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HPV Vaccine Under Scrutiny
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Pharmaceutical giant Merck & Co. has distributed 16 million doses of its HPV vaccine, known as Gardasil, in the United States since the vaccine's 2006 FDA approval. The vaccine protects against some strains of the human papillomavirus (HPV), which is a sexually transmitted disease that causes genital warts. HPV infection has also been associated with cervical cancer.

Merck's aggressive marketing of Gardasil has won pharmaceutical trade group awards, as well as billion-dollar revenues for the company. Parents and activists successfully fought against many of Merck's lobbying efforts for vaccine mandates last year (Education Reporter, March and December 2007), but state legislatures still moved ahead with laws promoting Gardasil in one way or another. Meanwhile, Merck's successful commercials told millions of girls that they could become "one less statistic" if they got the shots.

At least 17 states have enacted legislation requiring, funding, or providing one-sided "education" to the public about the HPV vaccine: Colorado, Indiana, Iowa, Maine, Maryland, Minnesota, Nevada, New Mexico, New York, North Carolina, North Dakota, Rhode Island, South Dakota, Texas, Utah, Virginia, and Washington.˙41 states have considered such legislation, with 24 of them considering requiring the vaccine for school entry - even though the disease is not communicable in a school setting. (www.ncsl.org/programs/health/HPVvaccine.htm)˙

Only Virginia so far has actually mandated Gardasil for young girls. Texas Gov. Rick Perry issued such a mandate last year, but the Texas legislature overruled him. The New Hampshire Health Department announced in 2006 that it would provide the vaccine at taxpayer expense to girls under age 18, giving them a false sense of security in sexual promiscuity.˙Lately, however, reports of adverse effects, skepticism from scientists, and even scrutiny by the mainstream media have made the nation think again about Gardasil.

'Guinea pig' death from HPV vaccine

"My Girl Died as 'Guinea Pig' for Gardasil" screamed a New York Post headline on July 20th. The story recounted how Jessica, a 17-year-old girl described as an "all-American teenager," complained of a pain in the back of her head, soreness in her joints, and fatigue after receiving a second dose of the HPV vaccine. When she later received the third dose of the vaccine, she complained that the same spot in the back of her head hurt again, and within a day she was dead.

The autopsy found no cause of death. Medical professionals are typically reluctant to identify vaccination as the cause of any death, even though no one can deny that unproven vaccines have caused deaths.˙Distraught parents are often met by a wall of silence when they demand answers for the sudden death of a healthy child after vaccination.˙Moreover, courts are rarely willing to hold in favor of vaccine victims, and federal law grants immunity to vaccine manufacturers for much of the harm they cause.

Parents and others, including Jessica's mother, are increasingly alarmed about the real effects of the HPV vaccine, which was approved after little testing on young girls.

Since its FDA approval, allegations have linked Gardasil to 20 deaths, 140 reports of serious adverse reactions, 27 of which were "life threatening," and ten spontaneous abortions.˙Since January 2008, it has also been linked to six cases of the debilitating Guillain-Barre Syndrome.˙The total number of adverse effects reported to the FDA for this vaccine is nearing 10,000, yet the FDA and Merck deny the harm.

In one reported case, a 14-year-old girl who received the vaccine collapsed almost immediately and fell unconscious to the floor, foaming at her mouth. Her blood pressure dropped to only 60/40, and she was described as having "a 60-second grand mal seizure" with "pale clammy skin." In another report, a girl given this vaccine subsequently "experienced a coma and is now paralyzed."

Scientists question effectiveness

Two August articles in the New England Journal of Medicine questioned the value of the HPV vaccine. In one article, Dr. Charlotte J. Haug said that insufficient evidence of the vaccine's effectiveness should make patients and policymakers proceed with caution.

Five years of testing simply cannot predict the long-term effects of Gardasil. Legislators in numerous states have reasoned that girls ages 12, 11, or even younger should receive the shots, since Gardasil is only effective before girls are exposed to the HPV virus through sexual activity. But no one knows whether the immunity from the vaccine will last into those girls' college years or beyond, when they are much more likely to contract HPV. The vaccine is not known to be effective for more than five years; most new vaccines are not effective any longer than that.

Even commercials for Gardasil admit, in the fine print, that "the duration of protection has not been established." According to Dr. Diane Harper, a principal investigator in clinical trials of Gardasil, some girls' immunity to HPV wore off just three years after they received the Gardasil series.

The long-term consequences of the HPV vaccine, just like its long-term effectiveness, are unknown. There have been no studies of possible longer-term risks of the vaccine, such as infertility or cancer.

Cervical cancer, a major killer in Africa and other parts of the developing world, is very rare in the United States. Routine Pap smears have removed cervical cancer completely from the list of the top ten most deadly cancers to Americans; it causes much less than a tenth of the number of deaths that lung cancer and breast cancer cause. Most of the few women who die of cervical cancer each year neglected to receive the Pap test, which would have detected precancerous cells. The abnormal cells take about a decade to become cervical cancer; doctors recommend that sexually active women have Pap smears to check for abnormal cells every one to two years. This recommendation has been extremely effective in reducing instances of cervical cancer.

The second article in the New England Journal of Medicine, from Harvard researchers Jane J. Kim and Sue Goldie, questioned the cost-effectiveness of current plans to implement HPV vaccination. Since Gardasil protects girls only against the strains of the virus that are associated with 70% of cervical cancer cases, sexually active women will still need routine Pap smears.

Merck sells Gardasil for $360 ($120 per shot in a three-shot series). Adding administrative costs, the overall cost to the public is $400-500 per child vaccinated. Doing the math, the cost of vaccinating 100 children will be at least $40,000, but only three out of those 100 will ever be exposed to the HPV types targeted by the vaccine. The average age of diagnosis of cervical cancer is 48 years old. Accordingly, the effective cost is $13,000 for each child who might be protected against a cancer over 30 years in the future.

The government is already providing Gardasil to the nation's poorest girls under age 18, at a likely cost of $1-2 billion. But the Harvard study found that it would become a useful public health initiative for patients on government health plans only if the three-shot series gave lifelong immunity, and if it could reduce the need for routine Pap smears. Gardasil can meet neither condition.

Merck recently received approval to market Gardasil to women ages 26 to 45. Merck also wants to vaccinate young boys, since they can pass on the virus to girls or women, and can themselves develop genital warts if they contract HPV. Angela Raffle, a British cervical cancer specialist, had her say on that idea in the New York Times (8-20-08). "Oh dear. If we give it to boys, then all pretense of scientific worth and cost analysis goes out the window," she said.

Media take a long, hard look

Gardasil enjoyed a long media honeymoon after its FDA approval, with many mainstream media outlets characterizing those who opposed HPV vaccine mandates as backward and anti-science. That changed this summer when the New York Times published two hard-hitting stories examining the case against Gardasil as an effective public health measure or mandate. Those stories informed readers that HPV vaccines were the "first vaccines approved for universal use in any age group that clearly cost the health system money rather than saved it, in contrast to less expensive shots, against measles and tetanus, for example, that pay for themselves by preventing costly diseases." (New York Times, 8-20-08)

Experts from various institutions confirmed that judgment again and again. "This vaccine will be more expensive than all other childhood vaccines put together," said John Schiller, of the National Cancer Institute.

Scientists at Merck made a laudable and successful attempt to create the first vaccine that could prevent some cases of cancer. Publicists at Merck, however, thought they could make billions from a vaccine of questionable safety, effectiveness, and utility — by forcing it on young girls through government mandates. Cervical cancer is not a major killer in the United States. It is preventable apart from the HPV vaccine: through abstinence until marriage by both husband and wife, or through regular Pap smears.

As pharmaceutical companies continue to explore how vaccines might prevent other types of cancers, let's hope they discover some for which there is actually a need. Then the free market, and not bad public policies, will reward the pharmaceutical industry's efforts with substantial profits.

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