Pfizer criticised over delay in admitting drug's problems
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《英国医生杂志》
Pfizer delayed announcing negative data about its painkiller valdecoxib (Bextra), Curt Furberg, a member of the US Food and Drug Administration's Data Safety and Risk Management Advisory Committee, told the BMJ this week. When the company eventually presented its data to the FDA, it also left out important details, Dr Furberg alleges.
Pfizer stood to gain by Merck's withdrawal of rofecoxib on 30 September, after reports linked the drug to increased heart attacks and strokes ( BMJ 2004;329: 816, 9 Oct). That gain was amplified when a major health insurer, BlueCross BlueShield, announced that they had added valdecoxib to their formulary after the withdrawal of rofecoxib.
Pfizer initially defended valdecoxib, saying the drug was safe in patients with osteoarthritis and rheumatoid arthritis. But on 15 October the company issued a news release, qualifying its earlier statement. The release said, "In two trials in a high-risk surgery known as coronary artery bypass graft (CABG), an increase in cardiovascular events was observed in patients receiving Bextra" (www.pfizer.com).
That news, said Dr Furberg, a member of the FDA's Data Safety and Risk Management Advisory Committee, should have been released earlier. Dr Furberg asked Pfizer, after the withdrawal of rofecoxib, to supply him with data regarding the cardiovascular effects of valdecoxib. "I was struck by what they excluded," he told the BMJ. "They did not mention either of two trials of cardiac surgery patients."
The first of the two trials was published but in a manner that obscured the risks, according to Dr Furberg. He said, "They listed each event individually and said the numbers were too small to analyse. But I added up heart attacks, strokes, and deaths and found a statistically significant fourfold increase over placebo."(Jeanne Lenzer)
Pfizer stood to gain by Merck's withdrawal of rofecoxib on 30 September, after reports linked the drug to increased heart attacks and strokes ( BMJ 2004;329: 816, 9 Oct). That gain was amplified when a major health insurer, BlueCross BlueShield, announced that they had added valdecoxib to their formulary after the withdrawal of rofecoxib.
Pfizer initially defended valdecoxib, saying the drug was safe in patients with osteoarthritis and rheumatoid arthritis. But on 15 October the company issued a news release, qualifying its earlier statement. The release said, "In two trials in a high-risk surgery known as coronary artery bypass graft (CABG), an increase in cardiovascular events was observed in patients receiving Bextra" (www.pfizer.com).
That news, said Dr Furberg, a member of the FDA's Data Safety and Risk Management Advisory Committee, should have been released earlier. Dr Furberg asked Pfizer, after the withdrawal of rofecoxib, to supply him with data regarding the cardiovascular effects of valdecoxib. "I was struck by what they excluded," he told the BMJ. "They did not mention either of two trials of cardiac surgery patients."
The first of the two trials was published but in a manner that obscured the risks, according to Dr Furberg. He said, "They listed each event individually and said the numbers were too small to analyse. But I added up heart attacks, strokes, and deaths and found a statistically significant fourfold increase over placebo."(Jeanne Lenzer)