terça-feira, 29 de agosto de 2006

Vacina para HPV/câncer do colo do útero e a "inverse care law".

Jornais divulgam o lançamento da vacina para o papilomavírus no mercado indicado para mulheres entre 12 e 26 anos sem atividade sexual para prevenir a infecção pelo vírus e, consequentemente reduzir o risco de câncer de colo uterino. A vacina é administrada em três doses com imunidade por cinco anos. O custo será de R$120,00 por dose, "proibitivo" na rede pública conforme declara o Secretário de Vigilância à Saúde do Ministério. A vacina será acessível somente a quem puder pagar e, quem o fizer receberá um recibo no valor da vacina e, ela própria ou o responsável poderá abater o valor total (R$360,00) no imposto de renda. Aliás, há uma contradição no preço ou na moeda utilizada pela Merck Sharp Dohme do Brasil, o informativo The Nation´s Health da American Public Health Association fala em US$360, o preço das três doses nos Estados Unidos. Comentário: o câncer de colo uterino é das doenças mais associadas às pobreza e deprivação social. Julian Tudor Hart desenvolveu a "inverse care law' que ganhou o apelido de lei de Tudor Hart. Com certeza, estamos mais uma vez comprovando o epidemiologista galês, ainda vivo e, repetindo a sua mesma assertiva há mais de 30 anos. "The availability of good medical care tends to vary inversely with the need for it in the population served. This ... operates more completely where medical care is most exposed to market forces, and less so where such exposure is reduced. The market distribution of medical care is a primitive and historically outdated social form, and any return to it would further exaggerate the maldistribution of medical resources." Hart JT. The inverse care law. Lancet 1971; i: 405-412.

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Paulo Lotufo disse...

From The Nation's Health

New Vaccine for Cervical Cancer Virus Raises Access Questions: Vaccine Approved
Posted 08/02/2006

Donya C. Arias

Now that a cervical cancer vaccine has won federal approval and has been recommended for routine vaccinations, questions remain over who will actually receive the vaccine and when.

A new vaccine against the two most dangerous strains of the human papillomavirus was licensed by the U.S. Food and Drug Administration in early June. Later that month, the federal Advisory Committee on Immunization Practices unanimously recommended that the vaccine, known as Gardasil, be routinely administered to 11-year-old and 12-year-old girls.

"This is a huge breakthrough for public health, for prevention and for cancer prevention," said APHA member Anne Schuchat, MD, director of the Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases.

The CDC Advisory Committee on Immunization Practices recommended that 11-year-old and 12-year-old girls routinely receive the vaccine to have a maximum impact, as vaccine immune response is higher in younger teens. The committee said the vaccine also could be used in girls and women ages 13–26, and as young as age 9 at the discretion of a health care provider. Ideally, the vaccine should be administered before a female is sexually active.

"The goal should be to get this vaccine to the largest number of people at the most effective time," said James Wagoner, president of Advocates for Youth, a group that has been outspoken in its support for the vaccine.

Health advocates heralded the news as a public health landmark, considering cervical cancer kills an estimated 250,000 women worldwide each year. And even traditionally conservative organizations that had been on the record calling for abstinence over inoculation — as HPV is sexually transmitted — seemed swayed in recent months by the science that showed the vaccine could significantly reduce the cancer's death toll within a generation.

One issue that may still draw fire is whether the vaccine will be a mandatory requirement for school attendance, which has caught the attention of both reproductive health advocates and pro-abstinence groups such as the Family Research Council.

"This appears to be a real step forward in health care for women," Charmaine Yoest, PhD, MA, spokeswoman for the Family Research Council, told The Nation's Health. "But we believe parents have the right to control their children's health care."

Wagoner, however, said he is hopeful that the new vaccine will be tied to school attendance.

"I think that makes good public health sense and good common sense," Wagoner told The Nation's Health. "From a public health perspective, if anything, this vaccine was a no-brainer."

Kirsten Moore, president of the Washington, D.C.-based Reproductive Health Technologies Project, said she wasn't surprised the furor over the vaccine seemed to die down just as FDA and the vaccine advisory committee were giving approval. Unlike the fight over emergency contraception, which has dragged on for the past three years despite many advocacy efforts and much scientific support, Moore said the HPV vaccine issue leaves the door open for both choice and compromise.

In clinical trials, the vaccine was 100 percent effective in preventing four strains of HPV, two of which are linked to 70 percent of all cervical cancer cases. But it does not protect against other strains of the virus or such sexually transmitted diseases as HIV, so those who have been vaccinated should still receive annual Pap smears and practice safe sex.

Vaccine Recommended for Federal Program
The advisory committee also recommended that the HPV vaccine be included in the federal Vaccines for Children Program, a victory for those who were concerned only the wealthy could afford the estimated $360 price tag for the three-shot regimen. The Vaccines for Children Program provides free shots to an estimated 40 percent of U.S. children and is aimed at children enrolled in Medicaid, American Indian and Alaska Native children and the uninsured.

The next steps, now that the federal Advisory Committee on Immunization Practices has issued a recommendation, are for officials with CDC and the U.S. Department of Health and Human Services to sign off on the advice, which they are expected to do. Once that happens, states typically follow the committee's lead and issue guidelines for vaccination.

Unlike other infectious diseases, there is no typical "high risk" population for contracting HPV. An estimated 80 percent of women have been infected, most with no ill effects, by age 50. But cervical cancer tends to be most deadly among lower-income minority women and those in developing countries. Health experts believe the higher death rates are tied to the fact that regular Pap smears can help detect cervical cancer and its precursors while still treatable, but women with little or no preventive care are likely to go undiagnosed until the cancer is terminal.

To help improve access in developing countries, the Seattle-based non-profit group Path in June launched a five-year effort to bring the vaccine to women in India, Peru, Uganda and Vietnam. The long-term goal of the program, which is being funded by a $27.8 million grant from the Bill & Melinda Gates Foundation, is to guide worldwide introduction of the vaccine and help design appropriate ways to deliver it, especially in countries where women receive little to no preventive care.

"Cervical cancer disproportionately affects women in developing countries because infrastructure is lacking," said Path Program Director Jacqueline Sherris, PhD. "Local health systems don't support preventive health care like routine Pap smears.

While simpler screening approaches are emerging, vaccines are the best hope for lowering the death toll of this disease in the long run, and could even make rates in the developing world as low as in wealthier countries."

In the United States, one question surrounding vaccine access is whether insurance companies will provide coverage. Insurance industry officials said in June they expected to review the federal recommendations and begin providing routine coverage within about three months, although the process could take as long as a year.

"Obviously, the decision-making process that the (Advisory Committee on Immunization Practices) has gone through is very important and is one of the main things health plans will look at in terms of benefit coverage," Mohit Ghose, spokesman for America's Health Plans, told The Nation's Health.

Price pressure also could help improve access globally and for the nation. Currently, Merck is the only company with an FDA-licensed vaccine, but GlaxoSmithKline is expected to come out with a cervical cancer vaccine within a year. Also, public pressure for affordability could help drive down the price of the three-shot series, said Advocates for Youth's Wagoner.

"I think some pressure around price may be the next advocacy wave," Wagoner said.

Moore said she would like the new vaccine to be integrated "into a service delivery model that becomes an opportunity for doctors" to have discussions with patients about taking care of their bodies and protecting their health.

"It's easy for us to look at a shot or a vaccine as being a silver bullet technology," Moore said. "It's not going to happen in the real world."

The popularity of the vaccine in the United States could depend largely on parents deciding whether their children should be vaccinated. Further clinical trials might lead to a recommendation for pre-teen boys to be vaccinated as well because HPV causes genital warts in both sexes.

Based on years of clinical trials, the Gardasil vaccine, manufactured by Merck, prevents cervical cancer, precancerous genital lesions and genital warts due to HPV. People who have not acquired HPV would get the full benefits of the vaccine. CDC officials estimated there are 9,710 new cases and 3,700 deaths from cervical cancer in the United States each year.

For more on the vaccine or HPV, visit www.fda.gov or www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm. For more news from The Nation's Health, visit www.thenationshealth.org.

— Donya C. Arias