While all of us are used
to hearing that some Member of Congress has been
indicted or that a local politician admitted to
taking a bribe, most of us have felt that certain
parts of our federal government are somehow above
reproach. Particularly
this has been the perception of the U. S. Food and
Drug Administration ("FDA"). The FDA is
non-partisan and protects us from bad food and bad
drugs.
Officially created in
1906, the FDA's mission statement says that it is
responsible for "protecting the public health by
assuring the safety, efficacy, and security of
human and veterinary drugs, biological products,
medical devices, our nation's food supply,
cosmetics, and products that emit
radiation." The items regulated by the FDA
account for 25 cents of every dollar spent by
consumers.
However, there is
increasing evidence that this confidence is
misplaced and that the FDA is really not
representing us at all.
HOW A DRUG IS
APPROVED
The Center For Drug Evaluation and
Research (CDER), a branch of the Food and Drug
Administration (FDA), is responsible for approving
new drugs. The CDER says it has the mission
to assure that "safe and effective drugs are
available to the American people."
After extensive testing in the
lab and in animals, some drugs are given approval
for testing in humans. Because of a
legitimate concern that these tests on humans be
as safe as possible, the human test subjects are
carefully selected and only include people who
will have the least likelihood of having
problems.
A drug is tested on
humans in Phase I, II and III clinical
trials. Phase I clinical trials normally are
done on approximately 100 healthy
volunteers. If this trial produces
acceptable results, the company goes on to Phase
II.
Phase II trials
generally involve 100-300 volunteers who have the
condition which the drug is intended to
treat. If the results of this test are
acceptable, then Phase III clinical trials are
started.
Phase III clinical
trials generally involve approximately 1,000
subjects and generally last from four to eight
weeks but sometimes involve more people and last
longer.
THE DEFINITION OF
SAFE
If the FDA reviews the results of the
Phase III clinical trial and determines that the
drug is "safe", then it is released to the
public. When most of us hear the word safe,
we think of "not dangerous" or "unlikely to cause
or result in harm, injury, or damage."
According to Janet Woodcock, M.D., director of the
Food and Drug Administration's Center for Drug
Evaluation and Research (CDER), safe has a
different meaning to the FDA.
When it comes to any
drug, "safe" means that the benefits of the drug
outweigh the risks for the population the drug is
intended to treat and for its intended use. "Safe
does not mean harmless."
So safe does not mean
harmless, but the CDER has determined that the
benefits of the drug outweigh the risks and that
is why there are paragraphs of risk factors
associated with the use of the drug. This
may not be so bad, but how can you know if the
benefits outweigh the risks if the test is done on
a tiny percentage of the population, less than
.001% of the population?
The CDER confirms
this when it says, "So, the safety profile for new
drugs that come on the market is never totally
defined because new drugs are studied only in
relatively small and homogeneous patient
populations. The complete safety profile of a new
drug will be defined only after it has been
approved and is in use on the
market."
All of us realize
that there are some illnesses, like cancer, which
are often fatal, and we certainly know that a
cancer drug that causes harm to some cancer
patients but may help others is one, if the risk
is known, that a cancer patient might choose to
take. However, the key here is for someone
to tell us that we are actually participating in
an unofficial test of the safety of a new drug
when it is prescribed by our doctor.
OFF-LABEL USES
To
compound this further, many drugs are being
prescribed to treat things for which they were not
approved by the FDA. This is called
"off-label" use. For example, many antidepressants
are being prescribed for the treatment of
pre-menstrual syndrome (PMS) or elbow pain or are
being used to promote weight loss. While
this is legal (a doctor can prescribe a drug for
any use), it is dangerous.
Dr. Randal Stafford
co-wrote "Off-label Prescribing Among Office-Based
Physicians". This article was published in
the May 8, 2006 Archives of Internal
Medicine.
The article
concluded, "Off-label medication use is common in
outpatient care, and most occurs without
scientific support. Efforts should be made to
scrutinize underevaluated off-label prescribing
that compromises patient safety or represents
wasteful medication use."
AFTER A DRUG IS
RELEASED TO THE PUBLIC
However, since the
FDA is charged with protecting our safety, a
reasonable person would assume that the FDA is
closely monitoring the effects of these drugs in
their real tests on the American public.
Unfortunately, this is not the case.
According to the 2003 report of the Office of
Inspector General of the Department of Health and
Human Services, a survey of CDER reviewers
revealed that 66% lacked confidence in the FDA's
safety monitoring of marketed prescription drugs,
and 18% had felt pressure to approve a drug
despite reservations about its quality, efficacy,
or safety.
Perhaps some of the
reason for the reluctance of the FDA to make sure
the American people understand the limited testing
of new drugs is that the FDA does not think of the
American public as its clients.
David
Graham, Associate Director of the FDA's Office of
Drug Safety, in an interview that appeared in
Fraud Magazine (September/October 2005 issue)
stated, "FDA is inherently biased in favor of the
pharmaceutical industry. It views industry
as its client, whose interests it must represent,
it views its primary mission as approving as many
drugs as it can regardless of whether the drugs
are safe or needed."
A reason for this attitude is
likely the fact that more and more of the FDA's
budget is coming from "user fees." These are
fees paid to the FDA by the companies who are
seeking approval of their drugs. It is
natural to want to please the people who are
paying your salary. The FDA no longer has to go to
Congress to get a significant amount of the
funding for drug approval and
oversight.
In 2006, the Union of
Concerned Scientists and Public Employees for
Environmental Responsibility distributed a
38-question survey to 5,918 FDA scientists in
order to examine the state of science at the FDA.
The results are distressing. The scientists who
responded pointed to significant interference with
the FDA's scientific work which in turn led to
problems with the FDA being able to fulfill its
mission of protecting public health. Here
are some of the results:
* Less than half (47
percent) think that the "FDA routinely provides
complete and accurate information to the
public."
* Less than half (49 percent)
agree that "FDA leadership is as committed to
product safety as it is to bringing products to
the market."
* One-fifth (20 percent) say they
"have been asked explicitly by FDA decision makers
to provide incomplete, inaccurate or misleading
information to the public, regulated industry,
media, or elected/senior government officials."
* In addition, more than a quarter (26
percent) feel that FDA decision makers implicitly
expect them to "provide incomplete, inaccurate, or
misleading information."
* Two in five (40
percent) said they could not publicly express
"concerns about public health without fear of
retaliation." More than a third (36 percent) did
not feel they could do so even inside the confines
of the agency.
* Nearly 70 percent do not
believe the FDA has sufficient resources to
effectively perform its mission of "protecting
public health, and helping the public get the
accurate, science-based information they need to
use medicines and foods to improve their
health."
Looking at the
results of the Union of Concerned Scientist's
study, one recalls the words of Joseph Goebbels,
Hitler's Minister of Propaganda:
"If you tell a lie big enough and
keep repeating it, people will eventually come to
believe it. The lie can be maintained only for
such time as the State can shield the people from
the political, economic and/or military
consequences of the lie. It thus becomes vitally
important for the State to use all of its powers
to repress dissent, for the truth is the mortal
enemy of the lie, and thus by extension, the truth
is the greatest enemy of the State."
It is time for
Congress to look at the FDA and shine the light of
truth on it before it is too late. If the
FDA is not looking out for us, then we need to
understand this and know that it is up to us to
protect ourselves by demanding full disclosure
before taking any FDA-approved drug for any
reason. Maybe that's not a bad idea
anyway.
