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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.

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

Brian Deer: Truth of the MMR vaccine scandal

24 Jan

The General Medical Counsel (GMC) hearings on doctors Andrew Wakefield, John Walker-Smith and Simon Murch are over and the decision is expected to be made public this week. Brian Deer, the reporter who broke the story exposing the possible misdeeds involved in the MMR-causes-autism research conducted at the Royal Free Hospital by Wakefield et al., has a story out in the Sunday Times:

Truth of the MMR vaccine scandal
After an epic misconduct hearing, the doctors who caused panic over the vaccine are about to learn their fate. A report on the greatest health scare of recent times

The story re-introduces the readers to the story of MMR scare and how it began. I suspect the real story will come out after the GMC decision is handed down and details from the patient records are discussed as in Brian Deer’s recent articles such as MMR doctor Andrew Wakefield fixed data on autism.

Mr. Deer faces a pretty major smear campaign from Dr. Wakefield’s supporters. I can only expect it to get worse after the decision is handed down–whatever that decision may be.

How Anti-Vaccine ‘Science’ Holds Back Credible Research

4 Jan

An expert panel says there’s no rigorous evidence that digestive problems are more common in children with autism compared to other children, or that special diets work, contrary to claims by celebrities and vaccine naysayers.

This is a totally non contentious piece of work. The panel examined all _credible_ research into the subject and decided there simply wasn’t anything available to support the idea of a things such as autistic entercolitis – a faux syndrome pushed by the section of autism anti vaxxers who believe Andrew Wakefields fake science.

Take careful note though of what they are saying:

1) That there’s no credible evidence. Parental anecdote is not credible evidence.
2) Thats autistic children may well have gut issues and that if they do they should be treated medically.
3) That special diets show no eficacy in _treating autism_ .

The issue for me therefore is that when autistic kids have gut issues they need to be treated properly by medical staff. This means making appointments that allow for the special needs of autistic people (either first in the day or last in the day to avoid waits, quiet waiting rooms with appropriate distractions and most of all well trained staff who won’t say caustic things to parents).

A TACA representative is quoted as saying:

“I’m filled with hope after reading this report,” said Estepp of the support group Talk About Curing Autism. “I wish this report would have come out 10 years ago when my son was diagnosed.”

Ironically, TACA who support the work of Andrew Wakefield probably _could_ have had a report like this ten years ago if the work of Andrew Wakeild hadn’t been so heavily promoted by groups like TACA.

The new report says the existence of autistic enterocolitis “has not been established.” Buie said researchers and doctors have avoided digestive issues in autism because of their connection with Wakefield’s disputed research, which set off a backlash against vaccines that continues to this day.

Quite understandably, researchers didn’t want to get involved in a field tainted by a person like Wakefield and his demonstrably false and disproven idea that MMR causes or contributes to autism. If they did, when they came out with science that contradicted Wakefield they would be subject to the same sort of hate crimes currently perpetrated against numerous other scientists such as Paul Offit who has recieved death threats. Who would want that?

Quite simply – if people like Wakefield admit their error and then shut up, more science will be done that will reveal more results groups like TACA may well support.

A quicker guide to the ‘Green Vaccines’ Initiative

30 Nov

Some music to accompany this entry.

Over at AoA, Kent Heckenlively must be making the rest of the crew nervoous. Maybe you haven’t read his brand new idea for making the ‘green our vaccines’ initiative a political…um…’force’. To whit:

We’re not going to get anywhere with our current legal system because everything gets funneled into Vaccine Court. We’re not going to get far with the current media because they’re so heavily funded by pharmaceutical drug ads. We’re not going to get far with the medical community because they’re part of the machinery.

And don’t even get me started on the politicians. On one hand you have pharma handing out millions of dollars to politicians, and on the other you have parents of children with autism who are slowly bankrupted by this disease. Who do you think is going to have more money to ‘support’ the politician of their choice?

So Kent wants to tackle the legal system, the media, the medical community and politicians. And how?

In the months leading up to this announcement I’ve spent a lot of time thinking about the necessary ingredients for a successful rebellion. Reading books on our own American Revolution has given me some guidance…

Cool. Nifty idea Kent. Tackle the legal system, the medical system, the political system and the media by reading a few books on the American Revolution. I think this is definitely a winner.

I’ve carefully scanned the article a few times (whilst wiping the tears of laughter away) but yep – that seems to be about it. And really, if we (god save us) look at this seriously for a moment what is it? Its a tacit admission that Kent doesn;t like the fact that these systems he wants to change don’t agree with him and his loon friends that vaccines cause autism. In fact, take a look at the comments and you’ll see its moved beyond autism to outright anti-vaxx. Is Kent proposing the very first anti-vaxx based political party? Some choice comments:

…thank you for the opportunity your statement gave us to refine the expression of our opposition to any form of vaccination.

I will never vaccinate again…

I no longer think any vaccine is safe…

There are no green vaccines. I am convinced.

I am in the camp that you can’t make vaccine safe ever

Finished listening to Pink Floyd yet? Good isn’t it?

Thoughtful House acknowledges that chelation can be dangerous and not effective

14 Nov

IV Chelation could cause death, and Thoughtful House acknowledges it:

From a recent story in the Austin Statesman:

Thoughtful House’s IV chelation consent form, which Juli Martinez provided to the American-Statesman, includes a long list of possible side effects that include intestinal disorders, joint pain and, in rare cases, “allergy, anaphylaxis, arrhythmia and even death.” It adds that the treatment offers no guarantee of success.

Wow, Thoughtful House admits that IV chelation, even as performed by them, could cause death.

I have read so many apologists for the doctor who killed Tariq Nadama with chelation. They typically read, “the doctor made a mistake” or “the doctor used the wrong drug” followed by statements that chelation is perfectly safe. And, yet, Thoughtful House seems to be saying that even the correct drug could result in death.

And there is no guarantee of success.

Parents in lawsuit over Thoughtful House treatement

14 Nov

Father takes ex-wife to court over son’s autism treatment is the title of a recent story on Statesman.com. The subtitle: Mother says intravenous treatment at Thoughtful House is unproven and too dangerous..

Yes, it’s about chelation. The kid has been undergoing chelation (suppository), but the father wants to do IV chelation. From the Statesman:

Mario Martinez wants his wife’s consent to let their 7-year-old son, William, undergo intravenous chelation — the use of chemicals to remove metals, such as lead and mercury, from the body. Martinez, 39, said he thinks his son is making steady progress at the Thoughtful House Center for Children in Austin by undergoing a less invasive form of chelation and wants the boy to start IV chelation.

The parents are divorced, with the father having primary care of the child. However, Thoughtful House requires both parents to consent to IV chelation.

The mother states that the suppository chelation has been ongoing for two years (yes, years) without progress, but with adverse side effects:

Juli Martinez said in an interview that her son has been receiving chelation in suppository form for two years, which she claims has made him ill. She said chelation hasn’t helped his autism but being in a regular classroom has.

The father has taken the mother to court to get the approval for the IV chelation.

Chelation is the process of removing metals from the body through drugs. Alternative medical practitioners (such as Thoughftul House) use chelation on the assumption that “heavy metal toxicity” is a factor in autism.

It isn’t. This is based on an incredibly bad hyptohesis (Autism is a “novel” form of mercury poisoning), and idea that actual medical toxicologists reject.

Chelation therapy for real heavy metal toxicity is not a prolonged process. Two years is very long. Chelation by suppository is a relatively inexpensive therapy. By contrast, IV chelation at thoughtful house involves $400 every two weeks in testing:

While there may not be scientific proof that chelation helps autism, anecdotal evidence exists, Mario Martinez said. He is willing to spend an extra $400 every two weeks on tests to make sure the twice-monthly IVs are safe, he said.

The father says that the IV chelation is great:

Mario Martinez, who has had primary custody of the couple’s two children since their 2007 divorce, disputes that chelation has made William ill and said that the boy had an IV chelation test that showed he easily tolerated it. He said it brought “immediate, dramatic results,” in which his learning and behavior improved.

I wonder what an “IV Chelation test” is? Did they do a round of IV chelation, without the mother’s consent? What about their rules that the mother has to approve?

Frankly, the mother should be the one taking the father to court.

The court proceeding has been put off until Dr. Jepson of Thoughful House can appear or give a deposition.

The mother is representing herself. Frankly, a medical toxicologist should step in to offer her some support to end this travesty.

Wired Magazine: an epidemic of fear

20 Oct

Amy Wallace has written her first piece for Wired Magazine, and it is sure to draw a lot of attention. The article, An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All, covers a lot of ground. The main focus is basically an extended interview with Dr. Paul Offit.

Just in case there are any readers who haven’t heard of Dr. Offit, he is an infectious disease specialist, co-inventor of a rotavirus vaccine, and outspoken critic of the idea that vaccines caused an autism epidemic. Or, as Ms. Wallace writes in her introduction, “To hear his enemies talk, you might think Paul Offit is the most hated man in America.”

Orac, over at Respectful Insolence, has already blogged the article.

The piece points out the very real dangers of vaccine preventable diseases. It also discusses briefly some of the luminaries of the anti-vaccine movement: people like Jenny McCarthy, Robert F. Kennedy Jr and his deeply flawed article in Rolling Stone, Barbara Loe Fisher…unfortunately it is a long list.

Ms. Wallace also discusses autism’s thriving alternative medical community. Search for “Enter the snake oil salesmen” if you want to find that section quickly. Ms. Wallace attended an Autism One conference and reports on her findings.

In discussing how the membership in the CDC’s Advisory Committee on Immunization Practices has changed from mostly medical and vaccine professionals to mostly epidemiologists and public health professionals, Ms. Wallace writes:

That’s not by accident. According to science journalist Michael Specter, author of the new book Denialism: How Irrational Thinking Hinders Scientific Progress, Harms the Planet and Threatens Our Lives, the controversy surrounding vaccine safety has made lack of expertise a requirement when choosing members of prominent advisory panels on the issue. “It’s shocking,” Specter says. “We live in a country where it’s actually a detriment to be an expert about something.” When expertise is diminished to such an extent, irrationality and fear can run amok.

Dr. Offit makes a very good point in the article about risk:

“The choice not to get a vaccine is not a choice to take no risk,” he says. “It’s just a choice to take a different risk, and we need to be better about saying, ‘Here’s what that different risk looks like.’ Dying of Hib meningitis is a horrible, ugly way to die.”

Unfortunately, we now have highly visible doctors like “Doctor Bob” Sears who recommend that people who don’t vaccinate “hide in the herd” so to speak. He tells people in his book that if they don’t vaccinate they should keep quiet about it so that vaccination rates stay high and their family remains protected by the rest of us who do vaccinate.

While morally reprehensible, Dr. Bob’s advice is accurate. From the Wired story:

The frightening implications of this kind of anecdote were illustrated by a 2002 study published in The Journal of Infectious Diseases. Looking at 3,292 cases of measles in the Netherlands, the study found that the risk of contracting the disease was lower if you were completely unvaccinated and living in a highly vaccinated community than if you were completely vaccinated and living in a relatively unvaccinated community. Why? Because vaccines don’t always take. What does that mean? You can’t minimize your individual risk unless your herd, your friends and neighbors, also buy in.

Wired makes special note of the organizations which are particularly vocal in the “anti-vaccine” message:

Anti-Vaccine Websites

Though many of these organizations would not define themselves as such, these are the most active organizations and websites in the current battle against vaccines:

National Vaccine Information Center
Autism One
Generation Rescue
SafeMinds
Treating Autism
National Autism Association
Autism File

As Orac points out, the Age of Autism blog would fit in well with the above list.

I wish I could bet on the criticisms that are headed towards Dr. Offit after this article. I’m fairly confident I can pick out the paragraphs that will be focused upon.

If you read the article, you will understand this: Bonnie, thanks for loaning us your husband. He is a true friend to children.

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