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BMJ instructs lawyers to “defend the claim vigorously” against Andrew Wakefield’s lawsuit

6 Jan

The British Medical Journal (BMJ) has issued a press release (below) about the lawsuit initiated by Andrew Wakefield claiming defamation arising from a series of articles published last year. The BMJ and Mr. Deer stand by their articles and statements and have instructed their attorneys to “defend the claim vigorously”.

Although not formally served with the legal papers, the BMJ is on notice that Andrew Wakefield has issued defamation proceedings, not in London as might be ordinarily expected as concerns a predominately English publication, but in Texas, USA, where he now lives. The proceedings primarily relate to an article written by Brian Deer and published a year ago on 5 January 2011, entitled Secrets of the MMR Scare: How the Case Against the MMR Vaccine was Fixed, and an accompanying editorial which related to Mr Wakefield’s now infamous Lancet Paper on MMR.

Of course, following the findings of the British General Medical Council’s Fitness to Practice Panel and Mr Wakefield’s history of pursuing unfounded litigation, any action brought against the BMJ and Mr Deer in London would have been immediately vulnerable to being struck out as an abuse of process.

Despite the findings of the GMC’s Fitness to Practice Panel and his co-authors having publicly retracted the causation interpretation put forward by the Lancet Paper, it would appear from the Claim filed at court that Mr Wakefield still stands by the accuracy of the Lancet paper and his conclusion therein, thereby compounding his previously found misconduct. While we await formal service, unsurprisingly the BMJ and Mr Deer standby the material published in the BMJ and their other statements and confirm that they have instructed lawyers to defend the claim vigorously.

NOTES TO EDITORS

1. The Lancet Paper was published on 23 February 1998 entitled “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children”. Its claims of a temporal association between MMR vaccine and autism were retracted by the authors (excluding Mr Wakefield) on 6 March 2004, following the first findings from Brian Deer’s investigation for The Sunday Times. The paper was retracted in its entirety by the Lancet on 2 February 2010, with the Lancet noting that elements of the paper “have been proven to be false” during hearings of a General Medical Council fitness to practise panel.

2. Following a 217-day investigation by the GMC’s panel, on 24 May 2010, the panel found Mr Wakefield guilty of serious professional misconduct. It found that Mr Wakefield “had a clear and compelling duty to ensure that the factual information contained in the [Lancet] paper was true and accurate and he failed in this duty”. The Panel also found that Mr Wakefield was intentionally dishonest and misleading in describing the patient population, and that he had been dishonest when questioned about it later. Similarly, the panel stated that “the description of the referral process was irresponsible, misleading, and in breach of [Mr] Wakefield s duty as a senior author”. The Determination also set out how Mr Wakefield compounded his misconduct by failing to correct the content of the paper.

3. As a result of Mr Wakefield’s “persistent lack of insight” into his behaviour, the GMC determined that his name should be erased from the medical register.

4. Mr Wakefield adduced no evidence in mitigation and made no arguments or pleas in mitigation in front of the Fitness to Practice panel. He did not appeal its decision and has not attempted to replicate the Lancet paper’s findings in order to attempt to vindicate his position.

5. At various times in the past, Mr Wakefield has brought claims and made complaints against Mr Deer, The Sunday Times, Channel Four and Twenty Twenty Productions in respect of allegations of dishonesty relating to his Lancet paper. In no case has he been successful. Indeed, in each instance the case has been dropped by Mr Wakefield. In Wakefield v Channel Four Television Corporation, Twenty Twenty Productions Ltd and Brian Deer [2005] EWHC 2410 (QB) Mr Justice Eady refused to grant a stay sought by Mr Wakefield, stating that the case would turn on fundamentally serious issues going to the heart of the Claimant s honesty and professional integrity.

In refusing the stay, Eady J considered Mr Wakefield’s conduct in relation to the various proceedings he had brought. He noted that Mr Wakefield had written to a number of other organisations including: the Cambridge Evening News; Evan Harris (an MP who criticised Mr Wakefield on a radio programme); and the Department of Health (which provided a link on its website to the Channel Four Dispatches website).

Mr Wakefield informed these entities in correspondence that he had issued proceedings against The Sunday Times, Mr Deer and/ or Channel Four, indicating that proceedings were ongoing. He made no mention of the stays which he had obtained, or was seeking. Eady J considered this misleading, and concluded that Mr Wakefield wished to use the existence of the libel proceedings for public relations purposes, and to deter critics, while at the same time isolating himself from the downside of such litigation, in having to answer a substantial defence of justification. The Judge believed that there was a pattern of using the existence of libel proceedings, albeit stayed, as a tool for stifling further criticism or debate.

6. On 2O December 2011, the BMJ’s solicitors, Farrer & Co, wrote to Mr Wakefield’s Texan lawyers setting out the matters referred to above, as well as other points. No response has been received.

7. Mr Wakefield’s allegations, that the MMR vaccines causes or contributes to autism, were investigated in three test cases in the United States Court of Federal Claims, heard from July 2007 and with judgments handed down on 12 February 2009. Although listed as a witness, Mr Wakefield was not called to give evidence, and his allegations were rejected. The judgments were upheld on appeal. In the lead case, Cedillo v Secretary for Health and Human Services, Special Master George Hastings said in his judgment with regard to evidence in the case: “Therefore, it is a noteworthy point that not only has that autistic enterocolitis theory not been accepted into gastroenterology textbooks, but that theory, and [Mr] Wakefield s role in its development, have been strongly criticized as constituting defective or fraudulent science.”

Andrew Wakefield takes to the courts again

5 Jan

Andrew Wakefield, one of the doctors who was stricken from the register by the U.K.’s General Medical Council, has filed a complaint in Texas claiming that Brian Deer (Journalist) and Fiona Godlee (Editor of the British Medical Journal). The complaint alleges that the articles, editorials and statements made later about those include “false and defamatory allegations” about Mr. Wakefield.

From the complaint filed:

This defamation lawsuit arises, in part, out of the publication on or about January 5, 2011 and thereafter, in the British Medical Journal, of an article authored for the BMJ by Brian Deer, titled Secrets of the MMR Scare (Exhibit A) and accompanying editorials by the BMJ’s editor, Fiona Godlee (Exhibit B 1-2). Defendants’ article and editorials, distributed to subscribers in Texas and which fonn the basis of Plaintiffs claims, contained unfair, incorrect, inaccurate and unjust criticisms of findings previously reported by Dr. Wakefield and 12 other co-authors. More significantly, Defendants accused Dr. Wakefield of fraud and of fraudulently and intentionally manipulating and falsifying data and diagnoses in connection with a clinical paper he co-authored called Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children, originally published in the medical journal The Lancet in 1998 (the “Lance,t Paper”). Defendants’ false and defamatory allegations have been widely disseminated by Defendants through the BMJ and other sources since their original publication.

Mr. Wakefield sued Mr. Deer in the past, but dropped that suit.

Mr. Wakefield’s legal team consists of William M. Parrish, J.D. Ellwanger, John D. Saba Jr of DiNovo Price Ellwanger & Hardy LLP, a firm which primarily focused on intellectual property and commercial litigation.

Mr. Wakefield does not specify an amount for damages:

Dr. Wakefield hereby prays for a trial by jury as to all disputed issues of fact, and upon findings appropriate, further prays for judgment from this Court against the Defendants for: nominal damages, actual and compensatory damages, special damages, including injury to reputation and character, injury to feelings, humiliation, loss of earning capacity, exemplary damages pursuant to TEX. CIv. PRAC. & REM. CODE §41.001, et. seq., declaratory relief, costs and expenses, prejudgment and post-judgment interest as allowed by law, and for such other and further relief to which he may be justly entitled.

Should this go to court, Mr. Wakefield, In arguing a “injury to reputation and character, injury to feelings, humiliation, loss of earning capacity, will have to quantify the state of his reputation and character, feelings, humiliation and loss of earning capacity at the time. This will have to take into account the fact that he had already been struck off the medical register in the UK after being found to have committed “serious professional misconduct” and had lost his job at Thoughtful House. Were the donors to the “Strategic Autism Initiative” less likely to contribute after the BMJ articles?

Honestly, I thought the Andrew Wakefield saga was over and I was glad of it.

Michele Bachman drops out of race for U.S. President

4 Jan

Yesterday was the first contest in the primary race for president here in the U.S: the Iowa Caucuses Michele Bachmann placed 6th in her bid for the republican party nomination with 5% of the vote. Today she announced that she is pulling out of the race.

Ms. Bachmann came into the discussion here on Left Brain/Right Brain after her claim that the HPV vaccine causes mental retardation. Even though she had no real evidence to back up her claims, she stood by them. Her comments received even more publicity when a bioethicist put up a $10,000 prize should she produce the evidence she claimed she had. After all this she did finally try to distance herself from that mistake three months later. As one might imagine, she became a favorite of groups who promote the idea that vaccines caused an autism epidemic.

While I doubt her vaccine comment was the prime reason she failed in her bid, it is being cited as one of her major mistakes. On Politico, it even rises to being #3 on top 10 misstatements of the GOP primary.

On an encouraging side note. In some discussions in the press, Ms. Bachmann is noted as having received criticism from the “autism community”. From Politico:

Leaving aside the fact that the terminology has long been outdated to describe people with developmental disabilities, Bachmann’s claim immediately drew fire from vaccination advocates, medical groups and the autism community.

With luck we can leave behind the legacy of the “autism community” being the promoters of bad information about vaccines.

Is Mark Geier finished as an expert witness in the vaccine court?

10 Dec

Dr. Mark Geier is a name which has come up frequently in the autism/vaccine discussion, and in alternative medical therapies (such as Lupron) of autism. Dr. Geier has been an expert witness for petitioners in the vaccine court for about two decades. He has been criticized by the court for almost as long. Dr. Geier has recently had his medical license suspended.

Mark Geier and his son David have worked for the Petitioners Steering Committee (the lawyers handling the plaintiffs’ cases in the Autism Omnibus). But their relationship seems a bit strained. They filed suit asking for $600,000 in payment. The Geiers have had previous requests for fees drastically reduced or denied, including one where they expected the Court to cover $20,000 as their costs (and hourly rate, including while sitting on planes) to attend conferences in Italy and France. The court called this “a complete abdication of billing judgment.”

In a recent court decision, Dr. Geier has been criticized again. Thoroughly. But this very strong statement from the special master makes it clear that Dr. Geier’s future as an expert witness or consultant will be very restricted:

I will not likely be inclined to compensate attorneys in any future opinions for consultant work performed by Mark Geier after the publication date of this opinion.

The decision focused on expenses the Petitioner’s Steering Committee (PSC) charged in the Omnibus Autism Proceeding for Mark Geier, his son David Geier and their colleagues. Much of these charges resulted from a study they published, Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink. Epiwonk (a former professional epidemiologist for the CDC) discussed the paper in New Study on Thimerosal and Neurodevelopmental Disorders: I. Scientific Fraud or Just Playing with Data?

The study noted in the acknowledgements that the study was funded by the PSC:

This study received funding from the Autism Petitioners’ Steering Committee of the no-fault National Vaccine Injury Compensation Program (NVICP).

The Geier/Young team billed the PSC, and the PSC billed the vaccine injury trust fund vaccine court. As you can read, they just weren’t successful.

The Geiers tried some fancy footwork to get the Young-Geier study paid for by our tax dollars.  Including an apparent attempt to get the non-doctor David Geier compensated by charging work at their company, “medcon”, rather than naming David Geier as the recipient.

Bottom line–the PSC asked for $440k to compensate the people who worked on the Young-Geier study.  They got $33k, and a strong statement that Geier will be unlikely to be compensated by the program in the future.

If you are curious about the value of the study itself, there is a whole section of the decision titled “The Young-Geier article itself did not add any value to the petitioners’ causation case.”

In their application, the PSC sought a total of $7,202,653 for interim fees and costs. with $1.35M for costs, primarily expert witness costs (note that the Geiers did not actually serve as witnesses, so they are part of the “costs”)

Out of $1,350,000 in costs one might ask how much of this was for the Young-Geier study?

As noted above, this Decision on Remand concerns the PSC’s claim for compensation for amounts paid, or to be paid, to four experts/consultants: Dr. Mark Geier, David Geier, Dr. Heather Young and Dr. Robert Hirsch. Conceptually, this claim can be broken into two parts. First, petitioners seek $447,004.02 to compensate all four of those individuals for work on an original medical article that was published in 2008. Second, petitioners seek $197,823.94 more for miscellaneous additional services provided by Mark Geier and David Geier between 2003 and 2008.

$447K. One third of the total. A large number of expert witnesses actually produced reports and testified, but the Geier team was to receive 1/3 of the total. If you take a high rate of $500/hour, this works out to 22 full time man weeks. For a study where they didn’t have to collect data, just analyze it. I find it difficult to believe this study took 22 weeks (or more, as the $500/hour is a very high estimate).

The Geiers were not slated to get the majority of the money. Heather Young, an associate professor at George Washington University, was to get the lion’s share. About a quarter of a million dollars:

Petitioners would receive $248,636.91 to compensate Dr. Young, $157,407.11 for the two Geiers, and $41,000 for Dr. Hirsch

Unless GWU pays their associate professors much more than is common, this represents well over one year’s pay for Prof. Young.

Thankfully HHS (respondent) argued against this request:

Respondent argues strenuously, in response, that it would be wholly unreasonable for the Program to provide compensation to these individuals for their efforts concerning the article.

Is it reasonable to charge for studies created for litigation? Are they of high value to the case?

I note that the Supreme Court has expressed the view that medical studies produced expressly for litigation purposes should be viewed with skepticism.

and

The views of these courts, then, reinforce the concern that if a lawyer involved in a Vaccine Act case chooses specific experts and pays them to carry out a study, the potential is great for bias in the study, toward the outcome that would assist the clients of the lawyer paying for the study. Thus, it is arguable that, as the respondent contends, it would be poor public policy, in general, for special masters to award public funds for such original studies.

and

Rather, I conclude that under all the specific circumstances of this case, it would not be reasonable for me to compensate the named individuals for the production of this particular article.

The PSC argued that the paper was not “litigation driven”.  The SM didn’t accept the argument:

As to the former point, I am simply not persuaded by the suggestion that the article was not litigation-driven….The mere fact that the PSC lawyers contributed or promised monetary support for another article co-authored by the Geiers, concerning the topic of whether thimerosal-containing vaccines can cause autism, is itself strong evidence that the article was litigation-driven.

Further, the very fact that the petitioners are now seeking Vaccine Act funds for the cost of producing the article is a very strong indication that the article was litigation-driven.

If that wasn’t enough, the PSC argument backfired in another way:

If the article was produced “completely apart from [Dr. Geier’s] involvement in this [Vaccine Act] litigation,” and would have been produced even absent that litigation, that would seem to contradict the petitioners’ claim that paying the cost of producing the article was a necessary and reasonable cost of the Vaccine Act litigation.

How was the Young-Geier study used in the Omnibus? Was it persuasive? Answer: it wasn’t really used and it wasn’t persuasive.

The HHS/DOJ’s experts were critical of the Young-Geier study:

Perhaps the strongest factor leading to my result here is my conclusion that the Young-Geier article itself did not add any value to the petitioners’ causation presentation in this case. Two epidemiologic experts, both of them testifying for respondent, testified at the trial in this case concerning the merits of the Young-Geier article, and both testified that the article was deeply flawed.

Even the PSC’s own experts were not impressed by the Geiers in general:

And, very significantly, none of the petitioners’ five medical experts who testified at the trial offered any testimony in support of the validity of the Young-Geier article. It is especially striking that among petitioners’ experts was an expert who has excellent credentials in epidemiology, Dr. Sander Greenland. Dr. Greenland in fact testified negatively about the Geiers’ prior epidemiologic articles concerning the vaccine-autism controversy, describing those studies as“deficient in methodology.”

Prof. Greenland didn’t speak to the Young-Geier article directly, just their methods in other studies.  But the special master points out that this appears to be a trick on the part of the PSC to avoid having to defend the Young-Geier study on cross examination:

Yet they [the PSC] put Dr. Greenland on the witness stand in this King case on May 12, 2008 (Tr. 69-135), did not ask him about the article, and did not reveal the existence of the article to the special masters and respondent until May 16 (see fn. 6 above), thus ensuring that no one could ask Dr. Greenland about the Young-Geier article. From these circumstances, the most reasonable inference is that petitioners’ counsel deliberately intended to avoid any questioning of Dr. Greenland, their epidemiologic expert, about the Young-Geier article.

The special master concludes that the study did not add any value to the PSC’s case and “no rational hypothetical paying client” would have agreed to pay for the production of such a “flawed study”:

In short, the Young-Geier study itself was severely criticized by respondent’s experts, who articulated persuasive reasons for that criticism. In my own analysis, the Young-Geier study also appears flawed. And the other special masters who reviewed that article reached the same conclusion. Clearly, no rational “hypothetical paying client” of the PSC would have agreed to pay for the production of such a flawed study. Thus, the fact that the Young-Geier article did not add any value to the petitioners’ causation presentation in this case is a very strong reason why I should decline to compensate the PSC for the cost of producing the article.

The Special Master notes that given the long history of the Geiers in the vaccine program, it would be unreasonable to expect the program to pay for the cost of the study:

A review of prior legal opinions discussing the Geiers casts strong doubt on the reasonableness of compensating the cost of an article co-authored by them.

The Special Master then goes into detail of those decisions , with an entire section  of the decision dedicated to “Vaccine Act opinions concerning the general credibility of Dr. Geier as an expert witness” including subsections “Criticisms of Dr. Geier for offering testimony outside his area of medical specialty” and “Opinions questioning Dr. Geier’s honesty, candor, or veracity” and “Opinions declining compensation or substantially reducing compensation for Dr. Geier’s services”

If you get the time, read through those. They are highly critical. A condensed version of 20 years of highly critical comments about the actions of the Geiers in the vaccine program (mostly Mark Geier):

Criticism of the Geiers is not limited to their activities in the Vaccine Court. In “Judicial opinions outside of the Vaccine Act” they quote decisions stating “federal appellate court concluded that Dr. Geier gave erroneous testimony” and “state court found Dr. Geier’s testimony to be “unsubstantiated” and unpersuasive” and “federal court was “unimpressed with the qualifications, veracity, and bonafides” and, lastly, “federal judge stated that he was “unconvinced” that Dr. Geier was qualified to offer testimony concerning certain vaccine safety issues.”

The Special Master went into detail about previous flawed studies by the Geiers on vaccines and autism.  He also notes that the assertion that Dr. Geier is qualified as an epidemiologist is not supported:

Thus, Dr. Geier does not appear to have had any formal academic training or degrees or medical faculty experience in epidemiology, and his medical experience has been chiefly in genetics rather than epidemiology. Thus, it is unclear why he was named a “Fellow” of the American College of Epidemiology, and it is doubtful whether he should be considered an expert in epidemiology. I conclude that the petitioners have failed to shoulder their burden of demonstrating that Dr. Geier should be considered an expert in epidemiology.

and

Further, a number of judges and special masters have also examined Dr. Geier’s credentials, and have specifically concluded that Dr. Geier should not be considered an expert in epidemiology.

He awards fees, as a consultant not expert, for Mark Geier’s other efforts on the Omnibus:

Accordingly, I awarded $33,130.35 (147.246 hours times $225 per hour) for the services of Dr. Geier.

No mention of payment for David Geier or Heather Young.

The Special Master makes it clear that even this amount was grudgingly awarded. Given that *in the past* it was reasonable to hire Mark Geier as a consultant:

I note that it is not an easy judgment whether to award any funds for the services of Dr. Mark Geier in this case. On balance, I conclude that, in light of the cases awarding funds to Dr. Geier as a consultant (see p. 33 above), it was not unreasonable in this instance (several years ago) for the PSC to employ Dr. Geier for consultant services.

But, after 20 years, the vaccine program may have had enough of Mark Geier:

I will not likely be inclined to compensate attorneys in any future opinions for consultant work performed by Mark Geier after the publication date of this opinion.

(emphasis added)

If the court won’t pay his fees, the career of Mark Geier as an expert for vaccine injury cases is over. His son David is not likely to be taking his place, as he has not been considered even viable as a consultant by the special masters. As noted above, Mark Geier’s license to practice medicine has been suspended (in multiple states). David Geier was charged with practicing medicine without a license. One has to wonder if or how the Geiers will re-emerge on the autism/vaccine scene.

Michele Bachmann Loves Vaccines After All

8 Dec

Remember Michele Bachmann? Republican presidential candidate in the US? The one who raised a stir with her comments that the gardasil vaccine causes mental retardation?

Well, according to Benjy Sarlin at Talking Points Memo, she actually loves vaccines.

He writes:

Michele Bachman, who was condemned as an anti-vaccination conspiracy theorist after suggesting that Gardasil causes “mental retardation,” said Wednesday that she was in fact a big supporter of vaccines. Not only that, she thinks there are too many regulations on them.

She sees vaccines as “cures” which are a miracle and have changed the course of victory:

Bachmann told a gathering of the Republican Jewish Coalition in Washington that cures for polio and other diseases “literally changed the course of history and this was good.” Until the government got in the way, that is: “[T]he problem is that bureaucracy has risen up to such an extent that today because of the FDA and other measures we’re no longer seeing the miracle of cures that were coming forward,” she said.

Thank you, Ms. Bachmann. I don’t know if this will undo the damage you caused, but it is a good step forward.

Another example of a “leading scientist” on the supposed “vaccine safety” side

30 Nov

Earlier this year a meeting was held in Jamaica as the self-named “Vaccine Safety Conference”.

Part of the “mission” of the meeting was “The conference will bring together leading scientists whose research has raised concerns about aspects of vaccine safety”.

Aside from Andrew Wakefield, who were among the “leading scientists”? Lawrence Palevsky, MD, FAAP. Dr. Palevsky is a holistic practitioner. I.e., alternative medical practitioner. His talk? “Rethinking the germ theory”. Yes, germs are a theory. The idea that viruses and bacteria are the causes of diseases is something which, after a bachelor’s degree and an MD, deserves more than a moment’s question.

Why?

Acute symptoms, such as fever, vomiting, diarrhea, rash, cough, runny nose, mucus production and wheezing, are all important ways in which children discharge stored accumulations of wastes or toxins from their bodies. These toxins enter and are stored in their bodies from repeated exposures to in utero, air, food, water, skin, nervous system stress, and injected materials, that for whatever reason, don’t easily exit their bodies through the normal means of detoxification. These toxins are too irritating to children’s bodies and must be removed. Eventually, a critical level of the toxins is reached, and children get sick with symptoms to purge them. Children, therefore, must be allowed to be sick, in order for them to get well.

Emphasis added.

You see, it isn’t the germs that cause disease. It is the build up of toxins. Children develop symptoms in order to purge the toxins.

How does one treat illness? In specific, how does one deal with fevers? Well, since “Dr. Palevsky does not recommend the use of over-the-counter medicine for fever reduction. He does not believe these medicines are safe for human consumption…” one should embrace fevers as an opportunity to purge toxins. So, instead of using these over-the-counter drugs to alleviate discomfort (or to ward off a really high fever, or protect your seizure prone kid from going into status epliepticus…) one can

To help your child feel better with the symptoms of fever, use one drop of lavender or German chamomile essential oil rubbed undiluted on the tops of both ears, and in the space between the largest vertebrae in the base of their neck and the vertebrae below it.

If there’s evidence and a good theory for that, it isn’t cited by the good doctor.

But wait, there’s more. Put your kid to bed with wet socks on. No, I am not making this up:

Use the wet sock treatment after the warm bath: put a pair of wet, cool, cotton socks on your child’s feet, followed by a pair of dry, wool socks, and put your child to bed. Dr. Palevsky thanks his naturopathic physician colleagues for this smart therapeutic intervention. Many parents report how much it helps to improve their children’s symptoms of fever and upper respiratory issues.

Once again, if there is a hypothesis (much less evidence) for why sleeping with wet socks is therapeutic, it isn’t discussed on his website.

I’ll leave with this paragraph talking about his speaking engagements:

Attendees will also learn that the expression of these symptoms is not necessarily caused by bacteria and viruses. Instead, these symptoms and illnesses occur as a sign our children are healthy; that their bodies are working to bring to the surface, and cleanse, any accumulation of wastes from deep inside, perhaps even with the aid of bacteria and viruses. You will come to understand that we are harming children with the constant use of over-the-counter medications, antibiotics, drugs and vaccines that treat and suppress common and necessary childhood symptoms and illnesses.

Yes, we should welcome these helping viruses and bacteria in our quest to cleanse ourselves of toxins.

Boggles the mind.

Mum’s plea: ‘Don’t miss MMR’ jab

17 Nov

The past couple of weeks has seen a lot of stories on vaccines again here at Left Brain/Right Brain. We’d all like to move along, but stories like “Mum’s plea: ‘Don’t miss MMR’ jab” just point out some of the real dangers involved, the real risks taken, when people don’t vaccinate.

Yes, there are people who can not vaccinate. Those of us who can vaccinate owe those people whatever protection we can offer.

She said confusion over the research by Dr Andrew Wakefield in the 1990s, which suggested the jabs could cause autism and bowel cancer, had convinced her not to allow her child to be inoculated.

However the 15-year-old was left in intensive care after being struck down with mumps.

His mother, who asked not to be named, said : “The doctor said to me it that if he didn’t have the MMR he would probably be okay because there would never be an epidemic.

There are a number of themes that come up repeatedly in discussions of vaccination online. Yes, Andrew Wakefield’s research has frightened (and continues to frighten) parents away from vaccination. Yes, there are doctors and parents counting on herd immunity to protect children (think Dr. Sears). Yes, these diseases are still dangerous, even in the developed world (for another example, read the story And another SSPE case: Angelina is dying and So predictable – so sad, Natalie dies of SSPE)

read the rest (it is relatively short) here.

In which I agree with Barbara Loe Fisher…

12 Nov

The response to the decision by Delta Air Lines to air a commercial by the National Vaccine Information Center (NVIC) has been much larger than I would have predicted. Case in point, the Atlanta Journal Constitution has an article, Delta in-flight ad opposed; airline considers video change, discussing the reaction to the NVIC advertisement. This article notes:

Delta Air Lines will change its approval process for in-flight programming after a video advertisement drew opposition, leading to an online petition calling for its removal.

They note the online petition, “Tell Delta to Stop Putting their Passengers’ Health at Risk” (at over 2400 signatures so far).

The AJC also quotes Barbara Loe Fisher of NVIC:

“I don’t understand why there’s this controversy,” she said. “We need to be able to criticize organizations that we think could do a better job. … For the people who want to use vaccines, we are fighting for safer vaccine policies and safer vaccines. I don’t see what’s wrong with that.”

And this is where I agree with Ms. Fisher. We do need to be able to criticize organizations that we think could do a better job. She seems unaware that this is precisely what a number of us who are doing in discussing Delta’s decision to host this video. Criticizing NVIC, whom we feel could do a (much) better job.

I will note I find that quote very strange indeed. I wonder if she realizes the strawman argument she has created? People are not criticizing NVIC about “fighting for safer vaccine policies and safer vaccines.”

For example, I count myself amongst those who want to use vaccines. In that effortI do not want the sort of support that NVIC offers in working towards safer vaccines. For example, I don’t want the spread of misinformation about vaccine-induced epidemics of autism, which NVIC promotes. It is a message which has caused and continues to cause harm in the autism communities.

Oddly enough, in a quick search for “safer vaccine” on the NVIC.org website, I found no examples of a statement of the type, “this new vaccine is a safer vaccine” or anything which actually calls a vaccine “safer”.

There were only four hits for the phrase “safe vaccine” on the NVIC website. Those links are mostly to comments on blog posts. No statements by NVIC saying, “here is a safe vaccine” or “here is our definition of a safe vaccine”. The one hit for something actually posted by NVIC was from a testimonial, where safe was put in quotes: “…and the doctor suggested she have this “safe” vaccine…”

I am very interested in the continued effort to improve vaccines, including improving safety. I do not feel that NVIC represents my views in any way. I do not find their brand of “information” to be the sort I would recommend to anyone looking to educate themselves on vaccines.

I do agree with Ms. Fisher: we should be able to criticize those groups whom we feel could do better. Do better NVIC, or you will continue to be criticized.

The lack of substance in Andrew Wakefield’s supporters’ arguments

11 Nov

Andrew Wakefield, the man who brought us the MMR scare, is back in the news. In a relatively small way. Earlier this year, Mr. Wakefield was in the news in a big way when the BMJ called him out for research fraud. At the time, Mr. Wakefield was enjoying the hospitality of wealthy patrons in a Jamaican resort, under the auspices of a “vaccine safety conference“. Also attending the conference were a team from the National Whistleblowers Center (aside, I am getting more and more leery of groups that put “national” into their name). Why is this important? Because instead of responding to the BMJ article directly, Mr. Wakefield provided material to one of members of the Whistleblowers Center so he could reply. The letter, by David Lewis, attempts to address one of the many issues involved with Mr. Wakefield’s research. It does not do this well, to be frank.

One problem with discussing Andrew Wakefield’s work is that there is just so much wrong that one can easily lose the forest for the trees. The big picture gets lost going over count after count of dishonesty and unethical behavior.

When analyzing Mr. Lewis’ argument, there are again many problems to discuss. Once again, it is easy to lose the story for the details. Allow me to address a few.

First, the argument is a classic strawman. Mr. Lewis posits that it is reasonable for Mr. Wakefield to have reported nonspecific colitis in his 1998 Lancet article, therefore no intentional misinterpretation was committed. To bolster this argument, he provided the BMJ with the original scoring sheets used by the pathologist who reported on the samples. Writes Mr. Lewis:

As a research microbiologist involved with the collection and examination of colonic biopsy samples, I do not believe that Dr. Wakefield intentionally misinterpreted the grading sheets as evidence of “non-specific colitis.” Dhillon indicated “non-specific” in a box associated, in some cases, with other forms of colitis. In addition, if Anthony’s grading sheets are similar to ones he completed for the Lancet article, they suggest that he diagnosed “colitis” in a number of the children.

As though, even if accurate, this would exonerate Mr. Wakefield. As the BMJ point out, in not one, but two pieces by specialists (gastroenterologist and pathologist), these grading sheets do not support the claims made in the 1998 Lancet article.

If you don’t have time to read those short articles, here’s the title of one: “We came to an overwhelming and uniform opinion that these reports do not show colitis”. Pretty clear.

And, yet, one can already see the battle lines being drawn and the talking points distributed. Before, people ignored the facts and instead tried to frame this as a personal battle: “Brian Deer, journalist, vs. Andrew Wakefield, Doctor.” Just a quick tweak and we have “David Lewis, expert who knows colonic biopsy analysis vs. Brian Deer, mere journalist.” This is, of course, more convincing that “Opinion of soil scientist vs. a pathologist and a gastroenterologist.” And, of course, easier than tackling the facts.

Let’s consider some facts, then. The first sentence of the (now retracted) 1998 Lancet paper: “We investigated a consecutive series of children with chronic enterocolitis and regressive developmental disorder. ”

“Consecutive series” was, at best, misleading given the facts of how the children were referred to the Royal Free. A fact not addressed in any way by Mr. Lewis.

“Chronic enterocolitis”. Note, “enterocolitis”. Not “non-specific colitis”. Let’s break this down. “-itis” means inflammation. Colitis “refers to an inflammation of the colon and is often used to describe an inflammation of the large intestine (colon, caecum and rectum).”

All fine so far. But, “enterocolitis“? The word actually used in the first sentence of the Lancet? The word used in the condition Mr. Wakefield coined for the condition he proposed, “autistic enterocolitis“? Enterocolitis is “an inflammation of the colon and small intestine.” And small intestine.

You can check the scores on grading sheets in the table Mr. Deer provided on his website. These include links to the scanned sheets themselves. For example, the sheets for Child 1.

The sheets and the table are arranged in a specific order: top down. From the highest point reached in the colonoscopy on down to the rectum (the exit of the large intestine).

Why point this out? Because you will notice from the table that for two of the eleven children reported (child one and twelve), there are no data for the duodenum (start of the small intestine) or the ileum (as noted in the Lancet article). Those reports start at the Caecum (the start of the large intestine) or lower. For some of the other children (child four, seven and nine), there are data, and they are listed as “normal”. The Lancet reports them as having lymphoid nodular hyperplasia. Child two has some notation, but again is checked “normal” by Dr. Dhillon. Likewise child 5 and child 6.

Which begs the question: how can you diagnose “enterocolitis”, inflammation of the large and small intestine, without data from the small intestine, or when the data you do have is normal? For 8 out of the 11 children, by my count.

Answer: you can’t. Hence the switch from “enterocolitis” to “non-specific colitis” in Mr. Lewis’ letter to the BMJ. In that letter, the term “enterocolitis” only appears in his citation of a Brian Deer article.

So, back to the first sentence of the Lancet article and ask, what is accurate? Let’s include the points made by Mr. Deer that not all these children demonstrated regression, and there wasn’t a single developmental disorder. So, with thanks to a reader who pointed this out: “We investigated a consecutive series of children with chronic enterocolitis and regressive developmental disorder(s).

or,

“We investigated children with developmental disorder(s)”

Not really very exciting.

While I have fallen into the trap I described at the outset, losing the forest for the trees, allow me to discuss one last piece of the way people are attempting to frame the way Mr. Wakefield wrote his paper. Instead of being an active researcher, it seems he is considered to be merely the man who collected the data and typed the manuscript. Mr. Lewis wrote, “I do not believe that Dr. Wakefield intentionally misinterpreted the grading sheets as evidence of “non-specific colitis.” ”

As though the entire process of diagnosing children with enterocolitis involved looking at Mr. Dhillon’s grading sheets. Once again, what did the Lancet article say? Under “Histology”:

Formalin-fixed biopsy samples of ileum and colon were assessed and reported by a pathologist (SED). Five ileocolonic biopsy series from age-matched and site-matched controls whose reports showed histologically normal mucosa were obtained for comparison. All tissues were assessed by three other clinical and experimental pathologists (APD, AA, AJW).

AJW refers to Andrew J. Wakefield. So, did he just accept the diagnoses from others, as we are being asked to believe now, or did he assess tissues, as he wrote in the Lancet in 1998? Seems an important point to downplay, as Mr. Lewis is not attempting.

To bring this to a close, a press release has been issued in support of Andrew Wakefield. Mr. Lewis is quoted:

“There was no fraud committed by Dr. Wakefield. The crux of the matter in Wakefield’s case, so far as research fraud is concerned, is whether Wakefield fabricated the diagnosis of non-specific colitis for 11 of the 12 Lancet children as claimed in Table 1. Drs. Paul Dhillon’s and Andrew Anthony’s grading sheets clearly show that Wakefield did not fabricate the diagnoses of non-specific colitis reported in the Lancet article.”

Well, no. Nonspecific colitis is not the “crux of the matter” at all. Mr. Lewis is referred to Mr. Deer’s article, and the discussion of regressive autism and when symptoms appeared. Facts which were not reported accurately in the Lancet.

And there’s that whole first sentence not being accurate at all thing…let’s not even get started on the concluding sentence:

We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunisation. Further investigations are needed to examine this syndrome and its possible relation to this vaccine.

Brian Deer on Andrew Wakefield: Pathology reports solve “new bowel disease” riddle

10 Nov

Today the British Medical Journal (BMJ) released a four articles on Andrew Wakefield and his research efforts at the Royal Free Hospital. To sum up the four articles in a single sentence (from Fiona Godlee of the BMJ): “Previously unpublished histopathology grading sheets apparently completed by Amar Dhillon, the senior pathologist on the paper, remove any remaining credibility from the claim that the Royal Free doctors had discovered a new inflammatory bowel disease associated with MMR”

For those who may wish a bit of background, earlier this year, the BMJ had a series of articles on Mr. Wakefield’s research:

Secrets of the MMR scare: how the case against the MMR vaccine was fixed (Feature by Brian Deer)

Secrets of the MMR scare How the vaccine crisis was meant to make money (Feature by Brian Deer)

The Lancet’s two days to bury bad news (Feature by Brian Deer)

and

Wakefield’s article linking MMR vaccine and autism was fraudulent (editorial by Fiona Godlee of the BMJ)

These articles came after Mr. Deer was able to review the transcripts of Mr. Wakefield’s “Fitness to Practice” hearings held before the General Medical Council (GMC).

Mr. Wakefield’s work focused on gastrointestinal disease. He went so far as to claim to have found a new syndrome, which he coined autistic enterocolitis. 13 years later, there is still no proof such a condition actually exists. When evidence came forward that the discussion of the children in the Lancet did not match the clinical records, Mr. Wakefield claimed that ““Dr Dhillon’s diagnosis formed the basis for what was reported in the Lancet,” and “I played no part in the diagnostic process at all.” Unfortunately it has been difficult to verify these statements. For one, the slides made from the samples taken from the children in the Lancet study are apparently missing, so direct comparison of what was reported in the paper to what was actually found in the children was difficult. Also, Dr. Dhillon’s analyses were not available. Until now. The scoresheets used by Amar Dhillon, the pathologist coauthor on the 1998 Lancet article, were recently made available to the BMJ. These form the basis for the articles published today.

In his new BMJ article, Pathology reports solve “new bowel disease” riddle, Mr. Deer discusses the pathology reports. He compiled a table based on these reports (for example, the report from Child 1). If I can summarize Mr. Deer’s discussion: what is striking about these reports is that they are not striking. Dr. Dhillon used his own score method to rank the disease found in the specimens. In most cases, these were “normal” or “mild”.

Mr. Deer shared the reports with a number of professionals for comment. Including Dr. Henry Appleman:

“Most of this stuff is so close to normal that you’ve really got to question whether there is really anything there,” said Henry Appelman, professor of surgical pathology at the University of Michigan and a specialist in gastrointestinal disease. “These are the kind of things that we in our practise here would ignore completely.”

And Ingvar Bjarnason:

“Everyone thinks I am crazy even asking them,” said King’s gastroenterologist Bjarnason, after discussing the scorings with other specialists. “All but one of the children is normal in their eyes. There is no enteritis and no colitis, simple as that.”

While the reports were not striking, there is indication of inflammation. Mr. Deer argues that a key point was left out of the Lancet article, the presence of constipation in many of the children, which would have put the inflammation signs into better perspective for the readers:

No less controversial, the authors omitted from the paper the children’s principal gastroenterological problem. “Almost all” had “severe” constipation.(30) The GMC panel heard, for example, that after bowel preparation by nasogastric tube, the first patient, who had mild caecal cryptitis, endured two attempted ileocolonoscopies that failed because of faeces in the caecum, with “scope trauma” noted on the second.

This omission of constipation was no small matter. It went to the heart of how the paper would be read. Specialists told me that both mild inflammation and prominent lymphoid follicles may be expected to be associated with this sign.

(30) Murch S, Thomson M, Walker-Smith JA. Authors’ reply. Lancet 1998;351:908.

Mr. Deer, of course, is not a medical professional. But, we do not have to rely solely on Mr. Deer’s report. The BMJ has two companion pieces by medical professionals.

In Commentary: I see no convincing evidence of “enterocolitis,” “colitis,” or a “unique disease process”, Karel Geboes, Professor Doctor, Department of Pathology Univ Hospital KUleuven reports:

In general, the data are rather similar to the reports of the Royal Free hospital pathology service, which I reviewed for the BMJ last year.(7) Although minor abnormalities are noted in a minority of patients, I see no convincing evidence of “enterocolitis,” “colitis,” or a “unique disease process” being present in all patients. The Wakefield et al paper is obviously problematic and its wording does not reflect the data shown in the grading sheets.

(7) Deer B. Wakefield’s “autistic enterocolitis” under the microscope. BMJ 2010;340:c1127.

In Commentary: We came to an overwhelming and uniform opinion that these reports do not show colitis, Dr. Ingvar Bjarnason, professor of digestive diseases, consultant physician and gastroenterologist at King’s College, London, writes:

The hospital pathology service found the histopathology to be normal,(3) and, except in the case of the child mentioned above, the grading sheets also note normal findings. The fact that these scores were interpreted as abnormal raises, in my opinion, questions for the authors of Wakefield et al to answer, and particularly for the consultant histopathologists.

From the histological and endoscopic reports, there are no grounds to believe that any new inflammatory bowel disease may have been discovered, or any possible “unique disease process” observed, as reported by Wakefield et al. Nothing can be said about the aetiology of any minor irritations noted, and nothing can be inferred regarding treatment.

(3) Deer B. Wakefield’s “autistic enterocolitis” under the microscope. BMJ 2010;340:c1127.

In Institutional research misconduct, Failings over the MMR scare may need parliamentary inquiry, BMJ editor Fiona Godlee discusses how there is no sign that the Royal Free Hospital (University College London) has begun the expected inquiry into the misconduct which occurred there in the 1990’s:

It is now more than 18 months since the UK’s General Medical Council found Andrew Wakefield guilty of dishonesty and other serious professional misconduct(1) ; and it is nearly a year since the BMJ concluded that his now retracted Lancet paper linking the measles, mumps, and rubella (MMR) vaccine with autism and bowel disease was an “elaborate fraud.”(2) (3) At that time, January 2011, we called on Wakefield’s former employer, University College London (UCL), to establish an inquiry into the scandal. Ten months on, no inquiry has been announced.

Ironically, these data were made available to the BMJ with the intent of exhonerating Mr. Wakefield.

In 1997, Dhillon was asked to reassess intestinal biopsy specimens taken from children enrolled in Wakefield’s research after the hospital’s histopathology service, under consultant and fellow coauthor Susan Davies, reported most of the children’s biopsies to be normal. His 62 A4 grading sheets were sent to the BMJ by c, a self employed environmental microbiologist. Lewis says he was given them by Wakefield after they met at a vaccine safety conference in January. In his accompanying letter, Lewis concludes that a non-expert pathologist such as Wakefield could have thought they showed that the children had non-specific colitis.

Ms. Godlee is being kind, in my opinion, using the title the self-styled “vaccine safety” conference chose. This was the same conference in Jamaica which was discussed here at Left Brain/Right Brain recently.

It strikes me as rather odd that Mr. Wakefield did not provide these documents to the BMJ directly. Perhaps in a response to the articles published earlier this year. What advantage he gained in providing them through a proxy is unclear.

When he was found guilty of misconduct by the GMC, Mr. Wakefield vowed that he would not go away. So far, this appears true. However, his arguments are getting weaker as time goes on. In this case, they seem to have outright backfired. Writes Ms. Godlee:

The grading sheets are certainly interesting, but not for the reasons Lewis (or, it may be assumed, Wakefield, in giving them to him) intended. We sent them to two independent reviewers and supplied the data for comment to two further senior gastroenterologists. We also showed them to Brian Deer, the investigative journalist who over the past eight years has uncovered the secrets behind the MMR scare and who arguably knows more about this case than anyone apart from Wakefield. Our expert reviewers are in no doubt that Dhillon’s findings—like Davies’s before him—are almost all normal, or as near to normal that the changes they reported were likely to be physiological.(6) (7) In an accompanying feature article, Deer explains what they add to our knowledge of the Wakefield saga.(8)

(6) Geboes K. Commentary: I see no convincing evidence of “enterocolitis,” “colitis,” or a “unique disease process.” BMJ 2011;343:d6985.
(7) Bjarnason I. Commentary: We came to an overwhelming and uniform opinion that these reports do not show colitis. BMJ 2011;343:d6979.
(8) Deer B. Pathology reports solve “new bowel disease” riddle. BMJ 2011;343:d6823.

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