The Cancer Industry:
The Classic Expose on the Cancer Establishment
New Updated [1996] Edition

© 1996 by Ralph W. Moss, Ph.D.
Published by Equinox Press
(All rights reserved. Please see Copyright notice.)


[WEBSITE NOTE: This is the fifth and final section of the Preface to the 1996 edition. It concerns the role of the FDA in the evaluation of alternative cancer treatments.See also our articles on the politics and economics of cancer from The Cancer Chronicles.

5. Role of the FDA


Congress's response to such problems has been anemic, at best. It was the antibiotics scandal that led to the famous hearings on the drug industry of Sen. Estes Kefauver's Antitrust and Monopoly Subcommittee. Yet ironically, what emerged from those hearings was not an assault on monopoly, but the safety and efficacy provisions of the FDA. These were feared by the drug industry at the time, but turned out to be in their interst, since they actually "raised the barrier of entry to new competitors and, over the long run, strengthened the position of the largest companies," (Robert Teitelman, Profits of Science. NY: Basic Books, 1994).

At first sight, the FDA appears to have an adversarial relationship with the drug industry. After all, FDA regulates them, tells them what they can and cannot do. But in truth, the major impact of FDA regulation is not to hamper industry giants, but to bar the entry of smaller competitors into their field.

Structurally, the FDA mirrors the industry it regulates: it is "highly centralized, hierarchical, full of pharmacologists, biochemists, chemists, physicians" (Teitelman, op.cit.) And the FDA, as a branch of the executive, has a powerful enforcement arm, which can make those whom it generally regards as its true adversaries (small drug and food supplement makers, health entrepreneurs, and alternative practitioners of all kinds) bend to its might-makes-right argument, as in its infamous armed raid on Jonathan Wright, M.D. on May 6, 1992.

FDA's general mandate is to limit risk to the public; the drug industry's goal is to limit competition. But their common strategy is the same: a stifling of innovation, especially when it originates from outside the members of the Pharmaceutical Manufacturers' Association, the "club." This convergence delivers rewards for insiders.

"Both manufacturers and regulators were thus designed not for great leaps of thought but for careful progress," said Teitelman. "The combination of increased regulation and pricing freedom gave the big companies a weapon against smaller competitors..." this astute business journalist added. "By lowering regulatory barriers, the club would have invited many small competitors to play."

Or as an economist wrote, "The sources of innovation are declining. With the cost of developing a new drug soaring, research is a game smaller companies cannot afford to play" (Business Week, February 21, 1977). And there are few blockbusters in the pipeline.

New ideas are limited to a relatively small pool of conventional thinkers. Drug executives are distressed by "the sinking realization that their research pipelines--the lifeblood of the industry--are drying up." Some say privately that "the industry is running out of ideas" (Wall St. Journal, op.cit.).

Are they surprised? The industry has spent decades discouraging radical innovation in medicine, branding them as "unproven" or even "quack" ideas. Now they are surprised that they have nothing radically new to offer for the treatment of cancer and other diseases? One might think that at such a juncture the industry would turn to alternative medicine, which is certainly rich in ideas. But that is difficult given the mindset they have helped foster.

HUNTING IN THE FIELDS

Sometimes they do go hunting the fields of alternative practices.

In May, 1995, for example, the Swedish giant, Pharmacia, Inc. invited Helen Coley Nauts to come to Lund to lecture on her father's treatment, Coley's toxins (see chapter 7). She gave a brilliant speech and one can only hope that something positive will come of this. But predictable problems arise when pharmaceutical companies try to fit such treatments into the new drug development.

Drug companies are not charities. They exist to serve their employees and stockholders, who invest their money in order to obtain good returns. They incur extraordinary expenses in researching, developing and marketing new products. Much of this goes to fulfilling the regulatory requirements of the FDA. In return, the government gives them the 17-year legal monopolies called patents, as a way of recouping these costs.

But one cannot patent Coley's toxins. These are naturally occurring byproducts of common bacteria. Someone I know recently produced 1,000 cubic centimeters of the toxins for $1,000--enough to treat many patients for months at a time. With mass production, even such prices could plummet. Coley's toxins could be virtually free!

The problem with Coley's toxins are emblematic of those of alternative treatments in general: often, they are natural products which one can buy by the carload. The industry is predicated on enormous costs and even greater returns. Nature does not always cooperate in this scheme. And so there is an ecnomic imperative to "improve" on nature's formulas, to create what the current NCI director Richard Klausner, M.D. calls "non-natural natural products."

Unfortunately, none of NCI's clever modifications ever seems to produce an agent that works as well as the original product. Recombinant tumor necrosis factor (TNF) simply cannot hold a candle to Coley's all-natural formula of one hundred years ago. And academic scientists have a collateral problem: how do they build a reputation for brilliance by rediscovering the work of some neglected or maligned scientists, who may have died decades ago? Can you investigate quackery without being suspected of it yourself?

And so, as we approach the Third Millennium, we are faced with an enormous paradox. The drug companies, which are awash with cash, inhabit architecturally stunning facilities, and wield astounding hardware, are beggars when it comes to new ideas. Alternative medicine has many brilliant ideas has almost no resources allocated to its development. (OAM's budget is about 1/1000th of the NIH total.)

HOW TO RESOLVE PROBLEM

How can this be resolved? In the end, the public could decide the issue by voting, not just at the ballot box, but with its feet and pocketbooks. Since the first edition of this book we have witnessed an enormous shift in public acceptance of alternative treatments. A 1993 survey by the ACS estimated that 9 percent of cancer patients already use complementary therapies, but this rose to 14 percent in the higher-income and more influential groups (Kennedy, BJ. J Cancer Educ 1993;8:129-131). Other reports put the figure much higher--as high as 50 or 60 percent (McGinnis, LS. Cancer 1991;67:1788-1792; and Hauser, SP. Curr Opin Oncol 1993;5:646-654).

In 1994, a conventional oncologist at New York Hospital polled her breast cancer patients and found that 30 percent had consulted unconventional therapists and 25 percent were already using some form of alternative treatment (OAM, Workshop on the Collection of Data, Bethesda, MD, 1994). Only about five percent of these patients abandon conventional medicine to pursue such treatments.

Many patients want to combine both kinds of treatment.

And this is a worldwide trend. In Holland, Poland, and England between 16 and 25 percent of cancer patients admit to using complementary treatments (Van der Zouwe, N. Ned Tijdschr Geneeskd 1994;138:300-306; Pawlicki, M, et al. Pol Tyg Lek 1991;46:922-923; Downer, SM. BMJ 1994;9309:86-89).

In South Australia 46 percent of children with cancer were receiving complementary, as well as conventional, treatment (Sawyer, MG, et al. Med J Aust 1994;160:323-324). In Germany, the figure reached 53 percent (Morant, R, et al. Schweiz Med Wochenschr 1991;121:1029-1034), and so on.

This is the background to the rise of the U.S. Office of Alternative Medicine. This development truly has the feel of an irresistible force, an idea whose time has come. The Congress of the United States has put its seal of approval on this development. Appropriations for it almost certainly will continue to grow.

Yet at the same time, the pharmaceutical industry appears to present an immovable object in its path. For how can the "medical-industry complex" cope with this emerging new world of patient empowerment, with its emphasis on low-cost prevention, good nutrition, improved life style, and natural medicine?

Perhaps the next turning point will be passage of the Access to Medical Practices Act (S-1035), which was drafted by Berkley Bedell, and introduced into the Senate by another one of his many admirers, Tom Daschle (D-SD). Co-sponsors include many of those who had already gravitated towards the OAM, including not just Sen. Harkin, but such influential legislators as Senators Abraham, Dole, Grassley, Hatch, Hatfield, Pell, Reid, Simon, and Simpson.

This landmark bill would "permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests." This is a modest proposal indeed! For it represents a daring "freedom of choice" manifesto, introduced at a time when many other health reform schemes threaten to greatly restrict patients' rights. Behind its seemingly innocuous words lies a revolutionary concept, a fact not lost on the billÆs opponents, who include the FDA, and some self-proclaimed 'consumer protection' organizations.

Passage of this bill could bring the whole question of medical freedom of choice to the fore. Passage will not be easy. Nevertheless, even if it takes a years, with sufficient public pressure, it could certainly pass. It will then make dispensing alternative treatments legal, while placing the persecutors of alternative doctors outside the law.

The Cancer Industry is an angry book, and it often generates anger in those who read it. Many readers wonder, what can be done? There is no quick fix. But by educating your own representatives, journalists, and opinion-makers of all kinds, any individual can make an important contribution to the resolution of the issues raised in this work. Two-thirds of America's families are slated to face cancer. There is no time to waste.

--Ralph W. Moss, Ph.D.


[NOTE: The interested reader can also consult on-line FDA's own official but rather sanitized account of its own history.]

The Cancer Industry Introduction:
1. Intro | 2. OTA Study Pt. 1 | 2a. OTA Study Pt. 2 | 3. OAM  | 4. Underlying Problems | 5. Role of FDA


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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