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Guest post by Leslie Botha, S.A.N.E. Vax
Increasing Number of Consumers are Concerned over HPV Vaccine Safety
The FDA’s December 22, 2010 ruling to expand the use of Gardasil for anal cancer prevention is unacceptable, according to Norma Erickson, President of S.A.N.E Vax. Last Wednesday, the U.S. Food and Drug Administration approved Gardasil for the prevention of anal cancer and associated pre-cancer lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years. Immediately, the news flooded the media – with many postings on HIV/AIDS sites.
However, medical consumers are unaware the 2010 Gardasil® Patient Product Information (PPI) states if a woman has “…immune problems, like HIV infection, cancer, or takes medicines that affect the immune system” they must be reported to the health care provider. This should be of grave concern to HIV/AID patients and their physicians who may consider the vaccine to “prevent” anal cancer.
Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females, and for the prevention of genital warts caused by types 6 and 11 in both males and females in the same age group. This same demographic has reported over 20,915 adverse reactions – mostly from Gardasil to VAERS – the Vaccine Adverse Event Reporting System. In addition, 89 deaths and 382 abnormal pap tests post vaccination have been reported with an estimated 1 to 10% of the population filing, according to the National Vaccine Information Center. The rate of deaths and adverse reactions are reported as a percentage of doses distributed, not doses actually administered, and therefore CDC statistics on reported injuries likely misrepresent their frequency.
Data on adverse reactions from males ages 9 to 26 are just starting to be reported to VAERS. Hundreds of social media sited, journalists, researchers and educators have joined forces to publicly decry the faulty science, data, research and fast-tracking of this vaccine through the FDA.
Of course, Merck & Co. denies a causal relationship between the adverse reactions and deaths to their award-winning vaccine. However, on December 20, the QMI News Agency in Canada reported a Quebec coroner can’t explain why a 14-year-old girl died after receiving a dose of the Gardasil vaccine. Even though coroner Michel Ferland’s report concludes the adolescent girl died from drowning, and while there is no evidence the shot killed the teenager, he is refusing to rule out a link between Gardasil and her death. On December 13, Michael Smith, North American Correspondent, MedPage Today wrote an article titled: Many Fail to Finish HPV Series as Recommended stating that “…Many girls and young women may not be completing all three doses of the quadrivalent human papillomavirus vaccine in a timely fashion…” According to Dr. Lea Widdice, Cincinnati Children’s Hospital Medical Center; in a single-institution retrospective analysis, only 14% of girls and young women completed all three doses within seven months of the first, and only 28% did so within 12 months.
Although statistical data was cited for non-compliance, SANE VAX wants to know if the girls were surveyed for their reasons in not completing the vaccine series. Until the true reasons are known, consumers must remain wary about the potential health dangers from the administration of Gardasil and Cervarix.
According to the FDA there are limitations on the use and effectiveness of Gardasil:
- GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.
- GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
- GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN.
- GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18. GARDASIL does not protect against genital diseases not caused by HPV.
- Vaccination with GARDASIL may not result in protection in all vaccine recipients.
According to the recently revised copy of “Cervical Cancer Prevention, Health Professional Version,” published by the National Cancer Institute (NCI): “The finding of HPV viral DNA integrated in most cellular genomes of cervical carcinomas supports epidemiologic data linking this agent to cervical cancer however, direct causation has not been demonstrated.”
On October 19, 2010 S.A.N.E. Vax submitted a formal letter to Jack Stapleton, M.D., Chair Vaccines and Related Biological Products Advisory Committee regarding Valid endpoint and reliable HPV genotyping for expanded use proposal of Gardasil® vaccine stating… “In the interest of promoting and protecting the public health, S.A.N.E. Vax, Inc. respectfully requests that expanded use for Gardasil® as an anal cancer preventive vaccine be delayed, until such time as the efficacy of the vaccine is properly evaluated using the true endpoint for anal cancer prevention, and a reliable HPV genotyping method for detection of type-specific HPV infections.” The Gardasil vaccine campaign on unsuspecting and ill-informed medical consumers must be halted until an independent study demonstrates the safety and efficacy of the vaccine. As it stands, this is a classic case of pharma/government vs. medical consumers with monumental social/political implications. The HPV vaccine travesty will go down in history as an example of unethical experimental medical procedures harming the health and well being of the very people the vaccines were supposedly designed to protect.
A few things that crossed my screen during my week-long holiday:
- Drug companies are becoming expert at using social media to promote pharmaceutical products. Soon, the US FDA will issue guidelines for such usage.
- Current methods of screening for ovarian cancer have not significantly reduced death from the disease.
- Surveys of women in nine countries reveal that “a range of factors influence a woman’s choice of contraceptive”. D’oh.
- The strange case of the disappearing o.b. tampons.
- “I don’t have a 28-day menstrual cycle, and neither should you”: Anthropologist Kate Clancy on the mythology of the 28-day cycle.
- Menstruation and blood symbolism in The Black Swan.
- Ovulating women don’t want to talk with their fathers, according to new research published in Psychological Science.
- Via CopyRanter, a billboard ad for maxi pads in Pakistan boasts that the pads stop leaks better than WikiLeaks. And it appears to be authentic.
re:Cycling will probably be pretty quiet over the next couple of weeks, as several of us are traveling and celebrating various winter holidays. Look for us to be back in full force after the first of the year.
There’s a new book about the intimate role of the pharmaceutical industry in the construction of diseases, using the example of FSD (female sexual dysfunction). The authors are Ray Moynihan, an Australian investigative journalist with a longstanding interest in this topic, and Barbara Mintzes, Assistant Professor in the Department of Pharmacology & Therapeutics at the University of British Columbia. I haven’t yet seen the book, but listened to the webinar, which is now available on the Canadian Women’s Health Network (CWHN) website.
There were a few things that struck me. One is how blatant the interference of the pharmaceutical industry can be. For example, the webinar includes a reference to an email sent to Lenore Tiefer letting her know that a formative 1997 meeting about female sexual dysfunction was only open to those who were either part of or willing to work with the pharmaceutical industry. Another was the way in which the language about the medical understanding of the cause of FSD tracked the introduction of 3 different potential drugs, each with different targets and different mechanisms. So far, each drug has failed in clinical trials.
The medicalization of human sexuality separates our bodies from our emotional lives, and creates a framework within which emotional or relationship difficulties are seen as being caused by the biological, rather than being interdependent. And little attention is paid to the ways in which pharmaceutical cures may even create relationship problems that were not there before.
There are, of course, parallels with other cases. For example, the idea that menopausal is a hormone deficiency disease makes it much easier to argue that every healthy menopausal woman should take hormone replacement therapy. This replacement language is unfortunately still alive and well in both medical and popular usage.
Another parallel is the construction of “premenstrual syndrome” into a psychiatric diagnosis. This has been provisionally incorporated into the Diagnostics and Statistics Manual (DSM) of the American Psychiatric Association, initially as “Late Luteal Dysphoric Disorder”, now “Premenstrual Dysphoric Disorder”. Among other things, this construction supported the repackaging and marketing of Prozac as Sarafem for this newly created psychiatric disorder, extending the marketability of Prozac beyond its patent expiry date.
The APA is currently working on DSM V, to be published in May, 2013, and there is an opportunity for activism. So far, PMDD is listed in the “needs more research” section. But chances are it will be put forward again for the next edition.
Not only does PMS not turn women into Vikings, heavyweight boxers, or Mexican wrestlers (see yesterday’s post about ads for Kitadol), it does not affect every woman who menstruates. Research using daily surveys to examine patterns of depression and anxiety symptoms in young women found that some women experience symptoms mid-cycle, others pre-menstrually, and still others do not experience mood changes in association with their menstrual cycle.
At least according to the newest ad for Kitadol, a menstrual pain reliever sold in Chile.
According to The Viking Network, Viking women retained property and inheritance rights after marriage, plus the right to divorce a husband who mistreated her or their children, insulted her family, or failed to be a good provider. These are considerably greater legal rights than most women had in that era (approximately 800-1050 CE).
I can think of worse metaphors for menstruating women.
- The National Women’s Law Center issued the 2010 national and state-by-state report card on women’s health, evaluating criteria such as percentage of women with health insurance, access to abortion providers, causes of death, frequency of annual mammograms and pap smears, and many more. As a nation, the U.S. meets just three benchmarks: the percentage of women getting mammograms regularly, the percentage of women visiting the dentist annually, and the percentage of women getting screened for colorectal cancer. FAIL.
- As U.S. readers know, Elizabeth Edwards died of breast cancer this week, at age 61. Amanda Hess takes on the body shaming she experienced from the press, in life and in death.
- More on new TSA (Transportation Security Administration) screening procedures and gender: Judith Levine explains why she’d rather be gazed at than groped.
- Congratulations to everyone at LunaPads on ten years of eco positive periods!
- Tips on avoiding shark attacks: “until controlled tests involving non-menstruating and menstruating women occur, there is no definitive or scientifically proven data that states women are at more risk of shark attack during menstruation.”
Apparently in the US the Republicans are advocating that the general public be given the opportunity to comment on the usefulness or suitability of publicly funded research. While on the face of it this might not seem to be related to menstruation research, it allows targetted campaigns against controversial research, such as that related to sexuality, abortion, etc. Moreover, stigmatized areas of research, like those related to menstruation, may also trigger reactions from people who feel that this is not a suitable topic for study.
In any case, it’s worth double checking titles and lay abstracts with this potential scrutiny in mind.
According to this article in the journal Radiology, menstrual timing affects how sensitive screening mammography is. The authors analysed the results of screening mammographies collected as part of the Breast Cancer Surveillance Consortium. They used menstrual timing (week of the menstrual cycle).
Overall, they found that there were no patterns, but when they subdivided by how recently women had had a mammogram, they found some interesting patterns. For women who had had a screening mammogram during the previous 2 years, they found that the mammography was more sensitive (correctly identified those with breast cancer as having breast cancer) during the first week of the cycle. For women having their first mammogram, the pattern was reversed, with screening during the first week tending to be less sensitive. And for women who had a prior mammogram more than 3 years previously, there was no pattern. The abstract says that menstrual timing did not affect the overall rate of detecting cancer. Other online coverage of this result quotes the author as saying that the difference between the first time detections and the detections in regularly screened women might be due to a difference in the size of tumours found – large tumours are picked up on first screenings, while subsequent screenings tend to find smaller tumours.
The study involved fairly large numbers (about 1200 cases of breast cancer in 380 000 mammograms), the results were found in subgroup analysis and the significance levels were around the 0.05 level. So it’s worth viewing these results with caution, and looking for confirmation in future studies.
In any case, those women with cyclic breast tenderness probably already know that mammograms are less painful if you time them appropriately, and it’s good that that coincides with the best sensitivity for women getting regular screening.