Volume 6  Number 6  August 27, 2009
Second Opinions

Galloping with Gardasil

"Certitude is not the test of certainty. We have been cock-sure of many things that were not so."
Justice Holmes

"I respect faith, but doubt is what gets you an education."
Wilson Mizener

Imagine for a moment that a new vaccine against cancer has been developed by two major drug companies and approved by the FDA. This cancer seen, only in women, has been decreasing worldwide thanks to an effective screening test that is simple and 99% effective. The new vaccine has never been shown to prevent this type of cancer since the studies that led to its approval by the FDA did not really measure it. Rather scientists used related precancer surrogates that predict invasive cancer only 10% of the time. In any event, it will take another 15-20 years to show that the vaccine actually works to prevent this particular cancer since it is being given mostly to younger girls and women well under the age of 30 when this cancer usually strikes. Like all vaccines, adverse reactions do occur with immunizations, and rarely, even death. (See below.) The FDA admits that the virus targeted by the vaccine does not alone cause this cancer. Even if the vaccine works against specific viruses, as claimed, it does not protect against 30% of these cancers anyway.

The vaccine is said to provide limited protection for only 5 years, yet the new vaccine is approved for girls and young women. According to my co-author, Dr. Paul J. Rosch of the American Institute of Stress, "one million girls would have to be vaccinated to prevent this cancer in 4 or 5 individuals and since this is fatal only in a third, you might possibly prevent one or two deaths at a cost of $400 million or more" (March 200909 Newsletter).

A series of three immunizations costs between $400 and $1000, depending on where and by whom it is given, making it the most costly vaccine on record. To protect fully against this cancer, regular traditional cancer screenings will have to be done anyway throughout life.

Knowing that there is some risk, yet no proven protection against this increasingly uncommon cancer, which can routinely detected by screening, would you take this vaccine or have your daughter receive it?

Put your imagination aside for now. The new vaccine does indeed exist, as you know, and is described as a "cervical cancer vaccine" Gardasil, by Merck, and Cervarix by GlaxoSmithKline, that targets the human papilloma virus (HPV), a sexually transmitted virus. It has been publicized extensively, has had FDA approval for almost 3 years, and sales are exploding. 23 million doses have been distributed in the U.S., 40 million worldwide, with more than seven million girls and women having already received the vaccine. Moreover the new vaccine is approved for girls and young women ages 9 to 26 and is recommended for routine vaccination of girls 11 and 12 by the CDC and major medical organizations. Adding to bureaucratic efficiency, the U.S. Citizenship and Immigration Services, following the FDA lead, added the Gardasil vaccination requirement in July, 2008 under a 1996 immigration law that any vaccination recommended by the U.S. government for its citizens becomes a requirement for anyone seeking permanent residency in the U.S. So, if you’re female and over 11, seeking residency here you must have at least one injection of Gardasil.

Attempts have been made to make immunizations mandatory in preteen girls in at least 20 states. An executive order from the Governor of Texas, (who received funding from Merck for his election) that mandated vaccination for all girls entering the sixth grade was subsequently overturned. See this strong letter to the Governor by Dr. Jane M. Orient.

Merck is urging vaccination for women up to the age of 45 and now wants FDA approval for treating boys starting at the age of 9, as well as men, to help prevent genital warts. The advertising campaign suggests that a Gardasil vaccination will mean one less case of cervical cancer. Yet, there are more than 100 types of HPVs and Gardasil targets only four. And about 90 percent of women with HPV infection, who are not treated, have normal cervical cells two years later. Close to 12,000 women are diagnosed with cervical cancer each year, but less than 3,900 die from this, and most have not had Pap smears.

More on Safety of Gardasil

Over 12,400 adverse reactions have occurred as of June 2008, and 32 deaths have been reported, originally blamed on the vaccine. Of the total number of reports, 772 cases were considered serious events, including 32 reports of death. Only 20 of the deaths could be verified; the others included four that were provided by the manufacturer without further information, and eight secondhand reports that could not be verified.

Yet, the FDA and CDC deny any relationship to most of the adverse events and deaths, and maintain that Gardasil is safe. The National Vaccine Information Center (NVIC) is now calling for the CDC and FDA to publicly release the study design, data, and names of principal investigators involved. The centralized federal Vaccine Adverse Events Reporting System (VAERS) was created under the National Childhood Vaccine Injury Act of 1986. It is estimated that only between 1 and 10 percent of all adverse health outcomes which occur following vaccination are reported to VAERS. In a study comparing serious adverse events with Menactra, a meningococcal vaccine vs. Gardasil, in girls that had received only Gardasil, there were 34 reports of thrombosis, 27 reports of lupus, 23 reports of blood clots, 16 reports of stroke, 11 reports of vasculitis and 544 seizures. On top of this, in the government's data base of 467 "rechallenge" reports of cases where symptoms worsened after a repeated vaccination, nearly 60 percent were from Gardasil!

On its web site, Aug. 20, the FDA reiterated its position that Gardasil is a safe and effective vaccine and noted that it will "continue to monitor" safety issues." The health news blog by Deborah Kotz says, "...the CDC study (admits) the monitoring system has some significant flaws. The reporting of adverse events by doctors and patients is voluntary, so there is a considerable amount of underreporting. What's more, 68 percent of the reports were filed by Merck... Of the reports Merck filed, a whopping 89 percent didn't include sufficient identifying information to allow medical review of the individual cases...

"Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,'' Dr. Charlotte J. Haug, wrote in an editorial in a recent issue of The New England Journal.(as well as in the JAMA). "With so many essential questions still unanswered, there is good reason to be cautious." Dr. Haug also added that "There are not a huge number of side effects here, that's fairly certain... But you are giving this to perfectly healthy young girls, so even a rare thing may be too much of a risk" (my italics). In addition, she stated the vaccines have been studied for a relatively short period. Both were licensed in 2006 and have been studied in clinical trails for at most six and a half years. Researchers have not demonstrated how long the immunity will last, or whether eliminating some strains of cancer-causing virus will decrease the body's natural immunity to other strains.

Another paper, Marketing HPV Vaccine, in JAMA described how Merck, whose sales of Gardasil totaled $1.4 billion last year, provided professional medical societies with grant 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. See also this article.

Although the tone of another study, published in The Journal of the American Medical Association was reassuring, the authors admitted that the analysis was based on imperfect data drawn from reports made to a voluntary government surveillance database. An accompanying editorial questioned whether any level of risk is acceptable when inoculating a healthy population against a disease that can be prevented through screening.

Martin F. Sturman, MD, FACP, Paul J. Rosch, MD, FACP

Copyright 2009, Mathemedics, Inc.

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