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March 29, 2012
Autism rate rises sharply to 1 in 88 children, CDC says
The U.S. Centers for Disease Control and Prevention announced today that it now estimates that 1 in 88 children has autism, a 23 percent rise over its last estimate.
The estimate is based on 2008 data from 14 communities around the country; the last estimate was just two years earlier. If the rate is up that much between 2006 and 2008, what is it now? The report says that increase is real in the face of changing autism definitions, varying classifications among communities and increasing diagnoses stemming from greater awareness of autism.
“One thing the data tells us with certainty - there are more children and families that need help,” CDC Director Dr. Thomas Frieden said in a prepared statement. “We must continue to track autism spectrum disorders because this is the information communities need to guide improvements in services to help children.”
In the 2006 estimate, the CDC said 1 in 110 kids had an Autism Spectrum Disorder, which are generally characterized by problems communicating, repetitive behavior and difficulty relating to others.
Today’s estimate shows that prevalence varies widely in the 14 communities with autism affecting 1 in 210 children in Alabama to as many as 1 in 47 children in Utah.
The CDC found that autism is five times more common in boys, affecting 1 in 54 compared with 1 in 252 girls. The biggest increases were among black and Hispanic children. The report did not answer the biggest question. Why? “Further work is needed to evaluate multiple factors contributing to increases in estimated ASD prevalence over time,” it said.
The CDC recommends that parents contact a doctor as soon as they have concerns about their child.
Safer Chemicals Healthy Families, a group concerned about environmental factors and autism, immediately issued a press release warning about unregulated neurotoxins.
The group didn’t name specific chemicals, but it’s clear that we know way too little known about the causes of autism, and that is a huge frustration for parents.
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March 12, 2012
Medical journal, reporter challenge Austin researcher's lawsuit
The editor of the British Medical Journal and the writer of a critical article about Andrew Wakefield of Austin are asking a Travis County court to dismiss Wakefield’s libel suit against them and require him to cover any lawsuit costs.
In their motion filed Friday in District Court, Editor in Chief Dr. Fiona Godlee and British investigative reporter Brian Deer call Wakefield’s libel suit frivolous. The motion argues that Wakefield had no basis to sue over the Jan. 5, 2011, article in the British Medical Journal.
Wakefield founded an autism center in Austin but later resigned. He is continuing to work in Austin.
At issue is the series, “Secrets of the MMR Scare,” which describes research Wakefield led in 1998 in which he suggests a possible link between the measles, mumps and rubella vaccine, called the MMR, and a new form of autism in children. It was published in the prestigious British journal, The Lancet.
Deer and Godlee’s motion says that the British Medical Journal report was accurate, written without malice and expressed opinions about Wakefield’s conduct, which is protected speech.
The articles say Wakefield doctored his research to fit his theory, behaved dishonestly and was out to make money, including by participating in a lawsuit against the makers of MMR. The General Medical Council, which regulates doctors in the UK, examined similar allegations and revoked Wakefield’s medical license in 2010.
The council also revoked the license of one of Wakefield’s co-authors, John Walker-Smith. Walker-Smith appealed to a higher court in England and won his case last week.
Wakefield’s lawyer, Bill Parrish of Austin, said that ruling is significant for Wakefield, too. “The judge said they were wrong on some of the issues, and they are the same (issues) with respect to Dr. Wakefield.”
Wakefield, who referred questions to Parrish, has maintained that he did not nothing wrong or unethical in his research.
“All he wants is his day in court, and they are going to extremes to prevent him from having that,” Parrish said of Deer and Godlee.
Wakefield has sued over Deer’s work previously in the UK and has written a book to present his side of the case, “Callous Disregard.”
“Dr. Wakefield may have figured that, in Texas, there would be little “downside” to filing frivolous libel claims and using the suit to raise money and harass his critics,” the motion says.
Wakefield, who has been a hero to some parents of autistic children, has continued to stand behind the Lancet paper even after his co-authors disavowed it and the Lancet retracted it.
“The Defamatory Statements were and are false and written and published with actual malice and intended to cause damage to Dr. Wakefield’s reputation and to permanently impair his reputation and livelihood,” says his January lawsuit.
Deer and Godlee counter that Wakefield’s suit was intended to intimidate and silence his critics by burdening them with cost of the litigation. They accused him of traveling around the world to raise money for his lawsuit,seeking contributions of up to $50,000 for membership in the “The Dr. Wakefield Justice Fund.”
Parrish said he was not familiar with the fund-raising.
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January 6, 2012
Austin autism researcher sues journal, writers for defamation
A British doctor who was stripped of his medical license in the U.K. in 2010 and who was accused of publishing bogus research data in a journal article a year ago filed a defamation suit this week in state District Court in Travis County.
Andrew Wakefield, who lives in Austin and founded an autism center that was on Bee Cave Road, is suing the British Medical Journal; its editor, Dr. Fiona Godlee; and investigative journalist Brian Deer — all based in the United Kingdom. His suit concerns a Jan. 5, 2011, journal article by Deer and an accompanying editorial by Godlee that called Wakefield’s research on autism and a novel bowel disease fraudulent.
“The Defamatory Statements were and are false and written and published with actual malice and intended to cause damage to Dr. Wakefield’s reputation … and to permanently impair his reputation and livelihood,” the suit filed Tuesday says. It seeks unspecified damages.
The journal issued a statement saying that it stood by the writings and would “defend the claim vigorously” in court. Wakefield, who is seeking a jury trial, has a “history of pursuing unfounded litigation, (so) any action brought against the BMJ and Mr Deer in London would have been immediately vulnerable to being struck out as an abuse of process,” an email from the journal says.
In a paper that appeared in the Lancet in 1998 and ultimately was retracted by the editors 12 years later, Wakefield suggested a link between a new kind of autism-bowel disease and the childhood measles, mumps and rubella vaccine. The Lancet paper, and Wakefield’s subsequent comments about it, set off a worldwide scare over the vaccine, known as the MMR.
Deer wrote in his article, “Secrets of the MMR Scare: How the Case Against the MMR Vaccine Was Fixed,” that Wakefield doctored his research to fit his theory on autism, behaved dishonestly and was out to make money, including by participating in a lawsuit against the makers of MMR.
Wakefield, who has been a hero in the eyes of some parents of autistic children around the world, has denied those claims and has continued to stand behind the Lancet article even after his co-authors disavowed the paper. The General Medical Council, which polices doctors in the U.K. and revoked Wakefield’s license, said in 2010 that Wakefield was guilty of serious professional misconduct and was dishonest and irresponsible in the research he performed in 1998.
Wakefield blasted the findings and came out with a book soon thereafter called “Callous Disregard” to present his evidence. He said a year ago that he would continue his research into autism in Austin, working with pediatric gastroenterologist Arthur Krigsman at Krigsman’s clinic on Cameron Road.
Krigsman and Wakefield resigned from the Thoughtful House Center for Children in 2010. The Thoughtful House has moved to 1700 Rio Grande St. and changed its name to the Johnson Center for Child Health and Development.
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May 5, 2011
Center for autistic children has new name, location
The Thoughtful House Center for Children — an Austin facility geared to education, research and treatment of children with autism and other developmental disorders — has a new name, address and faces.
It is now The Johnson Center for Child Health and Development, named for Betty Wold Johnson, a prominent donor and member of the family who founded the health care company, Johnson & Johnson. And come Monday, the center will be move from its longtime Bee Cave Road location to 1700 Rio Grande Street, Suite 200.
Other changes also have occurred, in staffing and services.
They were discussed in a recent letter to parents.
Thoughtful House was led by Andrew Wakefield until he resigned last year. The medical board in the UK took away his medical license for his role in a controversial 1998 study that suggested a possible link between autism, vaccines and bowel disease, and Wakefield said last year that he didn’t want to be a distraction from the work of Thoughtful House, which he said was getting away from a focus on gastrointestinal issues and autism.
Anissa Ryland, executive director of the Johnson Center, said the organization does not collaborate with Wakefield or a doctor who worked with Wakefield at the center, Dr. Arthur Krigsman. Another physician who worked with Wakefield and Krigsman, Dr. Brian Jepson, also has left the center.
Ryland provided a link to the center’s newsletter, which describes some of the new faces and services being offered there.
“We are excited to be moving to a location that will be more accessible to visiting families and professionals, as well as closer to the UT campus,” Ryland wrote in an email. “We have had the opportunity to include many students in our internship program and we hope to expand those opportunities in the near future.”
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January 21, 2011
Wakefield, autism researcher, subject of 3-part expose
An autism researcher in Austin who was stripped of his British medical license last year for misconduct in his research on children in England, is the topic of a three-part expose that recently wrapped up in the British Medical Journal.
The Statesman published a report about the first article that said Andrew Wakefield’s research that launched a worldwide scare linking vaccines to autism was built on “an elaborate fraud.” Children in the 1998 study were said to have autism symptoms emerge soon after vaccination with the measles-mumps-rubella vaccine. That is disputed by the author of the article, Brian Deer, a British journalist who has written extensively on the Wakefield saga.
The 1998 study was retracted by The Lancet, the journal that published it, last year.
Wakefield, right, denies the allegations in the articles and came out with a book last year to defend himself when his license was taken called “Callous Disregard.” He is continuing his research into autism at a clinic in Austin with Dr. Arthur Krigsman, a pediatric gastroenterologist, on Cameron Road. Both resigned last year from the Thoughtful House Center for Children.
Deer’s second article in the medical journal says that in 1995 Wakefield sought a patent for a test that would look for the measles virus in bowel tissue, furthering an autism theory Wakefield has long championed. Use of the proposed test in Britain and the U.S. would generate up to £72.5 million a year, Deer wrote, or $116 million in today’s dollars. Deer also writes about Wakefield’s work aiding an attorney suing the vaccine manufacturer.
The third article says that editors of the Lancet allowed the public to be misled about Wakefield’s research for six years. That’s how long Deer said it took editors of The Lancet to retract Wakefield’s paper after Deer first complained about it.
Wakefield issued a statement disputing Deer’s articles last week.
“I want to make one thing crystal clear for the record - my research and the serious medical problems found in those children were not a hoax and there was no fraud whatsoever. Nor did I seek to profit from our findings,” he wrote. “I stand by the Lancet paper’s methodology and the results which call for more research into whether environmental triggers cause gastrointestinal disease and developmental regression in children.”
He said Friday that he planned to issue documents that refute Deer’s articles. “There’s absolutely no question they committed serious defamation,” he said. “I will be dealing with this over the next several months.”
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May 24, 2010
UPDATED: UK medical board issues findings on Wakefield; he remains defiant
UPDATED: Wakefield will appeal, spokesman says (below)
The medical board that regulates physicians in the United Kingdom announced today that it intends to ban Andrew Wakefield from practicing medicine there, calling the sanction the only way to protect patients and the only penalty “proportionate to the serious and wide-ranging findings made against him.”
The General Medical Council found Wakefield guilty of serious professional misconduct, citing dishonest, irresponsible research he performed in 1998, among other activities. The research launched a worldwide scare over autism and vaccines, prompting Wakefield to leave England and to set up shop in Austin where, until recently, he was executive director of the Thoughtful House Center for Children.
The council said it will erase Wakefield’s name from the medical register in the UK within 28 days of his official notification of its decision, unless he appeals the punishment. Wakefield did not have a license to practice medicine in the U.S.
A spokesman for Wakefield said Tuesday that he will be appealing the sanction.
Wakefield, 53, remained defiant in an interview last week, saying he had done nothing wrong and was more convinced than ever that his theory linking autism, vaccines and gastrointestinal illness were correct, despite repeated studies finding no link. His only possible omission, he said, was failing to get approval from an ethics board before having blood drawn on young children at his son’s birthday party in 1999, he said.
“It was done with fully informed parental and child consent,” Wakefield said last week. “There was nothing unethical, but I did not have an ethical approval, and that may have been naive on my part.”
Wakefield has a book coming out today called “Callous Disregard,” that gives his side of the case. He plans to continue his research into autism in Austin, he said, working with Dr. Arthur Krigsman, who also worked at Thoughtful House until recently.
Here is the General Medical Council’s decision (in which Wakefield was one of three doctors reviewed):
Dr Andrew Jeremy WAKEFIELD
Determination on Serious Professional Misconduct (SPM) and sanction:
The Panel has already given its findings on the facts and its reasons for determining that the facts as found proved could amount to serious professional misconduct.
It then went on to consider and determine whether, under Rule 29(1) of the General Medical Council Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules Order of Council 1988, the facts as admitted or found proved do amount to serious professional misconduct and if so, what, if any sanction it should impose. It has accepted the Legal Assessor’s advice in full as to the approach to be taken in this case, and has looked at each doctors’ case separately but, when considering whether Dr Wakefield is guilty of serious professional misconduct, has looked at the heads of charge found proved against him as a whole. It has not confined its consideration to the heads of charge; it has also had regard to the evidence that has been adduced and the submissions made by Ms Smith on behalf of the General Medical Council. On behalf of Dr Wakefield, no evidence has been adduced and no arguments or pleas in mitigation have been addressed to the Panel at this stage of the proceedings. In fact Mr Coonan specifically submitted:
“……we call no evidence and we make no substantive submissions on behalf of Dr Wakefield at this stage.” “…I am instructed to make no further observations in this case”.
Nevertheless, the Panel considered the totality of the evidence in Dr Wakefield’s case including the reference dated 27 October 1995, from Professor Leon Fine, the then Head of the Department of Medicine at the Royal Free Hospital, when reaching its decision at this stage, having been asked to consider that as part of Mr Coonan’s submissions at Stage 1.
Serious professional misconduct has no specific definition but in Roylance v General Medical Council [1999] Lloyd’s Rep. Med. 139 at 149 Lord Clyde, in giving the reasons of the Privy Council, said:
“Misconduct is a word of general effect, involving some act or omission which falls short of what would be proper in the circumstances. The standard of propriety may often be found by reference to the rules and standards ordinarily required by a medical practitioner in the particular circumstances…”
Lord Clyde went on to say:
“The misconduct is qualified in two respects. First, it is qualified by the word ‘professional’ which links the misconduct to the profession of medicine. Secondly, the misconduct is qualified by the word ‘serious’. It is not any professional misconduct which will qualify. The professional misconduct must be serious.”
The Panel has acted as an independent and impartial tribunal and exercised its own judgement on these matters. It has borne in mind the relevant GMC guidance at the time, namely the 1995 Good Medical Practice and, in so far as the findings relate to events after 1998, the 1998 Good Medical Practice. It has considered what has been adduced and submitted on behalf of the doctors about the standards and procedures which were prevalent at that time.
In considering Dr Wakefield’s case, the Panel has also taken into account the passage of time before these matters were brought before it and the length of time this case has taken. It noted that the multiple sittings were for a variety of reasons including professional commitments of the Panel and requests from Counsel for reasons such as illnesses, accidents, unavailability of witnesses and preparation time.
The Panel has noted Dr Wakefield’s previous good character and taken into account everything it has heard including his qualifications, experience and standing within the profession, with patients and the parents of patients.
The Panel considered the conduct of Dr Wakefield whilst he was registered as a medical practitioner and employed by the Royal Free Hospital Medical School in 1996 and 1997, initially as a Senior Lecturer in the Departments of Medicine and Histopathology. Later, from 1 May 1997 he was a Reader in Experimental Gastroenterology and an Honorary Consultant in Experimental Gastroenterology at the Royal Free Hospital.
The Panel has already found proved that Dr Wakefield’s Honorary Consultant appointment was subject to a stipulation that he would not have any involvement in the clinical management of patients. On five occasions (child 2, 4, 5, 12 and 7) he ordered investigations on children, when he had no paediatric qualifications, and in contravention of the limitations on his appointment. The Panel considered this alone constituted a breach of trust of patients and employers alike.
In February 1996 Dr Wakefield agreed to act as an expert in respect of MMR litigation. In relation to the Legal Aid Board (LAB), the Panel found that Dr Wakefield accepted monies totalling £50,000 procured through Mr Barr, the Claimants’ solicitor to pursue research. A costing proposal had been submitted by Mr Barr to the LAB containing detailed information provided by Dr Wakefield, and Dr Wakefield ought to have realised that Mr Barr would submit it to the LAB.
The costing proposal set out costs in respect of the investigation of five children. It covered each child’s four-night stay in hospital with colonoscopy, MRI and evoked potential studies. Dr Wakefield admitted that the funding subsequently provided by the Legal Aid Board had not been needed for these items because these costs were borne by the National Health Service as the patients were being admitted as NHS patients.
The Panel found that Dr Wakefield had a duty to disclose this information to the Legal Aid Board via Mr Barr. It was dishonest and misleading of him not to have done so. The Panel concluded that his intention to mislead the Legal Aid Board was sufficient on its own to amount to serious professional misconduct.
The Panel also found that in respect of £25,000 of LAB monies, Dr Wakefield caused or permitted it to be used for purposes other than those for which he said it was needed and for which it had been granted. In doing so he was in breach of his duties in relation to the managing of, and accounting for, funds.
In September 1996 Dr Wakefield made an application to the Ethical Practices Sub-Committee of the Royal Free Hospital (Ethics Committee) seeking approval for a research project involving 25 children. This was approved by the sub-Committee as Project 172-96. He named himself as one of the three Responsible Consultants, thereby taking on the shared responsibility for the information given in support of his application; for ensuring that only children meeting the inclusion criteria would be admitted to the study; that conditions attached to the Ethics Committee approval would be complied with; and that children would be treated in accordance with the terms of the approval given.
In respect of Research and Ethics Committee approval, the Panel had regard to the particular ethical guiding principles with regard to conducting research on children. It rejected Dr Wakefield’s overall contention that Project 172-96 was never undertaken; that all the investigations carried out on the children were clinically indicated and that the research elements of the project were covered by another Ethics Committee approval.
The Panel concluded that the programme of investigations that these children were subjected to was part of Project 172-96. It further determined that the conditions for approval and the inclusion criteria for that project were not complied with. The Ethics Committee’s reliance on the probity of Dr Wakefield as a Responsible Consultant was not met.
With regard to nine of the eleven children (2,1, 3, 4, 6, 9, 5,12 and 8) considered by the Panel, it determined that Dr Wakefield caused research to be undertaken on them without Ethics Committee approval and thus without the ethical constraints that safeguard research. Ethical constraints are there for the protection both of research subjects and for the reassurance of the public and are crucial to public trust in research medicine. It was in the context of this research project that the Panel found that Dr Wakefield caused three of these young and vulnerable children, (nos. 3, 9 and 12) to undergo the invasive procedure of lumbar puncture when such investigation was for research purposes and was not clinically indicated. This action was contrary to his representation to the Ethics Committee that all the procedures were clinically indicated. In nine of the eleven children (2,1, 3, 4, 9, 5,12, 8 and 7) the Panel has found that Dr Wakefield acted contrary to the clinical interests of each child. The Panel is profoundly concerned that Dr Wakefield repeatedly breached fundamental principles of research medicine. It concluded that his actions in this area alone were sufficient to amount to serious professional misconduct.
The results of the research project were written up as an early report in the Lancet in February 1998. Dr Wakefield as a senior author undertook the drafting of the Lancet paper and wrote its final version. The reporting in that paper of a temporal link between gastrointestinal disease, developmental regression and the MMR vaccination had major public health implications and Dr Wakefield admitted that he knew it would attract intense public and media interest. The potential implications were therefore clear to him, as demonstrated in his correspondence with the Chief Medical Officer of Health and reports which had already appeared in the medical press. In the circumstances, Dr Wakefield had a clear and compelling duty to ensure that the factual information contained in the paper was true and accurate and he failed in this duty.
The children described in the Lancet paper were admitted for research purposes under a programme of investigations for Project 172-96 and the purpose of the project was to investigate the postulated new syndrome following vaccination. In the paper, Dr Wakefield failed to state that this was the case and the Panel concluded that this was dishonest, in that his failure was intentional and that it was irresponsible. His conduct resulted in a misleading description of the patient population. This was a matter which was fundamental to the understanding of the study and the terms under which it was conducted.
In addition to the failure to state that the children were part of a project to investigate the new syndrome, the Lancet paper also stated that the children had been consecutively referred to the Department of Paediatric Gastroenterology with a history of a pervasive developmental disorder and intestinal symptoms. This description implied that the children had been referred to the gastroenterology department with gastrointestinal symptoms and that the investigators had played no active part in that referral process. In fact, the Panel has found that some of the children were not routine referrals to the gastroenterology department in that either they lacked a reported history of gastrointestinal symptoms and/or that Dr Wakefield had been actively involved in the process of referral. In those circumstances the Panel concluded that the description of the referral process was irresponsible, misleading and in breach of Dr Wakefield’s duty as a senior author.
The statement in the Lancet paper that investigations reported in it were approved by the Royal Free Hospital Ethics Committee when they were not, was irresponsible.
Subsequent to the paper’s publication, Dr Wakefield had two occasions on which he could have corrected the content of the Lancet paper yet both times he compounded his misconduct.
First, in a published letter in response to correspondents who had suggested that there had been biased selection of the Lancet children, Dr Wakefield stated that the children had been referred through the normal channels, a response which was dishonest and irresponsible. He provided an inaccurate statement which omitted relevant information when he knew that the description of the population in the study was being questioned by the scientific community.
Second, at a meeting of the Medical Research Council, the Chair, Professor Sir John Pattison referred to the seriousness and importance of the implications of Dr Wakefield’s research and its major public health implications. At that meeting and on the issue of bias in generating the series of cases, Dr Wakefield stated that the children had come by “the standard route”, a response which was dishonest and irresponsible.
Regarding the issues of conflicts of interest, Dr Wakefield did not disclose matters which could legitimately give rise to a perception of a conflict of interest. He failed to disclose to the Ethics Committee and to the Editor of the Lancet his involvement in the MMR litigation and his receipt of funding from the Legal Aid Board. He also failed to disclose to the Editor of the Lancet his involvement as the inventor of a patent relating to a new vaccine for the elimination of the measles virus (Transfer Factor) which he also claimed in the patent application, would be a treatment for inflammatory bowel disease (IBD).
Even before the publication of the Lancet Paper, eminent professionals had expressed concerns about the LAB funding to Dr Wakefield and potential conflicts of interest. Dr Wakefield rejected these views. With regard to non-disclosure to the Ethics Committee, Dr Wakefield did in evidence accept that the Legal Aid Board funding should have been disclosed, but said that his involvement in the litigation need not, especially because of his interpretation of the questions in the application form. He said no question was asked which related to that matter and therefore felt no need to disclose. In evidence to the panel he stated:
“The form is set out expecting certain answers to specific questions and no such question exists. Therefore, since it was not asked, it was not answered.”
However, given the importance of an Ethics Committee’s reliance on the probity of an applicant, the Panel determined that this was a failure by Dr Wakefield and his actions amounted to serious professional misconduct.
With regard to the non-disclosure to the Lancet the Panel accepted evidence from the Editor of the Lancet, as to the importance of this issue. The Lancet published clear guidance in relation to the conflict of interest test that the applicant should apply and the need to discuss any issues arising from it with the Editor. The Lancet test was: “Is there anything that would embarrass you if it were to emerge after publication and you had not declared it?” Dr Wakefield chose not to declare or discuss any conflict of interest with the Editor. He stated that he was able to reconcile his position, was not embarrassed by it, and was quite proud of the position he had taken on behalf of the Lancet children.
Dr Wakefield was insistent that his involvement with the new patent had not given rise to any prior need to disclose. Despite the clear terms of the patent, he did not accept that the invention was envisaged as an alternative vaccine to MMR. He acknowledged that he had envisaged the use of transfer factor for at least a proportion of the population and that he had a financial and career interest in its success, but he said that it did not cross his mind to disclose it, and even with hindsight he insisted that there was a reasonable argument, as he put it, for non-disclosure. The Panel considered that his actions and his persistent lack of insight as to the gravity of his conduct amounted to serious professional misconduct.
In relation to the administration of Transfer Factor to Child 10, the Panel noted the admitted background of Dr Wakefield’s involvement in a company set up with Child 10’s father as Managing Director, to produce and sell Transfer Factor. Around the same time, Dr Wakefield inappropriately caused Child 10 to be administered transfer factor. The Panel accepted that information as to its safety had been obtained and that the approval to administer Transfer Factor to one child was granted in the form of “Chairman’s approval”, “on a named patient basis” in a letter from Dr Geoffrey Lloyd, Chairman of the Medical Advisory Committee at the Royal Free Hospital. Nonetheless the Panel found that Dr Wakefield was at fault because the substance was given for experimental reasons, he did not cause the details to be recorded in the child’s records, or cause the general practitioner to be informed, and he did not have the requisite paediatric qualifications.
Dr Wakefield’s actions were contrary to the clinical interests of Child 10 and an abuse of his position of trust as a medical practitioner. The Panel considered these to be serious departures from the standards of a registered medical practitioner and concluded that these amounted individually and collectively to serious professional misconduct.
Dr Wakefield caused blood to be taken from a group of children for research purposes at a birthday party, which the Panel found to be an inappropriate social setting. He behaved unethically in failing to seek Ethics Committee approval; he showed callous disregard for any distress or pain the children might suffer, and he paid the children £5 reward for giving their blood. He then described the episode in humorous terms at a public presentation and expressed an intention to repeat his conduct. When giving evidence to the Panel, Dr Wakefield expressed some regret regarding his remarks. The Panel was concerned at Dr Wakefield’s apparent lack of serious consideration to the relevant ethical issues and the abuse of his position of trust as a medical practitioner with regard to his conduct in causing the blood to be taken. The Panel concluded that his conduct brought the medical profession into disrepute.
Dr Wakefield defended the ethical basis for the taking of blood at a birthday party contrary to the experts who gave evidence to the Panel and who strongly condemned this action. The Panel determined that his conduct fell seriously short of the standards expected of a doctor and was a breach of the trust which the public is entitled to have in members of the medical profession. It concluded that this behaviour amounted to serious professional misconduct.
The Panel has borne in mind the principles guiding a doctor as set out in the relevant paragraphs of 1995 Good Medical Practice which relate to providing a good standard of practice and care, good clinical care, keeping up-to-date, abuse of professional position, probity in professional practice, financial and commercial dealings, and the general principles of conflict of interest, followed by particular provisions as to the way in which research must be conducted. The 1998 Good Medical Practice, relevant to Dr Wakefield’s conduct at the birthday party, lists the duties of a doctor in providing a good standard of practice and care, keeping up-to-date and the issue of research and the absolute duty to conduct all research with honesty and integrity.
In all the circumstances and taking into account the standard which might be expected of a doctor practising in the same field of medicine in similar circumstances in or around 1996-1998, the Panel concluded that Dr Wakefield’s misconduct not only collectively amounts to serious professional misconduct, over a timeframe from 1996 to 1999, but also, when considered individually, constitutes multiple separate instances of serious professional misconduct.
Accordingly the Panel finds Dr Wakefield guilty of serious professional misconduct.
In considering what, if any, sanction to apply, the Panel was mindful at all times of the need for proportionality and the public interest which includes not only the protection of patients and the public at large, but also setting and maintaining standards within the medical profession, as well as safeguarding its reputation and maintaining public confidence in the profession. It bore in mind that the purpose of sanctions is not punitive, although that might be their effect.
The Panel noted the submissions of GMC Counsel that the appropriate and proportionate sanction would be erasure in light of his serious and wide-ranging misconduct. However the Panel accepted the Legal Assessor’s advice that this was only a submission on behalf of the GMC and it was for the Panel to make up its own mind. Dr Wakefield’s counsel did not make any substantive submissions on his behalf.
The Panel went on to consider whether it should, pursuant to Rule 30(1), postpone the case. It received no submissions in this regard and so went on to determine whether it was sufficient to conclude the case without making a direction or with an admonition.
The Panel made findings of transgressions in many aspects of Dr Wakefield’s research. It made findings of dishonesty in regard to his writing of a scientific paper that had major implications for public health, and with regard to his subsequent representations to a scientific body and to colleagues. He was dishonest in respect of the LAB funds secured for research as well as being misleading. Furthermore he was in breach of his duty to manage finances as well as to account for funds that he did not need to the donor of those funds. In causing blood samples to be taken from children at a birthday party, he callously disregarded the pain and distress young children might suffer and behaved in a way which brought the profession into disrepute.
In view of the nature, number and seriousness of the findings the Panel concluded it would be wholly inappropriate to conclude the case without making a direction or with a reprimand.
It next considered under rule 31 whether it was sufficient to direct that the registration of Dr Wakefield be conditional on his compliance during a period not exceeding three years with such requirements as the (Panel) may think fit to impose for the protection of members of the public or in his interests. Conditions have to be practicable, workable, measurable and verifiable and directed at the particular shortcomings identified. The Panel concluded that Dr Wakefield’s shortcomings and the aggravating factors in this case including in broad terms the wide-ranging transgressions relating to every aspect of his research; his disregard for the clinical interests of vulnerable patients; his failure to heed the warnings he received in relation to the potential conflicts of interest associated with his Legal Aid Board funding; his failure to disclose the patent; his dishonesty and the compounding of that dishonesty in relation to the drafting of the Lancet paper; and his subsequent representations about it, all played out against a background of research involving such major public health implications, could not be addressed by any conditions on his registration. In addition, the Panel considered that his actions relating to the taking of blood at the party exemplifies a fundamental failure in the ethical standards expected of a medical practitioner. It concluded that conditional registration would not mark the seriousness of such fundamental failings in his duty as a doctor.
The Panel next went on to consider whether it would be sufficient to suspend Dr Wakefield’s registration for a period not exceeding twelve months. Dr Wakefield has demonstrated a persistent lack of insight and has insisted in many instances on his ethical propriety: in the context of the referral process and the treatment of the children in the research project in which he was engaged; in the context of the funding of the project; with regard to the terminology of the Lancet paper; with regard to his non-declaration of interests; with regard to not acting in the best clinical interests of the Lancet children and with regard to obtaining blood from children at a birthday party.
The Panel noted that the sanction of suspension may be appropriate for conduct that falls short of being fundamentally incompatible with continued registration; where there is no evidence of harmful deep-seated or attitudinal problems; and where there is insight and no significant risk of repeating behaviour. Although these points have been set out in the GMC’s Indicative Sanctions Guidance which was published subsequent to these events, the Panel considered that the guidance outlines the type of sanction appropriate to the gravity of misconduct and that the same principles are applicable to Dr Wakefield’s actions at the material times. The Panel considers that Dr Wakefield’s conduct in relation to the facts found falls seriously short of the relevant standards and that suspension would not be sufficient or appropriate against a background of several aggravating factors and in the absence of any mitigating submissions made on his behalf. Dr Wakefield’s continued lack of insight as to his misconduct serve only to satisfy the Panel that suspension is not sufficient and that his actions are incompatible with his continued registration as a medical practitioner.
Accordingly the Panel has determined that Dr Wakefield’s name should be erased from the medical register. The Panel concluded that it is the only sanction that is appropriate to protect patients and is in the wider public interest, including the maintenance of public trust and confidence in the profession and is proportionate to the serious and wide-ranging findings made against him.
The effect of the foregoing direction is that, unless Dr Wakefield exercises his right of appeal, his name will be erased from the Medical Register 28 days from when formal notice has been deemed to be served upon him by letter to his registered address.
Dr Wakefield is presently not subject to any interim order on his registration. The Panel will hear submissions on whether an immediate order of suspension should be imposed upon him pending the outcome of any appeal, first from Ms Smith on behalf of the General Medical Council and then from Mr Coonan on behalf of the doctor but will do that at the conclusion of the reading of all three determinations.
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May 19, 2010
Doctor at center of autism/vaccine scare expects to lose license but will keep research in Austin
Dr. Andrew Wakefield — the British doctor who came to Austin after fueling a worldwide scare over vaccines and autism — said that he fully expects to have his British medical license yanked next week in a final effort by the mainstream medical establishment “to silence me and stop the research.”
The General Medical Council in January found Wakefield guilty of acting dishonestly and irresponsibly in researching children with autism in England and writing a 1998 paper in the prestigious Lancet journal that was ultimately retracted in February. The council also said Wakefield showed “callous disregard” for children at his child’s birthday party in 1999 when he had blood taken from them, paying them about $10 each and later joking at a conference about it.
In his first in-depth interview since the council’s findings, Wakefield, who headed the Thoughtful House Center for Children in Austin until he resigned in February, said the charges were unfair and false and he does not intend to fade away. He is coming out with a book Monday, the same day he expects the council to take his license, called “Callous Disregard,” to give his side of the story. He also intends to continue his research into the potential link between vaccines and autism, including gastrointestinal problems in children with autism. He plans to do that work in Austin with Dr. Arthur Krigsman, who also, until recently, practiced at the Thoughtful House.
What the council will finish Monday “has been done for the specific purpose to silence me and stop vaccine safety research,” Wakefield, 53, said. “Vaccine safety is built upon the confidence of the public… and I’m not prepared to (compromise) that.”
Wakefield did not have a license to practice medicine in the U.S. but headed the research program at Thoughtful House, which treats children from around the world.
You can read more about what Wakefield had to say in the Statesman tomorrow.
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May 3, 2010
UPDATED: UT study says gluten-free diets don't help kids with autism
UPDATED BELOW WITH COMMENT FROM THOUGHTFUL HOUSE
A new study by researchers at the University of Texas at Austin says there is no evidence to support the hard-to-follow gluten-free and/or casein-free diets that some alternative-medicine practitioners recommend for children with autism.
Scientists at the Autism Spectrum Disorders Institute, part of UT’s Meadows Center for Preventing Educational Risk,reached that conclusion after analyzing 15 major studies published on those diets, according to the study published in the summer edition of the peer-reviewed journal, Research in Autism Spectrum Disorders.
Gluten is found in wheat, barley and other grains, while casein is found in milk and other dairy products. Putting children on a gluten-free, casein-free diet was developed on the theory that people with autism “have insufficient enzymatic activity in the gastrointestinal tract and increased gastrointestinal permeability. It’s suggested that they tend to absorb toxic byproducts of the incompletely digested proteins casein and gluten,” said Austin Mulloy, the study’s lead researcher and a doctoral student in UT’s Department of Special Education, in a news release.
An increasing number of parents of children with autism have tried the diet in recent years. And some, including parents of children who are patients at the Thoughtful House Center for Children in Austin, say their child’s behavior has improved as a result.
Kelly Barnhill, director of the nutrition clinic at Thoughtful House, said that the center remains steadfast in its belief of nutrition’s benefits and hopes more research trials will be done on the diets. The center’s “clinical experience of over 2,000 patients has been that a high percentage of children with autism have significant improvement in behaviors, GI function, and overall health as a direct result of this nutritionally sound, safe, and affordable intervention when done with appropriate professional supervision,” Barnhill said in a statement.
But the study says there is no scientific evidence that the diets help, and in fact, they can do harm, including reducing bone thickness, the study says. It concludes that such diets should only be used on children with autism who have “acute behavioral changes, seemingly associated with changes in diet, and/or (when) medical professionals confirm through testing the child has allergies or food intolerances to gluten and/or casein.”
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March 12, 2010
Vaccine court rules: Mercury in vaccines does not cause autism
In another anticipated autism/vaccine ruling this afternoon, a special federal court says it has found no connection between mercury in vaccines and autism.
This latest ruling by the U.S. Federal Court of Federal Claims Office of Special Masters is another blow to parents who sued the government and claimed their childs’ austim was brought on by a mercury preservative once commonly found in childhood vaccines — thimerosal. That preservative was removed from most childhood vaccines, except flu shots, in 2001. Since then, autism cases have continued to rise, instead of doing down.
The court set up to look into ways vaccines might cause autism ruled today on the last scenario: whether thimerosal on its own can cause autism, according to an article posted by Reuters. Last year, the court ruled against three families who said their children’s autism was caused by vaccines.
Here is a good backgrounder on the cases and what the court was charged with doing.
In a separate court, the government conceded that vaccines may have injured or aggravated the health of Hannah Poling, a Georgia child with autism, and agreed to compensate her family. That is evidence of thimerosal damage, and the government should compensate others, said Safe Minds (Sensible Action For Ending Mercury-Induced Neurological Disorders).
“The Department of Health and Human Services (HHS) is the defendant in vaccine injury cases and is also responsible for carrying out the very vaccine safety research that should be integral to court decisions,” it said in a statement. “This conflict of interest means the deck is stacked against families when they enter ‘vaccine court’ and is yet one more reason for parents to doubt the integrity of the National Immunization Program.”
Special Master George Hastings wrote in today’s ruling that the the family’s argument that mercury in vaccines caused their son’s autism was “scientifically unsupported,” Reuters reported.
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February 25, 2010
Austin autism center losing second key person
Days after the Thoughtful House Center for Children on Bee Cave Road in Austin announced the departure of its internationally known researcher and executive director, Dr. Andrew Wakefield, it said one of its two medical doctors is leaving.
Dr. Arthur Krigsman, a gastroenterologist who treats intestinal disorders and performs colonoscopies on some children, is leaving in early spring to set up a separate office, Thoughtful House said in a statement today. Krigsman, who also has a practice in New York, and Dr. Bryan Jepson are not employees of the center but see patients there.
“Dr. Krigsman’s decision to relocate his clinical practice to a facility outside Thoughtful House reflects his belief that the complexities inherent in a referral-based practice can be best addressed by his working independently,” the statement said. “We will continue to refer patients for gastrointestinal evaluations when appropriate and we look forward to continuing to work with Dr. Krigsman on research projects. We are grateful to Dr. Krigsman for his dedication to Thoughtful House and for the work he does on behalf of the children we serve.”
Thoughtful House’s media person did not address what those complexities were in response to questions. Krigsman made the decision several weeks ago, she said.
Last week, Wakefield, who is defending his medical license in England in the face of findings that he was dishonest and irresponsible in conducting research on children in England a dozen years ago, was said to be leaving so the controversy he is dealing with would not detract from the center’s work.
Written statements from Thoughtful House did not say Wakefield had resigned, although Jane Johnson in New York, managing director of the center’s board, said he did.
“Dr. Wakefield resigned because he wanted to pursue his defense before the GMC,” she said of the General Medical Council, which held hearings in London regarding the allegations against him. “It was his decision.”
Wakefield has called the findings “unfounded and unjust.”
Jepson plans to stay, Thoughtful House said.
Thoughtful House, a non-profit organization, which through Wakefield attracted celebrity supporters, said its work would go on.
“All of us at Thoughtful House continue to work every day to maximize the potential and strive for the recovery of children with developmental disorders,” it said in a statement. “We will continue to do our very best to accomplish our mission by combining the most up-to-date treatments and important research that will help to shape the understanding of these conditions which are affecting an ever-increasing number of children worldwide.”
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February 18, 2010
Beleaguered British doctor steps down from Austin autism center
Defending his medical license in England, the controversial British doctor who heads an autism center in Austin has stepped down as its chief, according to information from the center.
Dr. Andrew Wakefield, executive director of the Thoughtful House Center for Children, faces the possible loss of his physician license by the General Medical Council, which regulates doctors in the United Kingdom. A panel of the council said last month that Wakefield was dishonest and irresponsible in research he did on children in England a dozen years ago. The work fueled a worldwide scare over vaccines and autism.
The panel also said that Wakefield showed a “callous disregard” for children at his child’s birthday party when he had blood taken from them and paid about $10 each, later joking at a conference about them being “paid for their discomfort.”
The Lancet, a prestigious British medical journal that published Wakefield’s research study in 1998, retracted the study earlier this month.
The Thoughtful House removed Wakefield from its list of staff and issued a statement today that said:
“The needs of the children we serve must always come first. All of us at Thoughtful House are grateful to Dr. Wakefield for the valuable work he has done here. We fully support his decision to leave Thoughtful House in order to make sure that the controversy surrounding the recent findings of the General Medical Council does not interfere with the important work that our dedicated team of clinicians and researchers is doing on behalf of children with autism and their families.
“All of us at Thoughtful House continue to fight every day for the recovery of children with developmental disorders. We will continue to do our very best to accomplish our mission by combining the most up-to-date treatments and important clinical research that will help to shape the understanding of these conditions which are affecting an ever-increasing number of children worldwide.”
Thoughtful House did not answer other questions about the departure.
Starting April 7 in England, Wakefield goes to the next level of hearings before the council, which will decide whether he is guilty of serious professional misconduct and whether he should be sanctioned. Possibilities include stripping him of his medical license.
Wakefield does not have a license to practice medicine in the United States.
He told reporters outside the medical council’s office in London last month that he was “extremely disappointed” by outcome of the proceedings. “The allegations against me and against my colleagues are both unfounded and unjust. I repeat, unfounded and unjust, and I invite anyone to examine the contents of these proceedings and come to their own conclusion,” he said.
Wakefield is seen as a hero by many parents in the autism community who say he has helped their children improve. They believe in the theory he advanced in the Lancet paper — that some children may develop a form of autism and gastrointestinal disease possibly from exposure to the combined measles, mumps, rubella vaccine. The theory has been widely disputed by other researchers.
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January 28, 2010
British medical panel slams doctor who leads Austin autism center
A British medical panel today found that a doctor who leads an Austin autism center acted dishonestly and irresponsibly in doing research on children and writing a paper that fueled a worldwide scare over vaccines and autism.
The panel also said that Dr. Andrew Wakefield showed a “callous disregard” for children at his child’s birthday party when he had blood taken from them and paid the equivalent of $10 each, later joking at a conference about them being “paid for their discomfort.”
Wakefield now proceeds to the next level of hearings at which the panel of the General Medical Council, which regulates doctors in the United Kingdom, will decide whether Wakefield is guilty of serious professional misconduct. If so, he could be stripped of his medical license.
He does not have a medical license in the United States where he is executive director of the Thoughtful House Center for Children in Austin.
Wakefield told reporters outside the medical council’s office in London after it released its findings today that he was “extremely disappointed by the outcome of today’s proceedings. The allegations against me and against my colleagues are both unfounded and unjust. I repeat, unfounded and unjust, and I invite anyone to examine the contents of these proceedings and come to their own conclusion.”
Wakefield and two of 12 former colleagues who authored a 1998 article in the prestigious Lancet medical journal, Professor John Walker-Smith and Dr. Simon Murch, were called before the GMC panel starting in July 2007 to defend themselves against allegations that they behaved unethically and irresponsibly in pursing their work.
The panel said it found that Wakefield, who was senior author of the Lancet paper, subjected many of the 12 children to onerous procedures that were not in the childrens’ best interests. He also did not receive the required ethics committee approval for the research, the panel said.
Wakefield is beloved by many parents in the autism community who say he has helped their children improve. They believe in the theory he advanced in the Lancet paper, although it has been widely dismissed by mainstream medicine.
Wakefield and the Thoughtful House practitioners are investigating the theory that some healthy children develop autism after toxins from live measles virus (from the combination measles, mumps, rubella vaccine) leak into the gut, causing intestinal problems and ultimately affecting the brain, causing the child to regress into autism.
Thoughtful House also issued a statement about the panel’s findings saying: “We are all disappointed. But a careful examination of the full record of the Council’s inquiry will show that the charges made against Dr. Wakefield are unfounded and unfair. Our work on behalf of children with developmental disorders and their families goes on. Our sole focus continues to be to provide the best possible treatment for these children.”
The second phase of the hearings is scheduled for April 7 to June 11.
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December 14, 2009
People with autism not as engaged in thoughts of self as expected, new research says
A study published today out of England puts a new twist on autism, finding that people with the disorder often have problems engaging in self-reflective thought further compounding their social awkwardness.
It’s an interesting finding because the word “autism” comes from the Greek word “autos,” meaning self. The general thinking has been the people with autism are absorbed with the self. Yet researchers from University of Cambridge found in the journal Brain that the autistic people they studied thought no more about themselves than they did about another person who was suggested to them.
The researchers used functional magnetic resonance imaging (fMRI) to scan the brains of 66 men, half of whom are diagnosed with autism.
The lead researcher, Michael Lombardo, asked the participants to either judge their own thoughts, opinions, preferences, or physical characteristics, or someone else’s, in this case the Queen of England’s, according to the article posted on Newswise, a Web site for journalists. The scans enabled the researchers to visualize the differences in brain activity between those with and without autism and measure the part of the brain involved in how people view themselves. That part of the brain is called the ventromedial prefrontal cortex.
“This new study shows that within the autistic brain, regions that typically prefer self-relevant information make no distinction between thinking about the self or another person,” Lombardo said. The research suggests that people with autism not only are impaired in thinking about others, they are impaired in thinking about themselves.
The study suggests that the less a person was able to draw distinctions between themselves and others at an early age, the more socially impaired they were. It says:
“Individuals whose ventromedial prefrontal cortex made the largest distinction between mentalizing about self and other(s) were least socially impaired in early childhood, while those whose ventromedial prefrontal cortex made little to no distinction between mentalizing about self and other(s) were the most socially impaired in early childhood,” the study says.Permalink | Comments (1) | Categories: Autism
July 16, 2009
Suit filed against autism clinic alleges fraud, conspiracy
A lawsuit filed today in Travis County District Court accuses CARE Clinics, an Austin autism clinic, of fraud, conspiracy, malpractice and other claims.
The lawsuit was filed a day after the now-closed autism clinic was raided Wednesday by the FBI and IRS.
Federal investigators would not discuss their investigation, but three insurance companies had questioned billings by the CARE Clinics for alternative treatments provided there, mainly to children with autism.
In the lawsuit, Georgetown plumber Ron Stemp, 43, claims that after seeking help at the clinic at 4201 Bee Cave Road in November 2007 for possible memory loss, depression and problems concentrating and sleeping, he was put through a battery of tests and determined to have heavy metal poisoning after urine testing that he says was designed to provoke a specific result. He also claims he was told erroneously that he had Alzheimer’s disease, according to the suit. The suit alleges the CARE Clinics staff advised him to have chelation therapy as often as possible.
The CARE Clinics commonly used intravenous chelation, a chemical solution that binds to metals to sweep metals from the body. Some doctors consider it to be dangerous, and it is approved by the Food and Drug Administration for removing lead only.
The chelation made Stemp ill, caused him side effects and was “expensive and tortuous,” the suit says.
His lawyer, Sean Breen of Austin, said Stemp was billed through his insurance for $180,000 in testing and treatment over a 10-month period.
“When Mr. Stemp came to us we were dumbfounded,” Breen said. “I couldn’t believe someone would put him through these treatments just to make money.”
Kazuko Grace Curtin, owner of CARE Clinics, did not immediately return a call for comment. She is among those named in the suit.
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July 15, 2009
Autism clinic raided by federal authorities
CARE Clinics, an autism clinic on Bee Cave Road that was being investigated by insurance companies over insurance claims, was raided by the FBI and IRS agents today.
The clinic has been closed, perhaps permanently.
Agents are removing dozens of boxes of documents, but they declined to say what they are looking for. They directed inquiries to Special IRS Agent Mike Lemoine, who did not immediately return a call.
Kazuko Grace Curtin, owner of the CARE Clinics, said in a brief phone call that the clinic at 4201 Bee Cave Road has “finally closed.” She said she was on the property talking to “a man and a woman” but didn’t know what was going on. She declined to comment for this article.
Kurt Simons Co., property manager of The Schoolyard, where CARE Clinics once had a 9,000-square-foot space, locked out clinic employees this morning because of “outstanding matters,” said Karen Wendler, the company’s vice president. The clinic had recently reduced its space to 2,700 square feet.
Soon after the company locked out Curtin and her staff today, the federal agents showed up. The lockout was not related to the raid, Wendler said.
Wendler declined to say what problems led to the lockout.
“We helped her get started and we did not have a history of any problems,” Wendler said.
Traffic at the clinic had slowed, she said.
In a previous Statesman article, Curtin said three major insurance companies were investigating billings by CARE Clinics, causing her financial problems. She had cut staff and clinic hours and had unpaid bills, she said.
CARE clinics mainly treated children with autism using alternative therapies typically frowned on by mainstream doctors. Though some parents who brought their children to CARE Clinics say they’ve seen improvements in their child’s autistic behaviors, critics say the clinic uses therapies that lack strong scientific evidence. The clinic commonly uses intravenous chelation on patients, a controversial treatment that introduces a chemical solution into the body to bind with a metal or other substance to be removed.
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June 8, 2009
Big autism study hopes to unravel mystery of disorder
Autism researchers are recruiting 1,200 pregnant women who already have a child with autism for one of the largest studies to investigate early risk factors for Autism Spectrum Disorders, which now affect one in 150 children.
The researchers plan to follow the women to see if they can identify possible environmental factors and genes that might play a role in autism, according to information about the Early Autism Risk Longitudinal Investigation, also known as the EARLI study. It is being funded by the National Institutes of Health and Autism Speaks, a nonprofit advocacy organization.
The study sites are in Pennsylvania, California and Maryland, and although the women must live in one of the study areas to take part, the findings could be far-reaching. Results won’t come for several years, however. Based on a news release about the study, its goal is to assess the prenatal experience and the baby’s development through age 3.
One of the most frustrating things about autism is that its causes are largely unknown. Genetics are believed to be involved, and while some parents blame childhood vaccinations, there is no scientific evidence that vaccines cause autism.
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September 19, 2008
Government suspends chelation study for autism
A blurb from the Associated Press in the Statesman yesterday said the National Institute of Mental Health had dropped a study on chelation in autistic children because of safety concerns. Some newspapers ran more extensive versions, like this one in the Contra Costa Times.
There is high interest in this treatment, which is offered at the Thoughtful House Center for Children in Austin.
Chelation uses drugs that can be given intravenously, orally and other ways to sweep metals from the body. It is approved by the Food and Drug Administration for removing lead only. But some doctors still use the technique for treating medical conditions, and parents who believe mercury in vaccines or metals in the environment caused their child’s autism claim chelation has improved their child’s behaviors. Mainstream doctors frown on it, and some say it is downright dangerous.
The AP notes that the action by the government agency comes after a study last year linked a chelation treatment to lasting brain problems in rats.
The government agency’s statement says its board “determined that there was no clear evidence for direct benefit to the children who would participate in the chelation trial and that the study presents more than a minimal risk.” No children were recruited for the study.
A Thoughtful House representative said doctors would not be available to discuss the matter until next week.
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July 25, 2008
Researchers will study autism and diet
A pediatrician recently told me that almost every parent she knows with an autistic child had tried some kind of dietary change to see if it would improve their child’s behavior.
Some parents have told me diet makes a big difference; others say not so much. The trouble is: there is a lack of gold-standard research (randomized, controlled trials) to prove a connection between diet and autistic behavior.
That doesn’t stop parents — or doctors from experimenting. The diet most often tried, especially among parents and practitioners at Thoughtful House Center for Children in Austin — as well as others who believe the gut is related to the neurobehavioral disorder — is one that excludes dairy products and gluten (grains such as wheat, barley and rye) from the diet. It’s a strict, tough-to-follow diet in a world where fast-food snacks and ice cream tempt kids every day.
So now researchers from the University of Texas Health Science Center at Houston are mounting the “ Pilot Study: The Physiological Basis for Dietary Protein Intolerance in Children with Autism.” They plan to study children with autism, ages 3 to 9, who eat dairy and gluten and those who don’t. Then, they’ll measure the kids’ behavior as well as their intestinal changes.
“If we find that the tested proteins (casein, whey, gluten) are associated with the worsening of certain behaviors, a better-targeted therapy can be designed for a group of patients in whom those behaviors predominate,” the researchers wrote. “In addition, other studies could be conducted to determine which of those proteins (casein, or whey or gluten) are related to certain specific behaviors.”
The research is being led by Dr. Fernando Navarro, an assistant professor of pediatrics in the division of gastroenterology.
He and his team plan to recruit children in Houston. They expect to complete the study early next year, said Deborah Mann Lake, a spokeswoman for the health science center.
Information about the study will be posted on the Department of Pediatrics’ Web site in the next couple of weeks, Lake said.
I’m sure a lot of parents and doctors will be interested to see what the researchers come up with.
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