Monday, February 14, 2005

Bush Fills Long-Standing Vacancy at FDA

"President Bush said Monday he will nominate Lester M. Crawford to be commissioner of the Food and Drug Administration, filling a position that has been vacant for nearly a year amid rising concerns about the safety of drugs on the market." [AP Wire]

More Bad News For Merck Over Vioxx Article?

"An article published in the Wall Street Journal today questions when Merck knew their pain drug Vioxx caused patients to experience an increase in the risk of suffering heart problems.

"The article indicated a Merck panel looking at the safety of the arthritis pain drug had information that Vioxx increased the risk of heart problems after four months of patient use.

"The information appears to conflict with a statement Merck made when the drug maker pulled Vioxx off the market in September." [Health Talk]

RedNova News - Merck Says It Decided Against Vioxx Study Three Years Ago

"Merck & Co. three years ago proposed, but ultimately decided against, a study of its withdrawn painkiller Vioxx that would have specifically looked at the drug's cardiovascular risks.

"Instead, the drug maker, which detailed its decision in a filing posted Friday on the Web site of the Food and Drug Administration, decided to gather data of Vioxx's heart effects through other studies evaluating its impact on various cancers. Data from one of those trials led Merck to withdraw the drug from the market Sept. 30 because of increased risks of heart attack and stroke.

"In an article Tuesday, The New York Times cited other company documents that said the canceled Vioxx study could have provided answers to Vioxx's risks in March of last year or earlier." [RedNova News]

Merck's Successor To Vioxx Has Heart Aches

"Arcoxia, Merck's successor to Vioxx appears to be worse than other painkillers when it comes to cardiovascular problems and deaths, according to documents released Friday by U.S. Food and Drug Administration staff reviewers." [Health Talk]

FDA to Weigh Fate of Bextra, Celebrex, Similar Drugs

"When it debuted in 1999, Vioxx was hailed as a wonder drug, even though its advantage lay not in better pain relief but in fewer side effects.

"Soon, the drug and others like it in the same class of cox-2 inhibitors became widely prescribed, particularly to arthritis sufferers, thanks to heavy advertising by manufacturers.

"Now, the drugs face intense scrutiny over heart risks posed by the medicines. Starting Wednesday, a U.S. Food and Drug Administration (FDA) advisory panel will meet for three days to debate the future of the cox-2s and perhaps even their predecessors, the cox-1s." [Forbes.com]