Pandemrix Swine Flu Vaccine and Narcolepsy: Lesson for Autism Research?

                                                

                                                         (AFP Photo and Caption)

As the parent of a soon to be 15 year old boy with severe Autistic Disorder I have never attributed his autism disorder to vaccines. I have always accepted the view of public health authorities that there is little or no evidence linking autism to vaccines. With that mindset I never endorsed Jenny McCarthy's views of autism and vaccines although I admired her courage in fighting for her son.

At the other end of the vaccine autism battlefield I support vaccine programs generally as vitally important public health tools but I have become increasingly concerned by the campaign to discredit those who question vaccine safety and the certainty with which Vaccine Generals like Dr. Paul Offit and Dr. David H. Gorski aka Orac have declared that all vaccines and vaccine ingredients can never cause any autism disorder in any child.  Given the lack of certainty about what autism is biologically, given the shifting autism definitions used to attack what appears to be an obvious and astounding increase in autism disorders,  I don't see how the epidemiological studies can be that definitive. A particular question for me is whether the studies have actually ruled out the possibility that vaccines given to pregnant women might cause or trigger autism in the children they are carrying. Another major question arises from the failure to conduct studies comparing autism rates in existing vaccinated and unvaccinated populations. 

Dr. Offit is the gentle, sweater wearing uncle type who poses for an adoring media and declares parents to be timid fearful sorts who can not understand science and the big picture.  Dr. David H. Gorski, aka Orac, is the snarling pitbull who delivers incessant attacks on vaccine questioners AND actual anti-vaxxers with scientific terminology like WOO, QUACK, IDIOT  and so on.  Both may soon be called on to lead their minions into battle again with news of a study out of Finland, as reported by AFP, which found that children injected with the Pandemrix swine flu vaccine were nine times more likely to contract narcolepsy than those who were not vaccinated  :

"Children injected with the Pandemrix swine flu vaccine were nine times more likely to contract narcolepsy than those who were not vaccinated, a preliminary study by Finland's National Institute for Health and Welfare, THL, showed Tuesday.

"Currently, the most likely explanation is that the increase in narcolepsy is by joint effect of the vaccine and some other factor(s)," THL said.

The institute stressed in its preliminary study that more investigation was needed, but said young people aged four to 19 had a "manifold increased risk of falling ill with narcolepsy" if they had been inoculated against swine flu with Pandemrix."

....

Narcolepsy is a sleep disorder which causes extreme fatigue and often results in the patient falling soundly asleep without warning, even in the middle of an activity.

Doctors in Finland reported a more than trippling of narcolepsy cases during the swine flue pandemic, and THL said "the risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was nine-fold in comparison to those unvaccinated in the same age group."

...

"The observed association (with the vaccine) is so evident that it is unlikely that other so-called confounding factors could fully explain the phenomenon," THL said, adding its next step was to evaluate if other factors had created "joint effects" with Pandemrix.


It is interesting that a direct comparison of narcolepsy rates was made between those who were vaccinated with the H1N1 vaccine and those who were not. On the autism front former CDC directors Dr. Bernadine Healy and Dr. Julie Gerberding have both been reported in the past as stating that a comparison of autism rates amongst existing vaccinated and unvaccinated populations could and should be done. Their advice has been actively resisted by public health spokespersons. Dr. Offit and Dr. Gorski, each in their own way, will now undoubtedly be called upon to quell any concerns about vaccines and narcolepsy.


Meanwhile the comparative study of autism rates in existing vaccinated and unvaccinated populations will not be done. Unfortunately.

Whooda Thunk It? CNN: Study Raises Bias, Timely Disclosure Questions About Pharma Funded Drug Trials

Whooda Thunk It?

CNN reports that a recent study has disclosed evidence of bias in pharmaceutical company funded drug trials. The study found evidence of an inherent bias in favor of the drug being studies with such studies being 4 times more likely to report outcomes that favored the drug of the sponsoring pharmaceutical company. Industry funded drug trials were also less timely in providing public information about the trial results:

Researchers from the United States and Canada looked at 546 drug trials registered in ClinicalTrials.gov, a registry of both federal and private trials in the United States and abroad. 346 of them, or 63 percen, were funded by the drug industry. The remaining 200 were paid for by government or non-profit organizations. Study authors found that more than 85 percent of industry-funded trials in their sample posted favorable outcomes and were 4 times more likely to report findings that favored their drug.

"We did this study in order to determine whether there is an inherent bias because pharmaceutical companies fund trials on products in which they have a financial interest," said study co-author Dr. Kenneth Mandl of Children's Hospital, Boston. "The most reassuring result would have been that the rate of favorable outcomes would be the same regardless of funding sources. In a very dramatic way that was not the case and what we need to ascertain is if the cause of this shift toward favorable findings among trials funded by pharmaceutical companies is related to the details of the protocols and study design."

Dr. Florence Bourgeois, also of Children's Hospital, Boston and lead author of the study says typically trials sponsored by drug companies are more efficient and well funded. Still, she found the result stunning. "The implications of these findings are that we need more oversight in the way clinical trials are designed as well as in the analysis and reporting of the results. One option may be to make study protocols directly available on clinicatrials.gov as well as the comprehensive reviews complied by the FDA on trial results." She continued, "While we cannot specifically point to which factors contribute to the association between funding source and positive results reporting, our findings speak to the need for more disclosure of all elements of a study."

...

According to Mandl, industry funded trials also were less timely in terms of providing public information including trial results. He says even though drug trials are overseen by the Food and Drug Administration, there are still some variables that could favor pharmaceutical companies, including placebo comparisons, dosing and duration. "The concern is the pharmaceutical industry is funding the studies of the drugs in which they have a vested financial interest."

The influence of pharmaceutical companies in last years widely criticized H1N1 pandemic was examined by the Parliamentary Assembly of the Council of Europe (PACE). In its March 23 2010 report The handling of the H1N1 pandemic: more transparency needed the PACE expressed concern over the connections between World Health Organization (WHO) science advisors and pharmaceutical company interests:

11. Independent experts from the medical community mainly criticised the agenda setting and governance process concerning the H1N1 flu in terms of the criteria used for declaring a pandemic, the lack of empirical evidence justifying such a step and the clearance to use certain medicines and vaccines. They also repeatedly raised the issue of the influence that private stakeholders from the pharmaceutical industry might have had on major decisions taken by international and national authorities. For the purpose of this memorandum the rapporteur has compiled the main issues raised in a critical perspective. All arguments presented seem to have one common reference point: the disparity between the relatively mild unfolding of the influenza and the actions taken at European and national level.2

None of this, of course, is to suggest that there is any  unhealthy pharmaceutical company influence on public health authorities involved with autism issues ... right Dr. Gerberding?   Maybe Dr. Julie Gerberding, President of Merck Vaccines  can put to rest fears of pharma conflicts of interest by pushing for a comparative study of autism rates in vaccinated and unvaccinated populations as once called for by  former CDC  Director Dr. Julie Gerberding who once said that "such studies could be done and should be done".

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.

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Old Standby "Confusing Cause and Coincidence" Excuse Trotted Out in Advance of Adverse Events Following Swine Flu Vaccinations

"Confusing cause and coincidence" has been used by scientists for decades to explain away the onset of autism disorders in otherwise healthy children following vaccinations. The same people do not, however, bother to conduct credible studies to actually rule out a causal relationship in such cases.

Most notably, despite support for an observational study comparing autism rates amongst existing vaccinated and unvaccinated populations from credible sources such as Dr. Bernadine Healy, Dr. Julie Gerberding and Dr. Jon Poling, the IACC, under Dr. Thomas Insel, has engaged in procedural shenanigans and given questionable testimony to Senator Harkin's committee to prevent such a study from being done.

Now, the "confusing cause and coincidence" excuse is being trotted out to explain possible adverse events following H1N1 (Swine Flu) vaccinations BEFORE THEY EVEN OCCUR.

The Telegraph (UK) article People will die after swine flu vaccine - but it's just coincidence, Six people in Britain can be expected to die suddenly after having the swine flu vaccine but it will just be coincidence, researchers have said references a recently published article in the Lancet and contains prophetic gems of wisdom offered by super intelligent researchers to us, the lowly unwashed, who have such difficulty distinguishing between cause and coincidence.

Prof David Spiegelhalter, Winton Professor of the Public Understanding of Risk, University of Cambridge and Co-Director of Straight Statistics, said: "What a fine paper. If millions of people are vaccinated then just by chance we can expect bad things to happen to some of them, whether it's a diagnosis of autism or a miscarriage.

"By being ready with the expected numbers of chance cases, perhaps we can avoid overreaction to sad, but coincidental, events. And why don't we ever see a headline 'Man wins lottery after flu jab'?"

Professor Robert Dingwall, University of Nottingham, said: "The difference between cause and coincidence is difficult enough for specialists to grasp, let alone the wider public.

"However, this paper is very important in spelling out the fact that just because two events happen at the same time, they are not necessarily related. There is a background rate of death, disease and accidents that happen all the time regardless of what medical interventions are going on."

Perhaps Professor Spiegelhalter can explain why we never see headlines like Vaccine Researchers Make Fortunes Successfully Predict Winning Lottery Numbers. And perhaps Professor Dingwall can someday come to believe that we, the great unwashed, drooling, ignorant public do in fact understand the difference between cause and coincidence and that we have heard that argument before in connection with vaccines and autism.

If the learned professor can get his head around that one perhaps he can convince the other members of his club that research confirming or refuting their prophecies would be appreciated by those of us in the Ignorance R Us Club.

Based on prior history of the IACC refusal to conduct credible studies of possible vaccine autism connections I have my own prediction to make: no credible follow up studies to determine actual causes of deaths and other adverse events following Swine Flu vaccinations, including autism onset, will be done by the members of the We Are Smarter Than The Dumb Public Club.

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Autism and Vaccine Safety in the Swine Flu Era: Does Calling Something A Myth Make It So?

According to many mainstream media sources here in Canada the H1N1 Swine Flu is perfectly safe and effective and .... oh yes ... any possible connection between vaccines and autism has been disproved. These sources usually provide little or nothing to back up their sweeping claims other than to rely on, and refer their readers to, the web sites of public health authorities. "Journalists" in the mainstream media routinely dismiss anything published by a blogger as lacking credibility. These alleged journalists also routinely describe any position on vaccines and autism, or any statement that questions the safety of efficacy of the H1N1 vaccine, as a myth. In most cases the alleged journalists provide no reference to any study to back up their characterization of serious issues as myths held by cranks and hysterical parents. Obviously calling something a myth does not make it so but, in the current Swine Flu Era, name calling is routinely substituted for serious commentary. All in the interest of promoting public safety of course.

One childish example of the simplistic, vaccine cheer leading that passes for public health journalism in the Swine Flu Era is the opinion piece Separating myth from fact in debate about flu vaccine by Craig McInnes. You will not find any information casting doubt on vacine safety or efficacy in Mr. McInnes opinion piece. There is no mention of the four people in Sweden who died after receiving the H1N1 vaccine. Promoting intelligent thought and discussion about vaccines is not the objective of the McInnes opinion piece. No, the sole objective is to convince people that they must get the H1N1 vaccine. To help achieve that end any questions or concerns surrounding the safety or efficacy of vaccines generally MUST, be described, as arising from myths generated by ... ugh ... bloggers.

Mr. McInnes begins his opining with a bit of mockery:

So did you hear? You can protect yourself from swine flu by putting bowls of cut-up onions in every room of your house.

No really, it's true, I read it on the Internet, on the same website that had the skinny on the giant albino alligators that live in New York city sewers, a scandal that the government has tried to suppress for years.

And there it is. With that McInnes opens by relegating anyone whose views do not conform to those of public health authorities to the whackjob heap. (Except, presumably, those German authorities concerned about adjuvants in the H1N1 vaccine who are not mentioned in the McInnes opinion). Since this is an autism blog here is what Mr. McInnes has to say about vaccines and autism:

Myth: Thimerosal, which is used as a preservative in flu vaccines, contains mercury, a dangerous poison, and causes autism.•

Fact: The amount of mercury in a dose of H1N1 vaccine is less than you would get from a can of tuna and the version with the adjuvant requires only one-tenth that much.

The relationship between thimerosal and autism has been widely studied and no causal link has been found.

Mr. McInnes is not the first to use the tuna fish argument without mentioning that in fact cautions have been expressed by health authorities about tuna fish consumption for that very reason. Nor does he seem aware that digesting a tuna fish does not involve the same bodily processes as injecting a mercury preservative directly into the body of a pregnant woman or young child, thus bypassing some of the defensive processes involved with food consumption.

Mr. McInnes also appears to be unaware that a non blogger named Dr. Bernadine Healy, a former NIH head, has several times stated the need for more research on vaccine autism issues using as one reason the fact that the mercury based preservative thimerosal crosses the placenta. It has been indicated that Thimerosal will be contained in vaccines given to pregnant women in some Canadian jurisdictions, including here in New Brunswick.

Mr. McInnes, to his credit, does not go so far as to say that a thimerosal link has been disproved. He simply declares that no causal link has been found. With that though he ignores the anecdotal evidence of thousands of parents who saw their children regress after receipt of vaccines. He also fails to mention that the few, not many, studies that did not find a causal link have been criticized for their methodological weaknesses. One, the Madsen, Danish study of 2003 did not purport to offer itself as anything other than a call for MORE research. That study found that autism rates continued to rise after removal of thimerosal. The authors of the study pointed out, however, that the period studied overlapped a significant event - diagnostic definition changes in the DSM and ICD which added substantially to the numbers of persons receiving autism diagnoses.

In opining that no causal link has been found between thimerosal and autism Mr. McInnes also appears to be unaware that serious attempts to investigate such a connection have been expressly thwarted by the IOM review of 2004 and by the IACC which used procedural shenanigans to quash its own proposal to conduct an observational study comparing autism rates in vaccinated and unvaccinated populations. Such as study has been called for by Dr. Healy and by Dr. Julie Gerberding until recently a head of the CDC. Dr. Jon Poling has also called for more vaccine autism research. Mr. McInnes may be unaware that Dr. Poling is not a blogger. He is a neurologist whose daughter was the plaintiff in a vaccine case settled in her favor by the US government which acknowledged that her "autism like symptoms" may have been caused when her existing mitochondrial disorder was aggravated by vaccination.

Craig McInnes alleges that what he calls myths being spread contribute to increased illness and deaths from Swine Flu by persuading people not to get vaccinated. He does not refer to any studies which show that Swine Flu vaccine has been shown to protect against the Swine Flu. A few months ago we were warned by public health authorities that Swine Flu mutates rapidly. Now we are asked to believe that vaccine has been developed which has been demonstrated to be effective in preventing the flu even though it may have mutated into a different form? In fact he provides no reference to any studies which indicate that seasonal flu vaccines are effective in preventing other flus which, apparently, are in a process of continual mutation.

Apart from the lack of proven efficacy for H1N1 vaccines Mr. McInnes provided no proof that Canadians choosing not to get vaccinated do so because of internet bloggers. The fact is that mainstream media outlets have published survey results indicating that many front line health care workers including nurses and some doctors did not intend to get vaccinated for H1N1. And there is no proof at all that Canadians generally are not going to get vaccinated. News reports in recent days have shown line-ups with thousands of people waiting for hours for vaccines often without getting them.

Hopefully the learned Mr. McInnes will not also blame the internet or bloggers for the failure to ensure adequate vaccine supplies for those who want them or for the failure to provide sufficient organization to deliver them.

We do not need any more myths, including those generated by mainstream journalists like Craig McInnes.

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Is Autism an Adverse Event Following Vaccination?

An intense campaign has been waged to discredit parents of autistic children who report that their children regressed and developed autism disorders after vaccinations. The campaign has been led by Dr. Paul Offit and a mainstream media that follows faithfully and without questioning the Offit script ...... vaccines are the miracle medical tool of the past century, Dr. Offit is a modern day medical hero who has had his life and family threatened by anti-vaccine kooks, science has disproved for all time any connection between vaccines and autism disorders, parents who question the safety of vaccines are hysterical and desperate, anti-vaccine whackos, duped by celebrities. Professionals who question the Official Doctrine of the Vaccine Church are not mentioned or, if mentioned at all, are quacks ..... and of course .... the many parental reports of autism development in children after vaccination are merely coincidental.

Unlike fever, redness, or swelling on the arm following vaccination, the development of an autism disorder after vaccination is not considered an adverse event and is not tracked, followed or admitted by public health authorities.

A Government of Canada web page, Frequently Asked Questions - H1N1 Flu Virus, purports to provide answers to serious questions about the H1N1 virus and vaccines. It discusses, without mention of the development of autism symptoms, what constitutes an adverse event following vaccination:

Q1. What is an adverse event?

An adverse event is any unwanted medical reaction following immunization.

The majority of adverse events are minor reactions – like soreness at the injection site, or a slight fever – but sometimes, more serious events are reported. Serious adverse events are reactions that cause life-threatening illness, hospitalization, disability or death, like a severe allergic reaction, paralysis, or a seizure. These events are carefully investigated to determine if they are related to the vaccine directly, or if they were caused by an underlying health condition or some other reason.

Q1. Serious adverse events following immunization are rare. In any immunization campaign, from regular childhood vaccines to seasonal flu shots, the average reported rate of serious adverse events is about one case for every 100,000 doses distributed.

Careful monitoring and prompt reporting of any adverse event after immunization are an essential part of the Government of Canada's commitment to providing a safe and effective vaccine. Reporting an adverse event does not mean that the vaccine caused harm. Careful investigation is needed to determine if the events are linked or if they are coincidental.

If there is ever an indication that a vaccine, or a specific batch or lot of vaccine, is harmful to the general population, the Government of Canada has systems in place to quickly and effectively stop or alter immunization programs."

To the above information the Government of Canada should perhaps say that it does not consider evidence of autistic regression after vaccination to constitute adverse events, no matter how many times such non-adverse events are reported by parents. As to the assurance that the Government of Canada will act quickly in the event of an "indication that a vaccine is harmful to the general population" I don't expect to see any time soon publication of the Government of Canada's efforts to follow up on reports of autism disorder onset in children after vaccination. It would be helpful if the Canadian government actually did conduct a careful investigation to see if autism disorders are "are related to the vaccine directly, or if they were caused by an underlying health condition or some other reason."

Is autism in some children an adverse event following vaccination? I don't know and neither does the Government of Canada, the IACC or Dr. Paul Offit, none of which wish to admit that autism disorders might be post vaccination adverse events in some cases.

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Digital Journalist Offers Balanced Treatment of H1N1 Vaccine Safety

In H1N1 vaccine safety becomes an issue in Canada Stephanie Dearing, a digital journalist writing on the Digital Journal web site has, unlike most mainstream media vaccine cheerleaders, produced some balanced coverage of H1N1 vaccine safety issues in Canada. In particular, Ms Dearing points out that Canada, unlike many jurisdictions, including the US, is going bold with adjuvant boosted vaccines.

Amongst the interesting pieces of information found in the article is the State of California labelling requirement for thimerosal which will be contained in the Canadian purchased vaccines:

"The State of California has required products containing harmful metals, or chemicals be labelled with a warning

"This product contains the following ingredients for which the State of California has found to cause cancer, birth defects or other reproductive harm, which would require a warning under the statute: Thimerosal.""

The mainstream media has long ago abandoned any realistic pretence of objectivity on vaccine issues. It is no wonder that the aggressive public health campaign against those with questions about vaccine safety or efficacy has branded internet sources as inherently untrustworthy (unless they support vaccine programs). Ms Dearing's effort adds some much needed balance to a discussion that vaccine promoters are trying desperately to extinguish.

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Are Vaccines A Medical Community Cult? Read the Atlantic

The Atlantic has an excellent article on vaccines, including the medical establishment's cult-like (my description) belief in vaccine efficacy despite flimsy supporting evidence and the harsh treatment of medical community members who dissent or question the vaccine faith. The article is not focused on autism and is not diverted by the usual arguments about autism but it is definitely relevant and very thought provoking. Whatever your views on vaccine issues I recommend it for your consideration.

autism

New Brunswick's H1N1 (Swine Flu) Vaccine Autism Experiment

New Brunswick is about to conduct its own H1N1 Vaccine Autism experiment. The H1N1 vaccines used here will contain both thimerosal AND unspecified adjuvants. As with most public health authorities the NB government information is not balanced concerning the possible risks associated with the vaccines generally and specifically with respect to possible vaccine autism connections. There is frequent mention of authorities like the WHO which called this H1N1 flu virus a pandemic in the first place, and the CDC, in supporting the safety of the vaccines generally.

There is also the usual one sided information concerning possible vaccine autism connections, information which fails to mention credible health authorities like Dr. Bernadine Healy, Dr. Julie Gerberding and Dr. Jon Poling who have said that more research needs to be done on vaccine autism issues. Nor does the information release mention the critique offered by those like Dr. Healy who points out that the "science" to date on vaccine autism issues, the epidemiological studies, are not specific enough to determine the impact of vaccines on vulnerable population subsets, on individual children with conditions that might render them vulnerable. Dr. Healy also points out that flu vaccines have contained thimerosal and thimerosal crosses the placenta. (Dr. Poling, a neurologist, was involved with the issue with his daughter on whose behalf it was successfully claimed that her autism resulted from vaccination. The US government settled on the basis that her "autism like symptoms" were caused by the vaccine aggravation of her pre-existing mitochondrial disorder).

The NB government communication release does not mention that no observational study has been done comparing autism rates of vaccinated populations with autism rates of unvaccinated populations. With the use of vaccines containing thimerosal and adjuvants, most likely squalene, with pregnant women and young children targeted for early receipt of the H1N1 vaccines, the NB government is essentially conducting such a study. Hopefully they will remember these events in assessing NB autism rates 2 to 5 years from now as the young children vaccinated with the thimerosal and adjuvant (squalene) and the new born children of vaccinated pregnant women mature.

I don't know if vaccines cause or trigger autism. I am no longer assured by overstated health authority pronouncements that vaccines do not cause autism, that the science is closed on these issues, when people of such credibility as Dr. Healy, Dr. Gerberding and Dr. Poling say more research is needed.

I do hope that our NB health authorities turn out to be right whether it is from a lucky guess or not. I hope that they save every child and adult from H1N1 flu death with no resulting cases of autism. But I am far from convinced that such will be the case. I absolutely hope that they remember this H1N1 flu vaccine and assess future autism rates with an eye to its ingredients - thimerosal, squalene and whatever other ingredients it contains. And it is probably hoping for too much for them to actually record and compare the autism rates of children who are vaccinated with the H1N1 vaccine and those whose parents refuse the vaccination for them. Time will tell.

H1N1 flu virus update (09/10/08)

NB 1521

Oct. 8, 2009

FREDERICTON (CNB) - The following update on the H1N1 flu virus was issued by the Office of the Chief Medical Officer of Health for New Brunswick on Thursday, Oct. 8:

• We have moved forward with our seasonal vaccination program, according to plans. It started last week and will run for the month of October. The public awareness piece accompanying the campaign speaks to those most at risk of developing complications from seasonal influenza. They are: children six-to-23 months old, pregnant women, people with chronic health conditions, and the elderly. We encourage these groups to get the publicly funded vaccine. A list of clinics by region may be found at www.gnb.ca/flu.
• There has been a frequently referred to, but as-yet unpublished, Canadian study that suggests an association between seasonal flu vaccine and acquiring a mild case of the H1N1 virus. This study is inconsistent with other international studies, and has failed to show a relationship that one causes the other. Both the Public Health Agency of Canada and the World Health Organization have responded to the study, saying that preliminary data show that there is no link between having a severe bout of pandemic flu and having had a seasonal flu shot last year. New Brunswick's position on this study has never changed.
• We know that seasonal flu is fatal to 100-150 New Brunswickers each year, and that children are hospitalized by influenza more than any other age group.
• In making decisions for the province, we balanced this known significant risk and a vast body of published research against the results of one unpublished study, and determined that the best way to protect all New Brunswickers from both diseases was to move ahead with our plans to run a seasonal flu immunization campaign in October, and an H1N1 immunization campaign through November.
• We are running both campaigns because it is the best decision for New Brunswick. We made operational decisions early on that will allow us to have the capacity to offer both vaccines.
• There has never been a one-size-fits-all approach to seasonal vaccines in Canada, and this year is no different. Provinces and territories have not previously had to administer two separate flu immunization programs in a single season, and some of the decisions taken on seasonal and H1N1 vaccine timing reflect concerns over logistics, capacity and likely vaccine uptake.
• The seasonal flu vaccine is safe, and those in the high-risk groups, in particular, should take the steps to receive it as soon as possible.
• 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.
• New Brunswickers should continue to protect themselves and those around them by washing their hands thoroughly and often, coughing or sneezing into sleeves, staying home if sick, and keeping common surfaces clean.
• Persons at high risk of complications from influenza-like illness should seek medical attention promptly. Those at risk include pregnant women, people with underlying medical conditions such as diabetes, or those with compromised immune systems.
• Persons with influenza-like symptoms should stay home and minimize contact with family members as much as possible. If symptoms worsen, they should visit their physician or nurse-practitioner, a walk-in clinic or the nearest hospital emergency department.
• It is recommended that persons with influenza-like symptoms limit contact with other people, including other household members until they are free of symptoms and are feeling well.
• Those experiencing influenza-like illness should consider ending self-isolation when they are able to participate fully in all of their normal daily activities.
• It is important for New Brunswickers to understand that if they do not have influenza-like symptoms it is safe to go to work and school, to participate in activities and to socialize.
• More information on the H1N1 flu virus may be found online, or by calling the 24-hour H1N1 line, 1-800-580-0038.

• 09/10/08

  MEDIA CONTACT: Danielle Phillips, media relations, H1N1 Pandemic, Department of Health, 506-444-3821, flumedia@gnb.ca.

autism

Autism and H1N1 Vaccine Articles: Meagan Fitzpatrick Clarifies

I was quoted by Meagan Fitzpatrick of CanWest News Service in an article about autism and the H1N1 vaccine. 3 versions of the story appeared on line within 24 hours. I found this disturbing since the omission of information in the briefer versions, in my opinion, totally changed the story ... from one which was reasonably objective to one which followed the "Jenny McCarthy versus the scientists" script promoted by Dr. Paul Offit and other defenders of public vaccine programs who dismiss parental concerns. Ms Fitzpatrick called me, and at my request subsequently emailed me, to clarify her role and that of Canwest News Service:

Hi Mr. Doherty,

I would like to provide you with the link to the full story that was published by Canwest News Service related to the autism-vaccine debate.

I would also appreciate the opportunity to clarify that I did not, nor did Canwest News Service, publish different versions of the story. I write for Canwest News Service and when I file a story it is available for use by all of the publications that subscribe to our wire service. If different versions of the story appear either in the print or online versions of those publications it is because that individual publication edited it. It would be ideal for every publication to run my stories at their full length, but unfortunately that’s often not the case. It can be frustrating at times to see how my stories run in various publications. It appears that at least one newspaper published the autism story on its website that was only about half the length of the full article, and that is indeed unfortunate. I would encourage your blog readers to read the full article here:

http://www.canada.com/health/vaccine+rekindles+debate+over+connection+autism/2019601/story.html

Thanks very much,
Meagan Fitzpatrick

NOTES: (1) All three versions of Meagan Fitzpatrick's article were published under Canada.com logos. Canada.com, an internet portal, and Canwest News Service, are related media assets owned by Canwest Global Communications Corp.

(2) The mainstream media almost never mention that there are credible members of the scientific community who maintain that the science is not conclusive on these issues, that the studies relied upon by Dr. Offit and others do not address the impact of vaccines on vulnerable population subsets. The epidemiological studies to date do not even compare autism rates of existing unvaccinated to vaccinated populations, an observational study that could and should be done according to some prominent members of the scientific/health community (Dr. B. Healy, Dr. J. Gerberding, Dr. D. Alexander, Dr. J. Poling).

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CANWEST News and Megan Fitzpatrick Re-Publish Article, Change Swine Flu Vaccine and Autism Story

UPDATE The original full unedited version of the article is now online again and the 2 cropped versions removed.

I am reposting in their entirety 2 articles, one published yesterday, September 21, 2009 by Megan Fitzpatrick and the same story re-published today September 22, 2009 with half of the article edited out. The effect of the editing is to omit any middle ground quotes, including from me, and from autism researcher Dr. Derrick MacFabe of the University of Western Ontario on the need for parents to be heard on the issue of vaccines and autism and the need for further research on the issue. The further effect of the editing is to recast the whole debate as one between a celebrity activist parent and the medical community.

Many news organizations have followed the NYT lead and reported nearly verbatim the position of Dr. Paul Offit, vaccine patent holder, and consequent multi-millionaire, without mentioning that respected professionals like Dr. Bernadine Healy, Dr. Julie Gerberding and Dr. Jon Poling have all called for more research on the issue of vaccine and autism connections. The original version of the Fitzpatrick article displayed some balance. The edited version does not.

The two stories which I repeat verbatim because the two stories are now themselves news items are repeated, first today's shortened version, then yesterday's longer version with the omitted segment in bold italics.

Judge for yourself the difference.

H1N1 vaccine arrival refuels autism debate

BY MEAGAN FITZPATRICK, CANWEST NEWS SERVICESEPTEMBer222009

The much-anticipated H1N1 vaccine has given new life to an ongoing debate about whether vaccinations in children can cause autism, a discussion that will likely heat up as Canada and other countries move closer to releasing the new vaccine.

From one side of the debate come assurances that vaccines are safe and there is no conclusive link to autism; from the other, warnings that there is a relationship and parents should think twice about giving shots to their children.

Canada's chief public health officer, Dr. David Butler-Jones, has repeatedly said that vaccines have a long history of being safe and effective.

© Copyright (c) Canwest News Service

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Flu vaccine rekindles debate over connection to autism

BY MEAGAN FITZPATRICK, CANWEST NEWS SERVICESEPTEMBER 21, 2009

The much-anticipated H1N1 vaccine has given new life to an ongoing debate about whether vaccinations in children can cause autism, a discussion that will likely heat up as Canada and other countries move closer to releasing the new vaccine.

From one side of the debate come assurances that vaccines are safe and there is no conclusive link to autism; from the other, warnings that there is a relationship and parents should think twice about giving shots to their children.

Canada's chief public health officer, Dr. David Butler-Jones, has repeatedly said that vaccines have a long history of being safe and effective. Weighing in on the autism debate, he noted in a recent interview with Canwest News Service that vaccines are given to children at around the same age as when neurological disorders can surface.

"You can have a close time frame," he said. "Just because something's associated in time does not mean it's causal."

Butler-Jones said he recognizes that parents are searching for answers about autism's cause, but added claims that vaccines are the culprit have not been proven.

"The studies have been pretty clear and consistent that vaccination is not the cause of many of the things that have been claimed around the vaccine," he said.

The benefits of immunization far outweigh the risks, said Butler-Jones, but he understands people need to think carefully about it.

"It's important that they get the facts — not the theory, not the conjecture, not the claims — but the actual facts about what we know about the vaccine and the disease and I think . . . virtually everybody would choose the vaccine," he said.

The theory that childhood vaccines are behind an upsurge of autism cases emerged in the 1990s and in recent years has gained high-profile advocates such as Hollywood star Jenny McCarthy, whose son was diagnosed with autism. McCarthy is among the people who believe children receive too many vaccines, too close together, and that a mercury-based preservative called thimerosal used in some vaccines is harmful.

McCarthy is passionate about her cause, but she has her critics who are equally fervent on the pro-vaccination side of the debate.

Harold Doherty, a New Brunswick parent who writes a blog about his son's experience with autism, says his opinion on the controversy lies somewhere in the middle.

"While I once accepted without questioning the public health authorities' position that there is no vaccine-autism connection, I am no longer so sure," he posted in one entry. In an interview, he told Canwest News Service that not enough research has been done for him to accept or reject the theory.

"I've never said that my son's autism was caused by vaccines, or that vaccines have been proven to be a factor. I do believe that the research has not been sufficient to rule it out," said Doherty.

There will be no end to the "vaccine-autism war" unless an observational study is done comparing autism rates between vaccinated and unvaccinated populations, according to Doherty, and the H1N1 immunization program that will get underway this fall is an opportunity for such a study, he said.

Thimerosal has been removed from most of the vaccines given to children, but it is contained in influenza shots, including the new H1N1 vaccine.

Public health officials have said the vaccine will be ready in early November and children age six months to five years are among those who should get it first.

The Public Health Agency of Canada's most recent statement on thimerosal, issued in 2007, concluded that the weight of evidence refutes any link between thimerosal and autism, but that the long-term goal of removing the preservative from vaccines is advisable as a way to reduce total environmental exposure to mercury.

Dr. Derrick MacFabe, an autism researcher based at the University of Western Ontario in London, said parents who believe their child developed an autistic disorder after being immunized must be heard.

"These people's stories about what's happened to their children are completely valid," he said. "You can't deny what these people are saying."

At the same time, people shouldn't have "tunnel vision" when it comes to pinning autism on a single cause, he said. Vaccines should continue to be studied, but so should a host of other factors, including environmental toxins and infectious agents, said MacFabe.

© Copyright (c) Canwest News Service

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Swine Flu Vaccine and Autism: Some Disturbing Reporting by Megan Fitzpatrick

UPDATE The original full unedited version of the article is now online again and the 2 cropped versions removed

UPDATE: Shortly after I posted the following blog the article I checked on line and found that the original report from yesterday had been reposted by Megan Fitzpatrick and CANWEST.

The article was modified to omit my comments and those of Dr. Derrick McFabe. The result was to recast the debate as one beween parents and the health care community. For that reason I modified my blog comment title from "refreshingly balanced reporting" to "disturbing reporting". See my next post on this subject for more.

Harold Doherty

I was pleased to see the balanced reporting by Megan Fitzpatrick of CANWEST NEWS SERVICE in her report on the H1N1 Swine Flu Vaccine and a possible autism connection in Flu vaccine rekindles debate over connection to autism. I was interviewed for that article and Ms Fitzpatrick placed me accurately, and fairly, as being in the middle on vaccine autism issues. I no longer accept without questioning the official opinion that vaccines play no role in causing or triggering autism, and I do not believe that parents' observations of their child's development should be dismissed. I believe that more research needs to be done, a belief inspired by several prominent professionals including Dr. Bernadine Healy, Dr. Jon Poling and Dr. Julie Gerberding.

The article reported comments from Dr David Butler-Jones, Canada's chief public health officer, whose voice has been everywhere during this alleged swine flu pandemic. The public positions of Jenny McCarthy are reviewed along with some comments from autism researcher Dr. Derrick McFabe of the University of Western Ontario who stated that parents who believe that their children's autism resulted from vaccinations must be heard.

There have been a string of one sided media reports since the New York Times public relations style interview with Dr Paul Offit. It appears that many journalists have abandoned any pretense of old fashioned objectivity and have chosen to enlist fully in Offit's Army. They repeat ad nauseum his simplistic assertions that the research is "done" and that "science" has conclusively determined that there is no vaccine autism connection. In reading Ms. Fitzpatrick's article it was refreshing to see an honest attempt to convey all sides of the issues from multiple sources.

One omission from my interview that I wish Ms Fitzpatrick had included in her article is that I informed her that my belief that an observational study comparing autism rates between vaccinated and unvaccinated populations should be done is not my original idea. My belief is based on the statements of Dr. Bernadine Healy, Dr. Julie Gerberding, Dr. Jon Poling and other respected professionals who do see a need to conduct further research on possible vaccine autism issues .... and other possible environmental factors causing or triggering autism disorders. Media narratives invariably portray the vaccine debate as one pitting parents against doctors and professionals without mentioning that some credible health care professionals are of the view that the science is not "done" or concluded on these issues, that more research needs to be conducted.

What might be original in my comments is the notion that we may in fact be undergoing an unintended experiment on some vaccine autism issues with the public health authorities response to the current alleged swine flu pandemic. Not everyone agrees that we are in fact facing such a pandemic. Not everyone will be taking the swine flu vaccine. Those who are targeted - pregnant women and young children, will in some cases be receiving shots which include thimerosal and an adjuvant known as squalene which caused serious harm to Gulf War soldiers. If the young children receiving the shots, and the new born children of women who received the shot while pregnant have significantly higher autism rates than those who do not receive the shots will Offit, health authorities, and most of the mainstream media just ignore that information? Will they continue to decree in very unscientific like manner that the science is closed on these issues?

We will only know the answers if the data is recorded and made known. At this time we do not know if that will be done. We do not know if public health authorities will begin to take autism spectrum disorders, and the parents of children with autism, seriously.

We can only hope.

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NY Times: Swine Flu Virus Will Not Be Abnormally Lethal

Our own take is this: A swine flu epidemic this fall and winter is likely to infect more people than a normal flu, but the virus will not be abnormally lethal.

New York Times Editorial, August 31, 2009

Not to downplay the tragedy of any death, and the impact on families and friends, but it is difficult to see why world governments have reacted with such panic to the Swine Flu (H1N1) version of the flu, the ordinary versions of which kill people every year. Massive investments of public funds have gone into development of vaccines which are being rushed into production. The NYT editorial points out that only 54 residents of the large population NYC area died in last springs Swine Flu outbreak. And the virus has not become more virulent as it proceeds around the world.

Some of these vaccines are going first to young children and pregnant women. Vaccine's Don't Cause Autism spokesman Paul Offit should watch the outcome of that "experiment". "Adjuvants" of unknown effect will be included in some vaccines AND in the US vaccine manufacturers have been granted liability immunity.

Again, every single death is a real tragedy, and hopefully deaths will be reduced even further by the massive immunization program that the health authorities are pushing. Hopefully too though public health authorities will keep reasonably accurate records of possible side effects of these rushed into production vaccines including the development of Guillain-Barré syndrome, and GBS deaths, as occurred in 1976, and .... any autism diagnosis increases amongst the populations of young children and children born of women who received the Swine Flu vaccines.

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Is Swine Flu Panic Petering Out at the CDC?

The CDC is starting to sound as though it is not sure that the swine flu (H1N1) pandemic will actually occur. It is now talking about the swine flu being like any other flu, serious stuff which can and does kill people each year, but no more than normal. As reported by the AP:

WASHINGTON — Government health officials are urging people not to panic over estimates of 90,000 people dying from swine flu this fall.

"Everything we've seen in the U.S. and everything we've seen around the world suggests we won't see that kind of number if the virus doesn't change," Dr. Thomas Frieden, head of the Centers for Disease Control and Prevention, said in a C-SPAN interview taped Wednesday.

While the swine flu seems quite easy to catch, it so far hasn't been more deadly than the flu strains seen every fall and winter — many people have only mild illness. And close genetic tracking of the new virus as it circled the globe over the last five months so far has shown no sign that it's mutating to become more virulent.

.......

What is likely: A busy flu season that starts earlier than usual.."

Governments have invested billions of dollars and lifetimes of credibility promoting the speculation that the world would be hit by a pandemic. In the US swine flu vaccine manufacturers have been given immunity from suit. It now remains to be seen whether pregnant women will be given vaccines with thimerosal and adjuvants. It remains to be seen whether the vaccine program will be rolled out in full force in most countries. It remains to be seen whether a possible autism baby boom will be created by a panic driven vaccination program.

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Swine Flu: Pandemic or Panic? Will We See An Autism Baby Boom?

Influenza kills people every year. To date the numbers of deaths from the Swine Flu, H1N1, virus have not been reported as being exceptionally outside the norm. The fear, as I understood official reports, was that a second wave of Swine Flu was coming, one in which the virus will have mutated and become far more deadly. So far at least, according to a new realease from the CDC that hasn't happened, the Swine Flu virus has not mutated as it makes its way through the southern hemisphere.

As reported in USA Today:

"The H1N1 flu strain doesn't appear to be mutating as it makes its way through the Southern Hemisphere, the U.S. Centers for Disease Control and Prevention said today in a briefing.

One of the biggest fears has been that the virus, which first appeared in April in the U.S. and Mexico and which people don't have any built-up immunity to, might mutate into an even more dangerous form. Health officials have been keeping a close watch on the Southern Hemisphere, which is in its winter season now, to see what form of the virus is likely to travel north as fall comes to the U.S. and the rest of the Northern Hemisphere.

Flu viruses are unpredictable, so the fact that this one hasn't mutated is "somewhat reassuring" said Jay Butler, director of CDC's H1N1 Vaccine Task Force."

The failure of the Swine Flu to mutate .. to date .. will not stop the roll out of the massive Swine Flu vaccine buys by most western nations. The health authorities have invested much of their credibility in predicting a swine flu pandemic which does not yet appear to have materialized. Massive amounts of public monies have been invested. The vaccines will be given.

With young children and pregnant women near the top of the priority list for receipt of swine flu vaccines, and with the vaccines still containing thimerosal and adjuvants we will experience an unplanned observational study of whether vaccines are causally related to autism. The IACC pulled an observational study of vaccinated and unvaccinated populations off the table in January and IACC head Dr. Thomas Insel spent much of his credibility in opposing the need or the ethics of such a study. Despite the comments of medical and health professionals like Dr. Bernadine Healy, Dr. Julie Gerberding and Neurologist, professor and successful parental autism vaccine litigant Dr. Jon Poling, and despite the direct observations and cries of thousands of parents the IACC will NOT do a study which might confirm a vaccine autism connection. The Swine Flu vaccination program targeting young children and pregnant women might in fact save many lives as the health authorities continue to maintain. The same program might, unfortunately, provide evidence of a vaccine autism connection.

If another upswing in autism diagnoses occurs in 2011-13 remember the Swine Flu Vaccine program of 2009-10.

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