Bayer scientists even appeared at a public meeting called by the F.D.A on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results.Trasylol is the trade name for aprotinin. It is used to reduce the systemic inflammatory response after cardiac surgery.
In a highly unusual move, the food and drug agency released a public health advisory saying it had learned of the study's existence only on Wednesday.
A top F.D.A. official said the agency learned of the Trasylol study on Wednesday only after getting a tip from a researcher involved in it.
In a written statement, Bayer said 'that it mistakenly did not inform' the F.D.A. of the study and added, 'This data was not shared immediately with the agency because it was preliminary in nature.'
Bayer's study was performed by a contract research organization [whose name was not disclosed]. But Bayer did not inform the F.D.A. that the study was being done, even though that is routine practice.
It examined hospital record of 67,000 patients, 30,000 of whom received Trasylol. The rest got other drugs. It concluded that patients given Trasylol were at greater risk.
This case just seems to be just the latest example of a commercial research sponsor attempting to withold the results of a study which turned out not to be favorable to its interests. We have previously posted on other examples of such research suppression, e.g., see this post for discussion of some classic cases from the 1990s, and this post on the attempted suppression of the Famvir vs Valtrex study.
Each new example raises the worry that the entire clinical research base may be distorted by such witholding.
The Times quoted Senator Charles E. Grassley (R-Iowa), chairman of the Senate Finance Committee, "The remedy is mandatory reporting of all clinical trials and real teeth for the F.D.A to do its job holding drug companies accountable."
The current story, however, is one example of why this would not be complete remedy. The Trasylol study was an observational study, not a clinical trial, and hence would not be included in currently proposed mandatory reporting schemes.
I believe that this is another reason to question whether commercial health care firms should have any role in clinical studies meant to evaluate their products.