Although the United States and New Zealand are the only two countries permitting direct-to-consumer (DTC) advertising of pharmaceuticals, many other countries are taking a close look at their policies to see what will best meet the needs of consumers.
"A growing number of patients want to be empowered; they are demanding more information. We now have a situation where advertising lets patients know about potential new medicines so they have more knowledge about treatment choices when they sit down to discuss options with their physicians," said Jeff Trewhitt, spokesperson for the Pharmaceutical Research and Manufacturers Association of America (PhRMA), a Washington, D.C.-based national trade association of pharmaceutical and biotechnology firms.
In 1997 the U.S. Food and Drug Administration issued a regulatory "clarification" allowing DTC advertising; an explosion of television, radio, and print drug promotional advertisements followed (see News, June 21, 2000, p. 964).
The FDA requires all advertisements to provide additional referral information such as a toll-free telephone number or an Internet address as well as to recommend physician consultation. In addition, the advertisements must contain accurate information on risks, side effects, and benefits.
According to Nancy Ostrove, Ph.D., deputy director of the FDAs Division of Drug Marketing, Advertising, and Communications, the agency is reviewing "all publicly available data" this year in an effort to gauge the impact of DTC advertising regulation. Since 1997, FDA has sent about 20 letters per year to manufacturers for the most common violations. Complaints about ads are filed by advocacy and trade groups, individuals, and even competitors. Sanctions can include pulling ads, placing "remedial" or corrective ads, seizing products, and seeking injunctions or prosecutions against violators.
"Violations tend to revolve around overstatements of product efficacy, broadening product indications, and minimizing the risks associated with the product, or failing to provide a balance between information about risks and information about benefits," Ostrove said.
Promotional materials are required to be sent to the FDA about the same time they are publicly released but the FDA places high priority on broadcast ads, which are rapidly "flagged" for immediate review, she added.
In the United States, DTC advertising spending has been estimated at almost $2.5 billion in 2000 and surpasses $100 million annually for some individual drugs. According to a September 2000 National Institute of Health Care Management report, 40.7% of an overall $17.7 billion increase in 1999 drug expenditures can be attributed to the sale of 25 top-selling drugs promoted directly to U.S. consumers. Moreover, the sale of these drugs grew by 43% during that same year compared with a 13.3% growth in sales for all other drugs.
Critics have pushed for greater restrictions on DTC advertising, citing escalating health care costs. They also point out that heavily promoted new drugs have accumulated less safety and efficacy data while the growth of Internet pharmacies now allows patients to simply bypass physicians who resist the pressure to prescribe.
With drug ads now appearing everywhere from highway billboards to sporting events, effective monitoring and enforcement is, at best, difficult. Meanwhile, critics assert that the potential for inaccuracies, insufficient risk information, and exaggerated benefit claims are growing.
Regulatory Boondoggle?
Pharmaceutical industry spokesman Trewhitt maintains that the recent sanctioning of AstraZeneca for ads involving tamoxifen (Nolvadex) demonstrates that the existing system of monitoring and compliance works. (See sidebar, p. 330.)
"When it comes to direct-to-consumer ads, we think the FDA has the matter well in hand. This is something carefully monitored by the FDA, and we think they are doing a good job," he said.
Not so, according to Barbara Brenner, J.D., executive director of Breast Cancer Action, a San Francisco-based national advocacy organization. Since tamoxifen was approved in 1998 for use by healthy women at high risk for developing breast cancer, Brenners group has filed three formal complaints with the FDA charging that Astra-Zenecas print and broadcast ads touting tamoxifen overstate benefits and understate risks.
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Brenner also asserts that the Nolvadex case spotlights a regulatory agency that is poorly equipped to efficiently monitor all consumer advertising, is slow in reacting to violations, and is reluctant to impose stiff penalties.
"The FDA regulations are drafted and enforced in such a way that encourages drug companies to cross the linewith a lack of resources to identify violations and enforcing these regulations," Brenner said. "They do not have the resources to monitor drug ads prior to publication, so the burden of monitoring these ads then falls on the public."
But the FDAs Ostrove defends her agencys action in the Nolvadex case.
"No remedial campaign was requested because the agency did not believe that the violation warranted a remedial campaign. We look at the need for sanctions on a case-by-case basis. Most DTC [advertising] campaigns have been pretty compliant with the regulations," she said.
Brenners group has advocated forcing the FDA to review and preapprove all print as well as broadcast drug advertising, impose severe fines and penalties for violations, including a ban on future advertising for repeat offenders, and require manufacturers to publish "corrective" ads.
Because DTC advertising of prescription medications has been legal for a relatively short time in only two countries, it has not been comprehensively studied. Proponents point out that existing surveys suggest DTC advertising is effective both in prompting patients to visit their physicians and in familiarizing them with serious illnesses and associated symptoms.
A survey of physician prescribing patterns in Canada and the United States published in the British Medical Journal last month concluded that, while adult patients who requested a prescription were more likely to receive one, overall prescribing rates were similar for both advertised and non-advertised drugs. The survey, conducted in Sacramento and Vancouver, reported that while prescriptions were requested in only 12% of 1,431 patient visits, 42% of these requests were for products advertised to consumers. However, the authors also found that physicians prescribed requested drugs to 9% of patients and prescribed requested advertised drugs to only 4% of all patients.
Meanwhile, a poll of 1,900 U.S. adults released by the Kaiser Family Foundation in November found that drug advertising effectively prompted viewers to seek out more information both about the advertised drug and about the condition it treats. The survey reported that 30% of participants spoke to their physicians about a drug they saw advertised and that of these, 44% received a prescription for the drug. However, the advertisements were less successful at conveying drug risks and where to obtain additional information.
But perhaps the most important questionwhether information-seeking or increased prescribing attributed to pharmaceutical advertising has resulted in better health outcomes such as reductions in hospitalization or reduced morbidity and mortalityhas not yet been examined comprehensively.
Among "developed" nations, government officials pressured by pharmaceutical manufacturers, publishing interests, and others are increasingly reconsidering their bans.
For example, later this year the European Parliament is expected to vote on a European Commission proposal to allow DTC advertising of drugs used to treat HIV/AIDS, diabetes, and respiratory conditions such as asthma.
Australians, after considering the legalization of DTC advertising during a year 2000 legislative review, recommended permitting only comparative drug price advertising. That country, like the United Kingdom, does continue to allow very limited "disease awareness advertising" that does not mention drugs by name.
The DTC advertising debate has been particularly contentious in Canada, where regulators are reviewing existing laws that bar such advertising.
Canadas Food and Drugs Act completely bans DTC advertising and delegates monitoring and enforcement to the federal agency Health Canada, which can threaten violators with prosecution resulting in heavy fines and even imprisonment.
Although DTC advertising is officially prohibited, a 1978 provision allowing pharmacists to advertise comparative drug prices permitted ads with drug "name, price, and quantity" but banned brand name and intended use in the same ad. Further liberalization followed in 1996 when a clarification of Canadian law defined advertising merely as "activities with the primary aim of stimulating product sales."
Still, Health Canada concedes that not only does it lack regulatory authority over the airwaves, but that many Canadians are exposed to American television and radio drug advertising.
"Health Canada has done a reasonably good job of preventing advertising violations but there is such pressure to approve DTC [advertising] that eventually the government will probably give in and this will no doubt contribute to a further escalation in drug costs," said Canadian Medical Association president Henry Haddad, M.D.
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"When we look south of our border, the message U.S. consumers are getting is that pharmaceuticals are simply consumer commodities rather than complex therapeutics. We think that interferes with the physicianpatient relationship by raising the expectations of patients and pressuring physicians to prescribe drugs," Haddad said.
But pharmaceutical spokesperson Trewhitt maintains that physicians are independent health professionals who are going to make their own decisions and recommendation to patients.
"Theyre going to make the final decisions about a medication independently," Trewhitt said. "It comes back fundamentally to the independence and credibility of the doctors."
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