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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

Whooping cough epidemic declared in California

24 Jun

The largest whooping cough numbers in 50 years (over 900 confirmed cases throughout the state of California) has resulted in five deaths of Latino children under five years old. Public health officials declared an epidemic today as a result.

The announcement came after authorities noticed a sharp spike in reports of pertussis, the scientific name for whooping cough, which often is mistaken for a cold or the flu and is highly contagious. All told, 910 cases have been confirmed, with several hundred more under investigation. If the pace keeps up, the outbreak could be the largest in the state in 50 years, the California Department of Public Health reported.

Dr. Gilberto Chavez, the deputy director of the department’s Center for Infectious Disease, said health officials had seen a fourfold increase compared with 2009. And the worst may be to come.

“The peak season starts in the summer,” Dr. Chavez said, noting that July and August usually have the highest number of cases. “And we expect to see a much larger number of cases if we don’t intervene quickly.”

For five families, however, the state’s warning has come too late. Five children — all Latino and all under the age of 3 months — have died since the beginning of the year, Dr. Chavez said.

Source

Vaccinate your kids. Please.

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

Penn Jillette doesn’t know his ADA from a hole in the ground

23 Jun

Apologies for the title. But watching a Penn and Teller Bull**** episode a few times over has inundated me with profanity.

Penn and Teller are a magician team. They also have a show on American cable TV, Bull*****. They have an upcoming episode on the anti-vaccine movement and because of this Penn has recently put out a short video about Andrew Wakefield. When I blogged that piece, one commenter noted that Penn and Teller have taken on the Americans with Disabilities Act (ADA), claiming it is “bull**** on wheels”. OK, the commenter didn’t quote the “Bull**** on wheels part, but that’s how Penn describes it.

I found that there was an episode of Bull***** called “Handicap Parking”, in which Penn and Teller take on the ADA. The episode is below. Warning, Penn is fluent in profanity.

This is the first episode of “Bull****” I have watched. I will say parts of it are interesting. Watch what is going on in the background. There is a guy who is very adept at getting around in his wheelchair. Certainly more of an athlete than either Penn or Teller (or I, for that matter). Even while is he there to make the point that one can be in a wheelchair and still be quite capable, he also would not be able to get out of his car if someone were to park right next to him–and that is at the very beginning of the episode. No one is free from being poked at. Take the gentleman who most closely tells the story that Penn is promoting. At one point they have a voiceover from that gentleman talking about how with the ADA in place, people are not compassionate and accommodating. In contrast to that message, the video shows strangers pausing to open doors and be polite to him.

But those events are minor compared to some of what is said and done on that show:

Where to begin? I realize that they only had 30 minutes, but the ADA is not just about physical disabilities and certainly not just about parking. Penn’s approach is not so much ableist as libertarian: the government shouldn’t be mandating “compassion”. There’s ableism in there, don’t get me wrong. When discussing accessible buses he comments, “if you were disabled and lived in New York City what more could you ask for…other than not to be handicapped?”

Now here’s the bit of chicanery that got me to blog this. This comes about 4 minutes into the part 2 video.

“Who does the ADA classify as disabled? It starts with people who use a wheelchair, cane, crutches or a walker…” He goes down a list until he gets to “Now it gets a little vague. And here’s where it gets f***ed up. You see, in order to get to that 50 million number, according to the government, also includes people who have difficulty keeping track of money, doing light housework, and using the phone. No s***.”

They then cut to Teller in his car looking quizzically at his cell phone. When he can’t figure it out, he puts up a handicap placard and gets out. Yes, if you can’t use a phone you get to park in a blue space.

They are using the absurd to make a point with Teller and the phone. Sure. But what about Penn’s voice over leading up to that? Is he quoting the ADA? No.

The definition of a disability according to the ADA is:

(1) Disability

The term “disability” means, with respect to an individual

(A) a physical or mental impairment that substantially limits one or more major life activities of such individual;

(B) a record of such an impairment; or

(C) being regarded as having such an impairment (as described in paragraph (3)).

(2) Major Life Activities

(A) In general

For purposes of paragraph (1), major life activities include, but are not limited to, caring for oneself, performing manual tasks, seeing, hearing, eating, sleeping, walking, standing, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, communicating, and working.

(B) Major bodily functions

For purposes of paragraph (1), a major life activity also includes the operation of a major bodily function, including but not limited to, functions of the immune system, normal cell growth, digestive, bowel, bladder, neurological, brain, respiratory, circulatory, endocrine, and reproductive functions.

(3) Regarded as having such an impairment

For purposes of paragraph (1)(C):

(A) An individual meets the requirement of “being regarded as having such an impairment” if the individual establishes that he or she has been subjected to an action prohibited under this chapter because of an actual or perceived physical or mental impairment whether or not the impairment limits or is perceived to limit a major life activity.

(B) Paragraph (1)(C) shall not apply to impairments that are transitory and minor. A transitory impairment is an impairment with an actual or expected duration of 6 months or less.

No language “if you can’t use a phone, you get a handicap parking space.”

Where did that come from? They have a visual in place to support Penn’s voice over. That document is here. Did you notice the link? That’s a document from the Census Bureau, not a quote of the ADA at all. It’s a bit of sleight of hand, if I may call it that. He tells us the figures and definition are from the ADA website, but is actually using a document and statistics from another agency (the Census Bureau) created for a different purpose.

Maybe ada.gov has the 50 million disabled statistic Penn refers to. If so, I can’t find it. It doesn’t change things. Penn uses one definition of disability–a broad definition–to make the claim that the ADA is too broad.

This allows Penn to say, “The ADA equates the difficulties of a 21 year old blind girl with severe autism to some a-hole who can’t figure out how to use redial”.

No. The ADA does not equate the two. But that would get in the way of Penn’s narrative–that there are a lot of people without “real” difficulties who are misusing the ADA. One of his guests asserts that “Without this law, the *truly* handicapped would be socially, morally and financially better off than they are today”. Rather than back that statement up with some data Penn goes to comedy, pushing a guy in an iron lung around Hollywood.

As the episode goes on, they bring up a man who does appear to be misusing the ADA to demand money from businesses he claims are not accessible. Yep, there are bad people of all sorts. I won’t disagree there.

Nothing, including the ADA, should be above criticism. I have no problem with Penn and Teller taking a critical look. The ADA is far from perfect. But it’s important enough to get their facts straight. Also, I would disagree with the claim that society would be as accommodating if the ADA weren’t in existence.

His take, as I mentioned above, is rather libertarian. He quotes part of the purpose of the ADA, “to provide a clear and comprehensive national mandate for the elimination of discrimination against individuals with disabilities”. He then follows with, “How about the government sticks to courts, police, defense and corruption and leaves compassion to the people who f***ing have it!”

Nice straw man there. The ADA isn’t about compassion. The word “compassion” isn’t in the text anywhere. One can be bereft of compassion and not discriminate and one can discriminate while being full of compassion. It isn’t about making people physically equal as Penn asserts.

I’ll leave you with one last segment. One of the guests comments that accessibility is similar to racial discrimination. Penn counters, “Equating handicap access with racial discrimination is bullshit. Black people weren’t allowed in the front of the bus due to Jim Crow laws of segregation. Handicap people can’t get on the bus because of Isaac Newton’s laws of physics”.

What a strange comment. Here’s a hint for Penn: lift mechanisms on buses use Isaac Newton’s laws of physics.

The Court–part of what the government is supposed to do in his libertarian view–can require buses use Newton’s laws to allow access. Frankly, buses aren’t included in Penn’s litany of what the government should do anyway, but don’t let that get in the way of a good narrative.

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.

Penn Point: Anti Vaccination is Bull Andrew Wakefield and Jenny McCarthy

21 Jun

Penn of Penn and Teller has an internet TV show called Penn Point. In the recent installment Penn discusses Andrew Wakefield and Jenny McCarthy. I hesitated posting this as Penn is proficient, fluent even in, in profanity. So be warned. I also hesitate because I don’t want to get into the “My celebrity is better than your celebrity” arguments. I’m not putting this out because Penn is an expert. No, he’s no expert. He’s a celebrity. A celebrity who wants to champion the little guy being trampled by “the Man”. In this case, he says, “The man is right”, Mr. Wakefield and Ms. McCarthy are wrong.

Penn Point: Anti Vaccination is Bull*** Andrew Wakefield and Jenny McCarthy

Penn and Teller have been working for some time on an episode of their Cable TV program “Bullshit” which takes on the anti-vaccine movement. They fought with Showtime to do anti-aniti-vaccination. Yes, they had to fight to do this show. The anti-vaccine groups have had the sympathy of the media for some time. But, times are changing. Now, even a show like Bullshit, which takes on “The Man” (the establishment), is willing to take a critical look at people like Andrew Wakefield, Jenny McCarthy and Oprah.

The short bit in Penn Point notes that at the time they did the show Mr. Wakefield was not yet struck off so they were more careful with him. Keep that in mind when the episode airs. They went easy on him. Also of note, Penn references the Bad Astronomy blog. Bad Astronomy mentions this Penn Point in Penn’s – and the syringe’s – point.

The Penn Point show is here:

http://revision3.com/player-v5834

I could write the responses to that episode now, complete with complaints about how Mr. Wakefield’s study isn’t completely discredited ( [a] “it isn’t a study, it is a case series, [b] it has been replicated in five countries, [c] how dare he claim that Jenny McCarthy isn’t helping people–look at her books and talks….etc.).

But, again, I’ll stress: I’m blogging this not to say Penn is correct or to use his words as some sort of expert in the discussion. No. To me this is about the fact that the media viewpoint has shifted away from sympathy and false balance for the vaccines-caused-an-autism-epidemic groups. Consider the recent episode of Frontline and the recent episode of Dateline which both covered the vaccine-autism discussion and (especially in the case of Dateline) Mr. Wakefield. Both were very critical of Mr. Wakefield, and that was before Mr. Wakefield was struck off the General Medical Council register.

The groups focusing on vaccine causation have relied upon a sympathetic media for some time. Without it, they would have had a much harder time putting out a message which their media representative claims “…has severely eroded confidence in the cornerstone of health care: THE CHILDHOOD VACCINE PROGRAM.”

That said, I was actually looking forward to winding down discussion of Mr. Wakefield. He’s moved from front-page news in reputable media sources to a late night guest on AM radio shows which concentrate on UFO’s.

But, as long as I am on the subject of Mr. Wakefield (regular guy), let me make a few recent observations:

Mr. Wakefield recently gave a talk in London. Or, as it was billed, people were able to have an “audience” with Andrew Wakefield. The lecture presented his current stump speech and was followed by a book signing. About 40 people attended. The live feed of the event was to be carried “pay per view”, with a fee of about US$70. The organizers abandoned that idea and put it out free. Even with that they were only able to get about 150 online viewers, which included many skeptics (including members of the Bad Science forum).

A good example of the sort of information Mr. Wakefield’s speeches include is a shifting of blame for the drop in immunizations in the UK to the government. It was there decision, he asserts, to remove the single vaccines which led to the outbreaks. As noted in the Telegraph recently, the UK has never had a single mumps vaccine:

‘Rubbish,’ says Salisbury. ‘There was no mumps vaccination licensed for routine use – certainly none available in the UK. We had never used a single mumps vaccination.

We could go on and on. Mr. Wakefield, who has supposedly thoroughly researched vaccines and their safety, still thinks the Amish have prohibition on vaccination. Just for example. Rather than go through all those points, I’ll leave you with this. The “audience” had to be moved to a different location than originally planned. The organizers claimed there were “threats” that caused the move. The Bad Science community, however, noted:

The venue is the offices of a well regarded independent television production company. So Becky Fisseux wrote some of the directors: “I’m writing to express my extreme disappointment that such a well thought of production company as Objective is playing host to this event tomorrow evening.” … continuing with an explanation of the anti-vax nature, and rise of measles ending with …”Should you allow this event to go ahead, I fear your company’s reputation will be seriously tarnished, and respectfully ask you to reconsider your decision.”

She got a reply from a director who was confused… and that they will look into it. She says “Next morning, at about 9am I received emails from two directors saying that their rehearsal studio had been booked via a third party who was known to them, but the person who took the booking was not informed of the nature of the event, nor of the links to Wakefield and the anti-vax lobby. They withdrew the offer of the room.”

It’s not longer about a scientific debate when it comes to vaccines and autism and Mr. Wakefield. It’s about image management. If Penn is any indication, they need a lot of “management” for Mr. Wakefield’s image.

addendum: I forgot to credit the Countering Age of Autism blog for bringing the Penn Point episode to my attention.

Interagency Autism Coordinating Committee (IACC) wants your input

18 Jun

The Interagency Autism Coordinating Committee creates the Strategic Plan for the US Government’s research efforts in autism. They update this every year. They are seeking input from the public.

What do you think should autism research should focus on in the future? Now’s your chance to let your voice be heard. Public comments can be entered here: http://iacc.hhs.gov/public-comment/2010/index.shtml.

The website will take you through the entire Strategic Plan, section by section. You don’t have to respond to everything. If you just have a few short messages for the IACC, go ahead and let them know.

IACC Issues New RFI to Solicit Public Input to Inform the 2011 Update of the Strategic Plan

The IACC has issued a formal Request for Information (RFI) to solicit public input to inform the 2011 update of the IACC Strategic Plan for Autism Spectrum Disorder Research. During the six-week public comment period (June 18 – July 20, 2010), members of the public are asked to provide input to the committee on what has been learned in the past year about the issues covered in each of the seven chapters of the IACC Strategic Plan, and on what are the remaining gaps in the subject area covered by each chapter. In addition, the committee is seeking input on the introductory chapter and other general comments about the Strategic Plan. Comments collected through this RFI will be posted to the IACC web site after the closing date.

To access the RFI, please go to: http://iacc.hhs.gov/public-comment/2010/index.shtml.

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