Congress needs to strengthen drug-safety laws

I testified today before the House Subcommittee on Health in support of the most significant prescription-drug safety legislation in 45 years. I wasn't alone on my trip to Washington. Consumers Union took some 50 e-activists from around the country to join our lobbying efforts on a wide range of issues, including health care and, specifically, prescription-drug safety.

Amid the cacophony of political and industry voices, the clarity of consumers' personal stories was compelling. One such story was highlighted in an ad we ran in today's issue of USA Today.

At Consumers Union, we've focused for years on three particular problems in the prescription-drug marketplace. One is direct-to-consumer advertising, because it's likely to be a consumer's introduction to a new drug. Since the news is coming straight from the manufacturer, you know it will sound good. But drug ads drive up the cost of health care, overstate the value of prescription drugs, and underplay the dangers of new drugs that have not been proved safe over time.

Case in point: Vioxx. In 2004, about five years and more than $500 million advertising dollars after it hit the market, Vioxx, a prescription arthritis-pain medication, was pulled after being linked to an estimated 139,000 heart attacks, strokes, and other serious complications. That might have surprised the public, but it was no surprise to the drug's manufacturer, Merck, or to the federal Food and Drug Administration; they'd known of the safety risks since 2000, when the first study raised concerns.

Heavy advertising creates heavy demand, which is problem two. To counter the barrage of ads, consumers should have access to unbiased information about a drug's real risks and benefits. Unfortunately, current law doesn't require drugmakers to publicly disclose the results of their clinical studies. Patients and doctors should have access to all of the studies and results, so that they aren't left to get their information from 30-second sound bites.

Problem three: Even when there's an obvious need to amend a medication's warning label, the FDA doesn't always have the authority to require those changes. All too often, revisions happen only after, as one Consumers Union advocate put it, "negotiation, jawboning, and shaming the drugmakers into acting responsibly." Nor does the FDA have the authority, in most cases, to require the companies to conduct follow-up studies when questions are raised about the safety of a drug already on the market.

You, our readers, have reinforced for us the critical nature of health-care issues. Among the more than one-half million e-activists working with Consumers Union on a wide range of projects to improve the marketplace for all consumers, thousands are focused on health care through our Prescription for Change, CR Best Buy Drugs, and Stop Hospital Infections campaigns.

But your work and ours can go only so far. It's Congress's job to pass strong prescription-drug legislation. The bill before the House today expands on a bill passed in the Senate, and much of it makes solid measures even better. The House proposal limits direct-to-consumer ads for drugs with severe and unusual safety issues. It ensures that drugmakers register and report on all clinical drug trials--whether the results are good or bad--to make them publicly accessible. And it gives the FDA the authority to impose tough fines on drug companies that fail to comply with safety measures. The bill also limits conflicts of interest allowed for FDA panel members, though not severely enough, in our opinion. We believe that any conflict of interest can influence the decisions made by an advisory panel and, in turn, promote drugs that have not been given unbiased scrutiny.

If the bill becomes law, it will be a major victory for the Consumers Union e-activists and advocates who have worked for prescription-drug reform over many years and, ultimately, for all patients across the country.