The IACC Invites Your Opinion · 8 days ago

Yesterday, August 20, the National Institute of Mental Health issued the following Request for Information (RFI): Interagency Autism Coordinating Committee (IACC) Draft Strategic Plan for Autism Spectrum Disorder Research. The deadline for responses is September 30, 2008. (This is a separate RFI from the August 11 RFI seeking input to the IACC Services Subcommittee.)

The IACC’s draft Strategic Plan can be downloaded from the NIH website. The draft Strategic Plan enumerates the following goals:

Children with or at risk for ASD will be identified by 24 months and receive appropriate interventions.

Discover how ASD affects development, which will lead to targeted and personalized interventions.

Causes of ASD will be discovered that inform prognosis and treatments and lead to prevention/preemption of the challenges and disabilities of ASD.

Interventions will be developed that are effective for reducing both core and associated symptoms, for building adaptive skills, and for preventing the disabilities associated with ASD.

Communities will implement high quality, evidence-based and cost-effective services and supports across the lifespan for people with ASD.

Advances in intervention, education and services will support and enable individuals on the autism spectrum to lead fulfilling and productive lives in the community.

The draft Strategic Plan further enumerates research opportunities, and both short- and long-term objectives intended to support the attainment of these goals.

The Draft Strategic Plan RFI seeks input on the full range of issues considered by the IACC. It is imperative that autistic citizens (only one of whom serves on the committee), their families, service providers and researchers take this opportunity to advocate for scientific, educational and social research that is targeted toward the most promising areas of inquiry, and that will best promote the welfare of those affected by autism. It is also imperative that supporters of evidence-based medicine take this opportunity to counter the inordinate influence of generously- albeit obscurely-funded vaccine-injury plaintiffs’ lobbyists and promoters of dubious autism treatments and treatment providers. Although citizen input is vital to the establishment of sound public policy, politicization of the process of evaluating scientific data is not. Limited funding will only be squandered if it is expended on repetitive, ideologically- and economically-driven efforts to validate scientific hypotheses shown to be untenable in numerous completed studies.

This is your chance to be heard. Use it!

Request for Information (RFI):
Interagency Autism Coordinating Committee Draft Strategic Plan for Autism Spectrum Disorder Research

Notice Number: NOT-MH-08-021

Key Dates

Release Date: August 20, 2008
Response Date: September 30, 2008

Issued by: National Institute of Mental Health (NIMH)

Description

On behalf of the Interagency Autism Coordinating Committee (IACC), the NIMH is seeking comments on the IACC Draft Strategic Plan for Autism Spectrum Disorder (ASD) Research.

Background

The Combating Autism Act of 2006 (Public Law 109-416) re-established the Interagency Autism Coordinating Committee (IACC) and requires that the IACC develop and annually update a strategic plan for ASD research, including proposed budgetary requirements. The IACC includes Federal and public members who are active in the area of ASD research funding, services, or advocacy. One IACC member has an ASD and several IACC members have family members with an ASD. Driven by both the sense of urgency and a spirit of collaboration, the IACC developed an initial draft Strategic Plan for ASD Research, which is focused on the unique needs of individuals with ASD and their families, as well as other consumers of these efforts. The draft Strategic Plan was developed through extensive and iterative input from members of the public, academic, and advocacy communities. The draft Strategic Plan does not include cost estimates for implementation. However, the IACC has formed a Strategic Planning Implementation Workgroup to advise the IACC about the budgetary requirements needed to complete and fulfill the research objectives described in the draft Strategic Plan and to identify the agencies and organizations that will be accountable for launching research initiatives — for open competition and peer-review — to achieve the objectives outlined in the draft Strategic Plan.

The draft Strategic Plan is organized in two main sections. First, the foundation of the plan — vision, mission, core values, and crosscutting themes — is described. The remainder of the plan is organized around six critical questions asked by individuals and families living with ASD. At its next meeting on November 21, 2008, the IACC will review and discuss the public comments received on the draft and the workgroup’s recommendations regarding implementing the plan.

Information Requested

The IACC welcomes your comments on the draft Strategic Plan for ASD Research. The draft plan can be accessed [on the NIMH] website.

Please organize your comments by the sections of the draft Strategic Plan:

Introductory Material (including the Introduction, Vision Statement, Mission Statement, Core Values and Cross-Cutting Themes)

I: When Should I Be Concerned?

II: How Can I Understand What Is Happening?

III: What Caused This To Happen And Can This Be Prevented?

IV: Which Treatments And Interventions Will Help?

V: Where Can I Turn For Services?

VI: What Does The Future Hold?

Development Process for the IACC Strategic Plan for Autism Spectrum Disorder Research

References

How to Submit a Response

Responses will be accepted until September 30, 2008 via email to iacc@mail.nih.gov. Please limit your response to two pages (approximately 1,000 words) and mark it with the RFI identifier NOT-MH-08-021 in the subject line. You will receive an email confirmation acknowledging receipt of your response, but will not receive individualized feedback on any suggestions. The collected information will be reviewed by the IACC, may appear in reports, and shared publicly on the IACC website.

Inquiries

Inquiries regarding this notice may be directed to:

Attention: Strategic Plan for ASD Research RFI
Office of the Director
National Institute of Mental Health
6001 Executive Boulevard, Room 8235, MSC 9669
Bethesda, MD 20892-9669
Email: iaccpublicinquiries@mail.nih.gov

No basis for claims against the NIH shall arise as a result of a response to this RFI, or from the NIH’s use of such information.

This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the government. The government will not pay for the preparation of any information submitted or for the government’s use of that information.

Speak Out for Services · 9 days ago

On August 11, the National Institute of Mental Health issued the following Request for Information: Priorities for the Interagency Autism Coordinating Committee Services Subcommittee for Autism Spectrum Disorders. The deadline for responses is September 19, 2008.

On September 15, 2008, members of the Services Subcommittee will meet to review all public comments submitted to date, and will present these comments at the next meeting of the full Interagency Autism Coordinating Committee, which is scheduled for November 21, 2008. Members of the public are invited to participate in the September 15 Services Subcommittee meeting by conference call; for more information, please consult the public notice posted on the U.S. Government Printing Office website.

Members of the IACC Services Subcommittee include autistic advocate Stephen Shore, Ed.D.; Margaret Giannini, M.D., Office on Disability, U.S. Department of Health and Human Services; Christine McKee, J.D., parent of an autistic child; Patricia Morrissey, M.D., Administration for Children and Families; Peter van Dyck, M.D., M.P.H., Health Resources and Services Administration; Story C. Landis, Ph.D., National Institute of Neurological Disorders and Stroke; Gail R. Houle, Ph.D., U.S. Department of Education; Catherine Rice, Ph.D., Centers for Disease Control and Prevention; Lee Grossman, Autism Society of America; and Ellen W. Blackwell, M.S.W., Centers for Medicare and Medicaid Services.

Please take this opportunity to speak out for appropriate services and supports needed to enable autistic citizens to achieve maximum independence and a satisfactory quality of life.

Request for Information:
Priorities for the Interagency Autism Coordinating Committee Services Subcommittee for Autism Spectrum Disorders

Notice Number: NOT-MH-08-016

Key Dates:

Release Date: August 11, 2008
Response Date: September 19, 2008

Issued by: National Institute of Mental Health (NIMH)

Description

The purpose of this Request for Information (RFI) is to seek input from Autism Spectrum Disorders (ASD) stakeholders including individuals with ASD and their families, autism advocates, State officials, scientists, health professionals, therapists, educators, and the public at large about what they consider to be high-priority issues and concerns surrounding services and supports for children, youth, and adults with ASD.

Background

The Combating Autism Act of 2006 (Public Law 109-416) re-established the Interagency Autism Coordinating Committee (IACC) and, among other duties, requires that the IACC develop a strategic plan for ASD research. The IACC includes both members who are active in the area of ASD research funding, services, or advocacy, including several members who have family members with ASD, and one member with ASD. In March of 2008 the IACC established the Services Subcommittee, to assess and improve services and supports for people with ASD and their families. A previous IACC developed an ASD Services Roadmap, which is available on the IACC Website above. This RFI is a next step to obtain updated information about present and future services and supports to individuals with ASD, and their families across the lifespan.

Information Requested

The IACC is interested in receiving your input and ideas about high-priority questions and issues surrounding services and supports to people with ASD of all ages, and specific research initiatives on ASD services and supports.  For example, information is sought in the following areas that impact services and supports across the lifespan: education services, health and medical services (including dental), housing, transitions, employment, community inclusion, safety, older adults, finances, guardianship, and estate planning.

Responses

Please send responses to iaccservices@mail.nih.gov no later than September 19, 2008. Please limit your response to one page and mark with this RFI identifier, NOT-MH-08-016, in the subject line. The responses received through this RFI will be collated, summarized, and provided to the IACC Services Subcommittee and the public. Any proprietary information should be so marked. The collected information will be analyzed and may appear in reports. Although the IACC Services Subcommittee will try to protect against the release of identifying information there is no guarantee of confidentiality.

A summary of the results obtained from the responses to this RFI will be available to the public on the IACC Website.

Inquiries

Inquiries regarding this notice may be directed to:

Azik Schwechter, Ph.D.
Office of Autism Research Coordination
National Institute of Mental Health
6001 Executive Boulevard, Room 8203, MSC 9669
Bethesda, MD 20892-9669
Telephone: (301) 443-7613
FAX: (301) 480-4415
Email: schwechtera@mailnih.gov

An Inquiry Emerges · 14 days ago

Yesterday, I received a response to my August 1 letter to University of Kentucky administrators regarding Prof. Boyd Haley’s development and marketing of Oxidative Stress Relief, or OSR — a minimally-tested chelation drug of unknown toxicity to humans, recently entered into interstate commerce under the guise of a dietary supplement and marketed for consumption by autistic children allegedly suffering from heavy metal toxicity.

August 13, 2008

Dear Ms. Seidel:

This is to acknowledge receipt of your e-mail message of August 1st. We continue to review the situation, and will consider whether or not the University of Kentucky has any involvement. In any event, we will ask Dr. Haley to avoid using the university’s name in any matters involving his activities with an outside company.

I have asked several offices to review your e-mail message and the various hyperlinks you include. Please be assured we take your concerns very seriously, and will give them careful consideration.

Sincerely,

James W. Tracy, PhD
Vice President for Research
University of Kentucky


The following is my reply.

August 14, 2008

Dear Professor Tracy,

Thank you very much for your reply and your willingness to investigate the matter of Prof. Boyd Haley’s chelator-cum-“antioxidant” Oxidative Stress Relief (OSR). Since I originally wrote to you and your colleagues two weeks ago, additional information and questions have arisen about the origins of OSR, and about the role and responsibility of the University of Kentucky in its development and licensing.

1. Molecules which Prof. Haley has described at autism conferences as “chelators” and “antioxidants” are identical to molecules developed by University of Kentucky Prof. David Atwood and encompassed by U.S. Patent 6,586,600, “Multidentate Sulfur-Containing Ligands” (.pdf). The patent is assigned to the University of Kentucky Research Foundation. The chemical structure of one patented molecule, BDETH2, as described in Prof. Atwood’s Powerpoint presentation, “Heavy Metal Binding With Thiolate Chelates,” is identical to the chemical structure of OSR as described in Powerpoint presentations by Prof. Haley. Prof. Atwood’s Powerpoint presentation indicates that BDETH2 is toxic to minnows at 292 ppm — significantly more toxic than ethylene glycol (see p. 11). The chemical structure of a pyridine-based molecule described in Prof. Haley’s Powerpoints is identical to the structure of “PyDET,” a pyridine-based chelator also encompassed by Patent 6,586,600 and described in Matlock, Atwood et al.‘s 2002 paper, “Effectiveness of commercial reagents for heavy metal removal from water with new insights for future chelate designs.” It is clear that both BDETH2 and PyDET are synthetic compounds that do not exist in nature, they are not derived from foods, and are not synthesized versions of naturally-occurring compounds. Neither BDETH2 nor PyDET has a CAS number or a Materials Safety Data Sheet. Neither BDETH2 nor PyDET nor any derivative thereof can honestly be described as a “dietary ingredient” or a “food supplement.”

2. The University of Kentucky Office for Commercialization and Economic Development identifies Prof. Haley and “Haley Tech” as recipient of a startup license in 2007 for development of water soluble chelators. The university website offers no further information regarding the sort of applications for which Prof. Haley d/b/a/ Haley Tech was granted his license, or whether that license extends to the operations of either Prof. Haley’s Chelator Technologies or CTI Science business entities.

3. It has been reported that in addition to the rat toxicity studies described in Prof. Haley’s FDA submission, Prof. Haley has conducted experiments on OSR on goldfish, his own cat, and cats belonging to another family that were poisoned by melamine. It is unclear whether protocols for these pharmaceutical experiments on vertebrate animals have been approved by any Institutional Animal Care and Use Committee.

4. On August 30, 2005, Texas dentist and OSR distributor Paul G. Wilke, DDS was sanctioned by the Texas State Board of Dental Examiners regarding multiple instances of failure to obtain proper informed consent from a patient. According to SBDE Order No. 04-524-0308:

“During the time period from June 26, 2002 through September 26, 2002, the Respondent fell below the standard of care by failing to make, maintain, and keep adequate dental records on patient O.M. Specifically, the record does not include: a written informed consent signed by the patient for the administration of anesthesia on multiple occasions; or written informed consent for extractions performed on June 26, 2002 and July 16, 2002.”

Presumably, Dr. Wilke has satisfied the terms of his settlement agreement (i.e., payment of a $500.00 fine and completion of continuing education courses in crown and bridge procedures, risk management and recordkeeping). Nonetheless, his disciplinary history and his unprofessional demeanor in the direct-to-consumer sales pitches he has broadcast on Autism Speaks inspire little confidence in his competence to participate in an informed consent process involving OSR consumers, especially those who are not his patients.

After being publicly criticized for stating that “OSR was approved for sale by the FDA in July of 2008,” Dr. Wilke removed the statement from his website (compare this .pdf of the original version). However, his admonition to parents to “Be thankful that OSR was FDA approved and is available” remains viewable on the Autism Speaks message board.

Since you have expressed your intention to explore all of the hyperlinks contained in my previous letter, and since only registered members can access the ChelatingKids2 list on Yahoo!, I have attached .pdf files of several list discussions and posts so that you can verify the quotes and get a better sense of parents’ understanding of the purpose and function of OSR.

Also, since Autism Speaks has announced that it plans to close its message board in September, I have created and have attached .pdf’s of Dr. Wilke’s posts to that forum.

I have published my August 1 letter to you and your colleagues online under the title, “A Fine White Powder.” A second essay, “The Industrial Treatment,” discusses the University of Kentucky patent. I encourage you to read the public comments appended to this material, which include the observations of chemists, doctors, a former FDA fraud investigator, parents of autistic children, and autistic citizens. They offer a range of perspectives on the scientific and ethical implications of Prof. Haley’s development and testing of OSR, and his unconscionably premature and misleading marketing of this drug to the families of vulnerable disabled children.

Best regards,

Kathleen Seidel
neurodiversity.com | honoring the variety of human wiring

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