|
|
|
Jewish World Review June 16, 2005 / 9 Sivan, 5765 The FDA: Safety, Efficacy, Both or Neither? By Drs. Michael A. Glueck & Robert J. Cihak
http://www.JewishWorldReview.com |
A century or so ago, America noticed that, although life was getting
better, it was also getting more complicated. Science and technology were
churning out ideas and products as beneficial as they were
incomprehensible. When advance came to seem inseparable from bigness —
corporate bigness — a quaint, earnest breed of Americans known as
Progressives decided that the way to simplify things was to get the
government involved. And thus arose the regulatory apparatus that today
controls, or tries to control, nearly every aspect of our lives.
In the beginning, this was not necessarily bad. It was not bad because
government and law also operated on the "reasonable man" principle: the
average American, although perhaps ignorant of the finer points of science,
technology and business, was nonetheless capable of making his own
decisions, looking out for his own interests and generally behaving in a
rational manner. Today, the guiding principle is that people are either
idiots or raptors, either victims or (especially when organized into
businesses) victimizers. Either way, America requires ever more
micro-management, for its own good.
Today, this philosophy is failing in the classic manner of any belief that,
when applied to reality, doesn't work. It is also failing because the evils
of regulation now outweigh the benefits.
Current example: the Food and Drug Administration's power to ban drugs
until, after long and expensive trials, they are proven safe and effective.
Two aspects, please note. Safe and effective.
Safety is not an absolute. Nothing is ever totally safe; as your Medicine
Men love to point out, it all depends on the dosage and the usage. Safety
must be balanced against gain. What does safety mean to a person with AIDS
or terminal cancer or chronic, debilitating pain? And what might
constitute acceptable risk for one person may prove horrific for another.
Yet the FDA acts as though safety were some sort of absolute, and withholds
its imprimatur for years and decades from drugs whose benefits, although
risky, are proven in other countries, or yanks its approval from
established drugs at the slightest whiff of long-term effects.
Nor is effectiveness an absolute. Everything depends on the complex
interactions of patient, condition, circumstance and environment. Why set
absurdly high standards, which often take years and decades to prove, at
the cost of human lives and human suffering? And while we're on the subject
of money — how many worthwhile drugs never make it to market because the
manufacturers can't or won't pay for the studies. Yes, it's almost always
the manufacturers who pay.
Another is to let the FDA certify safety and effectiveness, but permit
uncertified drugs to be sold, subject to the standard criminal penalties
for fraud and related offenses.
Yet another is to have the FDA study safety only.
Your Medicine Men prefer another approach. The FDA should be tuned into a
private corporation (actually, a consortium), funded by a combination of
federal appropriations, corporate and other membership dues, and fees for
service. Drugs should be evaluated on the basis of safety and effectiveness
trade-offs and ranked in tiers, with only the clearly worthless and
dangerous prohibited.
All else should be available, subject to warning such as:
"Benefits not proven in all cases, but zillions of people swear by it. Side
effects are generally mild and may include death, impotence, baldness, loss
of teeth, delusions of grandeur and a sense of levitation, in some cases
accompanied by the reality. Before taking this or any medication, consult
your nearest trial lawyer, bureaucrat or politician."
Editor's Note: Michael Arnold Glueck, M.D., penned this week's commentary.
Every weekday JewishWorldReview.com publishes what many in in the media and Washington consider "must-reading". Sign up for the daily JWR update. It's free. Just click here.
Michael Arnold Glueck, M.D., is a multiple award winning writer who comments on medical-legal issues. Robert J. Cihak, M.D., is a Discovery Institute Senior Fellow and a past president of the Association of American Physicians and Surgeons. Both JWR contributors are Harvard trained diagnostic radiologists. Comment by clicking here. © 2005, |
Arnold Ahlert | |||||||||||
