Archive | February, 2010

Proposed HHS budget has $16M more funding for autism research

21 Feb

The United States Department of Health and Human Services is proposing an increase in autism research funding of $16 million, or about 8% over the 2010 budget:

Addressing Autism Spectrum Disorders: The Budget includes $222 million, an increase of $16 million, for Autism Spectrum Disorders (ASD). NIH research will pursue comprehensive and innovative approaches to defining the genetic and environmental factors that contribute to ASD, investigate epigenomic changes in the brain, and accelerate clinical trials of novel pharmacological and behavioral interventions. CDC will expand autism monitoring and surveillance and support an autism awareness campaign. HRSA will increase resources to support children and families affected by ASD through screening programs and evidence-based interventions.

The Obama administration had originally projected $210M by 2011, so if this gets approved they will be ahead of the original plan.

Last year the Obama administration proposed $211 million:

Supports Americans with Autism Spectrum disorders (ASd). The President is committed to expanding support for individuals, families, and communities affected by ASD. The Budget includes $211 million in HHS for research into the causes of and treatments for ASD, screenings, public awareness, and support services.

If I do my sums correctly, congress actually funded $206 million. Don’t be surprised if the amount funded for 2011 is less than the $222 million proposed. Then again, according to Jocelyn Kaiser at Science:

And in any case, the president’s budget proposal doesn’t mean much because Congress usually ends up giving NIH more than the president requests.

The budget mentions autism in other places:

INVESTING IN SCIENTIFIC RESEARCH AND DEVELOPMENT
Exploring Scientific Opportunities in Biomedical Research:
The Budget includes $32.2 billion for NIH, an increase of $1 billion, to support innovative projects from basic to clinical research. This effort will be guided by NIH’s five areas of exceptional research opportunities: supporting genomics and other high-throughput technologies; translating basic science into new and better treatments; reinvigorating the biomedical research community; using science to enable health care reform; and focusing on global health. The Administration interest for the high-priority areas of cancer and autism fits well into these five NIH theme areas. In FY 2011, NIH estimates it will support a total of 37,001 research project grants, including 9,052 new and competing awards.

Emphasis added.

also,

Autism and Other Developmental Disorders: The Budget requests $55 million, an increase of $7 million, as part of the President’s Initiative to support children with autism spectrum disorders and their families. This funding will continue to expand Federal and State programs authorized in the Combating Autism Act to research, and support screening and vidence-based interventions when a diagnosis is confirmed.

also,

National Vaccine Injury Compensation Program: The Budget requests $7 million for the Vaccine Injury Compensation Program to prepare for projected increases in claims and continue reviews of over 5,100 claims from autism proceedings.

also, under ADDRESSING RESEARCH PRIORITIES IN FY 2011:

In FY 2011, for autism spectrum disorders, again building on significant Recovery Act investments, NIH will undertake complete genome sequencing and comprehensive DNA analyses of 300 autism spectrum disorder cases, and will launch the first epigenomic studies of brain samples from individuals with and without autism. NIH will also use a network of health maintenance organizations to identify patterns of environmental exposure during pregnancy and perinatal life that may contribute to autism.

and,

In FY 2011, NIH will also accelerate Phase 3 clinical trials of a promising mGluR5 antagonist, begin a clinical trial of the drug rapamycin, and create a translational pipeline for advancing additional small molecule drugs for autism.

Would I like to see more funding applied to autism? Heck yeah. But, this is twice the commitment that the previous administration made in autism research.

The proposed budget continues the NIH commitment to research on environmental and gene-environment causation of autism.

Mark Blaxill attempts to support Andrew Wakefield?

20 Feb

As most have now gathered, Andrew Wakefield’s career in the UK is finished. However, the PR machine keeps spinning in the USA as a new fascinating web piece from Brian Deer reveals.

Brian tells the story of how Max Clifford’s daughter – who works for her father – had apparently been ready to take on Andrew Wakefield as a client:

They are looking to take us on for a few months…

However, her father – who previously refused to work with Michael Jackson – had other ideas:

It’s my company, and my daughter works for me, he said

…

We are not involved, and we will not get involved unless they are backed by top medical experts…

Heh. Not much chance of _that_ happening.

During the piece Brian discovers who might be financing Andrew Wakefield’s about-face in the public eye. He suggests a couple of names to Clifford’s daughter who confirms the participation of one Mark Blaxill:

…she appeared to take the bait over Blaxill. “Right, Mark. Okay. Mark is…” But then she paused to ask: “Brian, what’s your background?

Amazing that someone who was preparing to work with Brian Deer didn’t know who Brian Deer was but more interesting to me was the possibility that Mark Blaxill was preparing to fund Max Clifford’s PR firm to try and rehabilitate Andrew Wakefield’s public image. Go read the whole thing, its pretty interesting.

It’s official, Dr. Krigsman to leave Thoughtful House

20 Feb

Thoughtful House, the clinic and research center founded by Dr. Andrew Wakefield, is losing both Dr. Wakefield and, now, Gastroenterologist Dr. Arthur Krigsman.

From a Yahoo group (as posted by Mike Stanton in the comments on LeftBrainRightBrain):

Re: Dr. Krigsman

Dr. Krigsman’s decision to relocate his clinical practice to a facility outside Thought House reflects his belief that the complexities inherent in a referral-based practice can be best addressed by his working independently. We will continue to refer patients for GI evaluations when appropriate, and we look forward to continuing to work with Dr. Krigsman on research projects. We are grateful to Dr. Krigsman for his dedication to Thoughtful House and for the work he does on behalf of the children we serve.

Just to be clear, this is official.

Jane

Fees for the Omnibus Autism Proceeding hit $7M

20 Feb

In the United States, the court hearings on whether vaccines cause autism were held under the Omnibus Autism Proceedings (OAP). These proceedings represented over 5,000 families who filed for consideration that they had a child who (a) suffered a vaccine injury and (b) this injury resulted in autism.

The OAP heard six “test cases”. Each test case represented both the question of whether the specific test-case child considered suffered a vaccine injury and also the general question of whether the idea that vaccines cause autism was proven.

The first three test cases considered the question of whether the MMR vaccine could cause a vaccine injury resulting in autism. The second three test case considered the question of whether thimerosal containing vaccines could cause vaccine injury resulting in autism.

The decisions from the MMR cases have been handed down, and they were unanimously and definitively against the MMR causes autism theory. These have been appealed and that appeal was denied. I believe an appeal to the U.S. Supreme Court has been either filed or planned.

The decisions in the thimerosal cases have not been handed down yet.

The OAP was a very long process, starting in 2002 and still ongoing, involving multiple law firms and many lawyers and experts. It has been an expensive process. We are slowly learning just how expensive.

Last year an interim award of over $2M in legal fees was granted for lawyers working on the Cedillo test case. That was the first case heard in the MMR segment of the AOP.

The Court has now granted an interim award of $2,300,000 for the King test case, the first heard in the Thimerosal segment of the AOP.

During an unrecorded telephonic status conference on July 1, 2009, the law firm of Williams, Love, O’Leary, and Powers (WLOP) agreed to reduce its interim attorneys’ fees and costs request from $3,101,764.84 to $2,300,000.00, including $2,070,000 in fees and $230,000 in costs. Respondent’s counsel then indicated that respondent will not object to that amount. WLOP’s reductions included: the withdrawal of time and expenses relating to direct legislative lobbying, that is, any activity relating to efforts to affect the outcome of the political process; the withdrawal of time and expenses relating to “case specific” work in cases other than this claim, and unrelated to “general causation” work on the OAP; the withdrawal of time and expenses WLOP conceded were related exclusively to civil cases outside of the Vaccine Program; and the withdrawal of time and cost claims relating to public relations and media work during the pendency of the OAP. In addition, WLOP generally reduced the fees it requested for time spent on the OAP. Finally, WLOP agreed to significantly reduce the expenses for which it sought reimbursement, particularly those costs incurred while on travel.

Let me highlight a couple of statements:

the withdrawal of time and expenses WLOP conceded were related exclusively to civil cases outside of the Vaccine Program.

and

WLOP’s reductions included: the withdrawal of time and expenses relating to direct legislative lobbying, that is, any activity relating to efforts to affect the outcome of the political process

Bold is mine.

Apparently, the law firm applied for and was denied funding for work done for civil cases that were outside of the vaccine program and for lobbying efforts. What were they thinking trying to get tack that onto their fee request? Let’s face it, the Omnibus has already subsidized any upcoming civil cases by giving the lawyers time to research their arguments and pay experts. And, really, asking the program to pay for lobbying?

This is only an “interim” fee request. Fees are still mounting, and not all the past fees have been assessed:

Of note, this Decision resolves all fees and costs requested by the WLOP firm in the King interim fees application, at Tabs A & B of that application. This Decision does not resolve the amounts requested at Tabs C through U of that application.

I don’t know how much is involved with “Tabs C through U”, but it sounds like the remaining fees could be considerably more than the $2.3M granted.

It is interesting to note that the father/son team of David and Dr. Mark Geier have expert fee requests submitted (and as yet unpaid) for this case, even though they were not called as witnesses and, to my knowledge, did not submit expert reports:

This does not resolve the vast majority of fees and expenses relating to Drs. Geier and Young. The majority of expenses relating to Dr. Geier, David Geier, and Dr. Young are included in the PSC Committee Costs, at Tab C of the initial Fee Application

The Geier’s are well known “experts” in the vaccine court. Young, I suspect, is the same person as co-authored a paper with the Geiers purporting to show a link between neurodevelopmental disorders and thimerosal in vaccines. That paper was reported to have been recieved funding “…from the Autism Petitioners’ Steering Committee of the no-fault National Vaccine Injury Compensation Program (NVICP).”

I am all for petitioners in the Vaccine Court having access to good experts. I don’t consider the Geier team to meet that standard. Should the Petitioners’ Steering Committee have decided to fund this reasearch, I see that as their expense, not one that should be passed on to the vaccine program. Dr. Mark Geier has been referred to in court documents as:

There are multiple cases where Dr. Geier’s opinion and testimony have been given little or no weight because they exceeded the scope of his expertise.

and

Dr. Geier is “a professional witness in areas for which he has no training, expertise, and experience”

I frankly suspect that funding The team of Young, Geier and Geier in this instance is another attempt to get the Vaccine Program to pay for work the lawyers expect to use in the civil cases that will follow the likely rejection of the Vaccine Court hearings. Remember, they weren’t called as expert witnesses in the Omnibus.

One other expert witness of note, Dr. Vas Aposhian, is also mentioned in the fee ruling:

This decision resolves the $34,048.25 that WLOP requested for expenses related to Dr. Aposhian ($31,750.00 in fees; and $2,298.25 in expenses incurred in May 2008). This decision does not resolve the $207,382.53 in fees and expenses included in the PSC Committee Costs for costs relating to Dr. Aposhian, nor does it resolve the $7,910 requested by Williams Kherkher for costs associated with Dr. Aposhian. See Tab C at 3887 and Tab E at 4396-98.

We don’t have the decisions from the King hearing yet, but here are some comments from the Cedillo decision:

Thus, concerning this issue [genetic hypersensitivity to mercury], I conclude that the testimony of Drs. Brent and Cook was persuasive, and that the testimony of Dr. Aposhian was not.

I find that Dr. Brent’s testimony on this point [the lack of an established mercury efflux disorder] was persuasive, and that the testimony of Dr. Aposhian was not.

I wonder if Dr. Brent, whose expertise was persuasive, will be paid anything like the roughly quarter million dollars that Dr. Aposhian has billed.

So we have $2M in fees granted for the Cedillo hearings, and now $2.3M for the King hearings. This is part of a total of over $7,000,000 requested in interim fees:

In their application, the petitioners sought a total of $7,202,653 for interim fees and costs. This total reflected the fact that this case was, as explained above, one of the “test cases” in the OAP. Because this was a “test case,” in which the petitioners sought to present all of the “general causation” evidence concerning the theory that thimerosal-containing vaccines can cause autism, several different law firms participated in the development and presentation of the evidence, while five expert witnesses prepared expert reports and testified at length for petitioners during the evidentiary hearing. The high total sought reflects the participation of all those law firms and expert witnesses.

I don’t think anyone is surprised that this is a very expensive proceeding.

Millions of dollars were spent trying to prove the now discredited (and never well supported) hypothesis of Dr. Wakefield. The thimerosal hypothesis also never had much substance, and has cost millions more.

One thing good out of all this is that the proceeding also paid to compile expert reports from some real experts debunking the MMR and Thimerosal myths.

It’s time to get past the idea that autism is genetics

19 Feb

Or, at least, this is what David Kirby has to say in a recent interview.

Yes, I’m tired of David Kirby too. But some statements are just plain silly.

“I don’t believe autism is genetics,” he said. “I wish we could just get past that argument and accept the fact that these kids have been hit with some environmental trigger of some sort, or sorts, combined with these genetic predispositions … and get on with it.”

Here’s an admittedly sarcastic response: I am so glad when outsiders to the autism community spend years promoting an agenda that attempts to take focus away from needed science.

And, yes, I noticed that to David Kirby it is still all about “these kids”. Adults just don’t register on his radar.

Mr. Kirby is not always consistent. In the past he has stated:

I have always said there may be a small percentage of people with autism spectrum disorder (perhaps those with Asperger Syndrome) whose symptoms are a result only of their genetic makeup, with no environmental factors involved at all.

So, “a small percentage” in his view, can now be forgotten as we “get on with it”.

I wish Mr. Kirby well with his new book. I hope for the sake of the people whose lives he will affect, he has learned from the damage he caused to the autism communities.

Was Dr. Wakefield the complainant in his own GMC case?

19 Feb

Pop quiz: of these two people, who was the first to request that the General Medical Council (GMC) investigate Dr. Andrew Wakefield

a) Brian Deer
b) Dr. Andrew Wakefield?

Ah–trick question! Brian Deer didn’t ask the GMC to investigate Dr. Wakefield. Mr. Deer offered and gave information to the GMC, but, it turns out, only after Dr. Wakefield called for an investigation.

Let me start by saying I hesitated to publish this post as it will be just make it seem like there is a real controversy here. There isn’t. But after noting that the addendum to the Press Complaints Commission (PCC) complaint filed against Brian Deer included citations to LeftBrainRightBrain I decided to check into the “complainant” question.

Here’s the PCC complaint. Here’s the addendum.

There is a long “forensic analysis” argument to make the case that supposedly Brian Deer was the complainant. This struck me odd. Why do a “forensic” argument, unless you don’t have substantial proof.

In the matter of Dr Wakefield and the GMC, and based upon forensic analysis of all the available documentary evidence, one is entitled to believe that Mr. Deer was the original and only substantive complainant to the GMC, whether or not he was the ‘Complainant’ who instructed the legal prosecution of the case (which was the GMC through its lawyers Field Fisher Waterhouse).

OK, Brian Deer was the complainant, whether or not he was the ‘Complainant’. Everyone got that? Clear as mud?

It wasn’t to me, so I contacted the General Medical Council to ask a simple question:

I am sorry to bother you, but I was hoping you could help with a question. Is it public knowledge whether Mr. Brian Deer was a “complainant” for the Wakefield case? Was there any “complainant” or was this case brought forward by the GMC itself?

I received a very simple answer:

Dear Sir/Madam

The General Medical Council can act in response to complaints about doctors but we do not require someone to make a formal complaint to us before we can act. We can in fact initiate action against doctors of our own volition. This enables us to launch an investigation in response to publicly expressed concerns about the conduct of doctors, whether or not those concerns have been directly and formally referred to us.

The case against Dr Wakefield, Professor Walker-Smith and Professor Murch was brought by the GMC there was no complainant in this case.

I hope you find this information helpful and if you have any further queries relating to this case please do not hesitate to contact me.

When I asked if I could make this public, I was informed that this information is already public. Yes, I forgot the fact that Brian Deer had a letter from the GMC’s attorneys already. That is from May, 2005. I guess this whole, “he’s a complainant even if he isn’t a Complainant” thing has been going on for some time.

The “forensic analysis” seems to rest on the fact that Brian Deer has communicated with the GMC. There doesn’t seem to be any actual complaint filed, but, as we are told:

But what Deer does not reveal is that on February 25, 2004, three days after his article attacking Wakefield had been published in the Sunday Times, he had written to the GMC…

Yes, according to this timeline, Brian Deer published his article and then contacted the GMC 3 days later. It is characterized as a “spontaneous” communication in the complaint. As in, Brian Deer just out of the blue decided he needed to contact the GMC.

Dr. Wakefield left out an important part of the timeline. Namely, his own call for a GMC investigation. Here is a timeline:

February 22, 2004, Brian Deer’s article, Revealed: MMR research scandal is published.

February 23, 2004: Dr Wakefield states, “I’d welcome inquiry”

“Serious allegations have been made against me in relation to the provision of clinical care for children with autism and bowel disease, and the reporting of their disease. It has been proposed that my role in this matter should be investigated by the GMC. I not only welcome this, I insist on it and I will be making contact with the GMC personally.”

Two days later, on February 25, 2004: Brian Deer emails the GMC. This appears to be the first contact between Mr. Deer and the GMC. According to the excerpt in the PCC complaint filed by Dr. Wakefield:

email from Brian Deer to Tim Cox-Brown, Caseworker GMC, 12.16 pm 2.25.04. This is a sixpage letter concluding with the statement “As a matter of public duty, I write to offer this outline of my main findings, and to offer the GMC my fullest cooperation in getting to the bottom of these matters”.

Which, according to Dr. Wakefield, makes Brian Deer the “complainant” in the GMC hearing:

This reads as a spontaneous and intentional contact with the GMC for the purpose of requesting to put before them the substance of his complaint and in fact, doing so i.e. making a complaint.

Spontaneous? I guess if you leave out critical details like Dr. Wakefield’s own call for investigation. As I titled the post, couldn’t one say that Dr. Wakefield is the complainant? After all, it is Dr. Wakefield who appears to have called for the investigation.

Dr. Krigsman “steps down” from position at Thoughtful House?

18 Feb

In an article in the Times Online, the departure of Dr. Wakefield from Thoughtful House is confirmed, but also a statement is made:

It has also emerged that Arthur Krigsman, director of the gastroenterology clinic at Thoughtful House, has stepped down in recent weeks. The departure is not thought to be directly related to Dr Wakefield’s situation

Dr. Krigsman is still listed on the Thoughtful House website, where he is still listed as director of the gastroenterology clinic.

Dr. Krigsman is the director of the gastroenterology clinic at Thoughtful House Center for Children in Austin, Texas.

I am unclear on whether “stepping down” means he is still with Thoughtful House but not as director, or whether he has left Thoughtful House altogether.

Dr. Krigsman is the lead author on a paper which came out recently purporting to support Dr. Wakefield’s research.

Andrew Wakefield vs the PCC

18 Feb

On the 14th March 2009, David Kirby published a Huffington Post piece which stated:

Dr. Andrew Wakefield – the British physician who was accused in February by the Sunday Times of London of altering data in a 1998 paper on autistic children, bowel disease and the MMR vaccine – has filed a formal complaint against the freelance journalist who wrote the article.

….

Mr. Deer has failed miserably as a reporter and has done great harm to me and many others conducting autism research,” Wakefield said in the release.

The most sensational accusation against him printed in the Sunday Times held that Wakefield had altered and manipulated data on many of the 12 children who were written up in the paper.

David’s piece – as can be seen from the words of Wakefield above – show Wakefield as fairly salvering to get at Brian Deer and indeed, the Times stories were removed from their website. Wakefield reported this as the Times tacit admission the stories were wrong. This drew a stinging response from the Times who immediately republished some of the stories on its website indicating the truth which was that the stories were only removed at first as a courtesy to the PCC, not to Andrew J Wakefield.

As Mike notes in the above linked story, Wakefield is often the author of his own misfortune as he bumbles from one self created mess to another.

And now I’ve heard news that Wakefield no longer wants the PCC to hear the complaint he made until after he has appealed to the courts. In a private email corresponence with Brian Deer, he told me:

At my request, the PCC was last week asked if Wakefield will now pursue his complaint against The Sunday Times. His publicist James Moore, replied on his behalf. I can’t give you the email, as it is not for me to do that, but I can tell you that he has asked for the matter to be deferred until after any appeal to the courts by Wakefield.

Appeal? Why does Wakefield want to appeal? Wasn’t it he who stated:

I have no need of continued registration with the GMC…

If thats so, then why is he going to appeal? Could this be yet another delaying tactic by a man who has made something of a career out of delaying the game when it (as it always has) goes against him? After all, who can forget his now infamous bowing out of the libel case he pursued against Brian Deer? Particularly Justice Eady’s response to him when he tried to delay _that_ case;

It thus appears that the Claimant [Wakefield] wishes to use the existence of the libel proceedings for public relations purposes, and to deter other critics, while at the same time isolating himself from the downside of such litigation, in having to answer a substantial defence of justification.

And so here we are yet again – Wakefield wants to delay proceedings _he_ initiated because he got hammered by the GMC. Brian also said:

I’ve had these issues hanging over my head for six years. Moreover,Wakefield’s allegations (and those of Mr Moore) are published online as part of a campaign against me, while two Sunday Times reports carry tags referring to his complaint.

The courts have made clear, in defamation cases, that prompt action is a hallmark of a genuine complaint. Wakefield previously sought summary adjudication of his dozens of complaints, demanding that they be ruled on in advance of his GMC hearing and without our full reply being received. Now
he’s changed tack and plainly wishes to abandon his complaint without the penalty of saying so.

Quite.

Andrew Wakefield Resigns from Thoughtful House?

18 Feb

According to several anti-vax Yahoo news groups, Andrew Wakefield has resigned from Thoughtful House.

This is apparently the Thoughtful House statement:

The needs of the children we serve must always come first. All of us at Thoughtful House are grateful to Dr. Wakefield for the valuable work he has done here. We fully support his decision to leave Thoughtful House in order to make sure that the controversy surrounding the recent findings of the General Medical Council does not interfere with the important work that our dedicated team of clinicians and researchers is doing on behalf of children with autism and their families. All of us at Thoughtful House continue to fight every day for the recovery of children with developmental disorders. We will continue to do our very best to accomplish our mission by combining the most up-to-date treatments and important clinical research that will help to shape the understanding of these conditions that are affecting an ever-increasing number of children worldwide.

I’ve left a question mark ove this as there’s no official word of this on the Thoughtful House website and Andrew Wakefield is still listed amongst its staff.

Measles Vaccine Prevents Autism?

18 Feb

I blogged this in the past when the paper went online, but it is now “in print”:

Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study
Mrozek-Budzyn D, Kietyka A, Majewska R.

From the Department of Epidemiology and Preventive Medicine, Jagiellonian University, Collegium Medicum, Krakow, Poland

Study shows lower autism rate in vaccinated kids than in those who didn’t get the measles or the MMR vaccine. The timing of the publication is funny. I am surprised that there hasn’t been a call of “conspiracy” that this was released so close to all the recent drama.

Here is the abstract:

OBJECTIVE:: The first objective of the study was to determine whether there is a relationship between the measles-mumps-rubella (MMR) vaccination and autism in children. The second objective was to examine whether the risk of autism differs between use of MMR and the single measles vaccine. DESIGN:: Case-control study. STUDY POPULATION:: The 96 cases with childhood or atypical autism, aged 2 to 15, were included into the study group. Controls consisted of 192 children individually matched to cases by year of birth, sex, and general practitioners. METHODS:: Data on autism diagnosis and vaccination history were from physicians. Data on the other probable autism risk factors were collected from mothers. Logistic conditional regression was used to assess the risk of autism resulting from vaccination. Assessment was made for children vaccinated (1) Before diagnosis of autism, and (2) Before first symptoms of autism onset. Odds ratios were adjusted to mother’s age, medication during pregnancy, gestation time, perinatal injury and Apgar score. RESULTS:: For children vaccinated before diagnosis, autism risk was lower in children vaccinated with MMR than in the nonvaccinated (OR: 0.17, 95% CI: 0.06-0.52) as well as to vaccinated with single measles vaccine (OR: 0.44, 95% CI: 0.22-0.91). The risk for vaccinated versus nonvaccinated (independent of vaccine type) was 0.28 (95% CI: 0.10-0.76). The risk connected with being vaccinated before onset of first symptoms was significantly lower only for MMR versus single vaccine (OR: 0.47, 95% CI: 0.22-0.99). CONCLUSIONS:: The study provides evidence against the association of autism with either MMR or a single measles vaccine.

It is not the strongest study. But it adds yet more information to the conclusion: the MMR causation theory is basically dead.

This paper has also been blogged by Steven Novella and Orac.

More recently, Laurentius Rex has blogged it. I thank him for commenting here and reminding me about the study and, mostly for this line from his blog:

It is not my usual procedures to copy articles but this one certainly kicks the monkey study in the balls.

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