Archive | March, 2010

Senate Committee approves nominations for National Council on Disability

17 Mar

I received this from Meg Evans of the Autistic Self Advocacy Network (ASAN) on the 12th. Sorry for the delay in posting it. Ari Ne’eman (of ASAN) has been nominated by President Obama to serve on the National Council on Disability. This nomination was approved by a Senate committee and will now go on to the full senate for a final vote.

Nominees for Disability Council, Other Federal Boards Approved by Committee

The following seven nominations for members of the National Council on Disability were approved by committee and will go on to the full senate for vote:

o) Gary Blumenthal, the executive director for the Associated of Developmental Disabilities Providers. Blumenthal previously served as director of the President’s Committee on Mental Retardation under President Clinton.

o) Chester Alonzo Finn, a special assistant with the New York State Office of Mental Retardation and Developmental Disabilities. Finn is blind and developmentally disabled and is president of the national board of Self-Advocates Becoming Empowered, according to the White House.

o) Sara A. Gesler, a state representative in the Oregon State House of Representatives and the youngest woman in the Oregon State Legislature. She founded the non-profit FG Syndrome Family Alliance, which serves families dealing with the rare developmental disability FG Syndrome.

o) Ari Ne’eman, the founding president of the Autistic Self-Advocacy Network. He also serves as vice chairman of the New Jersey Adults with Autism Task Force.

o) Dongwoo Joseph Pak, vice president and loan officer of the Farmers & Merchants Bank and board member of Acacia Adult Day Health Care Services. He has also serviced on the Special Needs Advisory Board for the Orange County Transit Authority and on the California State Rehabilitation Council.

o) Carol Jean Reynolds, the executive director of the Disability Center for Independent Living. She is also a member of the governing board of the National Council on Independent Living. She has faced several mental health and substance abuse issues and has been in recovery for 26 years, according to the White House.

o) Fernando Torres-Gill, the associate dean for academic affairs at the UCLA School of Public Affairs. He was the first assistant secretary for aging in the Department of Health and Human Services, and is a polio survivor, according to the White House.

Bogus Urine Metals Testing Fails In Vaccine Court

13 Mar

The Thimersoal “test cases” in the OAP relied on bogus urine mercury testing. Among many other common problems the petitioners had in providing any sound scientific support for the notion that mecury can cause autism, that, was at least in part, the apparent conclusion of all three of the special masters.

I just skimmed through the recent decisions by the US Court Of Federal Claims in the Thimerosal “test cases” that were part of the Omnibus Autism Proceeding, and the expert testimony provided by Dr. Brent (respondent) in this regard is pretty clear:

From the Mead Decision

When specifically asked about the urine mercury tests that were performed on William, Dr. Brent said that the tests “showed pretty much exactly what you’d expect for the normal population, that their unprovoked specimens are normal. Yet, when they give chelators, most of [mercury excretion results] are increased.” Id. at 1852-1853. Dr. Brent expressed a concern about the use of data in this way to suggest that a condition exists that, in fact, does not. See id. at 1853. He stated that “it’s data like this that has been used as an excuse to subject these children to chelation therapy where the data supports [a finding] that their urine mercury status is totally normal.” Id. at 1853.

From the King Decision

Moreover, Dr. Brent explained that when the results of mercury testing of Jordan, both provoked and non-provoked, are viewed in their entirety, they are exactly what one would expect from an individual without any mercury-related problem. That is, Jordan’s non-provoked test results were within the normal range for non-provoked testing. (Tr. 1852-53, 4340.) At the same time, while his provoked results were outside the normal range for non-provoked testing, that is not surprising since the provocation/chelation process is designed to specifically provoke an increased excretion of metals. (Tr. 1852-53, 4340-41, 4347.) As Drs. Brent and Fombonne explained, administration of a chelating agent to anyone, autistic or not, mercury-poisoned or not, will always be followed by increased excretion of mercury.118 (Ex. M, p. 74; Tr. 1852, 4340-41, 4343.)

Interestingly, the added scientific clarity of the special masters with regard to bogus urine metals testing is also present to some degree in all three test cases:

Here’s one example from the Mead Decision

Moreover, a subsequent study, as reported in the 2007 Soden article filed as RMRL 458,150 could not confirm the 2003 Bradstreet study results. See Mead Tr. at 1844. The investigators found that “DMSA provoked excretion testing did not produce evidence of an excess chelatable body burden among the autistic [study] participants.” RMRL 458 at 480. The investigators concluded that “[i]n the absence of a novel mechanism of heavy metal toxicity or an alternate therapeutic action of chelators, the data presented provide[d] no justification for chelation therapy for the [study] participants.”

Many will remember the conclusion of Soden et al.

“In the absence a proven novel mode of heavy metal toxicity, the proportion of autistic participants in this study whose DMSA provoked excretion results demonstrate an excess chelatable body burden of As, Cd, Pb, or Hg is zero.”

But perhaps the most interesting of all, is the common thread that the reliance upon the bogus mercury testing seems pretty much acknowledged for what it is by both the special masters and the petitioners’ expert:

From the Dwyer Decision

Doctor Mumper’s willingness to rely on Colin’s mercury test results as evidence of high levels of mercury in his body was particularly troubling. She admitted that his results were not typical of those she saw in other autistic children. She admitted that she knew of no research into normal mercury excretion levels after chelation against which Colin’s one positive mercury test could be measured.741 It appeared that regardless of the results for mercury levels, Dr. Mumper was willing to opine that they reflected mercury’s role in ASD.

From the King Decision

In short, a careful analysis of the record demonstrates that there is no valid basis for Dr. Mumper’s view that the results of mercury excretion testing on Jordan King offer support for a conclusion that thimerosal-containing vaccines played a role in causing Jordan’s autism. To the contrary, the evidence supports a conclusion that Dr. Mumper’s reliance on such mercury tests has no basis in science or logic. Indeed, upon cross-examination even Dr. Mumper acknowledged that there is no particular profile or pattern of post-provocation test results that points to a finding that a child has mercury-induced autism. (Tr. 1555-60, 1568-69.) When pressed, Dr. Mumper could not even suggest an example of any type of result on a post-provocation mercury urine test that would not, in her analysis, support a claim of mercury-induced autism. (Tr. 1558-60.) Dr. Mumper’s analysis in this regard was illogical, and completely unpersuasive.119

Yep, regardless of the results of a scientifically meaningless test, it’s the mercury. Right.

Remember, these were the three Thimerosal “test cases”, presumably chosen by the Petitioner’s Steering Committee (PSC) because they offered the best opportunity to introduce good, and representative scientific evidence for the hypothesized role of thimerosal in the etiology of autism. It looks like they failed miserably, and this doesn’t seem surprising when it’s clear the cases leaned on at least one form of laboratory testing that’s clearly scientifically meaningless.

It won’t be surprising when many of the die-hard anti-vaccine and “alternative” autism medicine brigade ignore the fact that bogus urine toxic metals testing just had a bright light shined on it by the vaccine court. They’ll be likely to claim some form of conspiracy or politics about the cases, despite the fact that the spotlight revealed an apparent decision-making tool of many a “DAN! doctor” to not only be worthless in medicine, but also worthless in court.

On a related note, there has been recent news that a couple of “DAN! doctors” are facing a lawsuit in which bogus urine toxic metals testing is called out directly. Aside from numerous other problems they face in the complaint, it should be interesting to see how the defendants (Dr. Dan Rossignol, Dr. Anjum Usman, and Doctors Data, Inc.) explain the potential role of comparing chelator-provoked urine metals levels to a non-provoked reference range. If the three test cases in the OAP are an indication of the state of actual scientific support for such testing, the defendants would seem to have plenty to worry about.

Additional reading:

Mead v. Secretary of Health and Human Services Case No. 03-215V
King v. Secretary of Health and Human Services Case No. 03-584V
Dwyer v. Secretary of Health and Human Services Case No. 03-1202V
Thimerosal-Autism Test Cases Dismissed
Doctors sued over ‘dangerous’ autism treatment
Suing DAN! practitioners for malpractice: It’s about time
How the “Urine Toxic Metals” Test Is Used to Defraud Patients
24-hour provoked urine excretion test for heavy metals in children with autism and typically developing controls, a pilot study

Autism-study doctor facing grant probe

13 Mar

A story in the Philadelphia Inquirer today sheds some light on the situation involving Dr. Poul Thorsen.

Background for anyone who needs it: Dr. Thorsen is a Danish researcher who is co-author on a number of important studies. These include epidemiological studies on vaccines and autism. Dr. Thorsen did this work at the University of Aarhus, and has since left. There is an investigation ongoing apparently implicating Dr. Thorsen in a possible shortfall of about US$2M from the University.

Dr. Thorsen’s work was funded largely by the CDC. He started working for Emory University before leaving Aarhus (and this is a point of contention with Aarhus, as they state that Dr. Thorsen was not allowed a joint full-time appointment). He was also listed as adjunct faculty at Drexel University. Dr. Thorsen has also left Emory and his adjunct appointment at Drexel.

There has been a lot of speculation and discussion on this for the past week or so. The story has broken into the mainstream media, who have been good enough to get us some facts to work with. I have sent many emails over the past week, and almost all have been unanswered. I finally heard from one group in Denmark yesterday, and they to are unaware of the details of this case.

Today’s Philadelphia Inquirer has a story about Dr. Thorsen, Autism-study doctor facing grant probe by Jeff Goldstein:

A Danish scientist involved in two major studies that debunked any linkage of vaccines to autism is suspected of misappropriating $2 million in U.S. grants at his university in Denmark.

He also notes that Dr. Thorsen’s appointment at Drexler was unpaid, and he resigned it this week. (Drexel University is local to Philadelphia, where Mr. Goldstein works). Also of note, Dr. Thorsen was working with Emory University for about 6 years, much of that part time. The complaint by Aarhus involves him working “full time” in both Aarhus and Emory. This may go to the fact that it was pretty clear that Dr. Thorsen was at both Emory and Aarhus from his publication record. The complaint may not be about working in both places but, rather, having changed to full time status at Emory.

Mr. Goldstien notes that some groups have “seized” on these allegations to discredit the studies Dr. Thorsen worked on:

Anti-vaccine groups have seized on the allegations to contend that scientific studies disproving the vaccine link to autism are wrong. Those groups have long argued that thimerosal, a preservative in some vaccines, can cause autism, as can the MMR vaccine for measles, mumps, and rubella.

“I think it is quite significant,” said Dan Olmsted of the Age of Autism. “I think someone allegedly capable of ripping off his own university by forging documents from the CDC is capable of pulling off anything.”

And this is where the this situation becomes very important. If these allegations are true, does this negate the studies Dr. Thorsen worked on?

Mr. Goldstein addresses this with quotes from Mr. Olmsted (above) and people at the CDC and Denmark.

“Poul Thorsen had absolutely no influence on the conclusions regarding this paper,” wrote Mads Melbye, head of the division of epidemiology at the Statens Serum Institut in Copenhagen and senior author of the study, in response to e-mailed questions.

“Thorsen was not actively involved in the analysis and interpretation of the results of this paper,” Melbye said.

The second study, published in Pediatrics in 2003, examined 956 Danish children diagnosed with autism from 1971 to 2000. It concluded the incidence of autism increased in Denmark after thimerosal was removed from vaccines.

Kreesten Meldgaard Madsen, the lead author, said Thorsen played a minor role.

“Dr. Thorsen was not in a position to change or compromise the data,” Madsen wrote. “Dr. Thorsen was part of the review cycle, but never very active in giving input. Dr. Thorsen never had access to the raw data nor the analysis of the data.”

I doubt these statements will mollify Mr. Olmsted’s readers.

In a piece on WHYY (a public radio station in Philadelphia) has a story, Investigation of autism researcher’s conduct sparks controversy.

Dr. David Mandell of the Center for Autism Research agrees the studies Thorsen worked on should be reviewed. But he doesn’t believe the research has been compromised. He noted that Thorsen was not a lead researcher, the studies used government data, and they were peer-reviewed. This view is echoed in a statement from the Centers for Disease Control, which partly funded the vaccine research.

So, where does this leave us? With a lot more questions than answers still. One question in my mind at least is whether Dr. Thorsen is accused of transferring money to his own use or if he is accused of transferring money to fund his research at Emory when he left Aarhus. That aside, no matter what happens from here, this will be used to imply that vaccine-autism research (and not just that by Dr. Thorsen) is performed by corrupt individuals and should not be trusted.

Assume that the allegations are real. I can state that I am very angry at that possibility. I do not like dishonest people. I do not like dishonest researchers.

Mostly, I don’t like the fact that this will be (and already is being) used to put doubt in a lot of people’s minds about the role of thimerosal and MMR and autism. $2M is a small sum compared to the amount of suffering that will go on as this breaths a little life back into that movement.

My guess is that some readers are now ready to blame me of bias, of believing that Dr. Thorsen’s studies are accurate when I should be questioning everything he did. Let’s ignore the statements by his collaborators that Dr. Thorsen didn’t have access to the data to manipulate. Let’s just stick with the fact that the studies Dr. Thorsen worked on agree with the results of multiple other studies. The surprising outcome would be if on review the conclusions changed.

I am sure this story isn’t going away. And it should not. We need to know and we deserve to know what the details are here. Beyond that, I am sure that this will be forever in the lore of the vaccines-cause-autism community and will be used to convince ever more people to join.

For that, whoever is responsible for this mess, I am angry.

Vaccine Court Decision: thimerosal containing vaccines do not cause autism

12 Mar

The decisions are in for the second phase of the Omnibus Autism Proceedings–the “vaccine court” trials to determine if autism can be considered as a vaccine injury. The first set of decisions were handed down last year (those regarding the MMR as a causative agent). This set explored whether thimerosal, the mercury containing preservative formerly used in childhood vaccines, could cause autism.

The decisions are long, and I expect there to be much discussion. Below are the final paragraphs from the decisions. These are for the three “test cases”, the hearings held for three specific children who petitioned for compensation on the basis of autism as a vaccine injury. They are clear and decisive: the evidence does not support thimerosal containing vaccines as causing autism, in general or in these three children in specific.

Mead:

Petitioners’ theory of vaccine-related causation is scientifically unsupportable. In the absence of a sound medical theory causally connecting William’s received vaccines to his autistic condition, the undersigned cannot find the proposed sequence of cause and effect to be logical or temporally appropriate. Having failed to satisfy their burden of proof under the articulated legal standard, petitioners cannot prevail on their claim of vaccine-related causation. Petitioners’ claim is dismissed, and the Clerk of the Court SHALL ENTER JUDGMENT accordingly.

King:

Thus, I feel deep sympathy for the King family. Further, I find it unfortunate that my ruling in this case means that the Program will not be able to provide funds to assist this family, in caring for their child who suffers from a serious disorder. It is certainly my hope that our society will find ways to ensure that generous assistance is available to the families of all autistic children, regardless of the cause of their disorders. Such families must cope every day with tremendous challenges in caring for their autistic children, and all are deserving of sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing the evidence. Congress designed the Program to compensate only the families of those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of “causation-in-fact” evidence, to a listed vaccine. In this case, the evidence advanced by the petitioners has fallen far short of demonstrating such a link. Accordingly,

Dwyer:

Petitioners have not demonstrated by a preponderance of the evidence that Colin’s condition was either caused or significantly aggravated by his vaccinations. Thus, they have failed to establish entitlement to compensation and the petition for compensation is therefore DENIED. In the absence of a motion for review filed pursuant to RCFC, Appendix B, the clerk is directed to enter judgment accordingly.

AOL Health interviews Jeanette O’Donnell

12 Mar

America Online (AOL) has a series of articles on autism recently added to their site. They have 5 articles, including one on Jeanette O’Donnell. Ms. O’Donnell is very active online with her blog What are they thinking? and commenting as mom26children.

Ms. O’Donnel describes herself as:

I am the proud mother of 6 children. 5 of our children have autism. We do not feel our world has ended, but just begun. We do not chelate, intervene biochemically, give shots of any kind, practice ABA, etc. We treat them as we treat any humanbeing. We treat them with kindness and respect and expect the same from them. They are exceptional children.

The article, Caring for — and Blogging About — Her Five Autistic Children

I’ve always liked reading her posts and her comments. She’s a straight shooter, she doesn’t hold back, and she stays friendly.

Here is a section from the AOL piece (but take the time to go and read it)

O’Donnell:… But you still haven’t asked the question.

AOL: What is the question?

O’Donnell: People ask why I had six when I knew the first was autistic. First, the doctor told us there was no chance that a second kid would have it, so we didn’t know. But I want the people who question them to meet them. And I want them to tell me which one shouldn’t be here. Every one of my kids belongs. They are here for a reason. I don’t know what it is, but there’s a reason. Well, actually, I do know the reason.

O’Donnell: What’s the reason?

O’Donnel: So I could be their mama, that’s why they’re here! It’s very selfish. No, the truth is: They’re gonna teach the world a lot.

The Boston Globe defends the Judge Rotenberg Center

12 Mar

The United States Department of Justice has opened an investigation on the Judge Rotenberg Center. The investigation is to determine whether certain methods of the JRC violate the Americans with Disabilities Act (ADA).

An Op-ed piece in the Boston Globe defended the JRC

Shocking truths
The Rotenberg Center’s methods are undoubtedly unorthodox. But they work.
by Lawrence Harmon

You can read the article at the Boston Globe site. Here is the final paragraph:

THE JUDGE Rotenberg Center in Canton, which stands alone in its use of painful skin shocks to eradicate self-mutilation and sudden assault, is a storehouse of ethical and medical dilemmas. But it’s no shock – and no shame – that the parents of some autistic and mentally retarded children embrace this controversial school.

There are some very impassioned comments after the article. I won’t quote the JRC parents who posted without permission, but I would encourage you to read the comments.

One comment is by Nancy Weiss, who worked with the coalition of disability advocacy groups that filed the complaint against JRC is below:

The Judge Rotenberg Center likes to make the point that there are no other options for people with severe, dangerous behaviors, however not only are there people just like the people at the Judge Rotenberg Center who are being supported humanely and effectively all over the United States; there are people who were at the Judge Rotenberg Center who are doing wonderfully with positive behavior supports in community settings across the country. These are people who JRC warned would never make it outside of their center, people they said would need to be hooked to the shock devices for life, people who were moved in spite of the Judge Rotenberg Center’s dire warnings that they would be violent and dangerous. As I said to Mr. Harmon in a lengthy conversation prior to his writing his column, logic tells us that the 193 people at JRC can’t be the only people in the country with behaviors this severe. I’m sorry he didn’t take me up on the contacts I provided him so he could learn how people with behaviors just as severe are supported successfully without resorting to painful methods.

The Judge Rotenberg Center would like visitors to believe that painful electric shocks are used only infrequently and only for the kinds of extreme behaviors Harmon lists in his article: eye gouging, head banging and the like – but a New York State report found students as young as nine years old subjected to sudden, painful, repeated electric shocks for such harmless behaviors as “refusing to follow staff directions”, “failing to maintain a neat appearance”, “stopping work for more than ten seconds”, “getting out of seat”. “interrupting others”, “nagging”, “swearing”, “whispering” and “slouching in chair”, and “moving conversation away from staff..” The Boston Globe itself reported on the testimony of former employees who spoke about a student who received as many as 350 shocks in one day, a figure the Globe reported was confirmed by the school. That Globe article reported a former employee to testify, “the shock is more painful than described by school officials. I got hit accidentally on my thumb and I had a tingling up to my elbow, on the inner part of my arm, I would say for four hours. I was saying I can’t believe these kids can do this. My hand was shaking. I wanted to go home, that’s how bad it was.”1

The director of the Judge Rotenberg Center testified at a Massachusetts legislative hearing that one student received 5,300 electric shocks in one day. In his testimony, he stated that over a 24-hour period, this student, a teenager who weighed only 52 pounds, was strapped to a board and subjected to an average of one shock every 16 seconds.2 A 2007 New York Times article notes, “a former teacher from the school …said he had seen children scream and writhe on the floor from the shock.” The Times article also speaks to how painful the shocks are, “Technically, the lowest shock given by Rotenberg is roughly twice what pain researchers have said is tolerable for most humans, said James Eason, a professor of biomedical engineering at Washington and Lee University”.3 And, even more frightening, all of the statements above were made before JRC came out with its newest shock device – the GED-4 which, according to a 2006 Boston Globe article, “deliver(s) 45 milliampere shocks — 4 1/2 times stronger than the standard shocks” According to that article, ”Greg Miller, a former teacher’s assistant for more than three years, said one boy with autism was shocked by the higher-powered device so often that he had ‘burn scabs all over his torso, legs, and arms,’ forcing nurses to remove the electrodes for weeks so that his skin could heal”

Just a bee sting, used only occasionally in the most extreme circumstances? Harmon may have bought this but the facts don’t support it.

Harmon seems to think that these practices are OK because they are approved by parents and a probate judge. Let’s be clear that the Judge Rotenberg Center is a lucrative business. On their 2008 IRS forms (the most recent ones publicly available) JRC reported $390,301 in compensation for their Director. The Center was so beholding to the Judge who approved all the aversive procedures for their students that when he died, they re-named their facility in his honor. The facility used to be called the Behavior Research Institute but advocates would ask, “where’s the research?” Yes, the courts approve these practices, but one wonders how much they know about humane, effective alternatives.

And, in terms of parents approving the electric shock? Just ask parents like Evelyn Nicholson. In 2006, The Boston Globe reported that, “Evelyn Nicholson initially approved the shocks, but said she changed her mind as her son became more desperate, complaining that the shocks knocked him to the floor. Previously, she said, ‘I was advised that the shock . . . felt like a small pinch,’ and that the devices were rarely used.” Nicholson, like numbers of parents, when they found out what was being done to their sons and daughters, told JRC that they did not have their permission to use painful procedures on their kids and were told that if permission for the shock was not given they could come and take their son or daughter home. Parents giving permission? Not with any element of the free will that the term ‘permission’ usually implies.

Harmon speaks of other schools – schools he was told kids like these might be at if not for the Judge Rotenberg Center; schools where these kinds of students would instead be subjected to mechanical restraints. That might make a reader think that the Judge Rotenberg Center doesn’t use these restrictive techniques. The New York State investigational report on JRC states, “With mechanical movement limitation the student is strapped into/onto some form of physical apparatus. For example, a four-point platform board designed specifically for this purpose; or a helmet with thick padding and narrow facial grid that reduces sensory stimuli to the ears and eyes. Another form of mechanical restraint occurs when the student is in a five-point restraint in a chair. Students may be restrained for extensive periods of time (e.g., hours or intermittently for days) when restraint is used as a punishing consequence. Many students are required to carry their own “restraint bag” in which the restraint straps are contained.”4 The same report notes, “Some of these students were observed to be fully restrained in restraint chairs and wearing movement limiting helmets. One student left the school building in full restraint (hands and feet restrained with Velcro straps in a restraint chair), clearly agitated and upset, and returned the following morning carried to the conference room fully restrained in what appeared to be the same chair.”5

When I spoke to Mr. Harmon he seemed particularly swayed by the video called “Before and After” that almost every visitor sees. A 2007 Mother Jones article described the “before” footage shot in 1977, “An 11-year-old girl named Caroline arrives at the school strapped down onto a stretcher, her head encased in a helmet. In the next shot, free from restraints, she crouches down and tries to smash her helmeted head against the floor.” The Mother Jones reporter goes on to say, “Considering how compelling the “After” footage is, I am surprised to learn that five of the six children featured in it are still here. ‘This is Caroline,’ one of my escorts says an hour or two later as we walk down a corridor. Without an introduction, I would not have known. Caroline, 39, slumps forward in a wheelchair, her fists balled up, head covered by a red helmet. ‘Blow me a kiss, Caroline,’ Israel says. She doesn’t respond.”

And here we have perhaps the most important point that Mr. Harmon missed. If these methods worked – if their inhumanity was justified by their success, you wouldn’t have students still there after 33 years. You wouldn’t need to continually develop devices that deliver a stronger and stronger shock or methods to spread the electrodes so the electrical current passes through more flesh for the purpose of assuring greater and greater amounts of pain. Positive behavioral approaches are proven to have more staying power; they give people tools that they can use for life and they help them to change dangerous behaviors in ways that value, enhance, and include people rather than through the use of methods that are coercive, controlling, and inhumane. While the “after” portion of the tape Mr. Harmon watched might have seemed compelling, did he ask why, if these methods worked, people are still there 33 years later, still hooked up to the devices that are touted as being so effective?

I’m sorry Harmon was taken in, as so many casual visitors before him have been. It’s easy to spend a few hours and accept what you’re being told at face value. It’s easy when you’re under deadline to buy into the belief that no alternatives exist. Mr. Harmon said he feels that the concerns of the 31 disability organizations that signed the letter that motivated the Department of Justice investigation seem “too pat.” I hope it is clear that these organizations did not take lightly the decision to sign this letter. These groups represent the major, mainstream developmental disability organizations in the country including the American Association on Intellectual and Developmental Disabilities, The Arc of the United States, Easter Seals, United Cerebral Palsy and 27 others which together represent the most respected researchers in the country.

No one should be deluded into thinking that Mr. Harmon’s visit to the Judge Rotenberg Center told the whole story. The Judge Rotenberg Center has a business to run; they are not going to tell a reporter that humane options exist, but the several hundred thousand professionals and advocates represented by the 31 disability organizations that called for the Department of Justice investigation, know full well that they do. And because they do, this treatment of our most vulnerable citizens should not be tolerated by a society grounded in a commitment to the ethical treatment of all people.

Nancy Weiss

March, 2010

I would make a simple statement: the Judge Rotenberg Center is paid with over $50M of taxpayer money. Why shouldn’t the taxpayers spend a little more money (and a little more than the few hours Mr. Harmon spent) to insure that the Center is within the laws? For all it’s clients. All the time.

AOL Health interviews Dora Raymaker

12 Mar

AOL Health as a series of articles on autism. One, well worth your time to read, is by Dora Raymaker. The piece is Living with Autism, as Ms. Raymaker is an adult autistic.

I first became aware of Ms. Raymaker when she was blogging on Change.org. She is a member of the Academic Autistic Spectrum Partnership In Research and Education (AASPIRE) and the Autistic Self Advocacy Network (ASAN).

The interview is well worth the time, take the time to go and check it out. Here is a snippet:

AOL Health: So, how does autism affect your life?

DR: This question has never made much sense to me. There is no part of my daily life that is not affected by my developmental disability. At the same time, I am a complete person, and more things than just my developmental disability color my experiences. I can’t separate out the integrated parts of me. How does not having a developmental disability affect the life of someone who does not have one? How can that question be answered?

Barbara Loe Fisher’s lawsuit against Paul Offit dismissed

11 Mar

If you recall, last October Wired Magazine had an article: An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All. Barbara Loe Fisher of the self-named National Vaccine Information Center took issue with a section of that article and sued Dr. Paul Offit. The complaint is here.

Ms. Fisher was suing Dr. Offit, Amy Wallace (who wrote the story for Wired) and Conde Nast Publishing (who publish Wired).

For background, you can read Respectful Insolence Suppression of speech through legal intimidation, anti-vaccine edition: Barbara Loe Fisher sues Dr. Paul Offit, Amy Wallace, and Condé Nast for libel, as well as One possible reason why Barbara Loe Fisher chose to sue Paul Offit in Virginia?

Autism News Beats “Barbara Loe Fisher: “Not a person to be believed””

SkepticBlog (Steve Novella) Another Libel Suit – This Time Against Paul Offit ,

And Terra Sigillata’s Paul Offit, Amy Wallace, and Conde Nast being sued by anti-vaccinationist

The complaint centers around this section of the Wired story:

Paul Offit has a slightly nasal voice and a forceful delivery that conspire to make him sound remarkably like Hawkeye Pierce, the cantankerous doctor played by Alan Alda on the TV series M*A*S*H. As a young man, Offit was a big fan of the show (though he felt then, and does now, that Hawkeye was “much cooler than me”). Offit is quick-witted, funny, and — despite a generally mild-mannered mien — sometimes so assertive as to seem brash. “Scientists, bound only by reason, are society’s true anarchists,” he has written — and he clearly sees himself as one. “Kaflooey theories” make him crazy, especially if they catch on. Fisher, who has long been the media’s go-to interview for what some in the autism arena call “parents rights,” makes him particularly nuts, as in “You just want to scream.” The reason? “She lies,” he says flatly.

“Barbara Loe Fisher inflames people against me. And wrongly. I’m in this for the same reason she is. I care about kids. Does she think Merck is paying me to speak about vaccines? Is that the logic?” he asks, exasperated. (Merck is doing no such thing). But when it comes to mandating vaccinations, Offit says, Fisher is right about him: He is an adamant supporter.

Ms. Fisher argued:

“If defendants are correct, Plaintiff Fisher is not a person to be believed and because her stock and trade is information and opinion derived from it, she has no business worthy of acceptance and use, honesty being the foundation of every such reliance.”

The court’s decision is online.

The decision is quite clear. Ms. Fisher has no case against Dr. Offit, Amy Wallace or Conde Nast.

In this case, the article’s quotation of Defendant Offit’s comment that Plaintiff “lies” cannot reasonably be understood to suggest, as the Complaint alleges, that Plaintiff is “a person lacking honesty and integrity . . . [who should be] shunned or excluded by those who seek information and opinion upon which to rely.” Rather, the context of the remark – in a lengthy article describing an emotional and highly charged debate about an important public issue over which Defendant Offit and Plaintiff have diametrically opposed views – plainly signals to readers that plainly signals to readers that they should expect emphatic language on both sides and should accordingly understand that the magazine is merely reporting Defendant Offit’s personal opinion of Ms. Arthur’s [Barbara Loe Fisher’s] views.

In my opinion, this case was an attempt to shut Dr. Offit up, restrict his right to free speech by forcing him into costly litigation. In my opinion, the key section of the Wired article was this paragraph:

[Dr. Offit], meanwhile, still rises every morning at 4 am and heads to his small, tidy study in a spare bedroom. Every morning, he spends a couple of hours working on what will be his sixth book, a history of the anti-vaccine movement. Offit gets excited when he talks about it.

I wish Dr. Offit well in his next book. I thank him for standing up for free speech. In my view, Barbara Loe Fisher and the organizations that ally with her are very dependent on the very right that Dr. Offit just defended. They have the ability to voice opinions which are in direct contradiction to established science. I would think they would cherish the first amendment to the U.S. Constitution.

Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.

U.S. Supreme Court to hear vaccine-autism case

11 Mar

The Supreme Court of the United States (SCOTUS) has agreed to take on a vaccine injury case. SCOTUS is an appeals court, i.e. they only hear cases that have been already heard in other courts and this case is no different, having been heard in Vaccine Court and at least one appeals court. SCOTUS only hears a fraction of the cases that are submitted, choosing cases that set important precedents to help define U.S. laws. It is also worth noting that SCOTUS tends to decide on issues involving interpretation of law. In this case, they are not going to decide whether the child in question was injured, but, ratehr, the Court is to decide if a vaccine manufacturer can be sued directly. The question posed by the family in their petition is:

Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 [“the Act”] expressly preempts certain design defect claims against vaccine manufacturers “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” 42 U.S.C. § 300aa-22(b)(1). A-104.

The Question Presented is

Whether the Third Circuit erred in holding that, contrary to its plain text and the decisions of this Court and others, Section 22(b)(1) preempts all vaccine design defect claims, whether the vaccine’s side effects were unavoidable or not?

As noted above, the case was heard previously in the Third Circuit Court of Appeals. The plaintiffs (family) lost in that case:

We hold that the plaintiffs design defect claims are expressly preempted by the Vaccine Act. We also conclude that the plaintiffs have failed to establish either a manufacturing defect or a warning defect claim under the Vaccine Act. For the reasons discussed above, we will affirm the District Court’s grant of summary judgment in favor of Wyeth.

In other words, they were not able to prove that the had the right to bring a “design defect” claim at all, and they failed to prove if there was a manufacturing defect or a warning defect.

The SCOTUS docket is online. I found it interesting that the self-named “National Vaccine Information Center” has filed a “friend of the court” brief, with Jim Moody listed as the attorney. Mr. Moody is on the board for SafeMinds, a group active in promoting the notion that mercury causes autism, and has been active in the public relations effort to support Dr. Andrew Wakefield.

The paragraph of the Vaccine Act covering this is partially quoted in the question posed to SCOTUS above. This is from § 300aa–22. Standards of responsibility

(b) Unavoidable adverse side effects; warnings
(1) No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
(2) For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
(A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa–23 (d)(2) of this title, or
(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).

I often read comments by parents claiming that vaccine manufacturers have zero liability. This is not accurate, as noted below (and referenced in the quote above):

(2) If in such an action the manufacturer shows that it complied, in all material respects, with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and this chapter applicable to the vaccine and related to the vaccine injury or death with respect to which the action was brought, the manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in—
(A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine under section 262 of this title,
(B) intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or
(C) other criminal or illegal activity relating to the safety and effectiveness of vaccines,

which activity related to the vaccine-related injury or death for which the civil action was brought.

In other words, if there is really the corruption many parent groups claim, the vaccine manufacturers are liable for lawsuits. But, this is a diversion as the present case before SCOTUS is not about this. As noted above, they are trying to define the question of whether the Vaccine Act precludes suits for design defect claims.

They had argued (and lost) in previous cases that the vaccine was “negligently designed because the defendant knew of a safer alternative and failed to produce it”.

As noted in a recent post by Mary Holland at the Age of Autism blog:

A three judge panel of the Third Circuit unanimously decided in March 2009 that petitioner Hannah Bruesewitz did not have the right to sue vaccine manufacturer Wyeth, Inc. to assert that its vaccine design was unsafe. [See Bruesewitz-Decision] Hannah was born in October, 1991, and received her third DPT shot on schedule on April 1, 1992. Shortly thereafter she developed “residual seizure disorder,” recognized as a Table Injury at the time, meaning that causation was presumed. “Residual seizure disorder” was deleted from the Table just one month before she filed her case. Finally, on December 20, 2002, more than ten years later, Vaccine Court categorically rejected her claim. This hardly complies with Congress’ promise in the 1986 NCVIA that awards be “made to vaccine-injured persons quickly, easily, and with certainty and generosity.” The Bruesewitz family argues that the safer acellular DTaP vaccine was long available by the time Hannah received the DPT and suffered seizures, and that her vaccine injury was avoidable had the manufacturer used this demonstrably safer vaccine design.

There is a lot of history involved in the above paragraph. Let’s start with the fact that the NCVIA (National Childhood Vaccine Injury Act) was put into place largely because of a number of claims filed about the safety of the older, whole cell, DPT vaccine. “Whole-cell” means that the pertussis vaccine component (the “P” in DPT) was made from whole pertussis bacteria which were killed. The concept of the pertussis vaccine, and the DPT vaccine in particular, as being dangerous is largely due to a study in 1981, Pertussis immunisation and serious acute neurological illness in children. That study claimed, “A significance association was shown between serious neurological illness and pertussis vaccine, though cases were few and most children recovered completely.”

Another study (in 1981) showed a significant number of temporary adverse reactions, Nature and Rates of Adverse Reactions Associated with DTP and DT Immunizations in Infants and Children.

Given Ms. Holland’s statement above (and similar statements I have read recently by others), one might assume that the removal of seizure disorders from the Table Injuries was somewhat arbitrary. This is not the case. Between the time of the 1981 study and 1995 (when seizure disorders were removed from the Table), numerous studies were performed which showed no link between DTP and seizures or other neurological injuries. One large study, published in 1994 (shortly before the Table injury was removed) is Risk of serious acute neurological illness after immunization with diphtheria-tetanus-pertussis vaccine. A population-based case-control study. They found no increased risk due to DTP in about 380,000 doses given. A more recent study (2001) The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine, concluded “There are significantly elevated risks of febrile seizures on the day of receipt of DTP vaccine and 8 to 14 days after the receipt of MMR vaccine, but these risks do not appear to be associated with any long-term, adverse consequences.”

The question before the Supreme Court is not whether the vaccine causes an injury. But, it would seem that the plaintiffs might be able to argue that the DTP vaccine resulted in more short-term adverse effects, but not that the science supports the idea that seizure disorders were caused by the vaccine.

Vaccine injury cases must be first heard in the special “Vaccine Court”. This case is no different. The decision can be found on the Vaccine Court’s website. The girl, Hannah, started having seizures after her third DPT vaccination. These progressed to a very serious seizure disorder, including times of status epilepticus (a continual state of seizures).

On April 14, 1992, Dr. Ira Bergman, a pediatric neurologist, wrote that she was entirely well until April 1, 1992 when she went for her third DPT and HiB which were given at 10:00 a.m. She did well until 12:30 p.m. when she suddenly began screaming and had a stiffening spell of her arms and legs that lasted for less than one minute. She was mildly groggy afterwards and, then, within a few minutes, was back to normal.

Her parents argued that Hannah suffered an acute encephalopathy (which is a table injury), with their expert witness defining it as ““any disease of the brain.” The Court, however, recognizes a different definition, where brain function must be depressed for a significant time. In other words, even though Hannah suffered seizures, the fact that she appeared normal, even happy, between the seizures was taken as evidence that the seizures were not the result of an acute encephalopathy.

The statement by Ms. Holland above notes the long delay between when the vaccine was administered and when the hearing was held (10 years). This is, of course, not acceptable. However, it is worth noting that it appears that the family’s attoney (Mr. Clifford Shoemaker) was not prepared when the first

1) April 1992, the third dose of DPT was administered
2) April 1995, the family filed with the vaccine court.
3) July 2001, the hearing is scheduled (for late August)
4) August 2001, the hearing is postponed at Mr Shoemaker’s request
5) February 2002, the trial was postponed again at Mr Shoemakers request
6) March 2002, the one of the family’s expert witnesses withdraws and another is unavailable to testify on the specified date. The Special Master (judge) allows the family another extension.
7) July 2002, the hearing is held. The family is requested to submit some medical information.
8) November 2002 (there appears to be a typo of 2001 here), the final reports are submitted by the Government (HHS).
9) December 2002, the claim is denied.

Could the system have been more efficient? Yes. That includes the family’s attorney and expert witnesses.

While we are talking about the expert witnesses, I realized as I read this decision that there were familiar parts. First, one regular expert witness, Dr. Marcel Kinsbourne was supposed to testify for the family. He “chose to withdraw” from the case. Another regular expert witness to the vaccine court, Dr. Mark Geier was also involved. Dr. Geier’s “expert” report left something to be desired.

First, his second report has obvious mistakes:

Petitioners filed Dr. Geier’s second affidavit, dated August 28, 2001. P. Ex. 22. In it, Dr. Geier confuses Hannah’s case with someone else’s because he refers to her death and subsequent autopsy. Hannah is still alive. Based on a meta-analysis from the Institute of Medicine (IOM), Dr. Geier concludes that DPT caused her purported encephalopathy. He also refers to the VAERS reports regarding arthritic symptoms and hepatitis and rubella vaccines. (Hannah does not have arthritic symptoms; hepatitis and rubella vaccines are not at issue here.)

His fourth report has some odd statements, including using a movie as a reference (yes, a movie):

Petitioners filed Dr. Geier’s fourth report, dated March 22, 2002. P. Ex. 33. Here, inter alia, he discusses the movie “A Beautiful Mind” as evidence that DPT can cause afebrile seizures because the lead character was administered insulin in order to cause him to have afebrile seizures which was hoped to be a cure of his schizophrenia. Dr. Geier thinks DPT lowered Hannah’s blood sugar, causing afebrile seizures.

Why use a movie? I can’t be certain, but from what I’ve heard, there is no scientific evidence that pertussis vaccines (either DPT or DTaP) can reduce blood sugar.

Dr. Geier’s testimony was not convincing:

Regarding Dr. Geier, the specialist in genetics and forensic medicine, his affidavits and report are not credible. First, being a board-certified geneticist and forensic medicine specialist does not qualify him to diagnose neurological diseases and offer an opinion as to how doctors who do specialize in neurology define “encephalopathy.” Dr. MacDonald’s testimony about the definition of acute encephalopathy is more credible than Dr. Geier’s and is well-supported in the medical literature. Hannah did not have acute encephalopathy.

Beyond that, the facts were not convincing. As noted above, the fact that between seizures Hannah appeared normal was evidence against an acute encephalopathy.

The family’s counsel also argued a “non-table” encephalopathy. However, this argument also did not prevail. The girl’s EEG’s did not indicate an encephalopathy, and the seizure activity in the EEG’s did not appear unusual for someone with epilepsy.

I do not know if the arguments the family would put forth would be different in civil court, but it doesn’t seem likely that the arguments they made in vaccine court (which has rules

Back to the present case in front of the Supreme Court (SCOTUS). Why would the Court hear this case? The Vaccine Act is a major piece of legislation. Whenever the U.S. Government (or any sovereign power) alloys itself to be sued (which is what the Act does), it is a big deal. But, this case actually involves what happens outside of the vaccine court. This affects the vaccine program, a major piece of the American public health program. The government extended protection to vaccine manufacturers by taking on liability itself. The question is how far does this protection go? A recent case (2008) from an appeals court in Georgia stated that people could sue the vaccine manufacturers for a “design defect”, contrary to the decision from Colorado that is the basis for this SCOTUS case. We have two different appeals courts with two different decisions on a very important piece of legislation. In addition, the Obama administration, through the Department of Justice, filed a “friend of the court” brief in regards to the Georgia case. The administration would like to see the “design defect” question answered before the Omnibus Autism Proceeding completes and thousands of families look to the civil courts for their next step. The Georgia case was withdrawn by the family, but the DoJ requested that the Supreme Court take on the Bruesewitz case in order to answer this question. This is perfect territory for the Supreme Court. They won’t decide if any child was injured, but they will clarify the definition of a key piece of legislation.

This case isn’t specifically about the question of vaccines causing autism. The Bruesewitz case, as argued in vaccine court, involves a seizure disorder. The impact for the many families who may be denied claims in the Omnibus Autism Proceeding is obvious: if the Supreme Court allows “design defect” claims, this will open a window for these families to sue in civil court.

New LBRB Feature

10 Mar

Never one to rest easy when a new technology becaome popular, I wanted to find a way to harness Twitter to make it appealing to LBRB readers. I think I have now. If you go to https://leftbrainrightbrain.co.uk/tweets/ you’ll see a live updating list of the latest tweets from and about a selection of Tweeters including myself, Liz Ditz, Orac and others. Just leave the page open it’ll update itself as these individuals tweet. If it become popular enough I’ll port it into its own site.

If you tweet about autism and/or science that discusses autism then please contact me and I’ll add you to the list of contributors.

← Older Entries
Newer Entries →