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Newtown Bee: The FDA Needs Some Guts, Not PR

October 23, 2008
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By GAP Public Health & Safety Associate Jonathan Cantú. Versions of this op-ed also appeared in the Ashville Citizen-Times (NC), Sun Advocate (UT), Columbia Daily Herald (TN), and Davis Standard Examiner (UT).

The Food and Drug Administration’s management has got it wrong again: The agency’s troubles aren’t due to bad public relations. At least they weren’t until recently.

2008 has been yet another tormented year for the FDA. February brought Congressional hearings into the agency’s lax regulation of fatal drugs. March brought a Congressional report scorching the FDA for its woefully inadequate inspection of foreign products entering the US, shockingly illustrated by that month’s Chinese ingredient-tainted Heparin scandal that involved at least 81 American deaths. The summer months brought the FDA’s long struggle to contain a salmonella outbreak that it attributed to tomatoes but was caused by peppers.

What was the FDA’s response to this string of spotlighted failures? To hire a marketing firm to remake the agency’s public image. Comically, the FDA botched that task, too. Investigative reports show the agency circumvented the mandated competitive bidding process in order to steer the PR contract to a Washington, D.C.-based consulting firm.

After the failures of Vioxx, the respiratory drug Ketek, bacteria-laden spinach and a roster of other safety lapses, it’s obvious why the agency is seeking a reputation boost. But this won’t come about by Madison Avenue spin jobs. This PR debacle is a microcosm of the inherent problem at FDA which must be addressed: officials are more concerned with limiting bad press and helping corporate friends than with safeguarding public health.

There is a clear path to fixing these fatal flaws, but it won’t happen overnight. A new generation of FDA leadership must provide sustained support for decisions based on sound science rather than politics or the marketing imperatives of drug companies.

It used to be this way. Dr. Frances Kelsey is the signature example of a diligent FDA scientist who safeguarded the public health. In the early 1960s, Dr. Kelsey held fast to scientific integrity in the face of industry pressure, and was able to block Thalidomide from reaching the U.S. market. As a result, she was publicly lauded and received a major award from President Kennedy in a White House ceremony. She continued to work for the FDA for another 40 years and, upon her retirement in 2002, the agency named an award in her honor.

Tragically, today’s Dr. Kelseys are treated by the FDA as pariahs or enemies. When Dr. David Graham sought to warn the public that the painkiller Vioxx was related to tens of thousands of deaths, he needed Congressional intervention just to save his job and keep his findings from being suppressed by FDA brass. FDA veterinarian Dr. Victoria Hampshire’s investigation, concluding that a heartworm drug was related to hundreds of dog fatalities, resulted in her removal without explanation from reviewing the drug. She was placed under criminal investigation by the FDA, and it took a subsequent Senate investigation to finally vindicate her of any wrongdoing.

Today’s FDA works at cross purposes, tethered to its industry patrons when it should be singularly focused on the public good. The FDA’s Office of New Drugs, tasked with determining whether or not new drugs are safe, is largely funded by industry user fees. How are these fees determined? By industry and agency officials sitting down behind closed doors and negotiating terms of the drug approval process (without any consumer or patient representatives). Once a drug is approved and on the market, FDA’s Office of Surveillance and Epidemiology (OSE) is tasked with monitoring its safety. But OSE has no independent authority to take action against unsafe drugs, only the “power” to make a recommendation to the very body that approved the drug in the first place.

To restore trust in the agency, the FDA must be restructured so that its drug approval function is not tainted by industry conflicts, and its oversight function is not subordinated to its drug approval branch.

Drs. Graham and Hampshire are just two of many FDA employees who should be praised for coming forward. Their diligence in the face of industry pressure and subterfuge are the sort of everyday heroism that safeguards public health. Encouraging rather than subverting this type of work will make for credible, honest and effective PR for the FDA and restore the public’s trust.

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