BMJ editorial: Wakefield’s article linking MMR vaccine and autism was fraudulent

6 Jan

In a recent post here on LeftBrainRightBrain we discussed the first in a series of articles by investigative journalist Brian Deer in the BMJ. There is also an editorial by the BMJ, “Wakefield’s article linking MMR vaccine and autism was fraudulent“. The Lancet’s retraction of the Wakefield paper was fairly mild, citing only that the patients were not consecutively referred and the study did not have ethical approval. The BMJ’s statement is much more clear, and with a reason. From the editorial:

The Lancet paper has of course been retracted, but for far narrower misconduct than is now apparent. The retraction statement cites the GMC’s findings that the patients were not consecutively referred and the study did not have ethical approval, leaving the door open for those who want to continue to believe that the science, flawed though it always was, still stands. We hope that declaring the paper a fraud will close that door for good.

Perhaps wishful thinking on their part, as there will always be people who believe Mr. Wakefield.

The BMJ goes further. They are calling for a review of other papers by Mr. Wakefield with the question of whether more retractions are warranted.

What of Wakefield’s other publications? In light of this new information their veracity must be questioned. Past experience tells us that research misconduct is rarely isolated behaviour. Over the years, the BMJ and its sister journals Gut and Archives of Disease in Childhood have published a number of articles, including letters and abstracts, by Wakefield and colleagues. We have written to the vice provost of UCL, John Tooke, who now has responsibility for Wakefield’s former institution, to ask for an investigation into all of his work to decide whether any more papers should be retracted.

This parent of an autistic child welcomes this move by the BMJ. I am grateful to the editors for their action.

BMJ press release: there is “no doubt” that it was Wakefield who perpetrated this fraud

6 Jan

Here is the press release for the series in the BMJ on Andrew Wakefield.

Today, the BMJ declares the 1998 Lancet paper that implied a link between the MMR vaccine and autism “an elaborate fraud.”

Dr Fiona Godlee, BMJ Editor in Chief says “the MMR scare was based not on bad science but on a deliberate fraud” and that such “clear evidence of falsification of data should now close the door on this damaging vaccine scare.”

She is struck by a comparison between researcher Andrew Wakefield’s fraud and Piltdown man, that great paleontological hoax that led people to believe for 40 years that the missing link between man and ape had been found.

She also questions the veracity of Wakefield’s other publications and calls for an investigation “to decide whether any others should be retracted.”

A series of three articles starting this week reveal the true extent of the scam behind the scare. The series is based on interviews, documents and data, collected during seven years of inquiries by award-winning investigative journalist Brian Deer.

Thanks to the recent publication of the General Medical Council’s six million word transcript, the BMJ was able to peer-review and check Deer’s findings and confirm extensive falsification in the Lancet paper.

In an editorial, Dr Godlee, together with deputy BMJ editor Jane Smith, and leading paediatrician and associate BMJ editor Harvey Marcovitch, conclude that there is “no doubt” that it was Wakefield who perpetrated this fraud. They say: “A great deal of thought and effort must have gone into drafting the paper to achieve the results he wanted: the discrepancies all led in one direction; misreporting was gross.”

Yet he has repeatedly denied doing anything wrong at all, they add. “Instead, although now disgraced and stripped of his clinical and academic credentials, he continues to push his views. Meanwhile the damage to public health continues.”

“Science is based on trust,” concludes Dr Godlee. “Such a breach of trust is deeply shocking. And even though almost certainly rare on this scale, it raises important questions about how this could happen, what could have been done to uncover it earlier, what further inquiry is now needed, and what can be done to prevent something like this happening again.”

The BMJ will explore these and other questions over the next two weeks.

Brian Deer in the BMJ: How the case against the MMR vaccine was fixed

6 Jan

Brian Deer, the investigative journalist who broke the story of the misdeeds of Andrew Wakefield, has a new article in the BMJ, How the case against the MMR vaccine was fixed. The article is prefaced:

In the first part of a special BMJ series, Brian Deer exposes the bogus data behind claims that launched a worldwide scare over the measles, mumps, and rubella vaccine, and reveals how the appearance of a link with autism was manufactured at a London medical school

This article is damning enough, but as a series this may lay out clearly, in one place, the cases behind the multiple ethical breaches which cost Andrew Wakefield his license to practice medicine in the UK.

Some may ask “why?” There is so much information out there about Mr. Wakefield and his misdeeds. Do we really need it again? I would say yes. In this BMJ series we have the research (and other) ethical lapses laid out in a medical journal. No lengthy GMC transcripts. No news stories with false balance. No “Callous Disregard” book.

The full article is worth the read. Here is the summary from today’s article.

How the link was fixed

The Lancet paper was a case series of 12 child patients; it reported a proposed “new syndrome” of enterocolitis and regressive autism and associated this with MMR as an “apparent precipitating event.” But in fact:

• Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism

• Despite the paper claiming that all 12 children were “previously normal,” five had documented pre-existing developmental concerns

• Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination

• In nine cases, unremarkable colonic histopathology results—noting no or minimal fluctuations in inflammatory cell populations—were changed after a medical school “research review” to “non-specific colitis”

• The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations—all giving times to onset of problems in months—helped to create the appearance of a 14 day temporal link

• Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation

In multiple ways, the story of the Lancet article was crafted to support the conclusion Mr. Wakefield had–a conclusion he came to before starting on the research project.

Yes, before.

In his research proposal to the legal aid board, Mr. Wakefield made the following statement (quoted in Mr. Deer’s article):

““In contrast with the IBD cases [those set out in paragraph 2] which have a prima facie gastrointestinal pathology, children with enteritis/disintegrative disorder form part of a new syndrome. Nonetheless, the evidence is undeniably in favour of a specific vaccine induced pathology. ”

Mr. Deer presents a table comparing how the Lancet article reported the 12 children and how the records really show their cases. He compares regressive autism (only 1 patient’s records clearly show it), non-specific colitis (only 3 children showed it) and whether symptoms occured in the days following MMR (10 clearly did not, 2 are unclear). In all, none of the Lancet 12 children had all three features.

So that is the Lancet 12: the foundation of the vaccine scare. No case was free of misreporting or alteration. Taken together, NHS records cannot be reconciled with what was published, to such devastating effect, in the journal.

Mr. Deer opens his piece with a discussion he had with the father of child 11. Mr. 11 did not agree with the way his son was represented in the Lancet article. Mr. 11 states:

“Please let me know if Andrew W has his doctor’s license revoked,” wrote Mr 11, who is convinced that many vaccines and environmental pollutants may be responsible for childhood brain disorders. “His misrepresentation of my son in his research paper is inexcusable. His motives for this I may never know.”

We may never know the motives. In the end, I don’t care. It is the damage that this fraudulent research has caused to the autism communities and to public health that matter. Countless families have believed Mr. Wakefield, with parents blaming themselves for causing their child’s disability. As to public health, Mr. Wakefield is responsible for a drop in vaccine uptake in the UK, which led to disease and death.

Further reading on the subject can be found at Action For Autism with Wakefield and the MMR Autism Hoax

Paul Offit responds to Mark Blaxill

5 Jan

Over at Age of Autism today, financial whizz Mark Blaxill subjected Paul Offit’s finances to his usual searing intellect. I can’t quote from his post because its just to smart for me to understand!

Anyway, his conclusion has drawn the following response from Paul Offit in an email:

Just for the record: I no longer financially benefit from the sales of RotaTeq. My financial interests in that vaccine have been sold out by either The Wistar Institute, The Children’s Hospital of Philadelphia, or me. I will, however, continue to stand up for the science of vaccines because unfounded fears about vaccines have hurt children. That is why I do what I do and why I have always done it. And I will continue to closely follow the distribution of rotavirus vaccines because these vaccines have the potential to save as many as 2,000 children a day, which is why I joined the research team at Children’s Hospital.

Seems pretty clear to me 🙂

Quality of Life in Adolescents With Autism Spectrum Disorders: Reliability and Validity of Self-Reports

5 Jan

This is one of those papers I really wanted to read and report on, but I fear that I will not get the time to do an in-depth read for some time. But the subject is very interesting and I wanted to get this out before it drops off my radar.

Here’s the abstract:

Quality of Life in Adolescents With Autism Spectrum Disorders: Reliability and Validity of Self-Reports.

Shipman DL, Sheldrick RC, Perrin EC.

From the *Department of Pediatrics, Fallon Clinic, Worcester, MA; †Developmental-Behavioral Pediatrics Floating Hospital, Tufts Medical Center, Boston, MA.
Abstract

PURPOSE: This study examined the reliability and validity of self-reported quality of life (QoL) among adolescents with autism spectrum disorders (ASDs) but without mental retardation (IQ >70) using a validated QoL measure, Pediatric Quality of Life Inventory. Secondarily, the self-reported QoL of adolescents with ASDs was compared with published normative data.

METHODS: Thirty-nine adolescents with ASDs and their parents completed a QoL instrument and brief measures of psychosocial distress and self-esteem. A screening test of cognitive abilities was administered to adolescents; parents completed an assessment of behavioral and emotional symptoms and an assessment of the presence and extent of autistic social impairments.

RESULTS: Adolescent self-reports of QoL demonstrated internal reliability and concurrent validity. Self-reports on the Pediatric Quality of Life Inventory demonstrated moderate to large positive correlations with a measure of self-esteem and moderate to large negative correlations with measures of anxiety and mood. Concurrent validity with parent proxy reports fell within the range of expected values based on past studies of inter-rater reliability for QoL, with parents of adolescents reporting lower QoL when compared with adolescent reports. Adolescents reported QoL below the population mean for all domains.

CONCLUSIONS: Results of this study provide preliminary evidence that adolescents with ASDs are able to report on their own QoL in a valid and reliable manner. Based on our findings, the measurement of QoL may be useful for clinical care and research about adolescents with ASDs.

The idea here is excellent–ask the autistics themselves about their quality of life (QoL). The authors found that the adolescents were more accurate than their parents in describing their quality of life. Reported quality of life is lower than for the general population. QoL is higher for adolescents with higher self esteem and lower for “measures of anxiety and mood”. I don’t know if the authors can or tried to tackle the question of whether high self-esteem contributes to quality of life, or the other way around…or if it is a much more complex situation? The study is limited to autistics with IQ>70. The group is fairly small as well. Of course the big question–how to improve quality of life? What from this study can help in that regard, or in directing future studies.

The past is present (non autism related post)

5 Jan

Kev has recently discussed the book, Deadly Choices: How the Anti-Vaccine Movement Threatens Us All. Besides discussing the dangers the movement poses in its current form, Dr. Offit puts the anti-vaccine movement into historical perspective.

Ever since there was vaccination, there was a resistance to the practice. One of the easiest hooks is to discuss the ingredients. In the case of the original vaccine (which used the cowpox virus to protect humans against smallpox), the target was clear: it comes from cows. One of the more famous images was a cartoon made by James Gillray, showing people growing cow parts after vaccination (click image to enlarge):

It’s so 19th century. Or, is it?

I wasn’t aware of this image (or didn’t remember it) before I read the book. I was taken aback by the similarity to recent imagery used to frighten people about the rotavirus vaccine. If you recall, fragments of a pig virus were found in one of the rotavirus vaccine brands. This was a time for a reasoned, serious discussion. Was there potential for these virus fragments to be harmful? (as it turns out, the virus does not infect humans. It is even found in the fecal matter of humans who have recently eaten pig products).

Here’s one image:

Yeah, kinda cute and funny. The text of the post has headings like “Rotavirus Vaccines Use Monkey, Cow, Pig Materials for Production” and, for some odd reason, “Using Cancer Cells to Produce Vaccines? ” What this has to do with pig virus fragments in rotavirus vaccine is beyond me. The post goes on to link to a video by Barbara Loe Fisher, who discusses “fatal pig viruses”. Fatal to infant pigs, yes. Fatal to humans, no. But, Ms. Fisher doesn’t make that distinction.

Here’s another image, this time from the Age of Autism blog:

There is room for a real vaccine safety movement. In fact, vaccine safety advocates have been successful in creating real change. Dr. Offit makes this clear in his book. But scaring people with these images isn’t helping anyone.

Deadly Choices: How the Anti-Vaccine Movement Threatens Us All

4 Jan

I mentioned in a previous post that I was reading Deadly Choices and used it as the basis for a post on how much of a myth the idea of there being ‘mild’ diseases is.

I’ve (literally) just finished reading the book so I want to give it a review. I should be clear up front, I liked the book very much and I like Paul Offit too so you’re not going to find much negativity here.

The book is a clear and coherent look back at the roots of the modern anti-vaccine movement (mostly in the US but we get a sadly necessary large mention too), its leading proponents and figures. It also swings up to the modern day and looks at the contemporary anti-vaxxers such as Jenny McCarthy etc.

Sadly (from my point of view) it makes the role of modern day anti-vaccinationism clear: its mainly due to the confluence of vaccines and autism that has given rise to a politically motivated type of anti-vaxxer. To give examples we’re all familiar with its like when an out n out anti-vaxxer like the owner of the website whale.to became friends with the leaders of Generation Rescue that the initial overlap first occurred – first they borrowed material from each other then they become supporters of each other and now they follow the common goal of destroying the vaccine program in the West. That might sound a little over the top but its nonetheless true. Ask any anti-vaxxer what their goal is and that goal will be the eradication of vaccines.

Offit’s book is also a study of some of the incidents where vaccines _have_ been at fault and details how these rare occurrences are used to chronicle the side effects of vaccines and direct future safety testing. The first few chapters of the book make it clear just how important some of these tragic incidents have been to today’s safety testing. Another upcoming book that tackles this subject is Seth Monookin’s The Panic Virus and of course Offit’s own book The Cutter Incident details one such incident in great detail.

According to Offit himself:

I wrote this book for children; Deadly Choices is an attempt to stand up for them. A child’s vaccination decisions are made by his or her parents. If an adult chooses not to be vaccinated from Hepatitis B and she dies, that was her own choice to not be vaccinated. What bothers me is that children aren’t making that choice. Who represents the children?

And he’s absolutely right. In the same vein, whilst Deadly Choices is not an autism book per se, it should be the responsibility of the autism community to spread its message far and wide, partly because its the right thing to do and partly because its the modern day autism community that has spearheaded and led the contemporary anti-vaccine message. We have some wrongs to right.

How much is the U.S. Federal government’s obligation towards funding special education?

4 Jan

When the U.S. federal government passed The Education for All Handicapped Children Act in 1975, the law that has since become the Individuals with Disabilities Education Act (IDEA), they made a commitment to assist states in funding this mandate. In fact, the bill was originally introduced as “A bill to provide financial assistance to the States for improved educational services for handicapped children.”

Funding was obviously key to this bill.

I’ve often heard (and believed and written occasionally myself) that the government’s commitment is to fund 40% of special education costs. Here is a statement on Senator Dodd’s website as an example:

Currently, the federal government does not meet the goal it set in 1975 to fund 40 percent of states’ special education costs. The American Recovery and Reinvestment Act provided a one-time investment, which increased federal funding to 34 percent. However, federal funding has otherwise never exceeded 18 percent.

On researching a recent post, I found this to be not precisely true. The federal government isn’t required to pay 40% of special education costs. Instead, they are “required” to pay states an amount equal to 40% of the average cost per student for each special ed student.

If you feel like you have to read that again to understand what I wrote, I understand. It took me a while to work this out myself. And you can see that I didn’t find a brief way to write it, either.

Under “Grants to States” section of the law, one can read:

(a) Purpose of grants. The Secretary makes grants to States, outlying areas, and freely associated States (as defined in Sec. 300.717), and provides funds to the Secretary of the Interior, to assist them to provide special education and related services to children with disabilities in accordance with Part B of the Act.

(b) Maximum amount. The maximum amount of the grant a State may receive under section 611 of the Act is–

(1) For fiscal years 2005 and 2006–

(i) The number of children with disabilities in the State who are receiving special education and related services–

(A) Aged three through five, if the State is eligible for a grant under section 619 of the Act; and

(B) Aged 6 through 21; multiplied by–

(ii) Forty (40) percent of the average per-pupil expenditure in public elementary schools and secondary schools in the United States (as defined in Sec. 300.717); and

(2) For fiscal year 2007 and subsequent fiscal years–

(i) The number of children with disabilities in the 2004-2005 school year in the State who received special education and related services–

(A) Aged three through five if the State is eligible for a grant under section 619 of the Act; and

(B) Aged 6 through 21; multiplied by

(ii) Forty (40) percent of the average per-pupil expenditure in public elementary schools and secondary schools in the United States (as defined in Sec. 300.717);

(iii) Adjusted by the rate of annual change in the sum of–

(A) Eighty-five (85) percent of the State’s population of children aged 3 through 21 who are of the same age as children with disabilities for whom the State ensures the availability of FAPE under Part B of the Act; and

(B) Fifteen (15) percent of the State’s population of children described in paragraph (b)(2)(iii)(A) of this section who are living in poverty.

Emphasis added.

40% is accurate, but not 40% of special education costs. Instead “Forty (40) percent of the average per-pupil expenditure”. Average per-pupil expenditure is the average cost for all students, not just those in special education.

In the U.S., we spend about $10,000 per student, on average. So, the federal government is supposed to pay about $4,000 per special education student as their commitment. But they haven’t fulfilled their commitment. Rather than $4,000, they pay about $1,700.

$1,700. That’s how much the federal government pays each state per special ed student student. And–and–the state doesn’t pass all of that along to school districts.

If special education costs go up faster than regular education costs, the amount the Federal government is supposed to pay doesn’t go up.

This isn’t news. It’s been happening for about 35 years now. Long enough for states and school districts to factor this into their budgets. But, explains part of why districts may feel a bit of a pinch when it comes to special education costs. Special education is essentially an unfunded mandate. At a very real level it doesn’t matter that it is unfunded. Special education is the right and appropriate thing to do. However, it would sure help out a lot if the federal government would help out financially.

Autism and the Affluent

4 Jan

Autism and the Affluent is a piece in today’s Newsweek by Seth Mnookin, author of the upcoming book, The Panic Virus. It lays out how he got started on the book. Here is the first paragraph:

My wife and I first noticed our friends’ preoccupation with autism and vaccines in late 2007, right around the time former TV star and Playboy Playmate Jenny McCarthy published the first of several bestsellers in which she claimed that the measles-mumps-rubella (MMR) vaccine had probably given her son autism. As we soon discovered, McCarthy’s intuition-based approach to medicine (she referred to it as “mommy instinct”) had a number of adherents among our friends.

The rest can be found on the NewsWeek website.

Festivus isn’t over…

3 Jan

…until someone pins me.

Yes, in my listing of seasonal Holidays I neglected Festivus. (Festivus is a holiday invented by the family of one of the writers of the show Seinfeld and made known through that show). Festivus doesn’t end until the someone pins the host in the “feats of strength”. For the moment I’ll abscond with Kev’s rightful position as host of LeftBrainRightBrain and claim that since I have not been pinned, Festivus is still ongoing, I will use this opportunity to express another Festivus tradition: the airing of grievances.

The U.S. federal government was a major disappointment last year. There are many reasons, but today I will focus on the failure (once again) to fulfill their commitment to the Individuals with Disability Education Act (IDEA).

Barack Obama set out this promise during his campaign:

Fully Funding the Individuals with Disabilities Education Act: Barack Obama has been a strong and consistent advocate for fully funding the Individuals with Disabilities Education Act (IDEA). Congress promised to shoulder 40 percent of each state’s “excess cost” of educating children with disabilities, but it has never lived up to this obligation. Currently, the federal government provides less than half of the promised funding (17 percent). Children are being shortchanged, and their parents are forced to fight with cash-strapped school districts to get the free and appropriate education the IDEA promises their children. Fully funding IDEA will provide students with disabilities the public education they have a right to, and school districts will be able to provide services without cutting into their general education budgets. In addition to fully funding IDEA Barack Obama and Joe Biden will ensure effective implementation and enforcement of the Act.

Mr. Obama provided a big boost to IDEA funding, for one year. This was in the form of funding from the economic stimulus plan. Unfortunately, since this was a one-time-only boost, schools were unable to hire additional people or otherwise spend the money in ways that would require long-term investment.

In 35 years, the Federal government has never lived up to their promised contribution to IDEA. Fully funding the federal government’s commitment to special education is long overdue. Yes, it is focused on school age children and doesn’t apply to autistic adults. But, it would make a big difference especially in these tough economic times when districts are faced with big budget problems.

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