Tonight, The New York Times weighs in on the improper influence Dr. von Eschenbach more than occasionally (allegedly) exerted on what should have been solely independent agency science decisions (this time, as to a medical device, but as Salmon has shown, this pattern occasionally also carried over to drug candidates, at FDA, during the Bush years):
. . . .The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation. . . ."The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions," Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, said in a conference call with reporters. . . .
The report, written by top agency officials, said that Dr. von Eschenbach, who resigned as F.D.A. commissioner in January, became as a result of political pressure "personally engaged in the details of a process usually coordinated" by scientific staff. One agency manager concluded that Dr. von Eschenbach "was demanding not only an expedited process but also an outcome in favor of ReGen," the report stated. . . .
Dr. David R. Schmidt, the knee surgeon for the San Antonio Spurs, said he was involved in the original clinical trial of ReGen’s Menaflex device and concluded that patients did not benefit. He said he was surprised that the F.D.A. approved it. . . .
Click the following links, to read of prior reports of the same sort of conduct, alleged by Salmon, most recently here (as to some device approvals), and here (as to Schering-Plough's drug Saphris), also here, here, here (more generally, on the FDA's recently-amended drug approval process), as well as here (cancer drugs), and here (as to Merck's Vioxx).
Salmon only "scooped The Gray Lady" by about eleven months, right here, on this blog -- overall. . . .
