Researcher Blasts HPV Marketing

Gardasil Researcher Speaks Out
(Anyone with a daughter considering this vaccine should read this article.  It certainly should enlighten folks on the risk assessments made for vaccines and give a person some sense of what the FDA considers "safe".)

Amid questions about the safety of the HPV vaccine  Gardasil  one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing.

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Dr.[Diane] Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.

She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years.

This raises questions about the CDC’s recommendation that the series of shots be given to girls as young as 11-years old. “If we vaccinate 11 year olds and the protection doesn’t last... we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper. “The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.” She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.

Dr. Scott Ratner and his wife, who’s also a physician, expressed similar concerns as Dr. Harper in an interview with CBS News last year. One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she’d have been better off getting cervical cancer than the vaccination. “My daughter went from a varsity lacrosse player at Choate to a chronically ill, steroid-dependent patient with autoimmune myofasciitis. I’ve had to ask myself why I let my eldest of three daughters get an unproven vaccine against a few strains of a nonlethal virus that can be dealt with in more effective ways.”

Merck and the Centers for Disease Control and Prevention maintain Gardasil is safe and effective, and that adequate warnings are provided, cautioning about soreness at the injection site and risk of fainting after vaccination. A new study in the Journal of the American Medical Association found while the overall risk of side effects appears to be comparable to other vaccines, Gardasil has a higher incidence of blood clots reported. Merck says it continues to have confidence in Gardasil’s safety profile. Merck also says it’s looking into cases of ALS, commonly known as Lou Gehrig’s Disease, reported after vaccination. ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck and the CDC say there is currently no evidence that Gardasil caused ALS in the cases reported. Merck is also monitoring the number of deaths reported after Gardasil: at least 32. Merck and CDC says it’s unclear whether the deaths were related to the vaccine, and that just because patients died after the shots doesn’t mean the shots were necessarily to blame.

"The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC’s Dr. Barbara Slade) were 3.4/100,000 doses distributed. The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year. Indeed, the risks of vaccination are underreported in Slade's article, as they are based on a denominator of doses distributed from Merck's warehouse. Up to a third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine messages is sent home to parents the first day of school. Should the denominator in Dr. Slade's work be adjusted to account for this, and then divided by three for the number of women who would receive all three doses, the incidence rate of serious adverse events increases up to five fold. How does a parent value that information," said Harper.

Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women. But she says the side effects reported so far call for more complete disclosure to patients. She says they should be told that protection from the vaccination might not last long enough to provide a cancer protection benefit, and that its risks - “small but real” - could occur more often than the cervical cancer itself would.

...but is it?
Teen girl suffers permanent brain damage after cervical cancer vaccine

The report includes mention of another girl who died shortly after vaccination.

I'm submitting a whole lot of things to Snopes to see if they can make hide or hair of it...

Merck's Gardasil vaccine is supposed to prevent young women from getting cervical cancer. It really prevents some (but not all) of the genital warts that may lead to cervical cancer. Whether it will prevent cancer is unknown.

As of July, the federal government's Vaccine Adverse Events Reporting System has received over 9,700 reports of problems since the vaccine's introduction in 2006. These include paralysis, seizures, blood clots, and miscarriage. Twenty deaths have been reported although the government has not yet acknowledged a link.

Merck's marketing plan has been to persuade state legislators to make the shot mandatory. Company money has flowed to governors and legislatures to make it happen. Proposed state legislation calls for this vaccine to be given to minors without parental consent.

Vaccines were originally developed to protect the public from extremely contagious diseases spread primarily by air. Now we have dangerous and unproven vaccines mandated in the hope they will guard against diseases that require sex or very intimate contact to transmit. The pioneers of the public health vaccine program would be appalled.  

If we want to remain in control of our family’s health care we need to act NOW.
Please let your governor and state legislator know you oppose mandatory Gardasil vaccination.

American Association for Health Freedom, March 17, 2009

This site has a good repository of article links and summary of where things are right now.

Over 10,000 adverse reactions, including 29 deaths, have been reported to the Vaccine Adverse Event Reporting System (VAERS) in relation to Gardasil -- and that is just from the United States.

Merck has also been pushing for an expansion of uses for Gardasil. In the U.S., the vaccine can also be promoted to prevent two rare vaginal and vulvar cancers, and Merck just recently filed for FDA approval to use Gardasil for boys!

Side effects including paralysis and death have been reported in relation to Gardasil, among many, many others. Yet, on October 21, 2008 the Centers for Disease Control (CDC) in association with the FDA released a report alleging that the vast majority, or even ALL, of the 10,000+ adverse reactions reported are not related to the vaccine. Therefore, they say, Gardasil is safe.

Well, the National Vaccine Information Center (NVIC), which was co-founded by Barbara Loe Fisher, one of the top vaccine experts in the world, is now calling for the CDC and FDA to publicly release the study design, data, and names of principal investigators involved.

To not properly evaluate the risks of Gardasil, they say, is “a callous disregard for human life.” As Fisher said:

 “Parents of young girls and women cut down in their prime -- some of them paralyzed or dead within hours or days of getting Gardasil vaccine -- deserve better answers than a whitewashing of this vaccine’s very serious side effects.”

NVIC has been following the risks of Gardasil closely, and just released a new analysis comparing the vaccine to another for meningitis (Menactra). They found, compared to Menactra, Gardasil was associated with:

• At least twice as many emergency room visit reports (5,021)
• Four times as many death reports (29)
• Seven times as many disabled reports (261)
• Three to six times more fainting reports

Further, there have been a dizzying array of reactions reported among girls who received Gardasil alone, without any other vaccines, such as:

• 34 reports of thrombosis
• 27 reports of lupus
• 23 reports of blood clots
• 16 reports of stroke
• 11 reports of vasculitis
• 544 reports of seizures

On top of this, in the VAERS database there are 467 “rechallenge” reports, which involve cases where there was a worsening of symptoms after a repeated vaccination -- and nearly 60 percent of them are for Gardasil!