What constitutes a blogger “bully”?

10 Jul

There are events around the autism blog-o-sphere that are troubling as of late. Events which bring up the question of bullying in a very real way.

First some background:

Andrew Wakefield is on a book tour. He has spoken at a park in Chicago and to small groups in New York, Phoenix and London. Events surrounding these engagements have very strange, if you ask me. And it is getting stranger.

The Chicago event was, well, a bit of damp squib, to quote Kev. Not a big event, even though it was timed to coincide with a large autism parent convention. Many of the attendees were actually skeptics who showed up as a bit of a silent protest.

The event in London was originally billed as “Dr. Andrew Wakefield is at a secret location in London with a select group of ticket holders for a book signing and Q&A session.” At one point it was going to simultaneously shown as a pay-per-view on the internet (something like $70, if I recall correctly), but ended up being free. The event location was kept secret at first and is reported to have been moved with vague comments of “threats”.

Frankly, I take any possibility of threats seriously and I worried that this might be serious. While I disagree with much of what Mr. Wakefield has to say, I would strongly condemn any threats to his talks.

When I heard that there was controversy about Mr. Wakefield’s Phoenix appearance, I took it seriously and wanted details.

The Phoenix event was held at the Ritz-Carlton Hotel. Prior to the event, one skeptical blogger emailed the Ritz-Carlton. She states that she emailed the Ritz-Carlton twice. Below is her communication:

Andrew Wakefield June 26 at The Ritz in Phoenix

Dear Sir / Madam,

I’m writing to express my extreme disappointment that such a well thought of hotel as the Ritz is playing host to this event on Saturday.

Disappointingly, The Autism Society of Greater Phoenix has chosen your venue to promote unsupported quack therapies and to support Andrew Wakefield, a man whose scaremongering has led to disastrous falls in vaccination levels among children. Levels have fallen so far that measles – a potentially fatal or crippling disease, even in countries with good levels of health care such as the UK – is now reported as once again being endemic here. Vaccination is arguably the greatest medical invention or discovery of our age, and has without doubt saved more lives worldwide than any other medical procedure. Hosting a book signing by Mr Wakefield would only indicate support for his unethical methods (including taking blood from children at a birthday party, and carrying out colonoscopies on vunerable autistic children for non-medically indicated reasons)

Many anti-vaccine activists want to return us to an age of deaths from preventable illnesses, claiming, against all evidence that vaccines are harmful, simply in order to promote their own agenda.

Andrew Wakefield is not a brave, maverick doctor, fighting the establishment, as The Autism Society of Greater Phoenix would have it; rather he has recently been struck off the medical register for horrific breaches of ethics involving non-indicated clinical procedures on children and undisclosed conflicts of interest.

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.

Best regards,

Rebecca Fisher

Andrew Wakefield – GMC ruling: http://www.gmc-uk.org/Wakefield_SPM_and_SANCTION.pdf_32595267.pdf
Vaccine preventable diseases – American Academy Of Paediatrics: http://www.aap.org/pressroom/aappr-photos.htm

The AutismOne newsletter portrayed the blogger’s actions as:

Rebecca Fisher: Pharma Blowhard or Concerned Citizen?

You can’t be a parent in this community without bumping into them. Every article, TV program, blog or radio show brings them out in force. The mention of “autism” or “Dr. Wakefield” brings them scurrying out from under their rocks snapping and snarling and spitting about the wonders of vaccines and their self-anointed roles as concerned citizens in protecting the pubic health.

It’s a scam and we all know it. Most of the bloggers, poseurs, and self-ordained autism experts have ties either directly or indirectly to pharma or mainstream medicine (which is really one and the same thing). Age of Autism has done a remarkable job outing Orac and shedding light on the soft underbelly of the vaccine apologists.

Rebecca Fisher of the UK has been very busy lately. Blogging here under the title “JABS Loonies – Justice, Awareness, Basic Support and Mind Blowing Stupidity,” Rebecca recently left the Internet safety of anonymity to engage in more concrete acts of aggression against our community.

Rebecca’s current mission is attempting to frighten, bully or pressure venues Dr. Wakefield is scheduled to speak at on his current book tour into canceling the event. Hotels are under siege by email, fax, and phone demanding they cancel Dr. Wakefield’s appearance.

For a week before this past Saturday, Rebecca attempted to intimidate the Phoenix Ritz-Carlton site of Dr. Wakefield’s latest talk into capitulation. To their credit the Ritz told her, in essence, to take a hike.

Rebecca, who also blogs as Becky Fisseux, will continue to act in a dangerous and reckless fashion until she is outed and her connections to pharma publically revealed.

Still the attacks will continue until we take legal and other appropriate actions necessary to incur real costs on those who spread lies and misinformation.

Unfortunately, the Ritz-Carlton Phoenix will not comment on the event. Ms. Fisher make a reasonable list of alleged facts that are unsupported within the complaint raised in the AutismOne newsletter. She requests proof that:

[She has] sent any more than two emails to the Ritz Carlton Group

She has] have ever telephoned the Ritz Carlton Group

I have ever sent a fax to the Ritz Carlton Group

I contacted the Ritz Carlton Group on more than one day

I used language that could be construed as “bullying”, “intimidating” or “harrassing” in my two emails (actually just one email, sent to two addresses)

The Ritz Carlton told me to “take a hike” – or in fact contacted me in any way

The AutismOne newsletter references recent events involving the blogger Orac at Respectful Insolence. It doesn’t speak well of AutismOne that they believed the Age of Autism blog piece about Orac. That piece claimed that the surgeon behind Orac had undisclosed financial ties to a pharmaceutical company, leading to a campaign to get him fired from his job. Seriously, people were encouraged in the comments on AoA to contact his employer. It is a pretty low moment for the Age of Autism. (if you are curious, Steven Novella takes apart the claimed conflict in his piece Age of Autism Witch Hunt.)

It would be all too easy to claim that the threats (and real) intimidation level is rising. I don’t know if that is the case. In recent years a blogger was expelled from an AutismOne conference for asking a tough but pertinent question of Terri Poling (mother of Hannah Poling, whose case before the vaccine court was very important–and will be again once the final settlement is reached and announced.) AutismOne is reported to have ejected journalists as well.

It is worth noting that blogger Kathleen Seidel was subpoenaed by vaccine injury lawyer Clifford Shoemaker.

I take threats seriously, as I stated above. I take bullying seriously too. It is worth questioning whether this statement “Rebecca’s current mission is attempting to frighten, bully or pressure venues Dr. Wakefield is scheduled to speak at on his current book tour into canceling the event” is really upheld by the facts. Since the Ritz-Carlton will not comment, I will await some sort of substantiation that what Ms. Fisher has done constitutes “frightening” or “bullying” or “pressure”.

I’ll leave you with the final line from the AutismOne newsletter piece on this:

“Still the attacks will continue until we take legal and other appropriate actions necessary to incur real costs on those who spread lies and misinformation.”

China not impervious to dubious autism treatments

9 Jul

Dolphins to help treat autistic children in China according to a recent story.

Complete with anecdotes:

A five-year-old boy from Anshan city who used to speak only a few words was able to go to kindergarten and even sing along with songs on television after a one-and-a-half-month treatment, Chen said.

And an odd explanation of why it works

Chen said dolphins emit high-frequency ultrasonic waves which stimulate dormant brain cells in autistic children. However, such treatment is only an assisted therapy and is not effective for all autistic children.

and claims of efficacy.

“Although the effectiveness reaches 90 per cent, some families still said the treatment was not effective for their children,” Chen said.

Now that they have the reputation, they are no longer free. They plan to charge 2000 yuan per month. That’s as much or more that the monthly salary for many in China.

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

8 Jul

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

HELP PASS THE ABLE ACT IN THIS CONGRESS!

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

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

Background

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

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

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

Status of the Bills

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

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

Take Action

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

What to say:

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

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

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

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

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

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

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

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

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

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

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

8 Jul

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

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

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

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

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

Chicago Tribune racks up another award for series exposing autism quackery

7 Jul

The Chicago Tribune has earned honorable mention from the The Casey Medals for Meritorious Journalism for its year-long series on unproven and potentially harmful “treatments” for autism.

Reporters Trine Tsouderos, Patricia Callahan, and George Papajohn “courageously challenge doctors who peddle alternative autism remedies to parents desperate for help,” said Casey’s press release “Through inquisitive, fact-based reporting, the series exposes the flimsy science behind the anecdotal testimonials that underpin uncontrolled experimentation on children.”

The prestigious Casey Medals for Meritorious Journalism have recognized exeptional coverage of disadvantaged children, youth and families since 1994. The Tribune previously won recognition from the Association of Health Care Journalism for the same series.

Congratulations to the Chicago Tribune for their unbiased and well-informed coverage.

Lorene Amet of Autism Treatment Trust discusses her beliefs about autism

6 Jul

Lorene Amet, Principal Scientist at Autism Treatment Trust and I got into a debate at Autism Gadfly blog during which I asked her to discuss her view on vaccination. She expanded these views into a blogpost which she entitled ‘Autism and the Environment’. I was puzzled at first as to why she would name a debate about vaccines such a misleading title but then, look again at the ATT page in which Lorene Amet is listed at ATT. Her heading is described as Dr Lorene Amet and whilst she is no doubt a doctor, it is maybe a little misleading that her biography does not make clear that she isn’t a medical doctor.

Amet’s post is awash with Truthiness. Take this passage for example:

First point I would like to make is that Autism Spectrum Disorders (ASD), regressive autism, Pervasive Developmental Disorder-Not otherwise Specified (PDD-NOS) are conditions that are on the increase starting from about 1988. I believe this is a real increase that is not just related to a greater awareness of the conditions and change of diagnostic criteria. However, there is no clear picture as far as Asperger Syndrome (AS) is concerned. There is no data on prevalence of AS alone, and almost certainly this condition was essentially unnoticed, considered as some sort of quirkiness, even in very recent past. Equally, many adults with AS have remained undiagnosed to this day. It is therefore possible that AS is not on the increase, in any case, the data is not there yet to answer this question accurately. However for the rest of the ASD kids, the increase seems real. I can argue this point using a range of additional arguments, but let’s not get too distracted, even if this is an essential point.

Feels true doesn’t it? Except that ‘on the increase’ is a pretty ambiguous term. ‘On the increase’ suggests that there was a clear, unambiguous starting point where we knew exactly what the prevalence of autism was. The truth is, we don’t. There is no agreement from 1988 on an international level about the prevalence of autism. Even on a county by county level in the UK or State by State level in the US, data diverges wildly if it exists at all. If anyone disagrees with this, I’d love to see concrete figures from 1988. Because only from a concrete starting point can we make concrete estimates about ‘increases’.

Amet also falls into the trap of assumption. Assumption that the only two non-environmental aspects of an ‘increase’ can be a) greater awareness and b) change of criteria. Besides these two, there are issues such as greater attainment (more centres and more experts capable of diagnosing autism), diagnostic substitution and change in public policy towards ASD (amongst others).

So is there an autism epidemic? The absolute truth is that nobody knows. To claim or even infer otherwise is misleading. As Richard Roy Grinker says in Unstrange Minds:

…the old rates were either inaccurate….or based on different definitions of autism than the ones we use now.

Amet then goes on to discuss things other than autism – a lengthy part of her post which, as it doesn’t touch on autism, isn’t important to me or _this_ post.

She then says:

The fourth point I would like to make is that Autism is associated in about 60% of the cases with health issues, digestive system, immune system and commonly presents with a regressive feature (again about 60% of cases). Some preliminary reports can be found discussed in the BMJ. This is important because we are starting to conceive that some people might be more vulnerable than others if they are placed in situations of overload. Overload can be understood quite broadly. Overload in terms of insult to the immune system, overload in terms of specific toxins (e.g. organophosphates), or overload in terms of stress, etc.

This is a very contentious argument which is again more truthiness than true. The 60% figure is unsourced and _seems_ to be numbers gained from a very biased source – ATT caseload. I would warn Amet against the dangers of cherry picking data that seems to support your ideas. Maybe it would be better to find support from the independent science on this issue.

Although this is a post that is supposed to be about vaccines and Amet’s own views on the matter, the only ‘hard’ unequivocal statement on the matter comes here:

In short, yes, in my opinion vaccination is implicated in some cases of autism, my guess estimate is in about 20% of cases of today’s autism, possibly more, but not less. There are other issues that are very important to consider and vaccination almost certainly affects a person in combination with others environmental factors and together with a genetic susceptibility.

No data is presented to support Amet’s guess, or even to support Amets guesstimate of 20%. This is the crux of the matter to me and yet I see nothing of any substance in Amet’s long post to support this belief.

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.

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