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FLINT – In a move to protect consumers, State Representatives Brenda Clack (D-Flint), Paula Zelenko (D-Burton), John J. Gleason (D-Flushing) and Lee Gonzales (D-Flint Township) 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.

"Big drug companies should not be allowed to put profits before people," Clack said. "We need to make sure that they are open not only about the benefits of their products, but also about the damage they can cause. We must ensure that our residents have all the information they need to make informed decisions."

The House Democrats' 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, report in The New York Times. Vioxx is being blamed for tens of thousands of crippling and fatal strokes and heart attacks in otherwise healthy people.

"If we want to protect our residents, we must help them make informed decisions for themselves and their loved ones," Zelenko said. "Having access to all the information when it comes to something as important as your health gives our residents more control over important, life-and-death decisions. It's the right thing to do to keep our residents safe and healthy."

Under the Democrats' plan, drug companies that provide false results or fail to disclose all safety test 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. Studies for 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]

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 Food and Drug Administration approved Vioxx, Bextra and Rezulin – all of which turned out to have dangerous, life-threatening side effects," Gleason said. "That just goes to show that we can't always count on the FDA to keep our consumers safe. Giving them the ability to see all the facts for themselves is the best thing to help keep them safe."

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.

"My colleagues in the House and I will stand up to the big drug companies and do what's right for our residents," Gonzales said. "We refuse to be intimidated by smear tactics. I suggest the drug companies spend their money on creating safer products instead of targeting lawmakers who dare to stand up to them."

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.

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