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Every Child By Two: Oprah, Jenny McCarthy et al

20 Oct

An email from Amy Pisani – a thoroughly charming lady who runs the organisation Every Child By Two – made me nod appreciatively today. I’ll quote it in full:

It has been quite some time since Every Child By Two (ECBT) has asked you to take action on an issue related to immunizations. I write to you today with an urgent request for your assistance in reaching out to the Oprah Winfrey Show to urge that she dedicate a show to the science behind the question of whether vaccines cause autism.

More than fourteen credible studies have been conducted worldwide exonerating vaccines and yet the media and entertainment industry continue to frame this as a debate. ECBT and our public health partners have reached out to Oprah’s producers countless times without success. However, I recently had a lengthy conversation with one of the producers who recommended that we initiate a letter writing campaign by commenting within the Oprah.com feedback section of the website. This information is tabulated to determine whether there is enough interest to conduct follow up shows.

I urge you to take five minutes to fill out the Oprah Winfrey Show online form by following the link below. In your comments, please request that Oprah invite credible scientists and/or physicians to explain the science of vaccines to her viewers. We also would like her to invite parents who have suffered the loss of a child from a vaccine-preventable disease, and a parent of an autistic child who can speak on behalf of the many families that are frustrated over the continued focus on vaccines and their supposed link to autism and the therapies that focus on “repairing vaccine damage”. Please relate any personal experiences you may have with vaccine-preventable diseases or autism. In addition, please refer the Oprah Winfrey Show to Amy Pisani, Executive Director of Every Child By Two, for any follow-up questions.

And finally, please forward this to your family and friends and request that they also reach out to the Oprah Winfrey Show.

https://www.oprah.com/ord/plugform.jsp?plugId=215

An excellent idea. I’d like to see a show that mirrors the one sided show that Jenny McCarthy recently got – the one where she was free to spout off her latest game of ‘cure the Evan‘ (he’s cured, no he’s not, yes he is….) but this time with a careful step by step walk through the science that:

…is largely complete. Ten epidemiological studies [plus two clinical ones and the testimony of Stephen Bustin] have shown MMR doesn’t cause autism; six have shown thimerosal doesn’t cause autism; three have shown thimerosal doesn’t cause subtle neurological problems; a growing body of evidence now points to the genes that are linked to autism; and despite the removal of thimerosal from vaccines in 2001 [and the 10% drop in MMR uptake between 1997-2007], the number of children with continues to rise.

– Autism’s False Prophets, Page 247. Dr Paul Offit.

Compare this hard, clinical, transparent (and thus independent) science with Mother Warrior Jenny McCarthy’s recent evangelical call to arms:

“I made a deal with God,” she explains. “I said, ‘You fix my boy, you show me the way and I’ll teach the world how I did it.'”

Hallelujah! Or whatever. To misquote the Pythons – she’s not the Messiah, she’s just a very silly girl.

Please act on Amy Pisani’s request – do it right now.

The next mito-autism case?

20 Oct

It’s been nearly a year since the first autism/mitochondria case was conceded. The question of mitochondrial dysfunction and autism has evolved significantly in the minds of the public and insiders in that time.

Shortly after the concession, Tom Powers, lead attorney for the petitions was asked

.”..whether this was a possible break in the case, he replied that the particular case dealt with a claimant who had a diagnosed mitochondrial disorder. As a result, it probably won’t have much of an effect on the other cases.”

It wasn’t really on the radar for the Petitioners.

But, that was in December of 2007. In February of 2008, the concession document was leaked, followed by TV, online and print news-stories on the topic. Coincidentally, mitochondria and autism has changed from not “much of an effect on the other cases” to some people claiming as much as 1/2 of the Autism Omnibus cases being associated with mitochondria.

We’ve seen one Omnibus test case removed from the Omnibus because, the parents claim, the child’s case needs to be argued as a mitochondrial dysfunction case. We’ve gone from diagnosing mitochondrial dysfunction involving a difficult task of many tests and specialist’s opinions, to the point where David Kirby, a blogger, claims to be identifying mitochondrial dysfunction based on parental reports. We now have self-taught “experts” ready to answer questions on discussion boards about mitochondrial disorders, one of the extreme specialties of medicine.

While this is all lamentable, we now have the first “test case” for the mitochondrial autism notion, post concession. A family is arguing mitochondrial disorder (or an oxygen depletion disorder).

The case has gone through the first steps in the Court of Federal Claims (the “vaccine court”). The case hasn’t concluded, but a decision has been published. To summarize:

First, note that the parents are representing themselves, it appears. The decision notes:

On August 29, 2008, petitioners filed a Reply to the Order, making two assertions: (1) [The child] suffered from a mitochondrial disorder and oxygen depletion disorder which a later vaccination significantly aggravated, leading to autistic like symptoms (somewhat similar to the Hannah Poling case that respondent agreed to compensate); and (2) the vaccinations which [the child] received caused him mercury poisoning from thimerosal or ethyl mercury (which is the subject matter of the second round of autism cases in the Omnibus Autism Proceeding, the first round of cases having to do with MMR and autism).

Tthey seem to be both arguing the mitochondrial disorder idea and the Omnibus thimerosal theory. In support, they gave no expert medical reports. Instead, they submitted a single paper (which presumably is supposed to cover both, very different assertions):

by D.S. Baskin, et al., entitled “Thimerosal Induces DNA Breaks, Caspase-3 Activation, Membrane Damage, and Cell Death in Cultured Human Neurons and Fibroblasts,” published in 74 Toxicological Sciences (2003), available on the internet.

That’s really thin evidence (as discussed at some length by the Special Master). Some sort of expert report should link the theory to the specific child. The parents state:

They have not filed a medical report in support of their assertion of significant aggravation of [the child’s] autistic like disorder, claiming that no doctor would risk criticism from the medical community by providing such a report.

Anyone want to volunteer some names of people who would risk the criticism?

But, seriously, diagnosing a mitochondrial disorder is not a simple task. This isn’t something a parent (or David Kirby) can do by looking for similar markers to another case. Heck, it isn’t as though all the biomarkers for the conceded case are universally accepted by mitochondrial experts.

With such little support for the case, the Special Master was forced to conclude:

Petitioners have still not proved their assertion of significant aggravation.

Basically, the decision ends with a statement that the family has not made its case, but they have a chance to come back with a status report as to what their intentions are.

They have already signaled a possible intention:

Petitioners express an interest in suing civilly.

This case is built on even thinner evidence than most internet-discussion-group claims. At least with those, there are challenge tests, porphyrin tests or some other questionable test, together with the opinion of the doctor who ordered the questionable tests to support an idea of “mercury poisoning” or some such diagnosis. But here, we seem to have: the child is autistic, therefore it is mercury and/or mitochondrial disorder aggravated by vaccines.

The Special Master gave the family information on how to contact a lawyer familiar with the vaccine court. I hope, for their sake, they did. I doubt it will have much of an effect on their case, but at least they would have some advice as they move forward to civil court–where the expenses will be charged to the family.

The Truth About Andrew Wakefield

14 Oct

Regular readers will know that an eminent UK scientist writes the occasional guest blog piece for LB/RB. Here is his piece in the wake of the the Lipkin/Hornig study and the amusing claim that it vindicates Wakefield. Enjoy – Kev.

A scientist who has followed the Wakefield saga from the start sets the record straight.

According to recent newspaper reports Andrew Wakefield is planning to publish his account of the MMR/autism controversy next year, under the title The Lesser Truth. He is currently facing charges of gross professional misconduct at the General Medical Council (the case is expected to conclude in April 2009). Meanwhile, Wakefield and his supporters continue to claim that his research is valid and continue to smear the investigative journalist Brian Deer who exposed the conflicts of interest and dubious ethics – as well as the junk science – behind the claims of a link between MMR and autism. But it was Wakefield who was obliged to back down in court from his libel allegations against Deer. Wakefield was unable to contradict Deer’s claim that he has been “unremittingly evasive and dishonest in an effort to cover up his wrong-doing”.

Here are some truths about Wakefield and his research that may not find their way into The Lesser Truth:

Wakefield was never a respected researcher. His first foray into the Lancet was a controversial paper in 1989 saying that Crohn’s disease was due to problems in the blood supply to the gut (vasculitis). But this was wrong. In the early 1990s he was funded by pharmaceutical companies for research along the same lines, mostly in animal models, and produced a series of low-impact, forgettable, papers.

Wakefield first courted notoriety in 1993 when he claimed to have identified measles virus in Crohn’s disease gut tissue. Coincidently, measles virus can cause vasculitis so it is easy to understand how, from 1989 onwards, Wakefield had to find measles in Crohn’s. We now know this result was not possible: there is no measles virus in Crohn’s disease and the antibodies Wakefield used were not specific for measles either. In Wakefield’s own lab, a good molecular biologist, Nicholas Chadwick, could not find measles in Crohn’s by sensitive molecular techniques. However, Wakefield said he could find measles, using crude techniques using flawed reagents. Suppressing data which ruins your hypothesis is scientific fraud.

In February 1996 Wakefield cooked up the idea that MMR was involved in autism with the solicitor Richard Barr and parent activist Rosemary Kessick. He wrote a research protocol to get into the children’s colons to look for measles virus and gut damage, and applied to the Legal Aid Board for £55K.

By October 1996, the Royal Free team had scoped enough children to provide Wakefield with tissue samples so that his technician could look for measles virus in the guts of autistic children by immunohistochemistry. This was clearly research, without clinical or ethical justification.

By spring/summer 1997 Wakefield had enough cases and enough creative data for his story. He believed that autistic children had gut inflammation and most importantly, he believed that he had discovered the cause – measles virus persisting in the gut from MMR. Wakefield first tried to get this study published in Nature but it was rejected.

Towards the end of 1997 he sent an abstract of this work to be presented at Digestive Diseases Week in the USA in May 1998. He also submitted two papers to the Lancet. The first was accepted and published as the now notorious February 1998 Lancet paper. The second, the study claiming to have identified measles virus in the gut by immunohistochemistry, was rejected. To see Wakefield’s pictures of measles virus in the guts of autistic children go here (slides 37 and 38). The second paper was never published and has now mysteriously disappeared, although Wakefield showed it all over North America for years.

In 2000, Wakefield published a larger series on “autistic enterocolitis”, the new disease he claimed to have identified (Wakefield et al 2000 Enterocolitis in children with developmental disorders. American Journal of Gastroenterology 95: 2285-95). Analysis of the data in this paper has revealed that it was a scam: autistic children do not have a chronic inflammatory bowel disease. Normal findings in children were called pathology, pathological results were re-examined and sexed up, and new abnormalities were manufactured, all to make it appear that these children had gut inflammation (MacDonald TT, Domizio P. Autistic enterocolitis; is it a histopathological entity? Histopathology. 2007 Feb;50(3):371-9).

As the litigation in the UK began to heat up around 2000, the defendants (the MMR manufacturers) started to ask simple questions, such as, where is the paper which shows measles in the gut of autistic children? This was part of the MMR/autism story that was rejected by Nature and the Lancet. Who knows why Wakefield never published it? Maybe he realised it was junk since at the same time his identification of measles virus in Crohn’s disease had unravelled. Maybe he knew that the experts for the defence had looked at the data and the methodology and shown it was junk.

Wakefield now hooked up with Dublin pathologist John O’Leary. O’Leary was supposedly an expert in an unsound and discarded methodology called in cell PCR, which he claimed allowed him to amplify measles genetic material in tissue samples, in this case, from the guts of children with autism, and identify its cellular location. He also set up PCR techniques to amplify measles from samples of gut. The O’Leary lab’s studies of Wakefield’s gut biopsy specimens were published in another notorious paper (Uhlmann et al. Potential viral pathogenic mechanism for new variant inflammatory bowel disease. J Clinical Path: Mol Pathol 2002;55: 84-90).

In his testimony to the Omnibus Autism proceedings in Washington in summer 2007, London-based molecular biologist Professor Stephen Bustin showed the utter incompetence of O’Leary and his lab. He revealed the fact that a result was called positive if the sample contained measles virus but no DNA (a biological impossibility). He also revealed that if they analysed the same autistic sample 6 times and got a positive once, the patient was deemed to be positive, even though they were also getting positive measles results out of samples of pure water.

It seems that O’Leary has belatedly seen the error of his ways: in the recently published Hornig study, his lab – in common with other labs in the USA – failed to find measles in samples from autistic children (Hornig et al 2008 Lack of association between measles virus vaccine and autism with enteropathy: a case-control study. PLOS One 3(9):e3140). The attempts by Wakefield and his acolytes to claim that the Hornig study vindicates the Uhlmann paper are preposterous. Distancing himself from Wakefield as fast as is possible for any man of 20 stone, O’Leary cleaned up his lab and did things properly.

A review of the career of Andrew Wakefield is a trawl through the underbelly of science. Wakefield did not do experiments to seek the truth – he did experiments to confirm his own beliefs. He produced junk science for over a decade and did immense damage to patients with Crohn’s disease, and autistic children and their parents. Hopefully the GMC will nail the charlatan, and show some sympathy for the Royal Free clinicians who thought Wakefield was honest. The Andy Wakefield show has now moved to the USA where he can get the attention he craves and he can play the role of the selfless seeker of truth whom the establishment had to silence. Being a victim is a good career move for him. It will help Thoughtful House sell junk therapies for autism to desperate parents and allow Andy to live in a really big house, where he can entertain his showbiz friends. He really wanted to be a famous scientist, but he was rubbish at that, so he had to become (in)famous by other means.

Age of Autism use appalling scare tactics

11 Oct

In a recent post, the Age of Autism highlight the death of a baby girl where MMR was found to be a contributing cause. The US government settled with the parents, which is exactly what they should have done. The vaccine was at fault and this child died as a result.

But of course the anti-vaccinationists at AoA can’t leave it at that. They say:

God rest her little soul and comfort her parents, who tried to do right by her and ended up losing her. No, we don’t want to see children dying of preventable childhood diseases, don’t bother us with that canard. We also don’t want to see an ounce of prevention turn into a pound of death.

An ounce of prevention and a pound of death.

Lets establish a few facts shall we? The fact that children are dying right now of vaccine preventable diseases is no canard. Two have died in the UK since 2006 of measles. 345,000 died worldwide of measles in 2005. To belittle and dismiss the deaths of these people – mostly children – as ‘a canard’ is nothing short of evil. Using this little girls deaths to get a cheap shot in at a vaccine that has helped bring about a drop in worldwide deaths from 873,000 in 1999 to 345,000 less than a decade later goes beyond cynical to almost pathological.

What needs to happen for these people to see what it is they are promoting? Should we transport those 345,000 deaths from some dusty locale far, far away to New York? Atlanta? Washington DC? Manchester? Edinburgh? Would it seem real enough then to these soccer moms and weak men desperate to please their Mother Warriors? Would they still be burbling on about an ounce of prevention?

Lets have a look at the VAERS database for 2006. The year Madyson Williams received her MMR shot. According to VAERS there were 22 incidents involving ‘death’ and ‘MMR’. One of these reports stated:

the rpt stated info was recv as “hearsay” through small town grapevine

Another:

The reporter stated “a little girl up the street died after an allergic reaction to MMR.”

Another:

The consumer reported that she “heard of a patient who died after the second MMR shot.”

Another:

Information has been received from a consumer concerning her neighbor’s son who on an unspecified date was vaccinated with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3). On an unspecified date, post vaccination, the patient developed autism and eventually jumped in a lake and died…….The reporter refused to provide information beyond what was on the VAERS form . The reporter refused to provide the name and telephone number of the actual parents of the child.

There is a type of person who seems to feel it necessary to make everything – everything – about them. I hate vaccines therefore ‘my neighbours son’ died of them. I hate vaccines therefore ‘a little girl up the street’ died from them. the AoA article shows exactly the same casual disregard for human life in pursuance of their agenda. Disgusting and immoral.

The myth of mild measles

9 Oct

One of the common arguments from vaccine rejectionists is “These diseases aren’t really that bad”. Often this includes graphs of death rates over time, with the suggestion that the diseases were already going away by themselves when the vaccination program started. It boggles the mind that intelligent people can make that claim, but they do.

The other argument is that with modern medicine and sanitation, the diseases were not a big problem. Again, mind boggling.

People will say, without any hint of irony, “I got the disease and I didn’t die.” The response being so obvious (the dead people aren’t here to speak) that I am astounded that these people make this claim.

More recently, I’ve seen a few blog posts where old news stories are picked out and people say, “See, they didn’t think these were that dangerous”. How many times can I say “mind boggling” in one post?

That all said, I decided to look through old news stories to see what people thought of Measles over time. As it turns out, some really good stories were in Time Magazine, so I will use that as the source.

Let’s scroll back to 1934. In a piece simply titled Measles, Time states:

New York City’s Health Commissioner Rice warned parents to beware of measles as a “very serious malady,” but assured them that this is not a “measles year” in New York. In the first ten weeks of last year the city had 9.562 cases and 44 deaths, against 413 cases and two deaths for the same period this year.

It wasn’t a “measles year”, as in, this wasn’t a big outbreak. Yet, 44 2 people died. [see comments for correction]

OK, people will say, that’s before good medicine and sanitation. (boggle boggle boggle). How about more recently? How about 1966, just as the vaccine was being rolled out (or, as the rejectionists would have it, just about the time when measles decided to coincidentally morph into a mild disease). The title of the piece in Time magazine? End Measles Now. Take a look at the opening paragraph:

To the casual observer, the heavy snow, gale winds and high tides that struck most of the Northeast last week seemed to have turned Rhode Island into a disaster area. Like homeless refugees, long lines of crying children clinging to their parents snaked through the gloom. But it was not the storm that turned out the Sunday crowds. Rhode Island was engaged in a well-planned exercise in preventive medicine.

Yes, people were braving huge storms to go out and get their kids vaccinated against measles. Why? People realized that measles was still, in advanced-medicine-good-sanitation 1966, a major problem.

All over the country concern about measles is increasing. At the research level, physicians and other virologists have long been puzzled about how and when the measles virus attacks the brain, as it does in an estimated 4,000 U.S. cases of encephalitis each year

1966: 4,000 cases of encephalitis every year.

How about 1977? Clean, advanced 1977? An Alarming Comeback for Measles.

Adds Dr. Colette Rasmussen of the Cook County, Ill., public health department: “Too often the disease is looked upon as a sickness all children once had, as a kind of joke.” Unfortunately, measles is no laughing matter. While the overwhelming majority of victims recover in a week to ten days, some develop pneumonia or encephalitis. If the measles virus spreads to the brain, it can cause convulsions, coma and brain damage, and sometimes death.

1977: People still scared of the measles. But, people are starting to forget how bad measles was pre-vaccine.

And, then there’s today. In a piece, How My Son Spread the Measles, Time interviewed the mother of the child who imported the measles from Switzerland this year. They couldn’t use her real name, so they called her “Jane”. She describes the situation:

Jane says she did not know her son had been exposed to the measles while visiting Europe; and she didn’t know that her son was infectious. She and her husband select vaccinations for their children based on their age, their body’s ability to fight the infection, and the risks of the vaccination. Her infected son was not inoculated against measles. “We analyze the diseases and we analyze the risk of disease, and that’s how my husband and I make our decision about what vaccines to give our children.”

She gambled not only with her son’s life and health, but with the lives and health of other children. Other children, including those too young to be vaccinated against measles. But, she does feel “horrible” for the other people affected:

She adds about the outbreak, “I feel horrible for those children and their parents, but I want to protect all children from harm. And so by making sure there is more research done, we can help all children.”

Vaccines in general are a good thing, she says, but the problem is in the ingredients. Many vaccines contain mercury, formaldehyde, and aluminum, Jane argues. Thimerosal, which contains a mercury derivative, was once a common preservative in vaccines, she says. “This just can’t be good for you. Injecting yourself with aluminum can’t be good.”

She weighed the known risks of measles (death, brain damage, pneumonia, to name a few) against the perceived risks of vaccines (with the vague: “Injecting yourself with aluminum can’t be good”). Not a very quantitative comparison. But, she can make this decision because:

Because her children are healthy and well-nourished, Jane said they will sail through childhood diseases such as measles and chicken pox without trouble — and get lifelong immunity from the exposure. And she said, because the U.S. is a relatively healthy first-world country with a well-functioning health care system, she feels safe in making the choice to vaccinate selectively.

Let’s take a quick look at how an actual measles survivor recalls the measles:

I’m in a hospital bed, gasping for breath. Through the clear plastic of an oxygen tent, I see my Mom. Her face is red and she’s crying and crying. I feel hot. Every few hours a nurse opens the oxygen tent and gives me a shot. It hurts.

It’s 1959. I’m in second grade. I’d caught the measles, just like my brothers and sisters and friends. Except unlike them, my measles didn’t go away. It got worse and turned into something I’d never heard of: pneumonia. I spent a month in the hospital, survived, and spent a few more months recovering at home. But more than four million children got measles in the United States in that year and 385 died.

He doesn’t mention poor sanitation or bad medical care. Yes, it was 1959, but that’s supposedly when measles was becoming a “mild” disease. Yes, modern medicine kept him alive. Want to bet what his chances would have been 50 years earlier?

But, let’s look back at how “Jane” made her decision:

“Looking at the diseases mumps, measles and rubella in a country like the U.S…. it doesn’t tend to be a problem,” Jane said. “Children will do fine with these diseases in a developed country that has good nutrition. And because I live in a country where the norm is vaccine, I can delay my vaccines.”

Yes, because the rest of us are vaccinated and we vaccinate our children, she can delay vaccinating her kids. Well, sort of. Evidence shows that in reality, her kid did get a vaccine preventable disease because she “delayed” the vaccine. (It is an open question in my mind whether he child was ever going to get the MMR, but let’s move on).

What are the real risks of the measles….today…in the United States? From the Atlanta Constitution Journal piece:

Along with the pneumonia I had as a kid (1 to 6 percent of measles cases), the risks of measles include severe encephalitis (one per 1,000 cases) — about a third of which result in mental retardation. They also include one to 10 deaths for every 10,000 measles cases. Another risk is subacute sclerosing panencephalitis, a rare fatal illness (one per 100,000 measles cases) caused by an ongoing measles virus infection of the brain, in which symptoms of brain damage usually begin seven to 10 years after infection.

“Jane” made a decision that put a dozen kids at risk of death or brain damage. The odds were in her favor, and they seem to be OK (if you can call taking an infant to the hospital, “OK”). “Jane” won’t know for seven to ten years whether her child, or any of the 12 he infected, will come down with subacute sclerosing panencephalitis (SSPE). At 1 in 100,000 , the odds are pretty good that they will all be OK. But, not zero.

But, let’s compare that to the real risk of MMR. Again from the AJC piece:

And the side effects of MMR? Fever, malaise, a mild rash, swollen glands and a stiff neck in about 5 percent of the patients, febrile seizures in about three out of 10,000, and temporary low platelet count in about three per 100,000 patients. About one in 1 million have an easily treated anaphylactic reaction. And no deaths. Not one.

Because of the relationship of the measles virus to encephalitis, vaccine safety experts have had an ongoing concern that the MMR vaccine might be a rare cause of this disease. Fortunately, all studies with controls have found no association between the MMR vaccine and encephalitis.

So, on the one hand (catching the measles), you have a 1 in 100,000 chance of death by SSPE, a 1 to 10 per 10,000 chance of death right away, about 0.3 per 10,000 chance of mental retardation. On the other hand (getting the vaccine) you have no deaths, febrile seizures in about 3 per 10,000, anaphylactic reaction in 1 per 1,000,000 and 5% with more mild symptoms. Yes, those are all real reactions. But, the balance is clearly tilted towards vaccination. Except, as “Jane” put it, “And because I live in a country where the norm is vaccine, I can delay my vaccines.” Yes, if others are protecting your child, you can “delay” vaccinating and, usually, get away with it.

Let’s do the comparison for “Outbreak Jane”, shall we? With about 10 people affected, the odds were roughly

0.3% that someone could have suffered brain injury
0.1 to 1% that someone could have died
0.01% chance that in the next 10 years one of these people will die of SSPE. Pretty low odds, but, that’s a lot of chips on the table. Would you be happy if someone made that bet for you or your child?

And, that last bit is important. “Jane” made the decision for other people. Some were people whose children were too young to vaccinate.

Still, Jane says she was surprised by the number of calls she got from friends who wanted to bring their unvaccinated children over to play with her kids while they were infectious. Like Jane, they see getting the measles as far healthier than the vaccine.

That’s just a googleplex of boggles.

She said the recent measles outbreak in her region prompted her to do more research. That work has made her even more certain that she and her husband are choosing wisely to be very selective about vaccinations. “This is a difficult choice for parents; choose the vaccine or choose the disease. I have chosen the disease by not vaccinating.”

She chose wisely? She chose “the disease by not vaccinating”? Yes, I agree, she did. The problem is, she also chose the disease for many people other than her own family.

Measles is far from mild. And, no, it isn’t as though people in the past thought so. They just accepted the sickness and death that inevitably came with measles outbreaks. Dr. Keily is quite correct in his piece on the AJC

My mother wasn’t wrong to be crying, back in 1959. The risks of measles are real. Americans were right to be elated when the measles vaccine became available.

The MMR vaccine doesn’t hurt kids. Letting them go without it will.

[note: some small changes have been made since this was first published. Most notably, I corrected a mistake where I put the odds of SSPE at 1 in a million, instead of the correct 1 in 100,000]

Kirby launches torpedo at Verstraeten, sinks Geier

8 Oct

The thimerosal/autism study by Thomas Verstraeten is one of the big targets for those with the vaccines/mercury cause autism agenda. For what it’s worth, Autism’s False Prophets goes into the history of the Verstraeten study and clearly explains the history of that study.  Not surprisingly, the answer is somewhat different than you might find in, say, Evidence of Harm.

In his recent briefing on Capital Hill,  David Kirby took another jab at the Verstraeten study. He tried to assert that (a) the NIEHS claimed that the Vaccine Safety Datalink was unusable for autism studies and that (b) the CDC agreed. He was incorrect, and, luckily, a staffer caught Kirby at it.

Mr. Kirby is trying to explain his actions in a blog post in which he posts an open letter to that congressional staffer.

Let’s consider something here: the congressional staffer, an M.D., knew enough about the subject to catch David Kirby misquoting the NIEHS. I wouldn’t have been quick enough on my feet to catch the misquote.  Now, David Kirby wants to educate this gentleman. Frankly, the information should be flowing the other way. If Mr. Kirby had shown himself open to such education, say when EpiWonk made it abundantly clear (twice) what Mr. Kirby’s mistakes were, perhaps it would be worth the staffer’s time to discuss this with Mr. Kirby. That said, let’s take a look at Mr. Kirby’s letter.

In regards to Mr. Kirby’s misquotes, he has recently “clarified” his position.  He is writing to the Doctor who corrected him in his briefing here:

As you rightly pointed out (and as I concurred that day) I omitted an important detail in regards to Dr. Gerberdings’s letter to the Committee. I regret that, and never meant to mislead people in the room.

It was a rather artless sin of omission.

I think the lesson for me here is that, when you try to cram a two hour presentation into 25 minutes, it is wise to not include very complicated and, as you put it, “somewhat arcane” details that are difficult to explain in such a short period of time. In retrospect, I probably should have focused solely on the NIEHS report itself, and left the Gerberding letter out of the presentation entirely.

Mr. Kiby iscorrect, it is a confusing situation.  There are two documents–an NIEHS report and Dr. Gerberding’s response for the CDC. But, does that excuse misquoting the head of the CDC in his legislative briefing?

Here’s what David Kirby in his capital hill briefing “quoted” the NIEHS report as saying:

NIH: “We identified several areas of weakness that were judged to reduce the usefulness of the VSD for addressing the potential association between exposure to thimerosal and risk of ASD.”

That isn’t in either the NIEHS report or Dr. Gerberding’s response.  Here’s what Dr. Gerberding actually agreed to:

The panel identified several serious problems that were judged to reduce the usefulness of an ecologic study design using the VSD to address the potential association between thimerosal and the risk of AD/ASD.

Emphasis is mine.  But, we’ve already discussed that: Dr. Gerberding didn’t claim that the VSD has reduced usefulness in addressing the thimerosal/autism question. It made a claim that the ecological studies using the VSD had limitations. But, the recipient of Mr. Kirby’s letter would know that.

Back to Mr. Kirby’s open letter: David Kirby is now presenting his own interpretation of the NIEHS report, in place of Dr. Gerberding’s.

As I interpret things, the panel concluded that the database itself suffered from several weaknesses and limitations, which in turn reduced its usefulness for studies of autism risks from thimerosal (ie, Verstraeten) AND ALSO reduced the feasibility of future studies (ie, ecological ones) that are based on data collected within the VSD.

As EpiWonk aptly pointed out, Mr Kirby’s assertion is not the case. The NIEHS panel suggested a number of possible studies on autism using the VSD.  From the NIEHS report:

An alternate future study design that was viewed positively among panel members was a study of a high risk population, defined, in this instance, as siblings of individuals diagnosed with AD/ASD. A sibling cohort from the VSD would allow comparison of AD/ASD risk in siblings as a function of their thimerosal exposure through vaccination and the sample size would lend itself to supplemental data collection. A related study design based on sib-pairs or sets could be used to address discordant ASD/AD status in relation to thimerosal exposures. Another possibility that generated support by the panel was an expansion of the VSD study published by Verstraten et al (2004). The availability of several additional years of VSD data was seen as an opportunity to provide a more powerful test of any potential association between thimerosal and AD/ASD and would enable reconsideration of some aspects of the original study design (e.g., exclusion criteria). A related idea was to conduct a VSD retrospective cohort study using California-based MCOs linked with the California DDS, which would improve the diagnostic data and provide more complete ascertainment. For each of these designs, the ability to link medical records from mothers with those of their children was deemed critical.

As this reader interprets things, NIEHS seems to find that there is quite a bit of value in the VSD for studying autism, including an expansion of the Verstraeten study.

EpiWonk made the point first, but how can the NIEHS say that Verstraeten study design is not a good and that future use of the VSD is not useful, while at the same time suggest expanding Verstraeten?

The bottom line is that there are limitations to using the VSD alone in ecological studies of autism. One can overcome these limitations by going to chart reviews and other methods–as used in Verstraeten et al. and, more importantly, by VSD studies ongoing at CDC (one of which looks at autism).  As noted by Dr. Gerberding:

The VSD currently has a number of priority studies underway to address a range of important immunization safety questions, none of which utilize an ecologic study design. Instead, these current studies, including one study evaluating associations between thimerosal-containing
vaccines and autism, all evaluate individual-level data. This typically involves the review of individual medical charts to confirm the vaccines each individual received as well as the outcomes being studied. Studies using individual rather than group data provide stronger scientific evidence.

Mr. Kirby seems to be neglecting the fact that the CDC’s ongoing study (and the Verstraeten study) is not soley dependent on the VSD for the data.  He seems to be arguing that since the VSD, as a single data source, has limitations, the CDC can’t use it for any study. It’s like saying,

But, let’s take a closer look at what this says….and what Mr. Kirby is saying: The VSD on it’s own is not a good source of data to look at the thimerosal/autism question.

Now, anyone remember all the consternation that has been created by the fact that the VSD is not open to just any outside researcher?  Why should the VSD be opened to, say, Mark and David Geier?  Could they do the individual level data collection needed to make a VSD study valuable?

Apparently not. Recall this study by the Heather Young and the Geiers: Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink

This was a study paid for by the petitioners in the Omnibus proceding.   It, on it’s own, was bad enough that EpiWonk disassembled it.  Twice.

The recent Heather Young/Geier paper didn’t look at individual level data.  Any future study by the Geiers almost certainly wouldn’t as well.  Given the argument by the NIEHS, Dr. Gerberding…and David Kirby, the above study and any proposed study by the Geiers on the VSD would be useless.

Some how I doubt Mr. Kirby will make statements confirming that. But, I can’t see how he could hold any other opinion, given the arguments he, himself, has made.

Good Information being spread on Capital Hill

2 Oct

Last week, there was a briefing for U.S. legislators by Mr. David Kirby and Mr. Mark Blaxill. As you can imagine, the topic was vaccines and autism. As you can imagine, there were some inaccuracies and there was at least one outright misrepresentation.

I applauded an effort by Amy Pisani of Every Child By Two, who wrote the staffers ahead of the meeting. I was also appreciative of a letter by Voices For Vaccines.

Well, now I give a great big thank you to Congressman Waxman. Congressman Waxman is the chair of the Congressional Committee on Oversight and Reform. To put that in perspective, “Oversight and Reform” is the committee that Congressman Dan Burton used to investigate autism and vaccines. (a very good discussion of what went wrong there is in Autism’s False Prophets).

Congressman Waxman’s office sent out a “Dear Colleague” letter. It is a good, succinct discussion of autism and vaccines, and, as such, I think it worth posting. And forwarding to people who may have questions about this issue.

It’s also worth thanking Congressman Waxman for taking the time to work on autism issues.

Resources Regarding Vaccines and Autism

October 1, 2008

Dear Colleague,

Since 1998 some people have been raising concerns that there may be an
association between childhood immunizations and autism spectrum
disorder. I am writing to let you and your staff know that there are a
number of resources available to understand what the science says
about whether vaccines could contribute to autism.

Institute of Medicine report on vaccines and autism

In 1999 the Department of Health and Human Services contracted with
the Institute of Medicine (IOM) to review a number of different
vaccine safety issues and to make recommendations about future
research needs. IOM convened a committee of experts that was carefully
vetted for conflicts of interest. The committee issued nine reports,
all of which are available on line at: http://www.iom.edu/CMS/3793/4705.aspx.

In 2004, the committee issued its final report, which analyzed the
studies, published and unpublished, that looked at two theories:
whether the Measles-Mumps-Rubella (MMR) vaccine could cause autism;
and whether the mercury-containing vaccine preservative thimerosal
could cause autism. The committee concluded that the “evidence favors
rejection of a causal relationship between thimerosal-containing
vaccines and autism” and the committee also concluded that the
“evidence favors rejection of a causal relationship between MMR
vaccine and autism.” This report is available at:
http://www.iom.edu/CMS/3793/4705/20155.aspx.

Other resources on vaccines and vaccine safety

Since the IOM report was published there have been additional studies
that looked at a possible link between vaccines and autism. Below are
several other links to government or private organizations with
helpful information about the latest research into vaccines, vaccine
safety, and autism and vaccines:

The Centers for Disease Control and Prevention
http://www.cdc.gov/ncbddd/autism/vaccines.htm

National Network for Immunization Information
http://www.immunizationinfo.org

Institute for Vaccine Safety at Johns Hopkins University
http://www.vaccinesafety.edu

American Academy of Pediatrics
http://www.aap.org/healthtopics/Immunizations.cfm

Information regarding mitochondrial disorders and vaccines

Another concern that has received some attention is whether people
with mitochondrial disorders are more susceptible to vaccine injury.
This issue was in the media after it became public that in 2007, the
Vaccine Injury Compensation Program (VICP), the no-fault compensation
program for people who have been injured by immunizations, compensated
nine-year-old Hannah Poling for injuries she sustained from her
immunizations. Hannah Poling suffered from a mitochondrial disorder,
which is a genetic or acquired defect in the part of each cell that
helps produce energy. People with these disorders are susceptible to a
number of stressors, including fever, illness, dehydration and certain
kinds of medication. In Hannah Poling’s case, after her immunizations
she developed a fever, lethargy, irritability, and other symptoms of
encephalopathy. These symptoms worsened over a period of months to
includ! e muscle weakness and features of autism. Instead of taking
this case to the vaccine court, the VICP conceded the case and agreed
to compensate Hannah Poling.

This case raised concerns that there may be an association between
mitochondrial disorders and autism. Mitochondrial disorders are poorly
understood and there is much research that needs to be done. However,
according to the United Mitochondrial Disease Foundation: “There are
no scientific studies documenting that childhood vaccinations cause
mitochondrial diseases or worsen mitochondrial disease symptoms. In
the absence of scientific evidence, the UMDF cannot confirm any
association between mitochondrial diseases and vaccines.” This
statement is available at: http://www.umdf.org/site/c.dnJEKLNqFoG/b.3616911/apps/s/content.asp?ct=5087517.

Following this case, NIH, HHS, and CDC organized a workshop entitled
“Mitochondrial Encephalopathies: Potential Relationships to Autism.”
The workshop was held on June 29, 2008 in order to explore this
complicated topic and panelists included experts from around the
country. The proceedings from this workshop state that because
acquired infections and the associated inflammatory responses are a
known trigger for mitochondrial disease, “the workshop panelists
strongly encourage vaccinations in the hundreds of children they treat
for mitochondrial disease.” A summary of this workshop is available
at: http://www.ninds.nih.gov/news_and_events/proceedings/20090629_mitochondrial.htm

CDC has additional information on its website at:
http://www.cdc.gov/ncbddd/autism/mitochondrial.htm

I hope you find these links useful. If you are interested in other
resources, please do not hesitate to call Sarah Despres or Dr. Stephen
Cha on my staff at 5-5056.

Sincerely,

/s
HENRY A. WAXMAN
Member of Congress

Vaccines on the Hill III

26 Sep

Somehow I never thought there would be a “Vaccines on the Hill II”, much less III. That said, a question from Lisa (from about.autism.com) got me thinking and, well, I’d rather do this a post than a response.

I admit, this isn’t directly related to her comment, who commented on how David Kirby makes a point of stating he is not “anti-vaccine”.

Instead this is about frustrations with Mr. Kirby. As an example, let’s discuss how Mr. Kirby “quoted” a response that the CDC made to an NEIHS report in his congressional briefing. Yes, “quoted” is in quotes for a good reason.

On his presentation, page six, Mr. Kirby “quotes” (there’s those quotation marks again!) the NIEHS report:

NIH: “We identified several areas of weakness that were judged to reduce the usefulness of the VSD for addressing the potential association between exposure to thimerosal and risk of ASD.”

With the response from Dr. Gerberding at CDC of:

Gerberding General Response: CDC CONCURS

What was the real quote?

The panel identified several serious problems that were judged to reduce the usefulness of an ecologic study design using the VSD to address the potential association between thimerosal and the risk of AD/ASD.

Emphasis mine.

Yep. Mr. Kirby left out the fact that the NIEHS was specifically talking about ecological studies.

Makes a BIG difference in how that phrase is interpreted. This was a major part of two epiwonk blog posts, here and here. Mr. Kirby’s original blog post on this was retracted, so Mr. Kirby is well aware of the importance of the fact that the NIEHS limited the statement to ecological studies.

By the way, the real CDC response?

CDC Response: CDC concurs with this conclusion and does not plan to use VSD for ecological studies.

They did most certainly not concur with the statement that Mr Kirby “quoted”. Instead, they see the limitation for ecological studies. There is strength in using the VSD. They don’t see it as valuable for discussing the thimerosal/autism question, as we’ve discussed before.

Here’s the NEIHS report, and here, the CDC response.

Mr. Kirby’s “quote” of the NIH was incorrect. This isn’t incorrect in the way Dan Olmsted thinks that “has” vs. “have” is an important difference. No, the quote by Mr. Kirby completely changed the very meaning of the statement that NIEHS made and implied the CDC concurred with.

It sounds like Mr Kirby was caught red-handed trying it too, by a staffer who obviously came in very well informed. The bright side is that the legislature got an idea of Mr. Kirby’s tactics. The down side, they may not realize that the entire autism community is not represented by Mr. Kirby and his tactics.

This misinformation effort has already had an effect. Mr. Kirby’s original treatment of the CDC response made people think that the CDC position is that the Verstraten study was flawed. As epiwonk makes very clear, the opposite is true. The NIEHS panel suggested expanding the Verstraten study (which was not ecological) with additional years.

And people wonder why I get frustrated with Mr. Kirby.

Vaccines on the Hill part 2

25 Sep

We recently discussed the Malony briefing where she hosted David Kirby and Mark Blaxill in a discussion of autism and vaccines. As part of that post, I included a letter from Amy Pasani of Every Child By Two.

On a hunch, I checked with another organization, Voices For Vaccines, to see if they had contacted legislators. Lo and behold, they did:

Dear Senator or Representative:

The organizers of a briefing being held later today have listed your office as one from which a staff member will be in attendance. I would like to supply some information which may place the content of the briefing in context.

Today’s event, sponsored by Rep. Carolyn Maloney, will feature Mr. David Kirby and Mr. Mark Blaxill speaking on the claim that vaccines cause autism. This is a notion which is not supported by scientific evidence. It is also one that has been recognized by the mainstream medical community as posing a threat to the health of Americans.

I am attaching an Open Letter to Congress, issued last June, in which 84 national, state, and local organizations emphasized their support for immunization as a cornerstone of United States public health, and made clear their desire for Congress to follow a sound, evidence-based course in evaluating legislation related to vaccines. As you are undoubtedly aware, this year brought a sharp upswing in cases of measles, most of which were associated with importation of the virus by unvaccinated individuals. These outbreaks reflect vaccine reluctance borne of misplaced fears. The agenda for today’s briefing indicates that it will fan, rather than quell, those fears.

While the presenters will no doubt couch their claims in scientific-sounding language and the rhetoric of impending doom, you can rest assured that no new information has emerged to lead credible scientists to raise concerns about vaccine safety. The popular concept of an “autism epidemic” is largely, if not wholly, an artifact of diagnostic shifts and a broadened definition of autism. There has been no government concession that vaccines cause autism, only that they might have hastened the appearance of autistic-like features in one Vaccine Injury Compensation Program claimant. What autistic people need and deserve is funding for legitimate research and programs that will improve their quality of life — not distractions that squander resources and promote panic.

For further information on these topics, I recommend the following sites:

Centers for Disease Control and Prevention – Autism http://www.cdc.gov/ncbddd/autism

Centers for Disease Control and Prevention – Immunization http://www.cdc.gov/vaccines

American Academy of Pediatrics – Autism http://www.aap.org/healthtopics/autism.cfm

American Academy of Pediatrics – Immunization http://www.aap.org/healthtopics/immunizations.cfm

Vaccine Education Center, Children’s Hospital of Philadelphia http://vaccine.chop.edu

Best regards,

Lisa H. Randall, J.D.
Interim Executive Director
Voices For Vaccines
325 Swanton Way
Decatur, GA 30030
http://www.voicesforvaccines.org

If the reaction to Ms. Pisani’s letter is any guide, one sentence in the letter above will be particularly targeted by some vaccine-autism advocacy groups:

What autistic people need and deserve is funding for legitimate research and programs that will improve their quality of life — not distractions that squander resources and promote panic.

Some may complain about that, but not me.

Keeping the theme used for the previous post, I’ll close with this statement:

Why reproduce the Lisa Randall’s letter here? Because many in the greater autism community agree with Ms. Randall. This blogger certainly does. I hope that legislators know that members of the autism community side with Voices for Vaccines on this subject.

Vaccines on the Hill

25 Sep

With a hat-tip to Kim Stagliano at the Age of Autism blog. They got ahold of an email sent by Amy Pisani of Every Child by Two to legislators who were sending staffers to a briefing by Mark Blaxill and David Kirby on vaccines and autism.

Mr. Kirby promised to talk about, amongst other topics, Hannah Poling. That’s not what I would call a good briefing. A good briefing would be if the legislators asked HHS to talk to them about what the concession meant. Somehow, I think the two briefings would be significantly different. Then again, I suspect a briefing by the doctors who are studying that potential cause of developmental regression via mitochondrial dysfunction would also have a very different story to tell than Mr. Kirby. I strongly suspect that.

But, I digress, as I often do. You see, Every Child by Two thought that the legislators who were sending staff to the Kirby/Blaxill briefing should be informed that the information provided by that team was, well, not accepted by the mainstream.

The letter, respecfully written, respectfully submitted is quoted below. One reader of this blog asked Ms. Pisani for permission to reproduce it here. I am using the text from the AoA blog.

Why reproduce it here? Because many in the greater autism community agree with Ms. Pisani. This blogger certainly does. I hope that legislators know that many members of the autism community side with Every Child by Two on this subject.

So, after much delay, here is something written much better than the ramblings I’ve put together:

Today you have been invited to attend a briefing to provide “updates on the recent autism-vaccines debate”. While I recognize that most of you will likely be dealing with other priorities and will not attend the Maloney briefing, I write to you this morning because I feel it is critical to clarify that there is no debate among the scientific community regarding vaccines and autism. Instead, the debate rages on in the media due to the efforts of those who wish to sidetrack critical research away from finding the true cause(s) of autism and treating children and their families struggling with this condition.

‘Last week Dr. Paul Offit’s new book “Autism’s False Prophets, Bad Science, Risky Medicine, and the Search for a Cure” was published by Columbia University Press. This book is a must read for all those concerned with children dealing with autism. The Philadelphia Inquirer writes that “Offit’s account, written in layman’s terms and with the literary skill of good storytellers, provides important insight into the fatal flaws of the key arguments of vaccine alarmists, including such well-known names as Robert F. Kennedy Jr., Sen. Joseph Lieberman (I., Conn.), and Sen. John Kerry (D., Mass.).” And the Wall Street Journal writes “Ever since psychiatrist Leo Kanner identified a neurological condition he called autism in 1943, parents whose children have been diagnosed with the most severe form of the illness — usually in the toddler stage, before age 3 — have found themselves desperately searching for some way not to lose their children to autism’s closed-off world. Unfortunately, such parents have often found misguided doctors, ill-informed psychologists and outright charlatans eager to proffer help.”

In 1999 I was pregnant with my first son just as the questions first arose regarding the MMR vaccine and subsequently the thimerosal in vaccines. After attending Congressman Burton’s hearings (quite pregnant I might add) I too became alarmed. Fortunately, as the Executive Director of Every Child By Two I had at my disposal the scientific research and advice of the world’s leading experts on vaccines and I was able to confidently vaccinate my son without fear of side effects. As of today, eleven studies now show that the MMR vaccine doesn’t cause autism, six have shown that thimerosal doesn’t cause autism, and three have shown thimerosal doesn’t cause neurological problems.

I urge you to read a few of the reviews of Dr. Offit’s book which are listed below and contact us if you wish to have a copy sent to you.

I also ask that you please visit our new website www.vaccinateyourbaby.org – this site was unveiled in August with our new spokeswoman Actress Amanda Peet specifically for parents who have questions about vaccine safety.

at the risk of making this an extremely long blog post, let me do what the Age of Autism did not do: list some of the reviews of the book.

A definitive analysis of a dangerous and unnecessary controversy that has put the lives of children at risk. Paul A. Offit shows how bad science can take hold of the public consciousness and lead to personal decisions that endanger the health of small children. Every parent who has doubts about the wisdom of vaccinating their kids should read this book. — Peter C. Doherty, Ph.D., St. Jude’s Children’s Research Hospital and Nobel Laureate in Medicine for fundamental contributions in Immunology

As a parent it is my job to protect my children. Hearing all the rumors about vaccine side effects made me question the right thing to do. This book makes it clear that vaccines save lives, and that they clearly do not cause autism. — Amy Pisani, mother

In his latest book Paul A. Offit unfolds the story of autism, infectious diseases, and immunization that has captivated our attention for the last decade. His lively account explores the intersection of science, special interests, and personal courage. It is provocative reading for anyone whose life has been touched by the challenge of autism spectrum disorders. — Susan K. Klein, MD, Ph.D., Case Western Reserve Hospital, and Rainbow Babies and Children’s Hospital, Case Medical Center

No one has been more vocal-or courageous-than Paul A. Offit in exposing the false and dangerous claims of the growing antivaccine movement. Offit’s latest book lays waste to the supposed link between autism and vaccination while showing how easily Americans have been bamboozled into compromising the health of their own children. Autism’s False Prophets is a must read for parents seeking to fully understand the risks and rewards of vaccination in our modern world. — David Oshinsky, winner of the Pulitzer Prize in History for Polio: An American Story

All good reviews. But, dang, a Nobel Laureate in Medicine. Not just medicine but immunology? Plus a Pulitzer prize winner? Begs the question of why the Age of Autism didn’t include them.

I am so glad that they offered Dr. Offit’s book to the legislators. I hope that the legislators, or their healthcare legislative assistants take them up on the offer. It’s a well written book, and fairly concise. It really explains how we (the autism communities) got here (into a big mess where vaccines are such a high profile subject–at least in the media) even though we shouldn’t be (because the science has been done repeatedly and shown no link).

Word back on the briefing is that about 75 people attended–a mix of staffers, parents, possibly even a member of the press. One representative was noted. Mr. Kirby gave the short version of his talk (the full version is quite long–take a look at his power point presentations sometime!). But, we can all rest assured that Mr. Kirby is there to save the vaccine program (I do hope that autism-one puts this briefing on their website. I need to hear that claim by Mr. Kirby with my own ears). Mr Blaxill took on the “sickest generation ever” theme, common to the vaccine rejectionists (a claim that has been addressed ably by epiwonk).

But, again, I digress. Let me bring you back to what I see as the one message I think you should take home from this post (repeated from above):

Why reproduce it [Ms. Pisani’s letter] here? Because many in the greater autism community agree with Ms. Pisani. This blogger certainly does. I hope that legislators know that many members of the autism community side with Every Child by Two on this subject.

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