Archive by Author

Is there value in continuing to report on Andrew Wakefield’s ethical lapses?

15 Oct

Andrew Wakefield has been a major subject of discussion here on LeftBrainRightBrain and elsewhere for many years. The question comes up repeatedly as to what is the value of continuing to discuss someone whose ideas have been discredited, and who is no longer having much of an impact on the autism research discussion.

Mr. Wakefield has publicly stated that he is “not going away”. His book has come and, for all practical purposes, gone. He no longer works for Thoughtful House. His name is being dropped from papers for projects he has worked on.

He does have a new business venture to consult with some vaccine-advocacy groups, and I am sure that from time to time he will appear in the public’s eye.

We have already discussed here at LeftBrainRightBrain the outcome of the General Medical Council (GMC) fitness to practice hearings, which found Mr. Wakefield guilty of multiple ethics violations. I recently posted observations on Mr. Wakefield’s patent activities, based on the transcripts of the GMC hearings. A valid question is why? Why go through those transcripts? The GMC already reported the results when they struck Mr. Wakefield off the register. Brian Deer has covered the Wakefield story much more thoroughly than we can here. Some people are just tired to the point of being annoyed with discussions of a Mr. Wakefield, and I can understand that.

All that said, I find the transcripts very interesting. No way I can read them all, but what I have read leaves me even more dismayed. I didn’t think it possible, but there it is.

I have already read important facts that surprised me. As I already wrote, Mr. Wakefield applied for his patent without the knowledge of his hospital. That is an amazingly foolish maneuver. This could have invalidated the patent. It was also foolish in that he could have left out key claims that could have protected the Hospital’s intellectual property. On many, many levels, this was a foolish thing to do.

I remain intrigued by the hearing transcripts. I am finding things I didn’t know. I assume those who don’t want to read will skip the posts, and some will read and a discussion will ensue.

So, I will blog about the hearing transcripts. With apologies to those who are tired of the Wakefield story. With no apologies to those who defend Mr. Wakefield and have accepted his rationalizations.

One problem is that there are so many details, so many ethical lapses, multiple conflicts of interest, so many details that it is easy to lose sight of what all this means.

This is long saga. For the most part, each day is a separate Word document and there 155 of them. A typical day’s testimony can be 80 pages long. Even the GMC decision is long. But what it shows is a pattern of multiple instances of lack of respect for the disabled children in his group’s care, multiple instances of disregard for ethical standards, multiple instances of conflicts of interest.

There is a pattern here. And it is pretty ugly.

No association between XMRV and autism?

15 Oct

Recently there has been growing interest in XMRV (Xenotropic murine leukemia virus-related virus) and autism. I haven’t discussed it here on LeftBrainRightBrain as it has been very preliminary.

Well, it looks like I may not ever get into this story in depth as XMRV appears to not be associated with autism.

From ERV at ScienceBlogs, XMRV and Autism: Best conflict of interest EVAH! I learned of this new paper:

PCR and serology find no association between xenotropic murine leukemia virus-related virus (XMRV) and autism

Here is the abstract.

Xenotropic murine leukemia virus-related virus (XMRV) is a retrovirus implicated in prostate cancer and chronic fatigue syndrome (CFS). Press releases have suggested that it could contribute to autism spectrum disorder (ASD). In this study we used two PCR assays and one antibody assay to screen 25 blood samples from autistic children born to mothers with CFS and from 20 mixed controls including family members of the children assayed, people with fibromyalgia and people with chronic Lyme disease. Using a real-time PCR assay, we screened an additional 48 South Carolina autism disorder samples, 96 Italian ASD)samples, 61 South Carolina ASD samples and 184 healthy controls. Despite having the ability to detect low copy number XMRV DNA in a large background of cellular DNA, none of the PCR assays found any evidence of XMRV infection in blood cells from patients or controls. Further, no anti-XMRV antibodies were detected, ruling out possible low level or abortive infections in blood or in other reservoirs. These results imply that XMRV is not associated with autism.

“These results imply that XMRV is not associated with autism.”

ERV noted this paragraph of the paper:

In an interview given on the same day as the Lombardi publication, Dr Mikovits stated that they had found XMRV in a ‘significant number’ of autism spectrum disorder (ASD) samples and speculated that ‘this might even explain why vaccines lead to autism in some children’ [6]. Shortly thereafter, widely circulated articles appeared, containing non-peer reviewed data with reports that XMRV may be present in ?40% of people with autism [7]. Given the recent controversy over the connection between ASD and the MMR (measles, mumps, rubella) vaccine, a scientific evaluation of these statements is important [8,9].

Translation (via ERV):

Mikovits started talking to the media/patients/parents before she had any published science to back up her claims. She increased fear of vaccines. She still hasnt published anything. So I guess we are going to clean up this mess for her.

Also, ERV points out one of the most interesting competing interests statements in a paper:

COMPETING INTERESTS
BCS and RAG are employees of Cooperative Diagnostics. Cooperative Diagnostics is a commercial enterprise that owns the rights to the XMRV real-time PCR assay described in this manuscript, in addition to the Master Mix that was used. Publication of these results may well reduce the potential market that Cooperative Diagnostics could reach with its XMRV assay.

Yes, the authors are from a company which has rights to XMRV tests. If XMRV is not associated with autism, this company stands to make less money in the future.

Ironically, David Kirby is scheduled to present “breaking news” at an upcoming workshop in November:

Breakthrough News: David Kirby will discuss the recent research by Judy Mikovitz of the University of Nevada. Dr. Mikovitz helped discover that XMRV retrovirus was present in 95% of people with chronic fatigue, and she also found in 40% of a small sample of ASD kids. So far, virtually all of the kids whose moms have XMRV and chronic fatigue also have the XMRV virus.

Somehow I doubt the facts in this new study will divert Mr. Kirby from his “breaking news”. Facts have failed to stop him in the past.

Should the FDA issue more warnings on chelation and autism?

14 Oct

The FDA recently issued warning letters to a small group of companies which market chelators for, amongst other dubious reasons, the treatment of autism. As an example, one of these groups is selling sodium EDTA (with statements like, “Thus, there are no harmful side effects with Kids Chelat”).

I am not sure of the logic which led the FDA to target this small group for the first warning letters.

Why not warn, say:

Defeat Autism Now doctors? (a list of which can be found on the autism.com website)

DAN is a part of the Autism Research Institute, which claims that chelation is safe and effective in the treatment of autism.

Dr. Rashid Buttar is well known for his treatment of many conditions, including autism, with chelation.

Of course, one need only enter autism and chelation into google and watch what ads pop up.

Lee Silsby (a compounding pharmacy) is one of those ads. They list chelators like DMPS, EDTA and DMSA under “autism treatments”, with a links to “Read a patient’s inspiring story about our Transdermal DMSA.” and “View NBC new’s coverage of a patient’s amazing Lee Silsby Transdermal DMSA “story.

We can go on and on. The question is, why didn’t the FDA? Why stop at only eight warning letters?

Torturers of Autistic Man Walk Free

14 Oct

Taken verbatim from the NAS website. this is a very distressing story that needs to be widely publicized.

The National Autistic Society has reacted in anger at the news that three men who attacked and tortured a young man with Asperger syndrome have been denied a custodial sentence, and we need your help in calling for the Attorney General to review the ruling.

The victim, who is 17 years old, was subjected to a three day ordeal during which he was brutally and maliciously tortured. However, his assailants – Jack Bolton, Andrew Griffin and Nathan Marshall – were handed a meagre 80 hours of community service for their crimes. The victim’s family described the ruling as a “joke”.

To support our campaign to review the ruling and demand a tougher sentence for the perpetrators of the crime, please follow this link. We have set up an email action directly to the Attorney General’s office, demanding a review – it should only take you a couple of minutes to do.

Mark Lever, Chief Executive of the National Autistic Society, was “sickened” by the news, and labelled the judgement insulting:

We are sickened and appalled, not only by the heinous acts of violence committed against a vulnerable young man with autism, but by the abhorrent leniency shown to the perpetrators. Their sentence is profoundly insulting to people with autism and their families and in no way reflects the lasting damage disability hate crime inflicts on victims’ lives.

The National Autistic Society will be looking to work closely with Hazel Blears, who is the victim’s constituency MP, to seek Government action on this specific case. We will also be calling for firmer Government action to address wider issues around disability hate crimes. In representations to Dominic Grieve QC MP, the Attorney General, we will be calling for him to review the ruling.

Read our official media response to this story
Read the full story on the Daily Mail website (We would like to give advance warning that the content of this story is very distressing.)

Reading Age of Autism Part 5 – hodge podge of ideas

14 Oct

Chapters 5 and 6 are quite difficult to blog about. On the surface they carry a surfeit of information but somehow all that useful information gets lost in the authors determination to make the facts fit their ideas.

In Chapter 5 we’re introduced to the idea that ethylmercury in two forms was invented. Fungicide and medicinal. And thats about it. There’s little that’s contentious to blog about.

In chapter 6 however we finally start to meet Kanner and Asperger’s case study kids. This had the potential to be one of the most thrilling episodes of the book but from a literary standpoint it is badly botched and badly edited. It starts off reasonably well with condensed histories of a few of Kanner’s kids but then starts to degenerate into the realms of silliness desperately shoehorning the kids parents into two categories – ‘the fungicide cluster’ and ‘the medical cluster’. For example, Kanner’s Case 1 – Donald T – is placed by the authors into the fungicide cluster….why? Because he lived in the vicinity of Forestry work.

They have better luck with Fredrick W (Case 2) as his dad was a plant pathologist but even this is still not evidence. Correlation does not equal causation after all and the authors give no real insight into _how_ they think these kids were made autistic by ethylmercury, just offering some fairly scant evidence that one parent might have worked with mercury or that they lived fairly close to where fungicide was used.

The authors get going with gusto when they reach the medical cluster – why? Because now they can finally get their teeth into the _real_ source of their displeasure – vaccines.

The city’s residents were bombarded…

Page 180

…heightened risk of infant vaccination…

Page 181

One child had a mum who was a Paediatrician. However as they also state:

…there is an association in time – one we concede is speculative – with…the first thiomersal containing vaccine.

Page 184

Four of Kanner’s kids had dads who were psychiatrists. The authors claim this is more evidence as the standard of care for neurosyphilis was still mercury. But not, you’ll note ethylmercury. Blaxill and Olmsted have spent three chapters outlining the symptoms of mercury poisoning via neurosyphilis and hammering home the point that autism is _new_ with a _new_ set of symptoms and that various types of mercury poisoning produce differing symptoms. To go back all of a sudden and claim that now its _not_ new is more than a little duplicitous.

Four of Kanner’s kids have no connection to either fungicides or medicine via parent occupations. Blaxill and Olmsted attempt to explain these away by saying that these kids probably lived in areas where universal vaccination was in place. This is worse than speculative – its tenuous.

And speaking of tenuous:

Donald…underwent a series of treatments with Gold Salts that lasted several months…[which were]…the standard remedy for JRA [Juvenile Rheumatoid Arthritis] .

….

His arthritis cleared up…[b]ut something even more remarkable happened…the defining features of his disability lessened dramatically and permanently.

Page 197, inserts mine

What Blaxill and Olmsted fail to mention is that it would be _impossible_ to chelate mercury from the body using Gold Salts. Why? Because gold only dissolves mercury when both in their metallic state. Donald was administered Gold _Salts_ .

And lets look at these features of Donald T’s which defined his disability: nervousness, extreme anxiety and lack of sociability. The latter, yes, that’s obviously a clear autistic trait but the former two? What have they got to do with autism from a diagnostic _defining_ stance? The answer is nothing.

So here we have much ado about nothing. Donald was given a substance that could not _possibly_ have chelated him and even if it had, the most it did in terms of ‘curing’ his autism was to make him more social and even if it _did_ make him more social even the authors admit it only ‘lessened’ his unsocial nature, it didn’t remove it.

The book overall is starting to edge into familiar AoA (the website) territory now. Things that really shouldn’t be left unsaid are being so and things that are said are being squeezed dry of factual content in order to meet a pre-conceived agenda. Thats no good for a scientific approach.

FDA: Chelation not proven safe or effective in treating autism

14 Oct

Chelation is a process whereby metals are removed from the body using a drug, a chemical which binds to the metals and allows them to be excreted. Because of the incorrect notion that autism is caused by mercury or is a “novel” form of mercury poisoning, chelation is one of the more common alternative medical therapies applied to autistics.

The FDA has recently issued a warning to many of those who market unapproved chelators. Two articles appear on the FDA website today:

FDA Tightens Reins on Unapproved ‘Chelation’ Drugs

and a press release

FDA issues warnings to marketers of unapproved ‘chelation’ products.

They have also issued a printer-friendly pdf: FDA chelation warning pdf

From that pdf:

Federal regulators are warning eight companies to stop selling so called ‘chelation’ products that claim to treat a range of disorders from autism to Alzheimer’s disease by removing toxic metals from the body.

The Food and Drug Administration (FDA) says the companies have not proven their products are safe and effective in treating autism spectrum disorder, cardiovascular disease, macular degeneration, Parkinson’s disease or any other serious illness. Some of the companies also claim their products can detect the presence of heavy metals in the body in an attempt to justify the need for chelation therapy.

The groups that have been warned are:

• World Health Products, LLC: Detoxamin
Oral, Detoxamin Suppositories, and the
Metal Detector test kit
• Hormonal Health, LLC and World Health
Products, LLC: Kelatox Suppositories,
and the METALDETECTOR Instant Toxic
Metals Test
• Evenbetternow, LLC: Kids Chelat Heavy
Metal Chelator, Bio-Chelat Heavy Metal
Chelator, Behavior Balance DMG Liquid,
AlkaLife Alkaline Drops, NutriBiotic
Grapefruit Seed Extract, Natur-Leaf,
Kids Clear Detoxifying Clay Baths, EBN
Detoxifying Bentonite Clay, and the
Heavy Metal Screen Test
• Maxam Nutraceutics/Maxam Laboratories:
PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx,
Anavone, AV-Rx, BioGuard, BSAID, CF-Rx,
CreOcell, Dermatotropin, Endotropin,
GTF-Rx, IM-Rx, Keto-Plex, Natural Passion,
NG-Rx, NX-Rx, OR-Rx, Oxy-Charge,
PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and
the Heavy Metal Screening Test
• Cardio Renew, Inc: CardioRenew and
CardioRestore
• Artery Health Institute, LLC: Advanced
Formula EDTA Oral Chelation
• Longevity Plus: Beyond Chelation
Improved, EndoKinase, Viral Defense,
Wobenzym-N
• Dr. Rhonda Henry: Cardio

I wonder how the FDA chose these groups for the first round of warnings. I also wonder if/when there will be more warning letters.

Also from the FDA pdf:

FDA says consumers should avoid nonprescription products offered for chelation or detoxification. FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as the treatment of lead poisoning and iron overload. The agency says even the prescription medications carry significant risks, and they should only be used with medical supervision.

I don’t know why the FDA has taken so long to step in and take action. Chelation has been going on for years, and has never had a sound basis in science or even a good rationalization for the treatment of autism.

Trine Tsuderous has an article on the Los Angeles Times website, FDA warns about treatments for autism, heart disease.

Reading Age of Autism Part 4 – Stretching the truth

13 Oct

Over the last few days, I’ve tried to show how the authors of Age of Autism have retro-fitted the symptoms of mercury poisoning to try and make them await a diagnosis of autism. They have suggested things like tremors, paralysis, reddening of extremities and various other things are very similar to symptoms of autism. Or at least, they _will_ suggest these things in upcoming chapters (I’ve already noted a large passage on the thoroughly debunked Bernard paper later on in the book). They are also working hard throughout Chapters 1 – 4 to enforce the idea that things like schizophrenia, bipolar, Down syndrome and of course autism are _new_ things.

Nowhere (so far) in the book is this more apparent than Chapter 4 (entitled Pollution):

But were these men really seeing something that had been missed for centuries? Or did they happen to be in a position to observe a cluster of cases of chronic disease as it first appeared?…What if they were diseases born of the newest phase of human civilization, children of coal combustion, distributed mechanical power and the Industrial Revolution?

Page 125

However, a large block positioned itself in front of Olmsted and Blaxill in the shape of Dr John Haydon Langdon Down. The first person to classify what later came to be called Down Syndrome. However, as is clear from the work Of Dr Darold Treffert, he also found both early onset and late onset autism.

The authors don’t like this. It puts the carefully emerging hypothesis in grave danger. Why? If autism existed before the emergence of ethylmercury then their ideas are moot, the part of Chapter 5 I have read so far makes this clear. This is the very hypothesis they are working towards. So in order to protect their hypothesis, they rubbish Darold Treffert’s findings.

Down classified two groups that contain descriptions of autism. Groups he called ‘developmental’ (what might be called ‘regressive’ today) and ‘accidental’ (autistic from birth). First Blaxill and Olmsted tackle the problem (from their viewpoint) of ‘accidental’ autism.

Unfortunately, none of these accidental cases are ever fully described and so its impossible to distinguish between true autism cases or just the scattered presence of autistic behaviours.

Page 129

And then ‘developmental’ autism.

In making the case for Down as an early observer of autism, Treffert relies on his idiosyncratic willingness to set aside the timing of onset as a relevant marker for an autism diagnosis. Most of the cases he proposes as autistic wouldn’t pass that bar for other observers.

Page 129

However, in regard to ‘accidental’ autism I urge the reader to look at the following passages Treffert quoted from Dr Langdon Down:

“bright in their expression, often active in their movements, agile to a degree, fearless as to danger, persevering in mischief, petulant to have their own way. Their language is one of gesture only; living in a world of their own they are regardless of the ordinary circumstance around them, and yield only to the counter-fascination of music.”

“I know nothing more painful than the long motherly expectancy of speech; how month after month the hopes are kept at high tension, waiting for the prattle which never comes. How the self-contained and self-absorbed little one cares not to be entertained other than in his own dream-land, and by automatic movements of his fingers or rhythmical movements of his body… they have well-formed heads, finely-textured skins, well-chiseled mouths, sparkling eyes, features when in repose leading one to augur only brightness and intelligence… he runs to you when called but makes no response in words. He returns your kiss with a bite, and runs away with agile steps, rolling his head with a horizontal swaying motion…”

This is the group Blaxill and Olmsted claim are not described enough. Hardly. This is autism.

In regard to the ‘developmental’ group, Treffert quoting Langdon Down describes them thus:

In these children the early months of childhood were uneventful and “intelligence dawned in the accustomed way.” But later, around age six or so, ” a change took place in that the child’s look had lost its wonted brightness; it took less notice of those around it; many of its movements became rhythmical and automatic.” There was “cessation of increasing intelligence”, deferred speech and “lessened responsiveness to all the endearments of its friends.” Dr. Down writes “I have had many examples of children who had spoken well and with understanding, but who lost speech at the period of the second dentition, and had also suspension of mental growth.” Dr. Down provides several examples. One was a boy who “attracted no particular attention during the first six years of life” but then “during the period of second dentition” suddenly lost speech. “He heard everything that was said, but never replied to a question.” This child did gradually regain some speech but “afterwards always spoke of himself in the third person.” The other case example was that of two brothers who also “both lost speech at the period of second dentition.”

Blaxill and Olmsted dismiss this second category because of the phrase _first dentition proceeding_ stating that this means these kids were too old for an autism diagnosis. However, late regression is far from unknown in modern times. The author and ex-Guardian columnist Charlotte Moore describes her son Sam undergoing several regressions way past the modern ‘cutoff’ age of three.

I emailed Dr Treffert to see what he made of Blaxill & Olmsted’s claims. Here is his email to me quoted in full.

The authors, to the contrary, understate the remarkably perceptive and accurate observations Down made of what is unmistakably early onset and late onset autism. I discuss those highly accurate before-their-time observations by Down
in my internet posting of an article titled “Dr. J. Langdon Down and Developmental Disorders” in the articles section of the savant syndrome website at www.savantsyndrome.com. The authors omit many of Down’s terms and traits which apply so often to autism–
speaking in the third person; “fearless as to danger”; “living in a world of their own”; fascination with music; “self-contained” and “self-absorbed”; in a “dream-land”; “automatic movements of fingers or rhythmical movements of the body” and “runs to you when called but makes no response in words”. And so on and so on. Likewise Down makes clear reference to what we now call “early onset” and “late onset” forms of autistic disorder. I refer your readers to the article above where Down, while not using those present day terms, clearly lays out the existence of those two differing-onset scenarios.

Of equal interest is the fact the Down choose the term “developmental retardation” to describe this form of disorder separate from “congenital” and “accidental” types of “retardation”. Now in fact, over a century later, autistic spectrum
disorders are classified as “Developmental Disorders”. Another before-its-time credit to Dr. Down.

I read Down’s lectures in my effort to trace the beginning descriptions of savant syndrome. As I read about savant syndrome, I was surprised to find such an early description of “developmental retardation” which we now call autistic spectrum disorder by Dr. Down more than a century ago. I wrote my article above to provide some context for present day consideration of an ‘epidemic’ of autism. I wanted simply to point out that autism did not begin with Dr. Kanner’s description of it in 1943, but rather has no doubt been present in some portion well before that time. Dr. Down’s accurate description of both early onset and late onset autism, while he did not use that terminology, provided some documentation, and perspective, that autistic disorder has been around for a very long time. And that fact needs to be considered in looking at incidence and prevalence at present day levels.

The best way to answer the book’s portrayal of my observations and conclusions regarding Dr. Down and autism, is for the reader to go to my article and draw their own conclusions. I am sure they will agree that what Dr. Down described was early and late autistic disorder in unmistakable terms.

*Please note my conversation with Dr Treffert is ongoing, I’ll publish the whole conversation in a separate blog post* .

Later on, with irony so thick you could almost taste it, Blaxill and Olmsted after waving aside clear descriptions of autism say (regarding a separate matter):

There was no evidence, no proof, just an elaborate exercise in anthropological speculation that was also at odds with the facts.

Page 134

So far, that’s the best description of Age of Autism I’ve yet heard.

End of the R-word?

12 Oct

The following is a press release from The Arc of the United States. It discusses a new law which will change the wording in many governmental uses from “mental retardation” to “intellectual disability”

E-Newsletter Issue Date: Monday, October 11, 2010

On Friday afternoon, President Barack Obama put his pen to work signing the Twenty-First Century Communications and Video Accessibility Act of 2010 into law, delivering brief remarks on the impact of the law on people with disabilities and celebrating Rosa’s Law. The law, which was enacted by the President on Tuesday, substitutes the term “intellectual disabilities” for “mental retardation” in many federal laws.

Self-advocates William Washington (The Arc’s national office receptionist), Jill Egle (Co-Executive Director, The Arc of Northern Virginia) and Jeremy Jacobson (son of The Arc’s Chief Development and Marketing Officer Trudy Jacobson) joined Paul Marchand, Director of the Disability Policy Collaboration to represent the intellectual and developmental disability community whose advocacy resulted in this bill.

Nine-year-old Rosa Marcellino, for whom the law was named was in attendance with her family and received a hug from the President. Also in attendance were the bill’s sponsors, key policy leaders and musician Stevie Wonder.

Rosa’s Law was passed by the Senate earlier this year and passed the House in September. Self-advocates and The Arc have led the effort to get the bill enacted as part of a nationwide effort to remove the stigma of the “r-word.” The majority of states have altered their terminology by replacing the term “mental retardation” with “intellectual disability” in state laws and in the names of state agencies that serve this population.

Changes in terminology are another stepping stone toward realizing a more inclusive society. The Arc was instrumental in the passage of Rosa’s Law by galvanizing support across the nation and through vigorous advocacy. “We have achieved another historic milestone in our movement. We understand that language plays a crucial role in how people with intellectual disabilities are perceived and treated in society. Changing how we talk about people with disabilities is a critical step in promoting and protecting their basic civil and human rights,” said Peter V. Berns, CEO of The Arc.

The Twenty-First Century Communications and Video Accessibility Act increases accessibility for people with sensory disabilities to modern communications, such as internet access over smart phones. The Arc also advocated strongly for this legislation and celebrates its enactment.

Reading Age of Autism Part 3 – Building the case

12 Oct

Chapter 3 of Age of Autism (Age of Acrodynia) concentrates on two things. Firstly the text discusses Pink Disease which is:

…a disease of infancy and early childhood marked by pain and swelling in, and pink coloration of, the fingers and toes and by listlessness, irritability, failure to thrive, profuse perspiration, and sometimes scarlet coloration of the cheeks and tip of the nose. It is due to absorption of mercury. Called also erythredema polyneuropathy and pink disease.

Source

OK so thats all well and good. However the _subtext_ of this chapter is a little bit more paranoiac. Oh and when I say ‘subtext’ I’m being kind. It’s really not subtle enough to be a subtext.

Point one of the subtext – establish the idea that all forms of mercury poisoning are different from each other:

Over centuries of misuse, wide variations in formulation have generated a wide variety of symptoms, symptoms disparate enough to generate consistent controversy over whether they resulted from mercury exposure or something else. Anyone who believes he or she has isolated mercury’s specific effects and pinned one on an exact dose of a particular formulation is….showing a naive and inadequately respectful grasp of the dangers of quicksilver and its progeny.

Page 94

Here Blaxill and Olmsted begin to build the case that autism is _different than any other form of mercury poisoning_ and that those of us who believe it looks nothing like mercury poisoning are ‘naive’.

However, what Blaxill and Olmsted fail to grasp- or tell the reader – is that there are symptoms common to all forms of mercury poisoning which just do not apply to autism.

Methylmercury poisoning
– impairment of the peripheral vision;
– disturbances in sensations (“pins and needles” feelings, usually in the hands, feet, and around the mouth);
– lack of coordination of movements;
– impairment of speech, hearing, walking; and
– muscle weakness.

Elemental mercury effects
– tremors;
– emotional changes (e.g., mood swings, irritability, nervousness, excessive shyness);
– insomnia;
– neuromuscular changes (such as weakness, muscle atrophy, twitching);
– headaches;
– disturbances in sensations;
– changes in nerve responses;
– performance deficits on tests of cognitive function.

Inorganic mercury
– skin rashes and dermatitis;
– mood swings;
– memory loss;
– mental disturbances; and
– muscle weakness.

Source.

None of these symptoms look anything at all like autism to me. Sorry boys, swing and a miss.

Point two of the subtext – establish the idea that all forms of mercury poisoning were unique to their times.

Pink disease was _new_ . Once again the remedy was the disease and once again the clues were there.

By attempting to establish that Pink disease was new, it will be easier later on in the text for Blaxill and Olmsted to pretend knowledge that posits _autism_ as new. Once again though, they are troubled by the fact that autism doesn’t look like mercury poisoning…or are they?

Perhaps the most affecting evidence of calomel’s tragic legacy comes from the testimony of those who suffered from Pink disease and are now adults, many of whom still suffer from severe side effects. A high profile survivor is Heather Theile of Australia. She founded the Pink Disease Support Group in 1989. She describes her life today:

n particular, I have a terrible sense of position of both my body and hands. For example, it takes me ages to line up a clothesline, the clothes and the pegs to hang out clothes. I have to have a rope hanging down from the ceiling of my car port to be able to have a guide to park the car in the correct place. I am hopeless with any locks, catches, car seat catches etc. I go to open a door, but miss the catch by inches. I drift when walking and often bump into walls and doors. I cannot cope with verbal instructions at all and have to write “everything” down. This is known as “thinking in pictures” (Temple Grandin).

Grandin is probably the most famous person in the world diagnosed with autism; Thinking in pictures is the name of her best known book.

Well Dan and Mark, Heather Theile also says:

…As you said “mercury is mercury is mercury”, and I would add, “mercury poisoning is mercury poisoning is mercury poisoning”.

Given that you’ve worked so hard to shake off that very notion in the last three chapters, would you say Heather Thiele is _really_ someone you can rely on to be objective?

The game stepped up in this last chapter. Blaxill and Olmsted are working hard to prepare the ground for their main idea – autism is both new and a new form of mercury poisoning. However so far, they’re not doing all that well.

Andrew Wakefield’s vaccine patent

11 Oct

I’m reading through the transcripts from the General Medical Council Hearing on Andrew Wakefield and his colleagues at the Royal Free Hospital. It is long. Very long. Each day runs tens of pages (day 31 is 79 pages alone). Even beyond the bulk of the proceeding I find it difficult reading. I find it very difficult to read about the ethical lapses committed in the name of care of disabled children. Because of that, I quickly moved to a topic I have already written about and one that is less painful to discuss: the patent application Mr. Wakefield submitted on his “transfer factor”.

A thorough discussion of the patent history can be found on Brian Deer’s website. Brian Deer is the journalist who uncovered much of what the GMC was later to pronounce as ethical violations.

The patent is very clear in that it covers both the use of the transfer factor as a therapeutic agent and as a prophylaxis. In other words, Mr. Wakefield patented a treatment and a vaccine. Even though this is painfully clear, Mr. Wakefield has continually denied that the invention was a vaccine.

Day 31 of the hearing went into great detail about the patent. I was surprised to read (or had forgotten had I read before) that Mr. Wakefield applied for the patent without his hospital’s knowledge. This is very odd since the Royal Free was named as the applicant.

Below is a section from a memo, dated March 10, 1998 from Ruth Bishop to Cengiz Altan Tarhah, of University College, London (of which the Royal Free Hospital is a part).

Last summer, Andy Wakefield wrote to the School describing a patent application which he had personally filed along with Neuroimmuno Therapeutics Research Foundation (NIT). This was filed without the School’s knowledge, although in the name of the School. This application concerns the ‘transfer factor’ and Mr Wakefield asked if the School would be prepared to take on the prosecution and costs – he was (and is) meeting these himself.

Applying for a patent without approval from his institution is amazingly foolish. Aside from the obvious chutzpah, it basically invalidates the patent. For most people this would be a remarkable career mistake. While is is serious, it pales in comparison to the many other ethics violations that the GMC found Mr. Wakefield guilty of.

Let’s take a closer look at the question of whether it was Mr. Wakefield’s intent to use the invention, the “transfer factor”, as a vaccine. Mr. Wakefield submitted a business plan whereby he and the father of child 10 (the 10th child in the Lancet study) would develop the transfer factors.

In parallel with the clinical trial the company will develop a clinical diagnostic for the presence of the measles virus. It is estimated that the market for this diagnostic is about £4,000,000 per annum in the UK alone. The company will also investigate the potential of transfer factors as vaccine alternatives. An animal model trial of the value of measles specific transfer factor in preventing inflammatory bowel disease will begin upon securing funding.

Emphasis added.

Recally, Mr. Wakefield contended that the MMR was causing inflammatory bowel disease. He had plans to test his transfer factor to prevent IBD, not just to treat it.

It was a Vaccine.

Should that language be vague enough for some to still claim Mr. Wakefield didn’t intend on developing a vaccine. Here is a section from the “Strategy and Objectives” section of the business plan:

[Immunospecifics] is at present no more than a concept, but one with a unique opportunity. The strategic goal for the venture will be to achieve full regulatory approval for the use of antigen (infectious agent) specific transfer factors in a variety of clinical conditions where existing treatment regimes are either non-existent or have limited effectiveness. This strategy will permit the company to establish a clear technical and medical lead in this area with a resulting dominant market share. Paralleling the use of [transfer factors] as therapeutics will be a research programme aimed at demonstrating the value of [transfer factor] as a vaccine.

Emphasis added.

Again–a vaccine in addition to a therapy.

It was a vaccine.

A sub-heading of “Strategy and Objectives” reads: Establish the potential of the high specific active preparations as a potential measles vaccine. It just doesn’t get much clearer than that.

This study will be done in conjunction with ‘Immuno’ a subsidiary of Baxter Health Care, in Austria using simian model systems. The efficacy of the [transfer factor] will be assessed by its ability to prevent measles specific IBD during challenge experiments. ‘Immuno’ have agreed to undertake the preliminary work with the [Royal Free Hospital] at no cost, although Immuno’s contribution is estimated to be of the order of £100,000. If successful this concept will be developed further in collaboration with a major pharmaceutical company, such as Glaxo Wellcome’s Jenner Institute. The full relationship between ISB and Immuno needs to be resolved.”

They planned to develop this with someone like Glaxo Wellcome’s Jenner Institute. That would be a vaccine research group (Jenner being the inventor of the first vaccine, for smallpox, in the 18th century).

Further, the business plan included objectives:

“Medium term objectives for the venture will be: 1) to take the purified and characterised measles specific [transfer factor] through formal product registration by undertaking phase II and phase III clinical trials; 2) establish the most appropriate route for the commercial development of the product; 3) develop the potential for use of [transfer factors] as vaccine replacements; 4) introduce new anti-infectious agents TFs to the company’s product development portfolio and take them through to formal product registration.”

Emphasis added.

Vaccine replacements. Replacements. Not “we are using the name vaccine to mean a therapy”, but a replacement.

I know I’ve given the evidence a number of times in this post, but I just can’t understand why Mr. Wakefield even tries to deny his intent to develop a vaccine in the true sense of the word.

It was difficult to understand how people believed Mr. Wakefield’s story before. I will be amazed (but not surprised) that they continue to do so.

Just in case you missed it, here is one of the goals for Mr. Wakefield’s proposed company: “Establish the potential of the high specific active preparations as a potential measles vaccine”