staff at the Food and Drug Administration may not actively hate you
and want you to die, but a study of the agency's sordid history suggests
that they don't really care if you live either. Lucky for us, drug
companies are kind, conscientious, and self-regulating. For example,
in late September Merck and Co, makers of Vioxx, agreed to voluntarily
recall their famous drug, now that a new study suggests it may put
people at increased risk for heart attack. Isn't that nice of them?
. Unless four years doesn't qualify as "new"
findings leading to the drug's recall originally came out in a Merck-sponsored
study, the results of which were first published in The New England
Journal of Medicine in late 2000. It found that people over 40 with
rheumatoid arthritis who took Vioxx had four times the risk of heart
attack as comparable subjects who took a similarly acting painkiller.
Four years, four times, maybe there's something esoteric here. Perhaps
the FDA people have joined Madonna in the study of Kabala and now
know something we don't know. After all, on October 15h they announced
the new requirement that all antidepressants carry a "black box"
warning. The government's strongest safety alert was decided appropriate
since the publication of studies linking the drugs to increased suicidal
tendencies among children and teens taking them. Beyond the questionable
practice of putting children on antidepressants-I had to suffer the
horrors of adolescence armed with only Clearasil and Twinkies-warning
label strategies to prevent harm from drugs have failed miserably
in the past.
Ugly details surround Lotronex, a drug approved to treat irritable
bowel syndrome in women. The FDA approved Lotronex in February 2000.
In late November of the same year, the FDA requested that the drug
manufacturer, Glaxo Wellcome, voluntarily withdraw Lotronex. In those
eight months, 49 cases of reduced blood flow to the intestine (ischemic
colitis) and 21 of severe constipation, including instances of obstructed
and ruptured bowel were reported. 34 patients required hospital admission,
and 10 needed surgery. Five died.
Prior to the Lotronex recall, concerns were raised about risks of
the drug. By June, three patients had already required surgery, and
newly collected data confirmed risks suspected at pre-approval review.
Rather than recall the drug or halt sales until more testing could
be done, the FDA chose to issue a medication guide warning patients
of escalating risks. Then people died. Silly FDA, medication guides
are for safe drugs.
All of this begs the question: Why did the FDA approve Lotronex in
the first place? Well to paraphrase the FDA website: We got a shitload
of money from the Glaxco Wellcome people! And we helped develop this
filthy drug and we spent a whole bunch of money advertising it too,
and somebody has to give us all that money back!
The Center for Drug Evaluation and Research (CDER) is the arm of the
FDA charged with ensuring that drugs are safe and effective. The CDER
does not test drugs. They are a review team of physicians, statisticians,
chemists, pharmacologists, and other scientists, who evaluate a sponsor's
new drug application.
A company develops and tests a drug, including clinical trials--you
know, where they pay grad students twenty-five dollars to take these
pills and see if they die. The company then approaches the FDA for
approval. New drug applications must include the drug's chemical composition
and pharmacology, results of animal studies, how it's manufactured
and packaged, and how many grad students died.
The inherent flaw with this system is that it relies on the market
to investigate the drug. But a market-based testing approach is only
going to look at the positive aspects of a drug. It is unlikely to
consider or investigate the possible negative consequences. A Frontline
interview with Dr. Raymond Woosley, the then-vice president for Health
Sciences at the University of Arizona, included a perfect example
of how such an arrangement could backfire.
In the 1980s, oral lidocaines were being developed to prevent major
complications of heart disease. It was known that irregular heart
rhythms placed individuals at very high risk for sudden death, and
these drugs showed vastly improved electrocardiogram in their users.
A market approach would be likely to stop there. Better EKGs means
fewer sudden deaths. Only that wasn't the case. In a study specifically
designed to check, it was discovered that despite better heart rhythms,
more people died suddenly while on these medications than in the group
treated with placebo.
Treating the symptoms, e.g. assuming that better cardiograms means
fewer deaths, is called addressing surrogate endpoints or biomarkers.
But as demonstrated in the oral lidocaine tests, a cause-effect relationship
cannot be assumed. If you're developing a drug, you have to scrutinize
the final result, in this case death and heart attack.
Yet the FDA website, on a page titled: Benefit Vs. Risk: How FDA Approves
New Drugs states the following: " FDA has
taken steps to
make urgently needed drugs available sooner
Under the accelerated
approval rule, the agency can rely as a basis for drug approval on
a reasonable 'surrogate' endpoint--that is, an effect of a drug on
a marker of the disease, rather than an actual effect on survival
So the FDA is flying in the face of science? Oh yes. On the wings
of greed. In September 2000, USA Today reported that more than half
(54%) of the experts hired to advise the government on the safety
and effectiveness of medicine have financial relationships with pharmaceutical
companies. The conflicts typically included stock ownership, consulting
fees or research grants, and manifested as scientists helping a pharmaceutical
company develop a medicine, then serving on an FDA advisory committee
that reviews the drug.
Federal law prohibits the FDA from using experts with financial conflicts
of interest, but the FDA has waived the restriction more than 800
times since 1998, waivers presumably allowed because bribes and pressure
don't stop within the FDA. The Foundation for Taxpayer and Consumer
Rights (FTCR) reported that no U.S. governor or federal official raised
more money than Governor Schwarzenegger from the pharmaceutical industry
over the last year-other than President Bush. "The Governator"
came in at over $337,200 in campaign contributions from pharmaceutical
companies, while Dubya was clocked at $870,000 since the 2000 election.
So as not to be partisan, let's also mention Kerry's $349,312 from
drug companies since 2000.
results of such conflicts of interest have been well-documented. Numerous
news outlets report a long history of scientists who raise safety
questions about the drugs being dismissed by FDA officials and subsequently
marginalized. The culture of drug review within the FDA presents an
overall expectation that most drugs will be approved. To research
a perceived problem means facing hefty obstacles within the agency,
requiring enormous effort and justification. Conversely, approval
is seldom, if ever, challenged. Finally, since nay-saying scientists
are ignored, post-approval monitoring is not nearly as vigilant as
it should be.
major contributing factor to the pharmaceutical industry's stranglehold
on the FDA is marketing. In 2001, Merck spent roughly $170 million
promoting Vioxx. Let me put that in perspective for you: That's more
than the Coca-Cola Company spent advertising Coke, and more than Anheuser-Busch
spent advertising Budweiser. It was the first year in history that
the pharmaceutical industry spent more money advertising drugs than
developing new ones.
of such proportions has two major consequences: first, the company
wants that money back, and the only way to make it back is to sell
their junk-I mean medicine. Second, pharmaceutical companies get the
public on their side. People are pretty easy to entice; we want to
be thin, happy and healthy, and we don't want to work very hard to
achieve that. Remember the Fen-Phen fiasco? People were angry when
it was recalled. Many would gladly have risked heart attack in order
to be thin.
many cases, selling a pill means convincing people they are sick.
"Ask your doctor about the purple pill
you ever feel tired? Not yourself?" "Did you wake up this
morning? You might need a pill for that
." Part of this
strategy is response to the FDA: In 1962, FDA rules were overhauled
in an effort to improve drug safety. As part of this, companies have
to develop products targeted to specific diseases rather than general
conditions such as "stress." So companies now market not
just pills, but the diseases that they are supposed to cure. And if
you think you're sick, you'll push your doctor, and if he says no
you'll find another doctor.
FDA approval means, as claimed, that benefits outweigh risks, antidepressant
drugs like Prozac should never have been approved. In most company-controlled
clinical trials, the drugs failed to show a benefit greater than placebo.
The drug label claims there were 5,600 Prozac-exposed individuals,
but this apparently includes patients given the drug under a variety
of conditions other than actual clinical trials, like sold on the
street corner or out of a Lexus. Oh wait, that's OxyContin
The actual number of patients in the trials reviewed by the FDA turns
out to be less than 300. But hey, what's 5,300 test subjects between
a government agency and a drug corporation?
allowing Eli Lilly to use the placebo wash-out method dilutes their
supposed positive findings even further. It's been found in most studies
that nearly 50 percent of depressed patients improve on the sugar
pill. In some studies, nearly 90 percent improved on placebo. But
with the wash-out method, patients responding to a placebo within
4-14 days were dropped from the study and the trials restarted. Obviously,
this technique makes a drug seem more effective than it is. Apparently
though, it's commonly used in drug studies.
is not only antidepressants that don't get fully reviewed, or monitored
once approved, or reigned in after long-term studies confirm negative
consequences of a drug. Pfizer has been accused of misleading heath
care professionals as to how often patients need to take Celebrex.
Merk was pushing their now-recalled Vioxx for unapproved uses, such
as the prevention of cancer, and the treatment of Alzheimer's disease
even at four-times increased risk, the chances of Vioxx causing a
heart attack are still pretty low: This equates to a real-world number
of four heart attacks per 1,000 patients. Low, but not insignificant,
and it joins an already extensive list of warnings, contraindications,
precautions, and possible side effects on the Vioxx label. It is known,
for example, that Vioxx and other COX-2 inhibitors (like Celebrex,
Vioxx's main competitor) can cause reduced kidney function in elderly
patients and diabetics. Additionally, a number of cases of aseptic
meningitis were linked with the use of Vioxx.
these risks with the fact that Vioxx doesn't fix anything--it doesn't
rebuild cartilage or provide a simple hysterectomy--it just gets you
high enough that you don't really care. You may as well smoke pot
or shoot heroin, either one of which is significantly cheaper.
you hang out in the wrong (or right, depending on your perspective)
parts of town, people will come and give you things to try. Try it
once for free, see if you like it. Maybe even more than once, maybe
the first three times. Then you gotta pay, see. After you're hooked,
it's not free anymore. If you go to the doctor's office, you will
see stacks and stacks of sample packages of pharmaceuticals the drug
companies give to doctors to give to you. All you have to do is ask,
and you know how to ask because they told you on TV. More scrupulous
doctors are tightfisted with them, or give them to low-income patients
in lieu of an expensive prescription they could not afford to fill.
approval suggests an assurance of safety. But these assurances are
not based on testing or experiments; they are being purchased. The
price? A few million dollar bills, y'all. And, we can only hope, the
souls of the sick, greedy bastards at the drug companies and within
the FDA. The FDA's history of payoffs, rollovers and perjuries makes
that bad CEO Kenneth Lay look less like an economic serial rapist
and more like that big kid that took my lunch money every day. At
least he wasn't taking my life, just my dough.
other government administration can boast of such a long and thick
chain of corruption. To document it all would take volumes. Numerous
major news outlets have done investigations and exposés on
the FDA, with no consequent changes. The corruption is so systemic
that there is no obvious practical way to alleviate it. So face it:
your health is in your own hands. It's best to acknowledge that, every
time you take a drug, you're experimenting on yourself. Kind of like
being at a rave, only way more expensive.
advice? Become a Meals-on-Wheels volunteer. Find an especially cute
and endearing old person who doctors can't help but want to give away
drugs to. Chat them up about their pain, convince them it hurts more
than ever, and take them to a doctor (preferably a fresh, young, still-idealistic
doctor). Then raid their supply. Hey, Merck, Glaxo, Lilly and their
ilk are sending us all to hell anyway; you may as well feel good on
the trip down.