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.

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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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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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More Autism on the Way? Swine Flu Vaccine Adjuvants, Thimerosal and Autism

Pregnant women will be at the front of the line for the Swine Flu vaccine in many countries. Mercury in thimerosal crosses the placental barrier. So thimerosal will not be used in the Swine Flu vaccine right? WRONG!. Thimerosal will be used and its negative effects, including possibly autism in some of the women's children, could be enhanced by the aluminum adjuvants used in the vaccines.

Australian scientist Vera Scheibner Ph.D., has described the effects of aluminum adjuvants including the enhancement of mercury toxicity and possible autism implications amongst a host of other health issues in The Terrifying World Of Vaccine Adjuvants:

Adjuvants are formulated compounds, which when combined with vaccine antigens intensify
the body’s immune response. They are used to elicit an early, high and long-lasting immune
response. “The chemical nature of adjuvants, their mode of action and their reactions (side
effect) are highly variable in terms of how they affect the immune system and how serious their adverse effects are due to the resultant hyperactivation of the immune system. While
adjuvants enable the use of less *antigen to achieve the desired immune response and reduce vaccine production costs, with few exceptions, adjuvants are foreign to the body and cause adverse reactions”, writes Australian scientist Viera Scheibner Ph.D, (1) The most common adjuvant for human use is an aluminum salt called alum derived from aluminum hydroxide, or aluminum phosphate. A quick read of the scientific literature reveals that the neurotoxic effects of aluminum were recognized 100 years ago. Aluminum is a neurotoxicant and has been linked to Alzheimer’s disease and other neurological disorders.

The article cites Boyd Haley for the proposition that vaccines which contain both aluminum adjuvants and mercury based preservative, greatly magnify the neurotoxic effects. The article comments on squalenes used in vaccines and a process called molecular mimicry and ties molecular mimicry to the autism epidemic:

Tying molecular mimicry to the autism epidemic, many children have regressed into autism spectrum disorders after injection with the triple live virus MMR (measles,mumps,rubella) vaccine. Dr.Vijendra Singh’s research at Utah State University suggests that auto-antibodies are attacking myelin in these children. He has shown that many autistic children have auto-antibodies to brain myelin basic protein (MBP) as well as elevated levels of measles virus antibodies. “Immunoblotting analysis showed the presence of an unusual MMR antibody in 60% (75 of 125) of autistic children, but none of the 92 normal children had this antibody. In addition, there was a positive correlation (greater than 90%) between MMR antibody and MBP auto-antibody, suggesting a causal association between MMR and brain autoimmunity
in autism. This is one of the most important findings in autism to date, which prompted us to link measles virus in the etiology of the disorder”, writes Dr. Singh. (8,9,10)

These excepts are a small selection of the information contained in this article which I recommend for reading by anyone who is interested in reading beyond the standard public health authority assurances about the possible consequences of the still not tested Swine Flu Vaccines. Although I have extracted sections directly referencing autism the article covers many other issues associated with vaccine adjuvants.

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Swine Flu (H1N1) Vaccine Safety Questioned by Drug Policy Researcher and Professional Ethics Director

Some parents of autistic children have, for many years, questioned the safety of vaccines, vaccine ingredients and vaccine schedules in connection with the dramatic rise in autism spectrum disorder diagnoses. The standard response is that vaccines are safe and parents are typically branded as hysterical or ignorant or both. These responses ignore the fact that flu vaccines containing thimerosal are still given to pregnant women and that mercury based thimerosal crosses the placenta. The official "don't worry, be happy" responses also ignore the cumulative amounts of mercury from the multitude of vaccinations young children receive. With the Swine Flu (H1N1) panic upon us some parents question the safety of the Swine Flu vaccine being rushed into production without safety testing. They are not alone.

In What do we know about the vaccines' safety? Not enough , published in the Globe and Mail, Alan Cassels a drug policy researcher at the University of Victoria and Arthur Schafer, director of the Centre for Professional and Applied Ethics at the University of Manitoba, point out the fact hat public health authorities simply do not know whether the Swine Flu vaccine will be effective or whether it will be safe:

Public-health officials around the world seem to be suggesting there is a possibility this flu pandemic could get much worse, that is, become more lethal. If that were to happen, it seems “obvious” that wise people should seek to have a preventive flu shot or access to a pill. Many people will say to themselves: Why not get the shot, just to be sure?

Part of the answer to that question is that until a million people roll up their sleeves to get the vaccine, no one can be sure how safe it will be. This is also a decisive answer to those who favour making vaccination mandatory.

Some public-health officials have described flu vaccines as “highly effective,” but the internationally recognized Cochrane Collaboration (which accepts no money from the pharmaceutical industry) did a systematic review of all high-quality randomized trials (25 in all) studying influenza vaccination. They concluded that “the evidence does not support universal immunization of healthy adults.” Period.

Cassels and Schafer point out that this is not the first time public health authorities have recommended action for treating flu without evidence to support the safety or effectiveness of that course of action. The quote above references a review of influenza vaccination generally which did not support universal immunization of health adults. The authors also discuss Tamiflu and Relenza, anti-viral drugs which are supposed to reduce the severity and length of flu but which have been shown by scientific testing to be little or no better than a placebo. Worse, a recent international study reveals that about 50 per cent of children who have taken Tamiflu experienced side effects from gut problems, diarrhea, to serious, neuropsychiatric problems. Cassles and Schafer take authorities to task for glossing over the problems with these anti-viral drugs.

I have in the past criticized the Globe and Mail for repeating the "vaccines can do no wrong" mantra of public health authorities and marginalizing parents who express concerns about vaccine safety. I commend the Globe and Mail for offering this thought provoking article using credible sources to provide a different perspective on the current Swine Flu Pandemic/Panic and the rush to flood the world with an untested vaccine.

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The Great Autism and Swine Flu Vaccine Experiment

The vaccine causes autism debate will now be front and center for years to come as US Health and Human Services Secretary Kathleen Sebelius confirms that the Swine Flu (H1N1) Vaccine will be laced with the mercury based preservative thimerosol.

In an interview with Katie Couric Secretary Sebelius says thimerosol is safe and parents need not worry:

"study after study, scientist after scientist, has determined that there really is no safety risk with thimerosol. There is concern about parents of why autism rates are rising. And, as you know, we've got some special NIH studies, thanks to the president, focused on just what is going on.

But thimerosol has been proven to be safe. It's used in seasonal vaccine-- seasonal flu vaccine. And, again, we want to assure people that that-- the scientists, again, have confirmed-- that there is really a safe factor with using thimerosol. It's an effective preservative and one that we think actually adds to the likelihood that we'll have a safe vaccine for a while to come.

....

based on the science. And the science, again, continues to indicate that the ingredients we're anticipating using in this vaccine are safe to use."

The article Web Exclusive: Sebelius on Vaccine Fears does not indicate what studies Secretary Sebelius relies upon to assert that the science shows that thimerosoal is safe and does not cause autism. Given that pregnant women will be targeted it appears that the swine flu vaccine program will essentially be an experiment which could result, or not, in a new wave of autism diagnoses in the children of women receiving the swine flu vaccine. I hope that Secretary Sebelius is right in the result but I believe she has overstated the "science" supporting the safety of thimerosol and the alleged lack of any link to autism disorders.

Hopefully accurate records will be kept. In a feature last year, also on CBS, Dr. Bernadine Healy expressed concerns about vaccines and indicated that research of a vaccine autism connection had been expressly discouraged by health authorities. CBS also reported that:

"CBS News has learned the government has paid more than 1,300 brain injury claims in vaccine court since 1988, but is not studying those cases or tracking how many of them resulted in autism.

The branch of the government that handles vaccine court told CBS News: “Some children who have been compensated for vaccine injuries…may ultimately end up with autism or autistic symptoms, but we do not track cases on this basis.”"

There you go. First authorities do not research or track possible vaccine related autism cases. Then they claim the science does not support a vaccine autism link. And vaccine programs like the impending Swine Flu program are reported on the basis of "science" to be safe with no autism connection.

See no autism, hear no autism, speak no autism.

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Swine Flu Vaccines, Autism and Public Health Gamblers in Canada

As in Europe, and in the US, so too in Canada where officials are also fast tracking swine flu vaccines without proper safety trials. The CBC, as expected from a government financed media, offers an uncritical assessment of the Canadian fast track strategy in Swine flu vaccine fast-tracked in Canada, U.S., Europe. CanWest News offering a more independent, critical analysis of Canadian strategy reports that, unlike in the US, Canada does not have a plan in place to provide no fault compensation to people injured by the vaccine as occurred in the 1976 swine flu scare vaccination program:

A leading public health expert is calling on Canada to create a no-fault compensation program for people who may be harmed by a swine flu vaccine that millions of Canadians will be urged by the government to get this fall.

Kumanan Wilson, Canada research chair in public health at the University of Ottawa, said in an interview with Canwest News Service that children and adults could be exposed to an incompletely tested vaccine and that a compensation scheme is needed to encourage the public to buy into any mass immunization program.

When the World Health Organization last month proclaimed swine flu the first pandemic since 1968, Canada’s chief public health officer, David Butler-Jones, said everyone should get the new flu shot when it becomes available.

“The more people that have immunity, the easier it is to stop,” he said.

But Canwest News Service has learned that, unlike the United States, the Public Health Agency of Canada has no plans to compensate people who may be injured by an H1N1 vaccine.

A vaccine injury program would give people who suffer an adverse reaction faster access to compensation without having to go through the legal system. Quebec is the only jurisdiction in Canada that has a non-fault compensation program.

Public Health Agency of Canada officials acknowledged last week there won’t be time for a swine flu vaccine to go through standard safety testing before immunizations begin in the fall. The first doses are expected to be available in three to four months. Officials said they are working with regulators on ways to reduce any time required for getting the vaccine out. Canada could invoke emergency provisions to get the vaccine out quicker, before all the data from human trials that test safety are complete.

Hopefully Canadian governments will enact a true no-fault compensation system for those injured by the swine flu (H1N1) vaccine and will at least fully and accurately record what happens to those, particularly pregnant women and young children, who receive the untested vaccine shots.

Specifically, given some evidence that the swine flu (H1N1) virus has itself been linked to autism, governments should keep reliable records on autism diagnoses amongst children receiving the swine flu vaccine, or children born of mothers who received the vaccine while pregnant. Would it be too much to ask governments to keep such records and make the resulting information available before relying on the old "correlation does not imply causation", or "it's just a coincidence" arguments to mock those who see their children regress into autism after vaccination?

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Swine Flu Vaccines, Autism and Public Health Gamblers in the US

In Swine Flu Vaccines, Autism and Public Health Gamblers I commented on the gamble underway in Europe where the the European Medicines Agency is allowing companies to skip testing in large numbers of people before the vaccine is approved, a step that was admitted to be a gamble by Europeon Officials.

Now comes word, as reported on Bloomberg.com, that US officials are considering their own gamble permitting vaccine manufacturers to to use experimental, untested, additives to increase supply of swine flu vaccine shots.

These authorities may be making a decision they have to make to prevent swine flu deaths. And they may be causing other types of damage.

What the public health authorities should stop doing is trying to pretend that vaccines are inherently safe and that they can not cause neurological damage including autism. They should stop maligning parents who question vaccine safety and who argue that their child's regression into autism immediately after vaccine shots is more than a simple coincidence. They should start addressing their concerns seriously and stop playing cheap games such as occurred when , as reported at Age of Autism, parents were excluded from IACC hearings after several hours waiting, in some cases with their autistic children.

Vaccine programs are vitally important public health tools. But they should not become golden calves worshipped and placed high on an alter above and beyond public criticism and free expression.

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Can Swine Flu Alter Genes and Cause Autism, Alzheimer's and Schizophrenia?

A genetic epidemiological researcher who has worked in statistical genetics at the National Human Genome Research Institute/NIH, has posted an article Swine Flu Can Change Genes of Unborn at Blisstree.com suggesting that swine flu in pregnant women may change the genes of unborn children resulting in damage to the hippocampus. Grace Ibay points out that damage to the hippocampus is associated with a number of mental disorders including autism, Alzheimer’s and schizophrenia.

Ms Ibay refers to a study of pregnant mice injected with the swine flu (H1N1) virus published in the medical journal European Neuropsychopharmacology in which the newborn offspring had reduced hippocampus by 15% and 12 other altered genes. The journal article is Prenatal viral infection of mice at E16 causes changes in gene expression in hippocampi of the offspring in European Neuropsychopharmacology Volume 19, Issue 9, Pages 648-653 (September 2009).

The article abstract comments generally that the hippocampus governs memory formation and emotional regulation, that there is widespread evidence of hippocampal dysfunction in psychiatric disorders, including schizophrenia and autism and that there is abundant evidence that prenatal viral infection may play a role in development of schizophrenia and autism.

The abstract reports that the authors of the study, a research team led by S. Hossein Fatemi, of the University of Minnesota School of Medicine, observed:

"significant changes in gene expression in the offspring .... including a number of candidate genes for autism and schizophrenia ... qRT-PCR verified the direction and magnitude of change for 5 of the genes from the microarray data set and revealed mRNA changes for additional genes associated with schizophrenia and autism."

Ms Ibay, who is reported to be the mother of young children in addition to being a genetic epidemiological researcher, refers to this study as confirmation of the public health recommendation that pregnant women be vaccinated against the H1N1 (swine flu) virus. She makes no mention of any possible damage to the genetic makeup of unborn children that might result from injecting their mothers with the H1N1(swine flu) vaccine.

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Swine Flu Vaccines, Autism and Public Health Gamblers

You got to know when to hold em, know when to fold em,
Know when to walk away and know when to run.
You never count your money when youre sittin at the table.
Therell be time enough for countin when the dealins done.

Now evry gambler knows that the secret to survivin
Is knowin what to throw away and knowing what to keep.
cause evry hands a winner and evry hands a loser,
And the best that you can hope for is to die in your sleep.

Kenny Rogers, The Gambler

In Europe governments are rushing production and purchase of Swine Flu (H1N1) Vaccines before the winter cold season hits and flu cases traditionally rise as reported at NorthJersey.com:

"In a drive to inoculate people against swine flu before winter, many European governments say they will fast-track the testing of a vaccine, arousing concern among some experts about safety and proper doses.

The European Medicines Agency, the EU's top drug regulatory body, is accelerating the approval process for swine flu vaccine, and countries such as Britain, Greece, France and Sweden say they'll start using the vaccine after it's green-lighted — possibly within weeks.

In an interview, Dr. Keiji Fukuda, the World Health Organization's flu chief, warned about the potential dangers of untested vaccines, although he stopped short of criticizing Europe's approach outright.

"One of the things which cannot be compromised is the safety of vaccines," he said Friday. "There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies."

The WHO has predicted there could be 2 billion swine flu cases worldwide this year and next, and the U.S. Centers for Disease Control predicts 40 percent of Americans might contract the virus.

Flu vaccines have been used for 40 years, and many experts say extensive testing is unnecessary, since the swine flu vaccine will simply contain a new ingredient: the swine flu virus.

But European officials won't know if the new vaccine causes any rare side effects until millions of people get the shots. Still, they say the benefit of saving lives is worth the gamble.

"Everybody is doing the best they can in a situation which is far from ideal," said Martin Harvey-Allchurch, a spokesman for the European Medicines Agency. "With the winter flu season approaching, we need to make sure the vaccine is available."

In Europe, flu vaccines are usually tested on hundreds of people for several weeks or months, to ensure the immune system produces enough antibodies to fight the infection.

But to ensure swine flu vaccine is available as soon as possible, the European Medicines Agency is allowing companies to skip testing in large numbers of people before the vaccine is approved."

The swine flu pandemic preparations prove some simple points in the vaccine autism wars - governments are more than willing to cut safety corners when it comes to vaccination of the public against contagious diseases. Safety testing before vaccine usage can be waived, and will be waived, if governments deems it necessary. And yet, parents concerned about vaccines and possible autism consequences, possible neurological damage resulting from vaccine usage, are branded as quacks and crackpots?

As the quote above highlights fully, governments are more than willing to gamble, to take chances with the unintended consequences of vaccine injections, if such injections MIGHT prevent the spread of a deadly disease. But of course they would not attempt to cover up such consequences after the fact, would they? After all they do know in advance that UNTESTED vaccines will only produce RARE side effects right?

Shame on me for ever doubting our public health gamblers.

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