Archive | Legal RSS feed for this section

Audio of the Cedillo appeal part 1

15 Jun

The vaccine court case of Michelle Cedillo is apparently the last one of the Omnibus Autism Proceeding which is still undergoing appeals. I wrote about the appeal recently on LeftBrainRightBrain, but those were responding to second-hand accounts of the hearing.

With thanks to commenter Anne, the audio is here:

Cedillo appeal arguments

Below are notes I took on the first part of the hearing–the part where the lawyer from the Michelle Cedillo (also representing the rest of the petitioners) was speaking. I’ll get to the second half shortly. I tried to put my own commentary in italics.

Suffice it to say, the notion that the petitioners presented compelling arguments and the judges were entirely favorable to them isn’t born out from the audio.

Ms. Chin-Caplan (attorney for the petitioners, including Michelle Cedillo) argued that the rules of the civil procedure do not apply in the vaccine court and that the government used them as “a club and a shield”.

She complains that the government required them to go to a foreign jurisdiction (the UK) to obtain documents.

I found that odd in light of the fact that the petitioners did try to obtain documents from the UK as early as 2004.

In response to the complaint that the Special Masters required the petitioners to work with this foreign jursidction, the judge asks if the petitioners filed a motion (under rule 26) to compel the government to produce the documents. Ms. Chin-Caplan argued that the Federal rules of procedure do not apply in the vaccine court. The judge responded “that’s not quite true”. Under rule 7 of the vaccine rules, Ms. Chin-Caplan could have asked that the Federal rules be followed. The judge asked if the petioners made a motion to follow those rules.

The judge asks, since they wanted the underlying data why didn’t Ms. Chin-Caplan ask the Special Masters to “please compel the government to bring in the underlying data”. Rules were in place to do that, but the petitioners didn’t do this. Ms. Chin-Caplan discusses that they worked with counsel in the UK for advice on how to proceed in the UK. However, they gave up before filing for the documents.

Ms. Chin-Caplan argues that lack of due process was “pervasive” in the proceeding. One judge asks what other pervasive violations of due process existed. She referred back to the same situation about Dr. Bustin.

In other words, she dodged the question of “pervasiveness”.

Judge–weren’t you given the opportunity to follow-up and to question and challenge the testimony? Ms. Chin-Caplan talks about how new information was presented at the hearing.

She doesn’t discuss the opportunity to challenge the testimony in post-hearing briefs.

Judge–points out that the petitioners didn’t follow through on all avenues to get the material from the UK.

The petitioners abandoned the opportunity to request the material from the UK based on advice from the counsel they consulted with in the UK. In other words, they didn’t actually try to get the courts in the UK to unseal the documents.

Judge Lyn notes that there was a concession that Mr. Conway (Ms Chin-Caplan’s colleague in this case) conceded that the lack of access to these documents did not prejudice the case.

Ms. Chin-Caplan is stuck trying to argue that her own colleague’s concession was incorrect.

Ms. Chin-Caplan argued that the test-cases were supposed have the “general causation” arguments only made during the Cedillo hearing, not the Snyder hearing. Thus, when Dr. Rima testified in the Snyder hearing, council for the Cedillos were not present. Ms. Chin-Caplan argues that Dr. Rima presented a calculation based on information about Michelle Cedillo and that this was in error. She further argues that since she was not present for this hearing, she didn’t know about that until the decision was handed down and it included reference to this testimony.

I find it very odd that her argument is that she wasn’t following the other test cases in the Omnibus.

Ms. Chin-Caplan argues that she submitted the alleged Rima miscalculation–and added more post-hearing information that should have been admitted. This was filed for reconsideration of the decision. This includes a textbook by Prof. Zimmerman of the Kennedy Kreiger Institute and a paper.

The Judges point out that much of the information was available before the decisions were handed down. Ms. Chin-Caplan argues that the Special Master didn’t have time to read the textbook (it came out a month before the decisions).

One of the judges points out that the petitioners would still have a difficult time with the present state of the science proving their case.

Ms. Chin-Caplan notes that the Althen standard: that they have to present a plausible theory of events and have a timeline.

Ms. Chin-Caplan makes a statement I have a difficult time parsing: “Plausibility to some people for whatever reason seems to mean “possible”. But plausibility in the scientific and medical world means that it makes sense from a thinking it through from a scientific and medical standpoint that this can occur.”

Ms. Chin-Caplan discusses the theory they have for MMR causing injury in Miss Cedillo. A judge points out that Ms. Chin-Caplan appears to asking them to reweigh the evidence, which isn’t their job.

I would argue that Ms. Chin-Caplan and the others in the OAP did not present a plausible theory for how MMR would cause autism. Multiple witnesses for the government showed how each leg of their theory was implausible.

Another appeal heard in the Autism Omnibus

14 Jun

Part of the United States Court of Federal Claims includes the “vaccine court”, where claims against the government are heard regarding vaccine injuries. Probably the most well known activity of the vaccine court, especially to readers of LeftBrainRightBrain, is the “Omnibus Autism Proceeding“. The Omnibus comprises over 5,000 families claiming vaccine injury resulted in autism. Rather than hear all these cases individually, both sides agreed to first hear “test cases” where the stories of six children were heard to answer the question of whether vaccines induced autism in those children and to decide whether the general question of whether vaccines cause autism could be addressed. The first three test cases presented the argument that the MMR vaccine, either alone or with thimerosal from other vaccines, could cause autism. The next three cases presented the argument that thimerosal alone could cause autism.

The Omnibus is back in the news, in a small way, after another appeal for the Cedillo test case was heard last week. The attorneys and the bloggers are concentrating on whether the testimony and expert reports of Prof. Stephen Bustin should have been allowed. I’ll go into the detail about this argument below. It is worth saying at the outset that this argument is likely to accomplish nothing, whether they win or lose. The Special Master who decided the Cedillo case and the judge who heard the first appeal both stated, clearly, that the decision to deny the Cedillo claim would be the same without Prof. Bustin’s testimony and report.

That is worth repeating: win or lose on this point in the appeal, the Cedillo’s still do not have a compelling case that the MMR vaccine causes autism.

Before going any further, it is worth stopping and recognizing the human side of this proceeding. The “test cases” are six children whose families agreed to let their stories be heard and analyzed in public. They went into this with faith in their positions, but without the knowledge of the legal outcome. When the decisions were handed down against them (yes, they lost), they didn’t have the opportunity to change their arguments. They were committed. So, in two big ways, these are brave families. Agree or disagree with the science they depend upon, they had some guts to step forward as they did.

It is also worth noting that no one gets wealthy from successful claims in the Court. Settlements are typically around US$1 million. While this sounds like a lot, the purpose is to pay for the needs of the injured and to set up an annuity which will supplement the government support already in existence for the disabled. Most readers to this blog will have an idea to how far that support goes.

The Omnibus hearing and the appeals

The first of the test cases heard was that of Michelle Cedillo. Miss Cedillo is a severely handicapped girl with multiple disabilities. Her case was heard in June 2007. The decision, by Special Master Hastings, was handed down in February 2009. The Cedillo family appealed and the case was heard by a Judge in the U.S. Court of Federal Claims, Judge Wheeler, whose decision in August 2009 went against the Cedillo family. The Cedillo family appealed again, this time to the U.S. Court of Appeals for the Federal Circuit. Their appeal was heard on June 10 before judges Newman, Linn and Dyk.

The Court of Appeals for the Federal Circuit is probably the last appeal for the Cedillo family. Should this go against them, they have the right to appeal to U.S. Supreme Court. But the Supreme Court is not required to hear their case. In fact, the Supreme Court usually chooses cases which decide points of law. The arguments by the Cedillo family are more questions of procedure and, as such, I would expect the Supreme Court would refuse to hear any appeal. But, that is getting ahead of ourselves. Right now, we still haven’t heard the decision from the Appeals Court.

Public Responses to the Recent Appeal

What we have heard is some minor publicity about the hearing in the Appeals Court. The Age of Autism blog has Olmsted on Autism: Day in Court and one of the Examiner blogs has Oral arguments made in Cedillo Omnibus Autism Proceeding mercury and MMR vaccine test case appeal.

I haven’t heard the arguments made in court. I wish I had because in my experience there is a fairly large gap between what I’ve heard in past proceedings and how they are portrayed on the net. A fairly egregious example was in the portrayal of an expert witness for the Cedillos, Dr. Vera Byers. When she testified in 2007, someone was portraying her as coming across with the gravity of Dame Judi Dench (who plays “M” in the James Bond movies, amongst other roles). During the hearing, Dr. Byers was found to have seriously padded her resume, claiming she worked at the prestigious University of California San Fransisco when, in fact, she only used their libraries and attended their parties. She also accused the Department of Justice lawyer of “making faces” at her. I did not think of Dame Judi Dench when I heard her testimony.

Following the original hearings for the Cedillo case, many bloggers in the vaccines-cause-autism groups were optimistic. They felt that they had made a strong case and they would prevail, complete with imagery of “Dark Towers” being brought down by bolts of lightening. From my perspective, such cheer-leading seemed to border on cruel given the very weak case made to support the general question of MMR causing autism.

Given this background you would probably not be surprised that I look at the optimistic reports coming out of last week’s appeal with a somewhat skeptical eye. Which begs the question, “what was said” by these bloggers? From Mr. Olmsted’s piece, here are two quotes.

The first is from one of the attorneys working with the Cedillo family:

“I have a very positive feeling about the federal judges,” said Sylvia Chin-Caplan, who argued the appeal.

The second quote comes from an attorney who blogs for the Age of Autism blog and who, I believe, has a child who is a claimant in the Omnibus:

“I leave with the sense that the judges were very troubled that the government had not acted in good faith,” said Mary Holland. “Those judges were very troubled by what the government’s done – very troubled.”

The argument for the appeal: Prof. Bustin’s testimony

So, what are the judges supposedly “troubled” by? Well, this has to do with part of the appeals argument by the attorneys for the Cedillo family: the testimony of Prof. Stephen Bustin.

Professor Bustin is a world expert on a technique called polymerase chain reaction (PCR) which he describes as

Real-Time PCR is a variation of the polymerase chain reaction (PCR) that allows simultaneous (i.e. in real-time) amplification and detection of DNA templates. Because it is used to quantitate DNA, it is often abbreviated to qPCR, although that abbreviation is not universally accepted.

PCR played an important rule in the Omnibus. PCR was used in attempts to identify measles in tissue samples taken from autistic children’s bowels. One of the key papers for the families in the Omnibus was written by Uhlman et al. Potential viral pathogenic mechanism for new variant inflammatory bowel disease. The Uhlman paper concluded “The data confirm an association between the presence of measles virus and gut pathology in children with developmental disorder. ” One of the co-authors on that paper is Professor J J O’Leary, whose laboratory, Unigenetics, performed the tests on samples sent from the group headed by Andrew Wakefield in London. The same laboratory was used to test samples taken from Michelle Cedillo.

The presence of measles virus in the tissues is key to the theory argued in the Omnibus. This was made very clear when the expert reports were filed, in February of 2007. At that time, the Department of Justice attorneys sought information to rebut the “persistent measles in the gut” argument. One source they sought was information filed in the United Kingdom for the MMR litigation that was held there. In specific, they sought the report by Prof. Bustin, who had testified in that litigation. Those reports are sealed and require special permission to obtain. The DoJ attorneys received the first of those reports on May 31, 2007, 1 hour after receiving it, but only 12 days before the start of the Cedillo hearing. One week later, the DoJ filed two more reports by Prof. Bustin.

The attorney’s for the Cedillo family argued that they didn’t have time to assimilate such technical information and prepare a good response. Further, they argued that the reports were submitted after a deadline imposed by the Special Master. The Special Master allowed Prof. Bustin to testify and to submit his expert reports. The Special Master argued that the admissibility of the testimony and reports could be decided after the hearings.

This history and greater detail are summarized in the Wheeler decision denying the first Cedillo appeal.

Was Prof. Bustin’s Testimony Damning to the Case?

Professory Bustin is possibly the word’s number one expert on PCR. Not only that, he was given access to the Unigenetics laboratory and the notebooks they kept. He found that the Unigenetics laboratory was missing a key step in the process. PCR tests DNA. Measles is an RNA virus. So, there must be a step to turn the RNA into DNA or PCR won’t work.

At the time Unigenetics were testing samples for the Uhlmann paper and the sample from Michelle Cedillo, they weren’t using RNA–>DNA step. Whatever they were detecting, it wasn’t an RNA virus and, hence, it wasn’t measles.

Prof. Bustin also testified that at that time Unigenetics was not using “controls” correctly, making interpretation of their results problematic at best.

Prof. Bustin also testified that the laboratory notebooks had been altered after the fact.

Prof. Bustin also testified that Unigenetics found the same results from two different types of samples (fresh-frozen and formalyn fixed). That could only happen if they were detecting contaminants.

And the list of errors at Unigenetics goes on. (There is an extensive summary in the Hastings decision for the Cedillo case)

These are only parts of the testimony. But, yes, it is safe to say that Prof. Bustin’s testimony hurt the case the attorneys for the Cedillos were trying to make.

Would the case have been decided for the Cedillos had Prof. Bustin’s testimony been excluded?

As noted at the outset of this piece, Prof. Bustin’s testimony is not key to the decision to deny the claim of the Cedillo family. It also isn’t key to denying the question of general causation (does MMR, in general, cause autism).

Special Master Hastings has a section of his decision entitled, “Even if I were to disregard Dr. Bustin’s expert reports and hearing testimony, all my conclusions in this case would remain the same.” I quote that section in its entirety below:

Finally, even if I were to completely exclude and disregard all of Dr. Bustin’s reports and all of his hearing testimony, nevertheless all of my conclusions in this case would remain exactly the same.

First, the testimony and reports of Dr. Bustin were relevant chiefly in establishing my conclusion discussed at pp. 58-60 above, i.e., that there were severe problems with the facilities and procedures of the Unigenetics laboratory. But even concerning this narrow point, Dr. Bustin’s testimony was not the only evidence. Dr. Rima provided extensive, convincing evidence to the same effect, and Dr. MacDonald provided some corroboration as well. (See discussion at pp. 52-54, 58-59 above.) I would have reached the same conclusion, that there were severe problems with the Unigenetics facilities and procedures, based just on the evidence supplied by Dr. Rima and Dr. MacDonald, even without any information from Dr. Bustin.

Second, even if there had been no testimony from Dr. Bustin, Dr. Rima, Dr. MacDonald, or any other expert who participated in the British litigation, concerning the problems with the Unigenetics procedures and facilities, nevertheless I still would have concluded that the Unigenetics testing was not reliable. That is, as explained above (p. 77), the most important points in my rejection of the Unigenetics testing were (1) the fact that the laboratory failed to publish any sequencing data to confirm the validity of its testing, (2) the failure of other laboratories to replicate the Unigenetics testing, and (3) the demonstration by the D’Souza group that the Uhlmann primers were “nonspecific.” The testimony by Drs. Bustin, Rima, and MacDonald, about the many problems with the Unigenetics laboratory and procedures, was merely a secondary, additional reason to doubt the reliability of the Unigenetics testing. Accordingly, I would still have found the Unigenetics testing to be unreliable even if there had been no reports or testimony at all from Drs. Bustin, Rima, or MacDonald.

Accordingly, for all the reasons set forth above, I conclude (1) that there is no valid reason for me to disregard the evidence supplied by Dr. Bustin, and (2) that even if I did disregard that evidence, my conclusions concerning all of the issues in this case would remain the same.

Testimony of Nicholas Chadwick

One reason that the Special Master could be so decisive on the unreliability of the Unigenetics laboratory was the fact that other groups were unable to replicate those findings. One of those researchers was Nicholas Chadwick, a post doctoral researcher in Wakefield’s own group. Dr. Chadwick used PCR to test biopsy samples from autistic children–many of whom were a part of the now-retracted Lancet paper by Wakefield’s team–and found that they were negative for measles virus.

Dr. Chadwick’s Ph.D. thesis includes results from “Autistic enteropathy samples. Biopsies, PBMCs and Vero/PBMC cocultures were analysed from 22 patients with autistic enteropathy and 6 controls.”

He found

Results. Hybrid capture and RT-PCR could detect 104 molecules of a measles RNA transcript added to control tissue homogenates. The fidelity of NASBA, in terms of its nucleic acid error rates, was found to be comparable with that of RT-PCR. All samples were found to be positive for a housekeeping RNA species and internal modified positive control RNA. None of the samples tested positive for measles, mumps or rubella RNA, although viral RNA was successfully amplified in positive control samples.

Conclusion. The results do not support previous data implicating persistent measles virus infection with the aetiology of IBD or autistic enteropathy.

He studied gut biopsy samples, cerebral spinal fluid samples and blood samples.

This isn’t a separate group and different children. This is Mr. Wakefield’s own hospital, someone he was in contact with. It is likely that some of these children’s samples were also tested by Unigenetics and with false positive results.

Dr. Chadwick’s expert report and testimony are online.

Should Prof. Bustin’s Testimony have been Allowed?

Prof. Bustin’s report was submitted very close to the start of the Cedillo hearing. In fact, it was past a deadline imposed by the Special Master. The attorneys for the Cedillos have argued that they were unable to prepare a response to such a technical report and that they didn’t have access to the lab notebooks which Prof. Bustin relied upon.

Let’s take this in stages.

First, yes the report was submitted past the deadline. So were reports submitted by the attorneys for the Cedillos. The vaccine court is supposed to be flexible in allowing evidence in.

How about the idea that the attorneys for the Cedillos were unable to prepare a case in time? First, page back and recall how all this got started. The Cedillo’s attorneys submitted expert reports which relied upon the results of the Unigenetics laboratory results. Not only that, but the expert who submitted that report, Dr. Ronald Kennedy. Kent Heckenlively, blogger for the Age of Autism, wrote in a post following Prof. Kennedy’s testimony, “Dr. Kennedy is familiar with the Unigenetics Lab of Dr. John O’Leary and Dr. Laura Shields at Trinity College in Dublin, Ireland where measles virus RNA was diagnosed in the cerebral spinal fluid of Colten Snyder.” (Colten Snyder was one of the other “Test Cases”)

So, the attorneys for the Cedillos not only had an expert on their team to discuss PCR, but their expert was familiar with the Unigenetics laboratory. Their report was filed four months before Stephen Bustin’s reports and, presumably, their team had access to information from well before that.

How about the idea that the attorneys for the Cedillos didn’t have access to the lab notebooks which Prof. Bustin reported upon? First, it is clear that Prof. Bustin’s analyses did not rely solely on the lab notebooks. Some of the problematic results were public (from the paper) and other information he obtained in his 1,500 hours spent analyzing the Uhlmann work. Yes, 1500 hours.

The whole argument begs the question: how are the Cedillo’s attorneys and their expert (Prof. Kennedy) so confident of the Uhlmann results if they haven’t seen the notebooks?

One of those attorney’s is quoted:

Chin-Caplan told Examiner.com, “Two reports that he submitted on behalf of the government were of such technical matter and so incomprehensible that at the very least a motion to continue the hearing should have been entertained and it wasn’t.”

I am again at a bit of a loss. Why were Ms. Chin-Caplan and her team unprepared to respond to Prof. Bustin’s reports? She and her team were the ones who were admitting PCR testing as evidence.

Ms. Chin-Caplan is also quoted:

“The fact that they went over there (to the U.K.) secretly four months before the hearing to try and get these documents without giving me notice that they were going to do this leads me to think that they wanted to examine those documents without me being present,” Chin-Caplan told Examiner.com. “And that violates the concept of fundamental due process as far as I’m concerned.”

The idea of obtaining information from the U.K. litigation was not a surprise to the Cedillo’s attorneys. They had attempted as early as 2004–three years before the hearing–to obtain reports from the U.K. The idea that the DoJ attorney’s “wanted to examine those documents wihout me being present” is totally at odds with the fact that the DoJ submitted the first report 1 hour after receiving it. One hour.

One might ask why Ms. Chin-Caplan didn’t call upon, say, Andrew Wakefield or others to write reports or to serve as an expert witness. Mr. Wakefield is on the list of potential experts. Mr. Wakefield is one of the authors of the Uhlmann paper. Of course, the answer is that Mr. Wakefield, father of the MMR causes autism hypothesis, is not a very credible witness.

Friend of the Court Brief

Much of the argument for the appeal is summarized in a “Friend of the Court” brief.

That brief concentrates much space to the reliability of the O’Leary lab results. It introduces new “data”

Michelle submitted further compelling evidence of the reliability of the O’Leary lab results in her motion for reconsideration. She submitted a new study on the recovery of measles RNA from the gut tissue of autistic children. The multi-center Hornig study,57 relying on laboratories at HHS’s own Centers for Disease Control, Columbia University and Dr. O’Leary’s laboratory at Trinity College were all concordant in finding measles RNA in one clinical subject and one control, again showing the O’Leary laboratory’s reliability.

The Hornig study was an attempt to recreate some of the Wakefield group’s studies. The study was much more careful than Wakefield’s team’s efforts. It was discussed on this blog at that time.

I am always amazed when people try to use the Hornig study to support the MMR-causes-autism hypothesis. The paper concluded:

This study provides strong evidence against association of autism with persistent MV RNA in the GI tract or MMR exposure

As far as supporting the idea that the O’Leary laboratory was reliable, it is far from convincing. There is a vast difference between how a laboratory performs in, say, the late 1990’s and ten years later after facing much criticism and while under intense scrutiny for accuracy. In other words, it is very possible that the O’Leary laboratory’s methods were different for the Hornig study than used for the Wakefield/Uhlmann studies.

Summary

It seems unlikely to this observer that the Cedillos will win this appeal. They rely on discounting the testimony of Stephen Bustin. The arguments to throw out his testimony have not proven persuasive in a previous appeal. More importantly, the Court made it extremely clear that the decision would be the same whether or not Prof. Bustin’s testimony was allowed. The public statements being made about this appear to be coloring the facts somewhat to create an image of impropriety by the government. Also, those making public statements appear to ignore the fact that even without Prof. Bustin’s testimony, the case was not close.

At every step along the process of the Omnibus Proceedings, public statements have been heard suggesting the families had a strong case. In my opinion, this has been a disservice to those families. I worry that this is yet another instance of building up false hope for the families in the Omnibus.

Reading while black and autistic leads to arrest

10 Jun

Reginald Latson, an 18-year-old Virginia man with Asperger’s syndrome, faces one count of malicious wounding of a law enforcement officer, one count of assault and battery of a law enforcement officer, and one count of knowingly disarming a police officer in performance of his official duties, following an incident in a high school parking lot.

Stafford County deputies received a report of an armed person outside of a library, which prompted a lock down of six schools in Stafford County, including a high school.

From WJLA in Washington, DC:

Stafford County Sheriff’s Office spokesman Bill Kennedy says it all began at 8:38 a.m. with the report of an armed person in the parking lot of a library across from Park Ridge Elementary. The threat prompted a lockdown of six schools in Stafford County, including the high school, which is separated from the library and elementary school area by a wooded area.

Kennedy says deputies saturated the area after the call. About 20 minutes later, a Stafford High School resource officer spotted a man matching the description of the lookout. While the man was being questioned, he became irate and attacked the school resource officer, who is also a sheriff’s deputy, investigators said.

The man repeatedly struck the deputy, who pepper-sprayed the man, according to the Sheriff’s office. During the struggle, the assailant was able to wrest the pepper spray for the deputy and sprayed him, investigators said.

The man then fled. The deputy, Thomas Calverley, suffered head laceration, cuts, abrasions and a broken ankle. He was scheduled for surgery on the ankle this afternoon.

Latson was located in the woods about 45 minutes later by a canine officer and his dog, Vader. Investigators never found a gun, and now say the initial caller never actually saw a weapon.

Latson is currently being held at the Rappahannock Regional Jail under no bond.

You can read more about the case at this website started by Neli’s family.

“The actions that were taken by the police that day were excessive in the least and grossly mishandled,” writes Neli’s mother. “Someone says I see a suspicious black male and he “could” have a gun, while all my son was doing was sitting in the grass at the library. And you shut down six schools and go out on a manhunt for this dangerous black man who was sitting in the grass. Anyone reading this story can read between the lines and see that this just doesn’t add up.”

You can read the Stafford County Sheriff Dept. news release here.

The Panel has determined that Dr Wakefield’s name should be erased from the medical register

24 May

The following is taken from a GMC press release.

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

Date: 24 May 2010

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.

US Court of Appeals denies vaccine court case

14 May

The first of the vaccine court autism cases has been denied by the United States Court of Appeals, Federal Circuit. The Vaccine court (or, more accurately, the U.S. Court of Federal Claims) grouped the autism claims into an “Omnibus”, something like a class action case, where evidence to prove vaccines cause autism was presented in a few “test cases”, rather than hearing all the cases individually. The Omnibus Autism Proceeding heard six test cases, three on the theory that the MMR vaccine causes autism and three on the theory that thimerosal (a mercury containing perservative) causes autism.

The appeals decision is for the test case of Yates Hazelhurst, one of the MMR test cases. The case was summarized by the Special Master who decided the case:

[P]etitioners assert that the measles component of the MMR vaccine causes an immune dysfunction that impairs the vaccinee’s ability to clear the measles virus. Unable to properly clear the measles virus from the body, the vaccinee experiences measles virus persistence which leads to chronic inflammation in the gastrointestinal system and, in turn, chronic inflammation in the brain. Petitioners argue that the inflammation in the brain causes neurological damage that manifests as autism.

The Special Master (essentially the Judge in the vaccine court) denied the claim. The family appealed to the Court of Federal Claims, who upheld the decision. The recent decision is from the United States Court of Appeals, Federal Circuit, making this the second appeal affirming the original decision.

The family appealed on the basis, as the appeals judge put it:

On appeal to this court, the Hazlehursts argue that the special master improperly relied on certain evidence that should have been excluded and disregarded other evidence that should have been considered.

The MMR theory for autism causation relies on the notion that the measles virus from the vaccine persists in the guts of children. This, in turn relies on research by Dr. Andrew Wakefield’s team and in particular, the Unigenetics laboratory. The government brought in a witness, Dr. Stephen Bustin, to refute the validity of the results from the Unigenetics lab. Dr. Bustin’s testimony and level of expertise were very clear in showing that the Unigenetics results were faulty.

The special master found that Dr. Wakefield’s work had been largely discredited within the scientific community and that none of the studies indicating the presence of measles virus in autistic children had been successfully replicated by an accredited laboratory independent of Dr. Wakefield or Unigenetics. In particular, the special master found that Dr. Wakefield’s early 1990s research on persistent measles infections was reviewed by the Medical Research Council of the United Kingdom and found to lack important controls and sufficiently specific reagents for detecting measles virus. She also found that Dr. Wakefield’s subsequent research was dismissed by the scientific community as methodologically unsound. In that regard, she noted that 10 of 12 co-authors on Dr. Wakefield’s controversial 1998 article in the medical journal The Lancet subsequently retracted their support for the article’s conclusion that there is a potential causal link between the MMR vaccine and autism.

The Special Masters allowed the petititioners (including the Hazelhursts) time to rebut Dr. Bustin’s testimony, through cross examination and through documentation from the UK MMR litigation. The petitioners did not avail themselves of this opportunity.

Over objection, the government sought to introduce Dr. Bustin’s reports and testimony regarding the Unigenetics laboratory, which, by that time, had gone out of business.[ 2 ] The special master in the Cedillo case provisionally admitted the evidence. The three special masters in the omnibus proceeding then deferred decision on whether to rely on that evidence and stated that they would “favorably consider joining in a request” by the petitioners “for the release of relevant reports” from the UK litigation. The record remained open for more than a year following the Cedillo hearing to afford the petitioners sufficient time to present rebuttal evidence, to conduct additional cross-examination of Dr. Bustin, and to obtain documents from the British court. However, none of the petitioners recalled Dr. Bustin for further questioning or applied for access to any of the materials from the UK litigation.

The Hazelhurst’s argued that evidence should have been allowed that was not. In particular, they argued that some unpublished results demonstrate the persistent measles theory.

The special master further concluded that the unpublished and preliminary findings of the Walker group should not be accorded significant weight. She observed that Dr. Hepner had declined to “draw any conclusions about the biological significance” of the investigators’ findings and had testified that negative controls were not included with each experimental run. The special master also noted that the petitioners’ experts based their opinions on the characteristics of the “wild-type” measles virus, as opposed to the vaccine-strain measles virus, which is far less virulent and replicates poorly in the human body.

In the end, the appeals judge ruled that there was no reason to overturn the original decision:

Because we find no error in the special master’s consideration of the evidence, we also find no error in her decision to discount Dr. Corbier’s opinion that the MMR vaccine caused Yates’s autism. By Dr. Corbier’s own admission, his opinion depended heavily on the reliability of the scientific studies purporting to show measles virus persistence in autistic children.

Compensation under the Vaccine Act is limited to those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of “causation-in-fact” evidence, to a listed vaccine. The special master concluded that the Hazlehursts’ evidence failed to demonstrate the necessary causal link, and the petitioners have not identified any reversible error in the special master’s decision reaching that conclusion.

The petitioners now have the choice of appealing to the U.S. Supreme Court. As noted above, the Supreme Court hears cases which help define laws and this does not appear to be such a case. It would seem unlikely, then, that the Court would agree to hear this case. If so, this is the end of the appeals for the Hazelhurst’s in their case against the U.S. government. The next step would, then, be to take their case to civil court against the vaccine manufacturers. Such cases have not been successful so far. Civil cases require a higher level of evidence and expertise than the vaccine court. Having failed in the Federal Court, where the rules are more favorable to the petitioners, it would seem a difficult battle to win the case in civil court.

Extra clause added into UK Equality Bill

6 May

An extra clause has been added into the UK Equality Bill that will come into force in October of this year. The new clause was drafted specifically to cover cases where people (e.g. family members) are ‘associated’ with the person with a disability in question and reads;

Clarifies protection against discrimination by association, for example in relation to a mother who cares for her disabled child

This follows the case of Sharon Coleman who had to go to the European Court wo delivered the following verdict:

…discrimination law is there to combat all forms of discrimination, including those connected to protected groups of people.

The new Clause should prevent the necessity of taking the case to the European Court and will allow such cases to be settled at UK level.

Major fail by medical regulators: Dr. Rashid Buttar given slap on the wrist

21 Apr

Beware, North Carolina. Beware. Dr. Rashid Buttar is free to practice medicine.

So goes the title of a blog post by Orac at Respectful Insolence.

Background, Dr. Rashid Buttar is an alternative medical practitioner who has, amongst other things, “therapies” to treat autism. He has been a major proponent of chelation. He is also notorious for his urine injections. Yes, urine.

Dr. Buttar was investigated by his state’s medical examiners. Again, from Orac: Rashid Buttar’s going down: The North Carolina Board of Medical Examiners finally acts

From a news report at that time:

The panel also found that Buttar exploited patients by charging exorbitant fees for unproven therapies that didn’t work. The panel recommended that his license be suspended indefinitely, but that the suspension be immediately stayed. Until the board decides, Buttar may practice without restrictions.

from a recent news story:

In that Michigan case, Buttar treated the child without having first performed an exam, a violation of the state’s medical practice act.

Did he “go down”? No. Dr. Buttar was able to benefit from laws he, himself, pushed through his State’s legislature:

Dr. Rashid Buttar, whose alternative medical practice in Huntersville has been under scrutiny by the N.C. Medical Board for a decade, has accepted a reprimand from the licensing agency.

But Buttar, who was facing potential restrictions to his license, instead can continue offering unconventional treatments as long as he asks patients to sign a form acknowledging his practice is outside the mainstream.

“This was a witch hunt from the beginning,” said Buttar, 44, whose practice attracts patients from 42 states and 37 countries. “They were trying to discredit me … but I didn’t do anything wrong.”

The consent order, signed Friday, marks the end of a battle that Buttar had vowed to take to the U.S. Supreme Court. He said he has spent “hundreds of thousands of dollars” defending himself against the board’s allegations that he exploited patients by charging exorbitant fees for unproven therapies that didn’t work and by arbitrarily ordering expensive tests to make more money.

In recent years, Buttar led a successful effort by the N.C. Integrative Medical Society to get legislators to change state law to make it friendlier to practitioners of alternative medicine.

Again, quoting Orac:

But back to why Dr. Buttar might have agreed to this consent decree. The answer becomes obvious if you peruse the actual consent order. All it does is to reprimand Buttar and order him (1) to provide informed consent to his patients dictated by the board; (2) to obey all laws, as well as rules and regulations governing the practice of medicine; (3) notify the board if he changes his address; and (4) meet with the board periodically. In other words, Buttar got a slap on the wrist.

“A slap on the wrist”.

Wow.

The top treatment listed on Dr. Buttar’s website is IV treatements which, as we know, include chelation. These have been “pioneered by Dr. Buttar” and the fact that the vast majority of the medical establishment rejects his ideas is a selling point:

However, the use of these highly effective treatments, suspiciously unpopular among traditional medicine regulators, is only determined by the medical providers in the clinic (ie, the Doctors, Nurse Practioners or PA’s).

Yes, your young child could sit with 7 other people in a room and stare at pictures of Pooh Bear (I wonder about the copyright issue on that?) while having an IV needle inserted to deliver “suspiciously unpopular” treatments. Here is the picture of his IV suite:

The main change between before the consent agreement and now is that all you have to do is sign a paper noting that you accept the fact that you accept the fact that these treatments have not been proven effective…

Do you think this “consent order” is anything more than a slap on the wrist? Here is a quote from it:

I understand and have been advised that the treatments and therapies that are to be provided by Dr. Buttar have not been proven effective by traditional research studies or conventional clinical trials and may not have been approved by the FDA for my diagnosis. Dr. Buttar makes no specific claims or representations that the treatments and therapies that he will be providing will be effective or cure the condition or diagnosis that I have.

Take a look at Dr. Buttar’s website (or the quote above) again.

However, the use of these highly effective treatments…

Yes, he’s still claiming that his treatments are “highly effective”, even though they “have not been proven effective by traditional research studies…”

Dr. Buttar was a part of the team involved with Desiree Jennings, the Redskins spokesperson who claimed the flu shot caused dystonia.

Dr. Buttar still has his supporters. From a recent story on this case:

Many of Buttar’s patients came to his defense in 2008. Among them was Elrene Thomas of Lexington. When contacted Tuesday, she was pleased to hear that Buttar can continue to practice. A retired nurse, she went to him for treatment seven years ago when she learned her breast cancer had spread to her spine. Instead of going through chemotherapy and radiation again, she tried IV infusions five days a week for months and had hyperbaric oxygen therapy twice a day for several weeks. She paid Buttar’s center $100,000 and said it was worth it.

“I really feel like he saved my life,” said Thomas, 77. “I’m not healthy in that I have stage 4 (cancer), but I’m surviving and I’m doing all these things that he taught me to do. I believe in his treatment.”

Yes, this is one of his success stories.

What do you call therapies a doctor makes up on his own, untested by “traditional” means? I would call that experimental. I think that is being generous.

Medical regulation exists for a reason. Slapping doctors on the wrist is not the reason.

Listen to parents…except when they say things you don’t want to hear

25 Mar

How many times do we hear, “Listen to the parents” on medical issues involving their autistic kids? Usually this comes from alternative medical groups who don’t have the science to back up the safety and efficacy of their therapies. What happens when a parent disagrees with these groups?

In Lawsuit against alternative medical practitioners Usman and Rossignal we discussed a father who has brought suit against prominent Defeat Autism Now (DAN) doctors Usman and Rossignol, and the laboratory Doctor’s Data.

Orac, at Respectful Insolence, has discussed this case as Suing DAN! practitioners for malpractice: It’s about time, where he uploaded the actual complaint.

In that complaint the father is alleging many things. High amongst them is the question of whether the “challenge” chelation tests are valid, These were used on his child and supposedly showed heavy metal poisoning. In a challenge chelation test, a chelator drug is given to a child before a urine test is taken. Chelators are designed to draw metals out of the body and allow them to be excreted through the urine (and other ways). There are no standardized references for metal contents in challenge testing. The American College of Medical Toxicology has made a very clear statement about challenge chelation testing. Here is their conclusion:

It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

Recall, challenge testing is noted in the lawsuit. From the section of claims against the Doctor’s Data (who are also defendents in the lawsuit):

The non-standardized method of testing that Defendant utilized on or about April 22, 2004, January 27, 2006, January 13, 2007, February 26, 2007, May 26, 2007, August 6, 2007, October 30, 2007, November 13, 2007, January 12, 2008, January 26, 2008, April 26, 2008, October 29, 2008, and March 27, 2009, wherein specimens were collected after the administration of a provoking agent and compared to unprovoked or unchallenged specimens was an improper method of determining whether A.J. had a potentially toxic level of heavy metals in his system

So, challenge chelation testing isn’t scientifically validated, has no benefit, but was used to justify certain therapies on this child. How did the Autism Research Institute respond to this? They blame the parent’s marital situation.

No, really, I’m not making this up. Rather than accept the complaints on their face and give this autism parent respect, they dismiss his multiple complaints as being…well, you read it:

Recent articles by ABC News and the Chicago Tribune on M.D.s who subscribe to the Defeat Autism Now! approach to treatment indicate the spread of misinformation and misunderstanding in recent months. The complaints about Drs. Usman and Rossignol resulted from a custody case– a painful situation for any family, one that can lead to accusations that must be sorted out in a court of law—not the media

Yes, it isn’t because the father is really annoyed that he was told challenge chelation testing is valid, or that his family spent lots of money on testing and on chelation. It couldn’t be that the father has not seen benefit from these therapies. It isn’t any of that. It is a custody battle issue. For the record, the defendants in the case do not include his wife.

ARI defends their approach in rather vague terms:

The Defeat Autism Now! approach to autism invites the medical community to be more responsive, inquisitive, and knowledgeable about treating these disorders.

The approach is not in itself a source of controversy, since many treatment interventions are commonly prescribed by traditional health professionals.

My view differs from the ARI statement. It would seem to this observer that the approach is the source of controversy. From their own website:

The best diagnostic test for toxic metal overload is the chelation challenge test. The chelation drug is administered, followed by a timed urine test to help assess the body’s burden of toxic elements.

This is in direct contradiction to the statement from the American College of Toxicologists. The ARI approach (including challenge testing) is a key point of the lawsuit. I am not able to reconcile this with the idea that the “approach itself a source of controversy”.

The great problem is rather that chronic, unaddressed illness plagues many, if not most, of the children and adults on the autism spectrum. These conditions, thoroughly documented in the scientific literature, often involve the gastrointestinal system and/or the immune system, but the medical establishment has been professionally insensible to what is a desperate situation in the expanding autism population.

Odd. If anyone outside of the alternative medical community ever makes a statement that the is driven by “desperation”, they are sure to get jumped on.

The focus of the Defeat Autism Now! approach is twofold: to provide patients with allergen-free nutritional support, to uphold and to repair the immune system as needed, and, if appropriate, to reduce the body burden of environmental toxins; to provide clinicians in-depth medical and scientific information, with Continuing Medical Education credits.

There is the mention of what is a main crux of the lawsuit, “body burden of environmental toxins”. That’s it. No mention of challenge testing. They mention that the approach includes reducing “the body burden of environmental toxins”, but doesn’t address the key question: when is this approach “appropriate”. How is that decided? The challenge testing approach has not, to my knowledge, ever been defended in court. This case is

The ARI press release doesn’t discuss the real questions here. Brushing this off as a custody issue is not doing anyone any good and is rather insulting to the parent bringing this suit forward and his child.

Bogus Urine Metals Testing Fails In Vaccine Court

13 Mar

The Thimersoal “test cases” in the OAP relied on bogus urine mercury testing. Among many other common problems the petitioners had in providing any sound scientific support for the notion that mecury can cause autism, that, was at least in part, the apparent conclusion of all three of the special masters.

I just skimmed through the recent decisions by the US Court Of Federal Claims in the Thimerosal “test cases” that were part of the Omnibus Autism Proceeding, and the expert testimony provided by Dr. Brent (respondent) in this regard is pretty clear:

From the Mead Decision

When specifically asked about the urine mercury tests that were performed on William, Dr. Brent said that the tests “showed pretty much exactly what you’d expect for the normal population, that their unprovoked specimens are normal. Yet, when they give chelators, most of [mercury excretion results] are increased.” Id. at 1852-1853. Dr. Brent expressed a concern about the use of data in this way to suggest that a condition exists that, in fact, does not. See id. at 1853. He stated that “it’s data like this that has been used as an excuse to subject these children to chelation therapy where the data supports [a finding] that their urine mercury status is totally normal.” Id. at 1853.

From the King Decision

Moreover, Dr. Brent explained that when the results of mercury testing of Jordan, both provoked and non-provoked, are viewed in their entirety, they are exactly what one would expect from an individual without any mercury-related problem. That is, Jordan’s non-provoked test results were within the normal range for non-provoked testing. (Tr. 1852-53, 4340.) At the same time, while his provoked results were outside the normal range for non-provoked testing, that is not surprising since the provocation/chelation process is designed to specifically provoke an increased excretion of metals. (Tr. 1852-53, 4340-41, 4347.) As Drs. Brent and Fombonne explained, administration of a chelating agent to anyone, autistic or not, mercury-poisoned or not, will always be followed by increased excretion of mercury.118 (Ex. M, p. 74; Tr. 1852, 4340-41, 4343.)

Interestingly, the added scientific clarity of the special masters with regard to bogus urine metals testing is also present to some degree in all three test cases:

Here’s one example from the Mead Decision

Moreover, a subsequent study, as reported in the 2007 Soden article filed as RMRL 458,150 could not confirm the 2003 Bradstreet study results. See Mead Tr. at 1844. The investigators found that “DMSA provoked excretion testing did not produce evidence of an excess chelatable body burden among the autistic [study] participants.” RMRL 458 at 480. The investigators concluded that “[i]n the absence of a novel mechanism of heavy metal toxicity or an alternate therapeutic action of chelators, the data presented provide[d] no justification for chelation therapy for the [study] participants.”

Many will remember the conclusion of Soden et al.

“In the absence a proven novel mode of heavy metal toxicity, the proportion of autistic participants in this study whose DMSA provoked excretion results demonstrate an excess chelatable body burden of As, Cd, Pb, or Hg is zero.”

But perhaps the most interesting of all, is the common thread that the reliance upon the bogus mercury testing seems pretty much acknowledged for what it is by both the special masters and the petitioners’ expert:

From the Dwyer Decision

Doctor Mumper’s willingness to rely on Colin’s mercury test results as evidence of high levels of mercury in his body was particularly troubling. She admitted that his results were not typical of those she saw in other autistic children. She admitted that she knew of no research into normal mercury excretion levels after chelation against which Colin’s one positive mercury test could be measured.741 It appeared that regardless of the results for mercury levels, Dr. Mumper was willing to opine that they reflected mercury’s role in ASD.

From the King Decision

In short, a careful analysis of the record demonstrates that there is no valid basis for Dr. Mumper’s view that the results of mercury excretion testing on Jordan King offer support for a conclusion that thimerosal-containing vaccines played a role in causing Jordan’s autism. To the contrary, the evidence supports a conclusion that Dr. Mumper’s reliance on such mercury tests has no basis in science or logic. Indeed, upon cross-examination even Dr. Mumper acknowledged that there is no particular profile or pattern of post-provocation test results that points to a finding that a child has mercury-induced autism. (Tr. 1555-60, 1568-69.) When pressed, Dr. Mumper could not even suggest an example of any type of result on a post-provocation mercury urine test that would not, in her analysis, support a claim of mercury-induced autism. (Tr. 1558-60.) Dr. Mumper’s analysis in this regard was illogical, and completely unpersuasive.119

Yep, regardless of the results of a scientifically meaningless test, it’s the mercury. Right.

Remember, these were the three Thimerosal “test cases”, presumably chosen by the Petitioner’s Steering Committee (PSC) because they offered the best opportunity to introduce good, and representative scientific evidence for the hypothesized role of thimerosal in the etiology of autism. It looks like they failed miserably, and this doesn’t seem surprising when it’s clear the cases leaned on at least one form of laboratory testing that’s clearly scientifically meaningless.

It won’t be surprising when many of the die-hard anti-vaccine and “alternative” autism medicine brigade ignore the fact that bogus urine toxic metals testing just had a bright light shined on it by the vaccine court. They’ll be likely to claim some form of conspiracy or politics about the cases, despite the fact that the spotlight revealed an apparent decision-making tool of many a “DAN! doctor” to not only be worthless in medicine, but also worthless in court.

On a related note, there has been recent news that a couple of “DAN! doctors” are facing a lawsuit in which bogus urine toxic metals testing is called out directly. Aside from numerous other problems they face in the complaint, it should be interesting to see how the defendants (Dr. Dan Rossignol, Dr. Anjum Usman, and Doctors Data, Inc.) explain the potential role of comparing chelator-provoked urine metals levels to a non-provoked reference range. If the three test cases in the OAP are an indication of the state of actual scientific support for such testing, the defendants would seem to have plenty to worry about.

Additional reading:

Mead v. Secretary of Health and Human Services Case No. 03-215V
King v. Secretary of Health and Human Services Case No. 03-584V
Dwyer v. Secretary of Health and Human Services Case No. 03-1202V
Thimerosal-Autism Test Cases Dismissed
Doctors sued over ‘dangerous’ autism treatment
Suing DAN! practitioners for malpractice: It’s about time
How the “Urine Toxic Metals” Test Is Used to Defraud Patients
24-hour provoked urine excretion test for heavy metals in children with autism and typically developing controls, a pilot study

Vaccine Court Decision: thimerosal containing vaccines do not cause autism

12 Mar

The decisions are in for the second phase of the Omnibus Autism Proceedings–the “vaccine court” trials to determine if autism can be considered as a vaccine injury. The first set of decisions were handed down last year (those regarding the MMR as a causative agent). This set explored whether thimerosal, the mercury containing preservative formerly used in childhood vaccines, could cause autism.

The decisions are long, and I expect there to be much discussion. Below are the final paragraphs from the decisions. These are for the three “test cases”, the hearings held for three specific children who petitioned for compensation on the basis of autism as a vaccine injury. They are clear and decisive: the evidence does not support thimerosal containing vaccines as causing autism, in general or in these three children in specific.

Mead:

Petitioners’ theory of vaccine-related causation is scientifically unsupportable. In the absence of a sound medical theory causally connecting William’s received vaccines to his autistic condition, the undersigned cannot find the proposed sequence of cause and effect to be logical or temporally appropriate. Having failed to satisfy their burden of proof under the articulated legal standard, petitioners cannot prevail on their claim of vaccine-related causation. Petitioners’ claim is dismissed, and the Clerk of the Court SHALL ENTER JUDGMENT accordingly.

King:

Thus, I feel deep sympathy for the King family. Further, I find it unfortunate that my ruling in this case means that the Program will not be able to provide funds to assist this family, in caring for their child who suffers from a serious disorder. It is certainly my hope that our society will find ways to ensure that generous assistance is available to the families of all autistic children, regardless of the cause of their disorders. Such families must cope every day with tremendous challenges in caring for their autistic children, and all are deserving of sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing the evidence. Congress designed the Program to compensate only the families of those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of “causation-in-fact” evidence, to a listed vaccine. In this case, the evidence advanced by the petitioners has fallen far short of demonstrating such a link. Accordingly,

Dwyer:

Petitioners have not demonstrated by a preponderance of the evidence that Colin’s condition was either caused or significantly aggravated by his vaccinations. Thus, they have failed to establish entitlement to compensation and the petition for compensation is therefore DENIED. In the absence of a motion for review filed pursuant to RCFC, Appendix B, the clerk is directed to enter judgment accordingly.

← Older Entries
Newer Entries →