In the wake of major safety concerns over prescription drugs Vioxx and Paxil, I am asking you to immediately support needed measures to ensure prescription drugs are safe and effective, particularly a mandatory clinical drug trial registry, and put an end to misleading drug advertisements and marketing by the pharmaceutical industry.
Now that Vioxx has been pulled from the market nearly four years after concerns about its potential link to heart attack risk were initially raised, I am concerned the government has too cozy of a relationship with the industry it is supposed to regulate.
Studies conducted on Vioxx by drug maker Merck may have shown the potential risk as early as 2000, but the Food and Drug Administration didn't act on this or subsequent drug studies. What's more disconcerting, these clinical drug trial studies are not required to be made public, nor do drug companies have to register with the government when they start a drug study.
That is why I urge you to support the "Fair Access to Clinical Trials Act," (HR 2923, S 5252) to require all clinical drug trials be made available to the public. This bill would ensure that any potential safety risks would be made known to physicians, researchers and consumers, and shine light on the FDA safety approval process to prevent future Vioxx incidents.
In addition, I urge you to support:
-An independent Office of Drug Safety within the FDA to prevent pressure from the pharmaceutical industry to approve drugs that may have potential risks.
-Require the FDA to quickly halt misleading drug advertisements and marketing, and limit drug ads to focus only on the patient population the drug was intended to help.
-Halt marketing campaigns for drugs in which questions exist about unreasonable safety risks.
I appreciate your support of these measures, and look forward to Congress taking the necessary steps to ensure the safety of myself and my family.