[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.]
