"The people of Lenawee County and throughout Michigan need to have the knowledge to make smart decisions about the prescription drugs they take," Spade said. "Consumers deserve the opportunity to protect themselves and, with their health care providers, make informed choices about their medications."
- 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 some drug companies have withheld or manipulated information on their 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.
"The more open drug companies are, the more information consumers and doctors can receive and that can make the difference between life and death," Spade said. "We must act now because we have to protect consumers."
Under the plan, drug companies that fail to disclose all safety test results or provide false results will be fined $250,000 per incident. The fines go up to $500,000 for the second offense and $1 million for the 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 and Rezulin are both FDA-approved drugs and it shows that consumers cannot always count on the federal Food and Drug Administration to protect consumers from dangerous drugs," Spade said. "We have to do more at the state level to empower consumers and give them the information they need to protect themselves."
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. Deaths that Representative Spade believes might have been prevented.
"Michigan consumers are smart and informed people," Spade said. "Michigan has some of the most consumer friendly laws in this country, except when it comes to prescription drugs. Our economy is based on the assumption that consumers are in the best position to make smart choices for themselves. Let us help the system work more effectively by giving our citizens the knowledge they need to choose wisely."
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.
[1] The Philadelphia Inquirer, "A Prescription for Full Disclosure," 8/15/2004. www.philly.com.