by Susan Fletcher, BSc
January, 2009
Continued from Part I
On January 21, 2008, the Oprah Winfrey Show featured an interview with gynaecologist, Christiane Northrup, MD who pulled no punches in her comments about Gardasil®. She remarked, “That vaccine is of great interest to me because there are over 100 different HPV types and this vaccine only targets four of them, and although they are associated with cervical cancer, nobody has ever proved beyond a shadow of a doubt that HPV is the cause of cervical cancer.” Alluding to the possibility that poor innate health is the true cause of cervical cancer she noted that, “You see HPV associated with abnormal Pap smears in women who are on immunosuppressant drugs who have had kidney transplants or who have HIV disease. So it seems that that virus is associated with cancer in those whose immune system is already depressed, you see. So it’s like a marker for a depressed immune system. Where I’d put my money is getting everybody on a dietary program that would enhance their immunity, and then they would be able to resist that sort of thing.”
Celina Carter, BSc.N, was even more emphatic about her disregard for Gardasil®. In her letter to the U of Western Ontario Gazette, her first words were: “The hasty decision by our federal Health Minister to vaccinate young Canadian girls in Grades 6-9 against the human papillomavirus (HPV) is a monstrous mistake.” Referring to the unstinting praise echoed across the country by the majority of health authorities, she objected, “the medical support for this initiative is suspect. As a nurse who has been taught to think critically and use evidence-based practice, I started to research information about the Gardasil vaccine only to be alarmed on every front. I looked to experts at the Society of Obstetricians and Gynecologists of Canada for help to see why they are so enthusiastic about this vaccine and saw, to my surprise, that they were given a $1.5 million grant from Merck: did this money have an impact on their behaviour?” With nothing kind to say about Gardasil®, she ended with, ‘This vaccine and public in-school vaccination program is screaming “scam.” With all the unanswered questions and adverse side effects, why are we supporting this campaign?’1
A March, 2008 online article published by The Financial Times illuminated differences between precancerous lesions of various sorts. The focus of the article was on efficacy demonstrated against grades 2 and 3 cervical intraepithelial neoplasia (CIN2 and CIN3) in ‘Gardasil’ recipients during the FUTURE II pre-licensing study. Although efficacy against the earlier stage CIN2 was found to be significant, that against CIN3 was not. And efficacy against either CIN2 or CIN3 was found to be only 17% for women, some of whom were already infected with any type of HPV at the beginning of the trial. Referring to this, Dr Rick Haupt, head of biological clinical research and head of the HPV vaccine program at Merck, argued, “The total number of CIN that is actually reduced at a population level is actually quite high.” Of course, as well as CIN2 and CIN3, the general term, “CIN”, includes CIN1, the neoplasia most likely to resolve on its own and least likely to progress to cervical cancer.
Abby Lippman professor of epidemiology at McGill University told The Financial Times that CIN2 and CIN3 “have different prognoses and it may be that Gardasil’s effect on each is different. CIN2 lesions very often resolve on their own, whereas CIN3 is more likely to persist and progress to cancer if it is not picked up by PAP testing.” Because of this, she said, “The question is: would the CIN2 lesions in the study have resolved on their own, or was it due to Gardasil?” Another factor that may have helped produce faulty efficacy results is the difficulty in distinguishing between CIN2 and CIN3. According to Dr Warner Huh, a gynaecological oncologist at the University of Alabama, CIN2 pathology can easily be mistaken for that of CIN3. Dr Erick Suba, who has written extensively on cervical cancer, noted that a diagnosis of CIN2 is confirmed only after at least two of three pathologists agree that it is so. Indicating that Gardasil® may be ineffective against cancer, he remarked, “Suggestions for vaccination are premature, because there are unanswered questions about the vaccine…The manufacturers had an important role in promoting premature enthusiasm.”2
One of the recipients of the 2008 Nobel Prize in Physiology or Medicine was Harald zur Hausen, a German scientist who claims to have discovered that HPV causes cervical cancer. According to ace investigative reporter, Janine Roberts, the reason that Gardasil® contains “virus-like particles” is that nobody has been able to propagate HPV in any culture medium including cervical cancer tissue.3 In December, two months after zur Hausen was named a winner, the Toronto Star reported that Swedish anti-corruption agents were investigating allegations that AstraZeneca had unduly influenced the selection of award recipients. AstraZeneca is a pharmaceutical giant which holds patents on HPV vaccine ingredients. It contributes financially to infrastructure of the Nobel Prize process, has a director who is a member of the Nobel Assembly and, until 2006, employed as a consultant the present chair of the Nobel Committee.4
The Institute of Infection and Immunity of the Canadian Institutes of Health Research is funding a study to determine whether testing for HPV would be more accurate than the Pap test in finding evidence of cervical abnormalities. The study includes more than 33,000 Vancouver women aged 25 to 65 years. Results from three different study groups will be compared so that the best schedule for testing may also be determined. One group will be tested annually using the traditional Pap test or the HPV test; another will be HPV-tested again after two years if their first HPV test results were negative; and the third group will be HPV-tested after two years and again after four years if HPV was not found previously. Both Pap and HPV testing are problematic: the former often generates false positives while the latter generates false negatives. However, ethnicity and the age of the female being tested may also be found to affect reliability. A study led by Guglielmo Ronco and published in the Journal of the National Cancer Institute showed that HPV tests generated more false positives for women under 35 years than for older women.5
On April 28, 2008, the US FDA sent a warning letter to Merck and Company, Inc. It complained of many irregularities in vaccine and drug production found at their West Point, Pennsylvania manufacturing facilities between November 26, 2007, and January 17, 2008. One of the vaccines specified in the letter was Gardasil®. Sections of the very long letter discussed problems with production and process controls, investigations of production failures, lab controls, building facilities, equipment maintenance and containers and closures. It stated that, “The deficiencies described in this letter are indicative of your quality control unit’s inability to fulfill its responsibility to assure the identity, strength, quality, and purity of your drug product and drug substance.6
Amazingly, the following December, Merck Frosst Canada was awarded the Prix Galien Canada 2008, the “Nobel Prize for pharmaceutical research”. In their self-aggrandizing press release, Merck Frosst declared, “GARDASIL has benefited from 10 years of research and development including over five years in clinical trials involving close to 25,000 people in 33 countries. Its research program is one of the most extensive in terms of subjects studied and length of evaluation supporting the approval of a vaccine.” Five years should be the minimum length of time for vaccine trials, especially those testing efficacy and safety of vaccines which target slowly developing diseases such as cervical cancer. And “25,000 people in 33 countries”? That works out to an average of 756 per country, with only 378 of them receiving the vaccine. How many Canadians were trial subjects – or were any? And yet Merck Frosst boasts, “this award is given to the product that has made the most significant overall contribution to patient care in Canada in terms of efficacy, safety, benefits and innovation.”7
The day before the Prix Galien announcement, the National Vaccine Information Center sent out an E-Newsletter with the most recent information concerning US Vaccine Adverse Event Reports. As of the end of October, 2008, there were 9,762 Gardasil- related adverse events, including 30 deaths reported.8 In Canada, seldom are we told about the fate of vaccine recipients.
Apart from the mounting toll of injuries and deaths, little has changed in our knowledge of HPV vaccine. As of December, 2008, five significant reasons to question the advisability of being injected with Gardasil® remain:
Despite what health authorities and the media who quote them have been telling you, it remains unknown whether or not HPV causes cervical cancer.
Despite what health authorities and the media who quote them have been telling you, it remains unknown whether or not Gardasil® can prevent cervical cancer.
Despite what health authorities and the media who quote them have been telling you, it is unknown what percentage of cervical-cancer-associated HPV is represented in Gardasil®.
Despite what health authorities and the media who quote them have recently been suggesting, it is still unknown how long the first three-dose series of Gardasil® may remain effective against HPV infection.
And, despite what health authorities and the media who quote them have been telling you, Gardasil® is not “safe”.
Susan Fletcher, BSc
References
- ‘Government wrong to push human papillomavirus vaccine’ by Celina Carter, BSc.N; Letter to the Editor; U of Western Ontario Gazette; January 23, 2008
- ‘Merck’s Gardasil vaccine shows limited efficacy on precancerous grade 3 cervical lesions, physicians say’ by Klara Czobor and Sasha Damouni; The Financial Times Limited 2008; March 6, 2008, 13:49
- ‘HPV Vaccine Mysteries: Why is a Nobel Award Being Given For This On December 10th?’ by Janine Roberts; Dec 2008
- ‘Nobel corruption probe launched’ by Stuart Laidlaw; Toronto Star; Dec 18, 2008, 4:30 AM
- ‘A landmark study to compare HPV tests’ by André Picard; The Globe and Mail; March 25, 2008, 9:31 PM EDT
- Warning letter from the US FDA to Merck, April 28, 2008
- GARDASIL(R) honoured with a Prix Galien
- ‘Gardasil Deaths, Injuries and Money’ by Barbara Loe Fisher; NVIC Vaccine E-Newsletter; Dec 10, 2008
