Following the post last week on MedWatcher Japan’s efforts to bring the issue of HPV vaccines to light, my attention was drawn to a recent Wall Street Journal article which stated:
“Japanese women’s health is increasingly at risk as public-health policy is driven by conspiracy theories, misguided political interference and bureaucratic caution. This is particularly evident in the government’s handling of the human papillomavirus (HPV) vaccine to protect against cervical cancer.
In June 2013, just two months after the HPV vaccine was included in the National Immunization Program, the Japanese government made the unusual and perplexing decision to keep the vaccine in the NIP but suspend “proactive” recommendations for it. This was evidently in response to highly publicized accounts of alleged adverse reactions.
The result was that girls in the target age group, from the 6th grade of primary school to the third grade of high school, stopped receiving the vaccine. Vaccination rates dropped to below 1% from about 70%….
The Vaccine Adverse Reactions Review Committee, a task force established by the Japanese Ministry of Health, Labor, and Welfare’s Health Science Council, has repeatedly concluded that no causal link exists between HPV vaccines and professed symptoms, and that most reported cases were likely psychosomatic. A study of 70,960 vaccinated and nonvaccinated adolescent girls from Nagoya also found no significant association between 24 alleged vaccine-induced symptoms and the HPV vaccines….
In Denmark, Kusuki Nishioka, the Japanese doctor who first suggested the HPV vaccine caused brain injuries, appeared on television. The vaccination rate there has since dropped to about 20% from 80%.
The antivaccination movement is gaining traction in Japan. On July 27, 63 young women filed lawsuits against the Japanese government and vaccine manufacturers in the district courts of Tokyo, Nagoya, Osaka and Fukuoka, demanding compensation for alleged side effects from HPV vaccines….
These events are reminiscent of the biggest vaccine scandal in history. In 1998, Andrew Wakefield published “scientific data” in the Lancet as evidence that the MMR vaccine for measles, mumps and rubella caused autism.
Mr. Wakefield’s data was later found to be manipulated, but it was not until 2010 that his paper was retracted and his medical license revoked. Earlier this year, Mr. Wakefield released a movie called “Vaxxed: From Cover-Up to Catastrophe.” Robert De Niro, whose son is autistic, tried to premiere this movie at the Tribeca Film Festival. This once again fueled antivaccine sentiment in the U.S.
We can’t afford to sit back and allow a similar situation to develop in which unscientific claims jeopardize lives around the world. The Japanese government should reinstate its proactive recommendation for the HPV vaccine and set a positive example before irrational fear of the vaccine gains further momentum in other countries”.
Once upon a time it was public health doctors who decided what vaccines became part of national vaccination schedules. In Japan and elsewhere the introduction of HPV vaccines to the vaccination program was engineered by the makers of vaccines. Vaccination is a business as much as or even rather than a matter of public health. See HERE.
When concerns appeared in Japan and the government suspended the heavy promotion of the vaccine it triggered an international response with the Center for Strategic International Studies, a body set up in the Cold War “dedicated to finding ways to sustain American prominence and prosperity as a force for good in the world”, publishing a report on HPV Vaccination in Japan authored by Heidi Larson and others. HL and colleagues are based in the London School of Hygiene and Tropical Medicine, one of the institutions that spawned AllTrials – somewhere with close links to Sense about Science.
You’d never guess from this document that the HPV vaccine was adopted in most countries after intense corporate lobbying. Instead, we are told:
According to experts in rumor psychology, rumors help people make sense of the world and offer an initial explanation for anxiety-provoking information and events. The longer situations of uncertainty and anxiety persist, the easier it becomes for rumors to spread and the more difficult they become to counteract.
Governments need to get in there, we are told, and be the first to provide information; they need to tell people we feel your pain; when people raise concerns they need to be encouraged to “talk to your doctor”, (who of course has been briefed by our side only). Governments are told they need to avoid a vacuum that might be filled by “people who don’t have the public’s best interest at heart”. They need to be on board with Project Fear.
In Europe, especially in Denmark, there has been work in parallel to the MedWatcher Japan efforts, undertaken by Peter Gotzsche and Tom Jefferson who have filed a complaint with the European Ombudsman centered on maladministration by the European Medicines Agency of the safety data for HPV aimed at getting access to the data. Preliminary work on this material had shown real cause for concern – see Jefferson.
In response to the Wall Street Journal’s article above, Peter Gotzsche said:
Tom and a PHD student I employed two months ago are working with CRFs from the EMA on the HPV vaccines. To say that “most reported cases were likely psychosomatic” is an insult to these girls and their families. There are good data that make is pretty likely that most suffer from an autoimmune disease with antibodies against nerve tissue, but whether caused by the vaccine, a virus or something else needs to be found out.
We had a meeting about HPV vaccines on 24 Nov in Copenhagen. One of the presenters showed a slide that in Denmark, provided 100% of 12 year old girls get vaccinated, and that the vaccine is 70% effective, and protects against dying from cancer (which we don’t know but just think), then in the next 30 years, 10 will die if not vaccinated and 7 if vaccinated. Thus, even in the best of scenarios, the effect of the vaccine is likely to be very very small”.
What Gotzsche hasn’t said here is that company marketing of these vaccines has been full of rumors and scaremongering, portraying the vaccine as the last defense against a nasty and aggressive cancer, a defense that is close to completely successful and comes without problems.
In fact Pap Smears manage the problems very successfully, just as hand washing is our best defense against many other infections and both defenses come without a risk of neuropsychiatric adverse events. But we hear nothing about these approaches.
It’s not impossible that some of the Japanese cases are hysterical. The bigger problem we all have is that in the wake of the revelations about Tamiflu and Study 329 it is impossible to accept the bona fides of companies whose health depends on ensuring we get their treatments rather than rely on something else that is safer and costs almost nothing.
There is a certain sense in which the forces that fueled Brexit are fueling a Vaccinexit. If this happens the powers that be will have no one to blame but themselves. Peter Gotzsche and Tom Jefferson knew nothing about MedWatcher Japan before the post last week. The more people like this find each other, the more difficult it will be for the Heidi Larson’s of this world to manage the debate.Share this:
Copyright © Data Based Medicine Americas Ltd.
Heidi Larson | 19 Nov, 2016
It is apt that this week Oxford Dictionaries announced that the 2016 ‘Word of the Year’ is “post-truth” which they define as “relating to or denoting circumstances in which objective facts are less influential in shaping public opinion than appeals to emotion and personal belief.”
James C.Coyne @CoyneoftheRealm
Pharma is in #alltrials big time and no one seems to notice or care.
Note my revised article on Larson who works for the manufacturers of both HPV vaccine products.
John Stone AofA
The public deserves it.
Competing Interests: Heidi Larson serves on the Merck Vaccines Global Strategy Advisory Board and is a consultant to GSK on vaccine confidence.
Nature. 2015 Dec 3;528(7580):9. doi: 10.1038/528009a.
The world must accept that the HPV vaccine is safe.
J Stone2016 Jun 15 07:44 a.m.
In an earlier disclosure from 2015 which I cannot find in this article it is stated:
“HJL serves on the Merck Vaccines Strategic Advisory Board and is a consultant to GSK.”
Although not mentioned in this article Merck and GSK are the manufacturers of the two brands of HPV vaccine, Gardasil and Cervarix, so this may be considered a serious omission.
The two makers of HPV vaccines are Merck (Gardasil) and GSK (Cervarix). I guess it shouldn’t surprise me that the Center for Strategic & International Studies (CSIS) produced this report as part of a major conference on the global experience in addressing cervical cancer. A conference “made possible by the generous support of Merck & Co., Inc. and the Bill and Melinda Gates Foundation”, which heard from Dr. Julie Gerberding, Merck’s executive VP for Strategic Communications, Global Public Policy and Public Health. As well as Donna Altenpohl, VP for Vaccines, Communications and Government Affairs at GSK.
As for Heidi Larson, she serves on the Merck Vaccines Global Strategy Advisory Board, and is also a consultant to GSK on “vaccine confidence.”
The role of the Gates Foundation in all this drives home to me the dangers of letting public expenditures and programs wither, to be replaced by high-level corporate “philanthropy.” These days we are taught to celebrate and admire tech billionaires who announce they are going to solve the problems of our health care system (and our childrens’ education) through massive donations to their private foundations. Not only can this mean a double tax break for the corporations involved, and a decline in the actual funds spent on crucial services. Even more dangerous, it means we privatize the decision-making, letting corporate “philanthropists” shape global policy to echo their private interests.
The American Association for Cancer Research attempts to bolster HPV9 uptake with this probably unintendedly disastrous report:
“Results After controlling for past sexual behaviors, vaccinated women had a lower risk of testing positive for the 4 types included in the HPV vaccine (6, 11, 16, or 18; Table 1). This association became stronger when the number of recent sexual partners was controlled for. However, vaccinated women had a higher prevalence of nonvaccine high-risk types than unvaccinated women (61.5% vs 39.7%, prevalence ratio 1.55, 95% CI 1.22-1.98). After adjusting for the number of recent sexual partners, the difference in prevalence of high-risk nonvaccine types was reduced, but remained significant.
Conclusion HPV vaccination was effective for the protection against all four vaccine types in young adult women. Vaccinated women had a higher prevalence of nonvaccine
high-risk types, which suggests that they may benefit from vaccines that cover additional types of HPV.”
My two cents:
” In the case of the human papillomavirus (HPV) vaccine, an unexpectedly novel disease entity, HPV vaccination associated neuro-immunopathetic syndrome (HANS), has been reported and remains to be carefully verified. To elucidate the mechanism of HANS, we applied a strategy similar to the active experimental autoimmune encephalitis (EAE) model – one of the most popular animal models used to induce maximum immunological change in the central nervous system. Surprisingly, mice vaccinated with pertussis toxin showed neurological phenotypes that include low responsiveness of the tail reflex and locomotive mobility. Pathological analyses revealed the damage to the hypothalamus and circumventricular regions around the third ventricle, and these regions contained apoptotic vascular endothelial cells. These data suggested that HPV-vaccinated donners that are susceptible to the HPV vaccine might develop HANS under certain environmental factors.”
Dr Andrew Wakefield’s 1998 paper NEVER said MMR caused autism.
Neither was any data “manipulated”.
Dr Wakefield’s colleague Dr John Walker Smith who faced the same trumped up charges as Wakefield had his medical license reinstated when he appealed to the British High Court.
With all due respect Dr Healy I think you need to read up about the facts of this case and disregard the media smears against Dr Wakefield which are largely down to Brian Deer.
Just to be clear, the claim about AW is in a Wall Street Journal article. Its not from me
It reminds me of Fiona Godlee and BMJ when they paid Brian Deer to do a hit job on Wakefield and forgot to mention they were partners with Merck and GSK. Even when she was forced to acknowledge it the information was not made available with Deer’s articles, and they failed to acknowledge that BMJ not only carries Merck and GSK advertising but also receives unlimited grants from Merck’s education division Univadis (or certainly did in 2011):
Later on, in a visit to National Institutes of Health, she stated that she had not known that Merck and GSK were MMR manufacturers. It is in this video but I am afraid I don’t have the timing:
Ultimately, they fended off Wakefield’s libel action, brought through the Texas courts, by claiming that BMJ did not trade in the US’s second most populace state. They also claimed to be unaware that Wakefield lived there (despite having published several articles stating that he did).
It amazing how uninformed or amnesiac it is possible to be and still run a leading medical journal for 12 years.
In a review paper published in 2010, Ian Frazer states:
“HPV immunization induces peak geometric mean antibody titers that are 80- to 100-fold higher than those observed following natural infection . Furthermore, after 18 months, mean vaccine-induced antibody titers remain 10- to 16-fold higher than those recorded with natural infection , and these levels appear to be preserved over time, suggesting that immunization may provide long-term protection against infection…”
HPV ‘immunization’ inducing antibody titres that are 80- to 100-fold higher than those observed following natural infection seems to be a very unnatural response…
Is this a good thing? Does anybody know?
Frazer’s review paper is titled ‘Measuring serum antibody to human papillomavirus following infection or vaccination’, published in Gynecologic Oncology 118 (2010) S8-S11, and funded by Merck & Co. Inc. His reference for his high antibody titre comment is a paper by Diane M Harper et al – ‘Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial’, published in The Lancet, Vol 364 November 13, 2004, and funded and co-ordinated by GlaxoSmithKline Biologicals.
In their paper Harper et al state: “Geometric mean titres for vaccine-induced antibodies to HPV antibodies were over 80 and 100 times greater than those seen in natural infections with HPV-18 and HPV-16, respectively. Vaccine-induced titres remained substantially raised at 18 months, and were still 10-16 times higher than those seen in women with natural HPV-16 or HPV-18 infections, respectively.”
And: “We have shown that the HPV-16/18 virus-like particle vaccine adjuvanted with AS04 induces a level of antibody production against HPV-16/18 that is much higher than that induced by natural infection. Previous work has shown that combinations of the adjuvants MPL and aluminium salts induce an enhanced immune response compared with antigen alone or adjuvanted with only aluminium, at both the humoral and cellular level. These findings suggest that the immune responses induced in vaccinated women may provide a longer duration of protection than the protective effects induced by natural HPV infection; however, a protective antibody level has not been established nor is there sufficient data currently available to estimate the duration of vaccine-induced protection.”
Should we be concerned that HPV vaccines produce antibodies over 80 and 100 times greater than those seen in natural infections with HPV-18 and HPV-16 respectively, and which remain substantially raised months after vaccination?
“Should we be concerned that HPV vaccines produce antibodies over 80 and 100 times greater than those seen in natural infections with HPV-18 and HPV-16 respectively, and which remain substantially raised months after vaccination?”
This is a question I raised back in 2008 in a Rapid Response to the BMJ, a question that has never been answered.
Messenger versus Grimes..
Dr. Rob er David Grimes
Science Writer and Cancer Researcher, The University of Oxford
MOTHERS SHOULD LISTEN TO THE EXPERTS NOT DR GOOGLE
Cervical cancer is one of the few cancers we can prevent, which is why this vaccination programme is so important and why all parents should ensure their daughters receive this potentially life-saving inoculation, writes Dr Robert Grimes, Science Writer and Cancer Researcher at the University of Oxford.
Gardasil, the form of the vaccine currently used in the UK, has been extensively tested for years and recipients constantly monitored for potential adverse effects.
More than 200 million doses have been administered over the past ten years, with research and trials dating back to 1991. The vaccine has proved to be a safe and effective intervention with an extremely low complication rate.
Only last year, a report based on data from more than a million recipients concluded the vaccine had a ‘favourable safety profile’. But still claims of ‘vaccine damage’ continue to circulate online, to be stumbled upon by the many who daily consult Dr Google, instead of turning to highly trained health professionals for advice.
Much of it comes from anti-vaccine campaigners, not content with the damage already done by the discredited, downright dangerous claims linking the MMR vaccine to autism. Among the groundless assertions are that the HPV vaccine causes thrombosis and chronic fatigue.
I cannot blame anyone whose child becomes ill or permanently exhausted for searching for an explanation and cause.
However, if you are giving a medical intervention to everyone at a certain age, as in this case, it is a medical certainty that some people get sick in the days, weeks or months afterwards. It would, of course, have happened whether or not they had received the treatment. It is merely coincidence.
Perhaps another issue with the vaccine, for some parents at least, is having to face up to the fact that their children will likely become sexually active in the not-too- distant future.
But, although pretty natural, such squeamishness doesn’t give you the right to deny your child, or the people they may become intimate with, the protection provided by this vaccine.
This most recent scaremongering, from the American College of Paediatricians concerning a risk of premature menopause, is equally without merit.
This is not some august medical body (in fact, that’s the American Academy of Paediatricians), but rather a group of conservative activists opposed to abortion rights, gay marriage and pre-marital sex.
Their claim is motivated more by ideology than by any evidence, and is simply not supported by the overwhelming weight of scientific evidence. There is no link between the HPV virus and premature ovarian failure, so it makes no sense to suggest that the vaccine may cause this condition.
Yet still, there have been a number of legal challenges mounted against the manufacturers of Gardasil, supported by the ‘Regret’ group in Ireland.
The case made it all the way to the Irish High Court, and although it was refused, the movement shows no signs of abating.
We need only cast our minds back to the damage done by scare stories about the MMR vaccine to be reminded how dangerous this can be.
Those who are not vaccinated against the HPV will have a much higher risk of contracting cancer than they would have of becoming ill as a result of having the jab, so, from a parenting perspective, it’s a no-brainer.
What we must avoid at all costs are these tales of personal misfortune, which are ultimately unrelated to the vaccine, getting in the way of an inoculation programme that could save many thousands of lives.
David Robert Grimes @drg1985 9m9 minutes ago
David Robert Grimes Retweeted Caron Ryalls
(a) No idea who you or your daughter are (b) Going to go out on a limb & say no medical records say HPV vaccine caused ill health
Caron Ryalls@caronryalls 1h
U publicly claim my daughter’s ill health is unrelated 2 HPVvax but U hv no access 2 her medical records @drg1985!
David Robert Grimes @drg1985 3m3 minutes ago
The @DailyMailUK just ran page 3 model’s fears over HPV vaccine. Utter drivel. I was quoted in reply, w/ name mangled. Not linking.
David Robert Grimes @drg1985 2m2 minutes ago
..it’s utterly irresponsible of @DailyMailUK to run this crap, especially as I clearly stressed dangers of false balance to DM reporter.
David Robert Grimes @drg1985 3m3 minutes ago
And the sad thing is, the ramblings of a celebrity will garner far more press and panic than me or any scientist. Do better, @DailyMailUK
David Robert Grimes @drg1985 13m13 minutes ago
..it’s precisely this kind of thing that makes scientists weary about talking to the press; science is an afterthought. @DailyMailUK
Dear David Robert Grimes, If this vaccine is so safe and wonderful, why are you so concerned about the criticisms? Methinks you do protest too much!
As for your thought that ‘anyone suffering as a result would have been ill anyway’ – that is utter nonsense. If you want the public to see your side of matters, I suggest you stop making such sweeping statements. I say ‘thank goodness for Dr. Google’ and all other doctors who, at last, are giving us both sides of the coin, on important health matters, before we make our decisions!
The Mail report should mention that Grimes is a physicist not a medical doctor, pontificating with usual platitudes and appeals to emotion. It is not a recommendation in my opinion that he received the Maddox award from Sense About Science.
I used long ago to think highly of John Maddox’s radio broadcast (Talking with Scientists I think his programme was called) but the whole latter part of his career seems to have been humbug. Setting James Randi on Jacques Benveniste is a deep scandal – a thuggish way of trying to close a scientific question.
Beautifully put Mary.
Yes, hooray for Dr Google. It’s saved my husband from Cipro, (contra indicated for the over 60s, and he won’t be seeing 70 again anytime soon) and these very Blogs have shown him that Duloxitine, which he was given because he made too many bathroom trips in the night – prescribed for bladder busyness – was actually an anti-depressant!! Problem solved, fewer cups of tea at bedtime. No doctor happened to mention that the pills might affect his brain as well as his bladder! Lucky escape there then.
That phrase of David Robert Grimes’ ‘they would have got ill anyway’ reminds me of once telling a woman GP we had that we were feeling devoid of energy (it was actually sheep dip damage as it later transpired). “Oh”, she said, ” but you are 50″ it was a while ago!), “what do you expect at your age?” Maybe a zimmer delivered by courier. Or a bath chair.
Yes, hurray, hurray, thrice hurray, for wise Dr. GOOGLE
Without Dr Google I would no doubt be on the path to diabetes, heart disease and most certainly a premature death.
Dr Google has MUCH more superior knowledge (especially when it comes to AKATHISIA) than any GP or psychiatrist I have met.
Dr Google was amazingly helpful to me in correcting the mis-diagnosis I had been labelled with and has saved my life by informing me of the very real DANGERS of the prescribed medications which I had been told I needed to take for the rest of my life.
Again, three cheers for Dr Google
Myth: No Studies Compare the Health of Unvaccinated and Vaccinated People
The Great Myth of Vaccines and Autism
I am Iida Ruishalme, Finnish/Swedish expat in Switzerland, and I have Masters degree in Biology with a minor in Psychology. I am a co-author of four scientific papers in the fields
$230,000 up for grabs for ‘user-unfriendly’ drug approval packages of the FDA
The OpenTrialsFDA team is one of the six finalists for the Open Science Prize: a global science competition to make both the outputs from science and the research process broadly accessible to the public.
This is a collaboration between Dr. Erick Turner, Dr. Ben Goldacre and the OpenTrials team at Open Knowledge International. Competing for the $230,000 prize that will be awarded to the winner in February 2017, OpenTrialsFDA is working on a prototype that will make the information hidden in the user-unfriendly drug approval packages of the FDA (the US Food and Drug Administration) more easily accessible and searchable, and link these to documents and data related to clinical trials.
Intro video – with the all familiar GSK logo as the backdrop…
Sarah Boseley Health editor
Friday 2 December 2016 07.00 GMT
GSK’s Andrew Witty: the man who sold the world
Lest she forgets..
Sarah Boseley health editor
Saturday 3 May 2003 10.12 BST
The Light of Post-Truth Rumorology
Article, and Comments by many ‘familiar’ contributors
Pic: Ben with Ben bow
“Post truth” as a general principle?
ben goldacre @bengoldacre Nov 30
Before he was elected, but nonetheless, let me say this: as a general principle, you do NOT want to get “post truth” about medicine.
ben goldacre @bengoldacre 1h1 hour ago
ben goldacre Retweeted OpenTrials
We made a thing. You can now search the text of all FDA approval documents. This was previously impossible. Hurrah for coders and ideas.
Not only Alastair Benbow but BBC Science Correspondent Pallab Ghosh – at the time head of the Association of British Science Writers and also the “World Federation of Science Journalists”: he looks really tickled pink with it all. Ben got the award for trashing concerns by MMR citing a collection of completely dodgy, conflicted epidemiological papers – and a quoting an anonymous former colleague from the Royal Free badmouthing Wakefield. Ben has always stonewalled when asked about the epidemiology in that article, none of which could be remotely defended in detail. The award winning article had the ambiguous title ‘MMR: Never Mind the Facts’ and Ben certainly didn’t. Benbow was just the guy and the award came with the GSK insignia.
My impression is that introduction of the “GSK” version of MMR “Pluserix” was a sweetner for the merger between the then largely US company SmithKlineBeckman and Beecham, after the vaccine had already had to be withdrawn in Canada: their liability was under-written by the NHS. In 1992 both SKB (later GSK) and Aventis Pasteur (later Sanofi) withdrew from the UK market their versions of MMR containing the Urabe strain of mumps which was recognised as causing problems in Japan, although the British government had taken no steps. Goldacre’s father was the co-author of a British government paper that looked into the matter. This is another thing about which he has never liked being asked.
It should be said that in 2016 there would be very little need for the NHS to underwrite liability in this way because they could rely on the Legal Aid Agency to block any litigation.
But Rome wasn’t built—or rebuilt—in a day.
FiercePharmaAsia: GSK’s new China head
by Angus Liu |
Dec 1, 2016 4:07pm
GlaxoSmithKline just promoted Thomas Willemsen to become the head of the company’s Chinese chapter, succeeding Herve Gisserot who pulled the company out from the bribery quagmire.
GlaxoSmithKline is clearly eager to turn the page on its bribery drama in China. The weight of leading that effort now rests on the shoulders of the company’s newly appointed China head Thomas Willemsen, formerly deputy of that chapter. It was Herve Gisserot who took over from then China captain Mark Reilly back in 2013 and led the company through the critical investigation and recovery phases, and now, he is moving upward to become head of pharmaceuticals for the Asia-Pacific region. Years after handing over a record-high $490 million fine, GSK is, according to outgoing CEO Andrew Witty, “back into the growth.” But Rome wasn’t built—or rebuilt—in a day.
Even though the company just recently received China’s first HPV vaccine approval for its Cervarix and has been trying to revive its image by joining an HIV/AIDS patient program, the pricing pressure is still intense as it saw the company cut a hepatitis B drug price in China by about two thirds. And its worst nightmare just came back to haunt it again, as a private investigator couple involved in the bribery case sued GSK for misleading them and thus led to their imprisonment in China.
Look what swallowing a Seroxat does to the knowledge base..
”For obvious reasons, I’m not going to get into all the details of that.”
and, no, those aren’t floaters in your eyes…….
Clinical Trial Data Transparency on Trial – EMA Under Pressure From Pharma Lawsuit
Thursday 1 December 2016 | Clinical Trial Data | Blog Posts |
By Ancel.la Santos, Policy Advisor, Health Action International
Some words of reassurance from the Ministry of Truth (Tracey Brown):