OAM AND NCI MEET
TO PLAN EVALUATION
OF ALTERNATIVE TREATMENTS
© 1997 by Ralph W. Moss, Ph.D.
[Editorial note: See also the articles on the 2/98 Burton Hearings and especially Ralph Moss's
Testimony before the Government Reform Committee
for an update on POMES.]
From August 4 to 6, 1997, the Office of Alternative Medicine
(OAM) and the National Cancer Institute (NCI) held a large meeting on the
evaluation of alternative cancer treatments. The official title of the meeting
was the cumbersome "Conference on Monitoring and Evaluation Approaches
for Integrated Complementary and Alternative Medicine Cancer Practices."
Its purpose was to launch a new initiative called the "Practice Outcomes
Monitoring and Evaluation System." We shall simply refer to this by
its acronym POMES (pronounced "poems.")
The discussions at the POMES meeting were often technical, and seemingly
of interest to those with a detailed knowledge of how to evaluate new medical
treatments. However, the outcome of this discussion is of vital importance
to all of usour lives could literally depend on it someday. For
what is being talked about is how the government should evaluate unconventional
cancer treatments. I don't think any health conscious reader needs convincing
that such evaluations are of the highest priority.
What made the meeting historic was that it represented the first collaboration
between the OAM and its supporters and the much larger and more powerful
NCI. This came about because of a meeting some months ago between OAM's
director, Wayne Jonas, MD, and Richard Klausner, MD, the relatively new
director of the National Cancer Institute. As a symbol of his good faith,
Dr. Klausner's office put up half the money (over one hundred thousand dollars)
to fund the POMES conference.
Before we get into the particulars, let us review a few facts about the
relations between NCI and OAM. These two branches of the National Institutes
of Health represent the organization forms within government of orthodox
and alternative cancer medicine. When OAM was established in late 1991,
relations between the government and the alternative community were at an
all-time low. OAM was charged by the Congress to do things differently than
NCI had done them in the past, to "identify and evaluate unconventional
health care practices." Cancer was on most peoples' minds, and in fact
about 75 percent of public inquiries to OAM have been about alternative
The idea of the founders of the office (especially Rep. Berkley Bedell
and Sen. Tom Harkin) were that investigators from the OAM would go out into
the field and bring back "outcomes research" reports on various
alternative practices. Thus, it was imagined, investigators could go to
Burzynski's clinic, or to Dr. Revici in New York, and come back with a report
on whether that treatment worked or did not, and then issue a report.
Most government scientists balked at this simple (they would say simplistic)
approach. And no one balked more than the leaders of the NCI, the same ones
who over the years had most vociferously decried the lack of documented
results for those same treatments. All sorts of technical arguments were
raised about the difficulties of evaluating such treatments. Some of these
seemed to the outside observer to be mere obfuscations, part of the general
fear on the part of orthodoxy to discover the "bad news" that
some nonconventional treatments are actually beneficial in cancer. Other
objections were valid, however, if evaluations of such treatments were to
avoid the various statistical fallacies (and even frauds) that plague much
research into cancer treatments.
The OAM director, Wayne Jonas, is a strict methodologist. He is also
a very honest, and caring person, who sincerely wants nonconventional treatments
evaluated fairly. Thus, he has slogged through the N.I.H. bureaucracy for
us, put up with more arrows than St. Sebastian, in order to meet all the
objections of conventional scientists about how such treatments need to
be evaluated. POMES is the outcome of a five-year struggle by Wayne and
others to bring the NCI to the "bargaining table," as it were,
and find a common framework we all could agree upon for the testing of such
ROLE OF HISTORY
The biggest problem relates to history. Someone once said that history
is "past politics." Those of us who have fought the political
battles over the last few decades remember all too well the fiascos that
occurred when NCI attempted to evaluate alternative treatments. Laetrile,
vitamin C, hydrazine sulfate, Burzynski's antineoplastons--in each and every
case the so-called "evaluation" was outrageously stacked against
the proponents and the methods in question. The obvious interest of NCI
was to come up with a refutation of some popular treatment that was regarded
as a pain in the butt.
No surprise, then, that all the studies were designed to come up with
negative results, even when a child could see that the data had been tortured
until it confessed the bias of the orthodox evaluators. This happened in
each and every case. (It is also my contention that downright fraud occurred
in at least one of these evaluations).
Conferences like POMES are where the rubber meets the road, i.e. where
politics and science finally intersect. I had to live through at least ten
lectures on the glory of "scientific method" that week, and an
equal number on the towering objectivity of science. Sure. As I pointed
out at the time, the "scientific method" does not exist in a vacuum.
It is carried out by real people, individuals who have personal interests,
egos, and biases. That is why controlled clinical trials were invented and
why safeguards must be built into the process. These safeguards have
to guarantee that the kind of cover-up that happened in the above cited
cases will not happen again as a result of POMES.
So that's what POMES is, an attempt to get two antagonistic sides to
sit down and hammer out a set of rules which both can agree to, and then
to proceed with fair and honest evaluations of various promising new treatments.
TWO SIDES PRESENT
Many of the people who have distinguished themselves in the battle for
such evaluations were invited to the POMES meeting. But this was more than
just a reprise of the famous NIH "Chantilly meeting," five years
ago. This time there was a significant contingent from conventional oncology
as well. Chantilly represented the coming together of the alternative community
with some of the top leadership structure of NIH. However, the cancer
establishment has always been conspicuously absent from such meetings.
Now, however, in these extraordinary
times, a small but important group of oncologists have stood up publicly
and declared themselves in favor of really good testing of such treatments.
Comments made in both public and private made it clear that some oncologists
are now waking up to the enormous potential of these treatments. Personal
experiences are also driving this process. Some of the individuals there
admitted they became interested in the topic when they or a loved one developed
cancer. (Representatives of Memorial Sloan-Kettering also showed up at the
alternative medicine Congress in Arlington, VA a month later.) All this
is being played out against the backdrop of a general failure of the war
on cancer to find adequate solutions to most common forms of cancer. It
is time for a change, and alternative medicine provides a promising avenue.
(Cancer prevention provides another.)
And so for three days 100 or so practitioners and defenders of alternative
cancer treatments met, argued, ate, and 'schmoozed' with about a dozen leaders
of the conventional cancer field. These included Paul P. Carbone,M.D.,
director of the Comprehensive Cancer Center at the University of Wisconsin;
Dr. William Fair, chief of surgical urology at Memorial Sloan-Kettering;
Dr. Sidney Winower, M.D., chief of gastroenterology at Memorial Sloan-Kettering;
Lori J. Goldstein, M.D. of Fox Chase Cancer Center; Jeffrey D. White,
M.D., director of the Clinical Trial Groups Metabolism Branch, NCI; and
Douglas L. Weed, M.D., Ph.D., chief of preventive oncology at NCI.
Also present were top officials of two "Fortune 500" companies
interested in the food and supplement business. Ernst Wynder, M.D.,
president of the American Health Foundation, delivered a well-received dinner
speech, and was a prominent participant.
From academic medicine came a remarkable panoply of leading figures,
both here and abroad. These included academics from a wide array of institutions
including the University of Texas, Toronto Sunnybrook Regional Center, Humboldt
State University, Stanford University, Columbia University, University of
Minnesota; University of Kentucky, etc.
Advocates of various alternative cancer treatments were represented including
Keith Block, M.D. of Evanston, IL; Nicholas J. Gonzalez, M.D.
of New York; Gar Hildenbrand from the Gerson Research Organization;
Tori Hudson, N.D. of Portland, OR; I. William Lane of Cartilage
Consultants; Robert Mayo, president of Cancer Treatment Centers of
America; Dean Mouscher from the Burzynski Research Institute;Elena
Avram from the Revici Life Science Center of New York; Vincent Speckhart,
M.D. of Norfolk, VA; Georg Springer, M.D. of Chicago; Jack Taylor
of Rolling Meadows, IL; and Glenn Warner, MD of Seattle, WA.
Certainly, this was the first chance that many of these individuals had
gotten to see the "enemy" up close in this way. It was our impression
that important contacts and even friendships were being formed.
The meeting also included a number of advocates and prominent commentators
on the field, including the Hon. Berkeley Bedell, the original inspiration
for the OAM as well as the Access to Medical Treatment Act; John Boik,
author of Cancer and Natural Medicine; Marcus Cohen; Ms. Carolene
Marks, a cancer survivor and member of the OAM's advisory council;
Frank Wiewel of People Against Cancer; and myself.
An important aspect of the meeting was its international flavor. A major
presentation was made by Steven G. Ayre, M.D. on a treatment that
was developed in Mexico by three generations of physicians there. There
were half a dozen prominent physicians from Germany, which in many ways
leads the world in the evaluation of natural approaches, and from Canada.
The meeting was also significant for who was not present. First
of all, some of the main players from the N.C.I. did not even show up. These
included not just Director Klausner, but his deputies, Bruce Chabner, M.D.
and Robert Wittes, M.D., the Director of the Division of Cancer Treatment,
Diagnosis and Centers. POMES now needs implementation by NCI and OAM. But
without the active participation of the top officials of NCI it is certain
that the whole initiative will wither on the vine. The ball is in NCI's
court. The Congress and the public should publicly pressure Director Klausner
to implement the decisions of the POMES meeting. He can be reached at:
Dr. Richard Klausner
Bethesda, MD 20892
If you are an American citizen, Dr. Klausner works for you. You have
a right to know when he intends to implement the POMES process and test
alternative methods fairly.
Defenders of alternative medicine should give strong support to the POMES
process. But we should simultaneously demand that NCI drop all its hateful
statements on such methods that are widely disseminated around the world
by the Cancer Information Service. These statements condemn some of the
very treatments that NCI is now supposed to help evaluate. In fact, some
of the people in the POMES meeting were themselves the victims of these
slanderous statements.They are also used as the basis of disastrous court
actions of various kinds.
As I pointed out in my remarks to the meeting, one did not hear any talk
against the American Cancer Society at the POMES meeting.That is because
last year the ACS pulled its notorious "unproven methods" statements
and is reformulating them in the light of current attitudes and knowledge.
You did not hear any criticism of the DeVita "Cancer" textbook,
since the new Fifth Edition substituted its previous quackbuster article
with a fairly neutral chapter by former OAM director Joe Jacobs, M.D. But
you will continue to hear much criticism of NCI for its statements on alternative
cancer treatments. They are an abominationugly in tone, inaccurate
in many factual details, and prejudiced against the very methods we are
now supposed to believe they will evaluate fairly. No lasting trust can
possibly be built so long as these statements are being released on the
Internet and elsewhere.
In fact, the basis for new enlightened statements already exists. They
are found at the Web site of the University of Texas cancer alternative
project. Mary Ann Richardson's team has spent two years honing these statements
which are factual, neutral in tone (neither advocacy nor denigration), and
are devoid of that special pleading ("Come to N.C.I. for treatment!")
that marks and mars the government statements.
I for one am ready to help in any way I can to make POMES a success.
In my opinion, the few individuals who are responsible for these execrable
statements represent the last gasps of quackbusting in the U.S. government.
It will certainly be a historic achievement when this major impediment
to the normalization of relations between NCI and the alternative community
is finally removed.
It is contradictory to propose serious trials of these methods while
NCI continues to attack these very treatments as fraudulent in every possible
way. If Director Klausner is really serious about inaugurating a new era
in relations with the alternative medicine movement he will have to remove
THE CHOPPING BLOCK?
The other critical question pertains to the leadership of the POMES process.
The core of this is the Professional Oversight Board (POB). The three study
groups at the meeting each independently came up with a suggestion that
political activists be included in the body that will oversee the clinical
trials. The POB will ultimately have to sign off on whether or not an evaluation
has been performed fairly and adequately.
The question therefore remains of who will be on the POB. I remain hopeful
that if POMES ever gets off the ground that the POB will represent a wide
variety of interests and perspectives. But I would suggest to the public
that it remain on guard, since a POB without independence would just lead
to further disasters. Proponents of nonconventional methods need guarantees
that POMES represents a new beginning, not just an invitation to put their
heads on the chopping block.
Overall, I am encouraged by this historic meeting. Certainly, at the
very least some friendships were made between people who have stood on opposite
sides of the barricades. However, whether or not POMES progresses depends
not so much on the many technical problems uncovered but on the correct
handling of the political problems.
We will soon find out whether NCI really intends to do anything about
this urgent public matter or whether they intend to drag their feet indefinitely.
Dr. Klausner, we are waiting.
--Ralph W. Moss, Ph.D.
October, 1997; slightly revised February, 1998
Return to Fall, 1997 Cancer
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