A Solution to the DTC Advertising Dilemma

The pharmaceutical industry has been settling into its “good guy” role in recent days; first committing to $80 billion in cost savings over ten years to help defray the cost of health reform and then forking over $150 million to finance an ad campaign championing the administration’s plan. (Of course there was that slight fall from grace when it looked as if, in exchange, PhRMA had secured guarantees that Medicare would not be able to negotiate drug prices…click here for Maggie’s take on that.)

But what else can the industry do to help burnish its image with the American people? How about finally consenting to some common-sense limits on the barrage of prescription drug ads confronting consumers every time they turn on the TV or open a magazine? While a complete ban is probably not possible (in part because such a ban might violate the First Amendment) how about making prescription drug ads a lot more educational and a lot less like a hard sell for a new BMW?

Ads Hike Spending On Drugs

Direct-to-consumer advertising (DCTA) has been a boon for drug companies ever since Congress passed the Prescription Drug Marketing Act in 1987. Spending on consumer drug ads reached $5.0 billion last year, according to Nielsen Media Research and Americans see up to 16 hours of drug advertising on television each year. These slick appeals for sleep aids, impotence drugs and a host of other remedies, clearly pay off. Studies show that every dollar spent on DTC ads generates four dollars in additional sales of new drugs that are often only marginally better than far cheaper, generic versions or older drugs.

Proponents of direct-to-consumer drug ads—mostly representatives from pharmaceutical companies—claim that these appeals have an educational function, bringing ill patients into their doctor’s offices to receive sorely needed therapy. This benefit can be real when the advertised condition is serious and under-treated—hypertension, for example—and the treatment is highly effective and safe relative to its alternatives. But when was the last time you saw an ad on TV for a hypertension or cancer drug? Instead, aggressive advertising is much more common for therapies directed against so-called “lifestyle” problems like thin eyelashes, insomnia, toenail fungus and erectile dysfunction. And their side-effects can be quite serious.

Studies have shown that direct-to-consumer advertising has fundamentally changed the way doctors and patients communicate, mostly for the worst. Fewer than 10% of physicians believe direct-to-consumer advertising (DTCA) is a positive trend in health care. Doctors report that they now spend more time explaining to patients why an expensive new drug is no better than the one they already take, or that the patient isn’t suffering from a nebulous condition like fibromyalgia, just the normal aches and pains of aging.

Physicians feel pressured by patients who come in asking for these newer, more expensive (but not necessarily, better) medications by name. In a recent survey conducted by Consumer  Report, one-fifth of the respondents said they had asked their doctor to prescribe a drug they saw advertised on television or elsewhere: Some 70% of physicians complied with this request.

Proposed Legislation

With criticism mounting from consumer groups and pressure focused on reducing health care costs, there is a new sense among legislators that the time might finally be right for limiting DTC drug advertising. Three bills have been proposed so far, including:

1) Families for ED Advertising Decency Act—sponsored by Representative James P. Moran, (D-VA)-- this House bill would give the FCC power to ban ads for prescription sexual aids like Viagra and Cialis from prime-time television, on decency grounds.

2) Henry Waxman (D-CA), Chair of the House Energy and Commerce Committee, supports a moratorium on DTCA for two or three years after a new drug is introduced. This action, also supported by the Institute of Medicine and the American Medical Association is necessary to prevent wide-scale advertising to the public of drugs—like Vioxx—whose long-term health effects are still unknown. Two-thirds of the drugs that are withdrawn from the market due to safety concerns have been on that market for less than three years.

3) Say No to Drug Ads—Introduced by Rep. Jerrold Nadler (D-NY), this legislation would amend the tax code so that drug companies could no longer deduct DTCA spending as a business expense.

Opposition—Not Just the Drug Companies

Opponents of limiting DTC ads argue that moratoriums on pharmaceutical advertising would violate the First Amendment protection for commercial speech. Avoiding that battle is probably a good idea, because drug industry lobbyists aren’t the only ones making that argument. Drug companies are second only to the automotive industry in the amount they spend on consumer-directed advertising and in 2007, lobbyists representing media and ad agencies helped defeat Congress’s attempts to further regulate DTC ads. With ad pages down throughout the industry and networks vying for sponsors, the First Amendment arguments will only get stronger.

So, barring a ban on DTC drug ads, the best way to rein in misleading and manipulative marketing is to pass regulations that tightly control how these ads are structured. The FDA is supposed to be doing this already, by preventing the industry from making false and misleading claims. But when total funding for all of the FDA’s programs—including enforcement—is less than half of what Big Pharma spends on direct-to-consumer advertising, it’s clear that the agency just doesn’t have the resources to carry out this role. With more and more pharmaceutical advertising taking place on the internet—where, for example, it can be very difficult to discern drug company-sponsored sites from legitimate disease advocacy sites—the FDA’s ability to regulate this field has become exponentially more difficult.

Opponents of further regulation also like to point out that the industry polices itself. In 2005, PhRMA President and CEO Billy Tauzin announced that the industry group had adopted "Guiding Principles" that would promote patient education in DTC drug marketing and “foster responsible communications between patients and health care professionals to help patients achieve better health." According to Tauzin:

“With these principles, we commit ourselves to improving the inherent educational value of advertisements. Patients need accurate and timely information and should be encouraged to discuss diseases and treatment options with their physicians.”

Rebutting the Industry’s Arguments

But in an editorial in the Annals of Family Medicine, editor and physician Kurt C. Stange, says that FDA oversight and industry self-monitoring are not working. Neither approach has stopped drug companies from promoting drugs over healthy behaviors, or has lessened the deleterious effects the ads have on doctor-patient communication.

“How are communication and health fostered by manipulating patient-clinician communication toward drugs and away from health behavior, or by denigrating clinician recommendations for nonpharmacological health interventions? How does a broad-based medium designed to sell to the masses promote drugs in the individualized way that is essential for safety if the message largely reaches people who are not candidates for the drug? How does it improve public health to bombard the public with the message that life is happier, more fulfilling, more socially acceptable on drugs? What are the unintended consequences of the plethora of images and messages about health that are intended to increase patient demand for drugs?”

I have further questions for the industry: If the aim of these appeals is to be educational, then why do drug companies hire multi-national advertising agencies to design their ads, and not public health educators? Why are there no comparisons of therapies, clear information about risks vs. benefits and links to unbiased medical information? The answer is that today’s slick direct-to-consumer ads are really not designed to be educational; they are designed to boost drug sales and profits.

The Best Solution

So what’s to be done? First of all, Congress should consider Waxman’s proposal for a moratorium on DTC advertising on drugs that haven’t been on the market for at least two years. It shouldn’t be that much of a hardship for companies—only about 15% of DTC ads are currently for drugs that are less than a year old. Limiting drug ads in this way could also help companies avoid Vioxx-like situations where widely advertised and prescribed new drugs are found to have serious side-effects only after FDA approval.

In Congressional hearings on DTC ads that took place last June, representatives from Merck, Pfizer, Johnson & Johnson and Schering Plough told legislators that they already have a voluntary 6-month moratorium on advertising for new drugs. In reality, the companies need this delay in order to get their army of drug reps out to sell doctors on the new drug before they are faced with patient requests for information.

Senators Bart Stupak and John Dingell told the companies that this wasn’t long enough—they want to see a two-year moratorium on drug ads. Waxman agrees, although he now says that he is open to reserving the moratorium to drugs that are the most risky. He told Time magazine in February:
"It doesn't have to be a full two years," Waxman says. "It's allowed to be limited to drugs that the FDA thinks might be a safety problem."

Besides the moratorium, it is essential that drug advertising be educational and not just play to consumer emotions. Because, seriously, prescription drugs are not BMWs. Most people are able to think critically about car ads: they recognize that with images of beautiful women, long winding roads and a background of jazzy music, they are being sold a dream of luxury and social status.  They also understand that they had better check out some price and performance comparisons before trading in the 10-year-old Escort.

By contrast, when the average person sees a television ad for Lipitor, for example (which had over $12 billion in sales in 2008) they hear “high cholesterol,” “reduces risk of heart attack by 36%,” and get about 45 seconds of an attractive actor talking about the drug’s benefits; some 15 seconds are a rushed litany of potential risks. The viewer also knows that the FDA approved Lipitor and he believes the agency also approved the ad—there is a level of authority and trust in these ads that is not implicit in car or beer ads.

But there is a lot about statins like Lipitor that isn’t mentioned in these 60-minute spots. In “Do Cholesterol Drugs Do Any Good,” John Carey of Business Week says that Lipitor’s benefits to people without significant heart disease are far less clear when the numbers are expressed this way:

“[F]or every 100 people in the trial, which lasted 3 1/3 years, three people on placebos and two people on Lipitor had heart attacks. The difference credited to the drug? One fewer heart attack per 100 people. So to spare one person a heart attack, 100 people had to take Lipitor for more than three years. The other 99 got no measurable benefit.”

In fact, Carey writes, some of those other 99 might actually have been harmed by taking Lipitor for so long—experiencing side-effects that include muscle pain and cognitive problems. (See also HealthBeat’s two-part post on “The Cholesterol Con” here and here )

One of the most promising ideas for improving the educational value of drug ads is to have them include simple-to-read “fact boxes,” developed by researchers at Dartmouth’s Institute for Health Policy and Clinical Practice, that are similar to the nutritional information found on most packaged food. These boxes contain two sections: the top section lists what conditions the drug can treat and who should take the medication. The bottom describes the effectiveness of the drug—and how it compares with other treatments—as well as the percentage of patients who experience different side effects.

A study by the Dartmouth researchers  (which is available in the Annals of Internal Medicine ) looked at whether adding a drug fact box to DTC ads for prescription heartburn drugs helped consumers make better choices about medication. Some participants were given standard versions of ads for two heartburn drugs (with a long, fine-print text of drug information on the back) and others received the two ads with fact-boxes replacing the fine-print. In the end, some 68% of participants who got the drug fact boxes correctly identified the more effective drug; only 31% of those who got the fine-print were able to discern the superior treatment.

After meeting with the Dartmouth researchers in February, the FDA’s risk communication advisory committee unanimously urged the agency to require that drug fact boxes appear on all medication labels. They also recommended that they appear along with other drug information on the FDA’s website. Steven Woloshin, one of the Dartmouth researchers, says that he would like to see the fact boxes replace the fine print in DTC ads as well, but the FDA doesn’t have the authority to require this—that can only come from legislation. 

As the nation continues to struggle with health reform, deciding what to do about direct-to-consumer drug advertising might be pushed to a back burner. But that would be a mistake. We are just one of two countries (New Zealand is the other) that allows televised hawking of drugs; it’s probably not a coincidence that we also spend more than any other country on health care. These ads lead to overuse of expensive but not necessarily better drugs. They lead to the medicalization of health conditions that would be better treated with health and lifestyle changes. It’s time to require a lot more integrity from Big Pharma. It’s time to insist that they shift from the hard sell to helping us make informed choices about our health.

Comments

[robert ehrlich]

You have overstatted the impact of DTC advertising significantly. Only one outlier study shows a 4 to 1 return from DTC ads. Most studies show 1.5-2 return. That means of the 300 billion spent on prescription drugs, about 7-9 billion can be attributed to DTC ads.

Consumers think DTC serves a useful purpose in facillitating discussions with doctors. A recent Dana Farber study shows a wide majority of cancer patients like DTC ads. If doctors find it bothersome consumers ask more questions about drug treatments that is their problem, not DTC advertising's fault.

You say DTC leads to medicalization of diseases. Is it bad to have more people treated for high choleseterol,blood pressure and diabetes? I think you are blaming ads for cost increases which have been happening before DTC existed.

[Jeanette Williams, MD]

Excellent article. Advertisements for expensive, but often not better, drugs do not bring health benefits to patients. Those whose paycheck's depend on DTC however, like Mr Ehrlich, gain large benefits from these ads. When will we stop pretending that these ads are for patient benefit and not merely marketing techniques?