Council of Europe Committee Report Denounces Unjustified Swine Flu Scare, Waste of Public Money

Attached is the press release from the Social, Health and Family Affairs Committee of the Parliamentary Assembly of the Council of Europe (PACE) outlining the conclusions of the provisional PACE report, The handling of the H1N1 pandemic: more transparency needed. The Press Release  denounces the unjustified Swine Flu scare and waste of public money. Fiona Godlee, Editor-in-Chief of the British Medical Journal,  told the Council that, according to an investigation by her journal, scientists who drew up key WHO guidelines on stockpiling flu vaccines had previously been paid by drug companies which stood to profit.

Meanwhile, here in New Brunswick, Canada, on the same day the Council of Europe report was released questioning the handling of the H1N1 flu our Department of Health announced plans to expand  our seasonal flu vaccination program to cover all children under 18 "after the success of last fall's H1N1 campaign."  The Department of Health Deputy Chief Medical Officer Paul Van Buynter measured success solely by the large numbers of New Brunswickers who received the H1N1 shot.  There is no mention of the many credible voices, in Canada and in Europe who have questioned whether the scare campaign launched in Europe and elsewhere including here in New Brunswick was justified.

Press release - 455(2010)

PACE Health Committee denounces ‘unjustified scare’ of Swine Flu, waste of public money

Strasbourg, 04.06.2010 – The handling of the H1N1 pandemic by the World Health Organization (WHO), EU agencies and national governments led to a “waste of large sums of public money, and unjustified scares and fears about the health risks faced by the European public”, according to a report by the Social, Health and Family Affairs Committee of the Parliamentary Assembly of the Council of Europe (PACE) made public today in Paris.

The report, prepared by Paul Flynn (United Kingdom, SOC) and approved today by the committee ahead of a plenary debate at the end of this month, says there was “overwhelming evidence that the seriousness of the pandemic was vastly overrated by WHO”, resulting in a distortion of public health priorities.

Presenting his report, Mr Flynn told the committee: “this was a pandemic that never really was”, and described the vaccination programme as “placebo medicine on a large scale” (see video below).

In its adopted text, the committee identifies what it calls “grave shortcomings” in the transparency of decision-making about the outbreak, generating concerns about the influence of the pharmaceutical industry on decisions taken. Plummeting confidence in such advice could prove “disastrous” in the case of a severe future pandemic, it warns.

In particular, the WHO and European health institutions were not willing to publish the names and declarations of interest of the members of the WHO Emergency Committee and relevant European advisory bodies directly involved in recommendations concerning the pandemic, the parliamentarians point out.

However, attending the meeting was Fiona Godlee, the Editor-in-Chief of the British Medical Journal, who told the parliamentarians that, according to an investigation by her journal, scientists who drew up key WHO guidelines on stockpiling flu vaccines had previously been paid by drug companies which stood to profit.

The WHO has been “highly defensive”, the committee said, and unwilling to accept that a change in the definition of a pandemic was made, or to revise its prognosis of the Swine Flu outbreak.

The committee sets out a series of urgent recommendations for greater transparency and better governance in public health, as well as safeguards against what it calls “undue influence by vested interests”. It also calls for a public fund to support independent research, trials and expert advice, possibly financed by an obligatory contribution of the pharmaceutical industry, as well as closer collaboration with the media to avoid “sensationalism and scaremongering in the public health domain”.

The report is due to be debated by parliamentarians from all 47 Council of Europe member states on Thursday 24 June during PACE’s summer session in Strasbourg.

Contacts

In Paris: Francesc Ferrer, mobile: +33 (0)6 30 49 68 22

In Strasbourg: PACE Communication Division, tel. +33 (0)3 88 41 31 93, mobile: +33 (0)6 30 49 68 20

Autism Vaccine Myth Busting: Thimerosal Is Still Used In Vaccines

One of the myths pushed in the mainstream media is that thimerosal, the mercury preservative used in vaccines, has been removed from vaccines.  That position simply is not true. 

The recent H1N1 panic showed that health authorities and pharmaceuticals still push vaccines containing thimerosal when it suits them.  The Ipswich Massachusetts Chronicle web site on  February 2, 2010 advertised immunization clinics for February 16 and 25, 2010 for thimerosal containing H1N1 shots:

"Only the injectable (shot) form of the H1N1 influenza vaccine will be used.


Participants should wear a shirt with loose0fitting sleeves or short sleeves to the clinic since the injection will be given in the upper arm.


Just like the seasonal flu vaccine, many formulations of the H1N1 vaccine contain a preservative called thimerosal. The vaccine that will be used at the clinic contains thimerosal."

Here in New Brunswick Canada the H1N1 (Swine Flu) vaccine also contained thimerosal and adjuvants and which were declared safe by our provincial health authorities as reflected in this  October 8, 2009 NB government news release. Of particular note, our provincial health authorities declared that thimerosal does not cause autism and is safe to give to pregnant women, one of the high priority groups targeted to receive the H1N1 shot during the fall H1N1 Pandemic/Panic:

• There have also been reports and public speculation about the safety of the H1N1 vaccine. The contents of the H1N1 vaccine will protect against contracting H1N1. The included additives and preservatives are there to help the vaccine work, and are not cause for alarm.
• As a multi-dose vaccine, the H1N1 influenza vaccine will contain a mercury-based preservative called thimerosal to prevent contamination of the vaccine by serious infectious agents from the growth of bacteria. Thimerosal also has a stabilizing effect on the vaccine, ensuring its effectiveness.
• The seasonal flu vaccine and most hepatitis B vaccines are also multi-dose vaccines, and thimerosal is added during the manufacturing process to maintain sterility of the vaccine.
• There is no safety reason to avoid using vaccines containing thimerosal. The best available scientific evidence to date shows no link between vaccines containing thimerosal and any adverse health condition, including neurodevelopmental disorders such as autism.
• The National Advisory Committee on Immunization (NACI) has reviewed the safety of thimerosal and concluded that, "There is no legitimate safety reason to avoid the use of thimerosal-containing products for children or older individuals, including pregnant women." International bodies, such as the World Health Organization (WHO) and the U.S. Food and Drug Administration, share this opinion.
• Most of the H1N1 vaccine available in New Brunswick will also contain an adjuvant. An adjuvant is a substance that is added to a vaccine in order to boost an individual's immune response. It also means that less of the virus, or antigen, is needed to make a dose of the vaccine. Unadjuvanted vaccine has no booster element, and more antigen is needed to create this kind of vaccine.
• By developing an adjuvanted vaccine, Canada has used less of the virus material (antigen), allowing us to immunize more people in a timely manner.
• Adjuvants are not new. Many commonly used vaccines in Canada contain an adjuvant. Adjuvants have been used for several decades to boost immune response to vaccines. However, adjuvants have not previously been used with influenza vaccines in Canada.
• The WHO has indicated that it has no special concerns about the safety of adjuvanted H1N1 vaccines in general.

The WHO is now under scrutiny for its role in pushing the H1N1 panic button.  And not everyone shares our NB officials' unquestioning faith  that thimerosal does not play a role in causing autism particularly when given to pregnant women.  Dr. Bernadine Healy, a highly respected former US National Institutes of Health Director has stated several times that the issue of a thimerosal autism connection is still an open question. She has made particular reference to the possible effect of the mercury preservative thimerosal o the fetuses of pregnant women:

"thimerosal crosses the placenta, and pregnant women are advised to get flu shots, which often contain it. Studies in mice suggest that genetic variation influences brain sensitivity to the toxic effects of mercury. And a primate study designed to mimic vaccination in infants reported in 2005 that thimerosal may clear from the blood in a matter of days but leaves inorganic mercury behind in the brain."

Former NIH Director Dr. Healy's concerns do not appear to have been taken seriously by public health authorities during the great H1N1 Swine Flu scare of 2009.

autism

Was the H1N1 a Fake Pandemic? A Council of Europe Motion to Investigate Drug Sellers Influence

In WHO to Clarify H1N1 Data After False Pandemic Claim Bloomberg  reports that "The Parliamentary Assembly of the Council of Europe plans to debate the theme “Faked pandemics: a threat to health” at a plenary session in Strasbourg, France" next week.  

Not to quibble too much with "B"but the debate is not just debate of a theme in an academic or abstract sense.  It is  debate on an actual motion which calls on the member states of the Council of Europe to conduct investigation of the influence of "drug makers" in defining and declaring pandemics.

I am not, and do not pretend to be, prescient.  I do not know what the outcome of the debate will be.  Given the emphasis placed by governments around the world on vaccines as public health tools and the active and vigorous discouragement of any debate of any safety concerns around vaccines though I would not expect to see the Council of Europe pass the motion and conduct any real investigations.  Nor do I expect the Council of Europe to find that the H1N1 Pandemic was overblown.  Of course I have been wrong before.  

As for whether it was reasonably forseeable that the  "pandemic" would not be as harsh as predicted by public health authorities there were credible skeptics who questioned the pandemic rhetoric many months ago.  As with any questioning of vaccine related issues skeptics and critics of public health authorities' "consensus" on these issues were largely ignored, ridiculed or demonized.  

As for whether "drug makers" or pharmaceuticals have too  much influence over public health authority decisions concerning pandemics and other public health issues I will leave that question to someone truly knowledgeable on the subject ... someone like Dr. Julie Gerberding who led the CDC from 2002 to 2009 and who will now lead Merck's vaccine division:

 "WASHINGTON, Dec 21 (Reuters) - Dr. Julie Gerberding, former director of the U.S. Centers for Disease Control and Prevention, was named president of Merck & Co Inc's (MRK.N) vaccine division, the company said on Monday.... She may be charged with reigniting flagging sales of Merck's Gardasil vaccine to prevent cervical cancer by protecting against human papillomavirus or HPV. After an encouraging launch Gardasil sales have been falling and were down 22 percent in the third quarter at $311 million." [Bold emphasis added - HLD]

One thing I would like to see emerge from the H1N1 Pandemic, whether the Pandemic label was justified or not, are studies of the impact on the health, including any negative health  effects, if any, of the many people vaccinated with H1N1 shots.  In some countries adjuvants and other ingredients, including thimerosal, were included in the H1N1 shots.  

One of the high priority  target groups to receive H1N1 shots was pregnant women. Some credible public health authorities, including Dr. Bernadine Healy, have pointed out that thimerosal,  a mercury based preservative, crosses the placenta.  It would seem appropriate to me to keep data on the health effects of the H1N1 vaccine on  these women and the children who received the H1N1 shots in utero. 

It seems to this humble layperson that the developmental histories of children born during this time period from pregnant women who (1) did not receive the H1N1 shot (2) received the H1N1 shot without thimerosal, (3) received the H1N1 shot without adjuvants should be compared.   As someone with an interest in autism disorders and what causes them I am interested in particular in seeing a comparison of  autism rates 2+ years from now of children whose mothers were carrying them when they  received H1N1 shots containing thimerosal  and children whose mothers, while carrying them, received H1NH1 vaccine shots without thimerosal.

No I am not expecting such studies to be done and yes I do expect to be ignored, ridiculed or demonized for making these suggestions.  But I am making them anyway.

autism

An Open Letter to Dr. Steven Novella Concerning His Positions on Vaccines and Autism and Dr. Novella's Reply

UPDATE: See end of this comment for Dr. Novella's reply

Dear Dr. Novella

I am a parent of a 13 year old boy with Autistic Disorder. I also have a blog site on which I commented unfavorably on your response to the possibility that the IACC might recommend some vaccine autism research. I ask your response to a few questions if you have the time and are inclined to respond.

One is your apparent opposition to any further research exploring possible vaccine autism connections. I am not an "anti-vaxxer". I have never attributed my son's autism to vaccines. Until recently I accepted the official view that vaccines play no role in causing autism. More recently my views have moved toward an undecided position. This change began when reading Dr. Bernadine Healy's observations about the limitations of the epidemiological studies which are usually used to allegedly "debunk" any vaccine autism connection. In her comments she indicated that such studies are not specific enough to address the possible impact of vaccines or their ingredients on potentially vulnerable population subsets.To this layperson Dr. Healy's criticism seems reasonable as does her call, a call also made by Dr. Julie Gerberding, that an observational study comparing autism rates in existing vaccinated and non vaccinated populations could and should be done. Your opposition to further vaccine autism study does not, with respect, seem either reasonable OR science based. I ask if you could provide a clear rationale for opposing a study which has been called for by two prominent health authorities and which might provide useful information to what is a heated debate on all sides.

The second question I have for you concerns the increase in autism diagnoses which has really been quite startling by any measure. In my son's lifetime the figure has changed from 1 in 500 to 1 in 150 with the two recent studies indicating it might now be 1 in 91. Many authorities dispute though that the increases are real pointing to the autism definition changes in the DSM and ICD diagnostic manuals in the 1993-4 period and increased social awareness as the reasons for the increases in diagnoses. Is it your view that the increase in autism diagnoses does not reflect a real increase in autism disorders? If so what are the implications of that position for the argument that epidemiological studies have disproved any thimerosal vaccine link because autism rates increased after removal of thimerosal from MOST vaccines?

Also if you have the time and inclination do you think Dr. Healy's observations that thimerosal which continued to be found in flu vaccines, some of which historically were administered to pregnant mothers, was a matter worthy of investigation given that the thimerosal crosses the placenta is a legitimate concern worthy of further investigation? This is an important matter here in Canada where the squalene adjuvant was removed from the vaccines given to pregnant women but there has been no indication that thimerosal has been removed.

I would genuinely appreciate your responses to these questions which I am posting on my blog site. If you do me the courtesy of an informed reply I would be happy to post that reply as well.

Respectfully,


Harold L Doherty

cc. Facing Autism In New Brunswick

UPDATE:

Dr. Novella's Reply:

Harold,

Thanks for your thoughtful e-mail. I would be happy to address your questions.

Regarding further research - it is always possible, in the face of negative results, to call for still more research. And it is easy to make this seem like the default scientific position. ESP proponents, after a century of failed research, call for still more research, and accuses anyone who says further research is not worthwhile of being unscientific.

Also, to clarify my position, I am not categorically against further research into vaccines and autism. I think any such research is most likely to confirm the lack of a correlation. And if there is a susceptible sub-population, of course it would be good to know about it to make the vaccine program even safer. (But keep in mind - it is a common form of special pleading to argue that, when the effect you are looking for is absent, that is only exists is a subpopulation that existing data was not powerful enough to detect. This may be true, but it is just post-hoc speculation, and doesn't change the fact that the data is negative.)

My position is that ideological groups should not be dictating how scarce research funds are allocated. When we put money, people, and resources into chasing down an unlikely hypothesis those resources are not available for what might be more promising research. My position is that objective scientists, justifying their position with a careful analysis of the research, should decide how best to allocate scarce research funds. The anti-vax movement, however, is trying desperately to put their thumb on the scale - and that is what I oppose. They are trying to subvert autism activism to serve an anti-vaccine agenda - and they are hurting the autism community as a result, in my opinion.

I respect Healy and Gerberding, but I disagree with their approach in that they think more research will satisfy vaccine critics, but this is a naive position. The anti-vaccine movement has already demonstrated that they are impervious to facts and evidence, and spending time and money trying to placate them is a fool's errand. The CDC even went as far as to include them in designing a trial looking at vaccines and neurological disorders, and then only after the results came back negative, did they criticize the study.

You specifically mention an observational study comparing vaccinated and unvaccinated children - I do not oppose this. If it can be done with reasonable resources, there are scientists willing to carry out such a study and think it is worthwhile, and the results will be useful, then I fully support it and await the results. (And in fact I have never opposed such studies.) What I and others have written is that an experimental (not observation) comparison of vaccinated vs unvaccinated children is unethical, because it would randomize children to no get standard preventive care, and that directly violates human research ethical guidelines. Observational studies are fine, but they are never definitive, and they will not, in my opinion, change or end the debate. They will not move the anti-vaccinationists one bit

The increase in autism diagnoses has been studied from multiple angles - not just the expansion of the diagnosis.

You will find a summary of relevant research here: http://sciencebasedmedicine.org/reference/vaccines-and-autism/

So far, every way it has been looked at the hypothesis that the increase in diagnosis of ASD is due to increased surveillance and expanded diagnosis has been confirmed. There is evidence of diagnostic substitution (as ASD numbers increase, the numbers of other similar diagnoses decrease). There is evidence that different age groups have the same prevalence of ASD (rather than increasing with younger age, as would result from a true increase in ASD). And if you apply the same diagnostic and surveillance methods to a cohort over time, you get the same ASD prevalence. The data is actually quite convincing that true autism rates are not significantly increasing (you cannot rule out a small real increase, or decrease for that matter, that the data is not powerful enough to detect) but that there has been expanded diagnosis with diagnostic substitution and increased surveillance.

I discuss this further here ( http://www.sciencebasedmedicine.org/?p=95) and here ( http://www.sciencebasedmedicine.org/?p=340)

The implications of this position to the alleged thimerosal link is complex, but supports a lack of correlation. What the data shows is that in various countries ASD diagnoses began to rise around the same time (as diagnostic patterns changed), in the early 1990s, and have continued to rise through today. Meanwhile, vaccine policies have varied considerably with regard to total thimerosal dose, with several countries, at different times, removing most thimerosal from vaccines. Every study looking at the data shows no correlation between the steadily increasing ASD diagnostic rates with the rising and falling thimerosal doses at different times in different countries. This is powerful evidence for a lack of correlation. As you likely know, toxicity is always about dose, and seeing a proper dose-response is essential to proving toxicity causation. What we have with thimerosal is an absolute lack of any dose-response, in many studies and sets of data.

Also, please keep in mind that the anti-vaccine movement used the increase in ASD in the 1990s as their original justification for the claim that thimerosal causes autism. They predicted that autism rates would decline after thimerosal was removed from the childhood vaccine schedule, and we agreed that if that happened we would need to rethink the possibility of a connection. Well, rates continued to rise without a blip, effectively putting the final nail in the coffin of the thimerosal hypothesis.

Regarding thimerosal and pregnancy, to the extent that this has already been studied (again, you can find references in the vaccine-and-autism link above) there has been no correlation. I do not oppose further research, however, if the CDC or others think it is warranted and feasible.

Thanks again for the interesting questions, and I hope this adequately clarifies my position.

Regards,

Steve Novella

PS - You can publish my response on your blog, and I will do likewise.

autism

Ontario Health Official Calls H1N1 A Dud Pandemic

CBC interviewed Dr. Richard Schabas chief medical officer of health for Hastings and Prince Edward counties in eastern Ontario and former chief medical officer of health for the Province of Ontario about the H1N1 Pandemic and he called it a Dud:

""It's really not causing — and is not going to cause and nowhere has caused — significant levels of illness or death," said Dr. Richard Schabas, Ontario's former chief medical officer of health.

"But governments moved ahead regardless. They ramped up their response, spent a huge amount of money on vaccines and other things. I'm not sure the $1.5 billion includes the cost of new ventilators, the cost of Tamiflu stockpiles … the huge investment that's been put into planning for what has ultimately turned out to be, from a pandemic perspective, a dud."

Almost as stunning as Dr. Schabas comments in breaking ranks with the medical establishment is the willingness of the CBC to air an interview with Dr. Schabas.

Maybe there is still some hope for Mainstream Media journalism.

Maybe George Orwell's 1984 has not yet arrived in an H1N1 vaccine needle after all.

autism

Coincidence Says CDC When Young Athlete Suffers Guillain-Barre Syndrome After H1N1 Shot

MSNBC reports that a 14 year old high school athlete in Virginia is struggling to walk after coming down with Guillain-Barré Syndrome within 18 hours after receiving an H1N1 flu shot:

Jordan McFarland, a high school athlete from Alexandria, Va., left Inova Fairfax Hospital for Children Tuesday night in a wheelchair nearly a week after developing severe headaches, muscle spasms and weakness in his legs following a swine flu shot. He will likely need the assistance of a walker for four to six weeks, plus extensive physical therapy.

CDC spokesperson Dr. Claudia J. Vellozzi, deputy director for immunization safety provided a response heard often in possible vaccine autism cases, the usual it's all just a coincidence:

“We know that GBS and other illnesses occur routinely in the U.S.,” Vellozzi said, noting that 80 to 120 cases are diagnosed each week in the general population.

“There are events that follow vaccination. That’s what they are, they happened to follow vaccination.

Coincidence. Yeah, sure.

autism

H1N1 Vaccine, Cure or Cause? Moncton Wildcats Hockey Players Contract H1N1 AFTER Receiving H1N1 Vaccine

Since getting the shot, 17 Wildcats have caught mild cases of the flu. Two have confirmed cases of H1N1, and the other 15 suspected. All the sick players are quarantined, and several games have been cancelled.

The Globe and Mail, Nov 4, 2009

So how effective IS the H1N1 Swine Flu vaccine? Seventeen athletic teenagers whose health would be monitored closely by their hockey team contract H1N1 immediately after receiving the vaccine? Did the vaccine actually cause them to contract H1N1?

Hopefully cases where healthy individuals contract H1N1 immediately after receiving the vaccine will be investigated to see if the vaccine itself is causing them to contract the H1N1 Swine flu.

autism