UBC researchers advocate HPV vaccine scrutiny

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      A human papillomavirus (HPV) vaccine may trigger fatal autoimmune or neurological events in some cases, two UBC researchers say. Their findings come as public-health authorities, who maintain that the shots are safe, are urging young women to get vaccinated to prevent cervical cancer.

      Neuroscientist Chris Shaw and Lucija Tomljenovic, who has a PhD in biochemistry and is a senior postdoctoral fellow in UBC’s faculty of medicine, say that research on the HPV vaccine Gardasil (which is given in three shots over a six-month period) raises serious concerns and that the risk of adverse reactions is largely downplayed. In an interview at their lab, they maintain that the vaccine needs more scrutiny before health agencies promote it in public campaigns.

      “For reasons that are not understood, some people are having terrible reactions to this vaccine,” Shaw says. “Some people are more susceptible. Most people who get these vaccines are fine.…But some people may get sick from these vaccines, so claiming that there are no adverse reactions aside from a sore arm is not strictly true.”

      Shaw and Tomljenovic work out of UBC’s department of ophthalmology and visual sciences’ neural-dynamics research group. The two published a study called “Death after quadrivalent human papillomavirus (qHPV) vaccination: Causal or coincidental?” last month in Pharmaceutical Regulatory Affairs. The study focuses on two young women who were vaccinated with Gardasil and died following symptoms resembling those of cerebral vasculitis (inflammation of blood vessels in the central nervous system). Autopsies revealed no anatomical, microbiological, or toxicological findings that might explain the deaths. Shaw and Tomljenovic’s study showed that autoimmune vasculitis could have been triggered by certain HPV antibodies binding to the wall of blood vessels in the brain.

      “The fact that many of the symptoms reported to vaccine safety surveillance databases following HPV vaccination are indicative of cerebral vasculitis but are unrecognized as such (i.e., intense persistent migraines, syncope, seizures, tremors and tingling, myalgia, locomotor abnormalities, psychotic symptoms and cognitive deficits), is a serious concern,” they wrote. “It thus appears that in some cases vaccination may be the triggering factor of fatal autoimmune/neurological events. Physicians should be aware of this association.”

      Shaw and Tomljenovic concede that the study has limitations: only two case studies and no control group. Their research is ongoing.

      They say the most frequently referenced study of the vaccine’s safety comes from pharmaceutical giant Merck & Co., which developed Gardasil, one of two vaccines approved for use in Canada. (The other is GlaxoSmithKline’s Cervarix.)

      The Merck study involved almost 190,000 females who received at least one vaccine dose between 2006 and 2008. Published in the October 1, 2012, online edition of the Archives of Pediatrics & Adolescent Medicine, the study stated it “did not detect evidence of new safety concerns among females 9 to 26 years of age secondary to vaccination with HPV4 [Gardasil]”. “These findings support the general safety of routine vaccination with HPV4 to prevent cancer,” the study noted.

      Shaw and Tomljenovic note that this study has limitations. “First, we could only detect new-onset conditions requiring ED [emergency department] visits or hospitalizations within 60 days after vaccination; it was not designed to investigate long-term safety outcomes or risk of HPV4–associated recurrence/progression of disease,” the Merck study said. “Second, despite its large size, this study may have had insufficient power to detect very rare conditions.”

      The study was funded by Merck; the lead author receives research support from Merck, GlaxoSmithKline, and other drug companies. “The study sponsor, Merck & Co, provided substantial input into the study design and analytic plan,” Merck reported. “In collaboration with the Kaiser Study Team, the sponsor reviewed data analyses and helped draft and revise the manuscript.”

      Dr. Monika Naus, the B.C. Centre for Disease Control’s medical director of immunization programs and vaccine-preventable-diseases service, says that HPV vaccines are safe. HPV infections cause almost all cases of cervical cancer, she notes, and it’s estimated the vaccine can prevent up to 70 percent of cases as well as precancerous changes to the cervix that require aggressive treatment. During last month’s Cervical Cancer Awareness Week, the organization encouraged women who were born between 1991 and 1993 to get vaccinated at no cost. B.C. began offering the vaccine for free to girls in grades 6 and 9 in 2008.

      “Pap smears are still important for prevention of cervical cancer, but being vaccinated against 70 percent of the cause of precancerous lesions and cancer is a huge boon,” Naus says in a phone interview. “The clinical trials were large; they were done on thousands of women.

      “Bad things happen to people regardless of whether they’re vaccinated,” she adds. “You can drop dead from any variety of causes.…In some of [the vaccine] postmarketing outcome data, the types of issues that have been identified have been attributed to oral-contraceptive use, which is common in this age group of women. That’s an important reason for why we need to have controls. You need to be able to attribute cause appropriately. Safety data is available from many countries’ use [of the vaccine], and there’s nothing concerning emerging.”

      Naus adds that anyone who is concerned about the safety of the vaccine should speak to their primary health-care provider and gather information from reliable websites, not those that are “antivaccine”. “These are very effective, very safe vaccines,” she says.

      Shaw and Tomljenovic, meanwhile, want the potential for adverse reactions to be acknowledged. “We don’t give medical advice; we’re not medical doctors,” Shaw says. “But if people recommend this vaccine, at least recognize there may be significant adverse reactions. Then people can make an informed choice.…Informed consent is something UBC believes in and the Canadian Medical Association believes in.”

      The two are aware of the controversy that surrounds vaccines in general and emphasize that they are not antivaccine. But they can’t help but wonder whether their findings will be brushed aside simply because the topic is so heated.

      “Science evolves by constantly probing and questioning,” Shaw says. “We don’t make policy, but we think…there are certainly more questions to be asked and more experiments to be done. The issue is not a slam-dunk; it’s not over.…In science, the debate is never over.”



      Scepticism is Sometimes Good

      Nov 1, 2012 at 2:17pm

      Thank you for sowing a little doubt in population's mind!
      Lessons in Modern Economy teach us that corporate efforts to increase profits (and keep the shareholders happy) include investing large amounts to convince politicians and other government officials to make important political or legal decisions in their favour (also known as "lobbying"). Even when this has a possible negative (or unknown) impact on our health. The problem with this kind of economy is that truth or reality no longer matters when profit is concerned. Since pharmaceutical companies have discovered how much pay-back their "political investments" will give them, we've seen decisions after decisions taken by officials to enforce or urge systematic vaccination (the annual flu-shot, H1N1 and HPV vaccines are some of the most obvious cases of lobbying pay-offs). It is in fact surprising that so few researchers or medical officials will come forward to express their doubts. But there are also very few of them who will publicly admit that they feel confident this is the best thing to do. Either they are so entangled within the medical system that going public could mean losing their job, or no research dollars are afforded to counter-verify Pharmaceutical's medical "presumptions". Once you're done examining this problematic vaccine, maybe you can start looking at all those natural products currently being ordered off store shelves by Health Canada as a result of more pharmaceutical lobbying. We already know that pure capitalism supersedes environmental issues; we should be clear that it also supersedes health concerns. In a perfect world, lobbying would be forbidden as far as health is concerned.

      Mindano Iha

      Nov 1, 2012 at 2:43pm

      Information in the package insert states that the vaccine has not been tested for carcinogenicity. Absence of evidence is not evidence of absence.

      In addition, there is the extremely relevant issue of “replacement”, a normal phenomenon in virology where strains which have been removed are always replaced by new ones. It is not known to anyone, even the manufacturer, whether the new virus strains are more carcinogenic than the original ones which have been removed.

      In other words it cannot possibly be guaranteed that Gardasil does not increase the risk of cancer before at least the following three issues have been seriously addressed:

      - Lack of carcinogenicity testing of the vaccine
      - Replacement
      - Presence of aluminium bound recombinant DNA (rDNA)

      It may be most inappropriate and have deeply tragic consequences if Gardasil, which is sometimes incorrectly termed a “cancer vaccine” is shown to actually increase the risk of cancer.

      Mindano Iha

      Nov 2, 2012 at 5:12am

      Next time a doctor, vaccine nurse, health authorities, media or other promoters suggest Gardasil, ask them to provide serious unbiased peer reviewed studies with documentation for all these hitherto unanswered questions:
      Whether it prevents cancer, necessity for boosters, whether it increases the risk of cancer, whether there is increased risk of cancer due to the unexpected discovery by an independent laboratory of aluminium bound recombinant HPV DNA, whether Gardasil vaccinated may donate blood without the aluminium bound recombinant HPV DNA causing serious health consequences for the recipient, whether there is increased risk of autoimmune disorders due to the recombinant HPV DNA, if HPV is necessarily an infection transmitted by sexual intercourse, whether the vaccine causes genotoxicity, whether it targets the relevant virus strains in different demographics, whether the strains change in the course of time, adverse events due to concomitant administration with other vaccines, the true numbers and extent of serious adverse events, long term serious side effects, what the results would be if a true placebo had been used in all the clinical trials, what the results of clinical trials would be if Merck had not used their own exclusion criteria, whether there is increased risk of blood clots when Gardasil is combined with hormonal contraceptive pills, whether there is an increased risk of brain damage, consequences of “bridging” - the extrapolation of study results from one group to another, potentially serious consequences if the vaccine is not thoroughly shaken, whether the vaccine will increase the risk of infertility due to polysorbate, whether polysorbate is carcinogenic, health consequences due to the presence of the combination of polysorbate and l-histidine, whether aluminium adjuvant is safe, consequences due to the presence sodium borate (borax), whether the vaccine will increase the risk of miscarriages, stillbirths or babies born with anomalies, whether Gardasil is excreted in human milk, the complete list of ingredients, whether possible benefits outweigh the risks.
      After you are completely satisfied with all the answers, then you can start considering whether or not to take this vaccine!


      Nov 2, 2012 at 11:28am

      Other things to consider: Pap smears are extremely effective at catching pre-cancerous changes in the cervix and preventing cervical cancer. Sales of Gardasil in the third quarter of 2011 totalled $445 million US. It is naive to think that pharmaceutical companies do not have incredible power over research studies, government policies, and resulting public health campaigns.


      Tiny Hope

      Nov 5, 2012 at 7:08am

      MERCK should be enough for people to run the other way! Ever seen Dr. Maurice Hilleman's interview regarding the green monkeys? If not search U tube and you may be enlightened. Oh and don't forget vioxx!

      Laurie Willberg

      Nov 13, 2012 at 4:46am

      A recent meta-analysis performed at UBC completely discounts the Gardasil vaccine http://www.ncbi.nlm.nih.gov/pubmed/23016780
      reveals data misrepresentation by the manufacturer and unproven/unfounded claims.
      The public needs unbiased, independent evaluation of pharma products from independent labs.

      Independent Investigator

      Jul 16, 2013 at 10:51am

      The polysorbate and the boric acid increases Gardasil's lipophilicity and ability to move through the blood brain barrier.L-histidine a vaccine ingredient also an amino acid that is also transported through the BBB.I believe the target is the central nervous system and gardasil has the ability to cause inflammation and brain damage and possibly auto-immunity,due to the toxic composition of the vaccine.Yes,it is a neuro-toxin.Shame on Merck for fast-tracking this aluminum vaccine to market.