Promises, promises

For now at least, Vytorin, the controversial cholesterol-lowering drug under investigation by Congress and state attorneys general, will remain on the market. But its TV ads will not.

In mid-January, Schering-Plough Corp. and Merck & Co., which jointly market the drug, pulled the ads portraying family members dressed like food items to show genetic causes and food sources of high cholesterol. The ads were yanked after members of Congress questioned whether the two companies deliberately delayed releasing clinical trial results for the drug -- results that showed it was no more effective than a generic at reducing the buildup of plaque in the carotid artery. They also questioned whether the ad overstated benefits of the drug, a combination of Zetia and simvastatin (a generic of the statin Zocor).

Those questioning the ads -- John Dingell (D-Mich.), chairman of the powerful House Committee on Energy and Commerce, and Bart Stupak (D-Mich.), chairman of the Subcommittee on Oversight and Investigations -- are also investigating Lipitor advertisements that feature Robert Jarvik, who invented an artificial heart years ago.

“We are concerned that consumers might be misled by Pfizer’s TV ads for Lipitor starring Dr. Jarvik,” said Dingell. “In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine.” The congressmen have asked for all records related to the campaign, including the financial arrangements between Jarvik and Pfizer.

Criticism of the Vytorin and Lipitor ads has renewed the debate over the effect of TV drug advertising, even as efforts to rein in the ads have faltered. Last month, an initiative that might have increased FDA oversight over direct-to-consumer television ads for prescription drugs was quashed.

Drug companies are not required to have their TV ads approved before airing, but the companies are subject to warning letters and monetary penalties if the FDA finds that ads are misleading or false, says Areta Kupchyk, a partner at Reed Smith law firm in Washington, D.C., and a former associate chief counsel at the FDA. However, only about 35% of drug ads that make it on air are viewed by FDA staff, says Rita Chapelle, an agency spokeswoman.

The now-canceled oversight plan would have paid for increased FDA staff through fees from drug companies; they would have been charged about $40,000 for each ad reviewed. Although more than 30 firms signed up for the program, funding difficulties eventually scuttled it. That was a disappointment to experts who worry that too many drug ads now go unchecked. “Very few advertisers are really doing well enough when it comes to actually trying to educate the consumer,” says Wendy Macias, associate professor in the Grady College of Journalism and Mass Communication at the University of Georgia, who published a recent study on TV drug ads. “The ads,” says Macias, “are presented in such a way that the consumer would have to be paying very close attention and be adept at processing the information to really understand the risks as well as the benefits.”

Stepping into the breach, to a degree, is AdWatch, new on the Consumer Reports’ Health Blog. It will regularly raise questions about information included -- and left out -- of nationally televised prescription drug ads. First up: Requip, a drug to treat restless-legs syndrome, a rare disorder that can cause tingling or restlessness in the legs just before sleep. Trouble is, simply lying in bed waiting for sleep can also cause tingling and restlessness, but some consumers have begged their physicians for the drug even though they have no evidence of the syndrome. “That’s concerning,” says Steve Findlay, a health policy analyst in the Washington, D.C., office of Consumers Union. In some users, Requip can cause serious side effects, such as drowsiness, compulsive gambling and sexual behaviors.

The content and tone of television drug ads are of particular concern now, says Findlay, “because drug companies may ratchet up the claims for existing and upcoming drugs, as once-blockbuster medicines begin to lose their patents and their sales numbers.”

This year, for example, patents will expire for Merck’s osteoporosis drug Fosamax ($2 billion in sales) and Johnson & Johnson’s schizophrenia drug Risperdal ($2.5 billion in sales). With billions in sales at stake, Findlay says, companies may be increasingly desperate to sell consumers on their brand-name drugs. Already, drug companies spend about $4.5 billion for direct-to-consumer advertising each year, with the biggest share going to television ads, according to a recent Government Accountability Office report.

Glossing over side effects is a common problem in drug advertising, Findlay says.

Although the FDA requires that ads show “fair balance,” that it discuss the risks as well as the benefits of drugs, advertising professors at three universities published a study in the Journal of Health Communication in late 2007 that found that the balance of risk versus benefit is far from fair. The study found that the average 60-second commercial devoted less than 8 seconds to side effects; the average 30-second commercial had less than 4.4 seconds devoted to side effect information. (The study reviewed ads that aired in 2003, but the University of Georgia’s Macias, the lead author, says anecdotal reviews of currently running ads show a similar lack of balance.)

Dr. Peter Lurie, deputy director of Washington, D.C.-based Public Citizen’s Health Research Group says that, despite the concern over the ads for Lipitor and Vytorin, an election year is unlikely to be the time Congress makes changes to FDA oversight of prescription drug ads. At least for now, you’re on your own when it comes to believing and acting on the medication ads you see on TV.

“The patient needs to ask their doctor how many patients need to be treated in order for one patient to experience the benefit,” says Dr. William Shrank, a pharmacoepidemiologist at Harvard Medical School.

“For many drugs,” says Shrank, “the likelihood of benefit for a particular patient is low. The patient needs to clearly understand the potential harms of the medication, which are often de-emphasized in the commercials, and the frequency of those harms. And patients should ask their doctors about the cost of the medication and whether a less expensive medication is available that is just as effective. Armed with this information, the patient will have enough information to make a good decision,” Shrank says.

--

health@latimes.com