Gardasil HPV Cervical cancer vaccine - adverse reactions and 3 recorded deaths in US

Judicial Watch, The US public interest group Judicial Watch released documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing 1,637 reports of adverse reactions to the recently introduced vaccination for human papillomavirus (HPV), Gardasil developed by CSL Ltd of Australia and marketed under licence by Merck (MRK:NYSE). Merck is reported to have acheived sales of US$365 million for Gardasil in Q1 / 2007 - in the US a course of three shots, costs approxiamtely US$120 a dose.. Judicial Watch filed its request on May 9, 2007, and received the adverse event reports from the FDA on May 15, 2007.

3 deaths were related to the vaccine.

1. A physician’s assistant reported that a female patient “died of a blood clot three hours after rceiving the Gardasil vaccine.”

2. Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting.

Of the 1,637 adverse vaccination reactions reported to the FDA via the Vaccine Adverse Event Reporting System (VAERS) by May 11th there were 371 serious reactions.

Of the 42 women who receiving the vaccine whilst pregnant, 18 of them experienced side effects ranging from spontaneous abortion to fetal abnormities.

Manufacturers Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. These are not uncommon side effects to receiving vaccines, more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.

Judicial Watch President Tom Fitton is reported to view the matter with deep concedern and is quoted as saying ...“The FDA adverse event reports on the HPV vaccine read like a catalog of horrors,” ..... “Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports. It looks as if an unproven vaccine with dangerous side effects is being pushed as a miracle drug.”

About 10,000 women were diagnosed with cervical cancer in the U.S. in 2006 and nearly 4,000 died from the disease, according to the American Cancer Society. Bloomberg reported on 30/5/07 that GlaxoSmithKline Plc's competing product, Cervarix cervical cancer vaccine won't get priority review from U.S. regulators - a priority reviews may be given to products that serve an unmet need or represent significant improvements over currently available therapies. Glaxo is also awaiting a decision from the European Medicines Agency on the application it filed for Cervarix in Europe in March 2006. Financial analysts who are interested in the field (well money anyway) claim that Glaxo could be looking at the potential to generate US$1.5 billion a year by 2010 rising to US$5 billion.

Lord Patel has posted previously about the development, approval and the intense marketing of the vaccine, in what appears indecent haste, especially in schools - see especially the controversial Women in Government (WIG) campaign in Texas.

Anyone contemplating a course wuld be well advised to consult their doctor and the following two reports......

Click here for the Gardasil Related Deaths Reported to VAERS / May 11, 2007

Click here for the Vaccine Adverse Event Reporting System (VAERS) Reports / May 11, 2007

UPDATE

Meanwhile - literally hot off the Press .......

The Lancet (subscription only but Summary on Lord Patel's registration here) has published results today show that Merck’s cervical cancer vaccine, GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] was 100 % effective in preventing high-grade vulvar and vaginal dysplasias caused by HPV types 16 and 18, 2 types that are strongly associated with these diseases.

The 100 % protection was observed in women who were not infected with HPV types targeted by the vaccine -- 6, 11, 16 and 18 -- at the start of the study and through one month after receiving the third dose. Data published in The Lancet represent an additional year of follow up since data were presented to the U.S. Food and Drug Administration (FDA) for approval of GARDASIL.

All three studies were double-blind, placebo-controlled randomized studies and were conducted at 157 sites in 24 countries. More than 18,000 women participated in three trials and were between the ages of 16 to 26 at the time of enrolment. They received three doses of either GARDASIL or placebo at day one, month two and month six. The combined analysis evaluated the impact of GARDASIL on the incidence of high-grade vulvar and vaginal pre-cancers (VIN 2/3 and VaIN 2/3), common precursors to vulvar and vaginal cancers in younger women, caused by HPV types 16 and 18.

In the per-protocol population of this combined analysis, GARDASIL was 100 percent effective in preventing HPV 16- and 18-related VIN 2/3 and VaIN 2/3 in women who were not exposed to the relevant HPV types until at least one month after completing the vaccination series; no cases were observed in the vaccine group (n=7,811) compared to 15 cases in the placebo group (n=7,785).

In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent). Presumably, in absence of report no deaths recorded.

This is an interesting website which is opposed to Gardasil vaccination in Europe. It appears to be called LancetRecommendsCompulsoryVaccinationsForChildren - which refers to a Lancet editorial October 2006 which said Europe should take its lead from the US state of Michigan, which passed a bill on September 21 ruling that all 11 to 12-year-old sixth grade schoolgirls should be vaccinated.

PS : It may be said of course that vaccinating females does not preclude males passing the virus about, so there is a good argument, endorsed naturally by Merck and Glaxo that mlaes should be vaccinated as well.

Ther are a large number of blogs reporting / discussing the Lancet report Google Blogsearch