Commentary—

Congress Grants Impunity To Drug Ads

By Mark Cohen

Congress recently missed an opportunity to make meaningful changes in the way drugmakers peddle their often dangerous products. Wooed or intimidated by pharmaceutical corporations’ lobbying might, the Senate and House passed an FDA reauthorization bill that caters to the marketing interests of drug manufacturers and broadcasters, virtually ignoring public safety. Fortunately, not all courts are as willing as Congress to turn a blind eye to the distorting impact of direct-to-consumer (DTC) advertising.

The issue facing state Supreme Court Justices this summer in West Virginia v Johnson & Johnson was whether drug manufacturers are subject to the same duty as other manufacturers to warn consumers about their product risks. The traditional view was that they were not! Courts reasoned that prescription drugs are unique because they are taken at the direction of a learned intermediary, a licensed physician. The manufacturer need only inform physicians of risks; drugmakers have no legal obligation to warn the patient whatsoever!

But as the West Virginia Supreme Court concluded — and New Jersey’s highest court before it — this doctrine is an anachronism, borne of a completely different epoch in American medicine. In a 1948 wrongful death suit, the trial court noted that the manufacturer never advertised or made any representations about the product to the patient. How then could it be liable? The drug’s use was solely the choice of a doctor — “the learned intermediary.”

The doctrine made some sense until 1981. That’s when the first DTC ad appeared for a prescription drug. Then in 1997, under pressure from drugmakers and advertising-hungry commercial broadcasters, the FDA issued a guidance throwing open the floodgates on DTC ads. How much has changed since? DTC drug ad revenues mushroomed from $12 million a decade ago to $41 billion in 2005, a 342-fold increase. Just turn on the evening news: It’s all drug ads all the time.

Business Week reports that the country is on a “Lifestyle Drug Binge!” Difficulty sleeping? Drop an Ambien. If that leaves you nodding off during the day, pop a Provigil. Try the “purple pill” for heartburn,the “blue pill” for erectile dysfunction. Today, drugmakers spend more money on DTC than they do marketing to physicians! Doctors report increasing numbers of patients requesting particular brand-name prescription products. And physicians fear that if they don’t give the patients what they want, a competitor will.

In today’s bottom-line world of managed care, patients are far more likely to be herded through office visits and seen by virtual strangers than be attended in their home by kindly, lifelong family confidants. An FDA survey found that only one out of three patients was informed of dangerous drug side effects by their doctor.

Before entering the market, drugs have been tested on only a small number of people in clinical trials. In passing FDA reform legislation, Congress recognized that the FDA needs clear authority to act against drugs found to be unsafe only when they enter the market and are used by tens of thousands of people! But by turning a blind eye to the blockbuster impact of DTC advertising, Congress is inviting drugmakers to treat the American public as guinea pigs.

Common sense tells us that freeing drugmakers to promote unproven drugs as a license to harm, even kill. What happens when millions of people start taking the drug? Remember Phen-fen and Vioxx?

Reformers asked Congress to enact a three-year bar on ads for new prescription drugs, limiting the numbers of people put at risk. Unfortunately, Congress sided with lobbyists, taking cover behind the drugmaker’s claimed free speech rights to justify their inaction. Would lawmakers have us believe that Thomas Jefferson’s First Amendment passion was to ensure the unfettered right to market hair growth products?

Ultimately, sensible constraints on drug advertising may await other states following the lead of West Virginia and New Jersey. As more courts and states consider the reality of contemporary medicine and DTC advertising, the “learned intermediary doctrine” should be discarded as a vestige of a by-gone era. When it is, drugmakers will be legally and financially accountable for fully informing patients about the risks of their products. And that may do even more for the cause of drug safety than a three-year moratorium on new DTC ads.

(Mark Cohen is executive director of the Government Accountability Project, the nation’s leading whistleblower protection and advocacy organization, www.gap.org. )