IACC Meeting Friday to Finalize Federal Autism Research Plan
Update: Dear Members of the IACC:
Attached is a letter (HERE) from the autism advocacy organizations listed below regarding the draft strategic plan for autism research, respectfully submitted for your attention and review at your meeting tomorrow, December 12.
Regards,
Sallie Bernard, on behalf of -
Autism Society of America
Autism Speaks
National Autism Association
SafeMinds
Talk About Curing Autism Now (TACA)
Unlocking Autism
By Jim Moody, Esq.
The federal Interagency Autism Coordinating Committee (IACC) will meet this Friday, 9-4 at the Neurosciences Center (home of NIMH) in Rockville, Maryland. This is a continuation of the November 21 meeting because there was not enough time to go through the substantial edits and additions (most of which were submitted by IACC member Lyn Redwood, Safeminds, and broadly supported by the community) required to finalize the Strategic Plan for autism research required by the Combating Autism Act.
This is a crucial meeting as many of the topics to be discussed will determine whether the research spending will actually matter in in finding the cause and effective treatments for autism.
Registration is required for in-person attendance REGISTER HERE or to participate in the webinar CLICK HERE. For the second time, this meeting will be broadcast on a conference call: 888-455-2920, access code 3857872. General information about IACC, including charter, members, and documents can be found on its home page HERE.
The draft strategic plan HERE , background documents relating to development of the plan HERE, and the 148 public comments HERE received in September can be reviewed online.
Most of the revisions and additions to be discussed will make the plan an aggressive response to the national health emergency presented by the autism epidemic. The present draft basically continues business as usual and failed to even propose spending the minimum authorized by Congress in the CAA, about $640 million over the next three years. Ten leading advocacy and research funding organizations (supported by many others) filed a letter (HERE) with IACC on November 12 calling for major improvements in the plan, including recognition of the research enterprise as an urgent response to a national health emergency, full funding as authorized by CAA, increased funding for environment and treatment research, establishment of an Autism Advisory Board, and measures to increase community decision making in research decisions, transparency, and accountability.
Necessary improvements in the Plan to be discussed during the meeting include the following:
– Research on the autism-vaccine link. This is where the discussion left off last meeting. Congress and both Presidential candidates have called for this as have numerous public comments and letters from the community. For example, an August 14 letter to IACC Chairman Insel from Autism Speaks explained:
Second, as we expressed in our letter of July 9, 2008, there are still several key issues advocated by the IACC, and included in the CAA, that are not represented in the current draft ofthe SP. Specifically, the CAA and several IACC members urged a stronger emphasis on environmental factors, gene-environment interaction, and prevention of autism. Of particular concern is that the SP does not explicitly mention that the investigation of the potential role of vaccines in the etiology of autism is needed.
As you are aware, many stakeholders in the autism community remain concerned about the potential role of vaccines in the etiology of autism. While the weight of the evidence does not currently support this hypothesis, several recent developments (e.g. Hannah Poling concession, Dr. Bernadine Healy statements) suggest that more research is warranted. In addition, the legislative history of the CAA very clearly states that more emphasis on exploring the role of environmental factors, including vaccines, is needed. We feel that scientific inquiry into the questions that many stakeholders have regarding the potential role of vaccines in the etiology of autism is the best way to ensure that confidence and trust in our vaccine program is restored and maintained.
– Appointment of an Autism Advisory Board broadly representing the community (scientists, clinicians, advocates) that would, for example, oversee implementation of the Plan and its annual updates.
– Recognition of autism as a national health emergency driven by a real rise in cases and calling for a crisis-level response. This is an important point because President-elect Obama has stated his belief that the rapid rise in autism cases is real and not just better diagnosing and has committed to appointment of a Special Assistant to the President for Autism Coordination.
– Reprioritize finding toward a greater emphasis on environmental causes (including vaccines) and treatment.
– Recognition of autism as a whole body disorder.
– Development of an innovative approach to environment and gene-environment research.
– Significant community involvement in decisions relating to research, modeled on the successful model employed by the Department of Defense autism research program.
– Recognition that treatment and recovery of function can be accomplished and should be a focal point for intensive research.
– Treating the CAA budget authorizations as a floor and developing a significant increase in the research budget driven by a cost of disease analysis and the opportunity to perform quality research.
– Funding process re-engineering (such as special emphasis panels for each of the 35
major projects, and “innovation” fund, and rolling deadlines) to ensure accountability.
– Immediate appointment of a broadly representative work group to ensure effective implantation of the plan.
The importance of this Plan cannot be over-emphasized. It (along with annual updates) will direct all federal autism research. Attendees and listeners should pay particular attention to how the six community members advocate and vote for the necessary improvements in the Plan.
Jim Moody is a Board Member of SafeMinds and the National Autism Association and chairs the government affairs committee of SafeMinds. He is the founder of Citizens for a Competitive Economy. Jim is a practicing attorney and is active in cause-related advocacy for children with autism.
Lyn Redwood is an amazing advocate, she stayed calm and professional during this meeting when I would have been on the floor laughing or crying. I only listened to part of this meeting and I am struck at how stupid we've become. Are we really going to spend millions of dollars to determine which gene interacts with which toxic chemical. Wouldn't it be cheaper to get rid of all the toxic chemicals. Are we blaming the genes and not the chemicals? When someone said "we don't want to treat autism like an illness" I was shocked at how ignorant this committee is. Someone didn't even know what Kanner autism was. It's clear to me how the poisoning of babies got cleared, there is nothing but morons in our government. Quite scary.
Posted by: Maggie | December 14, 2008 at 07:48 AM
White paper
Chemotherapy and other Hazardous Drugs
Are causing childhood diseases such as Autism
First, we need to realize that the words medicine, pharmaceuticals, drugs and chemicals are synonymous. Some drugs, such as chemotherapy drugs, are the most toxic man made chemicals in existence, thousands more times toxic than PCB’s or Mercury.
Second, it is important to understand that the EPA has not regulated a pharmaceutical in over 25 years and the regulations on hazardous waste are over 32 years old. In those 32 years, millions of chemicals that have been created.
Third, a fact often overlooked is, the human body absorbs only a small percentage (often less than 10%) of the administered drugs (chemicals). The remaining un-metabolized drug (up to 90%) is excreted via the urine, feces, sweat, and breath.
These chemicals are so toxic that the drug companies subcontract the manufacture to reduce liability for exposure to employees. Active Pharmaceutical Ingredients or API’s are typically manufactured in small labs to control exposure to workers. The medicine is then packaged in sealed glass vials and shipped to hospital pharmacies. OSHA has written extensive regulations on how to handle Hazardous Drugs (HD) and they have determined that there is no safe exposure level for these chemicals. Most of the drugs are known to cause Cancer and are also known Teratogens. Teratogens **(a drug or other substance capable of interfering with the development of a fetus, causing birth defects)**
At the hospital, the pharmacist is required to prepare these drugs in a level 3 biological safety cabinet the same level of protection used to handle ANTHRAX. The pharmacist then takes the prepared drugs to the nurses to administer to the patient and tosses the empty vial, syringe and needle in the sharps container, or a residual Chemo container.
OSHA states in order to administer a dose of these drugs a nurse must wear special gloves, a protective gown and a splash shield to reduce risk of potential exposure (remember there is no safe exposure level). After the nurse administers the drug to the patient, the used tubing, IV bag and gloves are disposed of as a residual Chemo. If the patient urinates or vomits OSHA guidelines suggest the attending nurse first darn protective clothing prior to cleaning up the body fluids to protect him or herself from exposure to the drug that passed through the body. The sheets must also be disposed of as contaminated material. A larger problem arises when the patient goes home and uses the bathroom in their home, the chemicals pass thru the body unchanged and in some cases wipe out the bacteria in the septic system. For patients on septic systems chances are good that you are on a well, so your family will be drinking your chemo drugs. If you are on public sewer the medicine will pass thru the treatment plant unaltered or be concentrated in the sludge. The sludge will be dried and used to make fertilizer (yummy).
One of the problems is that the dose of some of these drugs is in the part per trillion range and are in water solutions. That means that even the best incinerator can only guarantee destruction in the part per thousand range. Have you ever looked at a smoke stack on an incinerator the white smoke is steam mixed with particles of chemicals.
The way these chemicals work is by breaking into the blood cell and breaking off the chromosomes in the DNA (high school biology). When the cell splits it is a different cell that has been mutated, the majority of chemotherapy drugs are mutanagenic. That means the drugs work on a molecular level and are not be dose dependent, that is why OSHA says there is no safe exposure to these drugs, and OSHA should know, as they have been researching this for 20 years.
Some of the more disturbing studies involve nurses who work on the oncology floor at hospitals. [Spontaneous abortions and malformations in the offspring of nurses exposed to anesthetic gases, cyctostatic drugs, and other potential hazards in hospitals, based on registered information of outcome. J.Epidem Comm. Health 39:141-7] These nurses had a miscarriage rates or “spontaneous abortion rates” of 4.7, almost 5 times the national average. That study was done in 1985, 23 years ago where is the outrage?
Exposure to Chemo can be shown by testing the urine of the nurses for damage to the DNA of the cell. The first studies of Chromosomal aberrations, or damage to the chromosomes were done in 1979 and showed an increased as the work week went on.
A study was commissioned in 2002 to find out if nurses on oncology floors had a higher rate of cancer; this study was canceled and canceled again in 2005.
Cancer will be the leading cause of death in 2010 and will affect 1 in 3 women and 1 in 2 men in there lifetime, that is staggering.
What is the solution? Ban chemotherapy? No. To start, we need to contain the waste and manage it properly. A few easy steps need to be taken and they are as follows;
• Collect all residual vials, syringes, tubes and IV bags and send for treatment and disposal in a secure landfill. Incineration will just put it in the air.
• Collect all gloves, smocks and any other material that has come into contact with the chemotherapy drugs and send for treatment and landfill.
• Collect the excrement from the patients for the first 48 hours following chemotherapy treatment, solidify and immobilize for landfill
• Collect any wastewater the patient generates from showering for 48 hrs and solidify for landfill
• Isolate patients for 3 days, using standard “infection control” precautions, as hospitals now do for patients with antibiotic resistant drug infections. (MRSA, for example)
This may seem a little extreme, but we need to recognize what we are handling and putting into the environment. Going Green may mean more than driving a hybrid car.
Jim Mullowney
B.S. Chemistry U-Mass 87
617-755-0883
[email protected]
September 15th 2008
Posted by: Jim Mullowney | December 13, 2008 at 12:46 PM
Thank you Kelli Ann Davis for all the updates. And Thank You Lyn Redwood for all your hard work!
I got a ideal from a post at the http://www.ageofautism.com/2008/12/on-media-autism.html?cid=142602004#comments
Julie Swenson: post, got me thinking.
"Perhaps we could launch a campaign using teachers with decades of first-hand knowledge that today's ASD numbers are far, far greater than they were years ago would be useful? It might help dispel the 'better diagnosis' myth. Just a thought".
Here is a ideal, the autism community could develop a comprehensive study that all (or most all) would respect, of vaccinated & non-vaccinated children, overall health, including autism, etc, etc.
The question is, how many would we need to study and how much would it cost per child? Would 20,000 children, be enough? Half vaccinated & half non-vaccinated, say it cost $1000.00 per child, could we if we all, worked together get 20,000 people to give $1000.00 for this study. We could use older teachers talking about 30, 20, 10, years ago & now autism rates in schools, a TV campaign asking people or a group of people to sponsor a child, or maybe 10 children. We could say, we have been trying to get the Government to do this for years but due to lobbyist we could not get the Government to do the right thing.
Considering what all Lyn Redwood has been going through at this IACC Meeting it looks like this maybe the only way to get this study done.
Posted by: Jeff Ransom | December 13, 2008 at 12:02 AM
During public comment, Karen Driscoll spoke as a military wife and advocate. She pointed out via "FOIA documents the prevalence rate for military children is 1 in 88."
Houston, we have a problem!!!
Tom Insel had this to say about an hour earlier regarding the 1/150 prevalence rate:
“Data pretty much done…The peer review may be wrong but it's still accepted”
Posted by: Kelli Ann Davis -- Huston, We Have A Problem | December 12, 2008 at 04:00 PM
Discussions centering on autism as epidemic due to prevalence increases is a disservice to “adults that have it but aren’t diagnosed with it.” Ellen
Huh? How can you say these adults *have it* if they aren't diagnosed with it???
Posted by: Kelli Ann Davis on Stupidest Comment of the Day | December 12, 2008 at 03:41 PM
Discussions on Biomarkers:
“At least 3 by 2011” language is adopted into SP.
Alison Singer: Stresses that is says, “at *least* three" and brings up the fact that "the numbers will be determined by budget” and wants the Committee to remember that when they discuss the budget later on.
Tom Insel: Immediately chimes in by stating, “This budget is not even close to what we need to do this.”
Translation: Don’t-Hold-Your-Breath-For-More-Than-Three-Cuz-We’ll-Be-Lucky-If-We-Even-Get-Three-In-The-First-Place.
Posted by: Kelli Ann Davis -- At This Rate I'll Be Dead And Buried | December 12, 2008 at 12:37 PM
CDC: "On some of these issues I do have concerns that we don’t have the expertise on this committee to answer these questions. We should put it to another committee. Biomedical expertise is not on this committee either."
Bottom Line: CDC is "uncomfortable to study vaccine safety" under current system in place.
LYN: "It's a high priority. We do have capabilities to do primate studies on the whole CCD schedule. It's difficult hearing 'we can’t do this'" and then she states that a VSD study already done suggests "several recommendations to move forward; feasibility already addressed in this report."
Bottom Line: Golly gee Gomer. No "expertise" on this Committee yet Lyn Redwood is telling CDC that the recommendations to move forward on this type of study is *ALREADY OUT THERE*.
Posted by: Kelli Ann Davis -- Lyn Challenges CDC on VAX/UNVAX | December 12, 2008 at 12:10 PM
Tom Insel:
Study says 80% of post vaccine swelling of brain after DTaP due to a specific gene mutation.
Posted by: Kelli Ann Davis on Tom Insel | December 12, 2008 at 11:56 AM
CDC: 90% vaccinated....small number to study....need unvaccinated...5,000 to 10,000 too small of a cohort group...this has hampered vaccine studies all along....demands very large population....all studies done suffer form small numbers.
Concerned about whether they have the expertise...how much it costs...discussions with AAP "What approach can we use that hasn't been done to date?"
Bottom line: NOT ready to *initiate* but ready to *design* the study....we need to decide whether we have the resources.
Posted by: Kelli Ann Davis CDC ON VAX/UNVAX STUDY -- CONCERNED ABOUT EXPERTISE AND COSTS | December 12, 2008 at 11:49 AM
CDC is asking for more money for gene/environment interaction studies cuz there's a discussion about raising the number of studies from 5 to 10.
Hey, CDC: There’s a *REASON* the CAA didn’t dole out a ton of money to you – that was NOT by accident.
Posted by: Kelli Ann Davis HEY CDC -- NO MORE MONEY | December 12, 2008 at 11:24 AM
for that Gold Star!!
I know it's tough (we're getting beat up) but there are still a few "tricks" up our sleeves.
Posted by: Kelli Ann Davis Hang With Me Tanner's Dad | December 12, 2008 at 11:16 AM
Good News -- Bad News
"Monitor the scientific literature regarding possible associations of vaccines and other environmental factors (e.g. ultrasound, pesticides, pollutants) with ASD to identify emerging opportunities for research and indicated studies." 12 votes
Alternative:
Focus scientific investigations on role of vaccines in ASD
OR
Make no mention of vaccine research – science does not support.
NO VOTE on the alternatives because majority vote already on ORIGINAL language.
At least the alternative saying *no vaccine research* was killed.
Oh and now, they're at *least* counting the votes -- outloud -- so we have a clue on the outcome.
Gee, I think that's a basic FACA rule -- good think they finally got it down on the last meeting before incorporating the Strategic Plan (SP), no?
Posted by: Kelli Ann Davis | December 12, 2008 at 11:12 AM
Interagency Autism Coordinating Committee
Interagency Autism Complacency Committee
Interagency Autism Composting Committee
Interagency Autism Conundrum Committee
I am sorry I will not last through the whole meeting today. Lyn is just out voted.
Posted by: Tanners Dad | December 12, 2008 at 10:17 AM