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President Obama signs Autism CARES Act into law

12 Aug

The Autism Collaboration, Accountability, Research, Education, and Support Act of 2014 has been signed by President Obama, making it law. This will extend and expand on the framework for authorizing appropriations for autism research and for coordinating research efforts in the U.S..

Here is the summary for the bill:

Autism Collaboration, Accountability, Research, Education, and Support Act of 2014 or the Autism CARES Act of 2014 – (Sec. 2) Requires the Secretary of Health and Human Services (HHS) to designate an official to oversee national autism spectrum disorder (ASD) research, services, and support activities. Directs the official to implement such activities taking into account the strategic plan developed by the Interagency Autism Coordinating Committee (the Interagency Committee) and ensure that duplication of activities by federal agencies is minimized.

Extends through FY2019: (1) the developmental disabilities surveillance and research program; (2) the autism education, early detection, and intervention program; and (3) the Interagency Committee.

(Sec. 3) Includes support for regional centers of excellence in ASD and other developmental disabilities epidemiology as a purpose of grants or cooperative agreements.

(Sec. 4) Requires information and education activities to be culturally competent. Allows a lead agency coordinating activities at the state level to include respite care for caregivers. Allows the use of research centers or networks for the provision of training in respite care and for research to determine practices for interventions to improve the health of individuals with ASD.

(Sec. 5) Revises responsibilities of the Interagency Committee concerning:
• inclusion of school- and community-based interventions in the Committee summary of advances,
•monitoring of ASD research and federal services and support activities,
• recommendations to the Director of the National Institutes of Health regarding the strategic plan,
• recommendations regarding the process by which public feedback can be better integrated into ASD decisions,
•strategic plan updates and recommendations to minimize duplication, and
•reports to the President and Congress.

Revises Interagency Committee membership requirements to specify additional federal agencies that might be represented and to modify the non-federal membership.

(Sec. 6) Modifies requirements for reports by the Secretary on ASD activities. Adds a requirement for a report to Congress concerning young adults with ASD and the challenges related to the transition from existing school-based services to those available during adulthood.

(Sec. 7) Authorizes appropriations to carry out the developmental disabilities surveillance and research program, the education, early detection, and intervention program, and the Interagency Committee for FY2015-FY2019.


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

Why the “Autism Policy Reform Coalition” was wrong

1 Aug

The Autism CARES Act has passed the Senate. Assuming it is signed by President Obama it will soon become law. This extends and expands the framework set up previously under Pub. Law No. 109-416. The only vocal opposition to this bill that I saw came from within the autism communities. (ASAN was neutral, I believe). In specific, a group of small organizations with a focus on vaccines as causing autism formed the Autism Policy Reform Coalition. Autism CARES had a lot of momentum and I think even a good alternative bill would have faced difficulty replacing Autism CARES. But the proposal by the Coalition was not good.

Let’s start with the current structure, as set out by Pub. Law No. 109-416. The government is advised on the research priorities–and other topics–by the Interagency Autism Coordinating Committee (IACC). The IACC has members representing the various federal agencies which fund autism research, representatives from private organizations funding autism research, researchers, autistics and family members of autistics. It does this through drafting and updating a Strategic Plan and an annual report to Congress on autism research advances.

It is important to keep in mind that the IACC policy as well as research mandates. Examples are the IACC Statement Regarding Scientific, Practice and Policy Implications of Changes in the Diagnostic Criteria for Autism Spectrum Disorder and the IACC Letter to Secretary Sebelius on Health Coverage. So it can advise on policy as well as research. There’s just a more clear structure to what is expected in terms of research advice (the Strategic Plan is required. Policy advice is not).

In order to make the current system work there is an Office of Autism Research Coordination (OARC). These are the dedicated people who do the hard work. For example, they plan the meetings, make them work (which takes a lot of people), put together the reports, and more. OARC are a lot of hard working people doing a thankless job, without whom this process would fall apart.

That’s where we are today (at least from my point of view). Autism CARES adds an additional duty–someone in Health and Human Services will be charged with being the point person on autism. Plus some specific projects (like a report on adults and transitioning youth).

The Secretary of Health and Human Services shall designate an existing official within the Department of Health and Human Services to oversee, in consultation with the Secretaries of Defense and Education, national autism spectrum disorder research, services, and support activities

This official will “take into account” the Strategic Plan and make sure that research is not unnecessarily duplicative.

All these details sound like a lot but it’s fairly straightforward–there is the IACC advising the government, with support from OARC and now a point person in HHS overseeing the implementation of the government’s strategy. It’s simple, and it puts stakeholders (autistics, family members and researchers) directly in the stream drafting the Strategic Plan.

Some people suggest that no one listens to what the IACC has to say. To those people, I say, take a look at who the federal members are. That’s a lot of high level, decision making people who are involved with drafting the Strategic Plan and who listen to the public members every meeting. Again, the process puts stakeholders right in the mix with the decision makers. Also, most of the research being performed falls into the project areas the IACC set out in the Strategic Plan. Does the IACC have control? No. Influence? Yes.

Now consider the plan that was offered by the Autism Policy Reform Coalition. Who knows if anyone in the legislature seriously considered this proposal as a viable option to Autism CARES. Let’s start looking at why I, for one, didn’t see this as a viable option. In place of the IACC, they create two offices. The Office of Autism Spectrum Disorders Research and the Office of National Autism Policy Coordination. OK, see what they did there? They split the research and policy parts into two offices. Each will create separate Strategic Plans, each in their own area. Each Office will have need support staffs, like the IACC has OARC. So now you have four entities. Where are stakeholders in this? Well each new Office gets its own “advisory panel”. So you have six entities, assuming that the advisory panels share the support staff of the Offices they are attached to. If not, then you have eight entities.

Getting confusing?

More than just creating a lot of jobs (coming out of the autism budget), while these proposed stakeholder advisory panels have voting power in drafting the Plans put out by each office, these advisory panels are one step removed from the planning process. They are separate

Why would someone propose this? I can’t say. I can say that in this proposal the advisory groups would be majority or entirely stakeholders. So, within their own advisory panels, stakeholders would have more power to make statements without having to convince non-stakeholders to vote along.

Much as I write about autism politics, I’m no fan of politics. I would never trade the opportunity to work directly with the decision makers for the chance to make statements.

Oh, yeah, and about those stakeholders. Here’s one paragraph discussing an advisory panel:

An Advisory Panel of qualified parents or other relatives of persons with autism shall be established, modeled on the integration panel for this purpose existing within the Congressionally Directed Medical Research Program (CDMRP). As with the CDMRP panel, the integration panel to the OASDR shall have voting rights with respect to the drafting of the annual strategic plan for autism research, and with respect to grant requests presented to the OASDR for the award of autism research funds.

If your eyes glazed over with the alphabet soup, let me draw your attention to the role of autistics in the advisory panel. Or, to be more accurate, the fact that there isn’t a role for autistic adults. We are back to “the autism community is comprised of parents” philosophy.

The fairly minimal costs for the administrative overhead for this Office should be found in offsets from the existing CAA funding by redirecting non-priority dollars authorized to the NIH and HRSA under the prior versions of the CAA

“Minimal costs” and a new government entity are not terms I would put in the same sentence. More important to me, what are “non-priority dollars”? Not spelled out, but no priority is given in their document to, say, improving the lives of autistic adults. Yes, there would be money to move around since priorities would shift.

Which begs the question, what do they put as a priority?

The statute should redirect HRSA resources on autism towards research designed to create a medical model for autism management, a special patient population standard of care.

In my own opinion, a large fraction of research effort is already directed towards medical management. If we look at the autism research portfolio (here data from 2010):

2010 ASD Research Funding by IACC Strategic Plan Question – All Funders
(Total ASD funding = $408,577,276)

figure3_2010

You might say, “treatments and interventions, that’s only 17%?”. Yeah, but you gotta include biology, and that’s another 22%. Without an understanding of the biology of autism, you will never get to effective therapies. Well, maybe in some sort of Edisonian approach. However that not only takes a long time, but it’s pretty obvious people aren’t light bulbs. Edison burned out a lot of light bulbs in his search to find a good filament. Groping around blindly for treatments can lead to disastrous results in humans. Perhaps the ARPC may feel they already know the biology of autism (vaccine injury, heavy metal poisoning, oxidative stress, neuroinflammation and more). That hasn’t always worked out so well.

At present the majority of federal autism research funds go to NIH. About 80% per an article in Congressional Quarterly that just came out. The Coalition’s proposal focuses primarily on NIH. Too much in my opinion. While one could say that might be justified given their large stake, in my opinion their proposal doesn’t do a good job of coordinating with the other federal funding agencies. And there little to no coordination with private funders. Private funders account for a large amount of autism research dollars. Simons Foundation, Autism Speaks, Autism Science Foundation and more private organizations contribute a great deal to autism research. In 2010, the Simons Foundation alone was the second largest funding agency after NIH. Yes, a larger contribution than any other federal agency than the NIH.

The Coalition further proposed assigning the funds for the NIH to their proposed Office of Autism Spectrum Disorders Research. It sounds like this would give more power to the advisory groups, but without some framework whereby this Office manages the funds, it’s just bookkeeping.

The Coalition presented themselves as wanting to delay Autism CARES to make some small but helpful changes. They were neither small nor helpful.

I had hoped to write something before Autism CARES passed. While it’s pretty much academic now (and likely was even before Autism CARES passed as I don’t think the Coalition had much traction), it’s worth reviewing their proposal.


By Matt Carey

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

More Canary Party financial documents

1 Aug

The Canary Party is a tiny organization focused on promoting the idea that vaccines cause autism. They have branched out some with GMOs and “health freedom”, but their core seems to be the failed idea that vaccines cause autism. I’ve previously posted some of their financial documents (here and here)

Here are finance disclosure forms for
2011
2012
2013
2014

They took in
$72,018.66 in 2011
$48,748.95 in 2012
$17,425.00 in 2013
$6,275.00 reported as of June 2014

they had about $3,100 on hand as of June 2014. Where before they had some large donors and a number of small donors, so far this year all donations have been from Canary Party officer Jennifer Larson.

In previous years, they had thousands of dollars in expenses for stays at the Hyatt/Ritz and Hyatt/Four Seasons, this year they have two modest travel expenses totaling under $1000.

No parties gatherings are listed this year like their $11,000 convention in 2012.

They’ve become less transparent in their expenses. In 2013 they list $4,500 as “Dues and Membership Fees: Software” and $2,250 one month and $2050 another in “Other Services: Outside Services”. Some or all of that could be payments to blogger Ginger Taylor, who in 2011 and 2012 was paid $4,500 a month for parts of the year as “media consultant” and “Public Relations/Fundraising Service”. Hard to say, it’s not transparent.

It looks like this effort may keep moving along, self funded at a low level, for the foreseeable future. But as a major, grass-routes organization it seems to be failing.


By Matt Carey

Are congressmen Justin Amash and Rick Nolan being courted by the vaccine/autism community?

30 Jul

The groups promoting the idea that vaccines have caused an epidemic of autism have always been politically active. There’s been a resurgence in recent years, with the Canary Party and lobbying and donations and lobbying asking for congressional hearings on autism. When I got an email today from Generation Rescue (an organization promoting the idea that vaccinesasking me to donate to Congressman Bill Posey, I thought I’d take a new look at opensecrets.org and see what donations have been made lately.

Canary Party officer Jennifer Larson donates from her company (Vibrant Technologies). Another Canary Party officer is Mark Blaxill. Searching OpenSecrets for their names I find that they are (a) not donating to Darryl Issa (whom I’ll discuss below), (b) donating to Bill Posey and (c) have started donating to Justin Amash and Rick Nolan. Here are screen shots (click and click to enlarge):

larson

blaxill

And I haven’t checked to see who else is donating to these members of Congress.

Jennifer Larson recently donated $40,000 to Congressman Darryl Issa. Congressman Issa chairs the House Committee on Oversight & Government Reform. This same committee held hearings on autism, sadly wasting a lot of time on the Canary Party’s failed vaccine message. One of those hearings included Larson’s colleague at the Canary Party (Mark Blaxill) presenting testimony. Interestingly, Congressman Issa did not attend the second hearing by his own committee last year. And now the money is moving to other politicians.

Congressman Amash sits on the Committee for Government Oversight & Reform (the same one that held the hearings). But he was criticized by one of the vaccine/autism groups for arriving late and not asking questions in the recent hearing.

amash1

Rick Nolan is a member of the Congressional Autism Caucus.

Ms. Larson also has a $2,000 donation to congressional hopeful Tom Emmer (May 13, 2014).

Interestingly, Gary Kompothecras does not seem to be supporting Bill Posey this election. He has in the past (and here) and lives in the same state as Congressman Posey. Whether the lack of donations this election cycle represent some of the friction within the autism/vaccine community is unclear.

Donating to politicians is of course appropriate and legal. As is following money from special interest groups.

I hope these politicians do their own research. The vaccine/autism idea has caused a great deal of harm to the autism communities and to public health.


By Matt Carey

Call your senators, ask to bring the Autism CARES ACT to the floor

29 Jul

The bill which authorizes funding for the US federal government’s autism research effort expires this September. The re authorization bill is called the Autism CARES Act (Autism Collaboration, Accountability, Research, Education, and Support Act of 2014). The U.S. House of Representatives passed the bill and it passed the Senate HELP Committee. If it passes the Senate and gets signed by the President (pretty likely) it’s a law.

It is now waiting to be brought to the floor of the Senate for a vote.

The last time the research authorization bill was passed (the Combating Autism Reauthorization Act), the reauthorization happened at the last minute: September 30th. A new Committee to advise and plan autism research didn’t start work until the next July. This IACC met for the last time a few weeks ago, so if events go as before it will be a full year without stakeholder input on autism research. If Autism CARES passes soon, the government can start working on a new committee earlier and the delay will hopefully be shorter.

The Senate will go on recess at the end of the week (by law they have the month of August off). So now would be a good time to remind them to bring this to the floor and get it moving.

Autism Speaks has set up a handy web app to help you do this: http://bit.ly/SensCall. Click it, input a little information and it calls you back and sets up the call for you to your senators’ offices.

FaxZero lets you send 5 faxes a day from the web and they have a handy web interface to help guide you to your own (or any other senator). That is http://faxzero.com/fax_senate.php

Want to fax everyone in the senate in one fell swoop? For about $10, http://www.faxyouropinion.com/senators will send the same message to each senator. Don’t worry, they change the “Dear….” line for you.

Want to send those 5 free faxes from FaxZero and wonder who might be someone worth faxing? Well, there’s a set of groups who have been trying to block Autism CARES. These groups set up a list of targeted senators (all these groups are in the “vaccines cause autism” persuasion, 3 directly associated with Andrew Wakefield…yeah, sit back, do nothing and Andrew Wakefield will help shape U.S. autism policy for you. Now that’s a cheery thought!)

Here’s their list.  (Their staffs are very nice.  One Senator goes straight to voicemail, though).

Senator Rand Paul in Kentucky

Senator Ted Cruz in Texas

Senator Mike Lee in Utah

Senator Tom Coburn in Oklahoma

Senator Roy Blunt in Missouri

Senator Ron Johnson in Wisconsin

Senator Jim Risch in Idaho

Calls only take a minute. You can just call and say, “I’m autistic and I want Autism CARES brought to the floor. Please support it” or “I’m the parent of an autistic kid and I want Autism CARES brought to the floor. Please support it”. Or you can say “Please kill the Autism CARES Act”. It’s your Senate. Use it.


By Matt Carey

Note: I serve as a public member to the present IACC, the committee which is authorized by the Combating Autism Act. My comments here and elsewhere are always my own.

Medicaid will start paying for autism therapies

26 Jul

Medicaid will start paying for autism therapies. The news was released at the last IACC meeting and I’ve been trying to work out how best to write it since. Seems pretty straightforward, doesn’t it? Not to take anything away from the person who presented it at the meeting but after a while of hearing things like:

Those categories include: section 1905(a)(6) – services of other licensed practitioners; section 1905(a)(13)(c) – preventive services; and section 1905(a)(10)- therapy services.

I just get saturated with the 1915(a) vs 1915(i) type language.

Here’s the announcement: Clarification of Medicaid Coverage of Services to Children with Autism

Here’s one of the first paragraphs:

The federal Medicaid program may reimburse for services to address ASD through a variety of authorities. Services can be reimbursed through section 1905(a) of the Social Security Act (the Act), section 1915(i) state plan Home and Community-Based Services, section 1915(c) Home and Community-Based Services (HCBS) waiver programs and section 1115 research and demonstration programs.

See what I mean? Take from this “the federal Medicaid program may remburse for services to address ASD”

How did this come to pass? A lot of people have been pressuring medicaid for some time to provide autism services. This includes lawsuits, like this one in Florida (Judge: Florida Medicaid Must Cover Therapy for Autism).

If you listen in or watch the IACC meetings, you know that for the past few years one of the sources of pressure on Medicaid has been from IACC member Idil Abdul. I don’t know if a meeting has gone by where Idil hasn’t talked about the inequities of a system where we say we will give medical support to our disabled poor, but we withhold support for treatments related to their disability. Or, to put it simply: why should kids with private insurance get speech, OT and other services while other kids don’t under medicaid?

People often ask what is the value of the IACC and here is one of those unquantifiable benefits. Idil did what a public representative to a federal committee should do: she informed federal members of the needs of the community. Across the table from her was John O’Brien of Medicare and Medicaid Services. John is a good guy and would often patiently correct some factual errors in what Idil had said. But he had to listen to Idil.

And for those of us who know Idil, when I say “she informed federal members” you have to know that “informed” is a major understatement.

Would this shift in Medicaid policy have happened without Idil? It was a big group effort as I’ve already said. Would it have happened later without Idil? We can’t rerun the experiment.

Just to be clear–this wasn’t an effort of the IACC. This was an effort of a member of the IACC. Made possible by her being on the IACC. It’s an odd distinction, but an important one. The structure congress created of the IACC got Idil’s voice in the right place at the right time.

While on the subject of distinctions: as always, my comments are my own and they do not represent the views of the IACC.


By Matt Carey

Recent Autism Gastrointestinal research funded by NIH

24 Jul

There are many parent advocates asking for research into gastrointestinal disorders and autism. My own anecdotal observations have been that these same parent advocates are of the belief that no work is ongoing. There are a number of projects ongoing and I’ve tried in the past to make that point (What projects are being funded in autism research? Part 1: vaccines and GI issues). I found 14 projects, nearly $3M in 2010. I found 11 projects for $1.7M in 2009.

I thought it time to revisit this question. I’m using a different data source–the NIH RePORTER database. Because of that these projects are those funded by NIH. Other Federal groups can and do fund autism research. Also private organizations like Autism Speaks

Below are the projects I found for the past few years. There are projects on epidemiology, treatment and biology.

While I think that the funding agencies could do a better job informing the communities about these projects, I sincerely wish that the parent advocacy groups calling for this research would inform their members that it is going on. I am actually very curious as to why they have not done that.

MECHANISMS OF AUTONOMIC BRAINSTEM DEVELOPMENT ($243,000)

Brainstem and autonomic circuitry, though understudied in neurodevelopmental disorders, are implicated in pathophysiology and co-occurring medical conditions, such as gastrointestinal disturbances (GID). The goal of this R21 project is to fill this knowledge gap, based on significant preliminary data.

CASEIN KINASE 1 INHIBITORS FOR TREATMENT OF AUTISM $349,610

The overall goal of our program is to (1) identify CK1 [Casein Kinase 1] inhibitors suitable for development as therapeutic agents and (2) to use these agents to investigate the suitability of CK1 inhibitors for addressing specific behavioral features of the complex, multi-symptom disorder known as autism.

The CADDRE SEED studies are multiyear but I haven’t listed all the grants. So the amount is much higher than even the substantial sums noted below.

MD CADDRE: STUDY TO EXPLORE EARLY DEVELOPMENT, SEED PHASE II $91,706

MD CADDRE: STUDY TO EXPLORE EARLY DEVELOPMENT, SEED PHASE II $1,600,000

CALIFORNIA CADDRE-SEED PHASE II $1,100,000

NC CADDRE: STUDY TO EXPLORE EARLY DEVELOPMENT (SEED) PHASE II $1,100,000

COLORADO CADDRE STUDY TO EXPLORE EARLY DEVELOPMENT CADDRE_SEED II $1,100,000

PA-CADDRE: STUDY TO EXPLORE EARLY DEVELOPMENT (SEED) PHASE II $1,100,000

SEED will address hypotheses including: ASD phenotypic variation, including the pattern of clustering of core symptoms, timing of onset, cognitive status, and presence of medical and psychiatric co-morbidities; gastrointestinal features; genetic variation and interaction with environmental risk factors (GxE); infection, immune function, and autoimmunity factors; hormonal factors and maternal reproductive characteristics; and sociodemographic and lifestyle factors.

INVESTIGATING THE GUT MICROBIOME FOR NOVEL THERAPIES AND DIAGNOSTICS FOR AUTISM $558,136 (also funded in 2013 for $558,136)

Based on compelling preliminary evidence, this project aims to explore the potential connection between GI barrier defects and altered behavior in preclinical models of autism. Our long-term goal is to explore possible serum biomarkers for ASD diagnosis, and potentially develop a novel probiotic therapy for at least a subset of children with ASD with GI issues.

2013 projects

TREATMENT OF MEDICAL CONDITIONS AMONG INDIVIDUALS WITH AUTISM SPECTRUM DISORDERS $488,568 (also, $339,591 in 2012, $264,726 in 2011, $578,006 in 2010, $535,209 in 2009, and $465,840 in 2008)

The life-long impairments in communication and social function are often complicated by the presence of medical comorbidities, including epilepsy, (and epileptiform discharges), gastrointestinal disturbances and sleep disorders.

REGULATION OF GASTROINTESTINAL NEUROMUSCULAR FUNCTION BY NIBP/NFKB SIGNALING $320,576 (and 2012 $343,747)

The proposed research is relevant to public health because the discovery of a novel function of NIBP/NFkB signaling in enteric neurons and glial cells is ultimately expected to increase the understanding of the pathogenesis of gastrointestinal diseases. It also shed light on the therapeutics for gastrointestinal inflammation and functional disorders.

ARE AUTISM SPECTRUM DISORDERS ASSOCIATED WITH LEAKY-GUT AT AN EARLY CRITIACAL PER $292,221 (and 2012 $302,820, and 2011 $302,820)

This project seeks to answer fundamental questions about the connection between early development of gastrointestinal (GI) problems (constipation, diarrhea, vomiting, etc.) and autism spectrum disorders (ASD)

From 2011

NEUROIMMUNOLOGIC INVESTIGATIONS OF AUTISM SPECTRUM DISORDERS (ASD) $264,726

A number of anecdotal reports have linked autism with gastrointestinal (GI) dysfunction; most notable among these are reports that autism is associated with “leaky gut” syndrome. Microbial translocation (MT) is the process by which bacteria or microbial byproducts permeate through the wall of the GI Tract (or other abnormally porous mucosal barriers) into the bloodstream. The microbial byproducts would then stimulate the immune system, which could have secondary effects on CNS functioning, or the byproducts could have a direct neurotoxic effect. We conducted assays of MT products in children with autism (from blood and CSF), as well as typically developing children (blood samples only).

and

Our ongoing phenotyping studies will be used to identify a cohort of children with autism who also have significant gastrointestinal symptoms in order to address this potentially important subgroup of patients.

A PRIMATE MODEL OF GUT, IMMUNE, AND CNS RESPONSE TO CHILDHOOD VACCINES $156,634


By Matt Carey

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