The painkiller Aleve is the latest of three widely used anti-inflammatory drugs to come under suspicion because of their potential health risks. No more examples are needed to...
The painkiller Aleve is the latest of three widely used anti-inflammatory drugs to come under suspicion because of their potential health risks. No more examples are needed to point out the Food and Drug Administration’s weaknesses.
First, Vioxx was pulled from the market this fall in the largest recall in recent memory. Then its sister drug, Celebrex, was linked to heart attacks and strokes last week, stopping a major clinical trial. Now Aleve, which a study suggests might increase people’s risk of heart attacks and strokes, is suspect.
The FDA needs help if it is to properly protect the public from unsafe drugs. Time to consider an independent, more assertive arm of the federal agency.
This division ought to have the independence to set up tough protocols to gauge a new drug’s efficacy. It would contract with independent clinicians and scientists for the final testing of all new drugs and medical devices.
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It would also weigh in on direct advertising to consumers, an element that has fueled the vast popularity of drugs like Celebrex and Vioxx but has also confused a populace uncertain if it is buying a pain reliever or a lifestyle.
None of this can be done within the existing structure of the FDA. The agency long has walked a fine line between its regulatory responsibilities and its dependence — financial and otherwise — on the user fees paid to it by drug companies.
Disappointingly, the FDA was slow to intervene in the cases making headlines. David Graham, an FDA whistleblower, told Congress last month that Vioxx may have caused more than 30,000 deaths. Its recall was the largest in recent history.
In the case of Celebrex, Pfizer made an ethically responsible choice to halt its $75 million advertising campaign. But Celebrex is still being sold.
People should feel confident about the drugs marketed to them. But public confidence fades when the FDA endorses drugs that later studies prove unsafe.
No drug is 100 percent free of side effects. Nor should the FDA’s approval of lifesaving drugs be unnecessarily slowed down. But the agency’s regulatory arm must be strengthened and made more independent.