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Monday evening, CBS 60 Minutes ran an investigative report, rather dramatically entitled "One Thousand Lives a Month", about the drug Trasylol, manufactured by Bayer (BAY) for the control of bleeding in patients undergoing surgery. The title of the piece is derived from the estimation that the drug may have contributed to the deaths of 22,000 people, or 1,000 people a month, since the time a signal was uncovered through a study that the drug might cause renal impairment or failure in patients.

I say it was dramatically named because, in a piece about evidence-based decision making, CBS named the story by using a figure someone guessed at. But that is beside the point.

The investigation by CBS News alleges several damning aspects as to how the drug was approved, stayed on the market and how the FDA investigates safety. If you did not see the piece, don't worry, you will probably hear a lot about it in weeks and months to come and I would imagine that some you will be hearing talk about it will be members of Congress.

The allegations of the piece are far too complicated to detail here, as are the implications. However, part of the story involves an FDA Advisory Committee meeting in which the drug was reviewed for safety and that safety was supported by the Committee, apparently because, according to the report, the Committee did not know all that it needed to know about the studies done on the drug.

There were many aspects of the report that call into question FDA practices - inadequate review for safety at the time of approval; once a safety signal is detected, the agency takes too long to react; the level of regard for observational studies that raise the possibility of a safety signal; and once it does react, it moves glacially and does not have the authority to ensure full disclosure and transparency.

The agency saw some action aimed at Congressional reform last year with the Food and Drug Administration Amendment Act (FDAAA). Surely a story such as this is going to fuel a greater passion for much more radical reform on the part of the FDA, particularly as we head in and out of this election cycle. From the looks of it now, I'd say the chances are very high that some further significant reforms will be proposed, if not enacted, that will re-shape the way FDA investigates safety in the coming years, in the same way that FDA was reshaped with FDAMA and PDUFA in the 1990's by the public outcry for increased access and swifter approvals. It is quite possible that the entire advisory committee structure might be reformed and new weight given to observational data, or at least to its regular collection and analysis.

Monday night, FDA chose not to participate in the story and did not have a spokesperson to explain the agency's workings. That allowed the story to be formed in spite of them, without their input. I'm not questioning the judgment of the agency with regard to that, but in the coming months, the agency needs to think long and hard about how it is going to shape the debate to come, or be willing to allow the debate to re-shape the agency.

Source: Bayer's Deadly Drug Poses Challenge to FDA Safety Policies