Thursday, December 27, 2007

How vaccine policy is made: the story of Merck and Gardasil

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


Behind the scene, Merck was found to be bankroll similar mandates below consideration in at tiniest 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 i.e. clearly a windfall for the one and only company that sell a cervical cancer vaccine.


The prolonged nationwide publicity given Merck's whereabouts frequently overlooked a key factor to the question of whether mass cervical cancer vaccination make sense whether they are mandate or voluntary. Cervical cancer is, by any measure, a sporadic disease in the U.S., afflicting a reduced amount of than 10,000 women and causing give or take a few 3,700 deaths respectively year.


And then nearby's the proverbial elephant in the room that not a soul seems to want to address. It have been prearranged for over three decades who is most likely to catch cervical cancer. In fact, it is agreed by geographical region. So why not save taxpayers' money, especially at a time when the states are running out of form dollars for children, and provide the vaccine for the girls most in need?


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


The final question is not answerable because the vaccine have only be available for eight months, and several hundred thousand girls must be vaccinated and followed for oodles years before any occasional or even uncommon serious adverse reaction can be documented. The longest follow-up is 4 1/2 years, so how long the protection lasts is another unknown.


What make this vaccine different from virtually all others currently given to babies and young children is the certainty 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 single 23 are considered high risk. "Rarely can an infection beside high-risk HPV develop into precancer or cancer. The majority of HPV infections go away on their own and do not inflict 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 justification for about 70% of adjectives cases of cervical cancer


Typically, a new vaccine go into use gradually, and a mandate comes lone after several years. The haste beside which Gardasil became mandatory surrounded by Texas is challenged. "This [cervical cancer] is not a public condition emergency, so the government have no right tell parents or kids to enjoy 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 subsequent to you on a bus. If you have TB, a pass judgment can tell you to purloin your drugs because you can give the disease to other nation and if you don't take the drugs, the find can have you confined," Dr. Policar said in a handset interview.


Physicians and public health experts quoted surrounded by the media be unanimous in their counsel of the vaccine, though some, like Dr. Policar, do not similar to the mandate. And all insist that strong evidence supports its safekeeping and efficacy. Physicians seem untroubled by the reality that no published HPV vaccine trial had participant under the age of 15. The CDC recommend the HPV vaccine for 11- and 12-year-old girls, and the American Cancer Society sees the vaccine as appropriate for girls as youthful as nine years of age. The girls must receive the vaccination past they become sexually active if not it will not be effective.


Why is within so little public discussion among doctors about the suitability of vaccinating adjectives young girls for a exceptional disease? "Great question," responded Dr. Policar. "Certain individuals are very tied into vaccines--pediatricians, infectious disease doctors, public vigour doctors--these people hold never seen a vaccine they didn't similar to. The pressure to vaccinate comes not single from them, but also from industry."


The rush to make a foreign vaccine compulsory appears to be all roughly speaking Merck making as much money as possible before Cervarix, GlaxoSmithKline's performance of the HPV vaccine, comes on the market. "Merck started three to four years ago convincing us that HPV is a dodgy infection," said Dr. Policar, noting that the company have been overdoing it. "HPV is a pointer for sexual activity. The majority of us are infected beside it and that doesn't mean we'll adjectives get cancer. This is another industry-created disease," he explained, stressing that adjectives HPV-vaccinated women should have regular Pap test. (For a critique of the Pap test, see page 4.) Dr. Policar is favorably inclined toward the vaccine, but have reservations about the excessive cost and possible entail for booster shots ("it took 30 years to learn that the pertussis vaccine wants a booster"). Dr. Policar said he has be "a paid don on occasion for Merck in relation to Gardasil."


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


She advises parents to inform themselves. But this is difficult when the trials are funded by the vaccine companies and the ultimate place parents will get an middle-of-the-road 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 adjectives vaccines as a medical triumph). In fact, Fisher's Web site www.909shot.com is the singular evidence-based independent Web site on this topic.


Science seemed to nick a back form in the prolonged medium coverage last month. The one trial that proved "sustained efficacy up to 4.5 years" be funded by GlaxoSmithKline, and published last year contained by The Lancet. This is the longest follow-up. The majority of the participants be over 18. About half of these 776 study participant were fitfully assigned to receive the HPV vaccine, thus the longest follow-up involves less than 400 women.


And immediately for the elephant in the room. Cervical cancer is largely a disease associated next to extreme poverty, smoking, lack of childhood, and less than sanitary living conditions. According to a 2005 National Cancer Institute report, most cervical cancer death occur surrounded by 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 plausible than other U.S. women to be diagnosed with other diseases approaching breast cancer, colorectal cancer and heart disease.


Wouldn't it make sense to aim the Gardasil vaccine suggestion at these women? Or better yet, given the set federal health dollars, why not spend some money to boost their health contained by general? The answer, logically, 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 maintain companies from shunning the vaccine business as risky and unprofitable. Merck needs to label as much money as quickly as possible from Gardasil since Cervarix goes on the bazaar. Each year in the U.S., give or take a few a million girls turn 11. Mandating a $360* series of three injections means an estimated $360 million-a-year souk.


It didn't take long for Merck to experience a well-deserved backlash. Within three weeks of Governor Perry's announced mandate at the run out 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 individual company to provide "unrestricted educational grants" to Women contained by Government, a Washington, DC based advocacy system of female state legislators. This group, the conduit for Merck donations, have also received funding from Glaxo, as well as Digene, a company that make a test that detects HPV.


The funding compensated off as feminine state legislators were outstandingly visible contained by the media coverage given Gardasil concluding month. The legislators were presenting themselves as champion of women's health and spreading the word roughly speaking the dangers of HPV, recurrently quoting worldwide cervical cancer statistics (500,000 deaths annually!! Second major cause of cancer death!!) as if these numbers pertained to U.S. women. The Merck people probably know that a vaccine company presenting itself as champions of women's robustness wouldn't fly with the public. Much better to dispatch in the womanly legislators to shill for them.

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