LANSING – In a move to protect consumers, State Representatives Bill McConico (D-Detroit, Highland Park, Hamtramck), George Cushingberry (D-Detroit), LaMar Lemmons Jr. (D-Detroit), LaMar Lemmons III (D-Detroit), Marsha Cheeks (D-Detroit) and Gabe Leland (D-Detroit), 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.
"Our residents put their trust in drug companies and the FDA that the prescription drugs they take are going to heal them, not harm them," McConico said. "We know that we can't count on the drug companies or the FDA to keep our residents safe from dangerous drugs, so we must act to protect them. Full disclosure will give consumers and their doctors the information they need to make important health decisions."
"Today we're sending a message to the pharmaceutical companies: Consumer protection must be held over the bottom line," Cushingberry said. "We can no longer afford to allow the drug industry to put our residents at risk. They must provide our health care providers and consumers with the information they need to make life-saving decisions."
The Democrats' plan would:
· Require drug companies to report all test results for all drugs sold in Michigan;
· Impose tough civil fines on companies that don't reveal test results or provide inaccurate results; and
· Establish 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.
Under the 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.
"We cannot rely on drug companies to police themselves," said Lemmons Jr. "We have to do what is necessary in the Legislature to make sure our consumers in Detroit and throughout the state are protected."
"Drug companies have to be more open with their test," said Lemmons III. "The more open they are, the better protection and the more information consumers will have."
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 BrownUniversity's Center for Clinical Trials and Evidence-Based Healthcare.[1]
"The FDA approved medications like Vioxx and Bextra and people died," Cheeks said. "If all test results for all medications, successful or not, were made public lives could have been saved. To not hold pharmaceutical companies accountable for withholding life-threatening information is the height of irresponsibility. Our citizens deserve better."
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 his 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 not drop this issue," Leland said. "We will continue to stand up to the big drug companies and pressure them to do what's right for Detroit and the entire state. Instead of putting big dollars into marketing and commercials, drug companies need to invest in consumer safety."
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.