Pharmaceutical

Vytorin illustrates the problems of direct-to-consumer advertising

Remember those Vytorin commercials with the split screen, comparing people to food? Aunt Barbara on the left and some tacos on the right? Mildly entertaining though they were, those ads underscore a big problem with the promotion of new pharmaceuticals. Evidence suggests that Vytorin’s manufacturers, Merck and Schering-Plough, promoted and sold the anti-cholesterol drug for nearly 2 years despite known clinical trial results that strongly suggested Vytorin to be no more effective than cheap, generic statin drugs.

Now Congress is investigating the promotion of Vytorin as lawsuits against its makers pile up in state and federal courts. But Vytorin isn’t the only heavily promoted new drug to cause problems, so some congressmen are planning to pull in the reins of direct-to-consumer (DTC) drug advertising.

Rep. Henry Waxman (D-Cal.) has renewed the call to give regulators the power to ban DTC advertising for new prescription drugs when their safety profiles aren’t fully known. The would-be legislation, which emerged in 2007 but ultimately failed to pass, is plowing ahead in the wake of some heavily promoted but beleaguered blockbuster drugs.

Like Vytorin, Chantix and Vioxx were more or less indicted after tests and reports brought unknown risks to light, and each made billions in profit before negative news rained on their parade.

Rep. Waxman, who becomes chairman of the House of Representatives Energy and Commerce Committee when the new Congress convenes in January, has expressed his interest in revisiting the drug ad issue.

“It is these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood,” Waxman said at a Prescription Project Conference.

Merck’s blockbuster anti-inflammatory drug Vioxx was taken by approximately 20 million people before its risk of cardiac events became known. Chantix was taken by millions of people as well before researchers understood the risks the drug posed for depression, suicide, and other serious side effects. And, of course, Vytorin, which millions of people took before one test exposed it as a dud and another as a possible caner risk.

To help ease the dangers posed by new medicines, Congress sought last year to give the FDA the authority to ban the television advertising of new prescription drugs for as long as three years if it was deemed necessary to protect the public. The ban would not be a blanket ban on all new prescription drugs, but would be enacted on a case by case basis.

Exaggerated benefits and minimized perception of side effects are two pitfalls of DTC advertising for the general public. Excessive prescribing is another, but that seems to be the whole point, at least from the drug manufacturers’ point of view. Television ads for new prescriptions aren’t made with the public’s good in mind. They’re made to maximize profit. Advertising for profit is the American way, but when it amounts to messing with the health of millions, clearly some restraint is needed.

According to a report by Reuters, drug makers claim that their ads are informative to the general public and that they have adopted voluntary guidelines that have them refrain from advertising for “an appropriate amount of time” so doctors can be informed of the new drugs first.

In the case of Merck’s diabetes drug Januvia, however, little time was wasted between the drug’s approval and Merck’s massive marketing efforts.

Another report by Reuters says that the “the product Web site was functional within 90 minutes of approval, and within eight days, Merck had reached 70 percent of target doctors and made first deliveries of [Januvia] to pharmacies. Within 14 days, discussions were completed with managed care organizations covering around 188 million patients or 73 percent of the insured U.S. population.”

The 2007 attempt failed after some lawmakers objected it would violate constitutional protections of free speech. Instead, Congress gave the FDA authority to fine companies for running false or misleading promotions.

Whatever restraint is exercised, no time is wasted in infiltrating the market.

The 2007 attempt to reign in advertising for new drugs failed after some lawmakers objected it would violate constitutionally protected free speech. Congress instead granted the FDA authority to fine drug companies for false or misleading advertising.