The Next Vaccine-Autism Newsmaker…5 years later

6 Feb

Years back, much focus in online autism parent community discussions focused on the Omnibus Autism Proceeding (OAP). This was the large “vaccine court” proceeding to explore if people could be compensated for autism as a vaccine injury. Those hearings were held in 2008, and the decisions went against the families.

A year ago I wrote (The Omnibus Autism Proceeding: effectively over), and while, yes, as an “Omnibus” it is effectively over, there is still activity for those who filed claims and were included in the Omnibus Autism Proceeding. Statistics as of today show there were 5,635 claims included in the Omnibus, and 4,564 have been dismissed. 2 claimants have been compensated, with the caveat given that “**HHS has never concluded in any case that autism was caused by vaccination.” This leaves 1,069 cases still pending. A relatively small fraction of the original Omnibus, but a large number nonetheless.

Another way to look at this is the Omnibus proceedings are over, the docket hasn’t been updated for quite some time but there are still individual cases to be decided. Including one case that was rather prominent in the Omnibus: that of A. Krakow. He was intended to be one of the test cases for the thimerosal but was pulled out to pursue another argument: that metabolic dysfunction is involved. David Kirby referred to him as “The Next Vaccine-Autism Newsmaker”, following the supposed game-changer of Hannah Poling.

That was in 2008. As it’s been nearly 5 years, I checked the status of the case. It turns out the first hearing was held in December (a hearing on fact) and a second hearing is set for expert witnesses to testify in April of this year. One way to explore the arguments the family may be taking is to review the experts that are testifying. For example, the family has chosen Richard Deth as an expert. His work has not focused on mitochondria. On the other hand, Yuval Shafir is also listed as an expert and has listed many articles on mitochondria with his report. Richard Frye’s CV was submitted (he also has some work on mitochondria and autism), but I don’t see that an expert report from him has been submitted.

Other experts date from 2008 (from when he was going to be an Omnibus test case) include: Elizabeth A. Mumper, Robert S. Rust, Richard Deth and Sander Greenland.

(edit to add, I see a report in the docket from Marcel Kinsbourne in 2010).

So, is this going ahead as a “mitochondrial autism” case? The “Next Hannah Poling” as David Kirby claimed in Spectrum Magazine? Well, even Hannah Poling wasn’t the game-changer some people predicted. Probably the most we can say is that is 10 years old, with a docket 16 pages long, will finally be heard.

edit to add: For the curious, here is the docket.
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By Matt Carey

A correction

5 Feb

Last year, following the autism hearing in the Oversight and Government Reform Committee, I wrote a piece Mr. Wright, is autism an epidemic or not? Why not give real examples of how to make a financial impact? In the article I used an example of how getting more autistics employed could make a real impact financially in our country.

It was pointed out to me that the way I framed it, it read that only a fraction of the autistic population would be able to gain employment. An adult self-advocate pointed out to me that this is not the case, that real employment should be a goal for the entire population. And this self advocate is correct and I regret the way I worded that article.

It is worth noting that a self advocate was informing the parent of a child with multiple disabilities, including intellectual disability, that employment should be a goal for all. There is an important lesson in that apparent role reversal. Self-advocacy does not mean one advocates only for one’s self, nor for only other self advocates. This simple message often gets lost in the stereotyped presentations of self-advocates and parents.

The autism community is broad. No one person will advocate great change. No segment of the population will be very effective on its own. We are going to work together or we are going to fail.

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By Matt Carey

IACC to take more active role

4 Feb

The U.S. Interagency Autism Coordinating Committee (IACC) met last week. There were presentations on important subjects but for me the real event happened in the final hour, during the discussion. You can get an idea of that from two Autism Speaks articles: IACC Pledges More Assertive Role in Federal Autism Policy and IACC Tackles Healthcare Disparities and Access to Care.

If one looks at Public Law 109-416 (the law based on the Combating Autism Act)

(b) RESPONSIBILITIES.—In carrying out its duties under this section, the Committee shall—
(1) develop and annually update a summary of advances in autism spectrum disorder research related to causes, prevention, treatment, early screening, diagnosis or rule out, intervention, and access to services and supports for individuals with autism spectrum disorder;
(2) monitor Federal activities with respect to autism spectrum disorder;
(3) make recommendations to the Secretary regarding any appropriate changes to such activities, including recommendations to the Director of NIH with respect to the strategic plan developed under paragraph (5);
(4) make recommendations to the Secretary regarding public participation in decisions relating to autism spectrum disorder;
(5) develop and annually update a strategic plan for the conduct of, and support for, autism spectrum disorder research, including proposed budgetary requirements; and
(6) submit to the Congress such strategic plan and any updates to such plan.

If you look at (2) and (3), they constitute a very broad mandate to “monitor Federal activities with respect to autism spectrum disorder [and] make recommendations to the Secretary regarding any appropriate changes to such activities”

This is an area which the IACC has up until not been the primary focus of the IACC, from what I have observed. The IACC has spent much effort, and rightfully so, on developing and updating the strategic plan for autism research.

The IACC is working on a document to offer advice on how autism should be considered in the implementation of the Affordable Care Act and the insurance exchanges the Act will set up.

The meeting started with Tom Insel (chair of the IACC, director of the NIMH) discussing some recent papers in autism. These include studies on elopement, markers of maternal inflammation as a risk factor for autism, an imaging study showing microglial activation in autistic brains, studies by IACC member David Mandell and more.

A presentation was given about the CDC Minnesota Somali Autism Project. The presentation discussed the methodology (using the same system as the ADDM network) and the difficulties in building the infrastructure from scratch. No information on preliminary results.

Jose Cordero spoke about the prevalence of autism in Puerto Rico. It is one of the highest in the United States at 1.6%. This is especially noteworthy given the relatively low prevalence for autism among the Hispanic communities regularly reported. Another presentation was made on the recent “Optimal Outcomes” study, with much discussion afterwards about what “optimal” outcomes really are. Of note was the fact that the study authors never made the statement that people “grow out of autism”, that was an interpretation added by journalists. Anjali Jain of The Lewin Group and Craig Newschaffer of Drexel University spoke about health outcomes among autistics, showing that there are more health issues among autistics. Alan Guttmacher of the National Institute of Child Health and Human Development spoke about the National Children’s study which is starting and will follow 100,000 children’s health outcomes and track possible environmental risk factors.

Public comments were given both orally and written. Unfortunately, there was no time for discussing the comments, which included statements by Dena Gassner, Amy Lutz, Dawn Loughborough and Jake Crosby.

The meeting was recorded by video. (I’ll try to get the embed code to work) http://videocast.nih.gov/launch.asp?17778

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By Matt Carey

note: I serve as a public member to the IACC but all opinions here and elsewhere are my own.

Jenny McCarthy loses gig for health-related fundraiser

3 Feb

I haven’t spent much time discussing Jenny McCarthy in a while. The reason is pretty simple, aside from her annual presentation at the AutismOne parent convention (where she criticizes parents who don’t use alternative medicine), she’s basically dropped out of the public discussion on autism. Years back she stopped expressing her views on vaccines publicly. Gone are the days of shouting “bullshit” at pediatricians on national TV and leading “green our vaccines” demonstrations in Washington DC.

So when I heard that she was going to headline a fundraiser for a cancer charity in Ottawa, I didn’t feel any need to write about it. Sure, it was a bad decision on the charity’s part. Why spend some of their credibility on Ms. McCarthy?

We are talking a cancer charity. Cancer patients often have reduced immune systems due to treatments they receive. They are highly dependent on the rest of us providing protection from serious vaccine-preventable diseases. The efforts of Ms. McCarthy and her organization have, by their own words, reduced vaccine uptake, endangering the very population the charity seeks to serve.

The Ottowa Citizen is reporting that Ms. McCarthy has been replaced for the event. I thank the charity for that. Ms. McCarthy is tweeting that she has a conflict and had to pull out. If this is true, perhaps she could return the “financial settlement” she is reportedly still being paid. In other words, I’m finding it hard to believe her tweet. If she wants to save face, she can save the charity money at the same time.

With luck, this will be the only Jenny McCarthy article here this year. Her time came and passed. We will be feeling the damage of her efforts for years to come. I’m not feeling much sympathy that she has to accept some consenquences.

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By Matt Carey

The Geiers’ Second Home

2 Feb

Mark Geier is well known within the autism alternative medicine community (think chelation, lupron) and as a consultant and expert for the attorneys in the vaccine court. David Geier is his son and has also been associated with the alt-med treatments (much criticised research, being accused of practicing medicine without a license) and tried to break in to the vaccine-court expert/consultant business. The Geiers are currently suing the attorneys who represented the families in the Ominibus Autism Proceeding (the vaccine court hearings on vaccine causation of autism). According to court papers, the Geiers are seeking $600,000 in fees and expenses they feel are owed to them. The vaccine court denied the application for paying for their fees.

In looking over the documents I was struck by an odd fact: the address given for the Geiers is not the same one I am used to seeing. It isn’t their usual home base in Maryland. So I decided to take a look at what sort of home they are currently claiming as their residence.

Here’s a picture (click to enlarge pictures):

House 1

The home is described online as 7,800 square feet, on a 20 acre lot. The backyard comes complete with a swimming pool.

House 2

Apparently, the estate was listed for $2.6M in 2011, but pulled from the market. Eidt to add: I’ve been informed that Mark and David Geier (not Mark and his wife) purchased the property in Nov. 2011 for $2M.

the Interior is not understated:

B-Room Geier

and

B-Room Geier

If you work out where they live, please don’t post it here. It is publicly available information, but it is not relevant to this discussion. What is releavant is this: there’s a lot of money in alternative medicine and promoting the idea that vaccines cause autism. Mark Geier has 20 years experience working with, and being critcized by, the vaccine court, including for double charging and for charging for costs well outside their roles (such as trips to Europe)

A single study they assisted in preparing for the Omnibus was billed at $440k, even though it was of low quality and was not useful in the case. The special master was very clear:

Clearly, no rational “hypothetical paying client” of the PSC would have agreed to pay for the production of such a flawed study. Thus, the fact that the Young-Geier article did not add any value to the petitioners’ causation presentation in this case is a very strong reason why I should decline to compensate the PSC for the cost of producing the article.

The Special Masters of the Court of Federal Claims (the vaccine court) appear to have closed the door on payments to the Geiers. But not until nearly two decades of low quality work was compensated. Mark Geier has lost his license to practice medicine in multiple states, but, again, not until after he was able to spend decades “treating” people with and charging people for therapies which make no sense.

The Geiers may not get the $600k they believe they are owed for work on the Omnibus. Their multistate franchise of lupron treatment centers may be closed. They may not be able to charge the American taxpayer for future low quality “expert” reports for the Court. Perhaps Mark Geier will have to retire a little early (reportedly, he’s 64), to his new home. Shared with his wife and son. Except for the living out one’s retirement with David Geier, I’m not seeing this as a difficult time for him. As to David Geier, one does wonder if he will ever amount to anything. Extrapolating from existing data, I’m not betting on it. But, as with his father, I don’t see cause to worry for his future. The U.S. taxpayers, and medical consumers, have taken care of this father/son team far better than we have our disabled citizens. And with less return to show for it.

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By Matt Carey

Princeton families make $1.5M donation to Rutgers to study adult autism

2 Feb

NJ.com is reporting Princeton families make $1.5M donation to Rutgers to study adult autism. Two families donated $750,000 each, matched by another gift to the university to endow a chair in the psychology department:

Located at the Graduate School of Applied and Professional Psychology, the Karmazin and Lillard Chair in Adult Autism will pay for research and training future professionals to work in the growing field.

I find it very encouraging that the donors are parents of adolescent autistics.

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By Matt Carey

IACC to hear about Minnesota Somali Project, Optimal Outcomes and National Children’s Study

28 Jan

The U.S. Interagency Autism Coordinating Committee (IACC) meets tomorrow (January 29th). The agenda is listed online and below.

The committee and the public will hear updates on the Minnesota Somali Autism Project–a project to explore whether there is a high prevalence of autism in the Minnesota Somali community and, if so, why. The autism prevalence in Puerto Rico ranks high for the U.S., even though the territory population is largely Hispanic and Hispanics typically have a low reported autism prevalence in the U.S.. An update on the autism prevalence in Puerto Rico will be presented. A recent study on individuals who achieved what the authors refer to as “optimal outcomes” will be discussed. Also, a study of health outcomes in children with autism and their families will be presented.

The IACC will also discuss plans for moving forward. There are many areas I would like to see some focus applied to. But three I have proposed and hope to discuss are (1) the needs specific to children and adults with autism and intellectual disability and/or communication difficulty and (2) difficulties in delivery of medical services to autistics and (3) autism and epilepsy. It is too late for comments to be included in the record for this meeting, but if you have opinions of where autism research and policy should be moving towards, send the IACC comments at IACCPublicInquiries@mail.nih.gov.

Here is tomorrow’s agenda:

10:00 a.m. Welcome, Roll Call and Approval of Minutes
Thomas Insel, M.D.
Director, National Institute of Mental Health
Chair, IACC

10:05 Science Update
Thomas Insel, M.D.
Director, National Institute of Mental Health
Chair, IACC

10:20 Round Robin

10:50 Centers for Disease Control and Prevention (CDC) Minnesota Somali Project Update
Amy Hewitt, Ph.D.
Director, Research and Training Center on Community Living
University of Minnesota

Mashalyn Yeargin-Allsopp, M.D.
Chief, Developmental Disabilities Branch, National Center on Birth Defects and Developmental Disabilities (NCBDDD)
Centers for Disease Control and Prevention

11:20 Update on Autism Prevalence in Puerto Rico
Jose Cordero, M.D.
Dean, Graduate School of Public Health
University of Puerto Rico
Member, IACC

11:35 Lunch

1:00 p.m. Oral Public Comments

1:30 Optimal Outcomes in Individuals with a History of Autism
Deborah Fein, Ph.D.
University of Connecticut
Board of Trustees Distinguished Professor Department of Psychology
Department of Pediatrics

2:00 Study of Health Outcomes in Children with Autism and their Families
Anjali Jain, M.D.
The Lewin Group

Craig Newschaffer, Ph.D.
AJ Drexel Autism Institute, Drexel University

2:30 National Children’s Study Update
Alan Guttmacher, M.D.
Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Member, IACC

2:50 Break

3:05 IACC Business
Thomas Insel, M.D.
Director, National Institute of Mental Health
Chair, IACC

Susan A. Daniels, Ph.D.
Acting Director, Office of Autism Research Coordination
Executive Secretary, IACC

•2012 Strategic Plan Update
•2013 Strategic Plan Update Process
•2012 Summary of Advances
•2011-2012 Portfolio Analysis
•Other Activities

4:15 Public Comments Discussion Period

4:45 Wrap-Up

5:00 Adjournment

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By Matt Carey

Note: I serve as a public member to the IACC. However, all comments and opinions, here and elsewhere are my own.
Note: I made small edits after I published this article to include the third area I would like to see get greater focus.

A paper retraction and a strange blog post

25 Jan

My pubmed email alerts had a retraction notice recently. Enhanced Polyubiquitination of Shank3 and NMDA Receptor in a Mouse Model of Autism now shows “retracted”.

Per a tweet from Steve Silberman:

It turns out a blog called “Autism Researchers” noted that figures in the paper included identical data, but in non-identical places. For example:

Aside from the odd possibility that a blog may have contributed to the downfall of a paper (not too odd if you recall ERV’s analysis of an XMRV paper), is the fact that the blog has one real entry. They have a first “hello world” entry, which is a throwaway WordPress first blog entry, and the one discussing this paper (Alleged Image Data Falsification in a CELL Paper). Looks to this observer like someone created a throwaway blog to note the possible problems with this paper.

This is a top journal (Cell), and a top research group and insitution (Johns Hopkins, The University of Texas Southwestern Medical Center, National Institute on Deafness and Other Communication Disorders and Sichuan University, Chengdu). The paper has been cited 54 times. Retraction Watch reports that the Office of Research Integrity (ORI) is aware if thus case.

The “improperly assembled” figures all appear in the same paper in Cell. This is unlike the case of (non autism researcher) Jan Hendrik Schön of Bell Labs, who had what could be phrased as “improperly assembled” figures (in his case, duplicated data) in multiple papers.

We don’t have the time and the money to have multiple researchers pursuing projects based on “improperly assembled” figures in a high profile paper. The Cell paper hasn’t led to public health scares, as another case of improperly assembled research data. But with NIH funding and 54 citations, it may be wasting time and money that are both very scarce in the autism world.

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By Matt Carey

An update: Adverse reaction data for alternative therapies for autism?

24 Jan

With apologies for how long this took to put online: Last September I wrote an article Adverse reaction data for alternative therapies for autism? In it I pointed out how the Autism Research Institute (ARI) had a different standard for reporting adverse reactions for FDA approved drugs and for altnerative therapies. Jane Johnson graciously participated in the conversation and saw that the web page in question was changed. The page now includes this paragraph:

If your son/daughter experiences side effects from taking prescribed medications, please contact the FDA at: http://www.fda.gov/medwatch. Since supplements may also lead to side effects, please report them to: http://www.fda.gov/Food/DietarySupplements/Alerts/ucm111110.htm. You can also call: 1.800.FDA.1088 (1.800.332.1088) to report adverse effects associated with prescription drugs and supplements.

I greatly appreciate the change and again apologize for taking so long to acknowledge it here.

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By Matt Carey

IACC Full Committee Meeting Tuesday, January 29, 2013

24 Jan

There will be a meeting of the U.S. Interagency Autism Coordinating Committee (IACC) next Tuesday. Full details can be found on the IACC website. The meeting will be from 10am to 5pm.

The agenda is:

The committee will discuss updates on ASD research and services activities, discuss plans for the 2012 IACC Summary of Advances and plans for the update of the IACC Strategic Plan for ASD Research.

And will be held at:

William H. Natcher Conference Center
45 Center Drive, Conference Rooms E1/E2
Bethesda, Maryland 20892
Map and Directions</blockquote>

One can attend in person or watch via videocast

One can submit comments. The deadline to be included for this meeting is today:

Notification of intent to present oral comments: January 24th by 5:00 p.m. Eastern
Submission of written/electronic statement for oral comments: January 25th by 5:00 p.m. Eastern
Submission of written comments: January 24th by 5:00 p.m. Eastern

One can always submit written comments (IACCPublicInquiries@mail.nih.gov), they will be held for the next meeting.

The meeting website has a long “please note”:

Any member of the public interested in presenting oral comments to the Committee must notify the Contact Person listed on this notice by 5:00 p.m. Eastern on Thursday, January 24, 2013, with their request to present oral comments at the meeting. Interested individuals and representatives of organizations must submit a written/electronic copy of the oral presentation/statement including a brief description of the organization represented by 5:00 p.m. Eastern on Friday, January 25, 2013. Statements submitted will become a part of the public record. Only one representative of an organization will be allowed to present oral comments and presentations will be limited to three to five minutes per speaker, depending on number of speakers to be accommodated within the allotted time. Speakers will be assigned a time to speak in the order of the date and time when their request to speak is received, along with the required submission of the written/electronic statement by the specified deadline.

In addition, any interested person may submit written comments to the IACC prior to the meeting by sending the comments to the Contact Person listed on this notice by 5:00 p.m. Eastern on Thursday, January 24, 2013. The comments should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. All written statements received by the deadlines for both oral and written public comments will be provided to the IACC for their consideration and will become part of the public record.

The meeting will be open to the public through a conference call phone number and webcast live on the Internet. Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. If you experience any technical problems with the webcast or conference call, please send an e-mail to IACCHelpDesk2012@gmail.com or by phone at (301) 339-3840.

Individuals who participate in person or by using these electronic services and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request to the Contact Person listed on this notice at least 5 days prior to the meeting.

To access the webcast live on the Internet the following computer capabilities are required: A) Internet Explorer 5.0 or later, Netscape Navigator 6.0 or later or Mozilla Firefox 1.0 or later; B) Windows® 2000, XP Home, XP Pro, 2003 Server or Vista; C) Stable 56k, cable modem, ISDN, DSL or better Internet connection; D) Minimum of Pentium 400 with 256 MB of RAM (Recommended); E) Java Virtual Machine enabled (Recommended).

NIH has instituted stringent security procedures for entrance onto the NIH campus. All visitors must enter through the NIH Gateway Center. This center combines visitor parking, non-commercial vehicle inspection and visitor ID processing, all in one location. The NIH will process all visitors in vehicles or as pedestrians. You will be asked to submit to a vehicle or personal inspection and will be asked to state the purpose of your visit. Visitors over 15 years of age must provide a form of government-issued ID such as a driver’s license or passport. All visitors should be prepared to have their personal belongings inspected and to go through metal detection inspection.

When driving to NIH, plan some extra time to get through the security checkpoints. Be aware that visitor parking lots on the NIH campus can fill up quickly. The NIH campus is also accessible via the metro Red Line, Medical Center Station. The Natcher Conference Center is a 5-minute walk from the Medical Center Metro Station.

Additional NIH campus visitor information is available at: http://www.nih.gov/about/visitor/index.htm

As a part of security procedures, attendees should be prepared to present a photo ID at the meeting registration desk during the check-in process. Pre-registration is recommended. Seating will be limited to the room capacity and seats will be on a first come, first served basis, with expedited check-in for those who are pre-registered.

Schedule is subject to change.

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By Matt Carey

Note: I serve as a public member to the IACC, but I do not represent the IACC here or anywhere else. All comments and opinions are my own.

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