FDA in the dock over drug scandals

- Last updated on GMT

Related tags: Drug safety, Non-steroidal anti-inflammatory drug, Celecoxib

US officials attempted to restore the reputation of the
pharmaceutical industry by announcing plans to introduce an
independent board, which aims to monitor the safety of drugs on the
market.

The move is expected to receive a mixed reaction within the industry, which has suffered multiple blows to many of its bestselling drugs that have not only raised questions about patient safety but also issues concerning clinical practice and interpretation of trial data. As a result, the US Food and Drug Administration (FDA) has been under intense scrutiny, placed under enormous pressure to act.

The move also comes on the eve of a crucial three-day hearing to investigate certain drugs that have been withdrawn from markets worldwide. The committees will discuss the overall benefit-to-risk considerations (including cardiovascular and gastrointestinal concerns) for COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines.

Criticism of how the FDA monitors after-market drug safety has grown in the past year, starting with concerns about suicidal behaviour in youths who took antidepressants and followed by Merck's September withdrawal of Vioxx. Questions also have been raised about the safety of Pfizer's Celebrex and Bextra, painkillers similar to Vioxx.

The FDA​ already has an Office of Drug Safety to watch for problems that appear after drugs win approval, but critics have said the office lacks sufficient independence and resources.

At a hearing in November 2004 held by Senate Finance Committee Chairman Charles Grassley, a veteran FDA drug safety scientist, said the agency was virtually defenceless against another Vioxx.

"I don't think it takes care of the problem that we have inside FDA,"​ he said, adding that he planned to unveil legislation around March 1 to make the Office of Drug Safety "truly independent."

In the same hearing the committee heard testimony from a senior safety official at the FDA, describing conversations that he had with his superiors asking him to withhold crucial data.

Dr. David Graham, associate director for science in the FDA Drug Centre's Office of Drug Safety, told Senate investigators he faced stiff resistance within the regulatory agency to his findings.

"Graham described an environment where he was 'ostracised, subjected to veiled threats' and 'intimidation,"​ Grassley said in a statement.

Graham said Grassley's characterisation was accurate. Raising safety concerns within the agency is "extremely difficult,"​ the 20-year employee had said.

Graham has already published a study, which estimates that up to 140,000 people developed heart disease from taking Vioxx in the US. His more recent study looked at Celebrex, Bextra and a number of other treatments such as Naproxen and Mobic. The results have yet to be published in a scientific journal.

In a statement, Acting FDA Commissioner Dr. Lester Crawford responded by saying: "The FDA understands that the public expects better and more prompt information about the medicines they take everyday."

"Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to US consumers."

The US health and human services secretary, Mike Leavitt, said that people wanted more oversight and transparency from the FDA. "They want to know what we know, what we do with information, and why we do it,"​ he said. There would be "a new culture of openness and enhanced independence."

Public confidence in the drugs industry dipped dramatically as the FDA was heavily criticised for being slow to respond to disclosures that most anti-depressants could be dangerous when taken by children and teenagers, even after British authorities had already issued warnings.

The agency was left with egg on their faces when the New York attorney general, Eliot Spitzer, filed charges against GlaxoSmithKline, accusing the company of suppressing data from trials that showed an increased incidence of suicidal behaviour among children taking its drug Paxil.

Related topics: Preclinical Research

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