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Boyd Haley comments on the FDA warning letter.

30 Jun

Below is a communication attributed to Boyd Haley. He is the president of CTI Science which is marketing “OSR#1”. OSR#1 is a chemical which was originally invented to chelate wastewater from mining operations. Mr. Haley’s company markets it, not for its chelating properties, but as a source of “oxidative stress relief” (OSR). The FDA has recently sent him a warning letter noting that it is likely that OSR is (a) not a supplement and (b) is a drug.

Jaquelyn: Below is my response to the Chicago Trib article. We have also had our legal help contact the FDA and explain our position. They have extended our time to respond in detail until the end of July and implied that they are willing to work with us on this issue.

The article by the Chicago Tribune and the warning letter from the FDA are fueled by a misconception. The chemical name of OSR#1 is N1N3-bis-(2-mercaptoethyl)isophthalamide which makes it sound to many like an exceptionally complex chemical with no natural components. However, looking at the structure of OSR it is easily seen that it contains a benzoate group (found in cranberries) and two cystamines (a metabolite of cysteine and found in all mammalian cells and on the terminal end of Coenzyme-A). The coupling of cystamine to benzoate is through the same type of amide linkage found in connecting amino acids to produce protein.

The FDA description of a dietary supplement as extracted from their letter is: To be a dietary supplement, a product must, among other things, “bear [ ] or contain [ ] one or more…dietary ingredients” as defined in section 20 I (11)( I) of the Act, 21 U.S.c.§ 321 (ff)( I). Section 20 1(11)( 1) or 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. Using this description it is obvious to a biochemist that OSR#1 bears and contains two dietary ingredients. It appears as if the chemical name (which we had to place on the label) has confused this issue. Hopefully this can be cleared up.

Regarding the toxic effects the FDA and Chicago Tribune comment on. The diarrhea and pancreas problems reported occurred during an UP/DOWN study to determine the LD-50 of OSR, that is “what amount of OSR would cause 50% of the test animals to die?”. Problem was that during the experimentation, even to reach the 5 grams/kg body weight they finally achieved, the researchers had to give the OSR (dissolved in corn oil) at three different times during the day. Even then the test animals showed no weight loss or ataxia or other signs of toxicity except diarrhea and a pancreas abnormality. They were giving these animals massive doses (e.g. 1,000 to 5,000 times the recommended level for humans) trying to kill them. Almost all supplemental materials would cause some problems at these levels and the LD-50 of OSR (decided to be greater than 5 g/kg) is considerably above the LD-50 of some commonly used supplemental compounds used today.
For example, a 220 lb (100 kg) person would have to take 500 grams/day or 5,000 OSR capsules/day to reach the 5 g/kg body weight level. We recommend 1 capsule or 0.1 gram/day level usage (i.e. 100mg) which is 5,000 times below the 5 gram/kg level in this example. When the long term study was done and the maximum amount tested was 1 gram/kg body weight the diarrhea and pancreas issues disappeared. At 1 gram/kg a 220 lb person would have to take 1,000 capsules/day to reach a level where no toxic effects were noted. In it’s initial letter responding to our Premarket Notification the FDA did not mention these test animal toxicity studies as being of any concern. I don’t know what changed their minds to make them go back and review this, but their review and the comments in this recent letter do not reflect a concern I would agree with.

Also, OSR has never been promoted by CTI Science as a treatment for any specific disease and FDA disclaimers are on every package.

I would point out that the FDA warning letter was not based on any reported adverse effect. Since CTI Science has been selling OSR (about 2 years) we have not had one severe adverse effect reported to our FDA based adverse effect reporting system. We have had many very positive responses from physicians and parents regarding the use of OSR. However, the fact is that I have to obey the FDA directive or risk damage to my co-workers as well as myself, and/or spend the funds to legally counter the FDA decision. What to do is under study. But from the above, you can see why I strongly believe that OSR is a dietary supplement by FDA criteria and that it is without detectable toxicity at the levels recommended.

Boyd E. Haley, PhD
Professor Emeritus

University of Kentucky
Chemistry Department

Boyd E. Haley, PhD
President

CTI Science, Inc.

It appears to this reader that Mr. Haley’s defense hinges on the part of the law which defines a supplement as “…or combination of any dietary ingredient from the preceding categories”. In particular, he appears to be claiming that his compound, which is apparently in the same form in a food, is a “combination” of other ingredients.

Mr. Haley can point to the various constituents of the molecule he is producing and marketing and state, “that part is from a food”. But, is that a valid argument? Does the law really intend that “combination” means “mixture” as in, say, a multivitamin?

Here is the full section of the law defining a “supplement”

ff) The term “dietary supplement”—

(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

(2) means a product that—

(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or

(ii) complies with section 411(c)(1)(B)(ii);

(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and

(C) is labeled as a dietary supplement; and

(3) does—

(A) include an article that is approved as a new drug under section 505 or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and

(B) not include—

(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507 7, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or

(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act.

Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act.

I’m trying to find some sort of case-law that would help define the word “combination” here. But I feel that Mr. Haley’s interpretation is not likely to hold.

Mr Haley has in the past described OSR#1 as “totally without toxicity”. Now, “Even then the test animals showed no weight loss or ataxia or other signs of toxicity except diarrhea and a pancreas abnormality. ” Yes, those animals were given massive doses. But, once again, it comes down to definition of words. Is Mr. Haley using the word “totally” appropriately? Is OSR#1 “totally” without toxicity?

OSR#1

30 Jun

My own contribution is here, with less science and more snark:

Please leave your comments there or here, it doesn’t matter.

Another Hero Of The Anti-Vaccine Movement Bites The Dust

29 Jun

So says Steven Salzberg in a Forbes blog post, Another Hero Of The Anti-Vaccine Movement Bites The Dust. Prof. Salzberg is referring to the recent FDA warning letter sent to Mr. Haley about his product, OSR#1. The FDA has warned Mr. Haley that his “supplement” meets the criteria for a drug and the testing involved indicates that there may be serious side effects.

Prof. Salzberg introduces Mr. Haley as a “hero of the antivaccine movement” for his outspoken positions on mercury, especially on thimerosal and autism. Prof. Salzberg poses and answers his own question:

Is Haley simply a confused chemist who fails to understand epidemiological evidence? Or does he have another agenda?

Well, he does: money.

The rest of the piece does not go favorably for Mr. Haley.

Given that piece, I decided to check the website for OSR #1. Mr. Haley has apparently not responded to the FDA formally as of yet but has responded on his website:

Why did the FDA send CTI Science, Inc. a warning letter about OSR#1®?

The FDA sent CTI Science, Inc. a warning letter dated June 17, 2010. They state that OSR#1® is not a dietary supplement because N1, N3-bis(2-mercaptoethyl)isophthalamide is not a known dietary ingredient. However, N1, N3-bis(2-mercaptoethyl)isophthalamide is a combination of two dietary ingredients, benzoate and cystamine coupled together by an amide linkage which is naturally found in proteins coupling amino acids together. The FDA further states that CTI Science, Inc. makes drug claims on its packaging, website and promotional material. CTI Science, Inc. does not believe that the claims it previously made about OSR#1® were drug claims. However, all claims the FDA referenced in its letter were removed from the website. The FDA further states that there may be a safety issue with regard to OSR#1®, because diarrhea was experienced in animal subjects when fed OSR#1® dissolved in corn oil by gavage three times daily at a rate of 5g per kg body weight. This would be the equivalent of 500g for a 220lb person or 5,000 capsules plus a bolus of corn oil. CTI Science, Inc. does not believe this diarrhea is a toxic effect as the animals continued to gain weight like controls and did not develop any toxic effects like ataxia. Using this definition any food, like milk, would be toxic if taken at such a high level.

The Company is evaluating the FDA letter and preparing its response

Now I am not a former chemistry professor, but a few points in the above statement struck me as odd.

First, he notes that his product is the combination of two dietary ingredients. Well, if the resulting chemical isn’t found in foods, isn’t that the real definition of “dietary ingredient”? It doesn’t matter what the source materials are. Heck, can’t you have synthetic sources of “dietary ingredients”? It is the end product, not the source materials that count.

Second, he hasn’t addressed all the issues that the FDA brought up in the warning letter.

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

Hair loss, “abnormalities of the pancreas”, “lymphoid hyperplasia”. Those are not mentioned on the OSR website.

Third, ” Using this definition any food, like milk, would be toxic if taken at such a high level.”. Did Mr. Haley just make a “the dose makes the poison” argument in his defense? Many people promoting the idea that mercury causes autism have rejected the “dose makes the poison” idea, claiming that any amount of mercury is toxic.

Back to Prof. Salzberg’s post. One observation: Forbes magazine is taking on the alternative medical community and their “treatments” for autism, at least in this one case. But take a look at the tags attached to the piece: “antivaccinationist, Autism, Boyd Haley, chelation, mercury, pseudoscience, thimerosal, vaccines”. Ouch.

Supporters of OSR #1, “drug” given to autistic children, see FDA warning as no big deal

24 Jun

The story broke yesterday that Dr. Boyd Haley has been given a warning letter by the FDA about his chelating product, OSR #1. The FDA has warned Dr. Haley that his own safety tests indicate the possibility for adverse reactions and that since the substance is not found in any food or mineral, it is not a “supplement” as he markets it, but a drug. Drugs require much higher standards of proof of safety.

One could make an easy bet that the Age of Autism blog, which has helped tout the drug/supplement OSR, would come to Dr. Haley’s defense. The way they went about this is quite surprising to me. In Chicago Tribune Protecting Consumers Against Natural Supplement (Again), the Age of Autism writes:

CTI Science got a letter from the FDA about its ingredients. They will respond. Dr. Weil got a similar letter last year when he dared to offer an immune support formula in place of the H1N1 vaccine. Drug companies get the letters every day of the week for their advertising claims. You think 50,000 people in America even know what OSR is? They will now.

Yes–the letter from the FDA is no big deal. One of their favorite alternative medical practitioners got one last year, and the pharmaceutical companies get them too. While it isn’t mentioned in the AoA piece, Dr. Weil appears to have ignored the warning letter without any repercussions as no response has been recorded.

Yes, “you don’t have to respond to the FDA’s letters” appears to be a valid excuse to the Age of Autism.

There is a major difference between the warning letters sent to Dr. Haley and Dr. Weil. Dr. Haley’s letter shows that his own safety data, data not previously made public from what I can see, indicates the drug he is selling has the potential to cause adverse reactions. Dr. Weil appears to be only making claims of efficacy which he can’t back up. Only.

And, yes, big companies flout the FDA letters too. Merck, a giant pharmaceutical company, has one warning letter. One. That’s for Vioxx. Merck didn’t respond. That didn’t exactly go well for them, did it?

The full warning letter to Dr. Weil is quoted below.

TO XXXXXXXXX
http://www.drweil.com

FROM: The Food and Drug Administration and the Federal Trade Commission

RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus; and

Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure the H1N1 Virus

DATE: October 15, 2009

WARNING LETTER

This is to advise you that the United States Food and Drug Administration (“FDA”) and the United States Federal Trade Commission (“FTC”) reviewed your website at the Internet address http://www.drweil.com on October 13, 2009. The FDA has determined that your website offers a
product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.

This product is your Immune Support Formula. The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 351, 352. We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.

In addition, FTC staff reminds you that the FTC Act, 15 U.S.C. § 41 et seq., requires that claims that a dietary supplement can prevent, treat, or cure human infection with the H1N1 virus, must be supported by well-controlled human clinical studies at the time the claims are made. More generally, it is against the law to make or exaggerate health claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims. Violations of the FTC Act may result in legal action in the form of a Federal District Court injunction or Administrative Order. An order also may require that you pay back money to consumers.

Some examples of the claims on your website include:

On a webpage entitled, “The Swine Flu – H1N1 ,” with the subtitle “Swine Flu and You”:

“[D]uring the flu season, I suggest taking a daily antioxidant, multivitamin-mineral supplement, as well as astragalus, a well-known immune-boosting herb that can help ward off colds and flu. You might also consider. .. the Weil Immune Support Formula[,] which contains both astragalus and immune-supportive polypore mushrooms ….”

On a product webpage describing the Immune Support Formula:

“The Immune Support Formula contains astragalus. . . . Astragalus … is used traditionally to ward off colds and flu and has been well studied for its antiviral and immunity-enhancing properties.”

“Th[e] synergistic combination of immune modulators [found in the Immune Support Formula] is especially useful for those who tend to get every bug that goes around during the winter.”

On the same webpage, under “Supplement Facts,” describing the Astragalus supplement (which is one element of the Immune Support Formula):

“Astragalus … is … used traditionally to ward off colds and flu, and has demonstrated both antiviral and immune-boosting effects in scientific investigation.”

On the website’s home page, DrWeil.com:

“Worried About Flu? Dr. Weil’s Immune Support Formula can help maintain a strong defense against the flu. It contains astragalus, a traditional herb that boosts immunity. Buy it now in one click, and start protecting your immune system against flu this season.”

On the Dr. Weil Vitamins – Daily Vitamin Packs webpage:

“[L]earn more about Dr. Weil’s Immune Support Formula, which contains astragalus – an herb Dr. Weil recommends to help ward off colds and flu.”

The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide involving the H1N1 Flu Virus that affects or has the significant potential to affect national
security. Following this determination and in response to requests from the U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products, provided certain criteria are met, under 21 U.S.C. § 360bbb-3. The marketing and sale of unapproved or uncleared H1N1 Flu Virus-related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1 Flu Virus in people.

You should take immediate action to ensure that your firm is .not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA. The above is not meant to be an all-inclusive list of violations. It is your responsibility to ensure that the products you market are in compliance with the FFDC Act and FDA’s implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not adulterate or misbrand the products in violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours, please send an email to FDAFLUTASKFORCECFSAN@fda.hhs.gov, describing the actions that you have taken or plan to take to address your firm’s violations. If your firm fails to take corrective action immediately, FDA may take enforcement action, such as seizure or injunction for violations of the FFDC Act without further notice. Firms that fail to take corrective action may also be referred to FDA’s Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.

FDA is advising consumers not to purchase or use H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning marketing unapproved, uncleared and unauthorized H1N1 Flu Virus-related products in violation of the FFDC Act. This list can be found at http://www.accessdata.fda.gov/scripts/h1n1flu. Once the violative claims and/or products have been removed from your website, and these corrective actions have been confirmed by the FDA, the published list will be’ updated to indicate that your firm has taken appropriate corrective action.

If you are not located in the United States, please note that unapproved, uncleared, or unauthorized products intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus offered for importation into the United States are subject to detention and refusal of admission. We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your product listed above to be an unapproved, uncleared, or unauthorized product that cannot be legally sold to consumers in the United States.

Please direct any inquiries to FDA at FDAFLUTASKFORCECFSAN@fda.hhs.gov or by contacting Kathleen Lewis at 301-436-2148.

It is also your responsibility to ensure that the products you market are in compliance with the FTC Act. FTC staff strongly urge you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. The FTC also asks that you notify it via electronic mail at flu@ftc.gov within 48 hours of the specific actions you have taken to address the agency’s concerns. If you have any questions regarding compliance with the FTC Act, please contact Karen Jagielski at 202-326-2509.

Very truly yours,

/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission

/S/
Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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?

NIH funded research includes search for possible vaccine-autism link

11 Jun

Much time is spent discussing whether a study of autism and vaccination status could or should be undertaken. Generation Rescue has been trying to get funding for such a study, but their proposal is weak and vague. The question arises, why doesn’t any group with real strong credentials consider this project?

Would you be surprised to find out that it is already ongoing? And that the principle researcher is someone with mainstream credibility?

It turns out that potential environmental causation of autism, including vaccines, are a part of a study which (if all went according to schedule) just finished the data collection phase. The NIH funded project, GENE-ENVIRONMENT INTERACTIONS IN AN AUTISM BIRTH COHORT, was headed by Prof. Ian Lipkin of Columbia University. The project started in 2003 and was prospectively monitoring a cohort of children diagnosed with ASD’s and another cohort of controls.

The project is discussed below:

Reports of increasing prevalence of autism spectrum disorders (ASDs), a set of highly genetic conditions, are intensifying interest in the role of environmental exposures, including infectious, immune, and toxic factors. Retrospective studies exploring associations between environmental factors and ASDs are compromised by selection bias, small sample sizes, possibly invalid diagnosis, and absence of biologic measures. This prospective study will employ an unselected birth cohort of 75,500 in which cases are ascertained through screening of the entire population, diagnoses established using uniform procedures, extensive histories and clinical data obtained, and biologic samples collected serially throughout pregnancy and early childhood. The application of high throughput laboratory assays to derive maximal information from developmentally-influenced, finite, and nonrenewable biologic samples, and inclusion of early screening and diagnostic assessments, will permit an unprecedented, rich view of the longitudinal trajectory and nascent signs and symptoms of ASDs, facilitate discovery of biomarkers, and afford unique insights into the role of gene:environment interactions in ASD pathogenesis. Specific aims are to: (1) establish the autism Birth Cohort (ABC) through ascertainment of cases of autism spectrum disorder (ASD, N=150-233) and selection of controls (N-1000) from the Norway Mothers and Child (MoBa) cohort; (2) examine biologic pathways that may predispose to ASD, through evaluation of immune, endocrine, and neuroregulatory factors in mothers during early gestation or at birth and in children, at birth or 30 months postnatal; (3) identify environmental factors that may be directly or indirectly associated with ASD, including pre- or postnatal infection, vaccination, very low birth weight or other obstetric risk factors in which infections are implicated, dietary and/or environmental exposure to methylmercury; (4) describe the natural history of clinical, anthropometric, and neurobehavioral features of ASD; and (5) explore genotypic influences that may be directly or indirectly associated with ASD by testing associations of ASD and/or its endophenotypes with family history of autoimmune disease or selected candidate genes, and investigating conditional gene-environment effects using antecedent factors found to influence ASD risk.

Emphasis added.

Prof. Lipkin was a member of the team which looked at children with gastrointestinal disorders, Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study. Amongst other findings, they found that (a) regression was not correlated with MMR vaccination and (b) persistent measles infections are not present in the guts of autistic kids more than in non-autistic kids. Basically it was the study that most closely replicated some of Mr. Wakefield’s team’s efforts and showed that Mr. Wakefield’s results were not reproducible.

Another study, THE CHARGE STUDY: CHILDHOOD AUTISM RISKS FROM GENETICS AND THE ENVIRONMENT, includes “vaccines” in the project terms. This study has been funded to the tune of about US$5,000,000 and is headed by Prof. Irva Hertz-Picciotto, who has stated that vaccines should be considered for research into autism causes.

If you are wondering if mercury is being investigated, AUTISM IN A FISH EATING POPULATION continues study on methyl mercury exposures in the Seychelles. Also, the University of Washington has a study ongoing, NEUROIMMUNOTOXICOLOGY OF MERCURY. Johns Hopkins has a study now going on 4 years, GENETIC SUSCEPTIBILITY TO MERCURY-INDUCED IMMUNE DYSFUNCTION IN AUTISM & ASD. Also, the University of Texas has a study, EPIDEMIOLOGICAL RESEARCH ON AUTISM IN JAMAICA, which also is monitoring heavy metal exposures.

I have two questions. First, why do groups like Generation Rescue, SafeMinds, the National Autism Association and TACA claim that vaccine-autism and mercury-autism research isn’t being done? They are represented on government committees. Second, what do they hope to learn from doing their own study that isn’t going to be done better and sooner by other groups?

Listen to parents…except when they say things you don’t want to hear

25 Mar

How many times do we hear, “Listen to the parents” on medical issues involving their autistic kids? Usually this comes from alternative medical groups who don’t have the science to back up the safety and efficacy of their therapies. What happens when a parent disagrees with these groups?

In Lawsuit against alternative medical practitioners Usman and Rossignal we discussed a father who has brought suit against prominent Defeat Autism Now (DAN) doctors Usman and Rossignol, and the laboratory Doctor’s Data.

Orac, at Respectful Insolence, has discussed this case as Suing DAN! practitioners for malpractice: It’s about time, where he uploaded the actual complaint.

In that complaint the father is alleging many things. High amongst them is the question of whether the “challenge” chelation tests are valid, These were used on his child and supposedly showed heavy metal poisoning. In a challenge chelation test, a chelator drug is given to a child before a urine test is taken. Chelators are designed to draw metals out of the body and allow them to be excreted through the urine (and other ways). There are no standardized references for metal contents in challenge testing. The American College of Medical Toxicology has made a very clear statement about challenge chelation testing. Here is their conclusion:

It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

Recall, challenge testing is noted in the lawsuit. From the section of claims against the Doctor’s Data (who are also defendents in the lawsuit):

The non-standardized method of testing that Defendant utilized on or about April 22, 2004, January 27, 2006, January 13, 2007, February 26, 2007, May 26, 2007, August 6, 2007, October 30, 2007, November 13, 2007, January 12, 2008, January 26, 2008, April 26, 2008, October 29, 2008, and March 27, 2009, wherein specimens were collected after the administration of a provoking agent and compared to unprovoked or unchallenged specimens was an improper method of determining whether A.J. had a potentially toxic level of heavy metals in his system

So, challenge chelation testing isn’t scientifically validated, has no benefit, but was used to justify certain therapies on this child. How did the Autism Research Institute respond to this? They blame the parent’s marital situation.

No, really, I’m not making this up. Rather than accept the complaints on their face and give this autism parent respect, they dismiss his multiple complaints as being…well, you read it:

Recent articles by ABC News and the Chicago Tribune on M.D.s who subscribe to the Defeat Autism Now! approach to treatment indicate the spread of misinformation and misunderstanding in recent months. The complaints about Drs. Usman and Rossignol resulted from a custody case– a painful situation for any family, one that can lead to accusations that must be sorted out in a court of law—not the media

Yes, it isn’t because the father is really annoyed that he was told challenge chelation testing is valid, or that his family spent lots of money on testing and on chelation. It couldn’t be that the father has not seen benefit from these therapies. It isn’t any of that. It is a custody battle issue. For the record, the defendants in the case do not include his wife.

ARI defends their approach in rather vague terms:

The Defeat Autism Now! approach to autism invites the medical community to be more responsive, inquisitive, and knowledgeable about treating these disorders.

The approach is not in itself a source of controversy, since many treatment interventions are commonly prescribed by traditional health professionals.

My view differs from the ARI statement. It would seem to this observer that the approach is the source of controversy. From their own website:

The best diagnostic test for toxic metal overload is the chelation challenge test. The chelation drug is administered, followed by a timed urine test to help assess the body’s burden of toxic elements.

This is in direct contradiction to the statement from the American College of Toxicologists. The ARI approach (including challenge testing) is a key point of the lawsuit. I am not able to reconcile this with the idea that the “approach itself a source of controversy”.

The great problem is rather that chronic, unaddressed illness plagues many, if not most, of the children and adults on the autism spectrum. These conditions, thoroughly documented in the scientific literature, often involve the gastrointestinal system and/or the immune system, but the medical establishment has been professionally insensible to what is a desperate situation in the expanding autism population.

Odd. If anyone outside of the alternative medical community ever makes a statement that the is driven by “desperation”, they are sure to get jumped on.

The focus of the Defeat Autism Now! approach is twofold: to provide patients with allergen-free nutritional support, to uphold and to repair the immune system as needed, and, if appropriate, to reduce the body burden of environmental toxins; to provide clinicians in-depth medical and scientific information, with Continuing Medical Education credits.

There is the mention of what is a main crux of the lawsuit, “body burden of environmental toxins”. That’s it. No mention of challenge testing. They mention that the approach includes reducing “the body burden of environmental toxins”, but doesn’t address the key question: when is this approach “appropriate”. How is that decided? The challenge testing approach has not, to my knowledge, ever been defended in court. This case is

The ARI press release doesn’t discuss the real questions here. Brushing this off as a custody issue is not doing anyone any good and is rather insulting to the parent bringing this suit forward and his child.

Autism-study doctor facing grant probe

13 Mar

A story in the Philadelphia Inquirer today sheds some light on the situation involving Dr. Poul Thorsen.

Background for anyone who needs it: Dr. Thorsen is a Danish researcher who is co-author on a number of important studies. These include epidemiological studies on vaccines and autism. Dr. Thorsen did this work at the University of Aarhus, and has since left. There is an investigation ongoing apparently implicating Dr. Thorsen in a possible shortfall of about US$2M from the University.

Dr. Thorsen’s work was funded largely by the CDC. He started working for Emory University before leaving Aarhus (and this is a point of contention with Aarhus, as they state that Dr. Thorsen was not allowed a joint full-time appointment). He was also listed as adjunct faculty at Drexel University. Dr. Thorsen has also left Emory and his adjunct appointment at Drexel.

There has been a lot of speculation and discussion on this for the past week or so. The story has broken into the mainstream media, who have been good enough to get us some facts to work with. I have sent many emails over the past week, and almost all have been unanswered. I finally heard from one group in Denmark yesterday, and they to are unaware of the details of this case.

Today’s Philadelphia Inquirer has a story about Dr. Thorsen, Autism-study doctor facing grant probe by Jeff Goldstein:

A Danish scientist involved in two major studies that debunked any linkage of vaccines to autism is suspected of misappropriating $2 million in U.S. grants at his university in Denmark.

He also notes that Dr. Thorsen’s appointment at Drexler was unpaid, and he resigned it this week. (Drexel University is local to Philadelphia, where Mr. Goldstein works). Also of note, Dr. Thorsen was working with Emory University for about 6 years, much of that part time. The complaint by Aarhus involves him working “full time” in both Aarhus and Emory. This may go to the fact that it was pretty clear that Dr. Thorsen was at both Emory and Aarhus from his publication record. The complaint may not be about working in both places but, rather, having changed to full time status at Emory.

Mr. Goldstien notes that some groups have “seized” on these allegations to discredit the studies Dr. Thorsen worked on:

Anti-vaccine groups have seized on the allegations to contend that scientific studies disproving the vaccine link to autism are wrong. Those groups have long argued that thimerosal, a preservative in some vaccines, can cause autism, as can the MMR vaccine for measles, mumps, and rubella.

“I think it is quite significant,” said Dan Olmsted of the Age of Autism. “I think someone allegedly capable of ripping off his own university by forging documents from the CDC is capable of pulling off anything.”

And this is where the this situation becomes very important. If these allegations are true, does this negate the studies Dr. Thorsen worked on?

Mr. Goldstein addresses this with quotes from Mr. Olmsted (above) and people at the CDC and Denmark.

“Poul Thorsen had absolutely no influence on the conclusions regarding this paper,” wrote Mads Melbye, head of the division of epidemiology at the Statens Serum Institut in Copenhagen and senior author of the study, in response to e-mailed questions.

“Thorsen was not actively involved in the analysis and interpretation of the results of this paper,” Melbye said.

The second study, published in Pediatrics in 2003, examined 956 Danish children diagnosed with autism from 1971 to 2000. It concluded the incidence of autism increased in Denmark after thimerosal was removed from vaccines.

Kreesten Meldgaard Madsen, the lead author, said Thorsen played a minor role.

“Dr. Thorsen was not in a position to change or compromise the data,” Madsen wrote. “Dr. Thorsen was part of the review cycle, but never very active in giving input. Dr. Thorsen never had access to the raw data nor the analysis of the data.”

I doubt these statements will mollify Mr. Olmsted’s readers.

In a piece on WHYY (a public radio station in Philadelphia) has a story, Investigation of autism researcher’s conduct sparks controversy.

Dr. David Mandell of the Center for Autism Research agrees the studies Thorsen worked on should be reviewed. But he doesn’t believe the research has been compromised. He noted that Thorsen was not a lead researcher, the studies used government data, and they were peer-reviewed. This view is echoed in a statement from the Centers for Disease Control, which partly funded the vaccine research.

So, where does this leave us? With a lot more questions than answers still. One question in my mind at least is whether Dr. Thorsen is accused of transferring money to his own use or if he is accused of transferring money to fund his research at Emory when he left Aarhus. That aside, no matter what happens from here, this will be used to imply that vaccine-autism research (and not just that by Dr. Thorsen) is performed by corrupt individuals and should not be trusted.

Assume that the allegations are real. I can state that I am very angry at that possibility. I do not like dishonest people. I do not like dishonest researchers.

Mostly, I don’t like the fact that this will be (and already is being) used to put doubt in a lot of people’s minds about the role of thimerosal and MMR and autism. $2M is a small sum compared to the amount of suffering that will go on as this breaths a little life back into that movement.

My guess is that some readers are now ready to blame me of bias, of believing that Dr. Thorsen’s studies are accurate when I should be questioning everything he did. Let’s ignore the statements by his collaborators that Dr. Thorsen didn’t have access to the data to manipulate. Let’s just stick with the fact that the studies Dr. Thorsen worked on agree with the results of multiple other studies. The surprising outcome would be if on review the conclusions changed.

I am sure this story isn’t going away. And it should not. We need to know and we deserve to know what the details are here. Beyond that, I am sure that this will be forever in the lore of the vaccines-cause-autism community and will be used to convince ever more people to join.

For that, whoever is responsible for this mess, I am angry.

A Nasty Little Franchise

15 Feb

Wakefield may have the highest public profile but he is just one of many who seek to profit from autism and he is by no means the worst. Remember the Geiers? This father and son team from Silver Springs in Maryland have an unsavoury record that makes Wakefield seem almost reasonable.

Wakefield breached the terms of his hospital’s ethics committee. The Geiers, operating out of the family home, invented their own IRB and granted themselves ethical approval for experiments on children with a powerful drug called Lupron. Lupron is used to treat precocious puberty, a rare condition in young children. It is also used is also used to treat prostate cancer in men, to treat endometriosis in women, and to chemically castrate sex offenders. The Geiers use it on autistic children and young adults.

Kathleen Seidel has catalogued their bad science, plagiarism, inflated academic resumes, the fraudulent IRB, cruel and unnecessary blood draws, attempted deals with TAP pharmaceuticals and the Lupron Protocol itself on her Neurodiversity website. Trine Tsouderos at the Chicago Tribune covers all the basics in her recent profile of the Geiers,  ‘Miracle drug’ called junk science.

The most disturbing part of Tsouderos’ story was the news that the Geiers were rolling out a franchise for others to cash in on their unproven and dangerous protocol. According to their website they offer the following

  • Genetic Markers (DNA Fragile X Syndrome, Blood Chromosome, Chromosome Microarrays, DNA Rett Syndrome, Angelman/Prader Willi Syndrome)
  • Mitochondrial Dysfunction (Carnitine, Lactic Acid, Ammonia, Hand Muscle Testing)
  • Hormone Imbalances (Total Testosterone, Free Testosterone, DHEA, DHEA-S, Androstenedione, Dihydrotestosterone, Total Estrogens, Estrone, Estradiol, ACTH, Aldosterone, Prolactin, FSH, LH)
  • Oxidative Stress/Inflammation (Neopterin, Lipid Peroxides)
  • Detoxification Pathways (Glutathione, Cystathionine, Homocysteine, Methionine)
  • Immune System Function (Immune Deficiency Profile, HLA-Testing, Immune Complexes, Food Allergies, Celiac’s Disease)
  • Heavy Metals (Porphyrins, Blood Metals, Urinary Metals)
  • Neurological Dysfunction (Brain MRI scans, Brain SPECT scans)
  • General Health Status (Comphrensive Metabolic Panel)

And this is the team that will deliver these services.

  • Maryland: Mark Geier MD, geneticist and David Young MD, Obstetrician and gynaecologist.
  • Springfield, llinois: Mary Young MD, psychiatrist and neurologist.
  • Ft. Lauderdale, Florida: David Claymore, neuroradiologist.
  • Parsippany, New Jersey: Paul King, industrial chemist.
  • Indianapolis, Indiana: Melissa Troutman, radiologic technologist.
  • Dallas, Texas: Janet Kern, RN, neuroscientist.
  • Louisville, Kentucky: Janet Pope, RN

And that is it. The only member of the American Academy of Pediatrics is Mary Young who has worked as a child psychiatrist. There are no board certified endocrinologists or anybody with the board certification to diagnose and treat precocious puberty in children.

And what of David Geier BA? He remains vice-president of the non-profit 501(c)3 Institute of Chronic Illnesses, Inc. and the non-profit 501(c)3 CoMeD, Inc. Much of the profit from the franchise will be directed to “these corporations dedicated to
autism research and advocacy efforts.” sure. So families or their insurers will be paying for treatments for their children that have been condemned by real autism experts as junk science. And the profits from this enterprise will be used to fund more junk science. Do they have a GMC in America? Do they want to borrow ours?

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IACC calls for $175 million in autism and the environment research

5 Feb

The Interagency Autism Coordinating Committee has posted the revised Strategic Plan. I blogged it recently here on LeftBrainRightBrain. I made a note of the large commitment to environmental causation research. I thought it worthwhile to highlight that section, since this is the cause of so much criticism of the IACC.

Strangely, the criticism doesn’t come from those who are supposedly “It’s all genetic” types. No, the “it’s all environmental” groups seem to be very loud in complaining that all the research funding is going into genetics.

The Plan is divided by a number of questions. Research into causation is listed in Question 3: “What Caused This To Happen And Can This Be Prevented?”

Under that category, there are seven projects on environmental or gene-environment research. Seven out of 10 projects. The estimated budget for all these projects? $175,900,000.

In other words, 70% of the projects and, if I did my math right, nearly 70% of the funding for causation is estimated to be going to environment and gene-environment projects.

This would seem like a great victory for those who have lobbied for more environmental research. I have yet to see anyone from that group even mention the new Strategic Plan, much less the large commitment to environmental research. Where are the statements from SafeMinds (who have a very vocal member who sits on the IACC proper and another who is on a working group)? How about Generation Rescue? The National Autism Association?

In my opinion, these groups really don’t care much about environmental causation unless it is either mercury or vaccines. Hey, I could be wrong. Let’s see if they surprise me with some acknowledgment of this effort by the US Government.

Here are the objectives if you would like to read for yourself.

Short-Term Objectives

1. Coordinate and implement the inclusion of approximately 20,000 subjects for genome-wide association studies, as well as a sample of 1,200 for sequencing studies to examine more than 50 candidate genes by 2011. Studies should investigate factors contributing to phenotypic variation across individuals that share an identified genetic variant and stratify subjects according to behavioral, cognitive, and clinical features. IACC Recommended Budget: $43,700,000 over 4 years.
2. Within the highest priority categories of exposures for ASD, identify and standardize at least three measures for identifying markers of environmental exposure in biospecimens by 2011. IACC Recommended Budget: $3,500,000 over 3 years.
3. Initiate efforts to expand existing large case-control and other studies to enhance capabilities for targeted gene – environment research by 2011. IACC Recommended Budget: $27,800,000 over 5 years.
4. Enhance existing case-control studies to enroll racially and ethnically diverse populations affected by ASD by 2011. IACC Recommended Budget: $3,300,000 over 5 years.
5. New objective
Support at least two studies to determine if there are subpopulations that are more susceptible to environmental exposures (e.g., immune challenges related to infections, vaccinations, or underlying autoimmune problems) by 2012. IACC Recommended Budget: $8,000,000 over 2 years.
6. New objective
Initiate studies on at least 10 environmental factors identified in the recommendations from the 2007 IOM report “Autism and the Environment: Challenges and Opportunities for Research” as potential causes of ASD by 2012. Estimated cost $56,000,000 over 2 years.

Long-Term Objectives

1. Conduct a multi-site study of the subsequent pregnancies of 1,000 women with a child with ASD to assess the impact of environmental factors in a period most relevant to the progression of ASD by 2014. IACC Recommended Budget: $11,100,000 over 5 years.
2. Identify genetic risk factors in at least 50% of people with ASD by 2014. IACC Recommended Budget: $33,900,000 over 6 years.
3. Determine the effect of at least five environmental factors on the risk for subtypes of ASD in the pre- and early postnatal period of development by 2015. IACC Recommended Budget: $25,100,000 over 7 years.
4. Support ancillary studies within one or more large-scale, population-based surveillance and epidemiological studies, including U.S. populations, to collect data on environmental factors during preconception, and during prenatal and early postnatal development, as well as genetic data, that could be pooled (as needed), to analyze targets for potential gene/environment interactions by 2015. IACC Recommended Budget: $44,400,000 over 5 years.

Read more: https://leftbrainrightbrain.co.uk/2010/02/iacc-strategic-plan-is-up/#ixzz0edI3Pe8h

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