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How Vaccine Policy is Made: The Story of Merck and Gardasil

Posted by medconsumers on February 1, 2007

Much has happened since the November HealthFacts took the position that the new cervical cancer vaccine should not be mandated. By now, most of the U.S. is probably aware that donations from Merck, maker of the Gardasil vaccine, influenced Governor Rick Perry’s decision to make Texas the first state to mandate Gardasil vaccinations for all girls entering the sixth grade.

Behind the scenes, Merck was found to be bankrolling similar mandates under consideration in at least 20 other states. In doing so, the company moved from the usual pharmaceutical industry hucksterism (hype the disease, hype the new drug) to blatantly purchasing a public policy that is clearly a windfall for the one and only company that sells a cervical cancer vaccine.

The prolonged nationwide publicity given Merck’s actions frequently overlooked a key element to the question of whether mass cervical cancer vaccinations make sense whether they are mandated or voluntary. Cervical cancer is, by any measure, a rare disease in the U.S., afflicting fewer than 10,000 women and causing about 3,700 deaths each year.

And then there’s the proverbial elephant in the room that no one seems to want to address. It has been known for over three decades who is most likely to get cervical cancer. In fact, it is known by geographical region. So why not save taxpayers’ money, especially at a time when the states are running out of health dollars for children, and provide the vaccine for the girls most in need?

All medical decisions made by and for healthy people boil down to probabilities. What are the odds of dying of the disease that the vaccine protects against? (There are three cervical cancer deaths for every 100,000 women in the U.S.) How protective is the vaccine? (70%, according to Merck) What are the odds of serious harm from the vaccine itself?

The last question is not answerable because the vaccine has only been available for eight months, and several hundred thousand girls must be vaccinated and followed for many years before any rare or even uncommon serious adverse reactions can be documented. The longest follow-up is 4 ½ years, so how long the protection lasts is another unknown.

What makes this vaccine different from virtually all others currently given to babies and young children is the fact that cervical cancer is a sexually transmitted disease. (The hepatitis B vaccine given to newborns since 1991 is the other exception.) There are more than 100 different types of human papilloma virus (HPV), but only 23 are considered high risk. “Rarely can an infection with high-risk HPV develop into precancer or cancer. The majority of HPV infections go away on their own and do not cause any abnormal cell growth,” according to the National Cancer Institute’s Edward L. Trimble, MD. Gardasil protects against two of the cancer-causing strains that account for about 70% of all cases of cervical cancer
Typically, a new vaccine goes into use gradually, and a mandate comes only after several years. The haste with which Gardasil became mandatory in Texas is challenged. “This [cervical cancer] is not a public health emergency, so the government has no right tell parents or kids to have the vaccine or even to opt out,” said Michael Policar, MD, associate clinical professor of Obstetrics, Gynecology and Reproductive Science at the University of California, San Francisco. “You can’t get this disease from someone sitting next to you on a bus. If you have TB, a judge can tell you to take your drugs because you can give the disease to other people and if you don’t take the drugs, the judge can have you confined,” Dr. Policar said in a telephone interview.

Physicians and public health experts quoted in the media were unanimous in their recommendation of the vaccine, though some, like Dr. Policar, do not like the mandate. And all insist that strong evidence supports its safety and efficacy. Physicians seem untroubled by the fact that no published HPV vaccine trial had participants under the age of 15. The CDC recommends the HPV vaccine for 11- and 12-year-old girls, and the American Cancer Society sees the vaccine as appropriate for girls as young as nine years of age. The girls must receive the vaccination before they become sexually active or else it will not be effective.

Why is there so little public discussion among doctors about the wisdom of vaccinating all young girls for a rare disease? “Great question,” responded Dr. Policar. “Certain people are very tied into vaccines—pediatricians, infectious disease doctors, public health doctors—these people have never seen a vaccine they didn’t like. The pressure to vaccinate comes not only from them, but also from industry.”

The rush to make a new vaccine compulsory appears to be all about Merck making as much money as possible before Cervarix, GlaxoSmithKline’s version of the HPV vaccine, comes on the market. “Merck started three to four years ago convincing us that HPV is a dangerous infection,” said Dr. Policar, noting that the company has been overdoing it. “HPV is a marker for sexual activity. The majority of us are infected with it and that doesn’t mean we’ll all get cancer. This is another industry-created disease,” he explained, stressing that all HPV-vaccinated women should have regular Pap tests. (For a critique of the Pap test, see page 4.) Dr. Policar is favorably inclined toward the vaccine, but has reservations about the excessive cost and possible need for booster shots (“it took 30 years to learn that the pertussis vaccine needs a booster”). Dr. Policar said he has been “a paid lecturer on occasion for Merck regarding Gardasil.”

More and more parents worry about the growing number of vaccines now given to babies and young children, according to Barbara Loe Fisher of the National Vaccine Information Center, who notes that 40 vaccine doses are already mandated for babies and young children. Fisher, an advocate for vaccine safety, is concerned that doctors are not giving enough attention to possible harmful effects of Gardasil when combined with other vaccines.

She advises parents to inform themselves. But this is difficult when the trials are funded by the vaccine companies and the last place parents will get an unbiased evaluation of any vaccine are the U.S. Centers for Disease Control and Prevention (federal promoters of vaccines in general) or the American Academy of Pediatrics (represents the specialty that sees all vaccines as a medical triumph). In fact, Fisher’s Web site is the only evidence-based independent Web site on this topic.

Science seemed to take a back seat in the prolonged media coverage last month. The one trial that proved “sustained efficacy up to 4.5 years” was funded by GlaxoSmithKline, and published last year in The Lancet. This is the longest follow-up. The majority of the participants were over 18. About half of these 776 study participants were randomly assigned to receive the HPV vaccine, thus the longest follow-up involves less than 400 women.

And now for the elephant in the room. Cervical cancer is largely a disease associated with extreme poverty, smoking, lack of education, and less than sanitary living conditions. According to a 2005 National Cancer Institute report, most cervical cancer deaths occur in black women in the rural South, Hispanic women living along the Texas-Mexico border, white women in Appalachia, American Indians in the Northern Plains, Vietnamese-American women and Alaskan Natives. These groups are also more likely than other U.S. women to be diagnosed with other diseases like breast cancer, colorectal cancer and heart disease.

Wouldn’t it make sense to aim the Gardasil vaccine recommendation at these women? Or better yet, given the limited federal health dollars, why not spend some money to improve their health in general? The answer, of course, is that this would not suit Merck, who appears to be setting the national agenda on cervical cancer. Nor does it suit the federal government and the special interests—so aptly represented in Congress—who want to do everything to keep companies from shunning the vaccine business as risky and unprofitable. Merck needs to make as much money as quickly as possible from Gardasil before Cervarix goes on the market. Each year in the U.S., about a million girls turn 11. Mandating a $360* series of three injections means an estimated $360 million-a-year market.

It didn’t take long for Merck to experience a well-deserved backlash. Within three weeks of Governor Perry’s announced mandate at the end of January, Merck revealed that it would stop lobbying state legislatures to mandate Gardasil. (Texas legislators are reportedly at work undoing the mandate.) But Merck is not the only company to provide “unrestricted educational grants” to Women in Government, a Washington, DC based advocacy organization of female state legislators. This group, the conduit for Merck donations, has also received funding from Glaxo, as well as Digene, a company that makes a test that detects HPV.

The funding paid off as female state legislators were highly visible in the media coverage given Gardasil last month. The legislators were presenting themselves as champions of women’s health and spreading the word about the dangers of HPV, often quoting worldwide cervical cancer statistics (500,000 deaths annually!! Second leading cause of cancer deaths!!) as if these numbers pertained to U.S. women. The Merck people probably knew that a vaccine company presenting itself as champions of women’s health wouldn’t fly with the public. Much better to send in the female legislators to shill for them.

*This is the most widely quoted price, but a random survey by the National Vaccine Information Center found the price varies considerably and can be as high as $825 plus office visit charges.

Maryann Napoli, Center for Medical Consumers© March 2007

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