Last week, it was hard to ignore the headlines trumpeting the news of Merck & Co.'s cervical cancer vaccine: “World's First Cervical Cancer Vaccine to Go On Sale in Weeks;” “Men Should Get Cervical Vaccine Too;” “Doctors Say HPV Vaccine Should be Given to Everyone.”
The hullabaloo began in June when the FDA approved Gardasil, a vaccine widely described as “100 percent effective” in preventing cervical cancer, a disease that kills some 233,000 women worldwide each year. The drumbeat grew louder last month when a federal panel recommended that all American girls and women ages 11 to 26 should be inoculated. And now there is talk that states may mandate the vaccine for all school-age children.
But before prescribing Gardasil for the entire population, it's worth asking a few questions: Why does the vaccine cost $360 for a three-shot regimen? How much do we know about the new product? And is this a cost-effective use of health-care dollars? The answers to these questions tell us as much about the American system of money-driven medicine as they do about the vaccine itself. The goal of our health-care industry is to generate profits. This should not come as a shock: by law, corporations are required to put their shareholders' interests first. But unless someone sits on the other side of the table, pushing back, profits will always come ahead of patients' needs. And low-cost preventive care will always take a back seat to high-cost treatment and so-called cures.
To be fair, Gardasil does mark a major breakthrough. With further development the vaccine could mean the end of cervical cancer -- at least in countries that can afford Merck's price. But right now, Gardasil is “100 percent effective” against only two strains of HPV (human papillomavirus) that causes cervical cancer. And those two account for just 70 percent of all cases. Scroll down a few paragraphs in a typical news story, and you'll discover that the vaccine has no effect on the viral strains which account for the other 30 percent.
Read a little further and you'll find out that because the vaccine protects against less than three-quarters of all cases, inoculated patients still will need regular Pap smear tests to check for signs of the disease. Merck itself emphasizes this point in the warning that Gardasil's customers will receive: “Vaccination does not substitute for routine cervical cancer screening. Females who receive Gardasil should continue cervical cancer screening.”
Most news stories about Merck's amazing breakthrough also don't stress the fact that, in the United States, we already have come close to winning the war on cervical cancer with the $30 Pap smear -- a simple test that has proven remarkably effective. Thanks to screening, between 1955 and 1992 the number of cervical cancer deaths plunged by 74 percent, and the numbers are still shrinking. From 1997 to 2003, deaths fell by an average of 3.8 percent each year. In 2006, it's estimated that cervical cancer will account for just 1 percent of the anticipated 273,560 cancer deaths among American women.
This is why the National Institutes of Health now lists cervical cancer as a “rare disease.”
That said, it's estimated that some 3,700 American women will die of cervical cancer this year. Those deaths cannot and should not be ignored. But most could have been saved by regular Pap smears. According to a study published in The New England Journal of Medicine, “more than half of all cases occurred in women who had never or rarely” had a Pap smear. Most of these women were poor or members of a minority. One can only wonder: How many of them will receive the new $360 vaccine?
Of course, if the states mandate the vaccine for school-age girls, taxpayers will be committed to paying to inoculate the nation's poorest children (age 11 to 18), at an estimated cost of $2 billion. But that still leaves those between the ages of 18 and 26 who don't go for regular gynecological exams at risk.
Meanwhile, all of the publicity has put enormous pressure on insurers. WellPoint already has announced that it will cover the vaccine. Keep in mind that this is not a gift: The price will be passed on to all of WellPoint's customers in the form of higher premiums.
Wouldn't it be cheaper -- and safer -- to set up a government program that ensures that all girls and women are screened regularly? While the vaccine protects against just 70 percent of all cervical cancers, Pap smears detect 90 to 95 percent. “If we had true universal screening -- as in some Scandinavian countries -- we probably wouldn't need both the vaccine and screening,” acknowledges Dr. Evan R. Myers, a physician at Duke University who has served as a consultant to Merck. (Those Scandinavian countries' national health insurance guarantees Pap smears regardless of ability to pay.)
Nevertheless, physicians like Myers point out that Gardasil doesn't just guard against 70 percent of cervical cancers -- it also protects against 90 percent of cervical warts. While not life-threatening, these warts, which affect men as well as women, are embarrassing and painful. More importantly, the vaccination reduces the number of “false positive” results that plague Pap smears. Inevitably, these false alarms lead to follow-up tests and treatments that create unnecessary anxiety and expense. This, nearly everyone agrees, is the major advantage of the vaccine for women who are already being screened.
But is the benefit of reducing false positive worth the cost of the vaccine? The answer turns on how long the vaccine protects the patient, says Myers.
In Merck's trials, the average patient was followed for just three and a half years before the FDA “fast-tracked” approval. At this point, Merck can only say that it believes the vaccine will remain effective “for at least five years.” After that, patients may well need expensive booster shots. And that expense could easily wipe out any savings achieved by avoiding “false positive” Pap tests.
How long would the vaccine have to last to be cost-effective? “From a public-health perspective five years isn't long enough,” says Meyers. “Ten years isn't long enough. Fifteen years is long enough.”
While the benefits of the vaccine remain uncertain, a 2003 study published in JAMA points to one clear risk: the danger that “women who are vaccinated [will] perceive themselves to be at low risk for developing cancer and, as a result [will] not participate in screening as recommended.” If they are lulled into a false sense of complacency, the study acknowledges, “gains from the vaccination may be offset.”
Pap smears are uncomfortable, and teenagers, in particular, tend to be self-conscious about gynecological exams. No one can predict how they will react. But one 25-year-old, a public school teacher in New York City, offered her opinion to me: “If I was vaccinated, there is no way I would have gone for Pap tests when I was in high school -- or even in college. Besides, the vaccine is going to protect you isn't it? I heard it's 100 percent effective against HPV.”
Even before Gardasil was approved by the FDA, Merck began breaking ground for its new product by funding a million-dollar television and magazine campaign which stresses the connection between HPV and cervical cancer. The “Tell Someone” ads depict mothers, with arms around their daughters, expressing surprise as they learn how many people are infected by HPV:
“Millions? That's insane,'' says one woman, wide-eyed.
“You can have HPV and not even know it,'' says another professional actress.
Merck's logo flashes briefly on the screen with no mention that it has a product on the way. Many women thought that they were watching a public-service announcement.
In truth, the ads exaggerate the threat. While the vast majority of sexually active women can expect to be infected by HPV at some point during their lives, most of these infections clear up without doing harm. Only a small percentage led to changes in the cervix that can develop into cancer. Even then, years elapse between the initial infection and the development of malignancy, leaving plenty of time for screening to intercept and prevent the cancer.
Merck's critics accuse the company of using scare tactics to drum up business for Gardasil. But when a Bloomberg reporter raised the question, a company spokesperson said that the campaign was merely “part of a broad and longstanding Merck public-health commitment to encourage education about the disease.''
While there may be questions about the need for Gardasil in the United States, there is no question that cervical cancer remains a scourge in the developing world. Worldwide, more than 200,000 women die of the disease each year -- mainly in countries where women do not have access to routine screening. But it is precisely these countries which are least likely to be able to afford a $360 vaccine.
Traditionally, drug-makers explain that they must charge high prices to cover the cost of researching and developing both the product in question, and the many others that never make it to market. But in a particularly candid moment, Pfizer Chairman Hank McKinnell admitted that this just isn't true. “It's a fallacy to suggest that our industry, or any industry, prices a product to recapture the R&D budget,” McKinnell explained in his 2005 book, A Call to Action. "Business doesn't work like that. Those are ‘sunk costs.' … [H]ow do we decide what to charge? It's basically the same as pricing a car, a consumer product, or an appliance. What will it take to sustain investors' confidence in the risk and rewards of an industry?"
"If we don't generate sufficient income in the eyes of our investors," McKinnell continued, "they will shift their capital to companies that can put it to more productive use, our stock will go down, and we'll have less capital with which to work.”
In other words, Merck arrived at the $360 figure after asking itself, “How much do we have to earn this year and next to meet Wall Street's expectations?" Merck sorely needed a new revenue stream. Zocor, its cholesterol-busting drug, lost its patent protection in June, and Merck still faces some 11,500 lawsuits over its once-popular painkiller Vioxx. Little wonder that, when it came time to price Gardasil, it picked a high number.
The good news is that, in June, the Bill & Melinda Gates Foundation pledged a $27.8 million grant to conduct a five-year effort to make the vaccine available in the developing world, and Merck has promised to cooperate. But unless the company offers a drastic discount, $27.8 million will only begin to cover the cost of buying and distributing Gardasil to the hundreds of thousands of women who need it.
When asked how much of a discount the company might offer, a Merck spokesman said that the question was “premature.” For now, the company is eying the “118 to 120 million women in the 11 to 26 age range in the U.S., the EU, and other high-income countries.”
If everything works as planned, Wall Street analysts predict sales of Gardasil could surpass $4 billion by 2010 -- and that's just if Merck peddles the vaccine to girls. The company had originally hoped to get the vaccine approved for boys, too. But, The New York Times reports, “although women have routinely allowed swabs to be taken of their vaginal cells, the company found that men rebelled against the use of emery boards to collect cells from their penises.”
Rest assured, Merck is working on the problem. Reportedly, the company has found that men are less skittish if they use jeweler's grade emery paper.
Maggie Mahar is the author of Money-Driven Medicine: The Real Reason Health Care Costs So Much (Harper/Collins 2006).
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