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EIGHTEEN DEATHS LINKED TO GARDASIL VACCINE REPORT CLAIMSBy NWV Staff Writer, Sarah Foster
Posted 1:00 AM Eastern
July 17, 2008
© NewsWithViews.comA recent publication by a conservative watchdog group has rekindled media interest in a controversial anti-virus vaccine and sent Big Pharma and federal health agency officials into damage control mode.In a 25-page special report released June 30, Judicial Watch -- a Washington DC-based nonprofit organization that promotes “transparency and accountability in government” – presents evidence based on government documents that in the two years since being licensed by the Food and Drug Administration, Merck & Co’s Gardasil, heavily promoted as a safe and effective vaccine against cervical cancer, has been connected with nearly 9,000 “adverse events,” including the deaths of 18 – perhaps 20 – girls and young women.In addition, there were 140 “serious” events reported (27 categorized as “life-threatening”), with 10 spontaneous abortions and six cases of Guillain-Barre Syndrome – all since January 2008.Guillain-Barre Syndrome (GBS) is a rare, potentially devastating autoimmune disorder that attacks the peripheral nervous system and can lead to paralysis and, occasionally, death. There is no known cure or cause, but a fact sheet from the National Institute of Health says it’s sometimes triggered by surgery or vaccinations. Judicial Watch uncovered a total of 38 cases of GBS have been filed with the FDA since June 2006 (six since January) among girls who had received at least one dose of the three-dose vaccine.The records indicate 10 deaths since last September, bringing the total number of Gardasil-connected death reports in the United States to at least 18 – four of these were from blood clots, nine from unknown or unidentifiable causes.The fatalities include:
“Not only will Gardasil not cure pre-existing HPV, it can also make symptoms worse,” warns Millspaw in the report. “Women who already have the virus without knowing it could suffer massive outbreaks of genital warts or abnormal precancerous lesions, both of which require extensive treatment.”“The outcomes that can result from pre-exposure are disconcerting and deserve far more attention.”Contacted by telephone, Millspaw told NewsWithViews of her concern that Merck did not screen women prior to vaccination for possible HPV exposure or infection.“The reason they target very young girls is it’s easier to assume they don’t have the viruses – but the women are not screened to see if they’ve been exposed. The FDA allows that, which I find very disturbing.”Asked whether the drug could cause sterility, Millspaw told NewsWithViews there’s “no indication” of this – “but they’re now vaccinating very young girls, so it will be years before long-term effects are known. They haven’t done enough tests to know at this point.”Millspaw brought up another long-range possibility. “A lot of scientists are worried that preventing these four strains may just cause other HPV viruses to take their place,” she said. “That could be serious, particularly because while the vaccine protects against two main forms of cervical cancer the other [13] strains are usually more severe.”“Given all the questions about Gardasil, the best public health policy would be to re-evaluate its safety and to prohibit its distribution to minors,” said Tom Fitton in a press release. “In the least, governments should rethink any efforts to mandate or promote this vaccine for children.”BacklashFitton was referring particularly to the action that sparked the most controversy about the vaccine and unleashed a furious backlash against it: Merck’s aggressive lobbying aimed at state legislatures.The company began marketing the drug even before the FDA gave the green light. Not by name – that would be illegal -- but through a sophisticated, high-pressure public relations campaign using TV and Internet ads designed to frighten young girls about cervical cancer and HPV, so that they would accept – and demand – the drug once it became available.But Merck was not content merely to advertise the vaccine and make it accessible to those who wanted it; as soon as it got the high-sign from the FDA it funded a huge lobbying effort to persuade state lawmakers to mandate Gardasil vaccination of young girls, including preteens, as a condition for attending public or private school.The campaign has been fairly successful. To date: 41 states have introduced legislation to require, fund or educate the public about the HPV vaccine and 17 enacted legislation. Three considered making vaccination mandatory.It was too much. Parents and consumer advocates from all points across the political spectrum were outraged, and in Feb. 2007 Merck announced it was dropping its lobbying campaign – though its TV advertising continues. But the lobbying was so intense, many former supporters were inspired to take a closer look at Merck and to question its motives for mass-marketing a drug before it’s been fully tested and evaluated for safety and efficacy.A ‘Wonder Drug’ for Merck?For instance, last July Judith Siers-Poisson, editor of PR Watch, authored a devastating four-part series for CounterPunch, a leftist biweekly newsletter, titled “The Politics and PR of Cervical Cancer,” in which she took a hard look at HPV and Gardasil – “the facts, the hype, and what Merck stands to gain, the marketing campaigns … and the media’s lack of attention to concerns about the rush to mandate vaccination…”“Guardasil is being touted as a “wonder drug” for women. Might it also be a wonder drug for Merck?” Siers-Poisson asked then answered:“In the world of drugs, vaccines for use by the whole population are close to corporate nirvana since they ensure a mass market for prevention instead of having to wait to identify the smaller number of people who actually develop a particular disease. In addition, mandating vaccination helps ensure a mass market and gets the government involved in what would otherwise be left to market forces.”The drug could likely go far in replenishing the pockets of the firm as it recovers from the Vioxx recall, in which Merck’s pain medication was held to be responsible for 27,000 heart attacks and sudden cardiac deaths. Analysts estimate that the Vioxx recall decreased Merck’s stock value, and could cost Merck up to $20 billion in legal settlements.At $360 for the three-shot regimen, Gardasil is the most expensive vaccine the FDA has ever approved. A measles-mumps-rubella combo costs $42.85. The New York Times estimates that making the vaccine mandatory would double the cost of existing vaccine programs. And John Schiller, a senior investigator for the National Institute, told the Times “This vaccine will be more expensive than all childhood vaccines put together.”But whether paid for by insurance, tax dollars, or individual parents – at $360 a patient Merck is guaranteed billions of dollars.It’s already paying off. Even without Gardasil being mandated, the incessant campaign has persuaded millions of young women to be vaccinated – and netted Merck $1.5 billion in sales revenue in 2007, according to the Securities and Exchange Commission.How Serious a Threat?But how serious a threat is the disease which is already costing millions of dollars to vaccinate against?Cervical cancer is a major killer of women in non-industrial nations – as it once was in this country. Worldwide it affects 470,000 women and kills 233,000 each year. This is not the case in the United States thanks to widespread Pap screening. This is a medical screening test involving the examination of cells taken from the cervix to detect pre-malignant and malignant cervical cancer cells. It is named after its inventor, Dr. George Papanicolaou, who developed it over 60 years ago.As a result of routine Pap tests and early, follow-up treatment when necessary, the deaths from cervical cancer plummeted 74 percent between 1955 and 1992, according to the American Cancer Society, and that rate continues downward by about four percent a year.Today in the United States cervical cancer is so rare that it is not on the National Cancer Institute’s list of 13 most common cancers. To qualify as a common cancer, the estimated annual incidence for 2008 had to be 35,000 cases or more.Nor is it among the top 10 deadliest diseases for women, which are heart disease and stroke, followed by lung cancer (third place, with 71,030 deaths), breast cancer (6th, with 40,480 deaths) and colon cancer (10th with 25,700 deaths), according to the American Cancer Society.The American Cancer Society estimates that in 2008, about 11,070 women in the United States will be diagnosed with invasive cervical cancer in the United States and 3,870 women will die from it. The tragedy behind those deaths is that they could likely have been prevented had the women received regular Pap tests and treatment.
Millspaw concludes: “With these statistics in mind, one must ask whether Gardasil vaccination is absolutely necessary, especially for children. At this point in time, we do not know if it will prevent cancer, or whether it will have unforeseen consequences. The American public must ask themselves if Gardasil is really worth the risk. Fast-tracking drugs and vaccines before their safety has been fully evaluated is unethical and dangerous, and until more tests have been completed on Gardasil no vaccination mandates should be established.”
Below is a list from the special report summarizing objections to the vaccine