SAFER PRESCRIPTION DRUGS—CALPIRG’s Emily Clayton speaks at a press conference on the steps of the Capitol to urge legislators to support a package of prescription drug bills. She is surrounded by seniors and other Californians demanding safe, affordable medicine.

This past May, congressional hearings revealed that Merck & Co. continued to aggressively promote its blockbuster drug, VIOXX, despite the company’s own clinical trial showing that VIOXX increased the risk of heart attacks and strokes. Merck told its sales reps, who were meeting with doctors, to aggressively tout the drug’s effectiveness and avoid discussing health risks.

“Sadly, we can’t trust drug companies to tell us the whole truth about their products,” said Emily Clayton, CALPIRG’s health care associate. “Doctors and patients need complete and accurate information about the safety of a drug, but they’re not getting it from the drug companies.”

CALPIRG is working with Asm. Majority Leader Dario Frommer (Los Angeles) to pass the Prescription Drug Right to Know Act. The bill requires drug companies and other sponsors of clinical trials to register their studies and publish the results.

According to research by the Food and Drug Administration (FDA), in less than five full years on the market, VIOXX accounted for more than 140,000 cases of heart disease in the United States.

Unfortunately, the scandal doesn’t end with VIOXX. Two other painkillers, Celebrex and Bextra, are now also linked to similar cardiovascular problems.

Additionally, in December 2004, ABC News uncovered industry documents from GlaxoSmithKline showing that the company knew of the dangers of its antidepressant, Paxil. According to ABC, “internal studies by GlaxoSmithKline concluded that Paxil had little or no effect in treating depression in children and adolescents. And as far back as 1997, the company was aware of studies reporting suicide-related behaviors in young patients taking the drug.” Despite this, GlaxoSmithKline continued to promote Paxil.

“Too many Americans have lost their lives because drug companies withheld or suppressed studies showing that their products caused serious harm,” said Clayton. “In California, we decided that we couldn’t afford to wait to see if Congress or the FDA would take action; we had to do something immediately to solve this problem.”

CALPIRG Fighting On All Fronts
Besides working to pass the Prescription Drug Right-to-Know act, CALPIRG is supporting legislation by Sen. Elaine Alquist (Santa Clara) to require doctors to report to the FDA’s MedWatch system all suspected adverse reactions that patients have from taking prescription drugs.

“Studies estimate the FDA currently captures reports for only 10 percent of the adverse drug reactions in the United States,” said Clayton. “This bill will ensure that the FDA receives more information from California.”

CALPIRG is also taking the fight for better information to the courts.

In February, CALPIRG joined with the Prescription Access Litigation Project to file a suit against Pfizer for deceptive marketing practices in its promotion of Celebrex.

The lawsuit charges that Pfizer knew about Celebrex’s health risks, but intentionally underplayed them while over-hyping the need for the drug. As a result, Pfizer was able to drive up the price and the market for Celebrex.

“This suit challenges Pfizer’s disregard for scientific evidence about the safety and necessity of its product,” concluded Clayton.