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Bayer Responds to Trasylol Studies

Posted by Jane Akre
Friday, February 22, 2008 12:09 PM EST
Category: Major Medical, Protecting Your Family
Tags: Trasylol, FDA and Prescription Drugs, Defective Drugs, Wrongful Death, Product Liability

Bayer AG responds to two new studies on its controversial drug Trasylol.

Image: Joseph Randone

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IB’s Akre - Does Bayer have anything to say to the Randone family profiled on 60 Minutes last Sunday?

“Bayer would like the Randone family to know we are very sorry for their loss.”

That from Bayer spokeswoman Staci Goofier concerning the troubling 60 Minutes profile of the Randone family of Long Island. 52-year-old Joseph Randone went in for the repair of a heart valve in January 2008, a procedure he was told had a 5 percent risk potential.

Eight months later, after his kidneys failed, his legs were amputated, his eyes were sewn shut and a pace maker was implanted in his chest. Eventually his body shut down and Joseph Randone died.   

Even his surgeon confessed to the family that Joseph had been given Bayer's Trasylol to lower the risk of bleeding during the surgery. The surgeon said he would be making an adverse event report to the FDA.

The 60 Minutes story shows how Bayer withheld vital and negative information on the drug during a September 2006 FDA advisory hearing. The company acknowledges it didn't release the information because Bayer says it was premature. One FDA panel member says that information would have caused him to cast a negative vote.  

But when a Canadian study of Trasylol had to be suspended because of the high number of deaths and a whistleblower told the FDA about those withheld negative findings, Bayer took the drug off the market in November 2007, something the company calls a ‘temporary market suspension.”

And now two new studies, published in the February 21, 2008 edition of the New England Journal of Medicine also show an increase in death and kidney failure among the Trasylol (aprotinin) group adding more weight to the chorus of alleged victims and lawsuits filed against Bayer over Trasylol.  (See story on new findings here)

The new studies come from Duke University (Dr. Andrew Shaw) and Harvard Medical School and Brigham and Women’s Hospital (Dr. Sebastian Schneeweiss).  Bayer had no comment before the 60 Minutes story but did go on the record to IB News.   

Scientists involved with the studies are invited to comment in response.

Jane Akre IB News  -  "We have 2 new studies out confirming Trasylol leads to more kidney failure and deaths than the more standard treatments. To what extent is Bayer calculating these study results in its final benefit / risk assessment of the drug? In other words, please respond to the findings of these studies."

Bayer’s Gouveia -   “The first article, submitted by Schneeweiss et al,* a consultant of i3 Drug Safety, is entitled “Aprotinin during Coronary-Artery Bypass Grafting and Risk of Death.”  The Schneeweiss article reports on one aspect of the i3 Drug Safety study, which is a retrospective observational study based on an administrative claims database.  The paper summarizes the information on in-hospital mortality included in i3 Drug Safety’s final report (Part A), and the subsequent Addendum - both of which have been posted on Bayer’s websites since September 2007.

“In the Schneeweiss study, as in the larger i3 Drug Safety study, Bayer believes that the database selected was unsuitable for comparing the safety of Trasylol and aminocaproic acid (commonly used to reduce bleeding- ed. add) in the complex clinical setting of CABG (coronary artery bypass graft) surgery. Key patient characteristics that impact the risk of in-hospital mortality were missing from the analysis or had been misclassified.  These fundamental problems with the data cannot be overcome through statistical analysis, particularly given the consistent evidence that Trasylol is typically administered to patients who are at higher risk for bleeding and other complications.

“The conclusions from the i3 Drug Safety study and the underlying data, including the conclusions and data on in-hospital mortality, were presented by Dr. Schneeweiss at the meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) on September 12, 2007.  At the close of the meeting, based on the Trasylol data from Bayer’s controlled clinical trials, and after considering data from observational studies, including the i3 Drug Safety study and public testimony presented at the meeting, the Committees recommended that US marketing authorization for Trasylol should be continued.  Additionally, based on concerns about the quality of the data, the Committees voted against describing the findings from the i3 Drug Safety study in the product labeling for Trasylol.

The second article authored by Shaw, et al. and based on a 10-year retrospective review of CABG (coronary artery bypass graft) surgery at the Duke University Hospital Medical Center, concludes that “patients who received aprotinin had a higher mortality rate and larger increases in serum creatinine levels than those who received aminocaproic acid (more commonly used drug to stop bleeding) or no antifibrinolytic agent.”  The authors, however, acknowledge several important limitations to their study, including the retrospective nature of the analysis, uncertainty about whether statistical methods can fully account for the fact that patients treated with aprotinin were at higher risk to begin with, and a pattern of increasing use of aprotinin over the study period.  The authors also note that they did not attempt to control for the practices of individual surgeons.  The authors conclude that it is unclear whether the apparent association between aprotinin and adverse outcome is caused by the use of aprotinin or by some other difference between the patients who received aprotinin and those who did not.  Bayer believes that the Shaw study does not provide evidence of a causal relationship between aprotinin and in-hospital mortality.  It is also noteworthy that Shaw et al did not show a statistically significant difference in the risk of dialysis among patients treated with aprotinin compared to either aminocaproic acid or no antifibrinolytic agent.  

"Bayer received and shared an abstract of the study by Shaw et al, with the FDA describing this study in advance of the September 12, 2007 Advisory Committee meeting, and that information was provided to the Advisory Committee.  Bayer believes that, based on the limitations acknowledged by the authors, the Shaw article provides no additional, definitive information that would negatively impact the benefit-risk profile of aprotinin."

IB News Akre - Will your company continue to try to bring Trasylol back to the marketplace?

Gouveia – “Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling."

IBs Akre -  “ I wonder at what point does Bayer take into consideration its reputation as "Big Pharma" putting profits before people in its final assessment of the drug and its viability on the market?

Gouveia – “ On November 5, 2007, given the concerns, Bayer temporarily suspended global marketing of Trasylol.  As noted in our statement, Bayer and regulatory authorities still await final results from the BART trial.  When those final results are received and evaluated, Bayer will work with the FDA and other health authorities to see what impact, if any, the BART final results and any other new data will have on the benefit-risk profile of Trasylol. At that time the temporary marketing suspension will be re-evaluated.  Bayer still awaits this information and has received no further update from BART investigators regarding the timing in which they expect to complete their final report.” # 

 

 

 

 

 

 


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