Drug Safety :: US Congress to act now on drug safety legislation

Today’s news that the Food and Drug Administration (FDA) is examining whether the maker of Zyprexa failed to submit clinical trial data about the harmful side effects of the antipsychotic drug underscores the urgent need for Congress to pass drug-safety legislation.

The Senate is slated next week to vote on a package of reforms.

“We’ve seen too many cases where drug companies downplayed, hid or ‘forgot’ their clinical trial data that showed harmful side effects, and patients ultimately suffered,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. “Congress has got to put a stop to this gaming of the safety system by the drug companies, and pass real reforms now that make drug-risk information public.”

The New York Times reported today that the FDA has questions about an Eli Lilly & Co. document from February 2000 that found patients taking Zyprexa in a clinical trial were three and a half times as likely to develop high blood sugar as a placebo. The document was not submitted to the FDA, and a few months later Lilly provided data to the agency that showed almost no difference in blood sugar between patients who took Zyprexa and those who did not. Untreated high blood sugar can eventually lead to diabetes.

In explaining the discrepancy, Eli Lilly told the Times the document was a preliminary analysis, and a final quality check of the data found that the analysis was incorrect.

The Senate is tentatively slated to vote next week on a major prescription drug bill that includes numerous safety reforms. The legislation includes requiring drug companies to register and make public most clinical trial results, as well as giving the FDA the authority to require label changes, post-market safety studies and other tools to monitor drugs for safety issues once they are on the market.

“The Senate has an opportunity to pass a common-sense bill that will better protect patients from drug risks, while still ensuring life-saving medicines get quickly to market,” Vaughan said. “Patients and their doctors need to know the risks of a drug, and Congress has the power to stand up to the drug companies and make that happen.”

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