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The Rouse letter: how Wakefield was almost caught in 1998

19 Oct

For those who have followed the story of Andrew Wakefield, the fact that he had multiple conflicts of interest is not news. The subjects in his now retracted 1998 paper in The Lancet were far from a random sample of autistics. They were even far from a random sample of autistics with GI problems. Brian Deer has made this very clear. The GMC ruled that it is clear that Andrew Wakefield was fully aware of the biased nature of these children.

But, Brian Deer was not the first to catch on. A letter to the Lancet in May 1998, a few short months after the now retracted Wakefield paper was published, a letter to the editor was published. It was by a Mr. Rouse, a public heath professional:

“Sir – After reading Andrew Wakefield and colleagues’ article I did a simple internet search and quickly found the Society for the Autistically Handicapped. I downloaded a 48 page fact sheet produced for the Society by Dawbarns, a firm of solicitors in King’s Lynn.

It seems likely then that some of the children investigated by Wakefield et al came to attention because of the activities of this Society and information from parents referred in this way would suffer from recall bias. It is a pity that Wakefield et al do not identify the manner in which the 12 children investigated were referred (e.g. from local GPs, self-referral via parents, or secondary/tertiary or international referral). Furthermore, if some children were referred directly or indirectly because of the activities of the Society for the Autistically Handicapped, Wakefield should have declared his co-operation with that organisation.”

It was so close to exposing the truth, but there would be another 6 years before Brian Deer would reopen the question and show that Andrew Wakefield did indeed have serious conflicts of interests (as well as many ethical failings) in the Lancet paper.

Mr. Rouse stressed the “Society for the Autistically Handicapped”, which Mr. Wakefield was able to claim no association with. Here, read the Wakefield response for yourself. The first two paragraphs refer to other letters to the Lancet, I am only showing the response to the Rouse letter:

A Rouse suggests that litigation bias might exist by virtue of information that he has downloaded from the Internet, from the Society for the Autistically Handicapped. Only one author (AJW) has agreed to help evaluate a small number of these children on behalf of the Legal Aid Board. These children have all been seen expressly on the basis that they were referred through the normal channels (eg, from general practitioner, child psychiatrist, or community paediatrician) on the merits of their symptoms. AJW had never heard of the Society for the Autistically Handicapped and no fact sheet has been provided for them to distribute to interested parties. The only fact sheet that we have produced is for general practitioners, which describes the background and protocol for investigation of children with autism and gastrointestinal symptoms. Finally all those children referred to us (including the 53 who have been investigated already and those on a waiting list that extends into 1999) have come through the formal channels described above. No conflict of interest exists.

Much discussion went into this exchange. There even appears to be two versions of the Rouse letter.

Mr. Wakefield argued that his response was factually correct. That he responded to some specific questions raised by the Rouse letter. I am reminded of the courtroom oath in the United States, that one must tell the truth, the whole truth and nothing but the truth. Mr. Wakefield seems to avoid “the whole truth” here and elsewhere.

Here is what the prosecution had to say about Mr. Wakefield’s response:

So even at that stage, we suggest that Dr Wakefield failed to set out in straightforward terms the nature of his involvement with the litigation and the receipt of funding, because he says he has never heard of the Society for the Autistically Handicapped – well, fair enough – but he does not state that he had heard of, and had been working for more than two years with, Dawbarns, who were the solicitors in the MMR litigation, as an expert for them. That is despite the fact that he is responding to an allegation which he himself understood to be alleging litigation bias.

Secondly, he says that he “has agreed to help evaluate a small number of these children on behalf of the Legal Aid Board”, but he makes no reference to the fact that they had funded his research to the tune of £25,000 at that stage, with more anticipated to come.

Dr Wakefield’s explanation for that, you will not be surprised to hear, is that he was responding to specific points only. It is our submission that it is a hallmark of his evidence that he falls back on this kind of terminological or grammatical analysis of allegations or questions which have been put to him in an attempt to obscure his own failure to respond openly and honestly and then he places the burden on others to pin him down and to ask for what he actually describes as “further and better particulars”. So he says that is what should be done if people want straightforward answers, in effect.

It is worth seeing how Mr. Wakefield’s colleagues thought of the Rouse letter. In summarizing the defense for Prof. Walker-Smith (one of the Wakefield team who was also sanctioned by the GMC), his attorney noted

(a) At the time that the Lancet children were investigated at the Royal Free, Professor Walker-Smith had no knowledge of Dr Wakefield’s dealings with the Legal Aid Board.

(b) Some time around the beginning of 1997, Professor Walker-Smith became aware that Dr Wakefield was acting as an expert on behalf of a number of children in a group action concerning MMR. Professor Walker-Smith did not want to have any involvement in actual or potential litigation.

(c) Professor Walker-Smith was not aware of the litigation status of the Lancet children at the time that the Lancet paper was written.

(d) It was not until the Rouse correspondence in the Lancet in 1998 that Professor Walker-Smith became aware that Dr Wakefield had agreed to “evaluate a small number of these children on behalf of the Legal Aid Board”. This was after the Lancet paper had been published.

(e) It was not until Mr Deer contacted him many years later that he was informed about a sum of money that had allegedly been paid to Dr Wakefield by the Legal Aid Board.

(f) It was not until 2004 that Professor Walker-Smith learned the number of Lancet children that were part of the “class action” in which Dr Wakefield was involved.

There is a lot in that statement of interest, but for this discussion I will focus on the statement that Mr. Wakefield did not disclose to his colleagues that some of the children he was working were involved with the Legal Aid Board. They learned about it from the Rouse letter. Why wasn’t Mr. Wakefield transparent even with his own colleagues?

Back to the Wakefield response, I think that it is a stretch to say that “no conflict of interest exists” or that the children came through formal channels. This ignores the fact that Mr. Wakefield played an active part in recruiting children into the study. This ignores the fact that Mr. Wakefield was aware that there indeed was a litigation bias involved in both himself and many of the study subjects.

As long as we are looking at the letters to the Lancet, here is one by Barbara Loe Fisher, of the self-named National Vaccine Information Center (in reference to a letter to the Lancet by members of the CDC):

“The pre-emptive strike by US vaccine policymakers on Andrew Wakefield and his colleagues’ investigation into the immunopathology of children with chronic enterocolitis and regressive developmental disorder brings into sharp relief the inappropriate intervention of politics into what should be an apolitical scientific examination.”

What is brought “into sharp relief” was that Mr. Wakefield’s study was not an “apolitical scientific examination”. Rather it was a litigation funded and driven project where crucial facts were hidden from the public. A true vaccine safety organization, which Ms. Fisher’s NVIC is not, would now be condemning Mr. Wakefield’s manipulation of the story. Instead, she gives him awards.

The Rouse letter shows that Mr. Wakefield failed in his duty to explain the details of his research to the public, and to his own colleagues. From where I sit, it also looks as though the Lancet failed to ask the direct questions that should have been raised at this point. They allowed Mr. Wakefield to avoid the sticky questions raised by the fact that Mr. Wakefield was involved in the MMR litigation.

Of course it is easy in hindsight to see the patterns. At the time, Mr. Wakefield was a highly respected researcher and much of what we now know was hidden. But it is very frustrating to think that the story could have been (should have been) exposed so quickly after the publication of the Lancet paper.

Safeminds defends treatments the FDA deemed “dangerously misleading”

18 Oct

The United States Food and Drug Administration (FDA) recently announced that they had sent warning letters to eight groups who were promoting chelation products without prescriptions and with unproven claims of efficacy.

Chelation is a mainstay of many alternative medical practitions, especially in autism. There is a hypothesis that autism is caused by mercury poisoning. Autism symptoms don’t look like mercury poisoning and multiple studies have been performed testing the hypothesis and shown no link. But the idea lives on. Autistics, mostly children, are subjected to chelation “therapy” to remove heavy metals from the body. After over a decade of this practice, there is still no demonstration that chelation does anything to help autistics. There are studies on Peruvian hamsters which are used to support the idea that autism is caused by mercury poisoning. No, seriously, one of the supports for the mercury/autism link is a study on Peruvian Hamsters. Just goes to show how tenuous the “science” backing chelation is.

Here is part of the FDA statement:

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.

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.

One of the more vocal organizations promoting the mercury/autism “link” is a group called SafeMinds. So it isn’t a surprise that they would respond to the FDA warnings..

Here is the opening paragraph from the SafeMinds response:

The FDA issued a media release and held a press conference on over-the-counter chelating products. A recording of the press conference was made available this afternoon (recording available at 800-839-7073). FDA issued warning letters to 8 companies promoting over-the-counter nutritional supplements for chelation therapy (HERE). Chelation is a method of removing heavy metals from the body. The FDA warning has no bearing on prescription chelation drugs which are used under the supervision of medical professionals.

“Nutritional Supplements”? How does a chelator count as a “nutritional supplement”? The human body does not produce chemicals like DMSA which are used for chelation. SafeMinds is well aware of the falacy of the “nutritional supplement” argument after the recent debacle over the chelator turned “supplement” OSR, which had to be pulled from production.

So, SafeMinds starts downplaying the fact that chelators are drugs and, as such, should be regulated.

But they quickly change the tune and acknowledge that these are drugs: “The FDA warning has no bearing on prescription chelation drugs which are used under the supervision of medical professionals.”

As I read this, I had to ask myself “Why did SafeMinds chose such imprecise language?” Let me explain:

Assume a medical professional, say a chiropractor or a nutritionist, “supervises” my use of the prescription drug DMSA, but sells the drug to me without a prescription (as these professionals can not write prescriptions). That would fit into the SafeMinds interpretation, but is clearly not the intent of the FDA statement.

Here is an accurate statement: The FDA warning does not have bearing on the use of chelation drugs prescribed by and supervised by a medical professional.

Continuing with the SafeMinds statement:

In its press conference, the FDA implied that chelation products were being used by parents of children with autism without a doctor’s supervision, but on questioning by reporters, FDA representatives were unable to back up the claim with any evidence of use of OTC chelation products by autism parents or of their use without medical supervision. The FDA asserted that the OTC products being promoted were dangerous and could lead to kidney damage, dehydration and death. On questioning by reporters, the FDA admitted that it had received no reports of adverse reactions to the products or to chelation in general, other than 1 death 5 years ago which was due to a medical error and in which a prescription drug was used.

Note that SafeMinds chose their words carefully. They don’t state that the practice doesn’t occur. SafeMinds just states that the FDA didn’t have the evidence on hand of the “use of OTC chelation products by autism parents or of their use without medical supervision.”

Is Safeminds so out of touch with the online autism community that they can’t find groups promoting over-the-counter (OTC) chelators by autism families? The practice is common. Surely SafeMinds members peruse the exhibitor booths at the parent-conventions (like Autism One).

Google search: “how to buy DMSA without a prescription”. Lot’s of hits.

Here is hit #2: dmsachelation.com/autism/. Pretty clear they are targeting autism treatment there, just from the URL. The blurb on Google for this site? “This page IS intended to show you where to buy DMSA without a prescription. You can get DMSA prescribed, however the cost will range from $2-3 per pill. …”

I didn’t capitalize “IS” in that statement, they did. They wanted to emphasize that one could buy chelators without a prescription.

SafeMinds states that the FDA has received no reports of adverse events from chelation in general. I find this odd. The FDA must not follow online autism parent groups such as those on Yahoo. The FDA must not have read transcripts of the Omnibus Autism Proceeding, which included a description of a child who regressed after being given chelation therapy (under the watchful eye of a prominent alt-med doctor). The FDA must not have performed a google search on chelation deaths with site set to CDC.gov.

First hit, “Deaths Associated with Hypocalcemia from Chelation Therapy — Texas, Pennsylvania, and Oregon, 2003–2005“.

When it comes to the question of “why” adverse events are not commonly reported I am again reminded of the OSR fiasco. The company that sold OSR specifically told their clientele to contact the company in case of adverse reactions. No mention was made of contacting the FDA (which can be done here). I guess I could search the websites of the groups that promote OTC chelators to see if they inform their clients of the ability to report their drug/supplements to the FDA. Somehow I feel confident that I would be able to find groups (possibly many or most) do not give that information.

SafeMinds posted their statement on the blog they sponsor, The Age of Autism. Another sponsor of that blog is Lee Silsby, a compounding pharmacy. They list chelators such as DMSA and EDTA under the category “autism treatments” (Specialties | Autism Treatments | Transdermal DMSA Cream, or Specialties | Autism Treatments | EDTA (calcium)). Not under “heavy metal poisoning” treatments, autism treatments.

The Autism Research Institute, a group which promotes much in the way of alternative medicine as therapies for autism, has a chart that is often used to promote chelation. In their survey, they claimed that over 70% of parents reported that their child got better with chelation. The survey has been often criticized as being unscientific and very biased. Even with this biased sample, 3% of parents reported that their child “got worse” with chelation.

A couple side notes are worth mentioning. First, in that survey the ARI list chelation under “Biomedical/Non-Drug/Supplements”. Non drug? Supplement? I doubt the FDA will agree. Second, the ARI survey lists secretin therapy as beneficial for autism. Secretin hit the news in the 1990’s as a potential autism therapy and has since been shown to be no more effective than a placebo. The survey is very, very biased towards “biomedical” treatments.

Surely SafeMinds is aware of this survey. As in, definitely they are aware of it. Just as Safeminds are certainly aware of the child in the Omnibus proceeding who suffered after chelation. But SafeMinds pretend as though there are no adverse reactions. It is disingenuous, to say the least.

SafeMinds ends their statement with this paragraph:

SafeMinds agrees with the FDA that products being promoted as drugs and biologics should have thorough and unbiased assessments for safety and that parents should work with their healthcare professionals when considering health interventions. SafeMinds feels that FDA has tried to cast autism parents in a negative light without any supporting evidence, by implying that autism parents were giving their children dangerous products without medical oversight. Only on questioning by the media did the FDA have to back off from its wild claims. SafeMinds feels the FDA owes the autism community an apology.

Basically, SafeMinds have taken the Human Shield defense. Rather than actually discuss the facts, SafeMinds attacks the FDA for “wild claims” and claims that the FDA owes the autism community an apology.

From the perspective of this autism parent I would say, yes, the FDA owes us an apology: for taking so damned long to address this issue. The abuse of chelation as a “treatment” for autism has been going on for many years. It is about time that the FDA cracked down and made the “wild claim” that a prescription drug should be given by perscription.

Heck, the FDA isn’t even making the “wild claim” that toxicology treatments should be performed by toxicologists. Just someone with a prescription pad.

Why isn’t SafeMinds telling autism families to seek out medical toxicologists to test and treat heavy metal poisoning? The answer is painfully clear. The methods of diagnosis and treatment that groups like SafeMinds promote do not compare to the methods used by those trained specifically to treat heavy metal intoxication.

Should make one pause to wonder.

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.

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 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”

Is the end of the Omnibus Autism Proceeding near?

2 Oct

The Omnibus Autism Proceeding (OAP or omnibus) is the way the Court of Federal Claims (vaccine court) has been handling the now 5,000+ claims submitted for autism as a vaccine injury. The Omnibus started officially in July of 2002 with Autism General Order #1. Along the way it was decided that the best way to handle the large number of claims was using “test cases”. Three test cases were heard for each of two “causation theories”. The idea was that “general causation” arguments could be made once, and very thoroughly, and the other cases could be decided on the outcome.

The first causation theory was that the MMR vaccine in combination with thimerosal could result in autism. The test cases for this theory were those of Michelle Cedillo, William Yates Hazelhurst and Colten Snyder. Attorneys for the families presented evidence for a mechanism where thimerosal was proposed to reduce the immune response and the MMR vaccine led to a persistent measles infection which, again as proposed, led to symptoms of autism. In all three cases the special masters (judges) ruled against the petitioner families. They found that the evidence did not support the mechanism proposed.

The second causation theory held that thimerosal in vaccines could result in autism. Three test cases were presented, again with individual and general causation evidence. The test cases, Jordan King and William Meade, and Colin Dwyer were heard. Their attorneys argued that mercury from the thimerosal in the vaccines accumulated in the brains and resulted in neuroinflammation which, in turn, resulted in autism. As with the MMR case, the special masters ruled against the petitioner families.

To put it simply: all the data and all the experts that could be put together to support the idea that vaccines cause autism weren’t persuasive. They came up with two stories (MMR and thimerosal) and neither story made a case that was even close (the special master’s word).

Some of the petioners appealed. Some appealed to multiple levels. The appeals were denied.

The Court recently issued an update letter. I quote part of it below:

As described above in part I of this Update, all of the court rulings in the six test cases described above have found no causal link between autism and MMR vaccines and/or thimerosal containing vaccines. Further, the PSC has informed the special masters that no additional OAP test cases are contemplated.

Therefore, the Office of Special Masters has begun discussions with members of the petitioners’ bar and respondent’s counsel about how best to conclude the approximately 4,700 autism cases remaining open on the court’s docket. To aid in that process, some petitioners’ counsel have contacted all of their OAP clients to advise them of the results in the test cases and to recommend a course of action with regard to their claims. Additionally, all petitioners who are not represented by counsel have been ordered to inform the court either that they wish to dismiss their claim or that they intend to proceed with their case. For petitioners who wish to continue with their claim, orders to identify a theory of causation, produce an expert report, and file additional evidence will follow. Petitioners’ counsel who have not yet done so are encouraged to contact their clients and determine how their clients wish to proceed.

The issue of attorneys’ fees and costs for petitioners’ counsel is part of the discussion about how to conclude proceedings on the OAP petitions. Mediation efforts are underway to develop methods to resolve the fees and costs issues, and a report on the progress in these talks is expected at the October judicial conference.

The special masters are assuming that no one will go forward with the MMR and thimerosal theories. Since those theories don’t hold up in court, it seems a good assumption.

Petitioners can still go forward as individual cases, as in any non-omnibus case. They will need to submit records and a theory of causation and support that theory in hearing.

The PSC (petitioner’s steering committee, a group of lawyers which has managed the Omnibus from petitioner’s side) has decided that no additional OAP (Omnibus) test cases are planned.

This is very important. They have no other theories to present. They don’t plan to present “too many too soon”. They don’t plan to present a Wakefield-like theory of persistent measles infections leading to “leaky guts”. They don’t plan to present a “mitochondrial autism” theory.

This last bit is very important. The Hannah Poling case made a lot of news when it was leaked that the government had conceded her case as a table-injury MMR encephalopathy. She was supposed to be one of the three thimerosal test cases. At the time of the concession and since, it was asserted that her case was “not rare” and that the attorneys were prepared to go ahead with the mitochondrial disorder story. It would appear that there are not many (if any) other “Hannah Poling” cases out there. There is at least one family pursuing a variation of the mitochondrial disorder theory. Alexander Krakow was scheduled to be a test case for the thimerosal theory and his family pulled out of the Omnibus to pursue the mitochondrial theory.

While there may be a case or two that we hear about from here on out, it appears that the Omnibus, the “class action” type phase, is over.

Katie Wright demonstrates AoA mentality

30 Sep

Over at the Clown Blog, Katie Wright pens a sulky screed targeting Peter Bearman. Lets go through it.

Dr. Peter Bearman, a professor of sociology at Columbia University, recently released a research paper alleging that half of the meteoric rise in ASD cases is an artifact. You know- “better diagnosis” and “greater awareness.” A blind, non-medical professional, could have diagnosed my son. Nevertheless in the case of HF ASD and aspergers (which comprise a small % of overall ASD) certainly greater awareness has played a role in the increasing number of those diagnoses. Still- 50%? Ridiculous.

And why ridiculous? Well….just because. Wright offers no evidence to counteract Bearman’s. No science is referenced to challenge Bearman’s work. It simply is ridiculous apparently. One can almost hear the foot stomp of a poor little rich girl out of her league intellectually.

After Dr. Bearman concludes that 50% of the increase cannot be attributed to greater awareness Insel asks what Bearman believes is driving the other 50%. Bearman answers: “genes, old parents and possibly a virus.” This is the best he has got? The NIH gave this guy millions to come with that?

Well no Katie, thats not what the NIH gave him his research money for. According to _you_ Insel asked Bearman what he _believed_ was driving the other 50%. He gave his answer as to what he _believed_ . But these beliefs were just that – beliefs. He presented the science he had done and then shut up on the evidence and opined and on what he was asked to opine on by Insel.

And even his opinion, his beliefs, are rooted in science. There _is_ a genetic component to autism, thats simply a fact. There _is_ research that links ASD to older parents. Katie Wright’s beliefs revolve around one extremely unscientific thing. Vaccines.

Yes, Bearman does acknowledge the possible role of some kind of toxin. Bearman is not sure what that toxin is but he is sure what it isn’t. Take a guess.

See what I mean. If it ain’t a vaccine, it ain’t worth considering according to Katie Wright.

…unbelievably Bearman says: “it isn’t autism that parents are worried about. They know they can deal with that, they know they can help their child, (and he would know this a non parent of an ASD child?) but it is autism organizations scaring parents!” I had no idea that a bunch of stay at home Moms with no money, no federal backing, no million dollar grants- who are already busy parenting autistic kids- have this kind of extraordinary power! Wow, what’s next for us? Ending the recession, solving the mortgage crisis, creating electric cars?

And hot damn Katie Wright, guess what? In my opinion he _is_ right! I’m not scared of autism. I’m scared of one note zealots stealing away research monies, scaring away legitimate researchers with their threats of violence and scaring the public into believing that autism is some kind of tsunami of evil ready to engulf them all in a tide of social security claims.

As for Katie Wright personally, it makes me sick to think of this little rich girl, who’s children will want for nothing, playing the ‘poor little me’ card. There are families out there struggling to get by on a day to day basis and she has the temerity to liken herself to a ‘stay at home mom’. Feh.

As far as blaming the parents for the national crisis of confidence in vaccine safety- grow up Dr. Bearman. The problem is the problem- not people talking about the problem.

Nice quote from that intellectual giant Jim Carrey there. Oh and guess what Katie Wright? You and people like you *are the problem* . Whilst you play offended at legitimate science, there’s a whooping cough outbreak in California that is killing children. You do know that don’t you Katie Wright?

Here’s what you need to do Katie Wright. You need to accept the fact that the science is against you. You need to accept the fact that you are a small scaremongering minority of the autism community. Sounding off about stuff that you clearly have absolutely zero knowledge about (science) makes you look foolish and all it does is show you to be frightened. You are behind the times. Get out of the way of progress.

Florida access to service bill morphed into vaccine bill

30 Sep

A recent story in the Miami New Times caught my eye recently. The story is about how a wealthy Florida chiropractor was attempting to gain access to Florida Department of Health records so that Mark and David Geier could use them for vaccine/autism research.

In the story, Penn Bullock and Brandon K. Thorp write:

But Kompothecras has all but bragged of his ability, via generous giving, to enlist politicians in the anti-vaccine fight. The Sarasota Herald-Tribune reported last year that he donated more than $15,000 to state Rep. Kevin Ambler and state Sen. Mike Bennett; both have backed legislation that would weaken Florida’s mandatory vaccine regimen.

Kompothecras told the paper that his personal lawyer had helped Bennett write an anti-vaccine bill. When he sent the irate email to DOH, the doctor copied Bennett. Whether Kompothecras’s political friends can enforce his will at the DOH is unclear. What is clear is that the DOH is afraid they might.

I tried to find this bill. A news story from 2009, Major GOP political donor Gary Kompothecras backs bill to alter Florida’s vaccine rules, had this to say:

SB 242 would give parents more authority to delay the pace at which their children are vaccinated against illnesses like measles, mumps and polio — as long as they are up to date with their shots by the time they enter the public school system. (Florida law already provides for exemptions from school vaccine requirements in the cases of religious beliefs or medical risks determined by a physician.)

The proposal, sponsored by Tampa Republican Rep. Kevin Ambler in the House, also would prohibit the use of vaccines for pregnant women and young children if the vaccines contain even a small percentage of ethyl mercury. Better known as thimerosal, it is used as a preservative in some vaccines, including flu and tetanus shots that are made in advance and in large quantities. Some people, including Kompothecras, believe thimerosal is the vaccine ingredient that makes their initially healthy children become autistic.

Senate Bill 242 was entered into the record on February 26, 2009. Here is a segment of that version:

11 Section 1.?If the parent or legal guardian of a minor who
12 is an eligible individual, as defined in s. 627.6686, Florida
13 Statutes, believes that the minor exhibits symptoms of autism
14 spectrum disorder, the parent or legal guardian may report his
15 or her observation to a physician licensed in this state. The
16 physician shall immediately refer the minor to an appropriate
17 specialist for screening for autism spectrum disorder.

It is a bill expanding access to services for parents of young autistic children. I’m sure we could have some interesting discussions about that bill, but it died. Well, even before it died, it morphed. Here is the second version after a series of amendments on 4/15/2009. It amends the vaccine statutes in Florida. Here is an excerpt:

36 499.005?Prohibited acts.—It is unlawful for a person to
37 perform or cause the performance of any of the following acts in
38 this state:
39 (30)?The sale, purchase, manufacture, delivery,
40 importation, administration, or distribution of any human
41 vaccine used for children under age 6 or pregnant women which
42 contains any organic or inorganic mercury compound in excess of
43 0.1 microgram per milliliter.

and

51 (6)?In vaccinating his or her child, a parent, legal
52 guardian, or other authorized person, in consultation with his
53 or her pediatrician, has the right to choose an alternative
54 immunization schedule to the immunization schedule recommended
55 by the Centers for Disease Control and Prevention, as long as
56 the child completes the required immunizations before beginning
57 kindergarten or initial entry into a public or private school,
58 whichever occurs earlier.

So, a bill that would expand access to services is completely scrapped. In its place a bill is created which seeks to change the laws on vaccines.

Leaving aside whether thimerosal should be allowed in vaccines. Leaving aside the fact that parents already have the right to an alternative schedule. Leaving aside that the language of that second section is so vague that parents might argue that any alternative vaccine schedule (including none) could be used for admission to school. Leave out whether the bill in its original form is good or not.

Leave all that aside for the moment.

Someone scrapped a bill expanding services in order to take on vaccine legislation.

I’ve said it before and I’ll say it again: many “autism advocates” and “autism organizations” don’t really focus on autism or disability rights.

They are willing to abandon autism legislation in order to focus on vaccines.

Incidence of autism in Berkshire

30 Sep

A Reading Borough Council report has shown that the incidence of autism in a borough of Reading, Tilehurst has increased over a period of eight years (2000 – 2008) from 68 to 186, more than doubling.

Lets put these figures in context of a few things. Firstly, thiomersal. Thiomersal was removed from all UK vaccines in 2004. The average age of autism diagnosis is five and a half (PDF) in the UK. This would mean that if thiomersal caused autism, a significant drop off in autism incidence would have been reported to have been occurring during late 2009 early 2010. This was not reported. This could be because the report did not go beyond 2008 but again there’s no mention of that either and I can’t find the relevant document on the Reading Borough Council website

Secondly, the report seems quite clear to refer to diagnoses of ASD which includes PDD-NOS and Aspergers Syndrome. Kate Manton of Berkshire Autism Society says:

People are being diagnosed much earlier now than they were 10 years ago. Children at two and a half are being diagnosed, if the condition is fairly severe.

Thirty years ago [someone] who was disruptive in class but fairly bright would be called naughty.

All good points and ones which mitigate against the obvious simplistic claims that there is some sort of epidemic of autism. There may well be some sort of ‘epidemic’ of _recognition_ of autism in all its many forms but thats not the same thing at all.

I’m left wishing I could get hold of a copy of the same data that the BBC did so to that end I have requested that the BBC send me a copy of the report. Hopefully they’ll reply.

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