Questions Over Zyprexa Clinical Trial Data Underscore Need for Congress to Act Now on Drug Safety Legislation

Senate vote could come next week on package of needed reforms

    WASHINGTON, April 25 /PRNewswire-USNewswire/ -- Today's news that the
 Food and Drug Administration 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."
 
 

SOURCE Consumers Union