Truth in Advertising
Truth in Advertising | Autry Parker, Lyrica, Pfizer, direct-to-consumer, advertising, Food and Drug Administration, Vytorin, MedWatch, PhRMA, Earle Weeks, WebMD, James Ensor, National Consumers League

Doctors Help Patients Separate Fact from Fiction on Drug Ads

As a specialist in pain management, Autry Parker, MD, sees many patients who are seeking relief from fibromyalgia. Managing pain that creeps into the body's muscles and joints can be difficult, so patients often arrive at his office anxious to learn more about Lyrica, a drug advertised as a strong pain reliever. Lyrica, produced by Pfizer, has had an aggressive direct-to-consumer advertising campaign, aimed specifically at people experiencing pain from fibromyalgia. So Parker must often speak with his patients to give them a more comprehensive picture of both the benefits and risks of such advertised drugs.

"The patient doesn't always have the ability to prioritize the information they get. So you've got to go through the information with them and tell them why this is or isn't good for them," said Parker.

Truth in Advertising

The drug industry spends several billion dollars annually on direct-to-consumer (DTC) advertising in an effort to motivate consumers to ask for specific drugs by name. For the past 15 years, the Food and Drug Administration (FDA), along with Congress, has wrestled with how to regulate drug advertising to ensure that the public receives fair and balanced information. Some Washington lawmakers have weighed imposing new restrictions on pharmaceutical companies to "protect American consumers from manipulative commercials," said Representative Bart Stupak. The Michigan Congressman voiced his concerns during House Energy and Commerce Committee hearings last May on Pfizer's drug, Vytorin. The television ad for the cholesterol pill was criticized by lawmakers for being manipulative and deceptive.

In response to Congress, the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade organization for the drug industry, released new voluntary restrictions in December that address DTC advertising. The guidelines state that drug ads will stop using actors or physicians without saying so, will stop promoting uses for a drug which haven't yet been approved by the FDA, and will include the FDA's new MedWatch number for reporting adverse reactions to a drug. A moratorium on releasing ads during the first six months after a drug has come to market is also suggested. These recent guidelines updated principles PhRMA first released in 2005.

"Through these strengthened principles, we renew our commitment to work with the FDA and healthcare professionals to further enhance the value of balanced DTC education for consumers and patients," said PhRMA President and CEO Billy Tauzin.

Knowledge is power

Patients can gain new information from advertisements or information on the web, but most need their doctor to help make sense of whether a drug is right for them. A 2004 FDA survey asked office-based physicians the role DTC ads had in influencing the physicians' practice and relationships with patients. According to the survey, 41 percent said the ads helped the doctor-patient relationship, 59 percent said it didn't, though 73 percent said the patient in the encounter had thoughtful questions due to DTC exposure.

"Rarely does anyone tell me something I don't already know and I usually have more up-to-date information than they have," noted Earle Weeks, MD, an oncologist with the Family Cancer Center. "I don't get as many patients coming with specific drug requests. And usually the requests are valid. There are many ways to treat pain and anxiety. If they've pulled up something that's valid and won't cause harm, I'll let them try it."

That sentiment is echoed by many physicians. To help his patients discern fact from fiction, Weeks directs them to medical Web sites that provide accurate information, like WebMD or mdanderson.com. He said the majority of pharmaceutical Web sites are also reliable.

"Advertising arms patients with more information," said practice manager Dan Hein of the Memphis Orthopaedic Group. "Whether that information is relevant or not is another story."

Physicians say relevance is the key since each patient presents his or her own unique set of healthcare issues. James Ensor, MD, considers much of drug advertising a waste of money. "They're asking people to use something they may or may not need," said Ensor, who practices at Memphis Internal Medicine. But he acknowledged that DTC advertising can prompt more discussion with patients or bring new information to the fore.

"Sometimes people bring stuff to me that I didn't know," Ensor said, describing a patient who recently told him about a new treatment for hepatitis C with no reported side-effects. "I hadn't heard of that, so I'll log on and read more about it."

The National Consumers League (NCL), a Washington, DC-based consumer advocacy group, states that while advertisements can motivate patients to speak with doctors about a new drug, their concern is ensuring that consumers receive balanced information. "(Advertisers) are very effective at drawing you in, but drugs aren't like other products that the public buys. They're powerful and can have a risk on the individual's health," said Rebecca Burkholder, NCL's vice president for health policy,

Studies done by the FDA indicate that consumers neither read nor understand the information currently printed in drug ads. Burkholder said it would be better if such language was made more consumer-friendly. Ensor agrees, adding that the risk of potential side-effects can be unnecessarily exhaustive.

Burkholder points to the recent changes to over-the-counter drug labels, where information regarding benefits and risks has been condensed to bulleted facts. She believes a similar move for prescription drugs would make information much easier for consumers to understand.

Another issue, according to Burkholder, is the screening of drug advertisements by the FDA. It's currently done on a voluntary basis, something the NCL would like to see changed. "We think the FDA should screen all DTC ads before they go on air or in print. Now it happens after the fact. Once a mistake is on-air, how do you correct it?"

Whether lawmakers will be satisfied with PhRMA's latest guidelines — and whether drug companies follow them — remains to be seen. In the meantime, doctors will continue to provide their patients the guidance they always have. And given the current healthcare climate, the choice of drugs that doctors prescribe for patients might come down to something much simpler: what the insurance companies will pay for.