Direct-to-consumer advertising misleads patients, upsets doctors

 You can't flip through a magazine or change the channel these days without noticing the dozens of advertisements highlighting the newest prescription drug for depression or a blockbuster pill that treats both good and bad cholesterol.

This form of advertising, used widely by both big-name and small pharmaceutical companies, is called direct-to-consumer advertising, or DTCA, and it's ruffling some feathers among doctors.

Dr. Wendy Rubinstein, medical director for the Center for Medical Genetics at Evanston Northwestern Healthcare, said there needs to be more regulation of the advertisements.

"There isn't much if any regulation surrounding that [the content of the advertisements]," said Rubinstein. "And then probably the larger question is if that's the best way to convey information or whether you really want to be getting it from your physician or somebody knowledgeable about the issue."

Another Northwestern Memorial physician, Rachel Oosterbaan, complained, "The problem is they end up with the wrong diagnosis. They'll listen to symptoms on TV, and they'll misdiagnose themselves. So not only are they choosing their diagnosis, but also they're choosing the medication."

Interviewed on the street in Chicago, David Derks said, "I'm a little overwhelmed actually. . .  It's kind of ridiculous as far as all of the different drugs that are really being pushed hard from the pharmaceutical companies.  Sometimes I almost get a little angry about it."

But despite such misgivings and criticisms, spending on direct-to-consumer advertising continues to increase at an even faster pace than the 5 percent growth rate of spending on drug research and development, a fact that isn't sitting well with some physicians in Chicago.

According to IMS Health Inc., spending on direct-to-consumer advertising in 2006 increased nearly 14 percent, 9 percent faster than the year before, from $4.2 billion in 2005 to $4.8 billion, the latest data available.

Pharmaceutical companies invested an estimated $58.8 billion in 2007 on the research and development of new medicines compared with $56.1 billion in 2006, according to the Pharmaceutical Research and Manufacturers of America.

"At a time when disease prevention is viewed as a top priority for policymakers at both the federal and state level, it is critical that we have an honest and open dialogue about the health benefits of DTC advertising," said Senior Vice President Ken Johnson of PhRMA in a press release in reaction to a recent Congressional hearing held to discuss the potentially misleading tactics used in the advertisements.

"It is clear that PhRMA member companies are dedicated to fighting disease and helping patients live longer, healthier lives," added Johnson, noting the recent spending figures.

At the hearing on May 8 in Washington D.C., representatives of the American Medical Association, big-name pharmaceutical companies, and the Government Accountability Office, to name a few, testified before the House Committee on Energy and Commerce subcommittee on oversight and investigations.

Specifically, the ads the hearing focused on were three television advertisements: ads for Lipitor, "Food and Family" ads for Vytorin, and "cancer fatigue" or "quality of life" ads for Procrit.

"I believe that Congress needs to decide whether the U.S. should continue to be one of two countries in the world that allow DTC ads, and if we continue to allow such advertising, whether any further limits to DTC ads should be required," said Rep. Bart Stupak (D-Mich.)

Marcia Crosse, director of health care at the U. S. Government Accountability Office, noted that new drugs ads must be submitted to the FDA for review, but "GAO found that FDA reviewed a small portion of the DTC materials it received, and the agency could not ensure that it was identifying for review the materials it considered to be highest priority."

FDA regulations require simply that drug companies submit DTC ads for review when they are first distributed to the public, but no preclearance is required. If the FDA objects to the ads, it may send a regulatory letter that asks companies to "take specific actions" such as stopping the distribution of the advertisements. If the FDA finds the violation to be more serious, then it can ask the drug company to run "another advertisement to correct misleading impressions left by the violative advertisement." Supak noted that if a company doesn't agree to do what the FDA asks, then the agency "cannot impose fines except through an administrative hearing."

The GAO said that from 2002 to 2005 the number of final DTC materials the FDA received had nearly doubled. Since 2006 the growth has continued.

But, according to Crosse, the FDA issued only four letters citing violative DTC materials in 2006, and a mere two in 2007, a result the FDA blames on a 2002 policy that required internal legal review of all draft regulatory letters. In 2006 and 2007, it took the FDA an average of more than five months to issue letters compared with an average of two weeks before the policy was enacted.

"We believe that delays in issuing regulatory letters limit FDA's effectiveness in overseeing DTC advertising and in reducing consumers' exposure to false and misleading advertising," said Crosse.

Dr. Nancy Nielsen, president-elect of the American Medical Association, added, "The AMA does not believe that the Food and Drug Administration has adequate resources to carry out its enforcement role of DTCA since the staffing has not kept pace with the proliferation of DTCA, nor has Congress provided sufficient funding to support quality, independent research on the impact of DTCA."

Nielsen said the AMA is calling on the FDA to subject all  prescription drugs that have just been approved to a DTCA "moratorium" until doctors have been "appropriately educated" about the drug.

"Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug's benefits than risks," added Nielsen in a press release. "Imbalances in these ads can diminish patient understanding of certain drug risks, and increase the need for ongoing dialogue between patients and physicians about the benefits and risks of prescription drugs."

But Johnson asserted that direct-to-consumer advertising increases communication between doctors and patients. In fact, a 2004 survey taken by the Food and Drug Administration, which polled over 500 physicians, showed that 53 percent of physicians said the number one benefit from the ads was the "better discussions" they had with patients regarding their health.

"Raising awareness of treatment options through DTC advertising not only informs patients potentially suffering from the disease, it also benefits the entire healthcare system in the U.S. by encouraging patients to seek medical attention that may help them manage their conditions and avoid unneeded hospital stays or surgeries," said Johnson.

In fact, not all physicians are up in arms.

Dr. Sean O'Connor, an internal medicine physician at Northwestern Memorial Hospital, said he thinks the regulation is "getting better."

"If you look at the content of the ads now, they're much more informative about conditions as opposed to saying 'We've got a better pill'," said O'Connor. "You can't just push them away. That's never going to happen."

O'Connor did add, however, that although the advertisements have potentially increased communication, he wasn't sure if it was "good communication."

Dr. Oosterbaan commented, "So what happens is they come into the office, and they'll say: 'I need a certain drug.' And a lot of times we'll spend more time either negating the diagnosis that they've made just by the commercial, in addition to explaining why that certain medication is not appropriate for the following reasons."

PhRMA responds by noting a 2004 FDA report that showed 88 percent of patients, when asking their physician after seeing an advertisement, had the condition that drug treats.

Oosterbaan doesn't discount the fact that sometimes the patients do have the condition, but she added that more often than not, advertisements create unnecessary anxiety.