Archive for the ‘Gardasil’ Category

New York Wants to Mandate HPV for School Kids

Saturday, February 20th, 2010

The Alliance for Human Research Protection (AHRP) reported last week that the New York State Senate Senate is about to vote on legislation permitting a school nurse of doctor the power to vaccinate children under 18 with the controversial vaccine, Gardasil (and hepatitis B) without parental “consent or knowledge.”Gardasil, a human papilloma virus vaccine, promoted by Merck as an immunization against cervical cancer, is riddled with controversy, and covered extensively in the media, and in my previous blogs.

Dr. Diane Harper, an acknowledged researcher who conducted pre-marketing clinical trials for both Gardasil and GlaxoSmithKline’s Cevarix vaccines, blasted marketing strategies for HPV vaccine, offered the New York State Committee her expert opinion on the vaccines. As Dr. Harper and others have already written, its period of effectiveness is unknown, and evidence shows it poses serious risks for some children and young women such that its risk/benefits are highly debatable.

AHRP has stated the bill, S4779B, violates parental rights to make medical decisions on behalf of their children. If a child is harmed by a vaccine given without consent, and, according to this law, beyond the bounds of school authority, who will bear medical, financial, and Legal authority? In a landmark decision last March, the U.S. Supreme Court ruled that in case of severe injuries or death, federal law does not prevent consumers from suing drug companies in State Court.

But who, if anyone would be entitled to sue the drug company or the State of New York-or both- in cases of misadventure following mandated vaccination of the HPV vaccine?To be noted is Merck’s record of aggressive, illegal marketing of drugs including the Gardasil vaccine.According to the AHRP Newsletter, Merck is on record of having bribed state legislators to support similar bills in Texas. Merck indeed made campaign contributions to the Governor of  Texas to mandate Gardasil. Other states are considering mandating HPV vaccinations. In my opinion, the HPV controversy should be investigated by the FTC, and the FDA if not the Congress.For further information, contact: Vera Hassner Sharav at veracare@ahrp.org

Gardasil Redux

Monday, October 26th, 2009

An article in the Philadelphia Bulletin, Oct.25, by Susan Brinkmann, entitled “Gardasil Researcher Drops a Bombshell,” describes more troubling news about the vaccine.

 

Dr. Diane Harper, lead researcher in the development of two human papilloma virus (HPV) vaccines, Gardasil and Cervarix and also a consultant to the World Health Organization , said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15…

“Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine…

In 2007, which was at the height of Merck’s controversial drive to have the vaccine mandated in schools, Dr. Harper remained steadfastly opposed to the idea and said she had been trying for months to convince major television and print media about her concerns, “but no one will print it.”

“It is silly to mandate vaccination of 11 to 12 year old girls,” she said at the time. “There also is not enough evidence gathered on side effects to know that safety is not an issue.”

“…To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guillian- Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.

Dr. Harper also participated in the research on Glaxo-Smith-Kline’s version of the drug, Cervarix, currently in use in the UK but not yet approved here. Since the government began administering the vaccine to school-aged girls last year, more than 2,000 patients reported some kind of adverse reaction … with 4,602 suspected side-effects recorded in total. The most tragic case involved a 14 year-old girl who dropped dead in the corridor of her school an hour after receiving the vaccination.

“I came away from the talk with the perception that the risk of adverse side effects is so much  greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all” said Joan Robinson, Assistant Editor at the Population Research Institute…

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More Glitches with Gardasil

Tuesday, September 8th, 2009

The Gezondheidsraad (Dutch Health Council advising authorities on health matters) admitted in a position Report on cervical cancer.”…Whether HPV vac­ci­na­tion sat­is­fies the…cri­te­ri­on – that the vac­ci­na­tion should be an ef­fec­tive means of pre­vent­ing the rel­e­vant disease – is harder to say. The vac­cines have been de­vel­oped only re­cent­ly and, because the in­ter­val between HPV in­fec­tion and the de­vel­op­ment of cer­vi­cal cancer av­er­ages about twenty years, there are as yet no data to show whether vac­ci­na­tion leads to a fall in the in­ci­dence of cer­vi­cal cancer…”

Yet a few paragraphs later, the Council states: “As­sess­ment against the cri­te­ria sug­gests that the ad­mis­sion of HPV vac­ci­na­tion to the NIP (National Immunization Program) would be jus­ti­fied.” Accordingly,  a mass vaccination program was undertaken. There was such a furor in the Dutch press about Gardasil earlier this year that intended the vaccination plan failed in large part.

A paper “Marketing HPV Vaccine” the JAMA described how Merck, whose sales of Gardasil totaled $1.4 billion last year, provided professional medical societies with gran money the organizations used to develop educational programs promoting the product. “The lectures glossed over questions about the vaccine’s effectiveness and whether booster shots would be needed,” said Dr. Sheila M. Rothman, the paper’s author.

I quoted another study in the JAMA in my newsletter in which the authors admitted that the analysis was based on imperfect data. An accompanying editorial questioned whether any level or risk is acceptable when inoculating a healthy population against a disease that can be prevented through screening.


Questions on Gardasil and Cervarix-1

Wednesday, September 2nd, 2009

An error in the premise will appear in the conclusion.

Baxter’s Law (Anon.)

The new vaccines, Gardasil by Merck and Cervarix by GlaxoSmithKline targets the human papilloma virus (HPV), a sexually transmitted virus of which there are over 100 types. Two have been found in 70% of human cervical cancers, but the vaccine has never been proven to prevent this cancer, since it will take another 20-30 years and millions of patients to prove its effectiveness. Sales are exploding since the vaccine was approved by the FDA in 2006, with 23 million doses distributed in the U.S., and 40 million worldwide. Attempts have been made to make immunizations mandatory in preteen girls in 23 states, as the CDC and major medical organizations have advised routine vaccination for girls beginning at age 11-12.

But wait.  Does this sound like a “slam dunk”? Over 12,400 adverse reactions and 32 deaths have been blamed on the vaccine. Some risk is acceptable in any vaccine proven effective against major diseases such as flu, and measles.  But in a vaccine that probably protects for only 5 years, if it is indeed proven effective for the 5 years it is claimed, against a cancer that is increasingly rare (13,000 cases last year), and virtually 100% detectable by pap screening-almost all 3,900 deaths occurred in unscreened women-one wonders if any risk is worth it.

Since all women vaccinated or not, will continue to require pap screening anyway for detection of cervical or uterine cancer well into adult life, the logic of exposing millions of girls to ANY risk of an unproven vaccine that possibly protects 70% of women, is indeed questionable. If one started immunizing pre-teen girls, it would require booster shots every 5 years until  the average age 30 and beyond, when cervical cancer generally occurs. Would the vaccine, incidentally, the most expensive on record, $400-$1000 per set of three shots, then have to be continued every five years to age 45? Merck, which has already made $1.5 billion on the vaccine has already asked for FDA approval for this recommendation, along with a request for treating boys starting at age 9, as well as men, to help prevent genital warts.

Stay tuned.