Creating A Market For And Testing HPV Vaccines

Photos

Girls 'should get cancer jab at 11'

see larger image

uploaded by bjtindle

A quote from the American Cancer Society web site states:

Seventy percent (70%) of human papilloma virus (HPV) infections are typically gone within one year and 90% are gone within 2 years.

When I read this fact at the American Cancer Society web site, I was stunned. I'm sure I'm not alone in noticing the high pressure national campaign, in print, on television and online, which began last fall 2006, to encourage the female population to be vaccinated with the new genetically engineered vaccine, GARDASIL, being advertised on television using the slogan “One Less” , as a tool to prevent human papilloma virus cancers.

In Medical News Today, it is explained:

One Less is the continuation of Merck's commitment to disease and vaccine education. GARDASIL is for girls and women ages 9-26 years of age. If these girls and women have already been infected with HPV, they may still benefit from GARDASIL because it is unlikely that they have been infected with all four types of the virus covered by the vaccine. To inform and encourage these girls and women, the campaign focuses on a strong and positive message that is designed to empower them to want to become (or help their daughters want to become) "one less" person who will battle cervical cancer.

The Food and Drug Administration (FDA) approved Gardasil, manufactured by Merck, for use in June 2006. It is a genetically engineered protein meant to block the growth of four of the over one hundred viruses that have been identified as human papilloma viruses or HPVs, with approximately 30 being identified, in rare cases, as causing cervical cancer. The FDA approved this vaccine for use in girls and women ages 9 through 26.

The National Cancer Institute (NCI), states at its website that the two leading HPV vaccines, Gardasil, produced by Merck and Cervarix, manufactured by GlaxoSmithKline, are based on, “.... technology developed in part by National Cancer Institute scientists.”

The National Cancer Institute web site further states, regarding HPV vaccines:

Neither of these HPV vaccines has been proven to provide complete protection against persistent infection with other HPV types, some of which cause cervical cancer.

Based on the urgency of the television ad campaign regarding HPV, I would have assumed there was an epidemic of some sort sweeping the nation. In pursuit of additional information on the virus and the vaccines claiming to prevent cancer, I visited the American College of Pediatricians' web site.

While applauding the efforts of all of the researchers, those identified as prelicensure study participants and vaccine manufacturers involved in the development and testing of the HPV vaccines, the American College of Pediatricians raised several points that should be highlighted and brought to the attention of those seeking additional knowledge on the human papilloma virus and the vaccines that have been developed.

The American College of Pediatricians, in a statement at its website, announced the organization's opposition to any legislation mandating HPV vaccination as a requirement for school attendance. They state that excluding children from school, “...for refusal to be vaccinated for a disease spread only by penetrating vaginal intercourse is a serious, precedent-setting action...”, infringing on the rights of parents to make medical decisions for their children as well as the rights of the children themselves.

It is further noted that administration of the vaccine would require explanation to both the parent(s), and the child, the nature of the vaccine. Parents may have chosen not to introduce the intimate subject of sexual activity to their 9 year olds, with most 9 year olds not being sexually active.

The American College of Pediatricians also provides information at its web site regarding the tests conducted. As of 2006, vaccines have been tested on 25,000 females in 33 countries. The Merck trials involved 20,541 women, ages 16 to 26 and 1,121 girls, 9 to 15 years of age. Studies have revealed cervical cancer causing HPV infection is only spread through direct, genital to genital intercourse.

The vaccine studies, as outlined by the American College of Pediatricians' web site, also raise questions concerning the long term effectiveness of these vaccines. Tracking for the Gardasil vaccine spanned 2 to 4 years, with antibody levels of the vaccine peaking at 7 months, with leveling or no change occurring by 36 months.

The organization recommends that until further research is completed, anyone receiving the HPV vaccine should be informed of the limited information available regarding the “....vaccine's potency and duration of protection.”

It is clear, regarding the Gardasil vaccine produced by Merck, that there has yet to be any long term studies of this drug.

At the National Vaccine Information Center (NVIC) web site, a non profit and the oldest parent led organization, founded in 1982, which has advocated reform of the mass vaccination system that has resulted in the vaccine safety movement that began in the 80s, states that one quarter of all reports filed relating to adverse reactions after vaccination with Gardasil reported neurologically related adverse events including loss of consciousness, syncope, defined as the temporary loss of consciousness due to inadequate blood flow and lack of oxygen, with related syncopal events and seizures.

On January 18, 2007, GlaxoSmithKline announced its plan to begin the first study of its kind, comparing their human papilloma virus vaccine, Cervarix with the Merck HPV vaccine, Gardasil.

GlaxoSmithKline's web site states:

The primary objective of the head-to-head trial is to compare the immune responses to HPV types 16 and 18 in U.S. women 18 to 26-years-old. Secondary objectives include evaluating the immune responses to HPV 16 and 18 in women 27 to 35-years-old and 36 to 45-years-old. In addition, the study will compare immune responses to other cancer-causing HPV types. Initial study results are anticipated 12 months after study enrollment is completed, and extended follow up will continue for another 17 months.

It is proposed that this study, by GlaxoSmithKline, will have “two arms”, with each group, divided into age groups 18-26, 27-35, 36-45, with one arm being given the Merck vaccine Gardasil and the other arm, Cervarix, the GlaxoSmithKline vaccine.

This is a troubling scenario. As outlined, this comparative study, although seemingly independent of the ongoing invitation to inoculation campaign, that began in November 2006 soliciting girls and women to be vaccinated with Gardasil, raises the issue that the girls and women being solicited for vaccination with the Gardasil, prior to and possibly during the GlaxoSmithKline study, are in reality themselves to be part of the study. Since no long term studies have been done on Gardasil, these girls and women are part of the long term study as well.

At this time, it needs to be clarified that this is not in and of itself any unique set of circumstances. Since the revision of the FDA's policies for approving drugs, several alliances have sprang up and intertwined among the pharmaceutical companies and organizations under the auspices of the Department of Health and Human Services (DHHS), among those being the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the National Cancer Institute and the Centers for Disease Control.

The field of genetic research, with the largest percentage being used to develop testing for a number of conditions following the identification of specific genes associated with a host of genetic conditions or diseases, is also intricately interlaced in these relationships, with scientists from all of these fields often belonging to numerous agencies and acting as consultants on ethics and policy boards interchangeably.

Because of technological strategies and goals and the inevitable overlap and duplication of work, all of the agencies and drug companies have with one another, they frequently interact, as stated previously when the National Cancer Institute identifies its scientists as having helped to aid in the creation of the two leading HPV vaccines.

Reported in the Boston Globe and released in a New England Journal Of Medicine study in May 2005 conducted by the Harvard School of Public Health with the University of Massachusetts Center for Survey Research, it was found that 41 percent of 107 academic institutions that take part in studies accept research contracts with drug companies that prohibit physicians and scientists from independently disclosing trial results, leaving the findings of the studies to be interpreted and presented by the pharmaceutical companies, entities with an obvious bias toward presenting any drugs involved in any study in a favorable light.

Research hospitals rely heavily on contracts with drug companies and medical device manufacturers for research dollars. Because pharmaceutical companies finance the hospital studies, they can exert influence on how clinical trial results are presented to the public.

The most disturbing aspect of all of these circumstances is the limited time devoted to long term observation of any new drug placed on the market. There may be early indicators of the possibility of a particular adverse result but, concrete evidence may not be available until a significant number of years have passed.

With federal agencies acting in concert with drug companies to aid the drug companies' ability to put their products on the market quickly, without long term studies in place, following participants in any study for no more than five years, it is uncertain the total efficacy of any drug or the harm it may do as a result of long term use.

According to a study done by researchers affiliated with the University of Pennsylvania's Annenberg School for Communication, it was determined the way the HPV vaccine was presented impacted whether women would seek vaccination. An excerpt appearing on line February 6, 2007, from Vaccine News and Commentary from the Ethics of Vaccines Projects of the University of Pennsylvania for Bioethics states:

When considering vaccine mandates, we should not focus our attention on those with strong beliefs opposing vaccination, as the exemption procedures provide, for better or worse, a relatively simple remedy. Instead, we must consider those silent in these debates, those not receiving even basic medical care, much less tracking the minute-by-minute developments regarding Gardasil....

It would be wise for any women or parents, mothers or fathers considering having themselves or their daughter(s) inoculated with either of these or any future HPV vaccines or any genetically engineered drugs to ask for as much information as they can get on these products.

Since the outcome of what will happen, due to lack of long term study, as in the case of genetically engineered human papillomavirus (HPV) vaccines, to any of the girls and women who have received these genetically engineered vaccines is unknown, and with trials to begin shortly on male subjects, everyone should give careful consideration before becoming part of a study, and in this case, consenting to be among the first to be inoculated, possibly becoming part of a study that has not been identified as a study.