Personal Injury Lawyer Blog

Trasylol Story a Sad Tragedy - Monday, February 18, 2008

As more facts come out about Bayer's antihemorrhagic drug Trasylol, it seems the story is more tragic and sordid that anyone might have guessed. When a Food and Drug Administration (FDA) panel voted to keep Trasylol on the market, it was acting in relative ignorance, an ignorance fostered and promoted by Bayer itself.

Although studies published in 2006 showed that the drug as much as doubled the risk of kidney failure in patients, the FDA was unconvinced, and on September 21,2006, 8 months after the largest of the studies was published in the New England Journal of Medicine by Dr. Dennis Mangano of the Ischemia Research and Education Foundation, voted to let the drug stay on the market with a caution about possible kidney failure.

By that time, however, Bayer's aggressive marketing of the drug had given it an equal share of the antihemorrhagic drug market for use during open-heart surgery. Over 200,000 people were being given the drug every year, often multiple doses. At $1000 a dose, Bayer was making $700 million a year from the drug. The two alternative drugs were nearly as effective at controlling bleeding, and were much cheaper at $50 per dose.

And now it seems that money was made with foreknowledge of Trasylol's possible side effects. In fact, in the early 1980's, a researcher at the University of Cologne went to Bayer with evidence that animals given the drug suffered kidney damage, but the company brushed him off. The company refused to accept that the drug was dangerous, and when Dr. Mangano's study was published, it hired Harvard professor Alexander Walker to conduct its own study, to be completed before the September meeting. However, when Dr. Walker's results came out the same as Dr. Mangano's, Bayer quashed the study and didn't report its results to the FDA.

A week after the committee voted to keep Trasylol on the market, Dr. Walker came to the FDA independently of Bayer and turned over his results, revealing that Bayer had tried to conceal them. However, the FDA did not at that time request a suspension of the drug. It was not until over another year later that this action occurred.

So let's review. Here's what the FDA did not consider sufficient to suspend the drug:

• Three studies showing that the drug increased the risk of death by 50-100%
• The possibility that more than 30 people were dying daily as a result of the drug
  
• Evidence that Bayer concealed results of damaging studies
• The existence of alternatives that in most cases were equally effective

All these things led to a label revision on the drug. So what was sufficient to ultimately prompt the removal of Trasylol from the market?

In 2007, a trial by the Ottawa Health Research Institute was halted because the group being given Trasylol showed an increased risk of death. This was considered the final result necessary to suspend the drug.

This is another situation in which our neighbor to the north has shown its strength in standing up to drug companies, similar to the Avandia ban late last year. In this country, the FDA seems content kowtow and toady to a drug industry eager to make profits despite the risks to patients. In this country, our only option is to try and make it unprofitable for pharmaceutical companies to market dangerous drugs, and the only way to do this is to make ruinous penalties for doing so. If you or someone you love has suffered dangerous side effects from taking Trasylol or another defective pharmaceutical, you have a responsibility to pursue your claim against the manufacturer. Contact PersonalInjury.com today to get in touch with a local defective pharmaceutical lawyer who can take your fight to the drug companies.

Labels: Canada, defective pharmaceutical, FDA, Trasylol

Health Canada Shows Its Strength - Wednesday, December 12, 2007

A recent study by the Canadian Institute for Clinical Evaluative Sciences (ICES) has not only increased concerns about Avandia and drugs in its class that are used to treat type 2 diabetes, but also raised increased concerns about why the FDA has not pulled the drug. The study compared patients treated with glitazones and those treated with other classes of diabetes drugs. The glitazone patients had a 60 percent higher risk of heart failure requiring hospitalization. They also had a 40 percent higher risk of heart attack, and a 30 percent higher risk of premature death compared to those on the other drugs. The study was conducted by analyzing data for 160,000 diabetics aged 65 and older from the Ontario Drug Benefit (ODB) database.

The data represents a study that is more than an order of magnitude larger than the largest prior study of Avandia. It definitively shows the heart risks attendant on the use of the class of medications and raises questions as to why this dangerous drug is still on the market. The figures show that there were three additional cases of heart failure, four additional heart attacks, and five premature deaths whose cause might be attributed to the drug for every 100 patients taking the drugs for the four years covered by the study, or approximately 8,000 deaths total. Health Canada withdrew approval of the drug for all but patients who could not tolerate other diabetes drugs early in November, but the US Food and Drug Administration (FDA) has been reluctant to do so, although it did put a black-box warning on the drug.

Is this an example of the FDA maintaining too close a relationship with the pharmaceuticals industry? It is impossible to say, but it sure seems likely. The study also points out the disparity between the weak, decentralized regulatory agency in the United States, and the comprehensive, independent, powerful health department in Canada. Although those whose wealth and power would allow them to buy expedited care in the US might complain that socialized medicine makes them wait in line with the hoi polloi, this case shows that the agency seems better equipped to look after the health of the population as a whole. In this country we rely on small studies, usually sponsored by the industry, of barely 14,000 individuals, and the majority of the studies are "inconclusive." Health Canada, on the other hand, is able to draw conclusions based on its own, wide-ranging data, data that cannot be concealed or cooked by pharmaceutical companies.

It is probably impossible that we would ever be able to reform the US health care system into anything like the socialized care in Canada. Instead, our only recourse to do the job that the FDA is either reluctant or unwilling to do is through the court system. Litigation is our last lever of power against major corporate interests in this country. Remember what Archimedes said, "Give me a lever long enough and a fulcrum on which to place it, and I shall move the world." If you or someone you love has suffered as a result of a defective pharmaceutical drug, contact PersonalInjury.com today, to get in touch with a local lawyer who can find his own fulcrum.

Labels: Avandia, Canada, defective pharmaceutical, FDA, federal government