Tuesday, December 21, 2004

Column on FDA Myths

Mythmaking about the FDA

Tibor R. Machan

Merrill Goozner is the director of the Integrity in Science project at
the Center for Science in the Public Interest, a Ralph Nader inspired
organization guided by, among others, the legendary Michael Jacobson who
has been the driving force of this group from its inception. Along with
other organizations, such as the Public CitizenÂ?s Health Research Group
and its main man, Dr. Sidney M. Wolfe, CSPI is in the business of
encouraging our government to live up to this wonderful insight by H. L.
Mencken: "The whole aim of practical politics is to keep the populace
alarmed (and hence clamorous to be led to safety) by menacing it with an
endless series of hobgoblins, all of them imaginary" (Minority Report,
[Johns Hopkins Univ Press, 1997]).

In his recent Op Ed essay for The New York Times (December 21, 2004),
Goozner advances some of the classic myths about government. First, he
tells us, Â?To make rational choices, doctors and consumers need the F.D.A.
and other agencies to be independent arbiters of not just the safety and
efficacy of new drugs and devices, but of their relative medical
usefulness and economic viability.Â? He continues his myth-perpetuation by
announcing that Â?the medical oversight system needs a new ethicÂ?one that
scrupulously adheres to a standard that says its studies and decisions
have been made entirely free of commercial bias and conflicts of interest.Â?

No sooner does our true believer in the power of government to solve all
our pharmacological problems, he does give a hint as to why it is all the
dream: Â?Sadly, that is very far from the situation today. Drug and device
companies sponsor most clinical trials; F.D.A. advisory panels are larded
with scientists tied to private companies; corporate user fees help
finance the F.D.A. that is conducting reviews; doctors get most of their
medical information either from sales representatives of drug companies or
corporate-sponsored continuing medical education; and the companies are
given primary responsibility for post-marketing safety surveillance of
their own products.Â?

Goozner mentions these obstacles to the possibility of impartiality and
objectivity of government policy making as if they were something only in
place �today.� And thus he charges ahead enthusiastically with the naïve
notion that Â?To break these ties, there needs to be an independent arm of
F.D.A. that contracts with independent clinicians and scientists for the
final testing of all new drugs and medical devices.Â? He proposes that
Â?After a company submits its drug application based on safety and early
efficacy trials, this arm would design the protocols to learn not just if
the new drug is effective versus a placebo, but how it compares to other
therapies and how it can be most effectively used. At the same time, the
F.D.A. agency would need an adequately financed post-marketing system that
would follow through on a drug's safety, using information and financing
independent of the drug manufacturers.Â?

These are all pseudo-noble notions and while they fall way short of
justifying what the F.D.A. is supposed to be doing at its idealistic best,
there is an omission in GooznerÂ?s discussion that amounts to out and out
malpractice: He fails to discuss either the very famous argument of
economist Sam Peltzman, of the University of Chicago, concerning the drug
lag problem or the Nobel Prize winning idea of Professor James M. Buchanan
of George Mason University called Â?public choice theory.Â?

Anyone who still has the temerity to propose that government is the
solution to problems associated with drug manufacturing and marketing has
the moral and professional obligation to discuss these two basic
objections to such an idea. The drug lag argument shows that even
following the intentions of the legislators who created the Food and Drug
Administration, the results are going to be disastrous. Yes, one can
always call up such rare victories as the banning of thalidomide (though
even this one is no slam dunk when the details are considered). But as
Aristotle taught us some 2600 years ago, Â?one swallow does not a summer

In fact, the F.D.A.Â?s policies produce even greater health hazards than
anyone could imagine it averting. The reason is pretty simple: By
insisting on certain types of tests for drugs that are being slated for
manufactureÂ?routinely requiring the impossible of proving a negative (Â?No
one will be put at risk from this drugÂ?)Â?Americans are often prevented
from gaining access to very effective means to fend off life threatening
diseases. The country thus lags behind many others and only those rich
enough to visit these others are able to overcome this obstacle to their
likely medical recoveries.

The merits of this argument are, of course, in the details. Yet it has
gained considerable credibility over the last five or so decades and
anyone who promotes greater powers for the F.D.A. needs to discuss it. The
same holds for BuchananÂ?s theory of public choice, one he developed with
Gordon Tullock in their book, The Calculus of Consent (University of
Michigan Press, 1962). In 1985 Buchanan received the Nobel Prize in
economics for this work and anyone who is proposing that outfits such as
the F.D.A. can escape the inherent problem of bias would have to address
his work.

Contrary to the suggestion by all those who propose to solve problems via
governmentÂ?namely, that all we really need is better people and more
stringent rulesÂ?public choice theorists argues that inherent in the
process of government regulation we invariably find the triumph of vested
interest. Bureaucrats, including the most honorable scientists who might
be hired to work in government agencies, are inclined to bolster their own
special purposes and goalsÂ?some call this their Â?selfish interestsÂ?Â?and
the way the welfare state works there simply is no way to curtail any of
this. The dynamics of the nearly unbound democratic system are such that
government must respond to those in the constituency who exert the most
clout. This is the most natural way of its operation. So it is sheer
fantasy to hope that new people or rules will manage to circumvent it all.

But, instead of at least hinting at such problems with his proposal, Mr.
Goozner charges ahead zealously, failing to raise any of the well
established skeptical concerns with what he wishes for, holding out the
myth of government regulators as Â?independent arbiters.Â?

Never mind that even at it most ideal conception, government regulation
is a violation of due process because it intrudes on peopleÂ?s lives,
imposing major burdens on those who have not hurt anyone at allÂ?a form of
impermissible prior restraint in a free country. Even the utilitarian
consideration that F.D.A. type operations have innate flaws fails to
receive acknowledgment in Mr. GooznerÂ?s proselytizing.

To return to an old theme of mine, isnÂ?t it interesting that when
journalists and pundits peddle their deadly wares, there is no requirement
for warning labels!

Machan teaches business ethics at Chapman University, Orange, CA. He is
research fellow at the Hoover Institution and advises Freedom
Communications, Inc., on libertarian issues. His most recent book is
Objectivity (Ashgate, 2004).

No comments: