Trasylol - ongoing tragedy

What is Trasylol? You probably haven't heard of this Bayer's blood clothing drug for the past 14 years it's been on the market. But, recently, it has become a big story - and not a happy one. Trasylol's deadly side effects don't seem to be bothering neither Bayer, nor the FDA. Here is the hystory of this drug, based mainly on the Trasylol story as presented on CBS' 60 Minutes. Draw your own conclusions.

▶ early 1980's, before the drug was approved for use on humans, Dr. Jurgen Fisher, director of the Institute of Experimental Medicine at the University of Cologne, alerts Buyer about Trasylol causing severe kidney damage in animals; he describes Bayer's reaction as "uninterested"

▶ 1992, one of the top country's hearth surgeons, Dr. Nicholas Kouchokos from the Missouri Baptist Medical Center, conducts a small Trasylol trial on 20 patients, 13 of which subsequently develop kidney problems; some other small studies have shown similar results, while some - mainly Bayer's - have not; no large enough study to be conclusive was ever conducted

▶ 1993, nevertheless, the FDA approves Trasylol (aprotinin) to be used to control bleeding in human patients, noting its possible kidney toxicity

▶ 1998, FDA expands the approval to all heart bypass patients

▶ aggressive marketing results in $300M sales in 2005, $750M in 2006, and $1 billion Bayer aspirations for 2007

▶ January 2006, a meta study based on hospital records of over 5,000 patients in 17 countries by Dr. Dennis Mangano, renowned researcher, director of the Ischemia Research and Education Foundation, a California-based nonprofit group, is published in the New England Journal of Medicine; the numbers clearly links Trasylol to significantly higher rate of kidney failure requiring dialysis, as well as significantly higher rate of hospital deaths

▶ in response, the FDA issues warning to doctors, and schedules an advisory committee meeting to take place in eight months

▶ in the meantime, Bayer hires Dr. Alexander Walker, to conduct its own 70,000 patient record study on the subject of Trasylol safety; the results come out similar to the Mangano study

▶ late 2006, the FDA advisory committee finally meets to review Trasylol safety; they listen to Dr. Mangano's report; Bayer's representative withholds the results of their study; the committee votes to keep Trasylol on the market

▶ the very next week, Dr. Alexander Walker blows the whistle to the FDA about alarming results of the study he conducted for Bayer; the FDA issues another warning to doctors; it took it a year to hold another advisory committee meeting

▶ February 2007, another study led by Dr. Mangano is published in the Journal of American Medical Association; the finding is that patients on Trasylol have higher rate of dying within a 5-year period than patients that received alternative drugs

▶ September 2007, the FDA advisory committee votes again to keep Trasylol on the market (!!!)

▶ October 2007, Canadian government terminates 3,000 patient study (BART), designed to show that Trasylol controls bleeding better than alternative drugs; the study was stopped when the death rate among those on Trasylol rose to 50% over the death rate in those that received alternative drugs

▶ Germany bans Trasylol; the FDA settles for temporary suspension of Trasylol - as of November 2007 - with limited use still allowed in "special cases"

So there we go. In these 14 years, over 4 million patients worldwide have received Trasylol, about 1/3 of them Americans. Dr. Mangano estimates that between his 2006 study and the suspension, some 430,000 patients have received the drug, with some

22,000 unnecessary deaths as a result.

For details on how agonizing dying from kidney failure can be, check out the 60 Minutes story's personal account of Joe Randone's tragic fall that begun with a "routine" heart murmur surgery in January 2007, and led into 19 surgeries in the next seven months - including amputated legs - resulting from complications caused by Trasylol (according to Joe's surgeon, who sent report to the FDA), ending with Joe's death in August 2007.

The irony is that, according to Dr. Mangano's study results, the other two (alternative) drugs have shown the

same efficiency as Trasylol, and no side effects.

In addition, they cost $50 per application, while Trasylol hits $1000+ mark. One has to wonder what kind of "marketing" is needed to capture such a large share of market with a product that is so much more expensive, and so much more dangerous than the alternatives, while at the same time without any significant efficiency advantage.

Neither Bayer nor FDA have accepted the offer to present their side of the story. The manufacturer still maintains that the drug has "favorable risk-to-benefit ratio" when used according to its label (should that imply that Bayer lays the blame with the surgeons, for inappropriate handling?).

Was anyone held responsible for all this suffering and deaths? Yes; Bayer has suspended two employees for not disclosing its study result at the 2006 FDA advisory committee meeting. As for the FDA,

it has taken no action against Bayer whatsoever.

Is this how the story ends? Yes, this particular story, if we let it be. But, regardless of how tragic, it is only one of many other similar stories of aggressive marketing of unsafe and dangerous drugs - most of which never get to be publicized - that show how deformed, inhumane and corrupted has become the prescription drug market. One has to wonder how big a tragedy we need to decide it is the time to act.

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