From: Ian Goddard (Ian@goddard.net)
Date: Sun Oct 31 1999 - 20:03:50 MST
(a working analysis with what may be new angles of
argumentation against the FDA posted for feedback)
SHOULD WE ABOLISH THE FOOD AND DRUG ADMINISTRATION?
Ideas like abolishing the FDA may sound absurd on
their face, but unless cases against a given system
are examined, supporting it is probably irrational.
Many people accept the case for the FDA on its face,
after all, who would want unsafe and/or bogus drugs?
But the claim that the FDA ensures safety and a system
of tort liability does not is not automatically true.
The following are a few features of what may be valid
and unique points against the FDA, posted in order to
acquire critique and/or supplemental supporting points:
FDA Approval provides promotion and legal protection for
the wealthiest members of the pharmaceutical-industrial
complex (PIC). The illusion is that the FDA is a watchdog
of PIC, and to some degree this is true, but the bottom
line is that (a) the FDA maximizes the profits of a few
manufacturers, (b) minimizes profits of or eliminates
smaller manufacturers and (c) steers consumers to drugs
that are marketed primarily because they are patentable
(which ensures maximum profits due to exclusive sales
rights) NOT primarily because they are safe and effective.
* The FDA causes patentable drugs to be favored over
non-patentable drugs, even if the non-patentables are
shown to be as-or-more effective and safer in any number
of studies conducted by research facilities not associated
with the company that plans to sell the drug (FDA over-
sight is merely the review of testing funded by the same
company seeking approval and the resultant profits). No
company will fund research for FDA Approval of a non-
patentable drug if all other companies can also sell the
drug without having paid for the Promotional approval.
Patent rights and the surety of large profits derived
therefrom, not safety and efficacy, define the structure
of contemporary medicine. The fact that FDA-Approval
protocols inherently favor patentable drugs is the
single largest feature promoting this harmful situation.
This situation causes safer and equally-or-more effective
non-patentable therapeutics like SAMe (which has been more
thoroughly tested in the sum of studies done by independent
research facilities than many FDA-Approved drugs) to be
valued and prescribed less than dangerous FDA-Approved
drugs like Prozac. The result is that consumers are steered
away from safer products that haven't been FDA Approved
toward far-more dangerous products that are being promoted
by their FDA-Approved status. This ensures that patent
holders make maximum profits while consumers are exposed
to maximum harm. The irony is that this is done in the
name of consumer safety and keeping businesses in line!
Notice that this perversity is not an attribute of FDA
corruption, but of the FDA working according to plan.
* FDA Approval acts as a legal shield in cases where FDA-
approved drugs are causing harm to some. The fact that
a drug is FDA Approved and has not been revoked is seen
by jurors in court cases against a drug manufacturer as
powerful evidence that the drug is not culpable in the
case at hand, regardless of the facts in that case. The
fact of this is verified when the FDA does revoke approval,
as it did of the drug Fen-Phen, whereupon a flood of libel
suits followed, even though Fen-Phen was just as harmful the
day before and numerous studies showing its harmful nature
were published years before FDA revocation. The fact that
law suits start en mass after approval is revoked is the
very measure of the legal protection provided by FDA Approval.
Lawyers know that juries will be swayed by FDA directives
more so than by any research or the facts in a given case.
There are many FDA-Approved drugs that are causing serious
harm to individuals who should be compensated for such harm,
but are not because judges throw out evidence and juries
are prejudiced simply because the drug is "FDA Approved."
* FDA Approval and the "bullet proof" legal status it
provides approved drugs establish logical incentives for
fraud that would be expressed in the following thinking
on the part of a drug manufacturer: "Gee, in our studies
that we will submit to the FDA for approval it looks
like this drug may be harmful, but if we simply fudge
the numbers a little to get it past the FDA-review panel,
it will then be 'safe' and insulated from liability, and
it will take years for the FDA to revoke it, if they
ever do, and by then we'll have made millions anyway."
However, in a free market they would think: "Gee, it
looks like this drug might not be safe, we'll probably
get sued if we sell it, better trash this one." In this
case "safe" is a matter decided by independent research
and in the courts per case, not by authoritarian decree.
This shows how FDA-Approval status provides an incentive
that could/should lead to unsafe and/or ineffective drugs.
* FDA Approval defines what 99% of medical practitioners
will prescribe BECAUSE FDA Approval is a legal shield.
Doctors are more vulnerable to a lawsuit if they prescribe
a non-FDA-Approved medicine than if they prescribe an FDA-
Approved medicine. If an FDA-Approved drug is prescribed
and it causes harm, the doctor can say "it was approved,"
but if they prescribe a non-FDA-Approved drug that causes
harm or fails to save the patient, they are more vulnerable
to law suits. Doctors know this, and will therefore tend
to stick with the FDA program. The result once again is
that consumers are led towards therapeutic options that
EXIST PRIMARILY BECAUSE THEY CAN BE PATENTED, NOT BECAUSE
THEY ARE THE SAFEST AND MOST EFFECTIVE TREATMENTS. The
result is that the function of the FDA is the promotion
and protection of the pharmaceutical-industrial complex
at the expense of consumer safety and access to options.
No wonder that safe and effective alternative therapeutics,
such as vitamins and herbs, that are not patentable have
been under attack from the FDA, with looming threats of
their being banned and forced to go through the FDA-
Approval protocol and then placed into the hands of the
wealthiest members of the pharmaceutical-industrial
complex who will sell those products at fantastically
inflated prices, as has happened in nations that have
followed through with vitamin restrictions. The con, by
design or default, is that the FDA is the champion of
anti-capitalist idealism when in fact it is the vehicle
of the most vicious and predatory capitalism imaginable,
a form of capitalism is that anti-free-market and pro-
mercantilism, ie, a form of capitalism directed not by
consumer demand but by authoritarian decree and force
where consumers, rather than being the directors of the
economy, are ripped off and plundered via State power.
* To prove that the FDA is working to benefit society,
we must show that there has been a decrease in harmful
drugs after the FDA's existence and a steady rate or
increase of new effective drugs coming to market. A problem
here is that the standard by which most will measure the
FDA is the FDA itself, that is, to determine the number
of unsafe drugs approved by the FDA we have to count the
number of drugs the FDA has revoked its approval of.
Like any enterprise, the FDA would have a disincentive
to admit that it is making things worse, and thus would
have a disincentive to revoke too many approved drugs,
just as laws that prove to be more harmful are rarely
ever revoked. Of course, there can be other means of
measuring drug safety, such as adverse reaction reports.
IN SUM: People usually think of life without some large
government institution as a return to the jungle. They
seem to forget that tort liability still exists in the
free market and it exerts a powerful effect on actors
in the market, such that the threat of law suits for bad
drugs will cause manufacturers and sellers to be careful.
We also tend to forget that it's EASIER to bribe or slip
bad data past an inspector or a small review panel than
to do the same to a myriad randomly-selected juries and
hundreds research facilities operated around the world.
Knowing that, companies would have an incentive to be
more careful when it's more difficult to bribe or lie,
which suggests that a free market would regulate better.
The result of slipping bad drugs past an organization
that issues authoritarian decrees of safety is by far
the greatest threat to public safety for it then gives
a bad drug bullet-proof status and the drug will have
free reign to harm the people while it makes the
manufacturer millions and millions. If you study the
case of Prozac and other SSRI drugs, the idea that the
FDA will revoke approval of drugs due to extraordinary
rates of reported adverse reactions is not indicated. A
drug may be revoked if a negative study appears in one
of biggest medical journals, and if you look at these
journals you will find them filled with advertisements
from the very companies the journal would harm if it
were to publish a study showing that one of the drug
manufactures it does business with is selling a bad
drug. In short, if a drug manufacturer like Eli Lilly
sends a journal X thousands of dollars per year, this
payment is, on its face, a de-facto form of bribery
to one of the main entities we have to rely upon to
keep the pharmaceutical-industrial complex honest.
There is quite a lot more to be said in terms of how
the FDA causes harm, which is perhaps most evident in
the cases of the routine delay life-saving therapeutics,
which potentially causes more harm than harm caused by
bad drugs getting out in the free market. The argument
is convincing that tens of thousands died of a heart
condition that could have been easily treated by the
drug propranolol when the FDA kept it off the U.S.
market while it was available in Europe; and that
up to 100,000 die each year due to the FDA's ban on
truthful health information about food and supplements
(See "Freedom of Informed Choice: FDA Versus Nutrient
Supplements," by Durk Pearson & Sandy Shaw, 1993).
Pages Questioning The Safety & Efficacy Of The FDA:
http://clipper.spinnaker.com/liberty/docs/fda.txt
http://www.ncpa.org/~ncpa/studies/s208/s208.html
http://www.aynrand.org/medialink/fda.html
http://www.internetwks.com/pauling/cando.html
http://www.iahf.com/index1.html
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