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OSR pulled from the market….or is it?

3 Aug

Here on LeftBrainRightBrain we recently discussed a letter from Boyd Haley, Ph.D. announcing his decision to voluntarily remove his product, OSR #1 from the market. The letter from Mr. Haley stated (in part):

The product will not be available for sale after that date until new drug approval has been obtained. Please continue to access our website, http://www.ctiscience.com , for updates on OSR#1® in the future.

The CTI website is down, and has been for a few days. The message I get when try it is:

HTTP Status 404 –

type Status report

message

description The requested resource () is not available.

Two locations I checked are still selling OSR.

The Forrest Health site has the letter from Mr. Haley noting that he has pulled the product from the market. They not only let you buy it, but they require that you purchase 3 or more “Note: you must order at least 3 items”.

Living Well International has OSR on their site as well. In response to my email, they response to my email request, “Do you still have OSR#1 for sale?”, they responded “Yes we do. It is $60 for a box of 30”

I do wonder how long before someone decides to make his or her own batch of OSR. Mr. Haley has been quoted as stating it was not difficult. The published recipe for the chemical indicates a few potential concerns. First, the chemicals are themselves not without hazards.

Triethylamine

Liquid causes first degree burns on short exposure; [CHRIS] Corrosive to skin; [Quick CPC] Short-term exposure at high concentrations may cause pulmonary edema. [ICSC] A lachrymator; [CHEMINFO] Experimental animals exposed repeatedly to 100 ppm show evidence of liver, kidney, lung, and heart damage. [HSDB] A corrosive substance that can cause pulmonary edema; [ICSC]

Chloroform has relatively high LD50 values (the amount where 50% of exposed animals die). But the MSDS lists reproductive toxicity as:

Birth defects have been seen in rats and mice exposed by inhalation of chloroform at concentrations greater than 100 ppm in air. Ingestion of chloroform by pregnant laboratory animals has resulted in fetotoxicity but not birth defects, and only at levels causing severe maternal effects.

Isophthaloyl chloride is only listed as an eye/skin irritant. I won’t go down the list of all the chemicals. I think you get the idea. It is likely that a competent chemist with a reasonable laboratory (including a fume hood and access to nitrogen gas) could produce “bathtub OSR” reasonably safely. I frankly cringe at the thought of someone attempting this at home. I will add, the yield of the published process for producing this chemical is about 72% without optimization. This begs the question to me as to how clean the product is in this form.

Opportunity to help improve care services for adults with autism

30 Jul

A consultation to help improve care services and healthcare outcomes for adults with autism in England was launched today by Care Services Minister Paul Burstow.

This is the next step to help adults with autism live full and independent lives as equal and included citizens and follows the publication of the strategy for adults with autism: Fulfilling and rewarding lives.

The strategy sets a clear framework for all mainstream public sector services to support adults with autism and is backed up by the Autism Act 2009, the first ever condition specific legislation.

The 12-week consultation process seeks views from those with autism, their families, carers, representative organisations and all sectors of society on a number of important issues such as:

*diagnosis of autism

*increasing awareness of autism amongst frontline staff

*provision of training and specialist training for frontline staff

*appropriate assessment of needs for those with autism

*provision of relevant services for young people and adults with autism

*local leadership for NHS and social care in relation to the provision of services for adults with autism

Care Services Minister Paul Burstow said:

“I hope people will take part in this opportunity to influence the direction and progress of our autism programme.

“It is unacceptable when adults with autism do not get the right care and support they need from health and social care services.

“The Government wants the consultation to reach as many people as possible, in line with our goal of giving people more say in the decisions that affect their lives. These views will help shape our priorities as we seek to help adults with autism live fulfilling and rewarding lives.”

Mark Lever, Chief Executive of the National Autistic Society, said:

“This is the vital next step people with autism and their families have been waiting for. During the passage of the Autism Act, Parliament described this statutory guidance as the ‘teeth’ of the Act, so it is vital that it secures real and lasting change at ground level.

“Now, I’d like to urge as many adults with autism, their parents and carers to take part in the consultation to make sure it is robust and can be used to hold their local services to account. The right support at the right time can make an enormous difference to peoples’ lives.”

The statutory guidance for health and social care will be published by December 2010. The strategy will be reviewed in 2013.

Go to http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_118058 for info packs.

Give the IACC your input on what autism research should focus upon

28 Jul

I’ve already blogged this a few times. The deadline is coming soon, July 30th. The IACC listens to public input. Whatever you think should be stressed or not stressed in autism research, let the IACC know now.

The link for the input form is here

They allow you to give very extensive responses. Don’t let this put you off. If you only have a couple comments, give them. Do it now.

Autistic adult left in van on hot day, dies of exposure

28 Jul

I have a real hard time discussing these events. The story Woods Services client dies in van appeared on a site called PhillyBurbs.com. Here are the opening paragraphs:

Middletown police are investigating the death of a 20-year-old Woods Services resident with severe autism who was left inside a van parked on the campus for more than five hours on the hottest day of the year.

Brian Nevins, originally from Queens, N.Y., died of hyperthermia Saturday after he returned with several others from a day trip to the Sesame Place theme park, said Bucks County Coroner Dr. Joseph Campbell.

ACT Now!

27 Jul

UK Autism campaigners are working together to ‘ACT NOW!’ about the proposed benefit cuts and assessments and have launched a petition which we intend to deliver personally to No 10 Downing Street. Please ACT NOW! and sign by accessing: http://actnow01.web.officelive.com/default.aspx

The proposed benefit cuts and the assessments will begin in 2013 for those on the Autistic Spectrum who are in receipt of Disability Living Allowance, Employment Support Allowance and other benefits. In addition the cuts across Local Authorities and Primary Care Trusts could have a catastrophic effect on the Autistic community, a group whose vulnerability already creates high levels of stress and anxiety to those involved.

Those who live with autism 24/7, 365 days each year will be at the core of these cuts and will have to live with whatever ensues as a result of the cuts. We are not opposed to cuts as such and understand that cuts need to be made. However the magnitude of the changes that these cuts will bring about and how they will impact on a community that is already marginalised and discriminated against, must be taken into account.

In 2008 the National Audit Office estimated that autism costs the UK 28.2 billion pounds each year and yet only 18% of Local Authorities who responded to the National Audit Office survey were able to give precise numbers of adults with low functioning autism known to services, with only 12% being able to do so for adults with high functioning autism. Given that thousands of children and adults do not meet the criteria for the provision that is available in their Local Authorities and Primary Care Trusts we would like to know how much of the money being spent is on crisis management.

The cuts to budgets in Local Authorities and Primary Care Trusts are going to make it even harder for children and adults to meet the criteria to access the provision that is available within Authorities and Primary Care Trusts, and we fear that only the minimum that can be supplied to these children and adults will be what is given. We also have grave concerns that there will be no new services that would directly benefit autistic children and adults, commissioned by Local Authorities and Primary Care Trusts.

We are calling for urgent talks with Her Majesty’s Government to ensure that those who live with autism 24/7 are consulted fairly and effectively in every aspect of the decision making process that will ultimately affect our lives.

We would like HMS Government to address and respond to our concerns. We WANT HMS Government to address and respond to our concerns.

ASAN Update on IACC Public Comment Deadline

27 Jul

The Interagency Autism Coordinating Committee (IACC) has the job of creating a strategy for the U.S. government’s research in autism. They are made up of government officials, professionals, parents and, most importantly, autistics. The IACC creates their Strategic Plan with input from the public.

One of the big opportunities to submit input is this week. The IACC has an “RFI“, request for information. This is your chance to tell the IACC what you think should (and should not) be stressed in autism research.

I was reminded of this deadline when I received an email from the Autistic Self Advocacy Network (ASAN), which I quote below:

This is another ASAN Update for bloggers in the Autistic and disability rights communities. The public comment period for the Interagency Autism Coordinating Committee (IACC) Strategic Plan for Autism Spectrum Disorder Research closes this Friday, July 30, 2010, as stated in the IACC’s reminder notice set forth below. The IACC is a Federal advisory committee that coordinates all efforts within the Department of Health and Human Services concerning autism. The Autistic Self Advocacy Network encourages public participation in the IACC’s proceedings.

As always, please feel free to contact us if you have any questions or feedback, and 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

The RFI announcement is below:

Reminder: IACC 2010 RFI to Inform the 2011 Update of the IACC Strategic Plan Closes This Friday, July 30, 2010

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 30, 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.

If you would like to respond to the RFI, please go to: http://www.acclaroresearch.com/oarc/2010rfi/. Responses will be accepted until this Friday, July 30, 2010.

Take the time to comment. You don’t have to give them permission to use your name. You don’t have to respond to every section. You can give a short comment or two (or more) and be done.

Now is the time!

OSR to be pulled from the market?

22 Jul

OSR #1, a chemical invented as a chelator and now marketed as a dietary supplement, will be pulled from the market in about 1 week’s time if the message below attributed to Boyd Haley is accurate:

On 18 June 2010, the FDA wrote to CTI Science questioning whether OSR#1® fit within the agency’s definition of a dietary supplement, indicating that instead it appeared to be a drug. Although we believe the product meets the legal definition of a “dietary supplement,” we have decided not to contest this point but to work with the agency. While achieving formal drug approval is lengthy and costly, CTI Science will in the course of it prove to FDA’s satisfaction the safety and efficacy of OSR#1® and ultimately be able to offer OSR#1® to the public with FDA-authorized therapeutic claims.

As a result of this decision, *CTI Science has voluntarily agreed to remove OSR#1® from the market effective Thursday, 29 July 2010*. The product will not be available for sale after that date until new drug approval has been obtained. Please continue to access our website, http://www.ctiscience.com , for updates on OSR#1® in the future.

On a personal note, I have met most of the medical professionals we deal with, and your passion and dedication to excellence are rarely seen these days. It has been an honor to work with you, and I am deeply appreciative of the support you have shown in the past. Please accept my best wishes for your continued success. I look forward to working with you in the future again with OSR#1®.

Boyd E. Haley, PhD

President
CTI Science-Color-EM
CTI Science, Inc.

The Twitter account for CTI science has the following message posted earlier today which would suggest the above message is accurate:

Registered Medical Professionals: Please review your email for an important message about the future availability of OSR#1®. http://www.OSR1.com

I will say that I welcome this move. I agree with the FDA that OSR #1 is not a dietary supplement and, as such, should undergo much more rigorous safety testing before being marketed.

More unidentified autistic adults found

17 Jul

One of the recurring themes heard in online discussions of autism is “where are the autistic adults?” The low number of identified adults is used as evidence of an epidemic and used to promote the vaccine-causation hypothesis.

A number of studies have started looking at adult populations and they always find a greater number of autistic adults than previously identified. Probably the largest study and the most discussed is one performed by the NHS in the UK which found a prevalence of about 1% in adults.

The NHS study looked at adults in the general population, outside of any institutional type setting.

One complaint that is often raised is where are the more severely challenged adults? The “obvious” autistics? How could they have been missed. Studies by Prof. Peter Bearman at Columbia and Prof. David Mandell have shown that, yes, we have miss counted autism in more challenged groups in the past.

Now a recent study from Iceland looks at autism in adults in Reykjavik with intellectual disabilities. They found that there were twice as many autistic adults than previously thought.

Prevalence of autism in an urban population of adults with severe intellectual disabilities – a preliminary study.

Saemundsen E, Juliusson H, Hjaltested S, Gunnarsdottir T, Halldorsdottir T, Hreidarsson S, Magnusson P.

State Diagnostic and Counselling Centre, Division of Autism, Kopavogur, Iceland.
Abstract

Background Research on the prevalence of autism in Iceland has indicated that one possible explanation of fewer autism cases in older age groups was due to an underestimation of autism in individuals with intellectual disabilities (IDs). The present study systematically searched for autism cases in the adult population of individuals with severe ID living in the city of Reykjavik, Iceland. Methods Potential participants (n = 256) were recruited through the Regional Office for the Affairs of the Handicapped in Reykjavik. First, a screening tool for autism was applied, followed by the Childhood Autism Rating Scale and finally the Autism Diagnostic Interview-Revised (ADI-R). Results The point prevalence of severe ID was 3.7/1000 (95% CI 3.2-4.1) with a male-female ratio of 1.2:1. Participation rate in the study was 46.5%. Participants were younger than non-participants and more often residents of group homes. The prevalence of autism was 21% (25/119) (95% CI 14.7-29.2) with a male-female ratio of 1.8:1. Of the individuals with autism, 10/25 (40%) were verbal according to the ADI-R definition, and 18/25 (72%) had active epilepsy and/or other neurological conditions and handicaps. Conclusion The study identified twice the number of autism cases than those previously recognised within the service system. Autism is a prevalent additional handicap in individuals with severe ID, which should always be considered in this population. There are indications that the estimated prevalence of autism found should be considered minimal.

Does this show that there has been no “epidemic”? No. But it does show (again) that the idea that autistics are so obvious that they couldn’t be missed is, well, a myth.

Withdrawn Monkey Study paper to re-emerge without Wakefield as an author

16 Jul

Consider this paper, now withdrawn:

WITHDRAWN: Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing Hepatitis B vaccine: Influence of gestational age and birth weight.

Hewitson L, Houser LA, Stott C, Sackett G, Tomko JL, Atwood D, Blue L, White ER, Wakefield AJ.

It was the big “Monkey Study” paper that was accepted for a major journal last year. It was called a “blockbuster” study at the time. Well, to Mark Blaxill at the Age of Autism it was a blockbuster. Caused a bit of a stir when Neurotoxicology withdrew the paper. Again, to the Age of Autism crowd. To the journal it only warranted a brief note, “This article has been withdrawn at the request of the editor. The Publisher apologizes for any inconvenience this may cause.”

The paper was withdrawn by the editors shortly after the Wakefield paper in The Lancet was withdrawn. It was withdrawn between the time it was published online but before it was published in a physical journal.

We’ve been told it will appear again. And, according to the references in the recent paper by Prof. Hewitson’s team, it will appear in the Journal of Toxicology and Environmental Health, Part A: Current Issues.

Hewitson L, Houser L, Stott C, Sackett G, Tomko J, Atwood D, Blue L, White ER
Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing hepatitis B vaccine: Influences of gestational age and birth weight.
J Toxic Environ Health Part A;
DOI: 10.1080/15287394.2010.484709.

Interesting. Andrew Wakefield has been dropped as an author.

When I do a search for Hewitson at that journal, I get no hits. I also don’t get a hit for the DOI number.

I also don’t find anything for a search “Delayed acquisition of neonatal reflexes” in pubmed.

If someone has a link to the paper already being published, let me know. But it looks to me like advance notice of where this paper will re-appear.

If you would like to read about that study, Orac at Respectful Insolence covered it in Some monkey business in autism research, 2009 edition. and 20 Monkeys by ScienceMom at JustTheVax

The genie is out of the bottle. Part II – more genies, more bottles

16 Jul

Was it any surprise that the journal that published the recent Hewitson stinker did so? Not really. Straight from the opening lines of the Editorial the direction this journals ‘science’ would take was clear:

This issue of Acta Neurobiologiae Experimentalis is fully devoted to the issues of autism. The idea for this topic came from Professor Dorota Majewska…

Did it indeed? I wonder if this is the same Professor Dorota Majewska who has signed her name at We Support Andy Wakefield? I’m not sure how common this name is but it would be a monumental coincedence if they weren’t one and the same person.

Getting back to the Editorial, we see some familar names from the outliers of scientific credibility – Hitlan, DeSoto, Geier – that give pause to the peer review process this journal makes its papers undertake. Are they aware of how little regard these names and their associated ‘science’ is held in in more prestigious journals and law courts?

The Editor discusses the Hewitson paper thusly:

An alarming finding is reported by Hewitson and coworkers (Ref. 4), showing that, in infant monkeys that were immunized, the amygdala does not show the normal pattern of maturation but is hypertrophied. Although these are only preliminary data, given the well-known role of the amygdala in generation of fear and other negative emotions, they support the possibility that there is a link between early immunization and the etiology of autism

How is it that an Editor and his peer review team missed that which LB/RB’s own Sullivan caught immediately? That according to this ‘alarming’ paper, pieces of the control subjects brains apparently shrank during the course of the experiment. That would certainly be an alarming result – if it were in any way true. How could it be accounted for? Too few animals in the control group or maybe just bad maths. Either way, to describe this paper as alarming might be accurate – but not necessarily for the reason that the Editor obviously feels.

They also seemed to miss Sullivan’s other finding – that two of the subjects just disappeared from the paper. To quote Sullivan:

Weren’t there 4 monkeys in the control group and 12 monkeys in the vaccinated group? What happened to the other 2 of the control subjects?

Shoddy.

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