By H. Sandra Chevalier-Batik
June 12, 2009
Should Doctors Be Testing For Allergic Reaction to
Gardasil Ingredients Before Injection?
Old school journalism would have described the Reuters story titled ‘Allergic Reactions to Gardasil Uncommon’, as “having legs”. The ‘Next-Gen’ journalist would describe the story as ‘going viral’.
The implied “No-Worries Mate” message was carried in Newspapers, Blogs and Journals across the Commonwealth and though out the US and EU. As I read the various accounts, I tracked the story back to the original published study, I wanted to know how many study participants, followed over what period of time, at what location, and who designed and funded the study and why.
The study was conducted in Australia, in 2007 and reported in The British Medical Journal in Dec 2008. Sharon Choo of the Royal Children’s Hospital in Melbourne reported that during 2007 more than 380,000 doses of the vaccine had been administered in schools in Victoria and South Australia under the Australian immunization program. Choo and colleagues noted some components of Merck’s treatment — such as aluminum salts and yeast — have been associated with allergic reactions. In the British Medical Journal article, published in late 2008, she and her colleges are quoted as saying, “Our clinical recommendation is that females with suspected hypersensitivity to the quadrivalent vaccine should be evaluated before receiving more doses, and any challenges with the same vaccine should be carried out in a supervised setting.”
In the British Medical Journal Article, Dr Sharon Choo and her Australian colleagues described the results of clinical evaluation, skin tests, and vaccine challenge in schoolgirls with suspected hypersensitivity to 4vHPV. “Thirty-five schoolgirls with suspected hypersensitivity reactions including urticaria (hives), generalised rash, angioedema (swelling of subcutaneous tissues) and anaphylaxis were reported to specialised immunisation services and 25 agreed to be referred to paediatric allergy centres for further evaluation.”
A detailed account of the reactions was noted including previous doses of the vaccine, time and severity of reaction, and previous clinical history. Skin prick tests of the quadrivalent and bivalent HPV vaccines were carried out, and vaccine challenges were administered intramuscularly. The schoolgirls were followed-up by telephone one week after the subsequent dose and any adverse events were recorded.
The researchers report that 19 girls had skin testing of the quadrivalent vaccine and all were negative. Seventeen of the 18 girls subsequently challenged with the quadrivalent vaccine tolerated further doses. One reported limited urticaria (hives) four hours after the vaccine was given.
Choo and associates reported that only three of the 25 evaluated schoolgirls had probable hypersensitivity to the quadrivalent vaccine, and conclude that true hypersensitivity is uncommon. They point out that suspected hypersensitivity reactions such as hives are often “idiosyncratic” and do not increase the risk of adverse reactions in subsequent vaccinations.
Immunisation specialist Dr Jim Buttery, who works at the Royal Children’s Hospital, declared Gardasil safe but said all adverse effect reports are taken seriously. The authors recommend that girls with suspected hypersensitivity to the quadrivalent vaccine should be evaluated before receiving more doses, and call for research into the mechanisms of hypersensitivity to the vaccine.
What is my take away?
OK, I’ve read the British Medical Journal article several times, as well as all the spin-off articles I could track and I have reached a conclusion and still have several questions.
My conclusion is that Doctor Choo and her colleagues were on the right track in 2007. Young women and girls need to be tested for hypersensitivity before being vaccinated with Gardasil.
Just reading the ‘FDA-approved product sheet Merck provides for Gardasil gets you there. The Gardasil product sheet clearly states:
“WHO SHOULD NOT RECEIVE GARDASIL?
Is allergic to any of the ingredients in the vaccine. A list of ingredients can be found at the end of this leaflet.”
The only way to know if a girl is allergic to Gardasil’s chemical amalgam would be to test her BEFORE the shot.
Based on the number of adverse reactions being reported around the world, it is time to step back and add a pre-vaccination safety procedure.
Merck has injected a sense of urgency around the HPV vaccine, that is simply not justified based the ‘developed’ world’s experience with Cervical cancer. In the developed world cervical cancer is rare, detectable and treatable inexpensively with current technology. The only rational for the red-hot hurry is Merck’s shareholders. In the undeveloped world, were cervical cancer is still a very real danger to women, Gardasil is too costly to deploy. It makes far more sense to find ways to get affordable cervical cancer screening and treatment to women in the developing countries, than spend Billions in the developed world chasing down, the possibility of a cancer that is already under control.
In my opinion, Dr Choo had the right question, but didn’t pursue it long enough.
With all due respect to Doctor Choo and colleagues, when did a “Study of 25 Australian girls” that indicated 3-girls with suspected hypersensitivity to the vaccine out of the hundreds of thousands of does administered become a “Study”? If this were consumer survey, 25 would be considered an insignificant sampling, considering some 380,000 doses of the vaccine had been administered in schools in Victoria and South Australia at the time of the “Vaccine Hypersensitivity Study”.
Professor Ian Frazer at University of Queensland is a co-developer of the cervical cancer vaccine. Australia was one of the first countries to roll out a national cervical cancer immunization campaign using Gardasil. According to published government statistics, 700 new cases of cervical cancer are reported each year in Australia, and in 2005 cervical cancer led to the deaths of 216 women The Australia government has strongly supported the National immunization program, and has given every indication that they fully intend to administer the HPV Vaccine to all females aged 12 to 26 in the country.
As of second quarter 2009, approximately 4.7 million doses of Gardasil have been distributed in Australia. According to official Australian government reports, there have been 1,304 suspected adverse events following vaccination with Gardasil. Australian health officials have used the following talking points to describe the Gardasil-related adverse events. American readers will recognize them — we have heard them all before.
• With this number of people receiving the vaccine, even if all are healthy and young, some serious events can be expected within days or hours of vaccination by chance alone and unrelated to vaccination.
• No vaccine is completely without side effects, and so adverse events following immunization are carefully monitored in Australia and regularly reviewed by expert advisory groups.
• A significant volume of reporting of adverse events is often seen shortly after the introduction of a new, widely used vaccine because of the higher degree of vigilance and lack of familiarity with the new product. Many of the reported events (such as headache, feeling dizzy or unwell) may be equally common in people of the same age who have not received the vaccine.
• An April 1, 2009 government report stated that of the 1,304 suspected adverse reactions reported in Australia following vaccination with Gardasil, the great majority have been mild and common problems such as soreness, swelling, or redness at the injection site. Most of the adverse reactions that have been reported are well recognized and listed in the Gardasil Product Information.
What Non-Government Sources Are Reporting
The unofficial reports differ drastically from the reassuring tone of the Australian Health Officials.
In a December 2007 article in the Heraldsun.com.au, (Herald and Weekly Times) Natali Tkacruk Sikora reported that, “ Almost 500 girls have had adverse reactions such as seizures, rashes and paralysis after taking cervical cancer vaccine Gardasil in Australia since it was released in April.”
The article went on to report that as of November 30, 2007, “there had been 496 adverse reaction reports to the Therapeutic Goods Association (Australian equivalent to the FDA Vaccine Adverse Event Reporting System) with the HPV vaccine as the sole suspected cause.” Tkacruk Sikora reported that in the U.S. more than 2220 reports were lodged with VAERS in past 12-month period, including controversial reports of more than seven deaths.
In response to the Herald Sun article, University of Queensland Professor and Gardasil co-creator, Ian Frazer, the Australian Health Department and vaccine manufacturer CSL, dismissed allegations of associated deaths in the US, claiming the women died of unrelated causes. Professor Frazer, a leading immunologist and former Australian of the Year, blamed anti-immunization groups for exaggerating data as a scare tactic against inoculation. (I guess now would be a bad time to bring up Merck’s award winning ‘Scare tactics commercials’ touting the clear and immediate danger of cervical cancer…a cancer that is detectable, treatable and who’s rate of incidence and death has been steady falling for the past 50 years; ever since the invention of and wide spread deployment of the PAP test and minimally invasive cervical cancer treatments.) The article quoted “unnamed leading experts” who defended the benefits of Gardasil and dismissed controversial reports of overseas deaths as unrelated and fictitious. Apparently the “unnamed leading experts” have no problem with obfuscation. I hate to rain all over Doctor Frazer’s patent royalty checks, but healthy, vibrant, American girls have died after receiving the Gardasil vaccine. American girls have suffered critical illness post Gardasil injection. Girls and young women around the world are suffering adverse events after being injected with the HPV-vaccine.
Right now the only common denominator to the injury and death of these young women is the injection of the HPV vaccine, Gardasil. If Professor Ian Frazer, the Australian Health Department and vaccine manufacturer CSL, and the un-named leading experts have proof that the HPV vaccine, Gardasil is not the causative factor, than share it with the parents of the girls who have already been effected and educate the parents of the girls you want to vaccinate.
The injection of Garasil should require a signed informed consent form, a complete medical work-up to determine predisposition to genetic disease, a current assessment of the girls immune system and to quote Choo’s recommendation from the BMJ; “Our clinical recommendation is that females with suspected hypersensitivity to the quadrivalent vaccine should be evaluated before receiving more doses, and any challenges with the same vaccine should be carried out in a supervised setting.”
Until that series of prudent medical protocol is practiced, Australian parents can expect to hear the same bureaucratic babble as the parents in the other Commonwealth counties, America, and the EU.
The Therapeutic Goods Association (TGA) while refusing to reveal detailed results said, “Gardasil was monitored by the US FDA and Centres for Disease Control, and in Australia by the Adverse Drug Reaction Advisory Committee, the Australian Technical Advisory Group on Immunization and the National Immunization Committee.”
The TGA’s Dr Rohan Hammett said: “All . . . advised that current rates of adverse reactions are consistent with those expected with any vaccine.”
…and that statement my dear reader is a topic for another Blog.
British Medical Journal / Research paper: Human papillomavirus vaccine hypersensitivity reactions: retrospective cohort study in Australia BMJ Online
HPV vaccine (GARDASIL) Advice from the Australian Therapeutic Goods Administration 05.05.09-