Wakefield’s Inquisition: Abuse of the legal system and media by anti-vaccine doctor

29 Jan

As the GMC approaches a verdict on the misconduct of Andrew Wakefield, anti-vaccine sources are engaged in a concerted effort to make the “doctor” into a martyr rather than a failed researcher. It is vital to ensure that the general public is not in any way lulled into sympathy for the “doctor”.  In my judgment, the most important point to drive home is that, while Wakefield and associates play up the image of the “doctor” being persecuted for his ideas, he is the one who has persistently acted to suppress any discussion not entirely in his favor.  To that end, I have compiled the following list, complete to the best of my ability, of recorded frivolous lawsuits, libels, complaints and harassment by Wakefield and his immediate associates against his numerous critics.

3 October 1996: Wakefield files a complaint with the Broadcasting Standards Commission over a broadcast critical of his claims that MMR was associated with Crohn’s disease.

1998-2003: Nick Chadwick withholds negative results suppressed by Wakefield from the public, apparently as required while litigation was ongoing.

February 2002: Wakefield files or threatens to file complaints to  the GMC against critical colleagues. One formal complaint involved a statement made in 1997. He reportedly told government chief medical health officer Sir Liam Donaldson: “It has come to my attention that you have sought details of our studies from the ethical practices committee of the Royal Free NHS trust. I infer from this that faced with an increasingly compelling scientific case against the MMR vaccine you are seeking to discredit the scientists involved. Your attempts to interfere in the scientific process are unacceptable. Not only do you have no right whatsoever to this information without permission, but also your action has had an indirect but nonetheless profound effect upon our ability to help these desperately ill children. I am seeking advice prior to taking this issue up with the General Medical Council.”

27 February 2004: The Sunday Times and the Lancet a letter from Wakefield’s attorneys denying Feb. 20 reports that Wakefield failed to disclose conflicts of interest related to the 1998 paper, with the stated purpose “to invite you to agree promptly to publish a full apology to our client”.

November 2004: Wakefield files a lawsuit against Brian Deer and Channel 4 for libel. At around the same time, his attorneys send a letter falsely alleging that Deer “has made a formal statutory complaint to the General Medical Council against Mr Wakefield and others concerning these matters.” The letter also refers prominently to “a current Press Complaints Commission” of Brian Deer, though no such complaint is on record. The claim of a complaint by Deer is taken up by Carol Stott, and continues to circulate to the present despite repeated denials by Deer and the GMC. Curiously, a February 27, 2004 BBC article stated, “The General Medical Council is now carrying out an investigation into Dr Andrew Wakefield, the doctor who led the 1998 study.” This statement, coming only five days after Deer’s first report was published, not only weakens any suggestion that Deer directly initiated the investigation, but raises the possibility that some form of GMC inquiry on Wakefield (conceivably rising from his own past complaints against others) was under way even before Deer’s allegations were made public.

March-October 2005: Wakefield’s attorneys seek to freeze further action in the libel suit against Deer. Justice Eady “The claim form was issued on 31st March but only served on 22nd June 2005. Thereafter, it seems, the particulars of claim were served with some reluctance following prompting by the Defendants and an order of Master Rose on 27th July of this year. They eventually appeared on 10th August. There has thus apparently been a rather relaxed and dilatory approach towards litigation of a kind which is supposed to achieve vindication of reputation.” He further questions Wakefield’s motives in the lawsuit as a whole: “Claimant wished to extract whatever advantage he could from the existence of the proceedings while not wishing to progress them or to give the Defendants an opportunity of meeting the claims.”

31 January 2005: Wakefield files a second lawsuit against Deer, over content of briandeer.com, and a third against the Sunday Times and Channel 4.

29  June 2005: Cambridge Evening News receives a letter from Wakefield’s attorneys over a citation of a Brian Deer report (worded as “the article alleged…”), calling on the paper to “publish an apology”.

July 2007: Martin J. Walker initiates smears against Brian Deer.  Claims include allegation that Deer initiated GMC hearings against Wakefield.  Though Wakefield condemns Walker on 3 November 2008, Deer reports a December 2009 newsletter for Wakefield’s “network” requesting donations to pay an additional 5,500 pounds to Walker.

6 February 2009: A letter sent to Brian Deer requests that an article (published 2 days later) presenting evidence that Wakefield case histories in 1998 paper not be published: “(Y)ou appear to be considering publishing an account which covers much of the same material as is being considered by the Panel. Publication of your allegations and account at this time will give rise to serious risk that the GMC process will be prejudiced and the faimess of the hearing compromised. You also know that, at this juncture in the GMC process it would be inappropriate for Dr Wakefield to give a detailed response to you. He has denied t he allegations and gave a detailed response  over many days to the GMC Panel.”

13 March 2009: Andrew Wakefield files complaint with Press Complaint Commission, over Feb. 8 story. The key allegations are that Deer “knew that these allegations were either false or misleading, based on incomplete records – or, at the very least, open to question” and that “it was he who brought the original complaint. He therefore has an undeclared interest in its conclusions.”

20 March 2009: Andrew Wakefield files addendum to complaint over Brian Deer’s statement, “I did not lay the initial complaint against Wakefield. This allegation is a fabrication, albeit rather a small one in the MMR issue.”  Bizarrely, Wakefield presents truth of his own allegation as immaterial: “(W)hether or not Mr. Deer initiated the GMC investigation as ‘complainant’ in his letter dated Feb. 25, 2004, or acted as an ‘informant’ in an investigation already begun by the GMC, he did not disclose his own direct participation in the GMC investigation in his most recent accounts in the Sunday Times, intending to give the public the misimpression that he was acting as a neutral and disinterested reporter.“

3 July 2009: Thoughtful House release, “Press Complaints Commission Orders Sunday Times to Remove MMR journalist’s Stories on Dr. Wakefield from Paper’s Web Site”, alleges, “The PCC decision today appears to indicate there are questions about the accuracy of the Deer stories,”  despite implicit admission in Feb. 6 that Deer reported only what had been alleged by others.

9 July 2009: Second press release, “Sunday Times Defies Press Complaints Commission”, alleges that “the Sunday Times has now defied the PCC by putting the stories back online after complaining Dr. Wakefield publicly announced the PCC’s directive.”

8 September 2009: NAA press release “Offit’s Failure to Disclose Jeopardizes Swine Flu Vaccine Program” is carried by Reuters.  The stated location of “Austin, Texas”, in contrast to NAA headquarters location of Nixa, Missouri, strongly suggests that Wakefield and/or Thoughtful House are the creators of the release. The release defends Wakefield, attacks Paul Offit, and by extension attacks Dateline broadcast in which Wakefield was portrayed critically.  It includes the claim, first made in a hoax published by Age of Autism, that “Offit’s share of a royalty sale for the Rotateq vaccine to Merck is a minimum of $29 million and may approach $50 million.” Wakefield’s use of a third party to promote the hoax in September raises the possibility that he significantly contributed to the hoax itself, in which figures were inflated through an inapplicable 2007 CHOP policy and documents from a patent which preceded the one which was sold.

27 January 2009: On the day before the GMC released its first findings against Wakefield, a 104-page complaint is filed with the GMC by multiple or.  The most straightforward and prominently publicized claim is that Drs. Horton, Salisbury, Zuckerman, Pegg, and Rutter “gave false statements”. Obviously prepared long in advance, this complaint can be presumed without merit, and could easily be used as a basis for countersuits. Its greatest significance will almost certainly be as yet another obstacle to timely disclosures of findings and to further legal actions, of which US disciplinary proceedings against Wakefield and litigation against him and Thoughtful House are the most threatening to the “doctor’s” interests.

In hindsight, there are many things that were “off” about Wakefield. He relied (perhaps not wholly by his own choice) on an image of a “young maverick”, though he was in fact a well-established but not distinguished researcher with dozens of previous publications (none of which is listed in a Thoughtful House bibliography!). He earned his doctorate in 1981, at the strikingly early age of 25, yet PubMed records only 3 papers of his published before 1991. He held several formal titles at Royal Free, yet his contract stipulated that he have “no involvement in the clinical management of patients.” His previous efforts to link MMR with Crohn’s disease came very close to drawing charges of fraud (see review )  His publications in the affair show a shifting roster of coauthors and repeated changes in publishing journals. I find the path of his career (particularly his early display of apparent talent followed by surprising early difficulties) strikingly like that of artists who go on to commit forgery.

The bottom line is that the only thing necessary to stop Wakefield was for those who knew the most about his conduct to speak up before his spurious claims became cultural currency.  The best way to ensure that similar (or even worse) offenders are exposed before they do harm is to reform the courts, so that litigation is NEVER allowed to trump timely criticism among scientific professionals.

GMC on the birthday party blood draws

29 Jan

One subject that has been discussed on this blog a number of times is the birthday party for one of the Wakefield children, where blood samples were taken from children for research purposes. Given that, and given that one key part discussed here has been found “not proved”, I thought I would use that as the first segment of the decision to discuss here.

Here is the section:

The Birthday Party
‘42. a. On a date unknown prior to 20 March 1999 at your son’s
birthday party you,

i. took caused blood to be taken from a group of children to use for research purposes,
(amended) Found proved
The Panel considers that the amendment is necessary to
reflect the state of the evidence.
ii. paid those children who gave blood £5 each for doing so,
Found proved
The Panel is satisfied by your own evidence (Day 55p41)
that you paid the children “as a reward at the end of the
party the children who had given blood all received £5”

b. On 20 March 1999 you gave a presentation to the
MIND Institute, in California, USA in the course of which you,
Admitted and found proved to the words ‘California, USA’

i. described the incident referred to in 42.a. above in
humorous terms,
Found proved
ii. expressed an intention to obtain research samples in
similar circumstances in the future;
Found proved
The Panel is satisfied that this has been found proved in its
entirety, having viewed the video.

‘43. a. Your conduct as set out in paragraph 42.a. above was unethical
in that,
i. you did not have ethics committee approval for your
actions,
Found proved
The Panel does not accept your explanation that you did
not consider this action to be unethical or that Ethics
Committee approval was required.
ii. you took caused blood to be taken from children in an
inappropriate social setting,
(amended) Found proved
The Panel considers that the amendment was necessary to
reflect the state of the evidence.
iii. you offered financial inducement to children in order to
obtain blood samples,
Found not proved
The Panel accepts that the children were not persuaded to give blood by being offered money first.
iv. you showed a callous disregard for the distress and pain
that you knew or ought to have known the children involved
might suffer,
Found proved
The Panel is satisfied by your evidence that the children
were “paid for their discomfort”(day 67p23), which it
concluded was evidence of a callous disregard.
v. in the circumstances you abused your position of trust as
a medical practitioner,
Found proved on the basis of the above findings.

b. Your conduct set out in paragraph 42.b. was such as to bring
the medical profession into disrepute;’
Found proved on the basis of the above findings.

The section found “not proved” is where Dr. Wakefield was reported to have offered money to the children to induce them to offer blood samples.

you offered financial inducement to children in order to obtain blood samples,
Found not proved
The Panel accepts that the children were not persuaded to give blood by being offered money first.

As I understand it, Dr. Wakefield’s explanation before the GMC was that the children were given the money at the end of the party in their goodie bags.

I guess this wasn’t funny enough to make it into the story given at the MIND Institute “…so we lined them up, wih informed parental consent of course, they all get paid five pounds, which doesn’t translate into many dollars I’m afraid, and they put their arms out with a cuff on and have blood taken. It’s all entirely voluntary [audience laughs]” He then went on to discuss in a humorous manner the discomfort of the children and how “they charge me a fortune”.

As funny now as it was then. (as in, not at all). My read is that he is left with having giving a false account of how the research was performed, during a presentation of that research, given the sequence of events he gave at the MIND Institute. That makes a good example of what was and was not a part of the GMC inquiry. They inquired into subjects that pertain to the doctor’s “fitness to practice” medicine. They didn’t not inquire into his research ethics outside of that.

Let’s consider another, very important point, which was found proved:

you did not have ethics committee approval for your actions,
Found proved
The Panel does not accept your explanation that you did not consider this action to be unethical or that Ethics Committee approval was required.

This exemplifies why Dr. Wakefield and his colleagues were investigated by the GMC–for ethics violations pertaining mostly to the children either under their care or, as in this instance, outside their care and outside of their ethics board approval.

General Medical Council hands down first decision on Andrew Wakefield

28 Jan

Kev put it well–“Andrew Wakefield – what were you expecting to happen?“. I doubt many people expected a different outcome than, “dishonest” and “Irresponsible”.

Kathleen Seidel at Neurodiversity.com has blogged this as well U.K. General Medical Council Rules Wakefield & Co. “Dishonest,” “Irresponsible”.

You can read the decision for yourself at Neurodiversity.com.

Dr. Wakefield has responded, and the BBC is hosting a video of that. Dr. Wakefield has invited people to look for themselves and come to their own conclusions. I have. I agree with the GMC. The BBC is also hosting video of Dr. Wakefield joking about the birthday party blood draws.

I’ll touch on some parts of the decision as time permits. There is enough of a blog storm going on with people defending Dr. Wakefield, often with, quite frankly, bogus arguments. I see none of them addressing the real charges or, for that matter, the real purpose of the hearings.

For example, here is an important quote from the decision:

The Panel wish to make it clear that this case is not concerned with whether there is or might be any link between the MMR vaccination and autism.

Whenever you read people talking about this being about the research itself (as opposed to the ethics of the research methods), you are reading someone who is misinformed or worse.

Andrew Wakefield – what were you expecting to happen?

28 Jan

The first of Andrew Wakefield’s days of judgement unfolded today amid hectic scenes of supporters running screaming from the room as the inevitable damning judgements were read out.

Wakefields action was proven to be dishonest and misleading, he was found in breach of managing public finances and that the funds he was in control of were not used for their intended purposes and a whole myriad of others. One of the most shocking is that it was found proved that:

You caused Child 2 to undergo a programme of investigations for research purposed without having Ethics Committee approval for such research.

And thats Andrew Wakefield’s career toasted in the UK. Read the whole thing at your leisure.

I would have gotten this post to you sooner but I was accompnying my two step-daughters to their H1N1 vaccinations as the decisions were being handed down.

autism epidemic science, autism vaccine science

27 Jan

Ex Derdrie Imus Environmental Center for Pediatric Oncology team leader Philip J. Landrigan is the latest scientist once associated with the debunked vaccine causation ideas to repudiate those ideas in a scientific journal.

Writing in Current Opinion in Pediatrics, Landrigan has published ‘what causes autism? Exploring the environmental contribution’ in which he explores what might be a plausible environmental causation. He also touches on genetics and the so-called ‘autism epidemic’.

Touching on genetics, he states:

Genetic and familial factors are unquestionably involved in causation of autism [4]. Families with multiple cases have been described. Autism has repeatedly been seen in sibs and twin pairs. Concordance in monozygotic twins is
reported to be as high as 70% [15], and, when the broader phenotype of autism is considered, concordance in monozygotic
twins approaches 90%. Concordance rates for autism in dizygotic twins appear no higher than among singleton siblings. Families with autistic children may contain members with ‘autistic traits’ such as social isolation or tendency toward repetitive behavior [13]. Autism occurs in a number of genetic conditions, among them Fragile X syndrome, Down syndrome, Cohen syndrome, Angelman syndrome [16] and Rett syndrome [17].

Regarding genetics as a whole Landrigan claims that autism can already be accounted for to the tune of between 7 – 8%. In an email to me he stated:

THE FRACTION OF AUTISM CASES THAT CAN RELIABLY BE ATTRIBUTED TO GENETIC CAUSES WILL CERTAINLY INCREASE AS MORE RESEARCH COMES IN

By how much though? No idea and Landrigan wouldn’t be drawn.

Regarding the ‘epidemic’ Landrigan states:

The reported increase in prevalence of autism has triggered vigorous debate as to whether the trend reflects a true increase in incidence, or is merely a consequence of expansion in the definition of ASD and greater awareness, improved diagnosis and better reporting [11]. This highly controversial question is not yet settled [14]. A
recent critical analysis concludes that increases in recognition, changed diagnostic criteria, and changing public
attitudes about autism have played a major role in catalyzing the upward trend in reported prevalence. This analysis observes, however, that the possibility of a true rise in incidence cannot be excluded [12].

Which should be – if one is truly interested in following the science so far – the correct conclusion. In other words, nobody really knows but the recent increases in recognition, changed diagnostic criteria and changing public attitudes (amongst other things) have played a major role.

In relation to vaccines, Landrigan states unequivocally that:

To address the issue, a series of studies was undertaken in the US, the UK, Europe and Japan. None of these studies have found any credible evidence for a link between vaccines and autism [12]…..Fear of autism does not justify failure to vaccinate children against life-threatening diseases [75].

In an email to me Landrigan stated:

IT WAS RESEARCH THAT NEEDED TO BE DONE. BUT NOW THAT WE HAVE MORE THAN DOZEN, HIGH-QUALITY NEGATIVE STUDIES OF THE ISSUE IT IS TIME TO MOVE ON…

I’m not sure it was research that needed to be done given the extremely tenuous hypotheses that began the various vaccine/autism strands but I agree that it is time to move on.

I was somewhat surprised at this paper as I had become used to seeing Landrigan’s name associated with those who believe vaccines cause autism and certainly his involvement with Derdrie Imus would indicate his belief in that set of ideas. It was a nice surprise to see that he was sticking to the science.

So what can we draw from this? First and foremost we have to say that a colleague of Derdrie Imus stating publicly that vaccines don’t cause autism is the biggest red flag so far that even the scientists who once gave credence to those ideas are moving away from them. Secondly we can say that althoough we cannot preclude the idea of a real actual increase, the major role in causing an increase in autism numbers still remains the combination of increased recognition, changed diagnostic criteria, changed public attitude, diagnostic substitution, more available locations for gaining a diagnosis and more doctors trained to give diagnoses. Lastly we can say that here is a toxicologist who acknowledges that there is a strong genetic component and that that component is likely to increase.

Pity for the Rankins

26 Jan

Its no secret that Wade and I were once pretty good internet pals. We regularly communicated despite our staunch opposition to the others beliefs regarding vaccines role in autism. That changed however as Wade sunk deeper and deeper into the bad science surrounding autism.

Wade and his wife Sym have recently been the subject of a piece by the Chicagoist following Wade’s open letter to the Trib. The Chicagoist reporter (one Mr Carlson) had obviously read both the Trib articles and Wade’s open letter before writing his own piece.

And now Wade has been obligated into writing yet another blog piece as it seems the Chicagoist has taken a similar line to the Trib. Wade says:

Reading through Mr. Carlson’s brief post gave me the distinct impression that somehow the meaning of our letter had gotten lost,

A brief digression. Wade and his family used to live in the South and were affected very badly by Hurricane Katrina. Once the dust had settled they decided to resettle in Chicago. Once there I learned they had become aquainted with the infamous Erik Nanstiel and David Ayoub, both hardcore believers of the vaccine causes autism idea. Not long after that Wade’s own beliefs on the subject hardened and it wasn’t difficult to see where this hardening of beliefs was being hardened from. I found it increasingly difficult to accept the things Wade was saying. An intellegent man, his new beliefs can be summed up in his opinion of Lupron and OSR.

…we have not, as yet, utilized either the Lupron protocol or OSR #1, both of which were the subjects of Tribune smear pieces. That is not to say, however, that those interventions may not be appropriate treatments in particular circumstances. On the contrary, we know families that these interventions have helped…

The old Wade would not have ever considered using these snake oil treatments. The old Wade would not have described the Trib articles as ‘smear pieces’. The old Wade wouldn’t have described knowing families who did use them and would have been much less credulous about their effectiveness.

SO, back to Wade’s statement that he believed the meaning of his open letter had been lost. It was lost, he’s right. It was totally lost on Carlson, it was totally lost on the commenters to the site and its totally lost to people like me. Not that I’m singling myself out for any special praise – thats kind of the point. I’m just an ordinary person with no special agenda and yet Wade’s point is totally lost on me and I very much suspect the vast majority of people who read Carlson’s piece or either of Wade’s long pieces on the subject. (Its hard to say which of the two points of the Somerset Maugham quote Wade utilises for his blog ‘Have common sense and … stick to the point’ that Wade has more strongly abandoned).

I miss the old Wade very much – a strong, principled and funny man, Wade has become just another sad foot soldier in Jenny McCarthy’s Bimbo Brigade alongside his fellow Chicago hardcore believers. His child is 10 years old and I doubt very much that xe is anywhere even approaching the level of ‘cure’ or ‘recovery’ that Wade has been promised by the various DAN doctors and new friends I have no doubt xe has been worked through. Wade’s tone in both of his blog pieces is a sad, tired sort of bewilderment – a bewilderment that the world just can’t see what he can apparently see. Sadly – pitifully – the viewpoint that he has adopted only means he’s going to become more bewildered.

OSR#1: Industrial chemical or autism treatment?

26 Jan

The Chicago Tribune has added another chapter to their ongoing series posing difficult questions to the autism alternative medical community. OSR#1: Industrial chemical or autism treatment?, by Trine Tsouderos demonstrates the very low standards the alt-med community is willing to accept, at least when it comes to “supplements”.

OSR#1 is being marketed as a supplement by Boyd Haley, retired professor of Chemistry from the University of Kentucky. The chemical used is a powerful chelator, which will come as no surprise to those familiar with Dr. Haley’s history as a proponent of the mercury causation theory in autism. However, “chelation” is not mentioned in the marketing for OSR#1.

Trine Tsudorous has a style I like. She asks very tough questions, points the spotlight on questionable practices and backs up her stories with quotes from experts in the field.

One of the biggest questions raised about OSR#1 is whether the appropriate safety testing has been performed. The marketing doesn’t mention that the chemical used is a chelator.

The company that makes the supplement, CTI Science, describes it as an antioxidant. But pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical Biology at State University of New York at Stony Brook, said it is obvious from the product’s chemical structure that it is also a “powerful chelator,” a compound that binds to heavy metals such as mercury.

Note that CTI Science used to be called “Chelator Technologies, inc”. The chemical used in OSR#1 was invented (and patented) by a colleague of Dr. Haley’s at the University of Kentucky. According to the Tribune story, the original purpose of the chemical was to chelate “heavy metals from soil and acid mine drainage.”

Why would someone avoid calling a chelator a chelator? Especially in the autism alternative-medical community which has been led to believe that chelation is a valid treatment for autism? It appears that chelators are drugs and, as such, are subject to much more stringent and costly safety and efficacy testing than supplements. Dr. Haley is quoted as describing the chemical as “a food”. To my knowledge, this chemical is not found in nature and is not an extract from some food but, rather, a synthetic compound.

From the FAQ for OSR#1

Is OSR#1® a natural compound?

OSR#1® is a combination of two natural compounds that are non-toxic.

Perhaps I missed something–but either this is dodging the question or this is an admission that OSR is not a natural compound. However, either way the wording is carefully chosen.

Ms. Tsuderous brought in an expert on antioxidants for her story as w ell.

“I would worry a lot about giving anything to a small child that hasn’t been scrutinized for both safety and efficacy by the FDA,” said antioxidant expert Dr. L. Jackson Roberts, a pharmacologist at Vanderbilt University School of Medicine.

Which brings up the question, has the safety and efficacy been scrutinized by the FDA? From the Tribune story:

In January 2008 Haley changed the name of his company from Chelator Technologies Inc. to CTI Science Inc. Less than a month later, he notified the FDA he would be introducing the compound as a new dietary ingredient.

Federal law allows manufacturers of dietary supplements to market them without the rigorous testing for safety and efficacy the FDA requires of drugs. Developing, testing and bringing a drug to market can cost hundreds of millions of dollars, according to some studies.

But the law does require makers of supplements containing new dietary ingredients — such as OSR#1 — to establish that the product can be expected to be safe.

In June 2008, an FDA senior toxicologist sent a letter to Haley that questioned on what basis the product could be expected to be safe and could be considered a dietary ingredient. According to FDA spokeswoman Siobhan DeLancey, Haley has not responded to the request for more information.

DeLancey declined to discuss OSR#1 specifically, but she said the government prohibits companies from selling a product until the safety requirement is satisfied. Penalties can include warning letters, seizure of products or criminal prosecution. DeLancey said she did not know of any actions taken against Haley or his company.

Haley did not respond to questions from the Tribune about the FDA.

Well, Dr. Haley hasn’t responded to the request for more information. He could face…a warning letter. Sorry, that just summons up images of Michael Palin doing the “Spanish Inquisition” sketch from Monty Python. So far the FDA seems to have let this case slide for over a year, and should they focus attention on OSR#1 and find fault they might issue a “warning letter”? Has the FDA no teeth?

Some of the questions that arise in my mind reading this article are:

1) Is OSR#1 a chelator?
2) is it being marketed as an antioxidant/supplement to avoid the more costly and time consuming process of approving a drug?
3) is the level of safety testing OSR#1 has undergone appropriate?
4) are the customers for OSR#1 buying it as a chelator or as an antioxidant/supplement?

Let’s take a look at these questions

First, is OSR#1 a chelator? It appears the answer is a fairly clear Yes:

The company that makes the supplement, CTI Science, describes it as an antioxidant. But pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical Biology at State University of New York at Stony Brook, said it is obvious from the product’s chemical structure that it is also a “powerful chelator,” a compound that binds to heavy metals such as mercury.

Second, is OSR#1 being marketed as an antioxidant/supplement to avoid the more costly and time consuming process of approving a drug? I don’t think we can tell the motivations of Dr. Haley or his company. However, the Tribune story seems to ask the same question:

In January 2008 Haley changed the name of his company from Chelator Technologies Inc. to CTI Science Inc. Less than a month later, he notified the FDA he would be introducing the compound as a new dietary ingredient.

Federal law allows manufacturers of dietary supplements to market them without the rigorous testing for safety and efficacy the FDA requires of drugs. Developing, testing and bringing a drug to market can cost hundreds of millions of dollars, according to some studies.

Third, is the level of safety testing appropriate? Again, the Tribune brings up the question of whether the FDA has had all its questions answered, even for the lower standard of a supplement.

While not directly on point as to the safety testing, two quotes from the Tribune story stick in my mind when it comes to safety/efficacy:

Ellen Silbergeld, an expert in environmental health and a researcher funded by the National Institutes of Health studying mercury and autism at Johns Hopkins University Bloomberg School of Public Health, said she found the sale of the chemical as a supplement for children “appalling.”

and

“Treatment of autistic children with a potent chelator is potentially hazardous and offers no benefits,” Grollman said.

Lastly, I posed the question of whether the customers for OSR#1 are buying it as an “antioxidant/supplement” or as a chelator. Again, it is very difficult to ascribe motivations. However, I will point out that in over 400 comments to the Tribune piece, few (if any!) discuss OSR as an antioxidant. Instead there is much discussion of mercury. Rather odd discussion for something that is marketed “only as an antioxidant supplement”.

If you want more details than in the Tribune article, OSR was discussed by Kathleen Seidel of Neurodiversity.com in three articles:

A Fine White Powder

The Industrial Treatment

and

An Inquiry Emerges

Kathleen Seidel is the blogger with the most thoroughly researched articles I have ever seen.

One of the complaints about Ms. Tsudorous’ previous articles, posed by those promoting alternative medical treatments for autism, is that she didn’t seek out “balance”. First, Ms. Tsudorous did enough hard legwork to support her stories without having to rely on pitting parent/advocate opinion on an equal footing with medical experts. Second, Ms. Tsudorous attempted to get comments from a prominent parent/advocate who had publicly touted OSR#1. The parent declined to let her opinion be heard.

The bottom line for this autism parent? OSR#1 doesn’t come close to being something I would give to my child, no matter whether you call it a supplement or a drug. First I side with Dr. Grollman (“Treatment of autistic children with a potent chelator is potentially hazardous and offers no benefits”). Second, what I have seen of the safety studies doesn’t meet my standards. That’s putting it lightly.

edit to add: the Tribune has posted some of the communications between the FDA and the company selling OSR#1:

Click to access 51678955.pdf

Autism Epidemic Talk Part II

25 Jan

Some more rumblings on the wider web regarding the autism ‘epidemic’ – I’m not allowed to carry on commenting at Harold’s (he allowed me one then when I further backed up my points he refused to allow those comments through. Amazing behaviour from someone who _invited_ me to take part in a dialogue!)

Take a closer look – always take a closer look – and what do we see from those convinced there is such a thing as an autism epidemic. We see opinion and we see personal anecdote. Much of it self fulfilling nonsense along the lines ‘before my Billy was diagnosed I didn’t know any autistic kids, now theres 20 just in his class!!!!’ or the classic ‘I asked my teacher/doctor/social worker/whatever and they said they’d never SEEN so many autistic people!’ Well…d’uh…of course not. Better diagnosis, increased ascertainment, more centres for diagnosis, more cultural awareness etc etc etc will lead to more people with a diagnosis. As would a real increase.

The bottom line for me is this: nobody knows if there’s a real autism ‘epidemic’ or not. Not in the strict epidemiological manner the word is used in. Why? Because really, despite all our bombast we (the entire autism and autistic community) know jack shit about autism from a perspective of how many autistic people thre are and what may cause fluctuations.

Take this story I found today which argues very persuasively that girls are not fully accounted for in autism epidemiology. Imagine that we take this too literally and hypothesise that autism is equally prevalent amongst girls as it is boys. The rate in the UK would shoot up to between 1.5 and 2% of the entire population. Would that have been a real increase? Of course not.

Beware of those people who will tell you with certainty that there is an autism epidemic. The truth is that there is no conclusive science either way. Until it is done *no one knows* .

Autistic Woman Raped in Broad Daylight

25 Jan

This is just a nightmare scenario in so many ways. Sexual abuse is just horrible in any form. Rape is just plain evil. I don’t think one can say any case is worse than another, but I can say that this case hurts me, a total stranger, very deeply.

An autistic woman was raped on a busy street in broad daylight.

I got the story from a google news alert pointing to this blog post, Autistic Woman Raped By Teen, No One Helps. It is worth reading the story, but I’ll pull one statement out, this from the victim:

“I’m ticked off because people were doing nothing. Just driving by. What kind of humans are we becoming?”

I wish I could talk more to this story, do more research. I just can’t right now. What a nightmare. I hope the victim gets the help she needs to heal as much as possible from this horrible trauma.

What are the charges against Dr. Wakefield?

25 Jan

The General Medical Counsel is set to publish their findings this week in the case of Doctors Wakefield, Walker-Smith and Murch. With that deadline there is a lot of discussion going on about the GMC hearings. I see a lot of comments about how this is some sort of referendum on the research, which isn’t really the case. So, I thought I would (again) post the list of charges.

Below is a short version. I say short because the full version is 93 pages long.

The goal of the GMC is *not* to determine the scientific quality of the research. Rather, it is to determine whether the three doctors acted ethically in their treatment of their patients and whether they acted ethically in preparing the research report. It is a “fit to practice” determination. I.e. the question asked is whether these gentlemen “fit to practice” medicine in the UK, not whether their research was accurate or of high quality.

The focus of the inquiry on the ethical treatement of the patients is why you will find the phase “Your conduct as set out above was contrary to the clinical interests of Child X” repeatedly in the GMC charges.

To make this point clear, here is a section of the GMC statements

The GMC does not regard its remit as extending to arbitrating between competing scientific theories generated in the course of medical research.

The GMC hearing is not about whether the team led by Dr. Wakefield questioned the safety of MMR. It is about whether they acted in an ethical manner. The accusations are quite serious in nature. I count about 30 instances of the phrase “contrary to the clinical interests” in the GMC charges. I personally find those charges to be the most serious. Well beyond any questions of professional misconduct involving the research paper.

At this point, these are still charges. Many are listed as “admitted and found proved”, but those are mostly statements of recorded facts such as what procedures were performed on specific children and when.

With that in mind, here is a short version of the GMC’s description of the Fitness to Practice Panel’s effort:

Dr Andrew WAKEFIELD
Professor John WALKER-SMITH
Professor Simon MURCH

Fitness to Practise Panel

Planned dates: 4 – 29 January 2010
This session is expected to last 20 days.

Please note that the Panel is currently deliberating in private session until further notice.

The Fitness to Practise Panel will meet at Regent’s Place, 350 Euston Road, London NW1 3JN, to continue its inquiry into three new cases of conduct.

This case will be considered by a Fitness to Practise Panel applying the General Medical Council’s Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules 1988.

Dr Andrew WAKEFIELD
GMC Reference number: 2733564
Professor John WALKER-SMITH GMC Reference number: 1700583
Professor Simon MURCH
GMC Reference number: 2540201

The GMC’s statutory purpose is to protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine.

We investigate complaints about individual doctors in order to establish whether their fitness to practise is impaired and whether to remove or restrict a doctor’s registration.

The GMC does not regard its remit as extending to arbitrating between competing scientific theories generated in the course of medical research.

The following is a summary only of the allegations which will be made before the Panel at the forthcoming hearing.

The Panel will inquire into allegations of serious professional misconduct by Dr Wakefield, Professor Walker-Smith and Professor Murch, in relation to the conduct of a research study involving young children from 1996-98.

Dr Wakefield, Professor Walker-Smith and Professor Murch, were at the relevant times employed by the Royal Free Hospital School of Medicine with Honorary Clinical contracts at the Royal Free Hospital.

It is alleged that the three practitioners were named as Responsible Consultants on an application made to the Ethical Practices Committee of the Royal Free Hospital NHS Trust (“the ethics committee”) in 1996 to undertake a research study involving children who suffered from gastrointestinal symptoms and a rare behavioural condition called disintegrative disorder. The title of the study was “A new paediatric syndrome: enteritis and disintegrative disorder following measles/rubella vaccination”.

The Panel will inquire into allegations that the three practitioners undertook research during the period 1996-98 without proper ethical approval, failed to conduct the research in accordance with the application submitted to the ethics committee, and failed to treat the children admitted into the study in accordance with the terms of the approval given by the ethics committee. For example, it will be alleged that some of the children did not qualify for the study on the basis of their behavioural symptoms.

It is further alleged that the three practitioners permitted a programme of investigations to be carried out on a number of children as part of the research study, some of which were not clinically indicated when the Ethics Committee had been assured that they were all clinically indicated. These investigations included colonoscopies and lumbar punctures. It is alleged that the performance of these investigations was contrary to the clinical interests of the children.

The research undertaken by the three practitioners was subsequently written up in a paper published in the Lancet in February 1998 entitled “Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis and Pervasive Developmental Disorder in Children” (“the Lancet paper”).

It is alleged that the three practitioners inaccurately stated in the Lancet paper that the investigations reported in it were approved by the ethics committee.

The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith acted dishonestly and irresponsibly in failing to disclose in the Lancet paper the method by which they recruited patients for inclusion in the research which resulted in a misleading description of the patient population in the Lancet paper. It is further alleged that Dr Wakefield gave a dishonest description of the patient population to the Medical Research Council.

The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith administered a purportedly therapeutic substance to a child for experimental reasons prior to obtaining information about the safety of the substance. It is alleged that such actions were irresponsible and contrary to the clinical interests of the child.

The Panel will inquire into allegations that Dr Wakefield was involved in advising solicitors acting for persons alleged to have suffered harm by the administration of the MMR vaccine. It is alleged that Dr Wakefield’s conduct in relation to research funds obtained from the Legal Aid Board (“LAB”) was dishonest and misleading. It will be alleged that Dr Wakefield ought to have disclosed his funding from the LAB to the Ethics Committee but did not.

The Panel will inquire into allegations that Dr Wakefield ordered investigations on some children as part of the research carried out at the Royal Free Hospital from 1996-98 without the requisite paediatric qualifications to do so and in contravention of his Honorary Consultant appointment.

The Panel will inquire into allegations that Dr Wakefield failed to disclose his involvement in the MMR litigation, his receipt of funding from the LAB and his involvement in a Patent relating to a new vaccine to the Editor of the Lancet which was contrary to his duties as a senior author of the Lancet paper.

The Panel will inquire into allegations that Dr Wakefield acted unethically and abused his position of trust as a medical practitioner by taking blood from children at a birthday party to use for research purposes without ethics committee approval, in an inappropriate social setting, and whilst offering financial inducement.

We cannot guarantee that all those wishing to attend the hearing will be able to do so, as seating is limited. If you plan to attend the hearing please email the GMC press office press@gmc-uk.org. In the event that we have to allocate seats those people who have notified the press office will be seated before others.
-Ends-

For further information please contact the Media Relations Office on 020 7189 5454, out of hours 020 7189 5444, fax 020 7189 5401, email press@gmc-uk.org, website http://www.gmc-uk.org.

The General Medical Council licenses doctors to practise medicine in the UK. Our purpose is summed up in the phrase: Regulating doctors, Ensuring Good Medical Practice.

The law gives us four main functions:
• keeping up-to-date registers of qualified doctors
• fostering good medical practice
• promoting high standards of medical education
• dealing firmly and fairly with doctors whose fitness to practise is in doubt

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