On February 17th, 2008, the investigative television
program 60 Minutes aired a segment on the prescription drug
Aprotinin, marketed by Bayer as Trasylol. In the report,
we are given the sordid 14 year history of the drug; from
concerns before its Food and Drug Association (FDA)
approval, an aggressive marketing campaign during the early
years of its introduction to the market, to numerous
fatalities resulting from common Trasylol side effects.
As far back as the early 1980's, the concerns over the
potentially fatal side effects of Trasylol have been
discussed. Dr. Juergen Fischer, director of the Institute
of Experimental Medicine at the University of Cologne,
found severe incidents of kidney damage in animals given
Trasylol. When he relayed the results of his research to
Bayer, they disregarded the information, overlooking a
potentially deadly Trayslol side effect. Soon thereafter,
similar side effects showed up in patients given the drug
in U.S. hospitals. Most common among the Trayslol side
effects was acute renal failure, also known as acute kidney
failure, resulting from damage to the kidneys. Cautious of
it's continued use, Dr. Nicholas Kouchoukos, one of
America's top heart surgeons conducted a small study on 20
patients given Trasylol. Of those given the drug, 13 had
problems with kidney function after taking the medication.
Ignoring these results and several other similar studies,
the FDA approved Trasylol for use in 1993.
Through a relentless marketing campaign and intense
pressure on the FDA, Bayer had all but cornered the market
on Trasylol's use in all open heart surgeries, and was the
favored drug to control bleeding in other major surgeries.
Sales of the drug hit $300 million in 2005, with projected
sales of $750 million for 2006. Dr. Dennis Mangano, a
leader in the medical research field, was finishing a study
around this same time, a study that had followed the
records of 5,065 patients in 17 countries given Trayslol.
Published in the New England Journal of Medicine in January
2006, this was the largest Trasylol study ever conducted
and ultimately the most illuminating, suggesting not only
an association between patients given Trasylol and acute
kidney failure, but also an tendency for increased chance
of death in the hospital.
When Dr. Mangano presented his results to an FDA advisory
committee, the reaction was less proactive than he had
imagined. Since Dr. Mangano's results were based on the
hospital records of patients rather than a more traditional
study involving a placebo, the committee was hesitant to
comply with his request to remove the drug from the market.
Unbeknownst to the committee, Bayer possessed the results
from a study conducted by hired Harvard professor Dr.
Alexander Walker, which looked at the records of nearly
70,000 patients in the same way that Dr. Mangano had
conducted his research. Even more amazing were the
startlingly similar results that Dr. Walker's study found:
patients given Trasylol had an increased risk of acute
kidney failure and death. Bayer's failure to inform the
panel of their confirming results led Dr. Walker to contact
the FDA, insisting that Bayer had deliberately withheld
potentially damning information to continue lucrative sales
of Trayslol. However, the FDA's only response to the
confirmation of the fatal side effects was the issue of
another warning to doctors; it would be a full year before
the committee would reconvene to reevaluate to efficacy of
the drug.
Meanwhile, a clinical study run in Canada in 2007 was
halted when participants in the study group began dying.
The German government immediately pulled and banned
Trayslol; through a combined effort between the Canadian
government and the FDA, Bayer was persuaded to put a
temporary hold on the continued marketing of the fatal drug.
It is believed that approximately 4.5 million people have
been given Trayslol worldwide; a third of those patients,
about 1.5 million people, were given the drug in the United
States in the 14 years the drug was available. By Dr.
Mangano's estimates, if, in the brief time frame between
his study and the most recent temporary moratorium on the
drug, the drug had been taken off the market, it could have
saved about 22,000 lives - approximately 1,000 people every
month.
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