By John Stone with editorial comments by Dr. David Healy. Originally posted here.
Editorial Note: This post is by John Stone at my invitation. I am broadly speaking pro-Vaccination and reluctant to stray into the Vaccination Wars but the issues about free debate in recent posts seem most acute in this domain. Anyone who even thinks about questioning is vilified.
There are important public policy issues involved in MMR but less so with the HPV vaccine and the Flu Shot. For many working in healthcare, the Flu Shot is worrying. While in Britain it is not compulsory, there is a lot of pressure even though the case for having it seems weak. Elsewhere Flu Shots have been made compulsory. I’m sure many of us wonder what we would do if put on the spot like this.
Some of the strongest Vaccination advocates double up as Pro-Transparency campaigners. A Furor Vaxicanus just doesn’t seem to match up with transparency. John Stone is a Vaccine Safety Advocate who to my mind has also been one of the most reasonable voices commenting on some of the posts on this site over the last year. I don’t know John from a bar of soap (as we’d say in Dublin).
But I do know Rokuro Hama whose work John cites here. Rokuro and the group behind MedWatcher Japan are the most extraordinary courageous scientists and lawyers and all round safety advocates there are. Their MedCheck Bulletin is being made available in English for the first time this week and will be worth following – see MedCheck.
The point being raised by Rokuro goes to the heart of Evidence Based Medicine. When “girls” complain of serious problems after Gardasil or Cervarix, what weight do we put on what they say? What weight do we put on what we know about the biology of the HPV vaccine? What weight do we put on the fact that any effort to ask about this runs into media flak from SMC UK, or SMC Australia, SMC Canada or SMC USA?
In 2012 Katie Couric was the best paid media presenter in the United States, referred to as America’s Darling. Late in November 2013 it was announce that Couric was to give room in her ABC Television show Katie to the subject of vaccine injury from HPV vaccine. The result was an immediate furore.
Wiki recalls aspects of this historic episode:
In December 2013, Couric ran a segment on the HPV vaccine…which critics accused of being too sympathetic to the scientifically unsupported claims that this vaccine was dangerous…For example, Seth Mnookin accused her broadcast of employing false balance. In addition, Alexandra Sifferlin, of Time magazine, compared Couric to Jenny McCarthy, a well-known anti-vaccine celebrity…On December 10, 2013, a week after the original segment was aired, Couric posted an article on The Huffington Post responding to this criticism, in which she stated:
“I felt it was a subject well worth exploring. Following the show, and in fact before it even aired, there was criticism that the program was too anti-vaccine and anti-science, and in retrospect, some of that criticism was valid. We simply spent too much time on the serious adverse events that have been reported in very rare cases following the vaccine. More emphasis should have been given to the safety and efficacy of the HPV vaccines.”
The show which was falling in the ratings was due to be taken off the air the following summer was suddenly terminated 19 December, but not before a follow-up program had been screened giving all its room to the vaccine advocates. This was obviously a huge professional humiliation for Couric, but it was not the whole of the story: on Couric’s website a gigantic battle raged between families of injured people supporting the show and an angry mob of “skeptics” – many of them Australians – who ridiculed them. There were probably more than twelve thousand posted comments in all: more than a thousand apparently came from the keyboard of ubiquitous vaccine program advocate Prof Dorit Reiss, an academic (but not qualified lawyer) from Hastings law school in San Francisco, which is in partnership with Kaiser Permanente who were hired by Merck to study the post-marketing effects of their HPV vaccine Gardasil. Kaiser Permanente are also partners with Centers for Disease Control. While Reiss was more well-mannered than most of the vaccine advocates she dismissed any attempt to discuss vaccine injury as anecdotal, and her tactics were copied and deployed more brutally others. Many people, of course, speculated on how she could post so often while carrying out her professional duties at Hastings.
The episode also closely echoed a campaign earlier in the year to have Jenny McCarthy – widely labelled “anti-vaccinationist” – excluded from broadcasting, an episode which also involved Reiss and her colleagues at Voices for Vaccines. V4V also parades as not accepting pharma money but is in fact an off-shoot of Task Force for Global Health, which does accept pharma money, and is in partnership with the Centers for Disease Control. It is interesting to note that the chair of Task Force’s Board of Directors is leading Atlanta product liability lawyer Jane Fugate Thorpe.
The View from Japan
It should be evident, whatever the words of Couric after the event, that these are not stories about science asserting itself but of corporate leverage and internet bullying. The strategies and their effect say nothing about the quality of the science at all. They speak to the ethics of the proponents. It is particularly salutary to view these events against the background of a recent review of the evidence in the independent Japan Institute of Pharmacovigilance bulletin Med Check – The Informed Prescriber (editor-in-chief Rokuro Hama). Hama is also a special advisor to the Cochrane Collaboration:
Harm of HPV
Abstract: Incidence of serious adverse reactions to HPV vaccine is 3.2% per year according to our recalculation using the latest data (3,200 cases per 100,000 person years). This is almost equivalent to the incidence rate of serious adverse events within 1.2 years after the first vaccination (annual rate of 2.8%) reported in the randomized controlled trials (RCT) of Cervarix. In Cervarix RCTs, the excess incidence of serious reactions, autoimmune diseases and death after 3.4 years comparing with those during 1.2-3.4 years was calculated as 4,000 patients, 630 patients and over 100 deaths per 100,000 person-years respectively. These might also occur in Japan. As to the epidemiological surveys from Europe and North America that Japanese Ministry of Health, Labour and Welfare (MHLW) based on as the evidence for safety of the vaccine have flaws in their methodologies. One study confuses prevalence with incidence, and the other two have serious bias derived from “healthy vaccinee effect”. While there is no evidence confirming that HPV vaccination decreases incidence of and mortality from cervical cancer yet, supposing that the vaccine could halve the cervical cancer mortality, the expected maximum benefit would be two deaths per 100,000 person-years at the most. Hence, the harm experienced is overwhelmingly greater than the benefit expected.
The DisUnited Kingdom
In the United Kingdom media reporting of the harms of HPV vaccines has died out since 2009. An article in the Sunday Express by Lucy Johnston, much sneered at by Ben Goldacre in the Guardian, reported much the same thing as Med Check :
The cervical cancer vaccine may be riskier and more deadly than the cancer it is designed to prevent, a leading expert who developed the drug has warned. She also claimed the jab would do nothing to reduce the rates of cervical cancer in the UK. Speaking exclusively to the Sunday Express, Dr Diane Harper, who was involved in the clinical trials of the controversial drug Cervarix, said the jab was being ‘overmarketed’ and parents should be properly warned about the potential side effects.
It looks as if the article was withdrawn after a complaint by Dr Harper because she had alluded to the aggressive marketing of Gardasil by Merck in the US when the main topic was GSK’s Cervarix and this was not clear in the otherwise sound report. Be that as it may this is still a vaccine where the benefits are six years later still entirely theoretical and speculative and there are apparently many injured young women.
They and their families should be allowed to speak to the world without harassment. The public pays for these very expensive vaccines twice, first through the public purse, then through the harms they inflict.
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