Putting patient safety first & fixing our drug safety system
Trust in our drug safety system has eroded. A March 2007 Consumer Reports national poll found that more than 60 percent of Americans agree that the Food and Drug Administration, and Congress, have failed to adequately protect them from harmful prescription drugs.
- Drug maker Eli Lilly played down the side effects of its antipsychotic drug Zyprexa for nearly a decade. Lilly failed to reveal data to doctors and the public that showed Zyprexa could significantly increase the risk of hyperglycemia and diabetes. Internal documents show that Lilly also told its sales representatives to promote the drug to doctors for unapproved uses so that it could be prescribed to far more people.
- Merck, the manufacturer of Vioxx, continued to heavily market its painkiller years after the company accumulated substantial evidence the drug significantly increased the risk of serious heart problems. FDA researchers estimate that Vioxx may have caused as many as 139,000 heart attacks and strokes.
- As far back as 1997, GlaxoSmithKline learned that adolescent use of its antidepressant, Paxil could increase the risk of suicidal behavior. Rather than revealing those tests to doctors and the public, the company continued to promote the drug for children and teens. ABC news broke the story to the rest of us in December 2004.
The FDA approves new drugs quickly, but then can’t effectively monitor safety once millions begin to take the drugs. We all become guinea pigs in a large scale test, made even bigger when companies spend millions on TV ads to turn a treatment that might be effective for only a few into a blockbuster. Although doctors and researchers report side effects to the company and the FDA, drug companies resist adding additional warnings to the label or publishing analytical studies for doctors and the public. We don’t get to know what they know until long after they know it.
Currently, drug makers are not required to make their clinical trial results public – results which show a drug’s effectiveness as well as harmful side effects. We believe that the findings from clinical trials, many of which include human volunteers, should be made public so doctors, researchers and patients have access to the information they need to make better health choices.
Most Americans agree — 92 percent of those polled agree that pharmaceutical companies should make public the results of all their clinical trial studies, which reveal a drug’s effectiveness and possible harmful side effects.
84 percent of Americans agree that the government should “have the authority to take any action necessary” to ensure drug safety.
Legislation: Consumers Union supports legislation that would work to ensure the FDA can adequately protect the public on drug safety issues and return the agency to the gold standard of prescription drug safety. S. 1082, (Kennedy/Enzi) recently passed by the Senate, and HR 1561 (Waxman/Markey) introduced in the House, are needed to reform our broken drug safety system.
These bills would help:
- Ensure that clinical trial registration and publication of results applies to all Phase II, III and IV trials, and require publication of most results within a set period of time, ideally no more than a year after completion of a trial, to avoid foot-dragging by industry.
- Improve the monitoring of drugs already on the market for harmful side effects, and allow the FDA to take safety actions on those drugs. Most drugs are tested on only a small group of people for short amounts of time; once they are on the market and used by millions, side effects often emerge. These bills would improve the FDA’s ability to monitor those side effects, and require label changes, further safety studies or safety limits on distribution to address the safety problems that may emerge. The FDA currently does not have that power.
- Dedicate more resources for the FDA so the agency can do its job. Increased resources will help ensure all drug advertising is reviewed, reports of safety problems analyzed, follow-up safety studies are conducted and FDA’s ancient computer system modernized.
- Improve openness and public participation in the negotiations between the drug companies and the FDA on safety disputes, and the development of risk evaluation and management strategies. It is important that safety disputes not be conducted behind closed doors, and that the public quickly be made aware of serious safety risks when they arise.
Congress must act now to give the FDA the authority it needs to require drug companies to conduct follow-up safety studies on drugs, make changes to a drug’s label where safety problems arise, and publicly disclose ALL drug side effect information.
Congress has an opportunity now to transform our drug safety system and pass strong reforms that will work to prevent Vioxx-type disasters from happening again.