Health

Investigation Exposes ‘Potentially Fatal’ FDA Failures, Wins National Award

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Clinical trials conducted under the auspices of the U.S. Food and Drug Administration are riddled with poor oversight and potential conflicts of interest, a lengthy investigation by the non-profit watchdog Project on Government Oversight (POGO) found.

POGO recently won the Society of Professional Journalists’ Sigma Delta Chi award for online reporting for exposing the FDA’s close ties with pharmaceutical companies and flawed clinical trials as Congress works on legislation to speed up the process for approving new drugs, the watchdog group announced.

News of the POGO award follows reporting by the Daily Caller News Foundation that former FDA Commissioner Margaret Hamburg, her hedge-fund husband, and Fortune 500 corporate giant Johnson & Johnson are defendants in a lawsuit that charges they conspired to profit by hiding the dangers of antibiotic Levaquin from the public.

POGO’s reporting on the “potentially fatal unreliability” of blood-testing devices — devices used in a possibly flawed trial by former Duke University researcher and now-FDA Commissioner Robert Califf — spurred an FDA meeting and plans to toughen standards on those devices, the watchdog group said.

POGO also found former members of FDA advisory committees were paid to help drug companies prepare for committee hearings, and the FDA enlisted outside experts with financial ties to pharmaceutical companies to review experimental drugs.

POGO, using thousands of pages of FDA documents obtained through sources and the Freedom of Information Act, also found the FDA rarely punishes doctors who mismanage clinical trials, even when the doctors are repeat offenders. The FDA sets the bar for approving new drugs so low that a product can obtain FDA approval when it’s only 50 percent as effective as a cheaper, decades-old generic drug, POGO said.

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