ABC Nightline video on the Judge Rotenberg Center

1 Jul

“No detrimental effects whatsoever”. That’s what Matthew Isreal has to say about the shocks used as aversives. I somehow remain unconvinced. The Judge Rotenberg Center has now come under the scrutiny of the United Nations Special Rapporteur on Torture, who has called on the Obama administration to investigate the center.

Obviously, major electrical shocks can be quite harmful. The most serious physical damage occurs when current passes through organs, like the heart. The JRC device appears to be designed to keep the shocks local. At about 50 seconds into the video they apply an electric shock from one of the JRC’s devices to the Nightline commentator. The shock is applied to her arm, but watch her leg twitch. The effects aren’t exactly localized, are they? That is troublesome to me because we don’t know what is going on internally from the shock.

As to emotional long term side effects, who knows? Seriously, can Dr. Isreal really make the claim of “no detrimental effects whatsoever”? Based on what evidence?

From a previous press release criticizing the JRC

The Judge Rotenberg Center (JRC) in Canton is believed to be the only facility in the country that uses often painful electric shock therapy on disabled children in order to alter behavior. In 2007, the State launched a criminal investigation into an incident where a prank phone call to the school led to the repeated electric shocking of two individuals in the dead of night. One of them, a child, was shocked 29 times, the other was shocked 77 times – sometimes while restrained, causing burns so severe they needed to be treated at a hospital. That investigation is apparently ongoing. In October 2009, the JRC made headlines again when Director Matthew Israel was fined by the Massachusetts Division of Professional Licensure for allowing 14 unlicensed employees at the school to use the title “psychologist.”

http://abcnews.go.com/assets/player/walt2.6/flash/SFP_Walt.swf

UN Calls Shock Treatment at Judge Rotenberg Center ‘Torture’

1 Jul

The Judge Rotenberg Center (JRC) is a school for special needs children. The JRC is known for the fact that they use aversives–in the form of electric shocks–as part of their program. Not all students get the shocks, but it is a part of the program there.

The ABC program Nightline will air an episode on JRC tonight. Their website already has a story, UN Calls Shock Treatment at Mass. School ‘Torture’.

Here is a quote from that story:

“To be frank, I was shocked when I was reading the report,” said Manfred Nowak, the UN’s Special Rapporteur on Torture. “What I did, on the 11th of May, was to send an urgent appeal to the U.S. government asking them to investigate.”

The United States Department of Justice already opened an investigation on the JRC earlier this year after a consortium of disability organizations sent a complaint letter.

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?

Trine Tsouderos/Chicago Tribune to hold online chat tomorrow

30 Jun

Join Chicago Tribune Science and Medical Reporter Trine Tsouderos tomorrow for an online chat about unproven and potentially dangerous alternative treatments for autism. Here is the link to join in. The fun starts July 1 at noon CST.

Tsouderos recently wrote about the FDA’s clamp down on Prof. Body Haley, a retired chemist who markets a toxic waste treatment chemical for the treatment of autism.

That article is the latest in a year-long investigation by Trine Tsouderos and Patricia Callahan into questionable autism treatments. The series earned the Chicago Tribune a first place in the Awards for Excellence in Health Care Journalism. The series was kicked off in March, 2009, with “Dubious Medicine”, which exposed the father-son team of Mark and David Geier, who use chemical castration drugs to “treat” disabled children.

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.

How to report adverse reactions to supplements

30 Jun

I have often complained that no one seems to be interested in collecting adverse event data from alternative medical treatments. For example, one child who was a test case in the Omnibus Autism Proceeding (the vaccine court) appears to have reacted very negatively to chelation. We only heard about this because the Omnibus proceeding. DAN and other organizations do not seem to be collecting or reporting on adverse events.

I have often read adverse reactions to alternative therapies in online forums. No one seems to consider reporting those.

In searching for information on supplements, I did find this FDA site for reporting adverse reactions.

There is an online form, MedWatch Online Voluntary Reporting Form (3500), which can be used to report adverse events.

I can not find a database comparable to VAERS which has the data from these reports compiled for view. Since I have never read of anyone reporting their bad reaction to an alternative medical treatment, I doubt whatever database the FDA is keeping is very complete.

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.

Evaluation of a Records-Review Surveillance System Used to Determine the Prevalence of Autism Spectrum Disorders.

28 Jun

Perhaps the most well-known statistics about autism come from the CDC’s autism surveillance project. The Autism and Developmental Disabilities Monitoring (ADDM) Network is a multi-state operation coordinated by the CDC. Their reports are the source of the “1 in 166”, “1 in 150” and “1 in 100” numbers one hears in the press and elsewhere. The Netweork looks at children’s medical records, educational records and sometimes both sets of records and make determinations of which children have autism spectrum disorders (ASD’s). This allows the Network to monitor large numbers of children. But they don’t actually test each child,bringing up questions of how accurate are the prevalence numbers.

A CDC team has looked into this question (actually, questions) in a recent paper:

Evaluation of a Records-Review Surveillance System Used to Determine the Prevalence of Autism Spectrum Disorders.

Nonkin Avchen R, Wiggins LD, Devine O, Van Naarden Braun K, Rice C, Hobson NC, Schendel D, Yeargin-Allsopp M.

Developmental Disabilities Branch, Centers for Disease Control and Prevention, 1600 Clifton Road, MS E-92, Atlanta, GA, 30333, USA, ravchen@cdc.gov.
Abstract

We conducted the first study that estimates the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of a population-based autism spectrum disorders (ASD) surveillance system developed at the Centers for Disease Control and Prevention. The system employs a records-review methodology that yields ASD classification (case versus non-ASD case) and was compared with classification based on clinical examination. The study enrolled 177 children. Estimated specificity (0.96, [CI(.95) = 0.94, 0.99]), PPV (0.79 [CI(.95) = 0.66, 0.93]), and NPV (0.91 [CI(.95) = 0.87, 0.96]) were high. Sensitivity was lower (0.60 [CI(.95) = 0.45, 0.75]). Given diagnostic heterogeneity, and the broad array of ASD in the population, identifying children with ASD is challenging. Records-based surveillance yields a population-based estimate of ASD that is likely conservative

If you are looking for a glossary for these terms, one can be found here.

Sensitivity: Proportion of persons with condition who test positive

Specificity: Proportion of persons without condition who test negative.

Positive Predictive Value (PPV): Proportion of persons with positive test who have condition

Negative Predictive Value (NPV): Proportion of persons with negative test who do not have condition.

The methods used scored well in specificity, positive predictive value and negative predictive value. What was somewhat lacking is sensitivity–proportion of people who test positive. Many children with ASD’s are not captured by the methods used, suggesting that the estimates by the CDC are likely low.

What would be very interesting to see would be how the sensitivity has varied over time. Is part of the rise in the CDC’s autism prevalence estimates due to changes in sensitivity? Could the records be getting better as a result of the autism awareness campaigns over the last 10 or more years?

National Council on Disability Newsletter, June 2010

28 Jun

I received the Newsletter for the National Council on Disability via email this morning:

Message from the Chairman:

I am truly honored to have been appointed by President Obama as Chairman of the National Council on Disability (NCD). I am delighted to be joined by seven new Members whose nominations were also confirmed by the U.S. Senate this Spring and our continuing Members appointed by President Bush. To learn more about our Members, please visit: http://www.ncd.gov/newsroom/members/members.htm.

This is the first newsletter of my chairmanship and as such I am actively seeking your input and advice to make NCD more transparent, participatory, and collaborative in implementing the public policy mandate found in NCD’s authorizing statute.

My primary objective is to build a solid foundation for NCD to carry its work into the future and that means being able to coordinate and collaborate effectively across the Federal Government, with state and local governments, and with a variety of stakeholders within the disability community. We are at a critical juncture. There is no longer any mystery about the broad policy objectives for people with disabilities. The uncertainties regard concrete and actionable steps toward implementing our policy objectives. Absent effective leadership and coordination, we will continue to fall short both in improving the lives of people with disabilities and in stabilizing our nation’s fiscal health.

To be an effective agent, NCD must actively engage with the community it was created to serve. Accordingly, NCD will be aggressive, creative, and steadfast in identifying ways to be transparent about its activities and to solicit input from all interested stakeholders. NCD’s engagement will also need to be timely and relevant. NCD will strive to help set the agenda where it can, but our greatest impact will frequently be on issues and topics for which there are windows of opportunity. We need to ensure that NCD is aware of these windows and how best to tailor and present its recommendations so that they make a real difference in advancing disability policy objectives.

I welcome and value your feedback on the Council’s activities, including what you want in future newsletters and communications with the public. The Council is embarking on a new era and we want to reach out to you in this open invitation for suggestions on everything we’re doing. You are our stakeholders and we depend on you to let us know how we can better serve the community. I encourage you to share your thoughts, ideas, and general comments. You can email NCD at ncd@ncd.gov. There is much work to be done and your feedback is key.

Sincerely,

NCD_signaature02.png

Jonathan Young

In the News

Congressional Testimony

On June 15th, Chairman Young had the privilege of testifying before the Subcommittee on Emergency Communications, Preparedness and Response on “Caring for Special Needs during Disasters: What’s being done for Vulnerable Populations.” His testimony can be found at: http://www.ncd.gov/newsroom/news/2010/HS_Subcomm_Young_Testimony_FINAL.htm. The purpose of this hearing was to receive testimony on the actions taken by FEMA, non-profits, and localities to address the needs of vulnerable populations, including people with disabilities, the poor, children, and persons with limited English proficiency, during disasters.

National Summit on Disability Policy 2010

Since Chairman Young’s confirmation he has been immersed in preparation for NCD’s National Summit on Disability Policy, which will take place at the Renaissance Washington, DC Hotel, 999 9th Street, NW, Washington, DC, July 25–28, 2010.

The Summit’s cross-cutting theme of Living, Learning & Earning is designed to launch a national dialogue on disability policies and programs in the 21st century. As the invited guests gather in Washington, DC to celebrate the 20th anniversary of the signing of the ADA, we want to begin substantive discussions about the future of disability policies and programs and promote extensive collaboration at all levels of government and among all stakeholders. The Summit now includes an additional half-day, post-Summit discussion session on July 28, where NCD will reflect on the Summit’s proceedings and entertain additional stakeholder input.

White House Launches Celebration Of 20th Anniversary Of Americans With Disabilities Act
On June 8th Valerie Jarrett, Senior Advisor to President Obama, kicked off the White House’s celebration of the 20th Anniversary of the Americans with Disabilities Act, delivering remarks to over 2,000 people from around the world at the VSA International Festival at the Kennedy Center. Read Ms. Jarrett’s full remarks at http://www.whitehouse.gov/blog/2010/06/08/white-house-launches-celebration-20th-anniversary-americans-with-disabilities-act

FCC ADA Anniversary Celebration

As part of its continuing effort to develop and implement consumer-focused policies, including disabilities access, the Federal Communications Commission (FCC) will begin its year-long celebration of the 20th Anniversary of the ADA on Monday, July 19, 2010. The event will be held in the afternoon, in the Commission Meeting Room. The event will include the following:

•Launch of the Commission’s Accessibility and Innovation Forum
•Announcement of FCC initiatives concerning disability access
•Technology Expo of emerging communications equipment and services
•Debut of a video documenting first-person testimonials on disability access
•Performances by Gallaudet University students

Additional information about the event will be released at a later date. The celebration is free and the public is encouraged to attend. Pre-registration is encouraged, but not required. To pre-register or request accommodations, please send an E-mail to: Pam.Gregory@fcc.gov, or call (202) 418-2498 voice; (202) 418-1169 TTY.

NCD Vice Chair Fernando Torres-Gil Addresses Aging

On May 27, NCD Vice Chair Fernando Torres-Gil, Ph.D., provided the keynote address at the 2010 Area 1 Agency on Aging’s “Celebration of Seniors” luncheon and awards ceremony in Eureka, California.

Read the entire advance story from the May 25 Eureka Times-Standard at http://www.times-standard.com/lifestyle/ci_15156690.

NCD Board Member Gary Blumenthal Discusses Center Closure

On May 20, NCD Board Member Gary Blumenthal’s guest column on closing a local developmental center appeared in the Waltham, Massachusetts, Daily News Tribune.

Read the entire column about the closure of Fernald Developmental Center at http://www.dailynewstribune.com/opinions/columnists/x258107902/Fernald-closure-saves-money.

On May 30, the Boston Globe published a letter to the editor by Mr. Blumenthal that discusses the benefits of community-based settings.

The letter can be found at http://www.boston.com/yourtown/sudbury/articles/2010/05/30/disabled_can_find_opportunities_in_the_community/.

Federal Medical Assistance Percentages

On June 7, NCD Chairman Jonathan Young sent a letter to Senate Majority Leader Harry Reid and Senate Minority Leader Mitch McConnell urging swift action in providing a six-month extension of the enhanced Federal Medical Assistance Percentages contained in the Senate-passed American Workers, State, and Business Relief Act of 2010 (H.R. 44213) but omitted from the American Jobs and Closing Tax Loopholes Act passed by the U.S. House of Representatives.

Anniversary of Olmstead v. L.C.

June 22 marked the 11th anniversary of the landmark 1999 U.S. Supreme Court decision in Olmstead v. L.C., in which the Court held that the unjustified institutional isolation of people with disabilities is a form of unlawful discrimination under the ADA.

Since that time, progress has been made. Many individuals have successfully transitioned to community settings, but waiting lists for community services have grown considerably and many individuals who would like to receive community services are not able to obtain them.

NCD believes that continued implementation of Olmstead is of paramount importance to the nation as demographics shift toward older Americans, and is one of the top priorities of the disability community.

CMS Announcement

Our partners at the Centers for Medicare and Medicaid Services (CMS) made a recent announcement that we believe will be of interest to you:

CMS State Medicaid Directors Letter # 10-008 issued May 20, 2010, entitled “Re: Community Living Initiative,” which reminded states of their obligations to implement the Olmstead decision, reported on recent progress made as a part of the Community Living Initiative and highlighted resources and guidance to help states in their compliance efforts.

You can download a PDF of the CMS State Medicaid Directors Letter from http://www.cms.gov/smdl/downloads/SMD10008.pdf.

The Affordable Care Act

A blog, entitled “What the Affordable Care Act Means for Americans with Disabilities” by Henry Claypool, Director of Office on Disability, U.S. Department of Health and Human Services, was posted on May 21, 2010, at http://www.healthreform.gov.

To read the entire blog, please go to http://www.healthreform.gov/forums/blog/disabilities.html.

ODEP Announces National Disability Employment Awareness Month Theme

On May 13, the U.S. Department of Labor’s Office of Disability Employment Policy unveiled the official theme for October’s National Disability Employment Awareness Month: “Talent Has No Boundaries: Workforce Diversity INCLUDES Workers With Disabilities.” The theme serves to inform the public that workers with disabilities represent a diverse and vibrant talent pool for hire.

To read the full announcement, please go to http://www.dol.gov/opa/media/press/odep/ODEP20100630.htm.

FCC and FEMA Announce Workshop on 21st Century Emergency Alerting: Leveraging Multiple Technologies to Bring Alerts and Warnings to the Public

On June 10, the Federal Communications Commission’s Public Safety and Homeland Security Bureau and the Federal Emergency Management Agency’s (FEMA’s) National Continuity Programs held a workshop on 21st Century Emergency Alerting: Leveraging Multiple Technologies to Bring Alerts and Warnings to the Public.

This meeting was important to people with disabilities because emergency warnings still do not adequately reach people with disabilities during disasters. Most disaster warnings broadcast via conventional media avenues only, which may not be accessible to people with hearing or vision disabilities.

For more information, please see the full announcement at http://hraunfoss.fcc.gov/edocs_public/attachmatch/DOC-298198A1.txt.

About the National Council on Disability Newsletter

The Newsletter, which is also available on the Council’s website at www.ncd.gov, brings you the latest issues and news for people with disabilities. To subscribe to the NCD listserv, go to http://listserv.access.gpo.gov, click on online mailing list archives, select NCD-NEWS-L, then join or leave the list, and finally, complete the short subscription form.

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

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