Earlier this month the FDA announced that the direct-to-consumer ads Merck has been using peddle its new cervical cancer vaccine, Gardasil, are “half-true . . . information currently being advertised could mislead the public.”
But “don’t get too excited that the U.S. Food & Drug Administration has regained its sanity,” says blogger Bill Sardi.
“This is the FDA in Thailand,” he explained. (Sardi picked up the news in the Bangkok Post)
Before taking a closer look at precisely why Thailand’s health officials are concerned about Merck’s ads—and why our own FDA isn’t raising a red flag– let’s step back and review our own government’s policy on drug ads that are beamed directly to you and me.
Earlier this summer Congress debated a proposal that would ban DTC ads until a product has been on the market for two years. Senate Majority Leader Bill First called for just such a moratorium in 2005, arguing that this would give physicians time to assess benefits versus risks before a manufacturer begins pitching a brand new drug to laymen.
Of course, sensible people might assume that the FDA wouldn’t let a drug come to market until clinical trials have established its worth. But recent experience with drugs like Vioxx (the widely promoted painkiller that Merck was forced to withdraw from the market after a study revealed that it significantly increased the risk of heart attacks, strokes and blood clots) shows that sensible people often are wrong.
The proposal calling for a waiting period before peddling new remedies to consumers was backed by the Institute of Medicine; this summer, supporters hoped that it might pass Congress as part of an FDA reform bill. But ultimately, the provision was not included in either the Senate or the House version of the FDA bill, thanks to what drug expert Merrill Goozner has described as “an unholy alliance” between lobbyists representing “big broadcasters, publishers and the drug industry.”
Broadcasters and publishers know that there is big money to be made from DTC drug advertising. As The New England Journal of Medicine revealed just last week, drug industry spending on promotion hit $29.9 billion in 2005, up from $11.4 billion nine years earlier. And pharmaceutical companies are spending a larger and larger chunk of their revenues on marketing their products: as a percentage of sales spending rose from 14.2% in 1996 to 18.2% in 2005.
Drugmakers don’t normally trumpet numbers showing just how much they invest in advertising. (They would prefer to have us believe that they plow every last dollar into life-saving research.) But the authors of the NEJM article managed to purchase information from three market-research firms that track spending on advertising, and after putting those numbers together with data publicly available from the FDA, they concluded that spending on direct-to-consumer advertising grew even faster than ads aimed at doctors—up 330% from $985 million in 1996 to $4.237 billion in 2005.
The researchers went on to point out that FDA oversight of DTC ads has failed to keep up with the advertising blitz. In 2002, just three FDA staff members were assigned to review the industry’s pitches to the public; in 2004 the agency added one more staffer to the skeletal operation. That year, the agency was able to review only about one-third of televised drug ads before they aired.
The issue is not whether pharmaceutical companies should have the right to communicate directly with patients says drug researcher Dr. Jerry Avorn in Powerful Medicines: The Benefits Risks and Cost of Prescription Drugs. It’s the way they do it: “these ads and commercials are helping to transform the medical care system from a professional enterprise focused on the health of people to just another marketplace, like those for fast food cars and pop music. The name of the game is buying as
big a media splash as possible, catching the eye of the consumer, winning market share.”
As an example, see my recent post on the healthcareblog calling attention to television ads pitching Mirapex, a remedy for Restless Leg Syndrome. No doubt you’ve seen the animated spots featuring a cute, curvy pair of legs tossing and turning trying to get comfortable in bed while catchy music plays in the background. At the end comes the warning about possible side effects which include “hallucinations, dizziness and nausea.” Patients also risk “falling asleep without any warning, even while doing normal daily activities such as driving.” Yet the ad is so entertaining, the music so upbeat that the warnings just don’t sound that alarming.
The industry’s critics suggest that drugmakers spend billions on DTC spots in order to pitch products that they might have a hard time selling to doctors: “I have a hypothesis about which type of oncology drugs are likely to be advertised directly to the consumer,” a medical ethicist observed in The Oncologist last year. “I think they are less likely [to advertise] drugs DTC that have been proven to have benefits, have no competitors, or are known to be cost-effective. There would be no reason to promote them as they are going to be used anyway. In contrast, it’s those drugs in competitive markets, at the margins of evidence-based medicine . . . that are advertised most [to the layman], which is worrisome."
This brings us back to Merck’s cancer vaccine—and the misgivings exrpessed by the secretary-general of Thailand’s FDA. In his August 6 annoucement FDA secretary-general Siriwat Thiptharadol stressed what consumers need to know about Merck’s vaccine: Gardasil can effectively protect against only two strains of the human papilloma virus ( HPV types 16 and 18,) which are responsible for 70% of cervical cancers. . . the product is not effective against several other types of viruses which are responsible for the remaining 30% of cervical cancer cases.” [my emphasis]
Unfortunately, Merck’s ads don’t make this point quite as clearly. In one two-page print spread that ran in a U.S. magazine earlier this year, the reader is told: “Now you can help protect against diseases caused by HPV types 6, 11, 16 and 18:
–Cervical Cancer
–Cervical Dysplasia
–Genital Warts.
What the reader is not told is that only two of these viruses (16 and 18) are associated with cervical cancer and they are linked to only 70% of all cases, leaving vaccinated women vulnerable to the viruses associated with the other 30% of cervical cancers. (The other two viruses mentioned in the ad, types 6 and 11, cause 90% of genital warts—an extremely unpleasant condition, but not life-threatening.) The ad does acknowledge that “Vaccination with Gardasil may not result in protection in all vaccine recipients” and notes that “Gardasil does not substitute for routine cervical cancer screening.” But it doesn’t explain why. Nowhere do the words “70 percent” or “30 percent” appear.
Earlier this year, print ads also avoided spelling out the fact that Garadasil leaves girls vulnerable to 30% of viruses that cause the cancer. One two-page spread headlined “Gardasil—help protect a generation of girls and young women” acknowledges that “Gardasil does not substitute for routine cervical cancer screening,” but it doesn’t say why. The numbers “70%” and “30%” do not appear anywhere on the two pages.
However, a more recent back-to-school ad (“ask you daughter’s doctor about getting her vaccinated with Gardasil at her back-to-school check-up”) does acknowledge that Gardasil will “help guard your daughter from 4 types of human papillomavirus [that] cause 70% of cervical cancer cases . . . “ (The change suggests that the secretary general of Thailand’s FDA may not be the only one who has complained that Merck’s ads have been misleading.) But even here, the first line of the ad exaggerates the importance of Merck’s new product “Gardasil is the only vaccine that may help guard your daughter . . ..”
While it’s true that Gardasil is the only vaccine that will protect your daughter against the virus, it is not the only tool that your doctor has at his or her disposal to insure your daughter does not die of cervical cancer. Nor is it the best. The truth is that regular Pap smears provide much fuller protection than the vaccine. In fact, in the U.S., thanks to widespread screening with Pap smears, this slow-growing cancer has become what the National Institute of Health classifies as a “rare disease.” Cervical cancer now accounts for less than one percent (.65%) of cancer deaths. This is why Gardasil will not save millions of lives in countries such as the U.S., Canada or the U.K. where Pap smears are readily available. There are not million of lives to be saved.
This is not to minimize the tragedy of the fact that cervical cancer will kill 3,700 American women this year. . But most will be patients who did not receive regular Pap smears. If the aim is to save lives, mandating vaccinations—which some states have already done—is not the most cost-effective way to achieve that goal. Rather than spending millions each year to vaccinate young girls against less than ¾ of the viruses that are associated with cervical cancer, we might invest much less in a media blitz reminding young women to go for regular gynecological exams that would detect virtually all cases of the cancer. That, combined with a campaign to make free or low-cost Pap smears to poor women who now account for the majority of cervical cancer deaths in the U.S., could save most if not all of those 3,700 lives.
In the developing world, by contrast, millions of women don’t have access to Pap smears and cervical cancer remains a scourge. But who in these countries can afford a $360.vaccine? And Merck has not yet made its vaccine available at a significant discount “We’re concentrating on high-income countries,” a Merck spokesperson told me last summer. After all, the company has a jump on a world-wide market that is estimated to be worth several billion dollars a year. It is not about to take its eye off the prize—it will need those revenues to battle lawsuits over Vioxx, the pain-killer that it was forced to withdraw from the market.
Meanwhile Merck’s television ads send confusing and contradictory signals. One familiar spot features quick images of vibrant, healthy young girls who chant the company’s message: "I want to be one less woman who will battle cervical cancer . . . One less family turned upside down.” The ad does note that “Gardasil does not prevent all types of cervical cancer so it’s important to continue with regular cervical screening.” And at one point “70 percent” is mentioned. But the dominant message drowns out everything else: "O-N-E-L-E-S-S. I want to be one less. One less." The slogan seems to suggest that as long as you are vaccinated, you will be spared. You will be “one less woman who will battle cervical cancer.”
The real danger is that “by over-hyping its potential Merck is creating a dangerous misconception—that it is [now] less important to have regular Pap screenings—the tried and true and very effective method of early detection and treatment,” blogger Judith Siers-Poisson’s wrote on the Center for Media and Democracy’s “PR Watch” last month. “It would be a tragic irony, she added, “if women’s infection and mortality rates from the disease actually increase due to the belief that they are completely protected against cervical cancer.”
Researchers foresaw the possibility that women might be lulled into a false sense of complacency back in 2003. As a study published in JAMA that year points out: “if women who are vaccinated perceive themselves to be at low risk for developing cancer and, as a result do not participate in screening as recommended, gains from vaccination may be offset.”
In the U.K., according to the Guardian, public health experts are worried that the “push toward mass vaccination” is having just that effect. In March, the paper quoted public health expert Angela Raffle who compared the lobbying tactics Gardasil’s promoters were using to “a battering ram [aimed] at the Department of Health and carpet bombing on the periphery . . . My worry is that the commercially motivated rush to make us panic into introducing HPV vaccine quickly will worsen our cervical cancer screening programs.”
That said, there is no question but what Gardasil represents a major scientific breakthrough. In the best case scenario, women will combine vaccination with regular Pap smears and fewer will ever develop the cancer—which means that fewer will have to undergo sometimes painful treatments. As a bonus, the vaccine also will shield them from 90% of the viruses that cause genital warts.
Most importantly, in time, researchers may be able to develop a vaccine that provides lasting protection against all of the viruses associated with cervical cancer. But that time has not yet come. All we know is that Gardasil seems to provide partial protection for up to five years. Long-term trials have not yet been done. After five years, booster shots may be needed. And nothing is known about potential side effects over the long term—though Merck does warn that Gardasil “is not for women who are pregnant.” This raises another question: what if a young woman does not know that she is pregnant when she is vaccinated?
Meanwhile, rather than working to distribute the vaccine in the developing world, where it is desperately needed, governments in developed nations like the U.S. and Canada are mandating vaccination within their borders, hailing Gardasil as a magic bullet. It is only recently that the mainstream media has begun to seriously question such enthusiasm for a partially-effective vaccine. Two weeks ago, Andre Picard wrote about “How politics pushed the HPV vaccine” in the Globe and Mail:
“Not since the Salk vaccine was triumphantly unveiled in 1955 as the miracle drug that would end the scourge of polio has there been as much hoopla surrounding a vaccine as there is today about one that is being touted for having the potential to eradicate cervical cancer.”
“Grandstanding politicians” both in the U.S. and Canada, have rallied around the drug, he observes. “ . . .since polio, no vaccine has gone from regulatory approval to mass use in government-funded programs with such dizzying speed.” Yet, “unlike polio, where children were dying and crippled in large numbers and immunization stopped an epidemic in its tracks, cervical cancer develops slowly and the positive or negative effects of a vaccine for human papillomavirus (HPV), which can cause cancer of the cervix, will not be seen for decades.”
When then, did the FDA fast-track Gardasil? Why the rush to bring it to market? On Wall Street, cynics suggest that Merck desperately needed a block-buster drug to replace revenues lost when it pulled Vioxx from the market.
Picard points out that in Canada “Finance Minister Jim Flaherty short-circuited the scientific and economic discussions [last March] by announcing $300-million to kick-start an HPV vaccination program. Ottawa’s move stunned public health officials.” Picard quotes Noni MacDonald, an infectious disease specialist and professor of pediatrics at Dalhousie University in Halifax: “Why are politicians making medical decisions? This is not how health-care delivery should be decided.” MacDonald declared.
Picard also interviewed Anne Rochon Ford, co-ordinator of Women and Health Protection. “The lack of transparency in a program that could have a dramatic impact on women’s health is troubling, she said, and doubly so because governments seem to have succumbed to backroom lobbying from the massive marketing campaign of Gardasil’s maker, Merck Frosst Canada Ltd., and its international parent: ‘It is staggering how quickly and secretly this has all happened and that points to some pretty active footwork behind the scenes,’ she said.”
According to Picard, Rochon Ford added that the “rhetoric about a vaccine with no long-term track record has been unbelievable, and the media has mindlessly and uncritically parroted outrageous claims, while ignoring the importance of proved measures of reducing cervical cancer like Pap testing.”
In the U.S., a recent editorial in The New England Journal of Medicine counsels prudence. The authors describes Gardasil’s effectiveness as “modest”—in part because it addresses only two of the viral strains that cause cancer– and they conclude by suggesting that “a cautious approach may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time.”
Finally, back in Thailand the secretary-general of the FDA also wants to go slow: “There are still questions about risk” the Bangkok Post explained, which is why in Thailand, “advertisements for the product in the mass media are prohibited . . . because the vaccine is still undergoing a monitoring process for side-effects for a period of two years.”