Commercial interruptions: The hidden costs of drug ads

Are they educational, infuriating or intrusive? Physicians find that direct-to-consumer ads for pharmaceutical products can be all three.

By Susan J. Landers — Posted April 2, 2007

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What do evanescent moths, wisecracking beavers and Abraham Lincoln have in common? The answer would be apparent to those who watch television or read magazines, because all are featured in commercials for pharmaceuticals, in this case sleep medications.

Ads aimed at consumers have been with us for nearly a decade now, and signals indicate that patients and physicians are becoming more savvy about using this powerful tool.

Richard Kravitz, MD, MSPH, professor of internal medicine at the University of California, Davis, has noticed a drop in the number of direct patient requests for advertised medications. "I think consumers are developing a healthier skepticism, and the requests tend to be framed more as, 'I saw this ad for product X, what do you think about it?' "

Physicians also may be becoming less annoyed by the whole phenomenon. "They are starting to learn how to handle it." Dr. Kravitz has researched these ads' effects on physicians' prescribing decisions.

Pharmaceutical companies continue to favor the ads, having spent an estimated $4.5 billion on them last year. "DTC advertising empowers patients, increasing awareness of diseases and available treatments," said Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, a Washington, D.C.-based trade group representing large pharmaceutical research and biotechnology firms.

One thing is certain: Patients are seeing more ads. A report last fall by the Government Accountability Office found that spending on these DTC ads increased twice as fast from 1997 -- when the practice began -- through 2005 as did spending on promotions to physicians or on research and development.

This could all change. Congress plans to examine DTC advertising this spring while crafting new drug safety legislation. Among the proposals that will be considered are user fees to cover the cost of reviewing advertisements and a required two-year moratorium on the marketing to consumers of a new product.

Plus, recent findings that the ads may not be packing the punch that manufacturers intend could hasten changes. PricewaterhouseCoopers' Health Research Institute and Life Sciences Industry Group found that only 10% of the consumers, physicians, researchers and other stakeholders queried last year thought DTC ads provided complete and useful information. In contrast, 40% of industry executives viewed the ads as useful.

The surveyors also found that nearly 94% of consumers, physicians and other interested parties agreed that drug companies spend too much money on drug promotion overall and, surprisingly, nearly three-quarters of industry executives agreed.

The study signals that "the kind of glitzy Madison Avenue imagery and the poor choices made in the past for drugs promoted in DTC advertising is a flavor that the public hasn't gotten out of its mouth," said study author Peter Claude, partner in the firm's Life Sciences Advisory Services Group.

Included among the heavily advertised drugs that produced this nasty taste was the COX-2 inhibitor Vioxx (rofecoxib), which was removed from the market in 2004 after serious side effects were detected.

On the one hand

Physicians are of two or even three minds about the ads. Some find them educational; others are outraged by their content; and still others consider them an unwelcome intrusion into an already-too-short patient visit.

They do open the door for communication about sensitive issues, said Frank Domino, MD, associate professor of family medicine at the University of Massachusetts Medical School. Dr. Domino urges physicians to sharpen their dialogue skills. "The advertisers have learned to communicate effectively with our patients. We need to learn how to communicate with them equally well if not better."

Based on his research, UC-Davis' Dr. Kravitz has honed his message to patients. "What I try to make really clear is that there is always a weighing of benefits and risks in prescribing drug therapy."

Some physicians desire strong and enforceable standards to govern ad content. Drug ads currently don't have to be reviewed before they are aired. The only requirement is that after a first airing or appearance in a magazine, a copy must be submitted to the Food and Drug Administration. But it could be a year before the agency gets around to looking at it, said Frank Palumbo, PhD, professor and executive director of the University of Maryland School of Pharmacy Center on Drugs and Public Policy.

Kurt Stange, MD, PhD, professor of family medicine at Case Western Reserve University in Cleveland, found a Novartis ad for Zelnorm (tegaserod maleate), a medication for irritable bowel syndrome, particularly offensive. The ad encourages patients to ask for the drug even after a physician recommends that they try other steps first, such as changes in diet, he said.

The ad "is actually encouraging patients to think that the doctor is being dismissive of their concerns," said Dr. Stange, who also edits the Annals of Family Medicine.

That's not the case, said Sherry Pudloski, Novartis Pharmaceuticals Corp. executive director for communications. "Our Zelnorm campaign is designed to support the dialogue between patients and physicians."

Although the ads do inspire dialogue, physicians charge that this can waste time during brief office visits.

Data show that three to four issues are addressed in the average 10-minute visit to a family physician, Dr. Stange said. "So you add one more problem. If that problem is one that should be a high priority, that's one thing. But if it's an issue that is a priority to someone who is trying to sell something, then it's really a distraction -- a competing demand."

An ad blackout

Views are mixed on whether a moratorium on ads for new drugs would help. Dr. Kravitz favors such a move provided it is combined with aggressive postmarketing surveillance by the FDA to detect adverse events as soon as possible.

"If they pass muster, they could go forward with whatever advertising campaign a drug manufacturer wishes, provided they maintain a legitimate balancing of risk and benefit," Dr. Kravitz said.

Dr. Domino can see a downside to a moratorium. "I'm happy we don't have tobacco and alcohol ads on television, but what if you came out with a new car but couldn't advertise it for two years?"

Dr. Palumbo believes it's a little late in the game for a moratorium on ads and noted there would be many issues to sort out. What if a new statin comes out? "Would it have to be subject to the same moratorium as a new drug?"

All recognize that the ads can wield great power over the public psyche. "Frankly, prescription drug advertising is probably the most prevalent health communication aimed at consumers," said Dominick L. Frosch, PhD, assistant professor of medicine at the University of California, Los Angeles.

Dr. Frosch and colleagues recently took a look at drug ads and found that while most did provide some basic factual information, typically in the form of detailing a condition's symptoms, they provided limited insight regarding the causes of a disease or who may be at risk. Their study is in the January/February Annals of Family Medicine.

Although the pharmaceutical companies have developed a broad set of guidelines for DTC ads, they are voluntary guidelines, Dr. Frosch noted. Plus, they aren't specific as to what the ads should include. "We need to remember that buying a prescription drug is not like buying a bar of soap. If you end up with the wrong bar of soap, that's not likely to have serious consequences to your health. In the case of prescription drugs, it could."

Dr. Domino would welcome certain changes. "If we could give one message to our pharmaceutical friends, it's that physicians would have a much more positive view of DTC advertising if they spent more time talking about how the patient must take greater responsibility for their health."

The ads could stress the incremental benefit of treating depression with both cognitive behavioral therapy along with medications, he said, offering an example. Or they could explain that patients can make the symptoms of reflux go away with a pill, but if they don't lose weight and change their eating habits, all the pill is going to do is mask the symptoms, as only lifestyle changes will successfully treat the problem.

David Kessler, MD, was in charge of the FDA when DTC ads were being debated in the 1990s, and he strenuously opposed them. "I put my body on the line the entire time I was commissioner and said 'No DTC ads' as I walked out the door." He recounted that scenario at a gathering of former commissioners held on Feb. 21 at George Washington University in Washington, D.C.

Although Dr. Kessler admitted to thinking at one point that perhaps allowing such ads could save lives, he doesn't think so anymore. "I think the major pharmaceutical companies may also regret DTC ads," he said. The ads have a detrimental affect on the companies' credibility, he said. "I think we have to figure out a better standard, and limits will have to be placed."

The industry's reputation has suffered because of the ads, said PricewaterhouseCooper's Claude. "I think they realize that they may have been too aggressive in DTC advertising. I think it became a more accepted promotional tactic without regard to what it was doing to their reputation."

He compared the pharmaceutical industry to the legal profession, which, he said, had enjoyed a better reputation before ads began appearing on television urging viewers to call 1-800-I-want-to-sue. Those ads may bring in clients, but the profession as a whole takes a hit.

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AMA crafts DTC guidance

The AMA Board of Trustees, at its 2006 Annual Meeting, presented a lengthy report on direct-to-consumer advertising of prescription drugs and implantable devices. Its findings are represented in Association policy to help shape these powerful promotional tools. Among the recommendations:

  • DTC ads should be indication-specific and enhance consumer education.
  • The ads should convey a clear, accurate and responsible health education message by providing objective information about benefits and risks.
  • A statement such as "Your physician may recommend other appropriate treatments" should be included.
  • Warnings, precautions and potential adverse reactions should be presented in a way that will be understood by a majority of consumers.
  • The ad should include information about alternative non-drug treatments, such as diet and lifestyle changes, when appropriate.
  • If actors portray health care professionals in ads, disclaimers should be prominently displayed.
  • The FDA should review and preapprove all DTC advertisements before they are run.
  • Congress should provide sufficient funding to the FDA to ensure effective regulation.
  • Ads for newly approved drugs or implantable devices should not be run until physicians have been appropriately educated about the item. The length of a moratorium could vary.

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Promotional spending

Spending on direct-to-consumer prescription drug advertising grew almost 300% from 1997 to 2005, according to a study by the Government Accountability Office.

1997 $1.1 billion
1998 $1.3 billion
1999 $1.8 billion
2000 $2.5 billion
2001 $2.7 billion
2002 $2.6 billion
2003 $3.3 billion
2004 $4.0 billion
2005 $4.2 billion

Source: "Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising," Government Accountability Office, November 2006

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External links

AMA policy on direct-to-consumer advertising of prescription drugs and implantable devices (link)

The Pharmaceutical Research and Manufacturers of America's "Guiding Principles on Direct to Consumer Advertising About Prescription Medicines" (link)

Food and Drug Administration proposals for changes in regulations including those for reviews of television drug commercials (link)

Frequently asked questions about the FDA's current regulations governing consumer-directed advertising (link)

The federal legislative information service for bill summary, status and full text of the S 484, drug safety legislation that includes provisions about drug advertising introduced by Sen. Edward Kennedy (D, Mass.) and Mike Enzi (R, Wyo.) (link)

"Recapturing the vision: Restoring trust in the pharmaceutical industry by translating expectations into actions," PricewaterhouseCoopers, January (link)

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