March 23, 2006
Two Minnesota legislators are urging the passage of a state law that would require drug makers to disclose the results of ALL clinical studies, both positive and negative. State representatives John Lesch and John Hottinger say this state law would help make up for the federal Food and Drug Administration’s failure to require full disclosure about the risks and benefits of prescription drugs.
Lesch and Hottinger feel it is only fair that medical providers and patients have access to the all the results of clinical research for particular drugs in order to make informed decisions based on an accurate assessment of drug safety.
In addition to these lawmakers, Minnesota residents who have been affected by the tragic consequences of drug side effects have joined in support of this proposed bill. Kim Witczak lost her husband after he committed suicide while taking Zoloft for a sleeping disorder. Since her husband’s death in 2003, Ms. Witczak has lobbied for increased reporting of drug risks.
With respect to Zoloft, the FDA has taken recent action to warn consumers of the increased risks of suicide in patients taking antidepressants. However, Ms. Witczak and others contend that Zoloft’s maker, Pfizer, has known about Zoloft suicide risks since the 1980s. She has filed a drug lawsuit against Zoloft’s makers. Ms. Witczak claims her case has revealed documents to prove the company had early knowledge of these serious drug risks.
She believes the state needs to step in and protect consumers where the federal government has “dropped the ball.”
This is not the first time state lawmakers have proposed this type of bill. Maine passed a disclosure law in 2005, which requires drug companies to publish all clinical findings dating back to 2002. The Minnesota law seeks the disclosure of all clinical drug trial findings since 1990.
If the Minnesota bill is approved it would require that drug companies pay $1,000 to cover the system’s cost and report their research findings on a public website.
Clinical trial disclosure laws are a reasonable reaction to the series of recent events that have unfolded in the pharmaceutical industry. For example, numerous Vioxx lawsuits, filed since the recall of this drug in 2004, have charged Merck with intentionally concealing crucial clinical trial information from the public.
“People deserve to know how their products perform under tests, especially safety tests. Why would prescription drugs be any different?” asks an official with the Consumers Union, a group that reports the proposed legislation in Minnesota.
For more information on drug safety information, please contact us to confer with an attorney.
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