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Senior Citizen Politics
Consumers Union Calls for Congress to Act Now on
Drug Safety
FDA questions about Zyprexa data
highlights Senate vote this week
April 30, 2007 - The news last week 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, says Consumers Union. The Senate is slated to
vote on a package of reforms this week.
Weve 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 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 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 this 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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