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From IMFAR to Poland: how a monkey study can totally change

16 Jul

I just blogged about a new paper “proving” once again that vaccines cause autism. This is a paper from Mr. Wakefield’s team. Thanks to a link provided by KWombles of the Countering Age of Autism blog, we can compare the current paper to what the authors claimed two years ago.

Here is the new paper (published in a journal from Poland):
Influence of pediatric vaccines on amygdala growth and opioid ligand binding in rhesus macaque infants: A pilot study

by Hewitson L. Lopresti B, Stott C, Mason N.S., Tomko.

Here is the abstract from IMFAR in 2008:

Pediatric Vaccines Influence Primate Behavior, and Amygdala Growth and Opioid Ligand Binding

L. Hewitson , Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA
B. Lopresti , Radiology, University of Pittsburgh, Pittsburgh, PA
C. Stott , Thoughtful House Center for Children, Austin, TX
J. Tomko , Pittsburgh Development Center, University of Pittsburgh, Pittsburgh, PA
L. Houser , Pittsburgh Development Center, University of Pittsburgh, Pittsburgh, PA
E. Klein , Division of Laboratory Animal Resources, University of Pittsburgh, Pittsburgh, PA
C. Castro , Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA
G. Sackett , Psychology, Washington National Primate Research Center, Seattle, WA
S. Gupta , Medicine, Pathology & Laboratory Medicine, University of California – Irvine, Irvine, CA
D. Atwood , Chemistry, University of Kentucky, Lexington, KY
L. Blue , Chemistry, University of Kentucky, Lexington, KY
E. R. White , Chemistry, University of Kentucky, Lexington, KY
A. Wakefield , Thoughtful House Center for Children, Austin, TX

Background: Macaques are commonly used in pre-clinical vaccine safety testing, but the combined childhood vaccine regimen, rather than individual vaccines, has not been studied. Childhood vaccines are a possible causal factor in autism, and abnormal behaviors and anomalous amygdala growth are potentially inter-related features of this condition.

Objectives: The objective of this study was to compare early infant cognition and behavior with amygdala size and opioid binding in rhesus macaques receiving the recommended childhood vaccines (1994-1999), the majority of which contained the bactericidal preservative ethylmercurithiosalicylic acid (thimerosal).

Methods: Macaques were administered the recommended infant vaccines, adjusted for age and thimerosal dose (exposed; N=13), or saline (unexposed; N=3). Primate development, cognition and social behavior were assessed for both vaccinated and unvaccinated infants using standardized tests developed at the Washington National Primate Research Center. Amygdala growth and binding were measured serially by MRI and by the binding of the non-selective opioid antagonist [11C]diprenorphine, measured by PET, respectively, before (T1) and after (T2) the administration of the measles-mumps-rubella vaccine (MMR).

Results: Compared with unexposed animals, significant neurodevelopmental deficits were evident for exposed animals in survival reflexes, tests of color discrimination and reversal, and learning sets. Differences in behaviors were observed between exposed and unexposed animals and within the exposed group before and after MMR vaccination. Compared with unexposed animals, exposed animals showed attenuation of amygdala growth and differences in the amygdala binding of [11C]diprenorphine. Interaction models identified significant associations between specific aberrant social and non-social behaviors, isotope binding, and vaccine exposure.

Conclusions: This animal model, which examines for the first time, behavioral, functional, and neuromorphometric consequences of the childhood vaccine regimen, mimics certain neurological abnormalities of autism. The findings raise important safety issues while providing a potential model for examining aspects of causation and disease pathogenesis in acquired disorders of behavior and development.

Emphasis added by me.

Why? First, to point out the change in the author list. Of 13 authors on the original abstract, only 4 remain. One can speculate as to why the others were dropped (or pulled their names) from the author list.

A new author was added, N.S. Mason.

How about other changes? Well, 2 years ago they had data on 13 vaccinated monkeys. Now it is only 9. Two years ago they had data on 3 controls. Now it is only 2.

What happened?

OK, while you are working that one out, here’s the big one. Two years ago the vaccinated monkeys “showed attenuation of amygdala growth”

Now, the amygdalas are larger in the vaccinated monkeys. What? Yep. Before they had “attenuated growth” and now they are growing faster than the unvaccinated animals?

The genie is out of the bottle: vaccines cause autism

16 Jul

That’s what you will read if you check out discussions of a new paper, Influence of pediatric vaccines on amygdala growth and opioid ligand binding in rhesus macaque infants: A pilot study, by L. Hewitson, B. Lopresti, C. Stott, N.S. Mason, and J. Tomko.

If you are wondering, yes, that is the same Laura Hewitson of Thoughtful House who first presented the “monkey studies” at IMFAR a few years back. And, yes, that is Carol Stott, formerly of Cambridge. And, yes, this is a part of the Wakefield-team “monkey studies” which has had such a checkered history.

What is this new study about? Well, here’s the abstract:

This longitudinal, case-control pilot study examined amygdala growth in rhesus macaque infants receiving the complete US childhood vaccine schedule (1994-1999). Longitudinal structural and functional neuroimaging was undertaken to examine central effects of the vaccine regimen on the developing brain. Vaccine-exposed and saline-injected control infants underwent MRI and PET imaging at approximately 4 and 6 months of age, representing two specific timeframes within the vaccination schedule. Volumetric analyses showed that exposed animals did not undergo the maturational changes over time in amygdala volume that was observed in unexposed animals. After controlling for left amygdala volume, the binding of the opioid antagonist [11C]diprenorphine (DPN) in exposed animals remained relatively constant over time, compared with unexposed animals, in which a significant decrease in [11C]DPN binding occurred. These results suggest that maturational changes in amygdala volume and the binding capacity of [11C]DPN in the amygdala was significantly altered in infant macaques receiving the vaccine schedule. The macaque infant is a relevant animal model in which to investigate specific environmental exposures and structural/functional neuroimaging during neurodevelopment.

Basically, they took 16 monkeys (rhesus macaque or Macaca mulatta). 12 of them were given vaccines in a schedule intended to mimic the U.S. vaccine schedule of the 1990’s, including thimerosal (which was added). 4 were given saline injections (controls). MRI scans were taken. “Time One (T1) at approximately 4 months of age and Time Two (T2) at approximately 6 months of age.”

From the abstract we see that they found that the “Volumetric analyses showed that exposed animals did not undergo the maturational changes over time in amygdala volume that was observed in unexposed animals.”

In other words, the amygdala volume was different from the controls at T2 for the monkeys given vaccines.

Want some more detail? Well, in regards to the right amygdala:

For the exposed group there was a nonstatistically significant increase in right amygdala volume over time (P=0.16; Table IIa). For the unexposed group there was a significant drop in right amygdala volume over time (P<0.0001; Table IIa).

Read that again. Did they just say that a piece of the brains of the control animals shrank between 4 months of age and 6 months of age?

They did. That’s what their data show. It seemed so odd to me that I double (and triple) checked. I’m sort of visual in how I like to take in data, so here is Figure 4(A) from the paper. This shows the left amygdala size for the two times (T1=4 months of age and T2=6 months of age). I’ve added text to the graph. It is in red so you know what I added. (click to enlarge)

The dotted lines are for the “exposed” animals. I.e. those vaccinated. The solid line is for the “unexposed” animals. See how at T1 they have amygdala sizes that are about the same size? But at T2 (2 months later) the amygdalas of the “unexposed” animals have shrunk, while the amygdalas of the exposed/vaccinated animals grew a little.

I’m not a primate expert, but it bothers me somewhat to hear that a piece of the brain might shrink. I would expect in my own naive way that pieces of the brain would grow as monkeys mature, so I decided to check: has anyone looked at amygdala size in Rhesus Macaques as a function of age? It turns out there is a paper just out in 2009, “Maturation of the Hippocampal Formation and Amygdala in Macaca mulatta: A Volumetric Magnetic Resonance Imaging Study” by Christa Payne et al. from the University of Texas and Emory University. They also were working with small numbers (11 in the male group). Here is Figure 6(A) from that paper:

FIGURE 6. Modeled developmental trajectories for left (thick, thatched lines) and right (thin, solid lines) amygdala volume in males (A) and females (B). Actual volume measurements are represented by filled (left hemisphere) and open (right hemisphere) symbols.

One line is for the left amygdala, and one for the right. Same with the datapoints, the filled are for one side, the hollow for the right. But the basic idea is clear–the amygdala grows with time in monkeys, not shrink. Yes, seems obvious, but I had to check.

How could the Hewitson paper report that the control monkeys have shrinking amygdalas? One possible answer: too few monkeys in the control group. There is a lot of scatter in the amygdala data from the U. Texas paper. If someone has only a couple of datapoints, they might get some strange results.

The Hewitson paper had really small numbers:

“A complete set of MRI data at both T1 and T2 were obtained from 9 exposed and 2 unexposed animals.”

But, wait, remember above? Weren’t there 4 monkeys in the control group and 12 monkeys in the vaccinated group? What happened to the other 2 of the control subjects? There weren’t many to begin with but half of the control group are missing in the data? What’s the reason for that? No, that’s a real question which I can’t find answered in the paper: what happened to the two other controls?

This paper is generating quite a bit of interest in places like the Age of Autism blog. Unfortunately for them, this paper is not the genie getting out of the bottle. Just another low quality paper. Just another 16 monkeys giving their lives for nothing.

The Arc Action alert – HELP PASS THE ABLE ACT IN THIS CONGRESS!

8 Jul

This is an action alert for citizens of the United States. The Arc is gathering support for a bill, the ABLE act, which would allow people to make tax deductible contributions to a savings account which could be used for them to use for “qualified expenses”. Here is the action alert:

HELP PASS THE ABLE ACT IN THIS CONGRESS!

Take Action!
Contact Your Representatives to Convene a Hearing and Vote on the ABLE Act

The Arc and UCP strongly endorse the Achieving a Better Life Experience Act (ABLE) of 2009 (S. 493/H.R. 1205).

Background

The ABLE Act will give individuals with disabilities and their families the ability to save for their child’s future just like every other American family, and help people with disabilities live full, productive lives in their communities. The ABLE Act will allow individuals with disabilities a tax deduction, up to $2,000 per year, for contributions to an “ABLE account.” The account could fund a variety of essential expenses including medical and dental care, education, community based supports, employment training, assistive technology, housing, and transportation.

The legislation continues to have widespread, bipartisan support. However, even though the House bill now has 180 co-sponsors and the Senate bill has 21 cosponsors, the bills have not advanced since they were introduced more than a year ago.

The time to pass this bill is now – Please contact your Representatives today to encourage them to convene a hearing and vote on the ABLE Act! Once the House votes, the Senate should follow. If we don’t get the ABLE act passed by the end of the year, we will have to start all over again next year.

Status of the Bills

House bill (H.R. 1205)
2/26/2009 – Introduced and referred to the Committee on Ways and Means and Committee on Energy and Commerce

Senate bill (S. 493)
2/26/2009 – Introduced and referred to the Committee on Finance

Take Action

Please call your Representative’s home district office during the Independence Day recess (July 2-12). Click on the “Take Action” link and enter your zip code to get the home district office number.

What to say:

* May I please speak to the staff member who covers disability issues?
* I am calling to urge Representative ________________ to pass the Achieving a Better Life Experience Act (ABLE) of 2009 (HR 1205) this year.
* I would like to request that Representative _______________:
* ask Ways and Means Chairman Levin to convene a hearing on the bill
* encourage House leadership to schedule a vote on the bill this Congress.

In case you are wondering what a “qualified expense” would be, below is the text from the House bill on what constitutes a “qualified expense”

`(i) EDUCATION- Expenses for education, including tuition for preschool thru post-secondary education, books, supplies, and educational materials related to such education, tutors, and special education services.

`(ii) HOUSING- Expenses for housing, including rent, mortgage payments, home improvements and modifications, maintenance and repairs, real property taxes, and utility charges.

`(iii) TRANSPORTATION- Expenses for transportation, including the use of mass transit, the purchase or modification of vehicles, and moving expenses.

`(iv) EMPLOYMENT SUPPORT- Expenses related to obtaining and maintaining employment, including job-related training, assistive technology, and personal assistance supports.

`(v) HEALTH, PREVENTION, AND WELLNESS- Expenses for the health and wellness, including premiums for health insurance, medical, vision, and dental expenses, habilitation and rehabilitation services, durable medical equipment, therapy, respite care, long term services and supports, and nutritional management.

`(vi) LIFE NECESSITIES- Expenses for life necessities, including clothing, activities which are religious, cultural, or recreational, supplies and equipment for personal care, community-based supports, communication services and devices, adaptive equipment, assistive technology, personal assistance supports, financial management and administrative services, expenses for oversight, monitoring, or advocacy, funeral and burial expenses.

`(vii) OTHER APPROVED EXPENSES- Any other expenses which are approved by the Secretary under regulations and consistent with the purposes of this section.

`(viii) ASSISTIVE TECHNOLOGY AND PERSONAL SUPPORT SERVICES- Expenses for assistive technology and personal support with respect to any item described in clauses (i) through (vii).

Autism Science Foundation’s interviews with IMFAR researchers: David Mandell

8 Jul

INSAR, the International Society for Autism Research hosts the the largest autism research conference: IMFAR, the International Meeting for Autism Research. 1700 people attended, largely from the research community. The program book has nearly 50 pages of researchers. It’s big.

This year’s conference was held in Philadelphia in the United States. The people heading the organization of this year’s conference were Program Chairs David Mandell and Manny DiCicco-Bloom and Meeting Chairs, Jennifer Pinto-Martin and Susan Levy.

The Autism Science Foundation has a strong presence at the conference. They were sponsors of the conference and they held luncheons for the graduates students which the ASF is supporting. In addition, the ASF sponsored a number of stakeholders to attend the conference. One of these stakeholders, D’oC, blogged about the conference here on LeftBrainRightBrain.

The Autism Science Foundation took the opportunity to interview a number of the researchers at IMFAR. Those interviews are now up on YouTube. I thought I would blog some of these interviews. Given that Prof. Mandell was one of the Program Chairs and gave an overview of the conference, I decided to start with his interview:

Prof. Mandell discusses the new studies that are coming out. Amongst the subjects: how there is a shift to groups crossing regular boundaries of genetics, biology and behavior are related; how treatment research is moving beyond the randomized control trial methods targeting all autistic types to targeting subgroups; and how there is much research on young autistics in school settings. Groups are moving beyond the early genetics studies which merely identify “hot spots” in the genes to trying understand what the genes do. He gives the example where groups of autistics with the same genetic differences give similar results in how their brains work, as detected through functional MRI.

FDA warns maker of OSR #1, dietary supplement for autistic children is a “toxic” “drug”

24 Jun

“OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious potential side effects, FDA warns”. So starts a recent article in the Chicago Tribune, FDA warns maker of product used as alternative autism treatment.

The article is by Trine Tsuderos who has previously reported on the the industrial chelator turned dietary supplement in Industrial chemical OSR#1 used as autism treatment.

According to the website for the product, “OSR#1® is a toxicity free, lipid soluble antioxidant dietary supplement that helps maintain a healthy glutathione level”. According to the story in the Tribune, the claim of “toxicity free” may not be accurate. According to the Tribune story:

The FDA letter lists side effects recorded during Haley’s animal studies: “soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas” and a rapid increase in normal cells contained in the lymph nodes.

Here is that section of the letter in full:

However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects.

Mr. Haley is not unused to criticism of his so-called supplement. After the previous story by the Tribune, Boyd Haley tweeted multiple times “Contrary to the Chicago Tribune implication, OSR1 has undergone extensive safety testing. The truth is at http://www.OSR1.com. Please retweet!” When I checked the OSR website, I could find no mention of these test results–the results Boyd Haley himself submitted to the FDA. Is that the “truth”?

The Tribune quotes Ellen Silbergeld, a John’s Hopkins researcher:

“It would be hard to imagine anything worse,” said Ellen Silbergeld, an expert in environmental health who is studying mercury and autism at Johns Hopkins University’s Bloomberg School of Public Health. “An industrial chemical known to be toxic — his own incomplete testing indicates it is toxic. It has no record of any therapeutic aspect of it, and it is being marketed for use in children.”

and

Silbergeld said the product represents a clear example of endangerment of public health and that the FDA should stop CTI Science from selling it immediately. She drew a comparison to a city’s drinking water system: If contamination is found, she said, “they turn off the pumps.”

“They don’t have to engage in a long discussion with you,” Silbergeld said. “It would be hard to imagine a more clear example of immediate endangerment of public health. Turn off the pump.”

Kim Stagliano, Managing Editor of the Age of Autism blog, has touted OSR #1 in the past. She was quoted in the Tribune article:

In an e-mail, Stagliano wrote that she continues to support Haley, a regular speaker at autism recovery conferences. “Having met Dr. Haley at conferences, including Autism One in Chicago last month, I continue to trust his science,” she wrote on Wednesday. “I’m sure CTI Science will address the letter appropriately.”

There doesn’t seem to be any mention of the fact that Prof. Haley appears to have withheld safety information from the autism community. She “trusts his science”, yet makes no mention of the fact that it is precisely “his science” that indicates that this chemical is toxic.

The warning letter from the FDA is quoted below:

WARNING LETTER CIN-10-107927-14

Boyd E. Haley, President
CTI Science, Inc.
2430 Palumbo Drive, Suite 140
Lexington, Kentucky 40509

Dear Mr. Haley:

This letter concerns your firm’s marketing of the product OSR#1 on your website, http://www.ctiscience.com.This product is marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.

Your firm markets OSR#l as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the Act, 21 U.S.C. § 321(ff). To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more … dietary ingredients” as defined in section 201(ff)(1) of the Act, 21 U.S.C.§ 321(ff)(1). Section 201 (ff)(1) of the Act defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. The only substance listed as a dietary ingredient on the labeling of OSR#1 is N1,N3-bis(2-mercaptoethyl)isophthalamide. N1,N3-bis(2mercaptoethyl) isophthalamide is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, N1,N3-bis(2-mercaptoethyl)isophthalamide is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because OSR#1 does not bear or contain a dietary ingredient as defined in section 201(ff)(1) of the Act, this product does not qualify as a dietary supplement under section 201(ff) of the Act.
Your website includes claims such as the following:

• “OSR#1® … helps maintain a healthy glutathione level.”

• “Both OSR#1® and glutathione scavenge free radicals, allowing the body to maintain its own natural detoxifying capacity.”

The claims listed above make clear that OSR#1 is intended to affect the structure or any function of the body of man or other animals. Accordingly, OSR#l is a drug under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1). Disclaimers on your website, such as “OSR#l® is not a drug and no claim is made by CTI Science that OSR#1® can diagnose, treat or cure any illness or disease,” do not alter the fact that the above claims cause your product to be a drug.

Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of OSR#1 without an approved application violates these provisions of the Act.

Your website includes the following statements: “Thyroid conditions, hypertension, and diabetes: Because thyroid conditions, hypertension, and diabetes have been associated with low glutathione levels …” and “OSR#1® … helps maintain a healthy glutathione level.” These statements suggest that OSR#1 is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Because thyroid conditions, hypertension, and diabetes are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, OSR#1’s labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). OSR#1 is not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that its labeling bear adequate directions for use because OSR#1 lacks an approved application.

Additionally, under section 502(a) of the Act, 21 U.S.C. § 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act, 21 U.S.C. § 321(n), provides that, “in determining whether a drug’s labeling or advertising is misleading, there shall be taken into account (among other things) not only representations made or suggested … but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations ….” Your website states that” [s]ome reports of temporary diarrhea, constipation, minor headaches have been reported but these are rare and the actual causes are unknown,” as well as “OSR#1 is without detectable toxicity” and “OSR#1® … has not exhibited any detectable toxic effects even at exceptionally high exposure levels.” However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects. Therefore, these statements render your product’s labeling false or misleading. As such, OSR#1 is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).

Because the labeling does not warn consumers of the above-mentioned potential for side effects, the product OSR#1 is also misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), in that the labeling lacks adequate warnings for the protection of users. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act, 21 U.S.C. §§ 331(a).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. In this regard, please note that products are misbranded under section 502(j) of the Act, 21 U.S.C. § 352(j) if they are dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the products’ labeling.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action, without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237, Attention: Stephen J. Rabe, Compliance Officer.

A description of the new drug approval process can be found on FDA’s internet website at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

Sincerely,

/s/

Teresa C. Thompson
Cincinnati District

This story is being discussed at Countering Age of Autism as FDA Steps Up to the Plate on OSR#1.

Addenda:

CTI solicited charitable donations to help get started through the CTI Science Foundation, which includes “Katie Wright, Julie Obradovic, Dr. Jerry Kartzinel, Dr. Julie Buckley, Scott Barli and Kathryn Wachsman”

Kim Stagliano discussed previous Tribune stories and the question of toxicity of OSR in another piece

I was contacted by Ms. Tsouderos for an interview about her forthcoming article on a supplement called OSR from CTI Science. CTI’s Science’s FAQ page says OSR is less toxic than aspirin and Vitamin E. If the Tribune has its own toxicity testing, I’m sure readers will be interested in seeing the data. In light of the skewing of parental interviews in the past, I chose not to respond to her requests for an interview. Others, like the founder of CTI Science, Dr. Boyd Haley, graciously allowed the interview process to continue until such time as it became clear that the writer’s goal precluded gaining meaningful insight.

It appears to this reader that perhaps it was CTI Science and Boyd Haley who may have kept the readers from obtaining “meaningful insight”. If a reporter asks about toxicity and you have data showing hair loss, discolorations, and “abnormalities of the pancreas, and lymphoid hyperplasia” shouldn’t you produce that data?

Ari Ne’eman’s previous work with the National Council on Disability

23 Jun

Ari Ne’eman has been appointed as a full member of the National Council on Disability. With that announcement came some criticism of the appointment, including comments on this blog indicating that Mr. Ne’eman’s doesn’t have the experience necessary to serve.

Given that, I thought I would share a couple of things I found on the NCD’s website. I was searching for an announcement of the Senate confirmation of his appointment. What I found was a surprise to me: Mr. Ne’eman has been working with the NCD since 2007 in the Youth Advisory Council.

This recent announcement acknowledges some of Mr. Ne’eman’s work bringing together a coalition of disability organizations:

Advisory Committee Member Achievement

NCD’s Youth Advisory Committee policy workgroup leader, Ari Ne’eman (NJ), received recent accolades for his successful leadership of advocacy work that mobilized the broader disability community on an international scale. In his thank-you note to the 22 disability rights organizations and countless individuals whose combined efforts resulted in withdrawal of an ad campaign depicting people with disabilities in a negative way, Ari noted “this is a victory for inclusion, for respect and for the strength and unity of people with disabilities across the world” (www.autisticadvocacy.org).

Mr. Ne’eman was a leader of the NCD’s Youth Advisory Council policy workgroup starting in 2007.

With its charter renewed until October 2009, NCD’s YAC met on November 15, 2007, after welcoming seven new members, new officers (Amy Doherty-chair; Carly Fahey -vice chair; Matt Cavedon -Secretary), procedural workgroup leaders (Ari Ne’eman-Policy; Daman Wandke-Outreach and Networking), and mentors (Stephanie Orlando and Miranda Pelikan). The committee reported topics and issues of interest such as aversives and restraints, healthcare accessibility, expanding ways of gathering youth and young adult perspectives, and planning to make a new proposal to NCD about disability history awareness-raising. We welcome aboard in FY2008 Jesutine Breidenbach (MN), Brett Cunningham (OK), Paul Fogle (PA), Eddie Rea (CA), Nicole Schneider (FL), Nathan Turner (OH), and Bryan Ward (DE). YAC meets again on January 17, 2008, at 4:00 p.m. EST. Please e-mail your questions about YAC to Dr. Gerrie Hawkins

Maybe it is time to give Mr. Ne’eman credit for years of service and welcome him to the NCD?

ASAN Update on NCD Confirmation

23 Jun

I received this email update this morning. I wrote a brief piece about the appointment yesterday.

This is another ASAN Update for bloggers in the Autistic and disability rights communities. The Autistic Self Advocacy Network would like to thank President Obama and the U.S. Senate for the nomination and confirmation of ASAN President Ari Ne’eman to serve as a member of the National Council on Disability (NCD). He will be the first Autistic person to serve as a member of NCD. An independent federal agency, NCD makes recommendations to the President and Congress on issues of importance to Americans with disabilities. To learn more about NCD, go to http://www.ncd.gov

An article about the confirmation can be found on Disability Scoop:

http://www.disabilityscoop.com/2010/06/22/neeman-confirmation/9133/

As always, we encourage you to contact us with your comments, and please let us know if you would prefer to receive these announcements at a different address or to be removed from the list.

Best regards,

Meg Evans, Director of Community Liaison
Autistic Self Advocacy Network

Ari Ne’eman appointed to National Council on Disability

22 Jun

Ari Ne’eman has been appointed to the National Council on Disability. This will make him the first autistic member of the Council. Mr. Ne’eman is the Founding President of the Autistic Self Advocacy Network (ASAN).

I have been checking the Senate Calendar periodically to monitor the status of his nomination, which was on hold. When I found his name was no longer on the calendar, I did a quick google search and round Senate Confirms Controversial Autism Self-Advocate To National Disability Council. Disability Scoop notes that Mr. Ne’eman’s appointment was unanimously approved by the Senate.

Earlier this year, Mr. Ne’eman was appointed to the Interagency Autism Coordinating Committee.

In support of David Gorski

22 Jun

To whomever it may concern,

You have probably recently had to deal with a handful of vitriolic comments regarding the online activities of David Gorski. You will probably have been pointed to an online essay by a young man called Jake Crosby in which he makes a series of claims regarding David Gorski and his ‘ties’ to vaccines/vaccine manufacturers and other entities.

I urge you to read these comments and this essay very, very carefully. Once you do I am in no doubt that you will see what the rest of us clearly can – that this work is the work of a highly impassioned young man who believes that he is right. He believes that vaccines cause autism to state it clearly and he believes that by having some kind of – any kind of – tie to a pharma organisation means that David Gorski is ‘tainted’. But what really annoys master Crosby is the fact that David Gorski regularly blogs in support of the science that clearly shows vaccines do not cause autism and blogs against the pseudo science that attempts – and continually fails- to draw any kind of a link between vaccines and autism.

So this, in master Crosby’s eyes, is David Gorski’s crime – supporting the science and decrying the bad science.

In order to cast some kind of suspicion over David Gorski’s support of science, Crosby has ‘discovered’ that Gorski is conducting research into ways to reuse some types of drugs – drugs developed by Sanofi-Aventis who of course also manufacture some vaccines. And that, despite another few hundred words from master Crosby is that. That is the sum total of his ‘investigation’ and the sum total of David Gorski’s crime.

The only real eye-opener on this issue is that Jake Crosby managed to wring out as many words as he did on this total non-issue.

I have known David Gorski online for a number of years. We often quote one another and link to one anothers posts. We regularly email each other and I was disappointed to be unable to meet him for drinks on a visit to the UK he took a few years ago. In my experience of the man he is rigorous, almost fanatical with regards to accuracy and brings these traits to many areas of blogging and online writing including the investigation of bad science.

Why does it matter to me? It matters because I have an autistic child and an autistic step child. When my autistic child was first diagnosed I firmly believed that her autism was caused by vaccines. It was only through being exposed to writings of David Gorski and his peers on the science of autism and the bad science of the autism/vaccine connection that I eventually saw for myself what was obvious: vaccines don’t cause autism and never did.

Scientists such as David Gorski often blog and write online anonymously. They do this because to be exposed to the sort of people Jake Crosby colludes with often means being exposed to harassment and threats. David Gorski is now finding that out for himself. I hope that you as his peers, colleagues and employers will see how vital it is that David Gorski continues blogging and that you will support him in both his work and his blogging.

Age of Autism Abandon Pretence part II

16 Jun

A while back Kev wrote a piece, Age of Autism Abandon Pretence, pointing out how they are drifting away from any real connection to the autism communities in favor of attacking the vaccine program. It wasn’t shocking then to anyone who reads the Age of Autism blog. It isn’t shocking now.

In her piece, Dr. Mayer Eisenstein’s New Book Merits Close Attention, Anne Dachel wrote:

These are people I’m in touch with everyday and who’ve written on autism and on vaccines. Some I’ve had on my threads for years. And as someone who’s been active in the national autism community for a long time, I’ve seen tremendous changes. More and more people are speaking out. We are now an organized and united group, thanks mainly to the power of the Internet. Our message has severely eroded confidence in the cornerstone of health care: THE CHILDHOOD VACCINE PROGRAM. (And keep in mind that there are many more experts writing about this, people I’ve never been in contact with, all challenging the unwavering safety claims of our health officials.)

Bold added by me.

Previous comments on the Age of Autism blog include:

With less than a half-dozen full-time activists, annual budgets of six figures or less, and umpteen thousand courageous, undaunted, and selfless volunteer parents, our community, held together with duct tape and bailing wire, is in the early to middle stages of bringing the U.S. vaccine program to its knees.

True vaccine safety advocates don’t resort to attempts to bring “… the vaccine program to its knees” or eroding “…the cornerstone of health care”.

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