LANSING – In a move to protect consumers, House Democrats today unveiled a plan that forces drug companies to make public all drug safety test results, including those that show negative and harmful side effects. Currently, drug companies are not required to disclose this important information that can save lives.
"Too often, the drug industry puts profits before people and secrecy ahead of safety," said House Democratic Leader Dianne Byrum (D-Onondaga). "If we're going to protect consumers, we need to shine a light on every drug and give our consumers and doctors the information they need to make life-and-death decisions."
The House Democratic plan:
- Requires drug companies to report all test results for all drugs sold in Michigan;
- Imposes tough civil fines on companies that don't reveal test results or provide inaccurate results; and
- Establishes a Web site that shows these test results, to be maintained by the Department of Community Health.
The plan comes as news reports and consumer groups show that drug companies have withheld or manipulated information on bestselling prescription drugs. Consumers Union said that in the case of Paxil, a full disclosure would have shown that the antidepressant was not only ineffective among youths, but also dangerous because it actually heightened the risk of suicides. Merck, the maker of painkiller Vioxx, hid safety risks in test results, the influential New England Journal of Medicine said in a Dec. 9, 2005, New York Times report. Vioxx is being blamed for tens of thousands of crippling and fatal strokes and heart attacks in otherwise healthy people.
"More openness means more information, and that can make the difference between life and death," Byrum said. "Full disclosure protects consumers and that's why we must act now."
Under the Democrats' plan, drug companies that fail to disclose all safety test results or that provide false results will be fined $250,000 per incident. The fines go up to $500,000 for a second offense and $1 million for a third and subsequent offenses.
The American Medical Association is calling for a national registry of all clinical trials. Successful drugs are three times more likely to be published than studies showing a drug's negative effects, according to Brown University's Center for Clinical Trials and Evidence-Based Healthcare.[1]
"Vioxx, Bextra and Rezulin – all FDA-approved drugs – show that we cannot count on the federal Food and Drug Administration to protect consumers from dangerous drugs," Byrum said. "More must be done, and our plan empowers consumers and gives them the information they need."
Bextra was pulled off the market in 2005 because of increased risk of strokes and heart attacks; Rezulin was yanked in 2000 after it was linked to more than 60 liver-poisoning deaths.
The Democrats' campaign is a continuation of their efforts to increase protections for consumers from dangerous drugs. It comes in the wake of a mailing blitz from the drug industry and its ally, the Michigan Chamber of Commerce, smearing Michigan legislators from both parties who want to repeal a Michigan law that exempts drug companies from consumer protection laws and gives them absolute immunity even when their products harm and kill people. The total immunity law – the nation's only such law – was signed in 1996 by then-Gov. John Engler.
"We will keep standing up to the big drug companies until they do the right thing for Michigan consumers," Byrum said. "Drug companies should devote their big bucks to making better, safer products, instead of putting out expensive hit pieces and slick television commercials."
Maine has passed a law requiring drug companies to disclose test results for drugs sold in that state. At least 15 other states are considering similar legislation.