Prescription Drugs—CALPIRG’s federal Healthcare Advocate Lindsey Johnson discusses prescription drug policies on CNN. Despite the recent VIOXX scandal, Johnson and other experts do not expect Congress to enact meaningful drug safety protections, leading CALPIRG to push for a state-level Prescription Drug Right-To-Know bill.

Legislature Delays Passage of Rx Bills

California patients and their doctors will have to wait at least a few more months before drug companies are required to disclose dangerous side effects such as those associated with VIOXX and Paxil.

The California Assembly failed to pass the CALPIRG-supported Prescription Drug Right-To-Know bill this session. The measure (AB 72), authored by Assemblymembers Dario Frommer (Los Angeles) and Wilma Chan (Oakland), would require drug companies to make public their clinical studies.

“The longer we wait, the more likely it is that we’ll face more tragic scandals like those surrounding VIOXX and Paxil,” said CALPIRG Legislative Director Steve Blackledge. Studies conducted by Merck & Co. linked the use of its drug VIOXX to an elevated risk of heart disease. Yet the company waited years before withdrawing the drug and only did so after an estimated 140,000 American patients were struck by heart disease because of the drug.

Studies have also linked the use of Paxil, an anti-depressant, with increased suicidal behavior in children and teens, and clinical trials by the drug’s manufacturer showed that it wasn’t effective at treating depression in those age groups.

Lobbyists for the pharmaceutical industry pressured the Assembly to defeat the bill, arguing that a voluntary program for reporting the results of clinical studies is already in place. Yet the editor-in-chief of the New England Journal of Medicine said the drug industry was “making a mockery” of its voluntary rules. Dr. Jeffrey M. Drazen told the Associated Press in May that drug companies were failing to provide meaningful information about their clinical trials, despite a pledge to do so.

Drug Ad Expenditures
An Assembly committee also defeated a CALPIRG- supported drug affordability bill (SB 163), authored by Sen. Jack Scott (Altadena). The bill would require drug companies to disclose how much they spend on marketing drugs to consumers.

“In any debate about prescription drug prices, the drug companies claim that high prices are going to support research and development,” said Emily Clayton, CALPIRG’s health care advocate. “We suspect that many firms are, in fact, spending more on marketing than research. Passage of this bill would help bring the facts to light.”

The defeat in committee also puts this measure on hold until 2006.

Drug Safety Reporting
Key legislation still advancing through the Legislature is an adverse reaction reporting bill (SB 380), authored by Sen. Elaine Alquist (Santa Clara). The measure requires doctors to report to the FDA’s MedWatch system their patients’ adverse reactions to prescription drugs. Currently such reporting is voluntary.

“This drug safety reporting bill will give the FDA accurate information about adverse reactions to drugs, which will help the agency address drug safety problems and enable doctors to make the right prescribing decisions,” said Clayton.

At the federal level, Lindsey Johnson, a healthcare advocate in CALPIRG’s Washington, D.C., office, continues to promote legislation by Sens. Grassley (Iowa) and Dodd (Conn.) to reform the FDA and require reporting of clinical studies. Those bills appear unlikely to move.