OAM AND NCI MEET
TO PLAN EVALUATION
OF ALTERNATIVE TREATMENTS

© 1997 by Ralph W. Moss, Ph.D.
(www.ralphmoss.com)

[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.

TROUBLED RELATIONSHIP

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 cancer treatments.

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 treatments.

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.

ROADBLOCK

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
Director, NCI
Bethesda, MD 20892
Phone: 301-496-5615
Fax: 301-402-0338

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.

HATEFUL STATEMENTS

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 this outrage.

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.

OUTLOOK

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 Chronicles

Return to Burton Hearings


Ralph W. Moss, Ph.D. is director of the The Moss Reports for cancer patients. Dr. Moss is the author of eleven books and three documentaries on cancer-related topics. He is or has been an advisor on alternative cancer treatments to the National Institutes of Health, the National Cancer Institute, the American Urological Association, Columbia University, the University of Texas, the Susan G. Komen Foundation and the German Society of Oncology. He wrote the first article on alternative medicine for the Encyclopedia Britannica yearbook. He is listed in Marquis Who's Who in America, Who's Who in the World, Who's Who in the East, and Who's Who in Entertainment (as a film documentarian). This Web site does not advocate any particular treatment for cancer. We urge you to always seek competent medical advice for all health problems, especially cancer. Before consulting our site please read our full Disclaimer statement.



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