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Thursday, December 16, 2004

FDA Scientists Feel Pressure to Pass Unsafe Drugs
According to an HHS survey, one fifth of FDA scientists surveyed two years ago said they felt pressured approve new drugs despite reservations about the drug's safety or efficacy. The survey supports testimony by Dr. John Graham last month that he was pressured to change his conclusions about the dangers of Vioxx. From the Washington Post:

The survey of almost 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency's ability to assess the safety of a drug.
The results of the survey, conducted by the Department of Health and Human Services' inspector general, appear to support some portions of the controversial Senate testimony last month by FDA safety officer David J. Graham. The 20-year agency veteran told senators that the FDA was unable to keep some unsafe drugs off the market, and that scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated.

Posted by Genevieve Smith, 12:06:56 PM

Wednesday, December 15, 2004

NIH Chief Rewrote Safety Report on AIDS Research
US officials reportedly knew of problems with AIDS drug nevirapine and hid their findings from the White House, allowing them to go ahead with a $500 million distribution plan of nevirapine in Africa. Another Associated Press report revealed that NIH chief of AIDS research, Edmund Tramont, rewrote the safety report on the US-funded drug study in Uganda, changing its conclusion and deleting negative information. Excerpts provided by the AP show the astounding difference between the originals and the revisions. For instance, the original report stated, "Acceptable or required timeframes for reporting SAEs (severe adverse events) and deaths were not followed.'' The statement was revised to say, " There was some concern expressed by one of the American physician monitors about the adequacy of standards of clinical care in Uganda.'' The documents obtained by AP include both the original and revised report as well as written correspondence from Tramont in which he expresses he dismisses attempts from his staff to address the problems with the Uganda study.

UPDATE: Another AP article shows that NIH doctors continued a clinical trial of nevirapine on a pregnant woman after they knew the drug was causing acute liver-failure, which eventually led to the woman's death. NIH then hid their knowledge of cause of death from the woman's family.

Read AP article.

Read AP documents.

Posted by Genevieve Smith, 04:18:00 PM

More on FDA's Failed Oversight
The New York Times reports that FDA's inability to find major problems with prescription drugs may carryover into their oversight of medical devices. The article details the failure of FDA inspectors to catch a faulty defibrillator that may have failed to operate up to 50 percent of the time.

Posted by Genevieve Smith, 09:42:04 AM