From: starr@genie.slhs.udel.edu (Tim Starr)
Subject: Why The FDA is a Mass Murderer
Organization: UDel, School of Life & Health Sciences
Date: Wed, 23 Dec 1992 04:30:16 GMT

A while back the subject of quality standards in medicine came up in the
argument about licensure, and the FDA was mentioned.  I claimed that the FDA
commits grievous positive harm, and should be stripped of its regulatory power
and its tax subsidy.  The following article is to support this claim:

The FDA's death penalty, by Alan Bock, senior columnist, Orange County
Register

What would you think if an external enemy bombed an American city of 100,000
each and every year, killing all the inhabitants?  That's about twice as
many Americans as were killed in the Vietnam war, a bit more than were killed
by the atomic bomb at Nagasaki.  Would such wholesale slaughter make you
angry?

Then get angry at the Food and Drug Administration.

Isn't that the agency that's supposed to protect us from unsafe medicines and
give us safer and heathier lives?  That may have been the original idea, but
for a government agency to end up accomplishing the precise opposite of its
stated mission shouldn't really surprise anyone anymore.

Here's how the FDA causes the premature deaths of about 100,000 Americans every
year.

About 1.5 million Americans have a heart attack every year; about half a million
of them die.  Of those, about 20%, or 100,000, die prematurely because they
have not been taking a simple, inexpensive, over-the-counter drug that has
been shown in scientific studies to reduce the risk of heart attacks.

The drug is aspirin.

You probably remember reading something about its impact in news stories a
few years ago.  But the knowledge hasn't really sunk in with a lot of people.
That's because the FDA explicitly forbids the drug's manufacturers from
educating the public about these scientifically accepted effects, either on
labels or in advertising.

It's an understatement to say that's absurd.  It almost certainly violates
the First Amendment.

The first published report on the protective effect of aspirin came in 1948.
More than a dozen other studies have been done.  Probably the most extensive
was the huge Physicians' Health Study, which involved more than 22,000 doctors
as subjects, was funded by the taxpayers (through the National Institutes of
Health), and was conducted by Harvard Medical School.

Previous studies had documented that aspirin - one every other day - could
reduce the risk of a second heart attack in patients who had already had one
heart attack.  This study reported that low doses REDUCED THE RISK OF A
FIRST HEART ATTACK BY 44% IN MEN OVER 50 YEARS OF AGE.

Did you get that?  A lot of people did, at first.  When the results of the
study were published in the Ne England Journal of Medicine in 1989, headlines
and major stories ran in most US newspapers.  Sales of aspirin skyrocketed -
for about 3 months.  Then they fell back to approximately pre-report levels.

That's not too surprising.  You can't expect newspapers to publish the same
news every few weeks to remind people that taking a half aspirin a day will
dramatically reduce their heart attack risk.  That's the manufacturers' job.
The surgeon general might want to start a campaign too.

Why don't they?  One company started to package aspirin in a "calendar
pack," sort of like birth-control pills.  That was too much like making a
claim to the FDA.  It issued a regulatory letter, making it perfectly clear
to all aspirin companies that they wre in no way, in any of their material
made available to the general public, to refer to the results of the
Physicians' Health Study.  They can tell doctors - not the general public -
about the reduced risk of a second heart attack.  But they can't even make
material available to doctors about the reduced risk of a first heart
attack.

(Although the Physicians' Health Study didn't include women, evidence from
other studies suggests roughly similar effects.)

Now some wealthy people or those with Cadillac health-care plans may get a
thorough check-up every year, through which they might catch early warning
signs of cardiovascular problems before a heart attack happens.  But most
people don't.  If aspirin manufacturers could mention the results of the
Physicians' Health Study in ads and on labels, a lot more people would take
it, and get that 44% protection factor.  (Some people shouldn't take
aspirin, including those whe are allergic to it, have an active ulcer, have
a bleeding disorder, or are already taking a prescription anticoagulant.)

Why does the FDA take such a crazy positon about the dissemination of
pefectly respectable, ucontroversial scientific information?  Because the
FDA itself has never approved aspirin for the prevention of heart attacks.
And it claims the right to promulgate rules preventing any claim on a bottle
or in an ad unless the FDA has approved it.

The FDA won't deny that the PHS results are valid.  It just won't let a
manufacturer tell the geral public about the.  Back in 1969, Squibb proposed
a double-blind study on aspirin for preventing heart attacks, but was
discouraged by the cost and absurdity of the rules and regulations the FDA
imposed, including requiring the company to submit ALL KNOWN STUDIES ON
ASPIRIN.  Since the drug has been used since 1899, and since a company
probably wouldn't be able to increase the price enough to cover the additional
costs imposed by FDA requirements, Squibb abandoned the study.

This censorship is not only crazy and anti-social, it probably violates the
First Amendment.  No big drug company will test it however; the FDA would most
likely move all its pending applications to the bottom of the pile - forever.

But the Life Extension Foundation (PO Box 229120, Hollywood, FL 33022), a
pesky smaller outfit, will send you a bottle of aspirin with beta-carotene
(a combination that in the PHS reduced the risk for those with pre-existing
cardiovascular disease by 100% - another result the FDA won't let any company
tell you about) for a $25 contribution to its First Amendment litigation
fund.  The label contains the PHS claims about aspirin that the FDA has
declared verboten.

Will the FDA crack down or back down?  It will be interesting to watch - and
to see if the media report on the controversy.


Tim Starr - Renaissance Now! - Think Universally, Act Selfishly
starr@genie.slhs.udel.edu

"True greatness consists in the use of a powerful understanding to enlighten
oneself and others." - Francois Marie Arouet Voltaire
Newsgroups: talk.politics.medicine