Tanto per far capire meglio come funzionano le cose. Mi raccomando
leggete Marco Bobbio: "Giuro di esercitare la medicina in libertà e
indipendenza. Medici e Industria". Einaudi, 2004.
ciao
m
Pfizer criticised over delay in admitting drug's problems
Jeanne Lenzer
New York
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[Free Full Text], 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 [adverse] 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."