Preemption has been a hot topic throughout the
pharmaceutical and legal fields for some time now and as we move closer to
monumental decision from the Supreme Court on the issue it has become a real
battlefield for both sides. The argument for preemption basically promotes the
idea that FDA approval of a medication should preempt or prohibit individuals
from filing lawsuits against the makers of the medication for injuries
developed as a result of taking the medication. This line of arguing can only
be considered logical if you assume that FDA had all of the information that it
needed at the time to determine that the medication is safe for public use. The
recent recall of Bayer’s anti-bleeding medication Trasylol, demonstrates that
these assumptions are false.
Aprotinin is a naturally-occurring enzyme produced by
cows. It was first discovered in the 1930’s, and brought to market under
the name Trasylol by Bayer in 1959. Trasylol increases the rate at which
blood clots, and Bayer sought FDA approval to use the drug during Coronary
Artery Bypass Graft (CABG, pronounced cabbage) surgery to reduce blood
loss and minimize the need for blood transfusion.
Trasylol was approved by the FDA in 1993 and was removed
from the market in 2007 after evidence showed that it was causing patients to
suffer renal failure, have heart attacks and strokes, and even die shortly after being given the drug. The number of lives that were lost as a result
being given Trasylol will never truly be know but some have estimated that the
drug could be responsible for as many as 1,000 deaths per month between 2006
Bayer claims that had no previous knowledge of adverse
effects linked to Trasylol until recently. According to German researchers this
was not the case.
Trasylol had been available in Germany since 1959 and as far
back as the 70’s prominent researchers began to suspect that the drug may cause
kidney problems, but Bayer chose to ignore these concerns. According to one of
the researchers, Dr. Juergen Fischer, in 1984 Bayer deleted almost all of the
warnings that he presented at symposium in favor conducting clinical trials on the effects
of Trasylol on kidney function from the published version of symposium
lectures. While Dr. Fischer’s concerns were based on lab animal studies, this was no reason for the company to completely ignore, and in fact attempt to silence his concerns.
This doesn’t sound like a company that didn’t know about
problems with Trasylol, but more like a company that did not care enough about the consumer to evaluate
concerns about the medication.
In 1993, the FDA
clearly made the wrong decision when it approved Trasylol for use on patients
undergoing CABG surgeries at “high risk” of blood loss. To their credit,
the FDA noted the drug carried a risk of kidney toxicity, but their decision
that the benefits of Trasylol outweighed those risks was incorrect because
there were already two other drugs on the market that were just as
effective as Trasylol and that carried none of the side effects. Perhaps
even more importantly, those other drugs cost about 1/10th of what Trasylol
In 2006 another well-respected physician, Dr. Dennis
Mangano, published the results of a 10-year study on Trasylol in the
prestigious New England Journal of Medicine. The $45 million study showed
startling evidence that Trasylol was linked to increased risk of renal failure.
Dr. Mangano recommended replacing aprotinin with tranexamic acid, another
similar medication that he believed would save millions and provide a safer
alternative to Trasylol.
When the FDA was confronted with the data it took the agency
eight months to convene a meeting to discuss the study. According to Dr.
Mangano the meeting was “a set-up.” Many of those attending the meeting had
written papers for Bayer or had financial interests in drug companies. The
panel voted, 18-0, to continue to allow Trasylol to be used in “high risk”
Mere days after the decision the FDA was contacted
by a researched who claimed that Bayer had not delivered evidence of company funded
study that showed similar result to that of Dr. Mangano’s study. When confronted with
these allegations by the FDA, Bayer claimed that they had “mistakenly” failed
to mention the study to the advisory committee. Bayer released the study six
This deliberate act to conceal information from the FDA is
practice that has been employed on numerous occasions by several pharmaceutical
companies to keep a dangerous but profitable drugs on the market.
Four months later the Journal of the American Medical Association published
another of Dr. Mangano’s studies that claimed that Trasylol was not only
causing renal failure but also actually killing patients. The study estimated
if aprotinin, Trasylol, had been replaced by either of the cheaper alternative
medications 2,000 lives could have been saved in 2006 alone, and 10,000 over
the next five years.
It would be another eighth months before an FDA advisory
panel would reconvene to reevaluate the safety of Trasylol.
When the September 2007 meeting was convened there was a
wealth of information that suggested that the risks of Trasylol overwhelmingly
outweighed the benefits of the drug; however, despite the mountain of evidence
the panel somehow voted, 16-1, to allow the drug to remain on the market.
You may ask how? How could the FDA not pull Trasylol from
the market when they had substantial evidence that the drug was so dangerous? Criticism over the methodology used to conduct the studies was reason for the peculiar decision. The FDA prefers to make decisions based on what are referred to as randomized control studies,
the holy grail of clinical trials, where data is draw by measuring effects of a
medication on a test group vs. a placebo group, and compared to a control
group. The studies that were presented were what are called observational
studies. Observational studies basically review existing data of thousands of
patients and draw conclusions from that data. The studies were not of the variety that the FDA prefers, but still it seems that the agency should have erred on the side of caution.
One month after the advisory panel voted to keep Trasylol on
the market a clinical trail, the BART study, being conducted in Canada had to
be halted after preliminary results showed glaring disparities between patients
being treated with Trasylol when compared with those being given a drug in the same category. The
study discovered that patients being administered Trasylol were dying at 50
percent higher rate than those being given competing treatments. When this news
reached the FDA the agency finally pulled the plug on Trasylol.
As it is seen here the FDA is far from perfect and the corporations behind most pharmaceuticals are far from honest.
Even when it has all of the necessary information, the FDA
may still make an error that results in the loss of lives and taxpayer
dollars. When that happens – especially if a pharmaceutical hid or
misrepresented data – it’s important for injured patients to be able to seek
appropriate compensation from the pharmaceutical that made the drug.
Preemption will force innocent patients to bear all the costs – human and financial
– of FDA mistakes and pharmaceutical deceit. Unless and until the
entire FDA pre and post drug approval process is reformed to put patients
first, preemption is bad public policy.