The Questionable Authority

ResearchBlogging.org
A series of articles just published in The Sunday Times reports that it appears likely that Andrew Wakefield falsified much of the data that was used in the 1998 Lancet article that first identified the MMR vaccine as a potential cause of autism. If the charges leveled by the paper are remotely accurate, Wakefield is guilty of homicide – perhaps not legally, but certainly morally. If previous claims made by the paper are accurate, Wakefield may have acted for financial gain.

If even a fraction of the accusations leveled by The Times are true, Wakefield engaged in absolutely outrageous academic misconduct, if not outright fraud. In order for any of the accusations to not be accurate, The Times would have to be lying about the contents of medical records.

In the original journal article, Wakefield and his co-authors reported on a series of 12 children who presented to the hospital exhibiting symptoms of what the authors referred to a a “syndrome” of combined gastrointestinal disorders and developmental setbacks. According to Wakefield, these symptoms presented in these patients developed shortly after the children received the MMR vaccine.

According to The Sunday Times, that is factually incorrect in the majority of the cases presented.

Specifically, the paper reports that evidence of developmental problems did not first show up soon after MMR vaccination in at least seven of the twelve cases discussed in the Lancet study. In one case, the symptoms were first noted 3-5 months after vaccine administration. In six cases, evidence of developmental difficulties was present prior to the first administration of the vaccine.

Wakefield did not report the presence of any confirmed or even possible neurological or behavioral issues in any of the cases detailed in the paper. In fact, he explicitly reported that, “[in] eight children the average interval from exposure to first behavioural symptoms was 6·3 days (range 1–14).” The statement that eight of the twelve children exhibited their first symptoms during the first two weeks after receiving the vaccine is clearly incompatible with the paper’s claim that earlier symptoms were present in six cases; according to the paper, Wakefield is at least 20% of a liar.

The accusations regarding the intestinal disorders alleged in the Lancet article are even more damning. Wakefield and his colleagues reported that colonoscopy findings for 11 of the 12 children showed abnormalities. The Sunday Times reports that in at least seven of these cases, the hospital’s initial pathology reports showed no abnormalities, and that these findings were changed after Wakefield’s team undertook a “research review” of the results.

In the Lancet article, Wakefield and his colleagues do not mention any initial disagreement about the pathology reports. Instead, they talk about “the uniformity of the intestinal pathological changes” and refer to “consistent gastrointestinal findings”.

Wakefield also described his patients as a “self-referred group”. According to the Sunday Times, this is also untrue:

The mothers of Child Two and Child Three told me what others said in medical records: they had heard of Wakefield through the MMR vaccine campaign, Jabs. Thus, when they arrived on Malcolm ward, and produced the “finding” about MMR, it was by no means a random sample of cases.

What parents did not know was that, two years before, Wakefield had been hired by Jabs’s lawyer, Richard Barr, a high-street solicitor in King’s Lynn, Norfolk. Barr had obtained legal aid to probe MMR for any evidence that could be used against the manufacturers. He is adamant that at all times he acted professionally, and diligently represented his clients.

That’s not a self-referred group that might be biased. That’s a carefully and non-randomly selected group with a very clear built-in bias.

Over the last several years, the Sunday Times has published a series of articles detailing a number of undisclosed financial conflicts of interest involving Wakefield and this paper. The conflicts include almost half a million pounds Wakefield collected as a result of his MMR work, in addition to the funds that were used for his research. The new report includes another massive conflict of interest bombshell:

In June 1996 – the month before Child One’s arrival at the hospital – Wakefield and Barr filed a confidential document with the government’s Legal Aid Board, appearing already to know of a “new syndrome”.

Referring to inflammatory bowel disease, and then bowel problems with autism, Wakefield and Barr wrote to the board, successfully seeking money.

“The objective,” they wrote, “is to seek evidence which will be acceptable in a court of law of the causative connection between either the mumps, measles and rubella vaccine or the measles/rubella vaccine and certain conditions which have been reported with considerable frequency by families who are seeking compensation.”

Needless to say, Wakefield did not mention his work with or funding from the Legal Aid Board when he submitted his article to the Lancet.

Taken individually, it’s possible – if only barely – that any one of these things could be an innocent mistake. However, the combination of all these circumstances – the failure to report the prior developmental symptoms, the failure to report the initial negative pathology findings, the failure to report the Legal Aid conflict of interest, and the document that described the existence of the syndrome to Legal Aid prior to the commencement of the research project – cannot reasonably be explained away so easily. Simply put, this is a pattern that is very strongly suggestive of outright fraud, with possible associated financial gain.

Even if deliberate fraud did not take place, the accusations – if even a quarter are true – represent gross research malpractice of an extent that’s rarely seen in the history of science.

Whether the result of malpractice or misconduct, the consequences of this research have had devastating effects. After the publication of the article, and the publicity that ensued as a result of both the article and Wakefield’s press conference, vaccination rates plummeted sharply, because parents were too frightened of the possible side effects to vaccinate their children. Predictably, measles rates shot through the roof, and in 2006 the UK saw its first measles fatality in over a decade.

Wakefield has done far more than his share to stir up and maintain the anti-vaccination hysteria. I suspect (although I’m not a lawyer) that it’s unlikely that there’s any way he can be held legally accountable for the drop in vaccinations, climb in measles rates, or any resultant fatalities. But there is no doubt in my mind that if the accusations are remotely true, if Wakefield committed either gross malpractice or outright fraud, there is blood on his hands.

Sadly, as Phil Plait already pointed out, it’s not likely that these latest revelations about Wakefield’s research practices will have any effect on most of the MMR causes autism proponents. Simply put, their belief in the perils of vaccination has reached almost religious levels. The existence of a large number of (better) studies that fail to demonstrate a link have not dissuaded them, and it’s unlikely that a revelation that the one article that supports their beliefs is fraudulent will change their minds.

As you may know, the MMR/autism issue is one that’s received a lot of attention here at ScienceBlogs over the years. If you are interested in learning more about measles, autism, or the manufactured relationship between vaccines and autism, I’d suggest that you look at a few of these posts:

At The ScienceBlogs Book Club:

A review of Autism’s False Prophets

At Respectful Insolence:

Thanks, Andrew Wakefield

Recall bias, vaccines, and illness

Antivaccinationists on the measles outbreak: The stupid, it burns thermonuclear

The Autism Omnibus: The difference between real scientists and crank scientists

At Aetiology:

Vaccination doesn’t cause autism volume what-are-we-up-to-now?

Big Questions, Little Answers: the debate over autism (guest post by Rachel Kirby)

At Deltoid:

Two more cases of scientific misconduct

At Denialism:

Autism Crankery at Huffpo – Again

Another Open Letter to Jenny McCarthy

Measles!

At Effect Measure:

Measles again

The Science-Based Medicine blog has also done a number of very good posts on the issue.

The posts I’ve linked represent only a fraction of the information that’s available here. A little bit of time spent using the search box on the ScienceBlogs homepage will turn up literally hundreds of posts on the topic. That’s because measles is a real disease, that can have real and serious consequences, and it’s a real damn shame (if not a real crime) that morons like Wakefield have been doing so much to hurt public health in so many places, with so few consequences.

(Hat Tip: Phil)

Reference:

A WAKEFIELD, S MURCH, A ANTHONY, J LINNELL, D CASSON, M MALIK, M BERELOWITZ, A DHILLON, M THOMSON, P HARVEY (1998). Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children The Lancet, 351 (9103), 637-641 DOI: 10.1016/S0140-6736(97)11096-0

Comments

  1. #1 HolfordWatch
    February 7, 2009

    Sadly, the implications about financial gain as a motivator for the MMR-autism link was laid out very clearly in Matanoski’s summing up on the final day of the first tranche of the Autism Omnibus Hearings (links for following in the above so as not to overload filter).

    It’s at best speculation, idle speculation. Now, at worst–at worst–it’s a contrivance. It’s a contrivance that’s been developed and articulated and promoted by its chief proponent, and that’s Andrew Wakefield. He promoted it for financial gain. Either way it’s not science. [pgs 28-9: Day 12 Transcript of Cedillo v. Secretary of Health and Human Services (pdf)]

    As part of Manatoski’s closing, he presented this unsettling chronology of events.

    I’ve mentioned several times in the course of these proceedings Andrew Wakefield and his theory, and there’s a reason for that. That’s because all the strands through these cases come back to him. He presented bad science.

    I’m going to run through the chronology again because it’s important, the chronology of how this arose and how it was promoted. In 1996, Alexander Harris, a firm of solicitors in Great Britain, approached Andrew Wakefield and asked him to consult with them in cases involving MMR, allegations of MMR causing autism. Andrew Wakefield was paid 55,000 pounds for his efforts at that point.

    Andrew Wakefield in 1997 took out a patent for a monovalent measles vaccine. In 1998, he published the paper that caused the stir that we’ve now seen reinterpreted, rearticulated a number of times until more than 10 years later we have it in our courtroom today.

    He did not reveal at the time that he published that paper that he had this financial interest. He did not reveal that several of his patients in that paper were in fact litigants in the MMR litigation.

    In 1998, Andrew Wakefield approached John O’Leary and consulted with him. John O’Leary went on to set up Unigenetics, a company of which he was the director and shareholder. Unigenetics’ purpose was to test samples for the U.K. MMR litigation.

    Now, you’ve heard testimony about the reliability of that testing. You’ve seen the papers that have come out of that lab. In fact, the Uhlmann paper that was discussed here at length and relied on so heavily by the Petitioners, the patients, some of the patients at least, some of the patients in that case study were MMR litigants. There’s a direct connection between that litigation and our litigation here. That litigation folded. Unigenetics went away, but we have it back here now in this case. It folded in 2004 after the whistle was blown on Andrew Wakefield and it was revealed his substantial financial connection with ongoing litigation. [pgs 30-2: Day 12 Transcript of Cedillo v. Secretary of Health and Human Services (pdf)]

    And now we learn even more about the true state of the evidence on which this shoddy edifice was erected.

  2. #2 Phil Plait
    February 8, 2009

    “Almost religious” levels?

    Read the comments on the antivax posts on my blog. Fundamentalists could take lessons from antivaxxers.

  3. #3 isles
    February 8, 2009

    Wakefield is worse than a common criminal. Most of them only take things from adults. Wakefield has caused children numbering into the thousands to suffer the measles, who knows how many to be hospitalized, and two to die. He has also caused innumerable autistic children to be subjected to colonoscopies and an assortment of quack treatments.

  4. #4 Krubozumo Nyankoye
    February 8, 2009

    It bears mentioning that the reporter on this story has been pursuing it with tenacity in the face of a good deal of intimidation for some years. Just google “Brian Deer”.

  5. #5 bensmyson
    February 8, 2009

    Was anyone paid to debunk Wakefield?

    Anyone know what, if anything, this has to do with the fact that there is increase in the number of children suffering brain injuries and in a few cases death, immediately after receiving the MMR,MMRV and HepB vaccines? Did Wakefield create this epidemic?

    I never heard of Wakefield prior to my son’s brain swelling up after his ProQuad, MMRV. Am I imaging the GI problems, the loss of speech, all the classical autistic like symptoms that resulted immediately after his vaccines?

    Any idea if these vaccines’ manufacturers are required to mention the possible brain damage or injury as a result of the administration of these vaccines to children? If so, did the FDA require the manufacturer to do so based on Wakefield’s study? OR did they do their own study?

  6. #6 Liz Ditz
    February 8, 2009

    I’ve done another round-up post — who is saying what about the Deer articles on Wakefield in the London Times. I’ve included your post.

    11 years on, Wakefield Manufactured Data showing MMR-Autism Link?

  7. #7 lollypop
    February 9, 2009

    Wakefield = GOOD (TRUTH, ENLIGHTEN)
    Vaccine Manufacturers = BAD (GREEDY, COVERUP)

  8. #8 John Kalinow
    February 9, 2009

    Not only has he hurt children whos parents thought vacination caused autism. Hes given a big black eye to all autistics and their familys with so much bad press. With so many children being born with autism and little to no help or press. Folks look at this vacination BS and think familys of autistics are nuts and hurting other kids when they where just given very wrong info to act on. Since next to nothing is offered to help autistics or familys of such they grasp at any straw. If your child was ill and no one helped or seemed to care you would probly do the same. Sadly this is the lot of 100000s of familys children and adults dealing with autisim in the US. And after reading so many cruel selfish anti autism posts online seems most americans could care less. And keep in mind these are just kids but you care not unless it effects you in some way.

  9. #9 Prometheus
    February 9, 2009

    If he had spent the last decade knowingly feeding himself with the false hopes of desperate parents he would deserve to be called a monster.

    What do you call someone who made bank on blaming an entire discipline and industry, successfully devoted to preventing illness, death and disfigurement of children, so that parents of autistic children could have something to beat their frustrated fists against?

    To call him monsters does a great disservice to monsters.

  10. #10 HCN
    February 9, 2009

    bensmyson said “Was anyone paid to debunk Wakefield?”

    If you had paid attention you would have known about the thrashing his data got at the Autism Omnibus hearings a while ago. On a court stand in front of the three Special Masters there was testimony that he refused to change the data from “positive” to the actual “false-positive”.

    If you had read the articles, you will realize that the information came out in the GMC hearings in the UK, another form of a court.

    You are just trying to pull the pharma-shill gambit:
    http://scienceblogs.com/insolence/2006/09/the_pharma_shill_gambit_1.php

    Continuing with “Anyone know what, if anything, this has to do with the fact that there is increase in the number of children suffering brain injuries and in a few cases death, immediately after receiving the MMR,MMRV and HepB vaccines? Did Wakefield create this epidemic?”

    What evidence do you have? Because the medical literature does not support it:
    http://www.theness.com/neurologicablog/?p=454

    Continuing with “If so, did the FDA require the manufacturer to do so based on Wakefield’s study?”

    Some history: The MMR vaccine went through all the testing and was approved in the USA in 1971. It was only used in the UK starting in 1988 (actually 1992 with the American version using the Jeryl Lynn mumps strain).

    Here is a newsflash: Wakefield did his “research” in the UK. That is out of the FDA’s jurisdiction. The FDA, CDC and IOM do not operate outside of the borders of the United States of America (unless they are cooperating with another countries similar entity). The “UK” stands for United Kingdom and is comprised of England, Wales, Scotland, Northern Island and some other islands, and their medical products are not regulated by any American agency.

  11. #11 Clifford G Miller
    February 20, 2009

    It turns our Brian Deer made it up:-
    Sunday Times Journalist Made Up Wakefield MMR Data Fixing Allegation:
    http://tinyurl.com/djbtzq

    And he was helping the US Justice Dept sink 4500 US kids claims for vaccine damage compensation – what kind of normal journalist does that? Ans: none.
    US Federal Court, US Justice Dept & The Sunday Times – More Questions Than Answers
    http://tinyurl.com/ac5xkt

  12. #12 Chris
    February 22, 2009

    Speaking of misconduct — Cliffy, as a lawyer you really ought to know about the libel laws in the UK (though you may be too small a fish for the Times of London to bother with).

  13. #13 Clifford G Miller
    March 6, 2009

    Chris,

    As you know, in broad brush terms there is no cause of action at law in defamation for what is true, justified or fair comment.

    Deer has not answered Melanie Phillips writing in The Spectator, nor has he produced any documentation to contradict what Phillips has
    written. She would never go into print on such matters if there were the remotest risk.  See The Spectator Monday, 16th February 2009 in A deer in the headlights and The witch-hunt against Andrew Wakefield Wednesday, 11th February 2009,

    Thanks for the personal and patronising nature of your remarks. Very helpful in making the other person look so much more reasonable. Keep it up.

  14. #14 The Science Police
    March 9, 2009

    Hi Greg

    Thanks for covering this.

    We thought you and your commenters might be interested in the following reaction to the claim that “Sunday Times Journalist Made up Wakefield MMR Data Fixing Allegation”:
    http://briandeer.com/mmr/mli-information.htm

    And we’d be interested in your opinion to our coverage — specifically, why has this thing dragged on for over 10 years?

    http://thesciencepolice.blogspot.com/

    Cheers,
    The Science Police

  15. #15 The Science Police
    March 9, 2009

    Hi Mike

    Thanks for covering this.

    We thought you and your commenters might be interested in the following reaction to the claim that “Sunday Times Journalist Made up Wakefield MMR Data Fixing Allegation”:
    http://briandeer.com/mmr/mli-information.htm

    And we’d be interested in your opinion to our coverage — specifically, why has this thing dragged on for over 10 years? To weigh in, check out our highly scientific poll here:

    http://thesciencepolice.blogspot.com/

    Cheers,
    The Science Police

  16. #16 Clifford G Miller
    July 2, 2009

    It looks like it was not Wakefield who was fixing the data but journalist Brian Deer:

    “Sunday Times Ordered ‘Remove Wakefield MMR “Data Fixing” Story’ ”
    http://childhealthsafety.wordpress.com/2009/07/02/briandeerdowninflames/

  17. #17 W. Kevin Vicklund
    July 7, 2009

    Not so much an order as a polite request to temporarily remove it until they can issue a ruling. And Wakefield’s response kinda backfired, since the Times put it right back up.

  18. #18 Ali
    January 21, 2010

    Here is a site with huge Information On Pregnancy Diseases And Genetic Testing. You can find information regarding Autism in:
    http://www.geneticsofpregnancy.com/Encyclopedia/Autism_Pervasive_Developmental_Disorder.aspx?pid=62

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