"We can't Fund SCHIP, but We Can Save Merck"

October 22, 2007
We Can't Fund SCHIP, But We Can Save Merck

Today, Bloomberg trumpeted the good news: "Merck Profit Gains on Cancer Vaccine, Diabetes Pill."

"Merck & Co., the third-largest U.S. drugmaker, reported a 63 percent gain in earnings," Bloomberg reported, a victory made doubly by the fact that Merck has seen some rough times. "Competition from generics and the withdrawal of the pain pill Vioxx in 2004 over heart risks have pulled net income down 39 percent since 2001," the story explained. Indeed, Vioxx gave Merck a black eye, and it's still battling lawsuits in the courts. But Gardasil, Merck's new vaccine to prevent cervical cancer, is turning out to be just the blockbuster the company needed. "Gardasil, introduced a year ago [already] has sales of $418 million"

Those of you familiar with my views on Gardasil may want to skip the below section, as it is pulled from an August post. I promise I won't do this often, but this is an important subject and it's example of how, if drug manufacturers and their lobbyists work quickly enough, they can sell their story to politicians and to the public before skeptics in the scientific community have a chance to weigh in. Remember the drug industry saying: "It's important to sell a new drug while it's still effective" (i.e. before people know too much about it).

On August 27, I wrote:

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)

In his August 6 announcement, 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.

A more recent back-to-school ad ("ask your 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 . . ." But this change comes after more than a full year of beating the drum for Gardasil in a way that suggests that it offers full protection. And 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.

"Pap smears"
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 millions of lives to be saved.
This is not to minimize the fact that cervical cancer will kill 3,700 American women this year. Each one of those deaths is a tragic, avoidable death. But almost all of the women who die 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. Such a blitz, 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 regular Pap smears. There, 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."

Could the Hype Lead Girls to Skip Pap Smears?
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 that 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.

Unknown Risks
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 vaccine that is only partially effective. 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."

Finance Minister "Short-Circuits" Scientific Discussion
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. (The problem with Vioxx is that, like Gardasil, it was hyped with advertising which suggested that it was the best pill for most, if not all, patients. In truth, it was suitable for only a small number of patients who couldn't tolerate other pain-killers. For the majority of patients, the risks of taking Vioxx outweigh the benefits.)

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"-- 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."

But in the U.S. we haven't gone slow. As today's Bloomberg piece pointed out, U.S. politician's jumped on the Gardasil band-wagon. Who wouldn't want to be part of a movement that rescues young girls from the threat of Cancer? (So what if it's not really a threat, but a rare disease.)

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It should come as no surprise, then, that as Bloomberg reported today, "The vaccine is now approved for funding through the U.S. Vaccines for Children program in all 50 states. About 40 percent of U.S. children get their vaccines through the program, according to the Centers for Disease Control and Prevention, a U.S. agency." A number of states also have committed large sums from state coffers to make sure every girl who wants the vaccine gets it.

We couldn't afford to fund SCHIP, but we can afford to bail out Merck.

Posted by Maggie Mahar on October 22, 2007
www.healthbeatblog.org