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More on Vioxx, the arthritis drug associated with tripled risks of heart attacks and sudden cardiac death. I talked about this fiasco in an earlier post, if you want to take a look, comparing this nonsense with the Rezulin debacle, which was recalled after folks started dropping dead from liver failure.

The FDA is attempting to defend its decisions about this drug and antidepressants found to have equally serious side effects.

With the FDA being criticized for not acting more aggressively when safety concerns arose about Vioxx, antidepressants and other medications, the agency’s acting commissioner cited its “well-documented and long-standing commitment to openness and transparency in its review of marketed drugs.”

[HOLY CRAP! That was a load of bullsh*t. Are we expected to believe that statement? — Pam]

Lester Crawford’s statement, sent by e-mail to reporters about 16 hours before the Senate Finance Committee’s scheduled hearing Thursday morning on Vioxx, also said the FDA initiated and paid for reviews of Vioxx and antidepressants after those drugs had hit the market. “That is evidence the system is working,” Crawford said.

Critics contend the agency ignored risks associated with antidepressants and Vioxx, then intimidated its own reviewers when they pointed to safety concerns in both cases.

In October, the FDA ordered that all antidepressants carry warnings that they “increase the risk of suicidal thinking and behavior” in children who take them. Vioxx’s maker, Merck & Co. pulled the drug from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.

“How can they see that type of problem and look back and say ‘We did everything right’?” Birchfield said. “When they’re not willing to recognize mistakes, we have no hope for them voluntarily taking measures to correct the situation.”

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Pam Spaulding

Pam Spaulding