they can to accommodate
people, especially those who are judged to be terminally ill.

I think somebody who is terminally ill, rather than say there is
no hope, they ought to give them every opportunity. And that is
why, I did not mean to go off on this speech, but I wanted to talk
about a couple of things that I think are very important.

Mr. Horn is also here. Mr. Miller is here, and Mr. Kucinich is
here, and we will let them ask questions in just a few moments.

We had testimony from Dr. Ralph Moss. I think he worked at
Sloan-Kettering, and he is a well-respected source of information


78

This will require a change in policy by the FDA. Requiring study
of each individual component of the system would not be productive
in defining the outcome of the method itself, since these are inte-
grated and nonlinear. There are many, many factors involved.

tudies incorporating both standard and/or alternative methods
should be conducted.

One of my great concerns is the lack of physicians to conduct
clinical trials. In my experience, the regulation of alternative medi-
cine has taken on the characteristics of a police state. There has
been a deliberate attempt by its opponents of alternative medicine
to characterize it as being fraudulent and unscientific.

Opponents encourage the reporting of all alternative care practi-
tioners to State and Federal regulators. This has discouraged many
physicians from entering this field and has placed a heavy financial
burden on those in practice. I, myself, have spent $300,000 in my
legal defense to maintain my license. Only last week did I get an
unrestricted license after a 5-year struggle. The Virginia board now
basically has said I violated no laws and I am vindicated.

I’m sure 110 of my satisfied patients at the hearing had some-
thing to do with the outcome, but I am so busy, I don’t know what
to do. I only schedule 3 months in advance, because I feel it’s un-
fair to the patients coming to me to schedule any longer than that.
I'm sure I could schedule patients a year or 2 years in advance; but
when you have cancer, you may not do that. So, to be realistic, I
schedule only 3 months in advance.

It has been a routine perception of mine that I can fill up my
book within 2 hours of the first day that I open my book. And now
I’m booked up until January. I can’t fit any more in. This is very
labor intensive on the part of the physician.

Physicians must be free to prescribe safe and effective therapies
from whatever school of thought they are trained. Remember, med-
icine, like law, engages in “practice”. There is no guarantee of out-
come. Using alternative therapies should not be a cause for license
revocation or probation.

I encourage the committee to fund both basic research, which is
very important, and clinical trials in alternative medicine through
the National Institutes of Health and the Office of Alternative
Medicine.

Thank you.

Mr. BuRTON. Thank you, Dr. Speckhart.

[The prepared statement of Dr. Speckhart follows:]


88

industrial profit it would meke the front page of every newspaper and be covered by
every TV news chat-el in the country.

Tetrongly believe that we are entering a new een in our apprcach to cancer therapy in
which not care, but control, of the malignant growth may be the goal of treatment. AsI
reflect on the approach to chronie disease taught in medical uchools, I am struck by the
fact that only with cancer do we consider the absolute cure of the problem is the only
acceptable goal. Yot in dealing with other chronic potential fatal diseases itis accepted
that control of disease progression is adequate even if cure it not possible.

‘Thus, while we recognize, for example, that the total cure of’ cardiovascular disease,
diabetics, asthma and arthritis is not currently possible, NIH funded research has enabled
advances that provide ways of controlling disease progression and maintaining or

improving quality of life even if cure is not possible.

‘We can potentially apply the same strategy to some cancer. In prostate cancer, for
‘example, it is recognized that the time from when the first cell undergoes a malignant
change until the disease can be a threat to life may well be :!0-30 years! Imagine, ifwe
could simply show the growth rate of the prostate tumor in 65 year old men using
complementary techniques such as nutrition, exercise, stress reduction, etc., by 50%—in
‘most men this Would be tantamount to a cure without resor ing to the potential morbidity

of radiation, surgery or chemotherapy.


43

communities. This resulted in several meetings on communication processes in CAM cancer
research and ended with a large meeting in August 1997 with both the CAM and conventional
cancer communities.

‘The purpose of the meeting was to discuss how the OAM, working with the NCI, can
develop the research infrastructure to clinically test CAM cancer interventions. A plan was
developed, called the Practice Outcome Monitoring and Evaluation System (POMES), and basic
consensus of the groups was achieved. As a result of this meeting, a Cancer Advisory Panel
(CAP) is being formed which will assist the NIH in evaluating claims of efficacy relating to
CAM, make recommendations to the NIH on whether and how further research on these claims
should be pursued, advise the NTH on the conduct of clinical trials of CAM cancer therapies and
identify opportunities for improved communications between the CAM and conventional
communities.

This panel, along with OAM and NCI staff, will provide a mechanism to address the third
issue in CAM cancer research, advisory input for prioritizing research opportunities. The
purpose, responsibilities, operations and membership of the CAP is designed such that both
conventional and CAM communities are well represented. The concept, functions and
membership categories of the CAP have been developed with outside expert consultation and are
now agreed upon by the NCI and the OAM. The concept has been distributed for comment to
the OAM’s Alternative Medicine Program Advisory Council and, upon Council approval, will be
convened, most likely before the end of the calendar year.

Implementing POMES
Since the POMES meeting, the NCI and the OAM have been working to implement the

POMES concept within the context of existing administrative and scientific structures.


CONTENTS

Hearing held on July 31, 1998
Statement of:
Fair, William, M.D., urologic oncology, Memorial Sloan-Kettering Hos-
pital ..
Gordon, James 8.
Jonas, Wayne, M.
Key, Larry Stephen, D.
sity ..
Klausner, Richard, M.D., Director, National Cancer Institute, NIH ..
Speckhart, Vince, M.D., oneologistprivate practitioner ..
Letters, statements, etc., submitted for the record by:
Cox, Hon. Christopher, a Representative in Congress from the State
of California, rnia, prepared statement of .
Willi urologic oncology, Memorial Sloan-Kettering Hos-
kal prepared statement o!
Gordon, James S., M.D., director, Center for Mind-Body Medicine, pre-
pared statement of
Jonas, Wayne, M.D., Director, Office of Alternative Medicine, NIH, pre-
pared statement of.
Key, Larry Stephen, D.0., urgent care physician, Michigan State Univer-
sity, pre] area statement of
Klausner, Richard, M.|
pared statement of
Speckhart, | Vince, M.D., oncologist/private practitioner, prepared state-
ment of
Waxman, Hon. Henry
of California, prepared ‘Statement of ..

inector, Oilice of Alternative Medicine, NIH
urgent care physician, Michigan State Univer-

Director, National Cancer Institute, NIH, pre-

dq),


106

Mrs. MorELLa. Thank you, Mr. Chairman, very much.

Mr. BurTON. Thank you, Mrs. Morella.

You mentioned that you were signing 170 death certificates a
year and now you are signing 2 or 3 and you attribute that to your
change in approach?

Dr. SPECKHART. Initially, when I first got into oncology, most
doctors are very happy to let you be in control of those patients be-
cause they knew that there is nothing that they can do. And basi-
cally many of them, being very savvy, saw that they were going to
die and they would just as soon not get involved in it. That is when
things were pretty loose in medicine. Now money is tighter, and
primary care physicians want to have control over their patients.

But at that time, yeah, when I got a case, then everything relat-
ed to that case regarding cancer was in my court. So I was directly
responsible for it.

But I found, I was a missionary for a while, and I saw cancer
in foreign countries, and they didn’t have the same problems.

I didn’t have chemotherapy over there, and I was also in practice
before chemotherapy became popular. It was my impression when
I started to give chemotherapy patients went downhill very rapidly.
I couldn’t look my patients straight in the eye and say, I think I
can help you. I knew that it was generally a downhill course for

em.

And when I started to use complementary care, they didn’t have
the side effects of drugs. I think we are looking more at the natural
effect of the cancer itself, rather than the compounding effect of
toxic therapies. To me, there was an increase in quality survival
just by being conservative with chemotherapy.

Now, it is hard to say when you use multiple modalities wheth-
er—which one is effective. It was my impression that chemotherapy
was very toxic, and it did not improve survival, not by me signing
170 death certificates. In a 15-year period, I could see complete re-
sponders in less than 20 cases in the thousands that I saw. It said
to me that I was missing the point somewhere.

And we were always encouraged, a cure is right around the cor-
ner, we have another drug or combination when, in fact, that
wasn’t the problem. The problem was the host, and there had been
precious little work ever done in that area. When I was in medical
school, that was the highest form of therapy; but yet when I start-
ed practicing, that was the lowest form of therapy.

So Prevention never really was part of therapy until I got in-
volved in alternative therapies, and then you could see that you
could identify the preconditions that led to cancer or lead to cancer.
The electroacupuncture therapy is a wonderful technique that
needs to be explored and documented.

Patients basically suffered a lot from chemotherapy in my experi-
ence, and it became a matter of conscience and I just couldn’t do
it. And gradually over time, I don’t think that my practice dipped
a bit. It was a gradual progression into alternative therapy.

Mr. Burton. Dr. Key, someone told you that no one dies of the
disease «you have, they die from the treatment? Who told you that?

Dr. Key. My specials ist in lymphoma.

Mr. BURTON. Before you went to Dr. Gonzalez?

Dr. Key. Yes.


THE WHITE-COAT BRIGADE
THOSE LITTLE THINGS THEY DON'T ALWAYS TELL YOU:
* MOST CHEMOTHERAPY MAKES YOU STERILE.

* ONCE YOU HAVE CHEMOTHERAPY OR RADIATION
YOUR CELLS (AND THEREFORE YOUR BODY) ARE
AFFECTED FOREVER.

* A SIDE-EFFECT OF CHEMOTHERAPY IS CANCER.
THOSE LITTLE THINGS THEY TELL YOU:

* "YOU MAY EXPERIENCE A LITTLE NAUSEA".

* "YOUR HAIR WILL COME BACK".

* "MY AUNT NEVER GOT SICK ON HER
CHEMOTHERAPY".

"EGOS...NOTHING MORE THAN EGOS": AN ONCOLOGIST'S
FAVORITE PHRASES.

* "I THINK THE TREATMENT IS WORTH THE
RISK."

* “IT'S NOT PERFECT...BUT IT'S ALL WE HAVE.”

* "DR. XXXXX WAS CHIEF OF MY TRAINING
PROGRAM AT "THE " UNIVERSITY. I DISCUSSED
YOUR CASE WITH HIM AND HE AGREES WITH
MY RECOMMENDATIONS. WE NEED TO MOVE
ON THIS RIGHT AWAY.

"YOU'RE DYING": THE DOOR TO ALTERNATIVE CANCER
TREATMENT

TT IS NOT UNTIL "ORTHODOX" MEDICAL TREATMENT OF
YOUR CANCER FAILS THAT TACIT APPROVAL OF ALTERNATIVE
TREATMENT IS GIVEN. ONCE AGAIN, GO BACK AND READ THE
OPENING PARAGRAPH OF THIS TESTIMONY BUT...READ IT
KNOWING ORTHODOX TREATMENT HAS FAILED. MANY SEEK
ALTERNATIVE TREATMENTS; WHAT FOLLOWS ARE THE REASONS.
THEY SHOULD BE SUPPORTED IN THEIR EFFORTS.

-4-


52

of Sciences, they have associate memberships, they stress a lot of
international memberships of academies of science. Could you tell
me a little bit about, No. 1, I know it is difficult to find something
similar to NIH. And that is one of our problems in Europe. There
is no institutional body that is regarded with credibility when you
get into something crazy like Mad Cow disease, which affects trade
and everything else. But just tell me a little bit about collaboration
with like-minded institutions and name a few.

Dr. KLAUSNER. I think the collaborations are quite extensive.
Just yesterday I was at a whole-day meeting with representatives
of the Imperial Cancer Research Fund from England, the European
Cancer Societies, the Australian Cancer Societies, and the Japa-
nese Cancer Institute to create formal collaborations in one area of
research.

The Clinical Trial System for cancer throughout Europe is offi-
cially linked to the NCI. In fact, the NCI funds the statistical cen-
ter in Brussels for that multinational agreement. The clinical trials
and oncology societies for doing clinical trials in New Zealand and
Australia joined the NCI cooperative group system just this past
year. The interactions I think actually are very good and very ex-
tensive.

Mr. Horn. Now, I realize scientists—it is an international dis-
cipline, obviously, and there are conferences all over the world, and
I am sure they meet and collaborate there. But, as you know, we
have heard a lot of criticism over the years of the slowness of the
Food and Drug Administration to authorize particular medicines or
processes, types of operations, so forth, to be used. That criticism
comes that, gee, Europe gets things on the market faster than we

lo.

What is the relationship between the National Cancer Institute
and the FDA in this? And what are your observations as a scientist
between how Europe clears pharmaceuticals versus how we do, and
should we change something there?

Dr. KLAUSNER. Well, of course, representing the NCI and not the
FDA as a regulatory agency, what I can say is that over the last
several years demonstrably, the approval process has become much
more rapid at the FDA. And I can say specifically for cancer it has
been, I think, quite extraordinary.

We have a very good relationship with the FDA. Many of the
people leading the FDA had been at the NCI and are experts in
cancer. And given the rapidity with which new therapies, and I
think some remarkable new therapies, are moving through the
FDA, I do not see Europe or anyplace else being more responsive
than what I see now at the FDA.

Mr. Horn. In terms of the FDA reviewing something, do they
call on the National Cancer Institute for advice?

Dr. KLAUSNER. Yes, they do; and so we interact greatly. And, in
fact, when we are designing studies we work with them up front
so that we do not get into the situation where we are designing a
study and the FDA might ask for something that was not built into
the study. And the collaborations, again, are getting much more in-
tense as we try to develop better markers for disease so we can get
answers more quickly. We are working with the FDA so that they


101

Mr. Burton. Let me ask a few questions.

I would just like to say that the recommendations that all of you
have made we have, and we will go through all of those. And Dr.
Klausner and others, we would like to write you a letter enumerat-
ing all of those, I’m sure you have all of those in your mind, and
make some suggestions that may be good or may not be good and
get your response to them. Because I think some of the things that
these gentlemen have said make a lot of sense and might help en-
hance your ability to get to the bottom of these problems.

Dr. Key, what advice would you give to others who have Hodg-
kin’s disease? You talked about you didn’t take—you decided not to
take chemotherapy and you decided not to take some of the other
conventional treatment because you thought it was going to do
more harm than good. You've taken these alternative treatments
and it’s—how long have you survived now with that?

Dr. Key. Well, 3¥2 years.

Mr. Burton. OK 3¥2 years.

Dr. Key. This is a relapse for me, also. I did have over a year
of chemotherapeutic treatment. So I have a very direct comparison.
In all honesty, what I would recommend without a doubt is, if I
were given the choice again, knowing what I know now, I would
have never taken chemotherapy for this disease. I say that know-
ing Hodgkin’s lymphoma and the treatment of it by orthodox meth-
ods has come a long way. I’m thankful that I did stay alive, but
the side effects and the—just the whole overall treatment were
devastating to me and my way of thinking.

I feel as though I’m a relatively well-trained individual and an
intelligent man, and I always ask myself—and I was thinking
today how many anecdotes make a fact. I’m sitting before you not
toxic, I’m able te work, I’m able to continue on my life because of
the work that’s been done with the metabolic nutritional approach
to cancer. I would recommend strongly to use that approach rather
than using the orthodox chemotherapeutic methods.

Mr. BurTON. And your doctor was——

Dr. Key. Dr. Nicholas Gonzalez.

Mr. BurTON. Dr. Gonzalez. I understand Mr. Horn has to leave,
so I'll yield to him for a question.

Mr. Horn. I thank you, Mr. Chairman. I’m sorry I have to leave
this hearing for the campaign finance discussion that will be on the

oor.

I have one question. All of your testimony was very interesting
and I enjoyed having it; but, Dr. Speckhart, I just want to know
one thing. You said of the 110 satisfied patients at the hearing, you
were sure they had something to do with the outcome. Those 110
which are satisfied patients, what percent of your particular clients
would they represent? Did you have 400 patients or 1,000 patients?

Dr. SPECKHART. About 1,000.

Mr. Horn. You’ve had about 1,000?

Dr. SPECKHART. Yes.

Mr. Horn. So this is about essentially 10 percent of the 1,000?

Dr. SPECKHART. That’s right. They’re living close enough to that
geographic area where they can come in for a hearing.

Mr. Horn. What happened to the other 900 patients?

Dr. SPECKHART. Most of them are doing pretty good.


26

As introduced, the Access to Medical Treatment Act
would ensure that individuals are free to choose to be
treated by any legally authorized health care
practitioner with any method of medical treatment--
provided that there is no evidence that the treatment
causes harm, and that the patient is fully informed

about any possible side effects.

However, in order for doctors to know for sure
that an alternative treatment does not cause harm and
to then inform patients about possible side effects,
agencies like the National Cancer Institute must
research the treatments. I look forward to hearing
from the Institute’s representatives about why that is

not happening.

Thank you Mr. Chairman.


What
Dietary
Supplements?

About ODS
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Grants, Awards,
& Contracts

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Opportunities

ODS Databa:
Accomplishments,

Publications

OFFICE OF

DIETARY About ODS

SUPPLEMENTS

What does the ODS do?

To explore the role of dietary supplements in the improvement of
health care, the ODS plans, organizes, and supports conferences,
workshops, and symposia on scientific topics related to dietary
supplements. The ODS can initiate such activities but more often
the ODS works in conjunction with other NTH Institutes and
Centers, other government agencies, professional organizations, and
public advocacy groups. The specific goals and outcomes of these
convening activities vary with the scientific topic.

Occasionally, the ODS will sponsor large conferences to provide an
overview of a scientific area and to bring together scientists and
professionals from different disciplines with the goal of identifying
gaps in research and joint directions for future endeavors.

As an example, on June 3-4, 1996 a major two-day workshop, The
Role of Dietary Supplements for Physically Active People, was
sponsored by the ODS in conjunction with the American Institute of
Nutrition and the American Society for Clinical Nutrition. This
workshop was also cosponsored by 1 | of the NIH Institutes and
presented a state-of-the-art scientific review of dietary supplements
as they may enhance the health of people who actively engage in
exercise or recreational sports. The proceedings of this workshop
will be published as a supplement to the American Jounal of
Clinical Nutntion. A Program with Abstracts and Bibliography of
published articles was prepared for this workshop.

More typically the ODS sponsors or co-sponsors small workshops
to promote scientific study of dietary supplements in a specific
scientific area of dietary supplement research. In 1996 and 1997 for
‘example, the ODS co-sponsored two workshops that were initiated
by the National Institute on Aging: Melatonin and Sleep and
Melatonin and Aging. The ODS 1s also co-sponsoring I'S similar
conferences or workshops in 1998 that were initiated by various
NIH Institutes and Centers in response to a request from the ODS.
‘These conferences are described in more detail in

As an office in the Office of the Director at NIH, the ODS does not
have the authority to directly fund investigator-initiated research
grant applications. Instead the ODS conducts research either


105

to just briefly say yes or no if you think NCI is moving in the right
direction in that regard?

Dr. SPECKHART. Yes, I think they are. However, having gone
through 5 years of Government supervision, 1 am very cautious
about what happens after you give permission for Government to
enter into your work; and it could very easily dissolve into nothing,
as previous experience demonstrates. So there has to be some way
where Government assists us, rather than we assist in Govern-
ment.

What is happening in the country is, rather than get Govern-
ment involved, there is a lot of private research going on; and cor-
porate structures want to get involved without having the imprima-
tur of government. And it seems to me that, as a licensed practi-
tioner, the only thing that having an M.D. did was it gave the Gov-
ernment the right to supervise what I was doing. And there are a
lot of people that would like to stay away from the aftereffects of
government intervention, which is control, and I would like to see
that change, if we can construct a way to evaluate this data so that
the innovator of this could maintain some control over the way
data is managed, rather than by just carte blanche turning it over
to a Government agency and waiting for something to happen.
They don’t have the same urgency that I have, I will tell you that.

Dr. GorpDon. I think it is important to be involved. Most of the
therapies are non-patentable. Large corporations are not going to
invest large amounts of money to develop these therapies. And I
think the role of the Government actually needs to be enlarged,
particularly in this area, in terms of supporting the research.

The second thing, and I think Dr. Speckhart pointed this up very
well, one of the roles that the Office of Alternative Medicine Center
at the University of Texas is doing is helping people like Dr.
Speckhart pull the research together. Because individual practi-
tioners, some who are doing the most interesting work, some of
them don’t have the research temperament, they don’t have the fa-
cilities and money to undertake these studies. I think in every
step of the way, the NCI and OAM can help people develop their
research projects.

The other thing that is important and I am re-emphasizing this,
it is crucial that there be more people trained to do this work. First
of all, encouraged to be open-minded. Medical school encourages
people to learn a lot but not always to be open-minded. We have
to encourage physicians to be more open-minded, and we have to
encourage people to be trained in these areas.

I have talked to many clinicians. We need more people who can
do our work. The demand is enormous. The demand, whether it is
for Dr. Gonzalez’s therapy or Dr. Speckhart’s work, any of the work
that we are doing is immense, and we need many more oncologists
who are interested in this work, and we ought to do whatever we
can to promote it.

Just as kind of a footnote, one of the interesting therapies that
I saw in China was electroacupuncture, and they are getting some
amazing results with very large tumors being shrunk to virtually
nothing in a very brief period of time.

Mrs. MoRELLA. Do you want to comment, Dr. Fair?

Dr. Fair. No.


34

We are also collaborating with OAM to implement the recommendations of the Practice
Outcomes Monitoring and Evaluation System (POMES) report including the
establishment of a Cancer Advisory Panel (CAP-CAM). A slate of potential members
has been jointly developed by NCI and OAM to be presented to the OAM advisory
board for their review in September. ‘The CAP-CAM will be expected to meet 2 or 3
times a year and draw its 13 members from a broad range of experts from the
conventional and CAM cancer research community. ‘This group will review and
evaluate summaries of evidence for CAM cancer claims submitted by practitioners,
make recommendations to the OAM and the NCI on whether and how these evaluations
should be followed up, and, be available to observe and provide advice about studies
supported by the OAM and NCI, and about communication of the results of those
studies. We are enthusiastic that this group can work collaboratively in a new
partnership between the conventional and CAM cancer research community. There
already are two submissions from the homeopathy community for review and
consideration once the panel is constituted. Rather than have NCI conduct “best case
series" review independent of the CAM community, the CAP-CAM will facilitate the
joint review of data using this model.

We are also moving ahead with a number of research efforts that involve the evaluation

of CAM therapy.

Due to public interest in the potential anti-cancer activity of shark cartilage and its
continued use despite the lack of definitive clinical evidence of efficacy, the NCI is
collaborating with OAM to sponsor clinical trials in this area. The NCI issued a public
request soliciting proposals to conduct randomized phase III clinical trials evaluating
the clinical activity and efficacy of a shark cartilage product. Five proposals have been
received and are in the process of being reviewed.

‘The NCI is working with OAM to begin an evaluation of Dr. Gonzalez’s therapy at
Columbia Presbyterian Medical Center, one of the NCI-designated Cancer Centers.
Both NCI and OAM will be providing support for the trial and NCI is working with the
‘Columbia clinical investigators to have the Investigative New Drug (IND) filed as
quickly as possible. It is expected that funds will be in place and the IND approved by
the end of September.

Another interesting area of potential research activity is the evaluation of green tea as a
cancer prevention strategy. NCI staff in the Division of Cancer Prevention have met
this week to review the evidence that exists, make an assessment of the weight of this,
evidence, and then propose recommendations about the appropriateness of moving
forward with future evaluations.



58

Mr. MILLER. The Alternative Medicine Office, it’s relatively
small, obviously, in the total budget of NIH. Is the purpose or ex-
pectation or the goal to not necessarily be a large, independent,
grant-issuing institute or do you do a intramural research or is it
basically extramural?

Dr. JONAS. We have a small intramural research training award
program in which some of the intramural labs from any of the In-
stitutes can make applications for doing projects intramural. But
we are a coordinating office and a crosscutting office across all 24
Institutes. So we work with all of them. And I and my staff spend
a lot of time working with each of the Institutes on developing spe-
cific projects with them, yes.

Mr. MILLER. One of the concerns we have on the committee, and
I don’t know how Representative Porter feels about this, we have—
physicians don’t make the decisions, that we need to rely on science
as much as we can. But I know over the past few years we've given
encouragement for the alternative medicine program in the appro-
priation bill. Over the past few years, what have we pushed you
toward and helped you along, good or bad?

Dr. Jonas. Well, as I mentioned in the testimony, we have sev-
eral projects now going on with over half of the Institutes, includ-
ing funding 11 research centers around the country and funding
several large clinical trials. We are looking at St. John’s Wort on
depression with the National Institute of Mental Health. I men-
tioned acupuncture and osteoarthritis with the Arthritis Institute;
nutritional therapies of heart disease with the Health, Lung, and
Blood Institute, and the funding that the office has gotten has gone
into those type of projects.

Mr. MILLER. One more question before my time is up. The Li-
brary of Medicine, how does that work as far as providing informa-
tion? They’re talking about the web site versus information in the
Library of Medicine. Is that separate or is that——

Dr. KLausNeER. It has that status, yes, as a separate Institute.

Mr. MILLER. They come separately in their appropriations?

Dr. KLAUSNER. Yes.

Mr. MILLER. But that’s a wealth of information. What informa-
tion is available through the Library of Medicine on this area of al-
ternative medicine?

Dr. Jonas. Yes, we worked very closely with the National Li-
brary of Medicine. They’re in the process of, for example, looking
at ways to enhance and increase the numbers of journals that they
enter into the National Library of Medicine’s electronic data base,
which is the main source for medical information throughout the
world.

We have also extracted complementary and alternative medicine
citations from their data base to make it easier to access, and those
are now available on our web site. And we've been working closely
with them in developing other data bases and enhancing the data
base in these areas.

Mr. MILLER. Would this be the No. 1 source of alternative medi-
cine literature in the world, is the Library of Medicine, or is there
some other that’s even more?


76

Mr. Burton. Mr. Speckhart—or Dr. Speckhart, excuse me.

STATEMENT OF VINCE SPECKHART, M.D., ONCOLOGIST/
PRIVATE PRACTITIONER

Dr. SPECKHART. Congressman Burton, distinguished members of
the committee, I thank you for inviting me to give testimony here

today.

As background, I graduated from New York Medical College 40
years ago, and have had a broad practice experience. Along the
way, I’ve been an Air Force flight surgeon, a medical missionary in
Malawi, Central Africa, a general internist, a medical oncologist
and, for the past 15 years, a practitioner of alternative medicine.

I very much _am in the marketplace as a physician, but I have
a desire for good research. I was the founding president of the Vir-
ginia Oncology Group, with the intent to find new statistical de-
signs. And I’ve also been a member of rather conventional chemo-
therapy groups such as Eastern Cooperative Group and the Mid-
Atlantic Oncology Program and had been for years.

After 13 years of using FDA-approved chemotherapy protocols, I
concluded that such therapies were extremely toxic, poorly toler-
ated and not effective in prolonging survival of most solid tumors
of adults. Over a 10-year period, I signed 170 death certificates a
year by using chemotherapy. It was obvious to me that I was not
treating the essential issues in the management of patients with
cancer.

In 1983, my patients began to request therapies other than
chemotherapy. I agreed and, without even knowing it, I became an
alternative medicine practitioner and was red flagged by the oppo-
nents of this form of therapy.

Being a classical oncologist at the time and a clinical investiga-
tor, I was pleasantly surprised by the clinical responses that I saw
using complementary and alternative medicine. I gave Urea to a
patient who had recurrent cancer after 1 year of very aggressive
chemotherapy by me. When I said that I think you need some more
chemotherapy, she looked me right in the eye and said, I’m not
going to take any more of that crap. This kind of surprised me. But
it was an honest response by a patient who obviously found the
therapies that I was giving being offensive.

By giving her Urea, she had a complete response of tumor in her
lung and liver by x ray and by other parameters. She had no bone
marrow toxicity, no hair loss, no heart damage. Her quality of life
was excellent. She was seen traveling on her husband’s Harley-Da-
vidson motorcycle 10 years later.

I could cite other responses using other forms of therapy.

For example, I reported to the Office of Technology Assessment
of the U.S. Congress a 75 percent response rate using Autogenous
Vaccine. They recommended that further trials be conducted. My
medical board, disregarding the fact that Autogenous Vaccine was
grandfathered into the 1938 Food, Drug and Cosmetics Act as the
ordinary practice of medicine, refused to let me use it. So here we
have a board of medicine monitoring research with no experts to
give them advice, other than for the people that were allopathic.

The first rule of therapeutics is “do no harm”. I could not adhere
to this rule by using chemotherapy. Therefore, I was eager to use


28

traditional or nontraditional approaches, can be brought to clinical
trial; and, therefore, at every step we need mechanisms to evaluate
the weight of evidence supporting an intervention. The rationale
behind it must be evaluated to prioritize which approaches we
move forward with.

The challenge before us, which I think we can meet, is to assure
that complementary and alternative approaches have real, credible
and fair access to the same processes of evidence and review that
all interventions must live up to.

The NCI is moving quickly to develop CAM information and ex-
pand research opportunities for CAM investigators. The activities

ave broadened in scope and include increased collaboration with
Dr. Jonas and his office, the careful evaluation of CAM therapies
and, importantly, the development and dissemination of accurate
information for the public.

While it is true that the relationship between the CAM commu-
nities and the NCI has been distant, at best, I feel we are truly
and finally moving beyond that. There is a real commitment by the
NCI to change that, to listen and to inform, as well as to speak.

We are in the final stages of appointing for the first time an indi-
vidual at the NCI to be the coordinator for CAM therapies and
evaluation, a position that has never before existed. This individual
will have the responsibility and primary interest of developing rela-
tions with the CAM community and to function as a liaison be-
tween the Institute and the NCI research community on behalf of
the CAM community to encourage collaboration and joint research
initiatives.

As you know, we are also working with the OAM, the Office of
Alternative Medicine, to implement the recommendations of the
practice outcomes monitoring evaluation system through the devel-
opment of the Cancer Advisory Panel, CAP, for complementary and
alternative medicine; and I think Dr. Jonas will talk about that.

What we think this is going to do is provide us with a group of
experts in both complementary and traditional medicine to work to-
gether, to learn to work together, to be an open door, to bring in
ideas, to look at the literature, to make sure that individuals with
ideas and interventions feel welcome to come in to learn to present
those interventions in a way that the evidence can be evaluated so
that we can make decisions about moving on to test those evalua-
tions.

There are multiple examples of that. We do not have the time
to go through all of them. But I will point out one that the NCI
and OAM have moved quickly to support, and that is the evalua-
tion at the Columbia Cancer Center of Dr. Gonzalez’s therapy. I
point that out because we will be hearing more about that later.

Of real importance to us is that the public has available accurate
and up-to-date information about CAM therapies as well as about
traditional therapies, and NCI has recently taken steps to assure
that this information receives not blanket negative judgment but
the same open consideration as conventional approaches both in
our evaluation and dissemination.

Detailed CAM summaries are now being prepared for cancer
therapies identified by the Cancer Information Service, along with
the OAM clearinghouse, as being of public interest. The develop-


94

The NCI Journal column I think is a wonderful idea. It’s another
one that we share.

I think there are a few other areas that are a bit harder. I
think—one is I think we really need to take a look, and this follows
the Institute of Medicine report, to really take a look at some of
the funding priorities at NCI, but not only at NCI, we're talking
about here, but all over NIH. How much money are we really de-
voting to prevention? How much money are we devoting—Dr. Wax-
man mentioned issues of tobacco, but there are other issues as
well. How much money are we devoting to complementary and al-
ternative therapies and what kind of research are we going to un-
dertake?

One of the things I think—although it’s important to look at spe-
cific agents, whether it’s a chemotherapy or shark cartilage or
green tea or any of the others, I think it’s really important to really
think through from the ground up what kind of research do we
want to do? How much do we want to devote, for example, for look-
ing at comprehensive therapies, rather than looking at specific mo-
dalities? And that was mentioned with regard to Dr. Gonzalez’s
work as well as Dr. Speckhart’s work, and there are many other
people. And that’s not often the way research is funded.

So I think we really need to kind of have a fundamental discus-
sion about research priorities. We also need to—and Dr. Klausner
and I were talking about this earlier. There needs to be a very
clear look not only at complementary therapies but at the process
of integration and of creating therapeutic settings at cancer centers
which address all of a patients needs—their needs for information
about complementary and alternative therapies, the integration of
specific therapies, and also just their human needs.

One of the sad things that happens in cancer centers across the
country is, the worst thing is not the complementary and alter-
native medicine isn’t included, although I think it’s important, the
worst thing is how people are treated humanly. And I think we
really need to devote a very high level of attention to that.

Very quickly, I agree with Mr. Kucinich in terms of putting out
more information. We need to do that. One of the things that we’re
doing—and this might be an example or something we could ex-
pand on—is we’re putting out the presentations at—that were
made at comprehensive cancer care along with the evaluations and
the critiques. And we're putting that out on our web site so that
people can read the data that’s presented and read, for example,
at NCI, scientist critique of that data. And I think this might be
a way to deal with some of the issues of putting out information
that has some kind of evaluation along with it.

International work is very important. I was in China last year.
There’s some very interesting complementary and alternative
therapies for cancer in China that we are not even beginning to
think about here. And I think that we need to—I agree there is a
foundation for doing that work. We need to do a lot more of it.

I think we need to look—and I know this is a particular concern
of yours. We need to look at FDA regulations. One of the advisors
to the American Cancer Society, when he was commenting on Dr.
Temple’s presentation at our conference, he said, the problem is not
you. The problem is not your scientific acumen or the way you’re


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17

Jess toxic methods of therapy, nutrients, vitamins, minerals, en-
zymes, chelation therapy. They all had a part to play in my case
management. Homeopathy seemed to be useful. Herbal therapies
all had their place. Com! fort measures such as massage therapy,
deep muscle relaxation techniques, lymph massage could help re-
markably in relieving the need for narcotics. Various detoxification
programs, including the use of saunas, acupuncture, hypothermia,
all seemed to have their place, in my clinical judgment.

I have just completed establishing a data base of 670 cases use
electroacupuncture. I can now demonstrate a relationship between
the bacterial, viral, fungal, chemical and pesticide signals for each
acupuncture point that’s clinically relevant. Even dental heavy
metals, such as mercury, gold and titanium, can be recognized in
various clinical conditions. In my experience, this technology has
great potential for clinical application and should be studied.

I’m in the process now of publishing that data. My fear is that,
if I get involved with government, that my data will be lost in the
recesses of the National Cancer Institute, and I will lose control of
my data, and that’s a very, very significant practical reality.

‘he basic scientists have been telling us all along that the
human body, like other biological systems, is integrated, nonlinear,
that it’s dissipative, nonequilibrial and dynamic. And I know these
are big words, but it basically says you have to feed it, you have
to follow it, and it’s not like ball bearings and spark plugs.

Alternative medicine addresses many of the issues of the non-
linearity and focuses on the body, the host in which the tumor is
growing; and the intent is to maximize the normal curative effect
with the host, with the body.

A cancerous tumor, therefore, is an effect. It’s an effect of the
body’s inability to maintain a healed state. Yet the current system’s
focus is almost entirely on the “lump and the bump,” that is, on
the tumor or its components with the object to destroy it by means
of a manufactured product.

This system is linear and reductionist. Suppressive therapy with
chemotherapy has led to enormous toxicity and to the development.
of multiple drug resistance, a current major medical problem. You
can go into any intensive care unit of a hospital and see that there
are antibiotics—and chemical therapy resistance is not a problem
of the future. It is a problem now. Research into nondrug therapies
is urgently needed in order to overcome this problem.

Specifically, biophysics should be explored in such areas as quan-
tum_and potential fields, magnetic field evaluation using the
S.Q.U.I.D. technology, that is the superconducting quantum inter-
ference devices. Subtle energy states and biological information
systems are all just on the horizon. We're entering into a new para-
digm, and we have to go from molecular biology to biological phys-
ics. It’s very important for us to get that through our conscious
thinking.

Many practitioners in alternative medicine have their unique
method of addressing the health care of their patients. One practi-
tioner may emphasize dental metals, another use of enzymes, yet
another immune stimulation. But they all use multiple modalities
of treatment. In order to evaluate the efficacy of each practitioner,
his method must remain intact. :


83
Mr. Burton. Dr. Fair.

STATEMENT OF WILLIAM FAIR, M.D., UROLOGIC ONCOLOGY,
MEMORIAL SLOAN-KETTERING HOSPITAL

Dr. Fair. Mr. Chairman, members of the committee, I’m Dr. Wil-
liam Fair, attending surgeon at Memorial Sloan-Kettering Cancer
Center and professor of urology at Cornell University Medical Col-
lege. I also serve as chairman of the Complementary and Alter-
native Medicine Committee of the American Urologic Association.

In addition to my professional qualifications, I also appear as
someone who has had a personal experience with cancer, in my
case, colon cancer, treated with four surgical procedures and a year
of intensive chemotherapy. My presence here today with an excel-
lent life quality 18 months after exhausting all curative therapy
known to allopathic medicine is in itself a testimony to the effect
of complementary medicine and cancer management.

In analyzing the available scientific data on complementary med-
icine, I was amazed and pleased to find out just how much good
clinical and experimental data exists showing a benefit of CAM
techniques in the management of cancer and how much oppor-
tunity there is to test essentially minimally nontoxic approaches
that promise to significantly improve or maintain the quality of life
in cancer patients.

On the other hand, I was dismayed to learn how little validated
scientific testing was done on some approaches despite widespread
use of these techniques among the lay population and how little re-
search funding is available to properly evaluate a number of com-
plementary medical approaches that anecdotally appear useful and
represent eminently testable hypotheses.

It is quite possible that some measures now considered alter-
native may eventually become standard therapy. For example, in
the 17th century the use of foxglove, the digitalis plant, was ridi-
culed by physicians when it was used as a substitute for blood-let-
ting or leaches in the treatment of congestive heart failure.

Unfortunately, the term CAM embraces a large spectrum of prac-
titioners, from those with valid scientific approaches to the char-
Jatans and the quacks who prey on the fears and anxiety of the
cancer patient for purely financial gain. Thus, the unscrupulous
promoter who advocates wearing crystals on your hand or ear can-
dling as a cancer cure should not be confused with those who use
nutritional support, exercise, stress reduction, acupuncture, herbs,
and spirituality to provide demonstrable benefit to cancer patients.
In fact, these modalities should be considered as part of standard
therapy.

Chaitman Burton has correctly pointed out that the very word
cancer is so terrifying and the impact on the individual is so pro-
found that, faced with a diagnosis, an individual seeks help and
treatment from whatever source he or she can find. The facts that
the alternative medicine business has grown from 13 billion in
1990 to an estimated 50 billion in 1997 and that more people visit
alternative medicine practitioners than primary care practitioners
in the United States speak to the attractiveness of these ap-
proaches to consumers.


5

ought to be investigating. But this committee has not looked at
that issue.

The reason I point that out is that it is easy to complain that
research and science has not given us the ways to stop cancer, but
we know ways that we could stop cancer and prevent it and not
have to struggle with the very difficult problems of cures and con-
trol. So it seems to me we ought to put this in perspective.

We want more research. We are willing to spend taxpayers’ dol-
lars to try to give us the hope of the way to deal with this disease.
But we know already a way to deal with the disease that would
be very, very successful, and the Congress of the United States has
refused to act.

I welcome Dr. Klausner and the rest of our witnesses. I look for-
ward to their testimony. And I yield back the balance of my time.

Mr. Burton. I thank the gentleman.

[The prepared statement of Hon. Henry A. Waxman follows:]


111

You have to be careful with alternative therapies because they
mean hope, but we have to balance to make sure that they are via-
ble, safe and effective, and I know that you are doing that. So I
appreciate your having this hearing. I know Dr. Jonas would love
to know that you are going to try to get him more money.

Mr. BurTON. Thank you all for being here, and we will be in
touch. The hearing stands adjourned.

[Whereupon, at 12:30 p.m., the committee was adjourned.]

[e)


81

Components with the object to destroy it by means of a manufactured product. This system is
linear and reductionist. Suppressive therapy with chemotherapy has led to enormous toxicity and
to the development of multi-drug resistance, a current major health problem. Research into non
drug therapies is urgently needed in order to overcome this problem, Biophysics should be
explored in such areas as quantum and potential fields, magnetic field evaluation using S.Q.U.LD.
(super conducting quantum interference devices), subtle energy states, and biological information
systems

Many practitioners in altemative medicine have their unique method of addressing the
health of their patients. One practitioner may emphasize removing dental metal, another use of
enzymes, yet, another immune stimulation. But they all use multiple modalities of treatment. In
order to evaluate the efficacy of each practitioner, his method must remain intact. This will
require a change in policy by the FDA. Requiring study of each individual component of the
system would not be productive in defining the outcome of the method itself, since these are
integrated, non linear systems. Studies incorporating both standard and/or alternative methods
should be conducted.

One of my great concerns is the lack of physicians to conduct clinical trials. In my
experience, the regulation of altemative medicine has taken on the characteristics ofa police state.
There has been a deliberate attempt by its opponents to of alternative medicine describe it as.
fraudulent and unscientific. Opponents encourage the reporting of all alternative care
practitioners to state and federal regulators. This has discouraged many physicians from entering
this field and has placed a heavy financial burden on those already in practice. I, myself, have
spent $300,000 in my legal defense. Only last week did I get back an unrestricted license after a

five year struggle. I am sure 110 of my satisfied patients at the hearing had something to do with


109

Mr. Burton. I want to introduce a bill that would mandate that
there be one person on there from the alternative and complemen-
tary medicine area and see if we can’t get that passed in the next
year, and maybe we can just make sure that there is somebody on
that board.

The other thing that I would like to suggest is that there are a
lot of suggestions here today from some eminent doctors, and what
I would like to do is send you, as I said before, a letter enumerat-
ing all of these and if you can evaluate and give us a response, I
would appreciate it.

yr. KLAUSNER. Sure.

Mr. BurTON. We also have committee proposals for extramural
research grants in the area of alternative therapies in health and
cancer practices. We will send that to you as well.

Also, we talked about the funding for the alternative medicine
and complementary medicine. Dr. Jonas says he gets $20 million
and you get $2 billion at NIH—or at NCI?

Dr. KLAUSNER. That is correct.

Mr. BuRTON. Maybe we should look into giving Dr. Jonas’ agency
more money and make the case on the floor about that. We will be
working on that as well, and if you folks agree with us, we would
sure appreciate your support. I am not suggesting that we take it
from you, Dr. Klausner, but maybe we can find some additional
money.

Do you have anything that you would like to say about the com-
ments of the gentlemen that just preceded you?

Dr. KLausner. Yes. I really appreciate the sense that we all have
that our therapies are not as good and they are often more toxic
than we would like. I would not like to leave the impression that
we have information that in any way would suggest that the major-
ity of patients treated with chemotherapy are killed by their chem-
otherapy. In fact, the only place we have that information is in the
context of clinical trials where we watch and measure the fraction
of patients who die from complications of treatment versus the dis-
ease, and it is overwhelming the patients that die from the disease
and not the chemotherapy. I appreciate and understand especially
the therapy that Dr. Key, the original therapy, MOPP, had a lot
of acute toxicity, and we don’t use it any more, and 11 years ago
when he took that, there were not the treatments for the side ef-
fects of therapy.

This is a process where we are struggling with a very difficult
set of diseases to try to get therapy that both is effective and less
toxic. Things are changing and moving.

I will point out that 40 years ago—you point out people said
things were impossible—a child with cancer, a child with leukemia
was given a month or two to live, and they all died.

Now with this chemotherapy, as imperfect as it is, through clini-
cal trials now for leukemia 70 to 80 percent don’t just live 5 years
but are cured; 1 out of 900 young Americans that are becoming
adults are now the cured survivors of childhood cancer. We have
a long way to go, but to not mention the many extraordinary people
who have spent their career and lives trying to save people’s lives
against a very difficult disease where the problem is not just—the


92

Mr. BurTON. Dr. Gordon.

STATEMENT OF JAMES S. GORDON, M.D., DIRECTOR, CENTER.
FOR MIND-BODY MEDICINE

Dr. GoRDON. Thank you, Chairman Burton. It’s very good to be
here.

I want to begin just by thanking you explicitly for your efforts
in representing Americans to move these issues ahead, not only
with regard to cancer treatment and cancer research but toward
expanding our whole perspective on what constitutes good medi-
cine. And I want to say that, because this movement to change
medicine is very much to transform medicine and enlarge it, it is
very much a popular movement; and I think that you and others
in Congress have had a major role in this movement. So I want to
acknowledge that.

I also want to say that I’m very pleased to be testifying with my
colleagues on this panel whose testimony really has moved me be-
cause of their personal experience and also with Dr. Klausner and
Dr. Jonas. I think that there’s definitely a new day dawning in this
work, and I feel very good about it.

I want to say a little bit about what my role has been and then
make some specific suggestions for this committee.

First of all, I spent 10 years as a research psychiatrist in the Na-
tional Institute of Mental Health; and, in recent years, I’ve been a
professor at Georgetown Medical School and founder and director
of the Center for Mind-Body Medicine and a clinician in private
practice. I was also the first chair of the Program Advisory Com-
mittee to the Office of Alternative Medicine.

So I have—on the one hand, I have the very immediate perspec-
tive of a practitioner and in some ways similar to Dr. Speckhart.
On the other hand, I have a kind of a national perspective. And
one of the roles that I’ve had consistently since 1971 is somebody
who is interested in the frontiers of medicine and of healing both
initially within the psychiatry but then much more broadly; and
my efforts have been to help bring people who are doing the most
interesting work together with those who are in a position to exam-
ine, evaluate and, if appropriate, forward that work.

And we're at that stage now. I see myself kind of as a convener,
if you will. We’re at the stage in cancer research where I think this
is an important function, not just for me but collectively for, I think
one that this committee is helping us to fulfill, and one that I think
all of us here need to be more responsible for.

Dr. Jonas mentioned the conference we had called Comprehen-
sive Cancer Care: Integrating Complementary and Alternative
Therapies this June. It was sponsored by the Center for Mind-Body
Medicine. We had cosponsorship from the Office of Alternative
Medicine, and it was an extraordinary event. Partly for, if I should
say with a little bit immodesty, but I was very impressed by the
willingness of people on all parts of the cancer care spectrum to
come to the conference, for people who are doing with the kind of
research that Dr. Speckhart is doing to—and Dr. Gonzalez to share
what they’re doing, for people from the NCI, including the Deputy
Director of the NCI, to come, to listen carefully, to respond
thoughtfully. And I think that this dialog is immensely important.


60

Dr. KLAUSNER. One of the things that the NCI did, and it was
pointed out in the IOM report, is that we set up a special advisory
committee to me of consumers, many of whom are particularly in-
terested in alternative and complementary medicine. There are
now 15 people; 400 people applied. We chose 15.

And one of the goals is to make sure that on all of our review
committees are consumer advocates to ask those questions, to see
how we make decisions, how we argue about science and that evi-
dence and for them to participate, not just to observe but for them
to participate.

e’re creating training programs for them, that they’re helping—
they’re actually helping us create by telling us what they need. And
my certain—my hope is that they are exactly that sort of gadfl
that says, why do you think that’s important? Why do you thin
that’s not important? Why are you criticizing this?

Mr. Horn. Thank you, Mr. Chairman.

Mr. BuRTON. Thank you, Mr. Horn.

We will excuse you now and have our next panel, and I appre-
ciate you staying around to hear what they have to say.

We have Dr. James Gordon, director of the Center for Mind-Body
Medicine; Dr. William Fair, Urologic Oncology at Memorial Sloan-
Kettering Hospital; Dr. Vince Speckhart, who is an oncologist and
private practitioner; and Dr. Larry Key, urgent care physician,
Michigan State University.

Stand and let me swear you in, please.

[Witnesses sworn.]

Mr. BURTON. We would like to, if it’s possible, have you limit
your statements to 5 minutes so we can get to the questions. We'll
try to be liberal if you really need a little extra time, and then any
additional comments you might want to have submitted for the
record, we would submit it for the record.

Who would like to go first? Dr. Key?

STATEMENT OF LARRY STEPHEN KEY, D.O., URGENT CARE
PHYSICIAN, MICHIGAN STATE UNIVERSITY

Dr. Key. I would like to thank you for inviting me here today.
It’s a real privilege to speak.

Chemotherapy by any other name is still chemotherapy. My
chemotherapy is no longer ABVD or MOPP but pancreatic enzymes
and a healthy diet. The ideal chemotherapeutic agent will produce
a minimum of toxic side effects. It would Tall only cancer cells, not
hair cells, sex cells or gastrointestinal cells from the mouth to
anus. It would be relatively inexpensive and openly available to the
public. It would not make you sicker or be, ultimately, responsible
for your death.

My treatment protocol utilizes pancreatic enzymes to attack can-
cer cells. These enzymes are naturally occurring substances and,
therefore, cannot be copyrighted or owned by any one company.
Certainly, no pharmaceutical manufacturer would willingly inves-
tigate a product they cannot own. No company or business should
be forced to take a loss in order to test a product it can never mar-
ket. On the other hand, cancer is such a far-reaching, devastating
disease that any reasonable treatment program should be consid-
ered.


56

working with the CDC right now to develop and use some of their
field investigation methods to go out and actually collect informa-
tion that practices this very type of information.

Mr. BuRTON. Well, can you solicit data bases from doctors who
are practicing CAM?

Dr. Jonas. Well, once there are networks, for example, that col-
lect data within practices, and this is one of the things that we’re
exploring. We’re planning to have a conference next year with the
main Federal agency that does this type of research called out-
comes research, the Agency for Health Care Policy and Research,
specifically looking at the use of this type of research and the col-
lection of this type of data in practices in CAM areas.

Mr. Burton. Mr. Miller.

Mr. KUCINICH. Excuse me, Mr. Miller. Would the chairman yield
for a minute?

Mr. Burton. If Mr. Miller doesn’t mind.

Mr. KucInicu. Mr. Miller, I want to point out something apropos
of what the Chair said. One of the problems I think we have in this
is that we have people who are alternative practitioners who, in
providing such information, may feel that they would be under
some kind of legal attack for practicing medicine. And I know
you've raised that issue before about making sure that those who
are alternative practitioners are not subject to those kinds of at-
tacks.

Mr. BurRTON. Well, I might add, I think we have a doctor before
us who is going to appear today who is under scrutiny because he
was using alternative therapies to help his patients, and they tried
to take his license away from him. Fortunately, that did not hap-
pen. But that is really counterproductive. If a doctor is using alter-
native therapies that work, rather than try to jerk his license, they
ought to try and find out why it’s working. You know, I don’t un-
derstand that.

Mr. Miller.

Mr. MILLER. Thank you, Mr. Chairman, and thank you for hav-
ing the hearing. Someone who sits in the Labor-HHS Appropria-
tions Subcommittee, Dr. Klausner, comes to us often, it seems like,
sitting through a lot of meetings as we go through that appropria-
tion process.

NIH—and John Porter likes to talk about this—was really one
of the crown jewels of the Federal Government. And we should all
be very, very proud about—it is not a partisan issue. We all sup-
port it very strongly.

Speaker Gingrich has said often, this is one of the highest prior-
ities for future growth and spending in the Federal Government.
We spend about—what—$13 billion a year total, and cancer, I
guess, about $2.5 billion. We’re talking about round numbers,
which is the largest, right?

One of the concerns I’ve had in going through those hearings is
I guess concerns of the bureaucracy. How many Institutes are
there, 23?

Dr. KLAUSNER. There are 24.

Mr. MILLER. There are 24 Institutes. And then there are these
offices, such as the Office of Alternative Medicine, and how many
offices of AIDS research—AIDS is not an institute, by the way?


What Are
Dietary
Supplements?

Opportunities

00S Databases

‘Accomplishments

Publications

her Relevant

18

OFFICE OF

DIETARY About ODS

SUPPLEMENTS,

The ODS is a Congressionally mandated office in the Office of the
Director, National Institutes of Health (NTH). As an NTH office, the
ODS embraces the overall mission of NIH:

“to uncover new knowledge that will lead to better health for
everyone.”

NIH works toward that mission by:

"conducting and supporting research, helping to train research
investigators: and fostering communication of biomedical
information."

The goal of NIH research is:

“to acquire new knowledge to help prevent, detect, diagnose, and
treat disease and disability, from the rarest genetic disorder 10 the
common cold."

The ODS supports research and disseminates research results in the
area of dietary supplements. The ODS also provides advice to other
Federal agencies regarding research results related to dietary
supplements. Each of the links below provide more detailed
information about the ODS.

vi ve 2

For more information about the ODS and its activities, please
contact the office at the following address:

Office of Dietary Supplements
National Institutes of Health
Building 31, Room 1B25

31 Center Drive, MSC 2086
Bethesda, Maryland 20892-2086
Tel: (301) 435-2920


41

Fact Sheets

The OAM js also working closely with the Cancer Information Service of the NCI to
produce “fact sheets” designed to provide information to both practitioners and to the lay public
‘on various forms of CAM cancer interventions. Fact Sheets are being developed on specific
modalities such as shark cartilage, hydrazine sulfate and antineoplastons, to name a few. These
fact sheets are being written by professional science writers engaged by the NCI after reviewing
the available literature. The style is such that it can be easily understood by the public, yet also
bbe useful to a practitioner or researcher since references will be given.

AA panel of experts on the topic, representing scientists and practitioners from both the
conventional and CAM communities, will review each fact sheet and make recommendations on
accuracy, bias, content and style. The OAM has provided the NCI with a list of over 50 potential
reviewers with varying expertise. It is anticipated that these fact sheets will be disseminated
through the OAM Clearinghouse, its web page and by the NCI through its extensive cancer
information services. The process is similar to that usually done to disseminate other non-CAM
information on a routine basis.

Database

Given the broad base of worldwide scientific literature on CAM and CAM related topics,
the OAM began working with the National Library of Medicine databases to develop a database
of CAM citations. As of August 1997, over 90,000 citations were catalogued and can now be
found on the OAM home page. These citations can be searched in a variety of modes, some still
under development. One search mode is by clinical condition. A search of “cancer” yielded

16,000 citations.


51

So I think there was a response to it. And one could always ask,
was it enough, was it appropriate, and it is very difficult for me
to judge that. We are working hard now.

r. BURTON. In my opening statement, I said 40 to 60 percent
of the people who have cancer are still going outside the normal
medical remedies to find alternative therapies, and they need to be
researched and looked at to find out if they are credible.

Exactly how much money has the NCI spent on funding clinical
research and alternative cancer therapies for each of the last 7
years? And this excludes the botanical project the NCI has been
funding for years where they are collecting potential active ingredi-
ents from plants around the world.

Dr. KLAUSNER. I do not know the number for each of the last 7
years. The funding last year, by our calculation using the criteria
from OAM, was about $16 million excluding the types of evaluation
of natural products, which we do. And you see from this that in
many ways it is very difficult to set a clear boundary. Many of the
alternative medicines relate to herbals and natural products; and,
in fact, many of the “traditional medicines” are exactly that.

I think the boundary is not as crisp and clear in terms of the re-
search and the practice and the science perhaps as the cultural dif-
ferences, which I think we need to work on. So we calculate about
$16 million directly and indirectly in this past fiscal year for the
areas of complementary alternative medicine as provided to us in
the definitions by the Office of Alternative Medicine. For direct
clinical trials, about $2.6 million.

Mr. BuRTON. Dr. Jonas, to what do you attribute the much-pub-
licized reduction in cancer deaths? Do you think the increased use
by cancer patients of CAM is a factor?

Dr. JONAS. Probably not, sir. I think Dr. Klausner can probably
answer this much better than me because he has been following
those statistics much closer. But certainly life-style changes are a
major contributing factor. Individuals are taking better care of
themselves. They are more cognizant of the factors that increase
their risks for cancer and other diseases such as heart disease. So
preventive measures, in my opinion, and also some of the large-
scale, newer therapies that are applied across the board I think are
the main factors.

Mr. BurRTON. Is there an annual report of CAM research activi-
ties at NIH?

Dr. Jonas. Yes. There is a biennial report that was required by
statute, and that is delivered to the Director and incorporated into
the biennial report of the Director of NIH.

wr BuRTON. Could we get a copy of that? We would like a copy
of that.

Dr. JONAS. Yes, sir.

Mr. BurTON. Let me refer to my colleague from California. Do
you have any questions, Mr. Horn?

Mr. Horn. With this panel?

Mr. Burton. Yes.

Mr. Horn. Let me ask a couple of general questions. You might
have covered it. Sorry I had to be late.

I am curious to what degree NIH collaborates with foreign insti-
tutions similar to NIH? en you come to the National Academy


80

| reported to the office of Technology Assessment a 75% response rate using Autogenous
Vaccine. They recommended that further trials be conducted, My Medical Board, disregarding
the fact that Autogenous Vaccine was grand fathered in the 1938 Food Drug and Cosmetics Act
as the ordinary practice of medicine, refused to let me use it.

The first rule of therapeutic is “do no harm”, 1 could not adhere to this rule by using
chemotherapy. Therefore, I was eager to use less toxic methods of treatment.

Nutrients such as vitamins, minerals, and enzymes all have an added benefit in treatment of
cancer. Chelation Therapy, although not curative, has been helpful in eliminating toxic heavy
metals. Homeopathy and herbals are useful, Comfort measures including massage therapy, deep
muscle relaxation techniques, and lymph massage frequently eliminate the need for narcotics.
Various detoxification programs, including the use of saunas, are also helpful. Acupuncture has
therapeutic benefit in many ways.

have just completed establishing a database in 670 cases using Electro-Acupuncture, 1
can now demonstrate which bacteria, viral, fungal, chemical, and pesticide signals are seen on
each acupuncture point. Even dental heavy metals, such as mercury, gold, and titanium can be
recognized in various clinical conditions. In my experience, this technology has great potential for
clinical application and should be studied.

The basic scientists have been telling us all along that the human body, like other
biological systems, is an integrated, non-linear system that is dissipative, non-equalibrial, and
dynamic. Altemative medicine addresses many of these issues and focuses on the body, trying
to assist it in maintaining disease free state.

‘A cancerous tumor is an effect of the body’s inability to maintain a healed state. Yet, the

current system’s focus is almost entirely on the “lump and bump”, that is, on the tumor of its


13

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55

And so the utility of that kind of information, unless it is col-
lected in very rigorous and systematic ways, is often extremely lim-
ited and in some cases not useful at all.

Mr. KuciNicu. I would grant you that response to therapies may
be idiosyncratic. Given that, we also know that there is a tradi-
tional resistance of traditional medicine to alternative therapies,
which basically argues against research into alternative medicine.

I might comment to the Chair that such a resistance ironically
mirrors the resistance of cancer to a cure by traditional medicine,
and that while conventional medicine has done much to improve
public health and quality of life, its rigidities may inadvertently be
slowing a cure for cancer. Even as conventional medicine could pro-
vide us with a cure, the frustration I think of alternative medicine
is making it difficult to get one.

And I think it points out the need to what the Chair is aiming
at and that is to have a more integrative approach, integrating con-
ventional autopathic medicine with the more complementary and
alternative therapies. And I think the—as you gentlemen represent
a divergence of views on that, we need some convergence so that
the American people can give us feedback as to what they’ve
learned and so you could take advantage of a new type of thinking.

But I would just like to conclude with this: We really need a new
type of thinking about this. We’re entering into a new millennium.
It’s time for a quantum leap, where we have a qualitative trans-
formation on the thinking about medicine itself, and this will lead
not only, I think, to looking at ways of better managing cancer but
also the symmetry which could lead to prevent it as well.

So I appreciate you gentlemen and your participation in this.
And I again want to thank the Chair for his outstanding leadership
in this area.

Mr. BurRTON. Thank you, Mr. Kucinich.

Before I yield to Mr. Miller, let me just say that Mr. Kucinich
I think makes a very valid point. Even if you did have a web site
and you did get information that was not complete, if you had some
staff people that could analyze these cases and check them out, you
might very well come up with some conclusive evidence or close to
conclusive evidence that could lead to additional therapies that
could be used in cancer.

To just say out of hand that the information you're going to get
from a computer or from a web site would say it doesn’t tell wheth-
er they used other things in conjunction with the alternative ther-
apy that they used, I think is to beg the question. The more infor-
mation you get from cancer patients who have been cured, the bet-
ter picture you can draw.

And I don’t understand why there’s a recalcitrance to this kind
of an idea. I think a web site and asking people who have had re-
markable cures from alternative therapies to put their information
in there would be great, and to have a review panel go through
that and look at it could be very helpful in coming up with new
procedures to save people’s lives.

Dr. Jonas. I just want to say we actually have been developing
along these lines and working very hard along these lines to de-
velop this kind of practice-based outcomes evaluation. Actually,
POMES refers to some of those ideas. Well, for example we're


2

He predicted a cure in 5 years. So far, cancer has won; and it has
touched probably every family in America one way or another. He
predicted a cure within 5 years. It has not happened. This despite
the fact that the budget of the National Cancer Institute has in-
creased over tenfold, from $223 million in 1971, to an estimated
$2.2 billion in 1998, This rate of increase has occurred in the face
of escalating cancer incidence rates and little improvement in sur-
vival rates. What is more, we seem to be making little progress to-
ward a cure or even in developing promising treatments. This is a
sad commentary, given the billions upon billions of dollars that
have been spent by this Government in the last 25 years to fight
this deadly disease.

There are growing numbers of cancer patients who want and
need options other than that which current conventional medicine
provides to them. There are growing numbers of cancer doctors
who realize that they are not meeting the needs of their patients.
We are going to hear testimony from a cancer doctor today who
tired of signing the hundreds of death certificates which faced him
in his practice over the years, he knew he had to begin searching
for alternatives to save his patients or, at the very least, to salvage
their quality of life. Today he treats cancer patients with a variety
of reatments which are nontoxic and produce more positive re-
sults.

In recent years, the media has reported that polls of American
citizens show an astounding 40 to 60 percent have used some form
of alternative therapy. at qualifies as alternative medicine?
Some define it as any kind of treatment that is not taught in con-
ventional medical schools. Most often, it is some therapy that a pa-
tient uses in conjunction with his or her conventional treatment.
Yet, the vast majority do not tell their physicians because they feel
they will reject anything not considered “conventional medical
treatment.” Perhaps we need to address medical education and en-
courage progress and change in that arena also.

In our February hearings, we heard sworn testimony from pa-
tients who feel that alternative and complementary treatment
saved their lives. We will hear more of that today from doctors who
have been stricken with cancer. We will hear the National Cancer
Institute trumpet the minor reduction in certain categories of can-
cer deaths in the last 5 years, but we must wonder if that is, in
fact, tied to the increased use of alternative therapies.

In past hearings, our distinguished ranking member, Mr. Wax-
man, and others pointed out that no matter how successful some
individuals might find these treatments, a crucial piece of the puz-
zle is still missing, and that is scientific research. Without well-doc-
umented data, anecdotes are still just anecdotes. But if research is
properly performed on the therapies that show promise, American
citizens will have the information they need to make intelligent
choices.

And if that research is federally supported, as it should be, then
it is much more likely that successful therapies will be more widely
used by physicians across the country, more often reimbursed by
insurance plans and, most importantly, will save more lives. The
intention here is not to throw the baby out with the bath water.
Conventional treatments for cancer have shown to be effective in


12

ORTHODOX DOC'S: MY WAY OR THE HIGHWAY

NOT WANTING TO WASTE AN OPPORTUNITY TO ASSIST MY HIGHLY
TRAINED ONCOLOGIST--I ASKED HIM IF HE WOULD LIKE TO "FOLLOW
ME" (MEDICALLY SPEAKING) DURING MY LITTLE FORAY INTO THE
WORLD OF ALTERNATIVE CANCER TREATMENT. ALL HE WOULD HAVE
TO DO IS PROVIDE AN EVALUATION AT REGULAR INTERVALS --
BLOOD WORK, AN OCCASIONAL X-RAY, AND SO ON. I EXPLAINED IT
WOULD BE A GOOD WAY TO DISCOURAGE OTHER RENEGADE
PATIENTS FROM VEERING OFF THE ORTHODOX COURSE.

I MEAN, I WAS A DOCTOR AND AN INTELLIGENT MAN, IF IT DID NOT
WORK HE COULD EXPLAIN TO THE OTHERS MY FOLLY. IF IT DID
WORK, HE COULD TRY THE TREATMENT PROTOCOL FOR HIS OTHER
PATIENTS (I WAS NAIVE). HIS "THANK YOU BUT, NO THANK YOU"
WAS PERCEPTUALLY COOL...I DO NOT THINK HE LIKED THE IDEA...
SOMETHING TO DO WITH A POOR WASTE OF GOOD COFFEE.

HAIR SAMPLES -- MAYBE THE FBI IS ON TO SOMETHING!

PRIOR TO MY ARRIVING IN NEW YORK FOR MY INITIAL
EVALUATION, DR. GONZALEZ HAD REQUESTED I SEND HIM A HAIR
SAMPLE TO ASSIST HIM IN ANALYZING MY METABOLIC STATE.
BEING IN THE OWNER OF ONE OF THE SHINIEST PATES ON TWO
CONTINENTS, I PUZZLED OVER WHERE TO OBTAIN THIS DESIRED
SAMPLE. I WAS NOT ABOUT TO HACK AWAY AT MY NEATLY TRIMMED
BEARD SO I OPTED FOR AN AREA A LITTLE LOWER COWN. I
THOUGHT..."HAIR WAS HAIR" AND WITH A SMILE, SENT HIM THE
SAMPLE, WHEN I DISCUSSED THIS WITH MY MEDICAL COLLEAGUES I
WAS MET WITH JIBES AND DISBELIEF. I MADE A MENTAL NOTE TO
NEVER AGAIN SPEAK ABOUT COFFEE ENEMAS AND PUBIC HAIR IN
PUBLIC.

I'LL TAKE MANHATTAN

NEW YORK CITY WAS EVERYTHING I EXPECTED AND MORE. NOISE,
CONCRETE, MORE NOISE, TAXI HORNS HONKING THEIR OWN
LANGUAGE, "STREET" PEOPLE, SAILORS, THE EMPIRE STATE
BUILDING. WHEN I FINALLY ARRIVED AT DR. GONZALEZ'S OFFICE I
WAS PERPLEXED AT FINDING THE SHRUBBERY CHAINED TO THE
BUILDING...WHOA...THESE PEOPLE STEAL TREES? CLUTCHING MY
WALLET I TRIED TO ENTER THE BUILDING. THE DOOR DID NOT
GIVE. I HAD TO PUSH AN INTERCOM BUTTON, IDENTIFY MYSELF
AND, BE "BUZZED" IN. SHADES OF SEINFELD...THIS WAS NEW
YORK! IF GONZALEZ LOOKED LIKE KRAMER... WAS GOING HOME.

-10-


27

Mr. Burton. I also ask unanimous consent that all articles, ex-
hibits and extraneous or tabular material referred to be included
in the record; and, without objection, so ordered.

Would you gentlemen please rise? We have a habit of swearing
everyone in.

[Witnesses sworn.]

Mr. BuRTON. Do you have an opening statement, Dr. Klausner
or Dr. Jonas?

STATEMENT OF RICHARD KLAUSNER, M.D., DIRECTOR,
NATIONAL CANCER INSTITUTE, NIH

Dr. KLAUSNER. Good morning, Mr. Chairman, Mr. Gilman.
Thank you for giving us this opportuni; . Iam pleased to be here
today on behalf of the National Cancer Institute to talk about the
evaluation of complementary and alternative medicine in cancer.

I am particularly pleased because a lot is happening, a lot is
changing along the lines of what both you and Mr. Gilman have
talked about; and that is the need to work together across these
communities.

Let me emphasize at the start that the basic tenet at the NIH
is to employ rigorous methodologies to reach conclusions based on
evidence and not on belief. That is what we owe our patients. It
is through such methodologies that the intersection between so-
called traditional and so-called alternative and complementary, or
CAM, medicine must be sought. Standards of evidence cannot be
compromised. And I am pleased that on this crucial point I and my
colleagues in the CAM community agree.

has been and is awarding more grants to support high-qual-
ity, CAM-related research projects, examining the effects of dietary
interventions and treatments in prevention; projects examining the
therapeutic effects of vitamins and minerals; and studies in stress
and pain management to enhance the quality of life of cancer pa-
tients, in addition to the question about the length of survival.
Also, to look at natural inhibitors of carcinogenesis.

Now those of us who are dedicated to eradicating cancer have at
least two reasons to be open to the evaluation of nontraditional
therapies: First, we will not be successful in alleviating cancer un-
less we are open to new ideas. We have learned through history
that anecdotes and folk traditions have often guided us to real and
effective therapies.

Second, as you have pointed out, many people avail themselves
of complementary and alternative medicine, and those people rea-
sonably ask who is providing evidence as to whether they help,
whether they do not do any good, or even whether they harm. The
challenge is, how do we best go about choosing which complemen-
tary and alternative medicines to evaluate through rigorous clinical
trials and, importantly, how do we design those trials that they
yield timely and credible results to all communities involved?

Let me emphasize that an evidence-based approach to evaluating
therapies must be imposed on every step that leads us to initiate
a trial. There are thousands of potential therapies for these hun-
dreds of diseases we call cancer, and that number multiplies in the
nearly endless combinations that could be tested. The result and
the reality is only a tiny fraction of what is possible, whether from


10

THAT PRAYING IS DRIVING ME NUTS!

BEFORE EACH TEST OR SCAN, BEFORE ANY PROCEDURE WAS.
PERFORMED ON ME, I ALWAYS PRAYED FOR GUIDANCE AS TO WHAT
TO DO. IT DROVE MY ONCOLOGIST NUTS! HE WOULD SAY WE NEED
TO THAT MEDIASTINOSCOPY RIGHT AWAY AND I WOULD SAY...LET
ME PRAY ABOUT THIS. I ALWAYS DID WHAT HE WANTED ME TO DO.

I WAS VERY THOROUGHLY EVALUATED; I CAN SAY THAT. AFTER
MUCH PRAYER, FAMILY DISCUSSION, AND CONSIDERATION, I
DECIDED THAT I WOULD HAVE NO TREATMENT AT ALL. WHEN I TOLD
MY ONCOLOGIST MY DECISION, HE WAS FLUSTERED. HE COULD NOT
COMPREHEND HOW AN INTELLIGENT MAN LIKE MYSELF, A DOCTOR,
COULD MAKE SUCH A DECISION. I SAID IT WAS FOR THOSE VERY
REASONS I COULD MAKE A DECISION. I WAS INTELLIGENT AND A
DOCTOR. 1 ASKED HIM HOW I WOULD DIE. HE SAID WHAT DO YOU
MEAN? HOW WILL I DIE I REPEATED. HE SAID FROM METASTATIC
SPREAD OF MY CANCER, FROM INFECTION. BUT, HE CONTINUED
...PEOPLE DON'T DIE FROM YOUR DISEASE, THEY DIE FROM THE
TREATMENTS. MY POINT EXACTLY. I WENT TO MY PRIEST FOR LAST
RITES AND TO MY ATTORNEY FOR A WILL. I WAS GOING TO DIE
WITH DIGNITY.

DEATH: YOU CAN RUN BUT YOU CAN'T HIDE

1 HAD LOST MY JOB, I WAS LOSING MY LIFE. I WAS TIRED AND
MISERABLE. WITH TOO MUCH TIME ON MY HANDS I STARTED
CLEANING OUT OLD PAPERS AND MEDICAL JOURNALS. I FOUND AN
AUDIO TAPE SOMEONE HAD GIVEN ME WHEN I WAS FIRST
DIAGNOSED WITH CANCER IN 1986. "THE METABOLIC /
NUTRITIONAL APPROACH TO CANCER TREATMENT" NICHOLAS J.
GONZALEZ, M.D....1 REMEMBER THINKING WHEN THE TAPE WAS
FIRST HANDED TO ME...JUST WHAT I NEED! A “HIPPY-DIPPY”
TREATMENT FOR CANCER. I HAD TOSSED THE TAPE INTO THE
BOTTOM OF A BOX AND HAD NOT SEEN IT FOR EIGHT YEARS. MY
WIFE AND I WERE GOING TO WATCH OUR GIRLS RUN IN A TRACK
MEET AND I BROUGHT IT ALONG FOR A LAUGH...SOMETHING FOR MY
WIFE AND I TO CHUCKLE AT AND MAKE FUN OF.


63

IT HAVE CANCER. I HAVE CANCER. I HAVE CANCER. I HAVE
CANCER. IT IS THREE O'CLOCK IN THE MORNING AND I AM AWAKE. I
HAVE CANCER. I WAS SLEEPING BUT NOW I AM AWAKE. I AM
STARING INTO THE BLANKET OF DARKNESS SURROUNDING ME. I
HAVE CANCER. I WANT TO SLEEP. I WANT TO BE LEFT ALONE, I
HAVE CANCER. IT USED TO BE JUST ME INSIDE MY BODY. MY
WHOLE LIFE WAS SPENT HAVING A RUNNING CONVERSATION WITH
MYSELF...WITH ME. I HAVE CANCER. IT WAS PRIVATE, INVIOLATE,
SOLITARY. 1AM STUNNED. THERE IS ANOTHER THING IN HERE
WITH ME. IT SINGS A MANTRA. OVER AND OVER. IT BECOMES THE
BACKGROUND SOUND TO EVERY MOMENT OF MY EXISTENCE. I HAVE
CANCER. I HAVE CANCER. IT HAS A SMELL, A TASTE. IT DRIPS LIKE
A FAUCET IN AN EMPTY SINK. I HAVE NO APPETITE. I WEAR
FATIGUE LIKE A SECOND SKIN. NO ENERGY. NO ENERGY. I HAVE
CANCER. I HAVE CANCER. I HAVE CANCER. I HAVE CANCER.

WHO GETS CANCER?

THE ANSWER TO THIS QUESTION DEPENDS ON YOUR VANTAGE
POINT. CANCER IS AT TIMES PERSONAL AND IMPERSONAL, IT IS
PERSONAL WHEN SOMEONE YOU LOVE OR CARE FOR IS STRICKEN.
IT IS IMPERSONAL IF IT HAPPENS TO "OTHER” PEOPLE...PEOPLE WITH
"FAULTY" GENES, "UNHEALTHY" HABITS, OR JUST PLAIN BAD LUCK.
CANCER GETS BEYOND PERSONAL WHEN YOU HAVE IT YOURSELF.

DO NOT READ ANOTHER WORD UNTIL YOU REREAD THE OPENING
PARAGRAPH OF THIS TESTIMONY. UNLESS YOU CAN PLACE
YOURSELF IN THE ROLE OF A CANCER PATIENT, FOCUS YOUR
THOUGHTS ON MY PRINTED WORDS, AND IMMERSE YOUR BEING
INTO MY WORLD--THIS TESTIMONY WILL NOT SERVE TO INFORM THE
ONE PERSON WHO SHOULD BE THE MOST AWARE OF CANCER'S
ENTRAPPING EFFECTS. THAT PERSON IS YOU. WHO GETS CANCER?
YOU GET CANCER.

WHAT CHANGES WHEN YOU GET CANCER?

YOU MAY OR MAY NOT KNOW THAT HAVING A VIEW OF YOUR
FUTURE "SELF", IS A DRIVING FORCE IN YOUR LIFE. IT IS WHAT
KEEPS YOU GOING...WHAT KEEPS YOU ALIVE. “FUTURE VISION"
MUSTERS A BROAD SCOPE. YOU SEE YOUR FAMILY, YOUR FRIENDS
AND COLLEAGUES...YOU SEE THE WORLD WITH FUTURE VISION. IT
SETS THE STAGE FOR HOPE. CANCER DRASTICALLY LIMITS YOUR
VIEW OF THE FUTURE...TUNNEL VISION WITH A CATARACT, LOSS OF
THE FAMILIAR. NOTHING IS THE SAME...NOTHING.


What Are
Dietary
Supplements?

About ODS
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& Contracts

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Opportunities

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me

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DIETARY About ODS

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QDS Home - Search - Question Index - Site Map - IBLDS - CARDS - NIH Home

Why was the ODS started?

Dietary supplements can have an important impact on the
prevention and management of disease and on the maintenance of
health. Dietary supplements in the United States are usually defined
as comprising plant extracts, enzymes, vitamins, minerals, and
hormonal products that are available without prescription and may
be consumed in addition to the regular diet.

Considerable research on the effects of dietary supplements has
been conducted in Asia and Europe where plant products, in
particular, have a long tradition of use. However, the overwhelming
majority of supplements have not been studied scientifically. It is
important to conduct objective research to determine the benefits
and risks of promising dietary supplements and to interpret data for
the public.

Recognizing these issues, Congress in November 1994 passed
we 1

‘AcU(DSHEA). This bill amended the Food, Drug, and Cosmetic Act
and focused on further defining aspects of that law that related to
the definition, regulation, and labeling of dietary supplements.
DSHEA included authorization for the creation of the Office of
Dietary Supplements (ODS) at the NIH and a Presidential
Commission on Dietary Supplement Labels. The ODS was formally
established on November 27, 1995 within the Office of Disease
Prevention, Office of the Director, at the National Institutes of
Health. Bernadette M. Marriou, Ph.D. was appointed Director of the
Obs.

Select a

[ee


37

site visits to practitioners, two-thirds of which deal with cancer; so-
liciting the CAM community for preliminary research information,
conducting workshops, and providing technical assistance to hun-
dreds of CAM practitioners, and having several contracts estab-
lished to do summaries of the science and specific CAM areas.

We have also funded a Center for Unconventional Cancer Re-
search at the University of Texas Health Science Center in Hous-
ton. This center has collected and summarized the current research
on over 25 of the main CAM cancer therapies used by the public
and identified possible and promising cancer research areas in need
of further evaluation.

In order to address the third issue, obtaining a wider advisory
input, the OAM has held a series of meetings to examine how to
execute CAM cancer research more effectively and how to build
better collaborative bridges between communities. Several meetings
were held on communication processes in CAM cancer research. We
were cosponsors for the Center for Mind-Body Study’s Comprehen-
sive Cancer Care Conference, of which you will hear about a little
later. And we also held, in conjunction with the NCI, a large meet-
ing in August 1997, that you mentioned that brought together
many representatives from the CAM and conventional cancer com-
munities.

The purpose of this latter meeting was to discuss how the OAM
and NCI could best develop the research infrastructures and the
collaborative processes needed to clinically test CAM interventions.
A plan was developed called the Practice Outcome Monitoring and
Evaluation System, or POMES for short, and a basic consensus of
these groups was achieved.

One of the main recommendations from this meeting was the de-
velopment of an advisory group. Such an advisory panel that Dr.
Klausner has mentioned is now being formed. It will have the fol-
lowing functions: it will assist the NIH is evaluating claims of effi-
cacy in CAM. It will make recommendations to the NIH on wheth-
er and how further research on these should be pursued. It will ad-
vise the NIH on the conduct of clinical trials. And it will develop
opportunities for improving communication between the CAM and
the conventional communities in the cancer area.

The purpose and the responsibility, the operation of this panel is
designed specifically so that both conventional and CAM commu-
nities will be well represented. After the POMES meeting, the NCI
and the OAM have been working to implement its recommenda-
tions within the context of existing administrative and scientific
structures. If identified CAM cancer treatments are deemed to
have sufficient data to warrant further research; and upon rec-
ommendations of the Cancer Advisory Panel, clinical trials can be
funded by the OAM using appropriate NCI mechanisms.

Let me illustrate a couple of these that are already about to
occur. We will be supporting two large clinical trials in specific
CAM cancer therapies this year. These will be implemented
through the NCI using recommendations from the POMES.

The first is the use of shark cartilage for the treatment of solid
tumors. Shark cartilage is one of the most frequently used single
unconventional interventions for cancer, and it is one of the most
frequently requested from our OAM clearinghouse to get informa-


57

Dr. KLAUSNER. That's right.

Mr. MILLER. Do you know how many offices there are?

Dr. Jonas. I think actually there are eight program offices.

Mr. MILLER. Eight program offices plus the 23.

Dr. Jonas. I may not be accurate on the total numbers. There
are both program and operational offices.

Mr. MILLER. Who do you report to? Who is your boss?

Dr. Jonas. My boss is Dr. Bill Harlon, who is the Associate Di-
rector of Disease Prevention.

Mr. MILLER. Are all of the offices under that?

Dr. Jonas. No. There are four offices—the Office of Rare Dis-
eases, the Office of Dietary Supplements, the Office of Alternative
Medicine, the Office of Medical Applications of Research—under-
neath him.

Mr. MILLER. One of those things I learned over the few years I’ve
been on this committee is the interrelationship of all of this. It’s
like—when we talk about AIDS research, which gets a very large
amount of the total budget, not as much as cancer, but the inter-
relationships of the research, what happens in AIDS research af-
fects cancer, cancer research can help AIDS and all the way across
there. So there are a lot of different benefits.

But I get concerned about this bureaucracy; and I don’t know
how Dr. Varmus can keep track of so many different offices and In-
stitutes. There are so many people reporting to him. Basic manage-
ment 101 says you have problems there. How does that work? It
seems like I read a report you had a meeting with DOD, because
they have a large amount of research. I mean there’s $200 million,
I think, for cancer research at DOD. How much time do you spend
in meetings trying to coordinate things each day? Is basically most
of your life just meetings constantly?

Dr. KLAUSNER. I spend a lot of time in meetings. And although
I think many of them are quite productive, I think in those discus-
sions and that coordination is how we recognize that—we do need
structures. I’m a scientist. I spend my life discovering things. Bu-
reaucracy is not something I like. But we need structures to make
things work, but actually science doesn’t neatly fall into these
structures. And so what really we need is a matrix of collaboration.

Actually, I think, by and large, that happens very well. We feel
as colleagues at the NIH, we come to it because we came with a
desire to work on disease, physicians and scientists. I’m trained as
a physician and a scientist.

AIDS is a good example. A lots of AIDS research goes on through
the NCI. And, in fact, with the AIDS virus, we were able to make
so much progress because it was a cancer-type virus. That was in
the range of cancer-type viruses that we knew a lot about. The
structure of the proteases, where we finally get effective therapies,
was not the answer, was solved at the NCI.

And it works through this matrix of people talking to each other,
collaborating, interacting. The scientists often don’t really pay
much attention to what institute they’re in or funded by. They seek
out their community that works. And we, in fact, try to make those
barriers as transparent as possible so that the science gets done
independent of the internal structures to make the wheels turn.


23

through contracts such as the Public Information Center Needs
Assessment Survey (link) that was initiated by the ODS and is being
conducted on contract and in collaboration with the USDA, or by
funding grants to scientific investigators in cooperation with the
Institutes and Centers at NIH, such as the Research Enhancement
Awards Program (REAP).

wy

To coordinate research and coordinate funding for research on
dietary supplements at NIH, the ODS has established a Dietary
Supplements Liaison Group, which consists of members appointed
by the directors of the Institutes and Centers at NTH. This group
meets periodically throughout the year and is in the process of
developing a workable mechanism for trans-NIH research
coordination on Dietary Supplements.

‘The ODS also serves as a member of the NIH Nutrition Research
Coordinating Committee (NCC) that is managed through the NIH
Division of Nutrition Research Coordination. The NCC serves to
coordinate all nutrition research at NTH and provides a regular
forum for Institute and Center dialogue about scientific issues
related to nutrition, diet and health. Dc 'Van Hubbard directs the
Division of Nutrition Research Coordination. In addition, the NCC
staff provides the link to the Department of Health and Human
Services interagency Nuirition Policy Board, which coordinates
nutrition research among the public health agencies and the
Interagency Committee on Human Nutrition Research (ICHNR),
which coordinates nutrition research at the federal level. The
ICHNR functions as a subcommittee of the Committee on Health,
Safety and Food of the National Science and Technology Council in
the Office of the President.

To fulfill the Congressional directives to collect and compile
databases of federally funded research and scientific papers on
dietary supplements the ODS is developing the two
databases--CARDS and LBIDS.

To provide advice to other HHS agencies and Congress related to
dietary supplements the ODS answers inquiries, writes reports,
makes presentations, and participates in interagency committee
activities on a regular basis.

Select a destination F] [eo


90

favor oa the Complementary Medicine Grants competing with other grants submitted to
the NCL I believe the only way to ensure adequate oversigin of those grants is for the
Chairman to push to have someone sympsthetic to the CAM community appointed to the
‘National Cancer Advisory Board. An individual with a true -nterest and commitment to
CAM sitting on this committee could exext a powerful influeace in assuring the
Complementary Medicine grants are given an adequate review, and equally important,
that information be disseminated from the National Cancer Advisory Board to the CAM
community conceming strategies to increase the likelihood of success of grant
applications.

A representative on the NCAB chosen because of research e perience and knowledgeable
conceming the role of complementary and altemative medicine in cancer management
‘would assure the CAM community and the American voter that our government is aware
of the growing demand for CAM services and determined to evaluate these modalities in
am impartial, scientific and carefully scrutinized method to er force effectiveness and
safety.

2.) At some future time a study section devoted to a reviewing CAM grants would be a
worthwhile goal but I believe such a demand would be impractical and unwarranted at

‘this time.


44

Additionally, if any CAM cancer treatment is deemed to have the requisite background of data
and upon recommendation by the CAP, clinical tials can be funded by the OAM, using NCI

mechanisms as appropriate to do definitive trials.

IV. OTHER CURRENT OAM RESEARCH ACTIVITIES IN CANCER

Several examples below illustrate other current CAM cancer research activities supported

by the OAM and NCI.
idemiology End R SEER P

‘The Surveillance Epidemilogy End Results (SEER) Program at the NCI is unique in its
two-decade plus tracking of diagnosed cancer patients. The willingness of the NCI to allow the
OAM to tap into this rich resource allows the OAM a potential wealth of information on CAM
use by cancer patients.

In 1997, the OAM participated with the SEER program by funding a contract
modification statement of work to the University of Hawaii SEER contract to study “Ethnic
Differences in Attitudes and Experiences Related to Altemative Cancer Treatments.” This
research examines the use of altemative cancer therapies by cancer patients, compares the quality
of life of these patients, describes experiences with its use and determines factors which
influence the adoption of alternatives therapies.

‘There is insufficient detail on the use of CAM cancer therapies by cancer patients and
special populations. In 1998, a contract was made to the Fred Hutchinson Cancer Research
Center in Seattle entitled “Use of Alternative Medicine by Cancer Patients.” The purpose of this
study was to describe more fully the magnitude and patterns of complementary and altemative

‘medicine use among cancer patients in the general population through extensive telephone


85

Mr. Chaimman, Members of the Committee of Government Cversight & Reform: I am
‘grateful to Congressman Burton and the committee member: for allowing me to address
the Committee and express my personal opinions an the neil for more research funding
in the area of complementary and alternative medicine.

am Dr. William R. Fair, Attending Surgeon and former Chef of the Urology Service at
Memorial Sloan-Kettering Cancer Center, and Professor of Urology at Cornell University
Medical College. I also serve as Chainnan of the Complementary and Alternative
Medicine Committee of the American Urological Associaticn. In addition to my
professional qualifications, I also appear as someone who hrs had a personal experience
with cancer—in my case colon cancer and over the past 3% years have had 4 surgical
procedures and a year of intensive chemotherapy. My preseuce here today with m
‘excellent life quality, 18 months after I exhausted all curative therapy known to allopathic
medicine, is in jtse}f a testimony to the effect of complementary medicine in cancer

‘management.

‘As a result ofa longstanding research interest in the role of autrition on cancer—
particularly prostate and breast cancer—plus the stimulus o1 my own condition, Ihave
extensively analyzed the available scientific data on complementary medicine, I was
smazed and pleased to find out just how much good clinical and experimental data exist
showing a benefit of complementary or alternative medicin? (CAM) techniques in the

management nf cancer and other chronic diseases. and how much opportunity there is to


62

is allopathic, osteopathic, homeopathic or naturopathic makes little
difference to patients who are struggling to make sense out of a
senseless disease. What is reasonable? Anything that works. And
you will never know what works unless you drop preconceived no-
tions about alternative treatments and support those programs
which show promise.

I have cancer. I sit before you today because I had the courage
to take on a treatment program that made sense to me as a trained
professional. You, as representatives of the people, need to take the
same kind of calculated risk I took. Personally, I would never fault
you for financially supporting individuals who are actively evaluat-
ing unorthodox methods as much as being disgusted with you for
not having the courage to risk for being thought foolish or gullible.
Saving face will never save lives when it comes to this disease.

On behalf of cancer patients in this country and the world over,
I ask your support both financially and in spirit for alternative can-
cer treatments. Thank you.

[The prepared statement of Dr. Key follows:]


86

test esseutially minimal or non-toxic approaches that promis: to significantly improve or
smsintain the quality of life in patients with cancer.

(On the other hand, I was dismayed to Iam how little validated scientific testing was done
on some approaches despite widespread use of these techniques among the lay
population, and how little research finding is available to properly evaluate a mumber of
complementary medical approaches that anecdotally appear useful and represent
eminently testable hypotheses.

Itis important for the committee to appreciate the distinction between complementary
and altemative medicine as used in my testimony. I believe the best term is
complementary medicine which embraces techniques not generally tanght as part of
medical school curriculum, that may be used to complement or augment standard therapy
rather than en alternative to replace orthodox treatment, Al-hough some mesures now
considered alternative may evenwally become standard therapy and replace commonly
ascepted procedures. For exatmple, in the 17° century the use of Foxglove, the digitalis
plant, was ridiculed by physicians when it was used as a substitute for blood-letting or

leeches in the treatment of congestive heart failure.

Unfortunately, the term CAM enhances a wide spectrum of practitioners, from those
with valid scientific approaches, to the charlatans and quac‘cs who prey on the fears and
anxiety of the cancer patient for purely financial gain. Thus, the unscrupulous promoter

who advocates wearing crystals on your bead or ear candling as a cancer cure should not


31

Opening Statement

Good morning. I am pleased to be here today to talk with you about the National
Cancer Institute (NCI) and the evaluation of complementary and alternative medicine in cancer.
1am pleased because we recognize that this is an important and challenging issue, and we have
been taking steps to significantly alter our approaches to complementary and alternative

Tam also pleased to be able to say unequivocally that this Nation is experiencing real
progress against cancer. This is evident in our cancer incidence and death rates, which are
declining. Between 1990 and 1995, these rates dropped for all cancers combined and for most
Of the top 10 cancer sites, reversing an almost 20-year trend of increasing cancer cases and
deaths in the United States.

After increasing 1.2 percent per year from 1973 to 1990, the incidence rate for all
cancers combined declined an average of nearly 1 percent per year between 1990 and 1995.
The rates declined for most age groups, for both men and women, and for most racial and
ethnic groups. The exceptions were black males, when the rates continued to increase, and
‘Asian and Pacific Islander females, when the rates were level. The overall death rate declined
an average of 0.5 percent a year from 1990 to 1995, with the declines greater for men than for
women, The only racial and ethnic group not included in the downturn was Asian and Pacific
Islander females.

We realize that these declines, while encouraging, must be accelerated and extended so
that all of our population benefits.

Recent Advances in Understanding Cancer

‘As we understand the nature of cancer, we understand that it is a unique set of diseases,
and that the answers to cancer are related to the most fundamental mysteries of life itself. We
know that cancer is not one disease, but at least 100 different diseases that share certain
features. Because of this it is unlikely that one magic bullet will solve the problem.

‘The most remarkable progress in the past 25 years has been in our knowledge of cancer
biology. We are dramatically extending our understanding of what is req
cell into a cancer cell. Cancer arises when a single cell changes so that it divides
continuously, released from the controls that constrain the replication of normal cells. This
transformation results from changes in the function and activity of genes. Of the
approximately 100,000 genes found in the human genome, the altered activities of only a
relatively small number of genes are responsible for transforming a normal, well-behaved cell
into a cancer cell. Identifying these cancer genes defines the central scientific hunt in cancer
biology, and opens an unprecedented window into the nature of cancer. Up until now, our
detection tools have lacked the sensitivity and the specificity that we must demand if early

1


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46

this process. The program is now ready for a randomized controlled trial at the Columbia Cancer
Center in New York. When funding for this project was withdrawn by Proctor and Gamble, the
OAM was quick to fill in the void and provide support for the proposed study using funds
already budgeted for cancer trials.

OAM CAM Cancer Center. A request for applications for a grant to support a large CAM cancer
research center will be issued at the end of August 1998. The plan is to use the standard funding
mechanism for NIH research centers (the so-called P50 mechanism), which requires several
viable peer-reviewed research projects at the time of funding. This way, there will be a
minimum of research start-up time, and research could begin almost immediately. The intent is
also to increase the OAM commitment to this center significantly. An award is anticipated by
the summer of 1999. Budget and programmatic issues permitting, the OAM has the option of

funding more than one CAM cancer center.

V. OAMPI )N DISSEMINATI
‘There is a tremendous demand for CAM related cancer information by the public. To
that end, the OAM has three activities dedicated to this need.
Public Information Clearinghouse
‘A public information clearinghouse has been maintained by the OAM since mid-1996.
Most of the calls to this clearinghouse are cancer-related. From July 1997 to July 1998, nearly
21,000 calls were received by the clearinghouse of which 65% , or 13,000+, were cancer related.
‘The most frequently asked questions are about common types of cancers such as breast, colon
and lung; what CAM interventions are available to treat them; and questions on specific CAM

modalities, such as shark cartilage or hydrazine sulfate.


STATEMENT OF CONGRESSMAN HENRY A. WAXMAN
HEARING ON "SOLVING THE CANCER CRISIS:
COMPREHENSIVE RESEARCH, COORDINATION AND CARE"
2154 Rayburn House Office Building
Friday, July 31, 1998

Mr. Chairman, today's bearing comes on the heels of last week's hearing in the
‘Commerce Subcommittee on Health and Environment regarding the state of cancer research.
‘The best and brightest cancer researchers in the United States testified about recent progress in
new cancer treatments, prevention and research. The National Cancer Institute provided a global
overview of our public portfolio of cancer research. It was a highly educational proceeding.

Today's hearing examines just one thread in the fabric of research and care described last
week, Alternative medicines and therapies are but one of many areas of investigation and
eligible for public funding.

Earlier this month, the Institute of Medicine released a report on priority setting in NIH
research funding. The report recommended that NIH “more fully engage the public” in its
priority-setting, by establishing a council of public representatives and offices of public liaison at
cach institute. In this respect, alternative medicines already enjoy substantial institutional
representation at NIH. In the past, Congress bas created an Office of Altemative Medicine and
an Office of Dietary Supplements reporting directly to the NIH Director. I would like to submit
information regarding both offices, following my statement, for the hearing record.

More importantly, the Institute of Medicine emphasized that NIH should continue to use
science-based criteria and “robust analyses of health statistics” to determine how to allocate its
funding and which scientific opportunities to target. On this point, there is almost universal
agreement -- science must decide how NIH invests our public dollars.

In the realm of cancer research, that means “alternative” medicines must compete
shoulder-to-shoulder on the basis of scientific scrutiny against Taxol, genetically tailored
antibodies, recombinant breast cancer vaccines and the many other promising areas of research
described last week by our country's leading cancer researchers.

believe that NTH has done a good job of balancing our country's many health needs in
defining our country's biomedical research portfolio. But clearly, more could be done,
‘encourage Dr. Klausner and Dr. Varmus to pay heed to the IOM’s recommendations.

I welcome Dr. Klausner and the rest of our witnesses, and look forward to their
testimony.

tt


40

v1 EV,

‘There are three main issues that must be addressed in pursuing research on CAM cancer
therapies. The first is the need for resources and a research infrastructure committed to rigorous
research of CAM cancer therapies. The second is the need to foster trust and collaborative
relationships between cancer research centers and practitioners who provide CAM cancer
therapies. The third is the need for expert advisory input for prioritizing projects in CAM cancer
areas, The OAM and NCT have been moving forward in addressing all of these issues.
Rigorous Research

In order to address the first issue, rigorous research, the OAM recognized very early that
significant inroads into research on use of CAM cancer interventions would require cooperation
and collaboration with the NCI. The OAM was established as a coordinating office within the
Office of the Director, NIH. As such, its role is to examine available scientific background for
specific interventions, be cognizant of the needs of the cancer patient groups, and work with the
NCI to implement selected studies in CAM areas.

‘There are many good reasons for taking this approach. First, research on CAM cancer
therapies, like all other CAM research, must be conducted using rigorous methodologies to reach
conclusions based on evidence and not on belief. The NCI has all the requisite resources to
execute appropriate research - both in clinical trials as well as basic research. It has in-house
scientific expertise in designing clinical studies, conducting pre-clinical and clinical research,
reviewing research proposals, and working with the Food and Drug Administration on
Investigational New Drug Applications. The NCI also is able to provide linkages to extramural
researchers and clinicians who may have detailed knowledge about specific cancers that can

augment in-house expertise.


19

Fax: (301) 480-1845
E-mail: ods@nih.gov

Select a destination

eg]


14

we, ABOUT THE OAM
@®: OEE OF ALTERNATIVE MEDICI
Fens General information
History Pumose Mission
ErogramAdvisory “Fiscal Year Budeet = QAM Program
‘Council Charter 1992-1997 Ams
History

The Office of Altemative Medicine (OAM) was initiated through
Congressional mandate under the 1992 National Institutes of Health (NIH)
Appropriations Bill. The NIH is one of eight health agencies of the U S.
Public Health Service and is part of the WS Department of Heautn and
‘Human Services (HHS)

The NIH is one of the world’s foremost piameaical research institutions, and
the Federal focat point for biomedical research in the United States. It
comprises 24 separate Institules. Centers. and Divisions. The OAM is
organized under the Associate Director of Disease Prevention within the
Office of the Director ofthe NIH

Purpose

The Congressional mandate establishing the OAM stated that the Office's
purpose is to “facilitate the evaluation of alternative medical treatment
modalities” to determine therr effectiveness. The mandate also provides for a
public information cleannghouse and a research training program. The OAM
does not serve as a referral agency for various alternative medical
treatments or individual practitioners. The OAM facilitates and conducts
research. The Office is located on the NIH campus in Bethesda, Maryland.
The QAM Clearinghouse 1s located in Silver Spring, Maryland.

Mission

The NIH Office of Altemative Medicine (OAM) facilitates research and
evaluation of unconventional medical practices and disseminates this
information to the public.

Alternative Medicine Program Advisory

Council Charter

‘The NIH Revitalization Act of 1993 provided for the establishment of

Program Advisory Council to provide advice to the Director of the OAM. The
‘approved a charter for the Councit in November 1993,

and the 18-member Council was offically formed in the summer of 1994

Council members are appointed by the DHHS Secretary. The first meeting
was held in September 1994. The Council meets three times a year.

Fiscal Year Budget

FY1992 FY1993.-FY1994.- FY1995.-- FY1996 F197
32M SSM = S3SM— SMM STAM 12M

OAM Program Areas


3

some cases. But more and more doctors are realizing that treating
cancer must involve more than trying to eliminate the cancer cells
with some form of surgery and toxic chemical regime. The use of
complementary treatments, a complete protocol consisting of a
number of therapies and approaches used together, often have
more favorable results.

Finding ways to change life-styles, reduce stress, strengthen rela-
tionships with loved ones and create a fulfilling spiritual life can
boost the immune system and provide a better quality of life and
often a longer life. We will hear from a distinguished doctor this
morning who founded a center for mind-body medicine, and he will
tell us about the necessity of treating the whole patient instead of
just the P sical symptoms.

As well, we will hear from a highly respected surgeon with Me-
morial Sloan-Kettering Hospital, who used complementary medi-
cine to treat his own cancer. In fact, three of the four members of
our second panel are physicians, doctors who have suffered from
cancer and bring an enlightened perspective of the necessity of re-
search of these therapies.

Despite the growing popularity and success of alternative and
complementary treatments, some of our government institutions
have resisted that trend. It has been 8 years since the New Eng-
land Journal of Medicine first reported an astounding increase in
the use of alternative medicine, and the Federal Government is
just now beginning to take steps needed to properly research these
treatments.

The Office of Alternative Medicine began in 1992 with minuscule
funding and still receives only a fraction of what is needed to con-
duct meaningful research. But some progress is being made. Last
year, the Office of Alternative Medicine and the National Cancer
Institute brought together approximately 80 experts across the
medical spectrum who made recommendations for how to move for-
ward with research on complementary and alternative treatments
for cancer. Implementing these suggestions has been slow, but it
must be done. And today we have the esteemed directors of both
the National Cancer Institute and the Office of Alternative Medi-
cine to provide us more information on how this research is going
to move forward.

The title of today’s hearing is, “Solving the Cancer Crisis: Com-
prehensive Research, Coordination and Care” because I believe
that the American people have clearly voted with their feet by vis-
iting alternative practitioners by the millions and by their wallets
by spending on alternative treatments in the billions of dollars.

Comprehensive research is imperative to assist the public in
their search for quality treatment. Coordination among agencies at
the National Institutes of Health and among conventional and un-
conventional practitioners is necessary for this research; and, if
done correctly, Americans stricken by cancer will begin to get the
care they deserve.

With that, I yield to my colleague from California, Mr. Waxman.

Mr. WaxMaN. Thank you, Mr. Chairman.

Today’s hearing comes on the heels of last week’s hearing in the
Commerce Subcommittee on Health and Environment regarding
the state of cancer research. The best and brightest cancer re-


108

And I was sitting there in front of him. I know it works. I had
this stomach problem for 2 years after I came back from Africa,
and it was gone. He walked away and wouldn’t talk to me.

And that is one of the things that I was talking to you about,
Dr. Klausner, a while ago. I don’t know if it is a mind-set that has
always been there and will always be there, but it needs to be
changed so that people like Dr. Marshall and the others that I
mentioned are at least looked at as far as their alternative thera-
pies are concerned.

I don’t think that I have any more questions other than just one.
Dr. Fair, you said that you tried to introduce the use of yoga for
presurgical patients at Sloan-Kettering. What happened?

Dr. Farr. I had 50 yoga teachers that were pro bono coming in
and were going to instruct the patients a week before surgery with
breathing and meditation and relaxation techniques and give them
a tape and at the time they came in for surgery would meet them
in the presurgical area at 6 a.m. The nurses were ecstatic, and the
surgeons were excited, and the anesthologists viewed it as a great
move because they would be able to look at pulmonary saturation
and so forth, but it sort of just died. The administration felt that
this was probably not the kind of thing that we ought to be doing
at Memorial or we should be more in a general program.

Mr. Burton. Scientific?

Dr. Farr. Yes. I have not given up on it yet, but it is still hanging
there in the balance.

Mr. BuRTON. I want to thank you. You might want to stick
around while we talk with Dr. Klausner and Dr. Jonas one more
time.

We really appreciate your testimony and, even more than that,
I appreciate your humanity and your concern and willingness to
take those chances to increase the knowledge of medicine. Thank
you very much.

If we can have you come back up, Dr. Klausner and Dr. Jonas.

How are you going to integrate the things that you have heard
here today into your research? Do you have any ideas about that?

Dr. KLAUSNER. I think, to reiterate some of the things, I think
the steps that we are taking are the steps that we need to both
communicate information about complementary and alternative
medicine, make it available and accessible to people. From all of
the things that we have heard from everyone is that we need vali-
dation. We need to be able to tell patients what is likely to work
and what is not likely to work, and I think that is what we are
setting up to do. That is what I heard, and I agree with that.

Mr. BuRTON. Would it be possible to put an alternative medicine
or complementary medicine person on the cancer advisory board,
National Cancer Advisory Board?

Dr. KLAUSNER. It is possible. The President appoints those mem-
bers, not me or even the Secretary. There are people on the board
who are interested in certainly aspects of complementary medicine,
but that is a Presidential advisory board.

Mr. BurTON. But there is not an advocate for complementary al-
ternative medicine on the board?

Dr. KLAUSNER. No.


69

MY LEGS REMAIN AS SMOOTH AS A BABY'S BUTT

I CONTINUE ON WITH MY LIFE. I GRADUATE FROM MY EMERGENCY
MEDICINE RESIDENCY. I AM TEACHING AND TRAINING RESIDENTS.
I BECOME A DIRECTOR OF MEDICAL EDUCATION. I TRY NOT TO
THINK OF CANCER TOO MUCH. I TELL PEOPLE I USED TO HAVE IT
BUT, I BEAT IT. 1 AM A CANCER SURVIVOR! MY DAUGHTERS ARE
ENVIOUS OF MY SMOOTH, HAIRLESS LEGS. SEEMS CHEMOTHERAPY
WORKS BETTER THAN ELECTROLYSIS. NO LEG HAIR EVER COMES
BACK...UNFORTUNATELY THE CANCER DOES.

LET'S SAY WE DO, THEN DON'T

IT IS ONE A.M, AND I AM AWAKENED BECAUSE IT FEELS LIKE
SOMEONE HAS THROWN A BUCKET OF WATER ON ME. I AM SOAKED.
NOT JUST SUMMER-TIME, DAMP PAJAMAS BUT, SOAKED. MY WIFE
TURNS TOWARD ME AND STARTS TO CRY. IT'S BACK ISN'T IT...

SHE ASKS..ALREADY KNOWING THE ANSWER. I CHANGE, THROW
SOME TOWELS ON THE BED AND TRY TO GET BACK TO SLEEP. I NOW
KNOW WHY I HAVE BEEN SO TIRED. IT WAS MORE THAN THOSE
SIXTY-HOUR WORK WEEKS I HAD BEEN PUTTING IN. MY OLD FRIEND
HAD COME TO VISIT ME AGAIN. IT HAD BEEN EIGHT YEARS BUT HE
WAS BACK... CAN HEAR THE MANTRA BEGIN.

SAME TUNE....DIFFERENT MELODY

AFTER A "WORK-UP" CONSISTING OF MULTIPLE TESTS, X-RAYS,
NUCLEAR AND CT SCANS, AND MAJOR ABDOMINAL SURGERY, THE
CONCLUSION WAS PRESENTED. MY HIGHLY TRAINED ONCOLOGIST
SUSPECTED I WOULD HAVE A NEW TYPE CANCER BROUGHT ABOUT
BY MY PAST CHEMOTHERAPY (NOT UNUSUAL). HOWEVER, THE MAYO
CLINIC INFORMED HIM IT WAS STAGE IV, MIXED CELLULARITY,
HODGKIN'S LYMPHOMA....QUIETLY RETURNED...RELAPSED...THE
MANTRA GOT LOUDER.

TELL YA WHAT I'M GONNA DO...

MY ONCOLOGIST GAVE ME THE TREATMENT CHOICES: SALVAGE
CHEMOTHERAPY OR A BONE MARROW TRANSPLANT. NEITHER
SOUNDED TOO EXCITING. HE WAS PUSHING THE BMT (BONE
MARROW TRANSPLANT) AND SCHEDULED ME TO BE SEEN AT THE
UNIVERSITY OF MICHIGAN TRANSPLANT CENTER. MEANWHILE, I DID
A COMPUTER SEARCH FOR THE RESULTS OF TREATMENT FOR
RELAPSED LYMPHOMA. I HAD A 24% CHANCE AT 5-YEAR SURVIVAL.
I WAS GOING TO DIE. I KNEW IT AND SO DID THE ONCOLOGIST.

-7-


24

Mr. BuRTON. We will recognize the chairman of the International
Relations Committee, Mr. Gilman.

Mr. GILMAN. Thank you, Chairman Burton, for bringing these
talented people together. These panels before us are so important
in this critical issue.

Studies have found that, as you have indicated, more than 40
percent of all Americans have been trying complementary and al-
ternative medical treatments and have been seeking out the advice
of physicians with regard to these treatments. And many individ-
uals who have suffered through the agonizing effects of traditional
cancer treatments, such as chemotherapy and radiation, are now
turning to the complementary and alternative treatments like
herbal therapy, meditation and nutritional therapy.

It is regrettable that research and studies that are done in our
Nation do not focus on complementary and alternative forms of
medicine enough. This collaboration between the National Cancer
Institute and the Office of Alternative Medicine is the perfect op-
portunity, I think, for the medical world to take important strides
in conquering the problems that we are confronted with as a result
of cancer.

It is clear that straightforward attempts to cure cancer can and
do work. Yet alternative forms of treatment can help our patients
in conjunction with more commonly used remedies.

There are many nations that accept alternative medicine and
rely on it regularly. But our Nation has always put a stigma on al-
ternative medicine; and, as a result, funding for alternative studies
has been difficult to acquire.

Significant achievements are being made in the cure for cancer
that are occurring overseas, in Europe and Asia. And it is long
overdue I think for our Nation to work together with its foreign
counterparts sharing information, sharing strategies, and looking
for better treatment.

Some cancer patients in our Nation have the ability to travel
overseas to receive alternative treatments, but we should be able
to offer all Americans that opportunity to access all forms of treat-
ment both traditional and alternative, and we should pool our re-
sources to create affordable, beneficial alternatives to common can-
cer treatments and alternative from which all cancer patients could
benefit from.

We need to commit to a joint effort between NCI and OAM and
pledge to commit a percentage of NIH’s budget to this cooperative
venture. Both organizations can benefit by working together, and
the cancer patients in our Nation will receive the best of care and
treatment that today’s physicians and scientists have to offer.

I thank the gentleman for yielding the time, and I look forward
to hearing the testimony today.

Mr. BurTON. Thank you, Mr. Chairman.

We will have other Members, I presume, that will come in from
time to time. I ask unanimous consent that all Members and wit-
nesses’ written opening statements be included in the record; and,
without objection, so ordered.

(The prepared statement of Hon. Christopher Cox follows:]


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29

ment of these summaries will follow the exact same model that
goes for conventional therapies, including specific trial results, the
references to the published literature, and review by the appro-
priate editorial boards that we have for reviewing all of our ap-
proaches to therapy, prevention, as well as supportive care.

The PDQ Editorial Board will now be supplemented with individ-
uals from the CAM community, and we have been provided with
a list of names of recommendations of individuals from Dr. Jonas
and Dr. Chung at the OAM.

Several months ago, as a result of my own concerns as well as
the constructive input from the CAM community directly to me, we
removed from the NCI web site all previous CAM information that
we really felt was very judgmental and did not represent the open-
ness that we are striving for, creating new information that treats
CAM dispassionately and fairly.

We will establish at the NCI a prominent lecture as part of the
medical Grand Rounds series in our Division of Clinical Sciences
open to all members of the NCI and NIH community about CAM
approaches. We think this is important as a way to disseminate in-
formation but very important as a statement of the importance of
inviting individuals from that community to work with us.

We are discussing, as we have talked about with Dr. Barnett
Kramer, the editor of the Journal of the National Cancer Institute,
the possibility of instituting a regular feature on CAM and cancer.
In my opinion, this will be very useful. This is an independent en-
tity, even though it is called the JNCI, and the decision about how
this ought to be done will have to rest with Dr. Kramer and his
editorial board, although I am very supportive.

As the Director of the NCI, I have a strong commitment to im-
proving our relations and to eliminating as best as possible the ten-
sion between the research communities. But in research commu-
nities, tensions will remain, arguments will continue. I think that
ought to be done on a healthy and mutually respected level. Both
communities share a common and admirable but extremely difficult
goal: to cure cancer. We will only get there through rigorous objec-
tive and dispassionate accumulation of evidence, not through anec-
dote, belief and philosophy.

I believe that the Ner and the OAM are working together in a
way that will successfully bring the power of science to alleviate
the suffering of cancer. It is vital that we work together to that

end,

If I could just add, I actually fully agree with you. And the rea-
son NCI exists is not to defend the treatments we have but because
we all agree our treatments are inadequate, not for all cancers. I
think actually we have made real progress. It is frustrating to all
of us that it is not fast enough. They are too toxic. They are not
specific.

My explicit goal as Director of the NCI is to have us move from
a real understanding of science to not guesswork and empiricism
about the development of therapies, be they traditional or nontradi-
tional, but to therapies that are specific, that are targeted, that we
know will work the way we expect our cars to be fixed. We go after
the specific machinery. And we are doing that. We have many ex-
amples.


98

public. Dr. Wittes, who was unable to be part of the panel, has also indicated his
interest in working with us on planning next year’s conference.

We look forward to creating a yearly event that will continue to provide state-of-the-art
information on integrative cancer care and research on complementary and alternative
therapies to all those who are providing care to cancer patients, doing or fostering
cancer research and offering information to the public.

My experience with this conference and over the years has led me to suggest the
following steps that would help establish a common base of knowledge, facilitate

information sharing and dialogue about difference, and foster creative collaboration.

1. The timely creation of a Cancer Advisory Panel, an advisory board to the Office

of Alternative Medicine and the National Cancer Institute which wi

include
leaders in conventional oncology, as well as in complementary and alternative
treatments. This panel, which has been discussed and agreed upon in principle by
the OAM and the NCI, will address all issues related to alternative cancer treatment
— therapies to be tested, the way trials should be done, how information will be
disseminated, etc. It will also serve as an ombudsman to mediate any differences
that may arise in the conduct of trials, dissemination of information, or any other

area.

2. Inclusion at every level of government involvement of men and women who are
committed to the thoughtful integration of complementary and alternative
therapies into cancer treatment. This would include the appointment of one or
more such people to be members of the National Cancer Advisory Board.


91

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While we have made some advances in the treatment of some cancers, it is painfully
clear that conventional therapy does not have all of the answers. It has also been clear
that conventional oncologists and cancer centers are, at present, ill-equipped to help
patients make wise choices among complementary and alternative therapies (more than
50% are already using these therapies), or to guide them in the integration of these with
conventional cancer care. This conference was designed to answer some of these
patient needs, as well as to provide guidance for future directions in research, clinical
practice, and the dissemination of information. It was a vehicle for providing and
critically evaluating information about complementary and alternative therapies that
seem promising and how they can be integrated into a truly comprehensive program.

The mood of the conference was remarkably harmonious. There was a sense that
people from all parts of the cancer care spectrum — NCI and FDA administrators and
scientists, as well as complementary and alternative researchers and clinicians - were
reaching out to one another, making the effort to move beyond past grievances and
misunderstandings to work together to help shape an agenda which would enable us to
better prevent and treat cancer.

The last session of the conference was a panel discussion on “Where do we go from
here?” The members of that panel enthusiastically agreed to help plan next year’s
meeting. These included Dr. Rosenthal; Wayne Jonas, MD, Director of the Office of
Altemative Medicine; William Fair, MD, Professor Urologic Oncology at Memorial
Sloan-Kettering; Emst Wynder, MD, who has been active for 40 years in exploring
causes and treatments of cancer; Mary Ann Richardson, DrPH, who heads the Center
for Alternative Cancer Research at the University of Texas; Clem Bezold, PhD, a
futurist and advisor to the ACS; and Ralph Moss, PhD, a leading figure in providing

accurate information about alternative therapies to the medical community and the


102

Mr. Horn. Did half of them die or what?

Dr. SPECKHART. No, it’s far below that. Whereas before I was
signing 170 death certificates a year, now 2 or 3 a year, maybe. But
that doesn’t mean that just two or three a year die. There are those
that are under the care of some other physicians, and some have
come in too late and all that. But in my clinical judgment, the use
of electroacupuncture and following that paradigm seems to me
quite useful in case outcomes, enough to drive me to continue doing
it.

And, you know, your work is judged by by its fruits. And, as I say,
I have such a large number of people calling me. I can’t handle ali
the problems, quite frankly. I have to teach this, and I have to pro-
vide peer-reviewed literature so I can get them to come. But also
I have to have the approval of the State. Because when you're dam-
aged goods, you can’t appeal to anybody. If you’re looked upon—if
you have a probationary license, that doesn’t exactly get a presi-
dent of a university saying, well, I want to do business with you.
So you really have to have some degree of credibility, and that was
the first thing that they went after, was my credibility.

Mr. Horn. Sure. Well, thank you very much for putting that in
broader context.

Dr. SPECKHART. You’re welcome.

Mr. Horn. Thank you, Mr. Chairman.

Mr. BurToN. Yes, sir. Thank you, Mr. Horn.

Dr. Fair, you work at Sloan-Kettering?

Dr. Fair. Yes, sir.

Mr. BurTON. And you have been a specialist in prostate cancer;
is that right?

Dr. Fair. That’s correct.

Mr. Burton. And before you had your bout with cancer, did you
have a different perspective on how to treat it?

Dr. Fair. Absolutely. Although we had been working for a few
years on the role of diet and slowing the progress of prostate can-
cer, and it’s another story, but I firmly believe that the end result
of prostate cancer will not be necessarily curing it but just slowing
the progression so that the man lives a normal life span.

But as a result of my own illness, I began looking around; and
even in my own institution, there was no place I could go that
could give me the information on these alternative therapies. So a
lot of it was on—I mean, all of it was basically my own effort,
which made me realize how difficult it would be, if not impossible,
for someone who doesn’t have the same training to find out this in-
formation.

So that what I’ve adopted is diet, nutritional supplementation,
exercise, stress reduction, such as yoga and meditation, herbal
therapy; and all of these were based on clinical or experimental
data showing it had some benefit in my disease. And I might add,
as soon as I find anything else that fits that criteria, I will use that
also.

Mr. Burton. And it worked?

Dr. SPECKHART. It seems to have.

Mr. BuRTON. Mrs. Morella, do you have any questions?

Mrs. MoRELLA. I appreciate your having this hearing, Mr. Chair-
man, and I am trying to get filled in on what you said. I have your


65

THE LANGUAGE OF CANCER:

"A NEOPLASM IS AN ABNORMAL MASS OF TISSUE, THE
GROWTH OF WHICH EXCEEDS AND IS UNCOORDINATED
WITH THAT OF THE NORMAL TISSUES AND PERSISTS IN
THE SAME EXCESSIVE MANNER AFTER CESSATION OF
THE STIMULI WHICH EVOKE THE CHANGE. THIS
ABNORMAL MASS IS PURPOSELESS, PREYS ON THE
HOST, AND IS VIRTUALLY AUTONOMOUS.”

-MY MEDICAL SCHOOL
PATHOLOGY TEXTBOOK

LET ME TRANSLATE. CANCER IS MEAN AND SENSELESS. IT IS
CRUEL AND DOES NOT CARE. IT PLODS ON WITH IMPUNITY. IT WILL
ROB YOU OF YOUR POSSESSIONS AND TAKE YOUR LIFE.

TESTING... TESTING... TESTING...STEP RIGHT UP AND SEE
THE HUMAN PIN CUSHION!

YOU SOON REALIZE THAT HAVING CANCER GIVES OTHER PEOPLE
THE RIGHT TO INVADE EVERY ORIFICE AND AREA OF YOUR BODY.
THIS IS USUALLY DONE WITH A SHARP-POINTED, METAL
IMPLEMENT. YOU ARE NOT EXACTLY SURE WHY THEY ARE DOING
THIS. YOU KNOW THEY TOLD YOU WHY...YOU EVEN SIGNED A PAPER
THAT SAID THEY COULD, BUT FEAR HAS NEATLY ERASED YOUR
MEMORY. YOUR MOUTH IS DRY, YOUR PALMS WET, YOUR GUTS
ROIL...YOU KNOW A SANE PERSON WOULD GET UP AND RUN.
BUT...YOU LET THEM DO WHAT THEY WANT TO DO. YOU HAVE
CANCER...SANE BEHAVIOR IS NO LONGER AN OBVIOUS CHOICE.

HOT LIGHTS, COLD STEEL, AND YOU...

OCCASIONALLY HAVING CANCER MEANS THEY WILL REQUEST THAT
YOU ALLOW THEM TO SURGICALLY EXCISE, IN PART OR WHOLE,
VARIOUS PIECES OF YOUR BODY. THESE EXPERIENCES HELP BRING
INTO FOCUS THE INVASIVE NATURE OF CANCER. IT SCARS YOUR
BODY, IT IMPRINTS YOUR MIND. IT CHANGES YOU FOREVER.

LIVING A "DAY-GLO” LIFE
YOU LEARN ALL ABOUT X-RAYS, "CAT" SCANS, MRI's, BONE SCANS

AND RADIATION THERAPY. YOU KNOW WHICH ONES ARE INVASIVE
AND WHICH ARE "NONINVASIVE".

-3-


val

IF IT'S BROWN AND HAIRY AND BARKS...CHANCES ARE IT'S
A DOG: COMMON SENSE AND CANCER TREATMENT

MAYBE I WAS CRAZY BUT AS I LISTENED TO WHAT THIS GUY
GONZALEZ SAID, HE MADE SENSE. CARROT JUICE...DIETS...
ENZYMES...IN THEORY IT HAD POSSIBILITIES. I WAS NOT
LAUGHING ANY MORE. I TALKED IT OVER WITH MY WIFE AND
DECIDED TO TRY AND FIND THIS GUY. THERE WERE FOUR DR.
GOZALEZ'S LISTED IN NEW YORK CITY...I TOLD THE OPERATOR TO
PICK ONE...SHE DID, AND GUESSED RIGHT.

HOLD THE PHONE...I'LL BE RIGHT OVER

T ASSUMED SINCE THIS WAS AN UNORTHODOX TREATMENT
PROGRAM I COULD JUST "SIGN UP" AND THEY WOULD WELCOME ME
(AND MY MONEY) WITH OPEN ARMS. I WAS WRONG. I WAS
INFORMED I NEEDED TO MAKE AN APPOINTMENT FOR A TWENTY
MINUTE PHONE INTERVIEW AND SEND MY MEDICAL RECORDS. I HAD
TO HAVE PROOF THAT I HAD CANCER--VERIFIED BY AN RECOGNIZED
AUTHORITY (MAYO, ARMED FORCES INSTITUTE)--NO "PSYCHIC"
DIAGNOSIS ACCEPTED. AFTER THE INTERVIEW--IF I WAS
ACCEPTED--I WOULD HAVE TO COME TO NEW YORK CITY FOR TWO
DAYS. THE INITIAL ASSESSMENT WOULD BE $1500.00. DON'T CALL
US...WE'LL CALL YOU. IF THIS GUY WAS A QUACK, HE SURE WAS
PICKY. I SET THE INTERVIEW DATE, GATHERED VOLUMES I & I] OF
MY MEDICAL RECORDS AND WAITED FOR OVER TWO WEEKS.
FINALLY DR. GONZALEZ'S OFFICE PHONED. HE WAS CONCERNED BY
THE MASSIVE DOSES OF CHEMOTHERAPY I HAD ALREADY HAD BUT
WAS WILLING TO GIVE ME A TRY. I MADE AN APPOINTMENT AND
BOUGHT PLANE TICKETS.

WE HAVE MET THE ENEMA...AND HE IS US

THE THOUGHT OF PUTTING JUAN VALDEZ'S FINE COLOMBIAN
COFFEE UP MY KEYSTER KEPT REPLAYING ITSELF IN MY MIND. IT
DID BEAT THE OLD “I HAVE CANCER" MANTRA, I DECIDED TO KEEP
AN OPEN MIND. I WOULD LISTEN TO EVERYTHING THIS GUY HAD TO
SAY AND IF I COULD NOT CONVINCE MYSELF THAT IT HAD A SOUND
BASIS IN ANATOMICAL AND PHYSIOLOGICAL FACT...1 WOULD SIMPLY
WALK AWAY FROM THE PROGRAM; $1500.00 POORER BUT WISER.
WHEN I WAS ACCEPTED INTO THE PROGRAM I WAS ASKED WHETHER
OR NOT I HAD ANY SPIRITUAL BELIEFS. I SAID I DID.

TWAS TOLD I WOULD NEED THEM...NOW THAT WAS A SWITCH!

-9-


16

Stanford University
Palo Alto, CA

‘Specialty: Aging

University of California at Davis
Davis, CA
‘Specialty: Asthma, Allergy, and Immunology

University of Maryland School of Medicine
Baltimore, MD

Specialty: Pain
Co-funding: The National Institute of Arthritis and
Musculoskeletal and Skin Diseases, NIH

University of Texas Heatth Science Center
Houston. TX
‘Specialty: Cancer
Co-funding: The National Cancer Institute, NIK

University of Virginia Schoo! of Nursing
Chartottesville, VA
Specialty: Pain
Co-funding: The National institute of Dental Research, NIH

Research Database and Evaluation

‘The Research Database Program provides an infrastructure for identifying
and organizing the scientific literature on complementary and altemative
medical practices.

Its goal is to establish a comprehensive electronic bibliographic database of
this literature. This effort entails examining and further developing the
classification system used to categorize information about complementary
and altemative medical practices. maintaining a comprehensive list of
journals that publish research on these practices, and expanding the
terminology used to classify this research.

The literature identified from the database will serve as an ongoing source of
information for scientists, researchers, practitioners, and the public. The
OAM has an intemal research database with more than 100,000 specific
‘atations on complementary and altemative medical topics.

The Eyalualion Program develops rigorous evaluation methods and appiies
them to the appraisal of complementary and alternative medical scientific
literature. The Program will detail systematic evaluation methods appropriate
for studies of complementary and alternative medical practices. These
methods will be applied to evaluate bodies of scientific evidence on these
practices. The Program is implementing a process for developing systematic
reviews and meta-analyses of complementary and altemative medical
scientific literature.

OAM Clearinghouse and Media Relations

The QAM Clearinghouse disseminates information to the public, media, and
health care professionals to promote awareness and education about
‘complementary and alternative medicine research.

The Clearinghouse provides sever

The Clearinghouse also provides a stotiten ‘Satore service for public
inquiries about OAM research and general information about complementary
and alternative medicine. This tol-free number is (888) 644-6226. The


99

. Participation of the NCI in co-sponsoring as well as planning and next year’s
Comprehensive Cancer Care conference.

. Establishment of a lecture series at the NCI, at which leaders among those who
are studying and using complementary and alternative therapies would present
their perspectives and their work to, and receive feedback from, NCI scientists.
The Center for Mind-Body Medicine would be happy to work with the NCI to
develop such a series.

. Creation of a regular column in the Journal of the National Cancer Institute on
news related to complementary and alternative therapies. The column would
present fair and objective evaluations of the work being done and help make

discussion about this work more a part of the ongoing NCI dialogue.

. Establishment of an ongoing discussion of NCI funding priorities. Only a small
portion of the NCI’s budget goes to prevention and to clittical trials. Research on
complementary and alternative therapies, most of which cannot be patented, may
well not be undertaken by pharmaceutical houses because it cannot be expected to
yield large profits. Therefore, there needs to be specific attention paid, and adequate
public funding set aside, for clinical research on complementary and alternative

therapies for cancer.

. Development of mechanisms and resources by which NCI and OAM can assist
researchers and clinicians to organize their data, present their findings, and do
research on complementary, alternative and integrative approaches to cancer.
This is the kind of work the Center at the University of Texas is already doing and
there needs to be a far greater commitment to it.


21

me
OFFICE OF

DIETARY About ODS

SUPPLEMENTS

What Are
Dietary
Supplements? What is the Congressional mandate for the ODS?
About ODS In the
News & Events Congress stated specific activities or mandates for the ODS and the
Director of the office.

Grants, Awards,
& Contracts

Explore the role of dietary supplements to improve health

Partnering care.

Opportunities

Promote scientific study of dietary supplements in
maintaining health and preventing chronic disease.

ODS Databases

Accomplishments

Publications Conduct & coordinate research on dietary supplements at
NIH.
Other Relevant

Links

Collect & compile databases of federally funded research &
scientific papers on dietary supplements.

Coordinate funding for research on dietary supplements at
NIH.

Provide advice to other HHS agencies related to dietary
supplements.

Select a destination



50

on cancer in the medical community. He was an invited participant
at the POMES meeting last year, and he served on the Advisory
Panel for the Office of Alternative Medicine. I am sure you are
aware of that, Dr. Jonas.

He testified that he saw firsthand the results of the first Laetrile
trials at Memorial Sloan-Kettering in the 1970’s, and that they
showed that Laetrile caused tumors to shrink dramatically in lab-
oratory mice. This is not somebody off the street. He worked at
Sloan-Kettering. He saw the test results. He saw the mice. And he
said that it dramatically reduced the tumors in laboratory mice,
Laetrile.

He says that the subsequent trials both at Sloan-Kettering and
at the Mayo Clinic were intentionally constructed so as to show
that Laetrile was worthless. Now I do not understand that, and I
think that is something that should be looked into, and I would
like to ask you if you would take a look at running some more
trials on that. Maybe it is worthless. I do not know. But why would
a man of his caliber say that he saw firsthand dramatic results
from Laetrile at Sloan-Kettering and it was later demeaned and
called quackery? I think there should be another review of that to
find out if there was anything to what Dr. Moss said.

This magazine, I do not know if you have seen this or not. It
says, “Meet the Mouse that Beat Cancer.” They are talking about,
I guess, something similar to Laetrile.

Dr. KLAUSNER. These are new potential drugs to prevent the
blood supply that nourishes tumors, yes.

Mr. BurTOoN. In any event, I wish you would take a look at that,
if you could.

et me get on to some questions. In 1990, the New England
Journal of Medicine published an astounding study that showed a
third of all Americans use alternative therapies. Why didn’t the
NCI immediately begin gathering data on the most promising
therapies and allocate money for clinical trials right away?

Dr. KLAUSNER. Well, of course, I was not at the NCI then. I do
know what happened around 1990, in response to the recognition
of how many individuals take complementary and alternative medi-
cine, which, of course, represents a tremendously broad range of
definitions of what individuals are doing. We developed a best-case
series approach to provide a mechanism for practitioners to a)
proach the NCI to bring that information or any information, ob-
fervations they had to see which would be amenable to clinical
trials.

I actually think that since that time there has been a significant
increase in both the openness to and evaluation of especially com-
plementary approaches, the types of approaches that we will hear
about from Dr. Gordon and I think Dr. Fair.

So I cannot exactly describe what was going on at NCI in 1990,
in response to that New England Journal article. But actually I
think what we have seen over this decade is an increasing amount
of literature, an increasing amount of discussion and an increasing
amount of research about complementary and. alternative medicine
for symptom control, for quality of life, and I think the majority of
what individuals avail themselves of is not necessarily alternative
medicine but complementary medicine.


95

enforcing the rules. The problem is some of the rules. They're get-
ting in the way.

id so I think that the work you’re doing in this area really
needs to be moved ahead so that we can develop more flexible ways
of studying some of these exciting new therapies and we can en-
gage the FDA as an ally in this process. The Office of Alternative

edicine, the NCI cannot do all of the work that needs to be done
in this area.

The Office of Alternative Medicine needs to become a center. It
needs to have a larger budget. It needs to have its own authority,
its own review committees, and that will be of considerable help in
moving and working together as a more equal partner with the

And, finally, there needs to be a great deal more, and a couple
of ple have mentioned this already, a great deal more in the
realm of education. In the realm of education at the medical school
level, it’s proceeding, but slowly in terms of complementary and al-
ternative therapies. And also—and Dr. Klausner and I were talking
about this earlier as well—we need to educate more and more peo-
ple, professionals who can provide the kind of function that per-

aps Dr. Fair and I provide in talking with people who have cancer
about what their options are and helping them put together the
best integrated program.

So I think that we need—and this is something that we’re very
eager to take part in—that we need an effort to train the people
to do that, people who are going to be responsible and thoughtful
about helping patients make the best possible choices.

Thank you very much, and thank you for the extra time. I appre-
ciate it.

Mr. Burton. Thank you.

[The prepared statement of Dr. Gordon follows:]


33

‘Those of us dedicated to eradicating cancer have two reasons to be open to the
evaluation of non-traditional therapies. However, under no circumstances can that replace the
need to subject them to vigorous tests of efficacy that must be based on rules of evidence and
not on anecdotes, beliefs or testimonials, no matter how compelling they may seem.

First, we will not be successful in alleviating cancer unless we are open to new ideas
and new approaches. We have learned that anecdotes and folk traditions have often guided us
to real and effective therapies.

Second, many people take complementary and alternative medicines and they
reasonably ask who is providing evidence as to whether they help, do nothing or are harmful.
The question is, how do we best go about both choosing which complementary and alternative
medicines to evaluate through rigorous clinical trials and designing those trials so that they
yield timely and credible answers.

Let me emphasize that an evidence-based approach to evaluating therapies must be
imposed on every step that Jeads us to initiate a trial. There are thousands of potential
therapeutics and that number multiplies with the nearly endless combinations that could be
tested. ‘The result is that only a tiny fraction of what is possible to test could possibly be
brought to clinical trial. At every step of the way, the weight of evidence supporting
imervention and the rationale behind it must be evaluable and evaluated to prioritize which
approaches to move forward with. The challenge before us is to assure that complementary
and alternative approaches have real access to the same processes of evidence and review that
all interventions must live up to.

NCI/OAM Collaborative Efforts to Evaluate CAM Cancer Rescarch

‘The NCI is moving very quickly in important directions to develop CAM information
and expand research opportunities for CAM investigators. ‘These activities are broad in scope
and include strengthening our relationship with the Office of Alternative Medicine (OAM), the
careful evaluation of CAM therapies, and the development of accurate CAM information for
the public.

+ While itis true that the relationship between the CAM communities and the NCI has
been distant at best, I feel we have finally and securely moved beyond this period.
‘There exists a real commitment by the NCI to learn as well as to inform and to listen as
well as to speak. We are in final stages of appointing an individual 1o be the
Coordinator for CAM therapies at NCI, a position that has never before formally
existed. This individual will be a member of the cancer research community whose
primary interest and responsibility will be to develop relationships with the CAM
‘community and to function as a liaison with the NCI research community on behalf of



17

service does not provide medical referrals to individual practitioners of
altemative medicine. The Clearinghouse is located in Silver Spnng,
Maryiand,

The Media Relations area facilitates accurate coverage and follow-up of
relevant stories with the news media, and provides information about the
OAM and its current activities to mass media audiences.

International and Professional Liaison

The Infernational and Professional Liaison Program supports and facilitates
cooperative efforts in research and education in complementary and
alternative medicine approaches worldwide, and with professional
‘organizations across the United States. The OAM was recently designated
as a World Health Organization Collaborating Center in Traditional Medicine.
‘The OAM is 1 of 19 established research centers that are active worldwide
in all phases of traditional, alternative, and complementary medicine.

Research Development and Investigation

The Research Deveiooment and Investigation Program screens, prioritizes,
and provides technical support to the most promising domestic and
intemational research opportunities in complementary and alternative
medicine. It provides technical assistance in research education, networks
experts in complementary and alternative medicine and research methods.
and brings together researchers to prepare for grant applications.

Intramural Research Training

‘The Intramural Research Training Program provides a foundation for
‘scientists to conduct basic and clinical research in complementary and
alternative medicine at the NIH. Three to 5-year post-doctoral training
positions gives researchers the opportunity to execute basic and clinical
research in complementary and altemative medicine at the NIH. Initially, the
program is limited to clinicians who are board certified in the United States
(Individuals with a Ph.O. are also eligible),

Other OAM Activities

‘A major function of the OAM is to facilitate the evaluation of various
altemative treatment modalities through institutes and Centers wi
NIH.

This cooperation is based on well-established expertise and encourages
collaboration on projects of mutual interest, The OAM has established a
network of coordinators in the NIH Institutes, Centers, and Divisions to assist
in problems related to the evaluation of alternative medicine practices.
Government agencies with which the OAM works include:

‘+ Agency for Health Care Policy and Research
‘+ Department of Defense

+ Food and Drug Administration

+ Health Care Financing Administration

‘+ Centers for Disease Control and Prevention

The OAM holds regular meetings with the FDA to enlist its cooperation in
re-evaluating current rules and regulations governing research on and use of
devices, acupuncture needles, herbs, and homeopathic remedies. The OAM
also has corresponded with many attemative medical organizations
providing them with information about research support and development.


61

It is that word reasonable which becomes a stumbling block. Who
decides what is reasonable? Taking a chance on sounding crass, I
must remind you that, to some, cancer patients are a crop, a re-
newable resource.

In 1935, the treatment of my disease, Hodgkin’s lymphoma, was
arsenic and radium/radiation treatments. Have we come much fur-
ther? In some ways, yes. But at what cost? I, myself, have deprived
a State medical facility of nearly $1 million by refusing a bone mar-
row transplant. That same facility is recognizing the additional loss
of over $89,000 for chemotherapeutic treatments I refused to take.
This does not include the loss from standard testing which is al-
ways required with orthodox treatment protocols.

It would seem illogical to have many of our main cancer research
programs driven and funded in large part by those corporations
which stand to gain the most financially from the continued use of
their products.

If I’m a researcher whose research program is financially depend-
ent on the support of a major pharmaceutical manufacturer, how
likely am I to be absolutely honest with my findings, if those find-
ings financially threaten my ongoing research and my livelihood?
I’m not proclaiming some great conspiracy is at hand, only that
human nature is just that, human.

The converse is also true. There are charlatans and quacks tak-
ing money from cancer patients as I speak. Those patients are buy-
ing what is offered. They are dying and do not care about the
claims of either orthodox practitioners or alternative therapies.
What is reasonable? They are dying. Anything is reasonable. The
key is in what is offered. If the orthodox practitioners and re-
searchers proclaim alternative approaches are bunk, without giving
them an honest, open-minded evaluation, they could be missing an
answer. The answer.

I am reminded that a moldy orange is the basis of the entire
antibiotics industry. By the same token, any person who claims
only those products which are natural should be used in the treat-
ment of disease is as much in error as those who say only man-
made products can be trusted. Most of us throw out moldy oranges
without a second thought. We cannot afford to do this with possible
cancer cures.

The rub is man-made products generate billions of dollars yearly,
have vast research facilities and are attractive to the brightest
minds. Alternative treatment programs, unless hawked as info-
mercials, have no hope of ever being fairly evaluated and ascribed
as valid treatments. It would be hard to imagine an infomercial
pushing the benefits of bone marrow transplants or expounding on.
the nifty effects a hit of vinblastin produces.

There is no need to do this because these products are wrapped
in the cloak of respectability given to doctors, researchers and
pharmaceutical companies. They hold a monopoly on the treatment.
of protocols which are very lucrative. Pancreatic enzymes are a
great deal less expensive than orthodox chemotherapy and, in my
opinion, a great deal more effective. This is bad news to the makers
of classic chemotherapy and bone marrow transplant centers.

Cancer patients do not care about credentials, chemistry or credi-
bility. They care about staying alive. Whether or not their doctor


4

searchers in the United States testified about recent progress in
new cancer treatments, prevention and research. The National
Cancer Institute provided a global overview of our public portfolio
of cancer research. It was a highly educational hearing.

Today’s hearing examines just one thread of the fabric of re-
search and care described last week. Alternative medicines and
therapies are but one of many areas of investigation and are eligi-
ble for public funding.

Earlier this month, the Institute of Medicine released a report on
priority setting in NIH research funding. The report recommended
that NIH “more fully engage the public” in its priority-setting by
establishing a council of public representatives and offices of public
liaison at each institute.

In this respect, alternative medicines already enjoy substantial
institutional representation at NIH. In the past, Congress has cre-
ated an Office of Alternative Medicine and an Office of Dietary
Supplements reporting directly to the NIH Director; and I would
like to submit information regarding both offices following my
statement for the hearing record.

More importantly, the Institute of Medicine emphasized that
NIH should. continue to use science-based criteria and robust anal-
ysis of health statistics to determine how to allocate its funding
and which scientific opportunities to target to determine how to al-
locate its funding and which scientific opportunities to grant
awards and contracts.

On this point, there is almost universal agreement. Science must
decide how NIH invests our public dollars—not anecdote, not wish-
ful thinking, but science.

In the realm of cancer research, that means alternative medi-
cines must compete shoulder to shoulder on the basis of scientific
scrutiny against Taxol, genetically tailored antibodies, recombinant
breast cancer vaccines and the many other promising areas of re-
search described last week by our country’s leading cancer re-
searchers.

I believe that NIH has done a good job of balancing our country’s
many health needs in defining our country’s biomedical research
portfolio, but clearly more can be done. And I encourage Dr.
Klausner and Dr. Varmus to pay heed to the IOM’s recommenda-
tion.

Before yielding back my time, I just want to make a comment.
This week is the anniversary of the only tobacco legislation the
Congress is going to pass, and that was a provision snuck into the
Balanced Budget Act that gave the tobacco companies a $50 billion
tax break.

The reason I point that out is that, if we had a serious effort to
reduce smoking in this country, the cancer rates would plummet.
We would be talking about the great success of the war on cancer.
Yet the Congress has been unwilling to do anything to offend the
tobacco companies—for good reason. The leadership in the House
of Representatives has received millions of dollars from the tobacco
companies, and they do not want to offend those contributors.

So the only bill that we saw passed was one that was snuck into
law giving the tobacco companies this huge break. It is the kind
of thing that a committee looking at campaign finance abuses


93

We had over 1,000 people come to the conference, 115 presenters
from all over the world and representatives of many of the major
private cancer Institutes. Dr. Fair was there from Memorial Sloan-
Kettering and many of the other institutions.

And there’s some information about that conference, so I won’t—
in the packet, that everyone has—so I won’t go into that in detail
except to say that I was so impressed by Dr. Wittis; by Dr. Robert
Temple, who is representing the FDA; Dr. David Rosenthal, who is
president of the American Cancer Society; to come and to listen
sometimes to people airing grievances and, more often, to people
presenting data and to really take it seriously and to offer im-
mensely constructive suggestions. We’re going to be continuing
with that conference each year; and we, of course, invite you to par-
ticipate in that as well.

Now one of the things that’s very interesting in listening to and
reading Dr. Klausner’s testimony, is how many of the things that
I'm suggesting—that I have sug; egested in my written testimony,
they are all under way at the NCI and between the NCI and the
OAM, and I’m extremely gratified. And some others we had an op-
portunity to speak before this meeting, he agreed to several other
initiatives as well.

So what I want to do is go very quickly through the things that
I feel are important and then to respond to some of the questions
that you and some of the other Members have asked and some of
the issues that have been raised.

First of all, I think the Cancer Advisory Panel moving ahead
quickly is extremely important; and I just want to express my ap-
preciation for that. I agree with Dr. Fair that there needs to be a
member of the community that has a vital interest in complemen-
tary and alternative medicine on’ the National Cancer Advisory
Board. That seems to be extremely important, and I see that that
needs to go forward. That represents a real commitment to having
that voice represented.

Third, I spoke with Dr. Klausner about that I was going to sug-
gest, I ask that NCI cosponsor as well as help us plan next year’s
comprehensive cancer care conference, and Dr. Klausner expressed
his enthusiasm for doing that. So I’m very pleased to say that.

Dr. Klausner mentioned a lecture at NCI on complementary and
alternative medicine. I would suggest that they there needs to be
more than one lecture, that there needs to be some kind of series
to advance the dialog.

One of the things that I noticed when I’ve lectured at NIH is the
number of scientists, particularly some of the younger scientists,
who are exquisitely interested in these areas of complementary and
alternative medicine research. I remember one talk I gave, there
were nine, I happened to count them, nine young scientists who
came up afterwards and said, how can we do work in this area?
I’m a molecular biologist or I’m interested in heart disease and
whatever it was, how do we develop intramural research projects?

So I think we need to address that as well, and one of the ways
to do it is by beginning to have kind of a lecture series where peo-
ple can ask the hard questions and there can be this ongoing ex-
change.


38

tion about. Protocols to conduct a rigorous test of shark cartilage
are currently under review by the NCI and funds have been trans-
ferred for this project.

Diet and nutritional supplements are the most frequently used
unconventional approaches to cancer. A second study will test the
use of diet and nutritional supplements for the treatment of pan-
creatic cancer, an often rapidly fatal disease, using the program de-
veloped by Dr. Gonzalez as previously mentioned.

This particular project I think is an example of how CAM practi-
tioners can go through a series of evaluation steps and get their
practices properly evaluated, starting with the best-case series,
going on to a practice outcomes evaluation, and then on to a con-
trolled trial.

The OAM currently supports a cancer research center. It is our
intent to increase commitment to CAM research centers signifi-
cantly. And depending on budget and programming issues, the
OAM has the option of funding more than one CAM cancer center.

Finally, there is a tremendous demand for CAM cancer-related
information by the public. The OAM has three activities that ad-
dress this issue. First, a public information clearinghouse was es-
tablished in mid-1996 with a toll-free number available to the pub-
lic. Last year, 65 percent of its inquiries were cancer related. The
OAM is working closely with the Cancer Information Service of the
NCI to develop fact sheets in areas such as shark cartilage, hydra-
zine sulphite, antineoplastons, just to name a few.

The OAM has been working with the National Library of Medi-
cine to develop data bases of CAM citations. There is currently a
data base of over 90,000 citations that are catalogued and can be
found on the OAM home page. A search of the word “cancer” yields
over 16,000 citations.

For the future, the OAM plans to intensify its efforts in research,
clinical trials, data evaluation, and information distribution. The
basic background for all these activities is solidly in place, and
there is a growing and mutually beneficial interaction between the
CAM and conventional cancer communities.

The Office of Alternative Medicine and the National Institutes of
Health have a strong commitment to seeing complementary and al-
ternative medicine practices evaluated in a scientifically rigorous
and in a publicly relevant manner. By working together, we can
make better and more informed choices about the treatment of can-

cer.

That concludes my statement. I would be happy to answer any
questions.

Mr. BuRTON. Thank you very much. I appreciate the work that
is being done, the coordination that is taking place so far.

[The prepared statement of Dr. Jonas follows:]


100

8. Transformation of the Office of Alternative Medicine into a National Center for
Integrative Medicine with a significant increase in its budget. Even with the best
will and re-evaluation of its priorities, it cannot be expected that the National Cancer
Institute will be able to meet all the needs for clinical and basic research in
complementary and altemative therapies for cancer. A National Center for
Integrative Medicine would have the authority and the flexibility to do field
investigations of new therapies, establish granting mechanisms and review
committees with the appropriate degree of expertise, and to gather, evaluate and

disseminate information about the utility of complementary and alternative therapies.

It is my hope that this committee will consider and further these initiatives, and that
those of us outside and inside the National Cancer Institute can continue to work.
together to devise the most comprehensive, effective, and respectful strategies for the

prevention and treatment of cancer.


4)

Using the research expertise and infrastructures from existing Institutes and Centers is
proving to be an efficient and successful model for conducting clinical trials in many CAM areas.
Examples include a large clinical trial testing the herb St. John’s Wort for the treatment of
depression being conducted in collaboration with the National Institute on Mental Health; a test
of the effectiveness of acupuncture for the treatment of osteoarthritis conducted with the National
Institute of Arthritis and Musculoskeletal and Skin Diseases; and, a request for studies of
nutritional therapy of heart disease to be done through research centers supported by the National
Heart, Lung and Blood Institute. In his testimony, Dr. Klausner has provided a summary of the
significant progress being made at NCI to develop and execute research on CAM cancer
therapies using a similar cooperative approach between OAM and NCI.

Building Trust and Collaboration

To address the second issue, building collaboration and trust, the OAM began a series of
activities to build bridges between CAM practitioners and the research community and to begin
to identify research opportunities. Between 1993 and 1995, the OAM funded 42 “exploratory”
grants. These were small awards designed to determine whether certain specific CAM
interventions, modalities and systems, when used against some clinical conditions, showed signs
of promise and therefore warrant larger, more in-depth studies. Of the 42 awards made, 10 were
related to cancer.

From December 1995 to the present, an oncologist from NCI was detailed to the OAM on
a part-time basis to assist with bridging activities and assisting in the evaluation of CAM cancer
practices. This NCI oncologist, along with OAM staff made site visits to over 40 CAM
practices, two thirds of which deal primarily with cancer treatments. Next steps for the

evaluation of these therapies have been identified. In addition, OAM and NCI staff have