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FDA expert accuses agency over Vioxx
Christopher Bowe / Washington November 20, 2004
'A profound regulatory failure, FDA is incapable of protecting America against another Vioxx'.
The US is “virtually defenceless” against another scandal such as Vioxx, senators investigating Merck’s withdrawal of its popular painkiller were told yesterday.
Pharmaceuticals regulation was “broken”, Dr David Graham, a senior Food and Drug Administration safety official, said. The federal agency “let the American people down” by not doing enough to warn of Vioxx’s risks.
He told the Senate finance committee: “Vioxx is a terrible tragedy and a profound regulatory failure the FDA as it is presently configured is incapable of protecting America against another Vioxx. We are virtually defenceless.”
Vioxx, widely used to treat arthritis, was pulled from sale six weeks ago amid concerns that prolonged use increased the risk of heart failure.
Raymond Gilmartin, Merck chief executive, insisted the company had followed a rigorous scientific procedure every step of the way.
All early reports suggesting a link between Vioxx and cardiovascular problems as early as 1999 had been inconclusive, he said, adding: “My wife was taking Vioxx, using Vioxx, up until the day we withdrew it from the market.”Dr Graham led an agency-sponsored study that estimated Vioxx could have caused at least 28,000 heart attacks or deaths.
He presented preliminary findings in August, but was attacked by Merck and senior FDA officials. A month later, Merck withdrew Vioxx.
Dr Gurkirpal Singh, a professor of medicine at Stanford University, said internal documents showed Merck could have known in 1996 of potential heart risks for Vioxx, which was approved in 1999.
He said Merck tailored clinical trials to stop risky side-effects showing up that company officials said would “kill the drug”.
Merck, he added, tried to intimidate him after he criticised the company and its refusal to provide data on a key early study. He told the hearing: “I was warned that if I continued in this fashion, there would be serious consequences for me.”
Dr Graham said the FDA system gave too much power to the agency’s office of new drugs, which not only approves new products but also has to act on issues raised by the office of drug safety.
“The same group that approved the drug is also responsible for taking regulatory action against it post-marketing. This is an inherent conflict of interest.” Dr Graham also launched a swingeing assault on the FDA’s approach to drug safety, saying it regarded post-marketing safety as an “after-thought”.
In response to questioning, he listed five drugs on sale he believed presented serious potential risks: AstraZeneca’s Crestor, which lowers cholesterol; Abbott Laboratories’ Meridia, a weight-loss drug; Roche’s Accutane, to fight acne;Pfizer’s painkiller, Bextra; and GlaxoSmithKline’s asthma treatment, Serevent.
Dr Sandra Kweder, acting director of the FDA’s new drug office, said later she did not share Dr Graham’s concerns on the five drugs, and defended the FDA’s performance. She also said Merck acted responsibly.
The FDA, she insisted, “worked actively and vigorously with Merck to inform public health professionals of what was known regarding cardiovascular risk with Vioxx, and to pursue further definitive investigations to better define and quantify this risk.”
Christopher Bowe / Washington November 20, 2004
'A profound regulatory failure, FDA is incapable of protecting America against another Vioxx'.
The US is “virtually defenceless” against another scandal such as Vioxx, senators investigating Merck’s withdrawal of its popular painkiller were told yesterday.
Pharmaceuticals regulation was “broken”, Dr David Graham, a senior Food and Drug Administration safety official, said. The federal agency “let the American people down” by not doing enough to warn of Vioxx’s risks.
He told the Senate finance committee: “Vioxx is a terrible tragedy and a profound regulatory failure the FDA as it is presently configured is incapable of protecting America against another Vioxx. We are virtually defenceless.”
Vioxx, widely used to treat arthritis, was pulled from sale six weeks ago amid concerns that prolonged use increased the risk of heart failure.
Raymond Gilmartin, Merck chief executive, insisted the company had followed a rigorous scientific procedure every step of the way.
All early reports suggesting a link between Vioxx and cardiovascular problems as early as 1999 had been inconclusive, he said, adding: “My wife was taking Vioxx, using Vioxx, up until the day we withdrew it from the market.”Dr Graham led an agency-sponsored study that estimated Vioxx could have caused at least 28,000 heart attacks or deaths.
He presented preliminary findings in August, but was attacked by Merck and senior FDA officials. A month later, Merck withdrew Vioxx.
Dr Gurkirpal Singh, a professor of medicine at Stanford University, said internal documents showed Merck could have known in 1996 of potential heart risks for Vioxx, which was approved in 1999.
He said Merck tailored clinical trials to stop risky side-effects showing up that company officials said would “kill the drug”.
Merck, he added, tried to intimidate him after he criticised the company and its refusal to provide data on a key early study. He told the hearing: “I was warned that if I continued in this fashion, there would be serious consequences for me.”
Dr Graham said the FDA system gave too much power to the agency’s office of new drugs, which not only approves new products but also has to act on issues raised by the office of drug safety.
“The same group that approved the drug is also responsible for taking regulatory action against it post-marketing. This is an inherent conflict of interest.” Dr Graham also launched a swingeing assault on the FDA’s approach to drug safety, saying it regarded post-marketing safety as an “after-thought”.
In response to questioning, he listed five drugs on sale he believed presented serious potential risks: AstraZeneca’s Crestor, which lowers cholesterol; Abbott Laboratories’ Meridia, a weight-loss drug; Roche’s Accutane, to fight acne;Pfizer’s painkiller, Bextra; and GlaxoSmithKline’s asthma treatment, Serevent.
Dr Sandra Kweder, acting director of the FDA’s new drug office, said later she did not share Dr Graham’s concerns on the five drugs, and defended the FDA’s performance. She also said Merck acted responsibly.
The FDA, she insisted, “worked actively and vigorously with Merck to inform public health professionals of what was known regarding cardiovascular risk with Vioxx, and to pursue further definitive investigations to better define and quantify this risk.”
