FDA'S STEPCHILDREN

From The Cancer Chronicles #10
© Autumn 1991 by Ralph W. Moss, Ph.D.

[This was an overly optimistic assessment of the prospects of the U.S. Food and Drug Administration under Commissioner David Kessler. Kessler turned out to be deeply prejudiced against alternative medicine. --RWM]


"A lot of precedents are being set," said Food and Drug Administration (FDA) Commissioner David Kessler in late July. He was referring to an FDA advisory panel's approval of the drug DDI as an AIDS treatment. A few days earlier, another panel had tentatively approved THA for Alzheimer's disease. In neither case did Kessler's agency require rigorous proof of efÞcacy, as had been demanded of new drugs since the 1963 Kefauver-Harris law. Yet the FDA has re-fused, so far, to extend this "precedent" to innovative, non-toxic cancer therapies.

Notice the word "non-toxic." FDA routinely approves cancer drugs of appalling toxicity. Despite claims to the contrary, most are totally ineffective at prolonging survival in patients with common forms of advanced cancer; many themselves cause secondary cancers. But such drugs are usually developed at taxpayer expense by the NCI and then handed over to big drug companies for vigorous marketing. Although Dr. Kessler recently wrist-slapped a major drug company for œagrantly advertising "unapproved and unproven" uses for anti-cancer drugs, the new "precedent" is bound to beneÞt precisely such major players.

By contrast, innovative, non-toxic therapies are put on FDA¼s "slow track"--to oblivion. Their main crime is that they are cheap, abundant, unpatentable and, therefore, unproÞtable. Or they work by radically new mechanisms. They stoke no egos at the big institutions, enhance no resumÈs. They are the stepchildren of the FDA.

A formidable mechanism has been created to keep such 'disreputable' substances out of the cancer marketplace. Ignore them. Declare them worthless, without a trial. Finally, brand them as dangerous quackery. Participants in this canard include the American Cancer Society (ACS), whose Unproven [Questionable] Methods committee issues statements condemning such approaches; the NCI, which misinforms doctors and patients alike through its Physicians Data Query (PDQ) computer database; and, of course, the medical police, the FDA. We postulate no conspiracy: but there are shared economic interests, a revolving door among members of the "cancer establishment," and a mindset that therapies "Not Invented Here" [i.e., N.I.H.] are worthless. But are they? After a three-year study, the Office of Technology Assessment (OTA) in 1990 found over 180 scientiÞc papers supporting the efÞcacy of innovative, non-toxic methods.

Systematized harassment pervades the Þeld of innovative cancer therapy. Kessler could help clear the way for fair evaluation, by applying his "precedent" to all such methods, including hydrazine sulfate, Coley¼s toxins and antineoplastons.

Kessler could move cancer research a giant step forward by applying his "precedent" to such innovative non-toxic therapies. But there is another, more compelling, reason to do so. That is the fundamental question of human rights.

People with cancer--like people with AIDS, Alzheimer¼s and other diseases--must have unfettered access to all available information on treatments and the freedom to make an individual choice. Patient autonomy is an essential part of democracy. In his classic On Liberty, John Stuart Mill wrote that "over himself, over his own body and mind, the individual is sovereign." In 1914, Judge Cardozo ruled that "every human being of adult years and sound mind has a right to determine what shall be done with his own body...."

In 1987, the Second Circuit U.S. Court of Appeals afÞrmed: „We see no reason why a patient should not be allowed to make an informed decision to go outside currently approved medical methods in search of an unconventional treatment." In a masterful review, Berkeley law professor Marjorie Shultz concluded: "patient autonomy should be recognized and protected as a distinct legal interest." Since 1963, FDA has demanded a preponderance of medical opinion before allowing a new drug to be marketed. This can take decades and millions of dollars. By applying this unreasonable standard, FDA systematically limits a cancer patient¼s free choice. Unanimity of opinion in medicine is rare. History provides many examples of tragic errors shared by a preponderance of experts.

Some consumer advocates fear that patients are too unsophisticated to make life-and-death choices, and that weakening the Kefauver amendments will create anarchy in the medical marketplace by opening the œoodgates to quackery.

ÝÝThere are dangers in allowing any freedom, including freedom of speech and the press. But isn't taking this risk what democracy is all about? Does the state really have greater wisdom than the afœicted individuals and their loved ones over such momentous questions as the choice of cancer therapy? The patient has the greatest stake and must make the ultimate decisions. Today, people with cancer Þnd it almost impossible to get objective information about, much less obtain, such therapies. This is the result of the smokescreen laid down by ACS and NCI, reinforced by the police powers of the FDA.

Kessler is an activist in a decrepit agency. He has fought fraud, tangled with a major pharmaceutical giant and forced a food conglomerate to stop calling its reconstituted orange juice "fresh." But so far he has failed to address himself to the question of non-toxic cancer therapies. This problem remains high on the public¼s agenda: previous commissioners have seen their own Þne plans wrecked on these very shoals. How Kessler deals with "FDA's stepchildren" will ultimately tell more about his tenure than the well-publicized battle of Citrus Hill.Ý

articles on freedom of choice

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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