Jan 28 2010

Andrew Wakefield “Acted Unethically”

Andrew Wakefield, the UK researcher who sparked unwarranted fears about the risks of the MMR vaccine, has been the subject of a two-and-a-half years ethics investigation by the General Medical Council (GMC). This afternoon the GMC announced their conclusion, ruling that Wakefield acted “dishonestly and irresponsibly” in his research and with “callous disregard” for the children that were the subject of his research.

Wakefield’s Story

In 1998 Wakefield and others published a story in the Lancet where they claimed to find an association between finding the measles virus in the GI tract of children with autism following the MMR vaccine. The study itself was small – only involving 12 children, and the conclusions were modest, not specifically suggesting a link between MMR and autism. But in subsequent press conferences Wakefield raised the alarm, saying, “Urgent further research is needed to determine whether MMR may give rise to this complication in a small number of people.”

The result was a significant drop in MMR compliance and a resurgence of measles cases, as this BBC chart demonstrates.

_47195653_mmr_466

The original Lancet article spawned follow up research which failed to replicate Wakefield’s results. (Also see here and here.) The final disconfirmation came from a recent study finding no link between MMR, measles virus, and autism. Most significantly, the PCR technique used to detect measles virus in the original Wakefeld paper (which was itself later discredited) was performed by Professor O’Leary, who also did the PCR in the recent study contradicting Wakefield.

Doing sloppy research that is later discredited happens frequently enough in science and itself does not warrant investigation for ethics violations. That came from other accusations – specifically that Wakefield paid children 5 pounds at his child’s birthday party to participate in the study.

Further, investigative journalist Brian Deer has uncovered a host of dubious behavior on the part of Wakefield, beginning with serious conflicts of interest. These include applying for a patent on an alternate MMR vaccine – so Wakefield could potentially benefit from the results of his research. Also, Wakefield was being paid by an attorney specifically to support the claim that the MMR is linked to autism, and some of the same children whose parents were involved in such law suits were part of Wakefield’s Lancet study. These conflicts caused the Lancet to later withdraw their support from the paper.

Most recently Deer has published what he believes is evidence that Wakefield may have even faked some of the data in his original paper.

After a multi-year investigation, the GMC finds that there is some truth to the accusations against Wakefield and has ruled against him. They will now deliberate on what sanctions should result from their findings (which should take a couple of months).

MMR and Autism

But of course, conflicts of interest and unethical behavior, while it calls into question Wakefield’s research, is not the final word on the science. The question of MMR and autism has been thoroughly investigated and no link has been found. The data is very robust because we have the opportunity to observe autism diagnosis rates in various countries with differing MMR policies over time.

We now have data from Poland, the UKDenmark, Finland, and Japan (the Japan study is most interesting because there the MMR vaccine was actualy withdrawn and was not followed by any decrease in autism). These studies show a remarkable concordance of evidence – there is no association between MMR and autism. (See here for a more complete list of studies.)

Conclusion

The Wakefield story is a disturbing one. By all accounts he conducted scientifically and ethically dubious research, with undisclosed conflicts of interest, and used that to trigger fears about the safety of MMR, resulting in a demonstrable increase in disease. He also helped propel the overall anti-vaccine movement.

It is good to see that the GMC had done a thorough investigation and are now bringing Wakefield’s malfeasance to light, and I await to see what sanctions they decide are appropriate.

Meanwhile, Wakefield in unrepentant. He has moved his practice to the US where he continues to be a darling of the anti-vaccine movement. In fact, official judgments against Wakefield only serve to increase his status as a cult-hero among anti-vaccinationists.

Unfortunately, the Wakefield story is not over.

Share

49 responses so far

49 Responses to “Andrew Wakefield “Acted Unethically””

  1. gingerwigon 28 Jan 2010 at 4:21 pm

    I wonder if there is a child death count related to Dr Wakefield’s claims? Unfortunately even if there is he will never face criminal charges.

    Wayne Povey, UK

  2. ChrisHon 28 Jan 2010 at 5:46 pm

    Yes, two in the UK, and possibly several on the continent. There is also other injuries due to measle: Focus: The real victims of Britain’s MMR scare.

    Also several people, including very small children, have been hospitalized in the USA and elsewhere due to reduction of herd immunity of measles, mumps and rubella.

  3. Jerryon 28 Jan 2010 at 5:49 pm

    well, there’s always the http://www.jennymccarthybodycount.com/Jenny_McCarthy_Body_Count/Home.html

    This should’ve happened within a few years of wakefield’s fraud. It’s too late now :(

    Of course, the media won’t come out now with SCIENTIST FORGED DATA!!! – why would they, they didn’t when it seemed a small part of the IPCC report was not entirely correct.

  4. lizditzon 28 Jan 2010 at 7:16 pm

    One of my blogging habits is to collate pro and con posts on a particular issue.

    One reason to do is that each blog has its own set of commenters and often the comments reveal aspects of the issue previously not considered elsewhere.

    The comments at pro-Wakefield sites are fascinating, in a “I can’t look away from the car wreck” sort of way.

    Today’s issue is the UK’s General Medical Council’s ruling on Andrew Wakefield.

    I’ve included this post in the list.

    The list can be found at

    http://lizditz.typepad.com/i_speak_of_dreams/2010/01/andrew-wakefield-dishonesty-misleading-conduct-and-serious-professional-misconduct.html

  5. _Arthuron 28 Jan 2010 at 8:53 pm

    Wakefield was being paid TWICE to perform the same research/”study”/”project” ?

    And all the money came (indirectly) by the UK government ?

    Life is good.

  6. superdaveon 28 Jan 2010 at 11:03 pm

    the AoA is reporting that Wakefield study has finally been reproduced. Nevermind that the people reproducing it work for his organization. Can you look over that paper they are waiving around?

  7. sheldon101on 29 Jan 2010 at 3:10 am

    The other approved study was Walker-Smith could take 2 extra biopsies during colonoscopies.
    ———————-
    Much has been made of the fact that Dr. Wakefield and the others had blanket ethics approval for the research component of the studies they did that ended up in the 1998 Lancet Paper. This is the two studies theory.

    Unlike bullet 399, which really did all that damage, the two studies theory is a bad joke.

    Specific details on this other, approved study, have not been easy to find even though it was used as a defense by many of Wakefield’s fans.

    I never could understand what it was. Thanks to the nice people at Age of Autism, we now have the details.

    The approved study that is supposed to exonerate them was merely permission for Professor Walker-Smith to take 2 additional biopsies for research purposes during colonoscopies he performed at the hospital. That’s it.

    The GMC specifically rejected this argument.

    For details see http://vaccineswork.blogspot.com/2010/01/16295-or-162-95-two-studies-defense-of.html

  8. provaxmomon 29 Jan 2010 at 8:35 am

    While I’m pleased at the decision and eagerly await the sanctions, I’m afraid the anti-vax people will just see this as an opportunity to introduce martyrdom into their scenarios. Poor Dr. Wakefield…..persecuted because he chose to question the system .

  9. Eternally Learningon 29 Jan 2010 at 10:10 am

    Steve,

    Maybe I’m just missing something here, but that graph confuses me a bit. Sure I can see the relationship between the dip in compliance and the rise in measles clearly in the trend that peaked during 2003, but the sudden sharp increase in measles from 2005 to 2009 seems to completely ignore the compliance statistics. Is there some other factor at work here that isn’t represented or does this imply that the two are not really related as closely as it seems?

  10. Gareth Binkson 29 Jan 2010 at 11:21 am

    Great piece…..its the blogging of this kind that will hopefully get picked up as the proper facts.
    As with homeopathy its the reporting of this in the mainstream that will changing the general publics perception.
    There will be loads of fluff pieces coming out and denial from JMarthy about everything!

  11. Gareth Binkson 29 Jan 2010 at 11:21 am

    Great piece…..its the blogging of this kind that will hopefully get picked up as the proper facts.
    As with homeopathy its the reporting of this in the mainstream that will changing the general publics perception.
    There will be loads of fluff pieces coming out and denial from JMcarthy about everything!

  12. sensecharityon 29 Jan 2010 at 12:13 pm

    You’re right, the story is not over, and we must start to focus on rebuilding the public perception of the vaccine.

    I work at Sense, the charity for deafblind people and we work with families still living with the effects of previous rubella outbreaks. You can read our full response to this story on our website: http://bit.ly/dARXbU

    So, how can we start giving parents the confidence again to have their children vaccinated.

  13. Steven Novellaon 29 Jan 2010 at 12:16 pm

    EL – there is a delay from the drop of compliance to the later rise in measles cases. Even though MMR rates increased after 2003, they still leveled off at below herd immunity levels. The persistent sub-herd immunity levels eventually kicked off an epidemic, and that is the sharp increase.

    We are still dealing with an infectious disease with its own unpredictable patterns and ups and downs. You can really only look at the big picture – sustained vaccine levels below 90% leading to an eventual return of measles as endemic in the UK.

  14. provaxmomon 29 Jan 2010 at 12:40 pm

    Autism News Beat just posted the story, including a link to this morning’s Today show coverage. “Wakefield vowing to press on…” blech

  15. Matt Pon 29 Jan 2010 at 1:21 pm

    A few minutes after seeing the Wakefield news, I saw this on an autism “report” (a blog that just copies the beginnings of other published stories and links you to the rest):

    Critical Work of Dr. Andrew Wakefield Replicated

    Clinical Presentation and Histologic Findings at Ileocolonoscopy in Children with Autistic Spectrum Disorder and Chronic Gastrointestinal Symptoms http://www.la-press.com/article.php?article_id=1816

    I read the study, and although I didn’t understand a lot of the words in it, it seems to me to be saying, “Kids with autism and stomach problems have autism and stomach problems.” I couldn’t find anything that seemed to have “replicated” Wakefield’s “critical work.”

    Am I missing something? What did this study accomplish, exactly?

  16. daedalus2uon 29 Jan 2010 at 1:58 pm

    A correction, the original Wakefield paper used antibodies to “detect” (actually a false postive, but then antibodies are not very specific) the protein said to be from measles virus. Wakefield knew those were false positives at the time because his collaborator and graduate student Nicholas Chadwick did PCR on the exact same samples that Wakefield found to be “positive” and found only false positives. Every positive Chadwick got via PCR he sequenced and found it was a false positive. Chadwick testified under oath that he told Wakefield that they were all false positives before the Lancet paper was published.

    Later very sloppy PCR (not done by Chadwick) showed “positives”, but none of those “positives” were done properly, they didn’t have the right controls and none of them were sequenced to verify that they were true positives.

    PCR is many orders of magnitude more sensitive and orders of magnitude more specific. If a PCR result is negative, then a positive immunological result is useless because it is virtually certain to be a false positive. If Wakefield had released the PCR data, the immunological data would have been rejected as artifact.

  17. Juanon 29 Jan 2010 at 2:45 pm

    I have to admit I am not familiar with the legal matters in medicine but shouldn’t these revelations result in Wakefield loosing his license abroad and here? How is he able to practice anywhere?

  18. etorigoeon 29 Jan 2010 at 3:21 pm

    The bars in the chart are a little misleading. The bars represent the % of children who are being vaccinated. A better comparison would be with the total population without immunity to MMR (mostly due to a lack of vaccination I would guess). When the % vaccinated drops, the rate of growth (the slope) of this population increases.

    If the normal % vaccinated is 90% and a scare causes a drop in the rate to 80%, and there are N children eligible to be vaccinated, then that means that there are an additional (0.1)*N unvaccinated children in the population due to the scare.

    The population of the UK is 62 million. According to Wikipedia 18% of the population is between 0-14. So let’s guess that the population eligible to be vaccinated (0-5) is N = (0.06)*62 million = 3.7 million. So if the scare causes 10% fewer children to be vaccinated then the unvaccinated population increases by an addional 370,000 children.

    Guesstimating from the graph and again assuming a normal rate of vaccination to be 90%, over 10 years the scare has increased the unvaccinated population by 2.4 million children in the UK alone.

    While there may be a phase lag, the number of cases of measles certainly seems to correlate with the growth in the unvaccinated population.

  19. Steven Novellaon 29 Jan 2010 at 4:30 pm

    Regarding the percent unvaccinated – you also have to understand the the unvaccinated are not randomly distributed. They typical occur in pockets – or rather, there are communities with particularly low vaccination rates – and that is where the measles outbreaks are occurring.

  20. sheldon101on 29 Jan 2010 at 5:48 pm

    Re: Critical Work of Wakefield Replicated

    Krigsman did 143 colonoscopies on ASD kids. What he definitely replicated was the concern of the GMC with Wakefield, Walker-Smith and Murch— namely doing invasive research on kids without ethics review board approval and in fact doing it after it was denied.

    So how did Krigsman manage to get his research into a peer reviewed journal on which he and Wakefield are on the editorial board?

    They used a commercial ethics review board company and even then limited the use of the review board company to “IRB approval was limited to retrospective review and compilation of findings using these procedures.”

    I guess that means they weren’t concerned that the hospital was concerned enough that Krigsman was doing research colonoscopies on kids that they put in place a requirement that each colonoscopy he did had to be approved by another doctor.

    So I’ve sent an email to Copernicus, the IRB company, asking them to retract their approval for the study.

    More details here:http://vaccineswork.blogspot.com/2010/01/letter-to-copernicus-group-re-ethics.html

  21. ChrisHon 29 Jan 2010 at 6:39 pm

    sheldon101:

    So how did Krigsman manage to get his research into a peer reviewed journal on which he and Wakefield are on the editorial board?

    Possibly because it is not a peer reviewed journal. It is their own journal, as you can see by the list of editors (Wakefield, Carol Stott, Brian Jepson, etc). It is very similar to Gary Goldman’s Medical Veritas (where Wakefield is also an editor/author) and Medical Hypothesis (which is indexed at PubMed, though that may change after publishing a bunch HIV/AIDS denialist articles).

  22. ChrisHon 29 Jan 2010 at 11:11 pm

    Sheldon, more on the journal the Krigsman article was published in:
    http://leftbrainrightbrain.co.uk/2010/01/autism-insights-another-journal-for-questionable-autism-research/#comment-74998

  23. etorigoeon 29 Jan 2010 at 11:41 pm

    I think I made a calculation error earlier. On a yearly basis there are probably 1/5 of the 3.7 million I originally quoted who are scheduled to get the vaccine in the UK. That would mean that the UK gives around 700k child vaccinations per year. Does that number sound correct?

    Anyway, adding up the additional unvaccinated children due to the scare between 1998 and 2008 from the graph I get a number closer to 500k.

    This is a very back of the envelope calculation that I thought was interesting. It is a measure of the cumulative effect of this misinformed anti-vaccination campaign. I made a lot of assumptions and guesstimations that limit the accuracy of this number.

    Based on the spatial density fluctuations of the unvaccinated (as noted by SN) and other non-linear factors it will probably hard to determine an expected relationship between the unvaccinated population and the rate of infection. So, I’m not making a strong claim about the meaning of this 500k number I calculated.

  24. johnmatthewsonon 30 Jan 2010 at 1:26 pm

    The real problem here is that the British Government refused to allow single vaccinations. They absolutely insisted that babies have the triple vaccine rather than three, separate single vaccinations. Wakefield cannot be blamed entirely for the measles outbreak.

    Remember that the British Government once insisted that beef was safe and the CJD fears were unfounded. One of the scientists involved in the CJD scare was also hunted down by the government but he was vindicated by events.

    Obviously to launch a “scare” on the basis of one research paper is wrong and governments should quieten the media. But the way the British Government behaved was a mistake, they should have allowed single vaccines for a period, discussed the research with Wakefield, asking him to call for calm and ensured a rapid replication/follow up study.

  25. ChrisHon 30 Jan 2010 at 1:56 pm

    The UK NHS failing in one area in no way exonerates Wakefield. If you look, you will see the 1998 Lancet paper did not in any way show that the MMR was the cause of autism, and the call for single vaccines was only presented by him in a press conference.

    The MMR vaccine being used in the UK since 1992 is the same one that has been used in the USA since 1971.

    The call for single vaccines is incredibly stupid and unfounded. It means three times as many vaccines, with more time between them. This leaves more chance of a child getting one of the three diseases, and more chance of an injury from the needle (which is small, but why triple it?).

    Plus, single vaccines just does not work. It did not work in the UK in the 1980s, and it did not work in Japan in the 1990s/2000s (a country which exported measles to the USA, and is now having problems with mumps).

    Do not even try to argue that girls should not be protected from mumps, or boys do not need to be vaccinated for rubella as a way to reduce injections. It is extremely ignorant to think that herd immunity can be maintained by vaccinating only half the population. Even if all the girls get vaccinated for rubella, there is a chance the vaccine will not take, leaving a pregnant woman vulnerable to some little boy who could pass rubella to her. Go up and read the link from “sensecharity.”

    Also, I think it is incomprehensibly sexist to deny girls a mumps vaccine because they do not become infertile. There are other side effects from mumps, including deafness and oophoritis (look it up!).

    No, Mr. Matthewson, the blame is on the media. They created a tempest in a teapot and a mountain in a molehill. Except there was no teapot, nor was there a molehill.

    Wakefield lied. The media ran away with that lie, and children have suffered for it.

    I suggest you read Ben Goldacre’s book Bad Science. Or at a minimum read the pertinent chapter here:
    http://www.badscience.net/2008/08/the-medias-mmr-hoax/

  26. johnmatthewsonon 30 Jan 2010 at 2:48 pm

    “The call for single vaccines is incredibly stupid and unfounded”.

    No, it would have been a sensible transitional arrangement before returning to MMR when the evidence was in. Your comments are typical of the approach of the government

  27. ChrisHon 30 Jan 2010 at 3:24 pm

    Obviously you have issues with reading. Actually, it is the approach of science. If you have any evidence that it would have worked, please present it. Did you look up oophoritis? Did you read the link posted by “sensecharity”? do you think that the Sense Charity is a government group? Do you understand the concept “herd immunity”?

    If you have any evidence that MMR (which, I repeat has been used in the USA since 1971) has issues that would require the use of some other vaccine method please present it. By what I mean by evidence, actual scientific studies, and not government conspiracy rants.

    In the mean time, I am reading a very long PDF I downloaded from Ben Goldacre’s BadScience blog:
    http://www.esrc.ac.uk/ESRCInfoCentre/Images/Mapdocfinal_tcm6-5505.pdf

    Another prominent theme of the coverage was the proposal to give parents the choice of three separate jabs. While this proposal is strongly supported by Dr Wakefield, there is no empirical research that suggests this is a safer option. Some newspapers actively campaigned for this option, although most media simply reported the fact that there was support for it. Either way, some 31 per cent of respondents in our October survey now appear to favour this option, with only 47 per cent now preferring the MMR jab. This loss of confidence was initially overestimated in both the early coverage and by our respondents, but there is no doubt that the long term public health consequences of a fall in vaccination levels are profound.

  28. tmac57on 30 Jan 2010 at 8:23 pm

    johnmatthewsom-”No, it would have been a sensible transitional arrangement before returning to MMR when the evidence was in.”
    So, by that logic, anytime some “researcher” make a statement questioning some therapy in a press release, then governments around the country, or the world should immediately cease the standard of care regarding that therapy, until new studies show that it is safe?

  29. johnmatthewsonon 31 Jan 2010 at 4:21 pm

    Reply to tmac57:

    Many of the correspondents seem to be forgetting that when Wakefield made his results public no one knew whether or not MMR was responsible for the results.

    If a piece of “research” is creating a health scare then firstly it should be assessed by scientists in the department of health. Next, if, as in the case of Wakefield’s research, it appears as if something unexpected might be occurring they should get the researcher to announce that as yet no definite conclusions can be drawn and should sponsor research to check the findings.

    If the scare is undermining public health they should introduce stop-gap measures until the situation is clear to ensure that the risk to the population is minimised.

    Wakefield is an example of one of these incidents where the researcher was wrong. The history of health research is littered with examples from the “Stepney pump” to CJD where the government got it wrong and they persecuted the researcher who brought the bad news. The civil servants in government should stop being so incompetent and devise a civilised plan for dealing with these events – after all, they occur every decade or so.

    I stick by my initial comments, a competent government would have saved Wakefield from himself and the country from an increased prevalence of measles.

  30. ChrisHon 31 Jan 2010 at 7:57 pm

    Actually, what he reported in the press release had nothing to do with what was written in his paper. There was a complete disconnect.

    In short: he lied.

    He lied in the paper, and he lied in the press release. He also suggested that the single vaccines be spaced a year apart, which would make children more vulnerable to disease and further erode herd immunity (again, do you understand the concept of herd immunity?).

    There is absolutely no reason for a public health policy to be changed on a two bit researcher’s press release that misrepresented his own results (which were fudged).

    Now, what you seem to be missing is even if he had not lied, it was just a small reporting of twelve case reports. In no way did it show actual problems with the MMR. Which (in case you forgot, or seem to be ignoring) had been used in the USA and else for over two decades.

    You are also missing that the government did not have control over the media mania that perpetuated his lies. Really, read the links I gave, especially the one on the analysis of media reports on the MMR, climate change and cloning.

    Stop trying to blame a government for the media treatment. Are you suggesting that a “competent” government is one that has control of the media? Kind of like what is happening in Venezuela?

    You say “Wakefield is an example of one of these incidents where the researcher was wrong.” He had one paper that showed nothing remarkable (and he actually lied about it). That does not in any way change the decades of research conducted on the MMR before he was contacted by a lawyer. Plus, in the decade of research after his press release his “results” were never replicated, and the MMR has again proven to be safe (in studies covering the medical records of hundreds of thousands of children in several countries).

    Also, you have failed to show any data that would show that the single vaccine option would be safer. Why is that? Do you have something against real science?

    Is your empiricism just based on what you think the results should be? If it is, then you are doing it wrong.

    Show that Wakefield contributed anything useful, or that the single vaccine offer would have been safer with real evidence. And evidence directly relating to the MMR vaccine, measles, mumps, and rubella — not distractions into other research or governments. In short: put up or shut up.

  31. ChrisHon 31 Jan 2010 at 9:39 pm

    I know you will not read Ben Goldacre’s book Bad Science, nor will you read Paul Offit’s Autism’s False Prophets, that both detail the story behind Wakefield’s paper, and why it was not to be taken seriously in 1998. It is quite clear you have not even read what Dr. Novella wrote, and are completely ignoring all the other input.

    But I do have a copy of both books, and noticed that the excerpt in the link provided above did not include certain passages from Dr. Goldacre’s book. I have hand typed them and present them here for you (though really, you should try to catch up the the whole history and science behind this whole fiasco, perhaps even read about the devastation iin Germany caused by Wakefield’s action here: http://justthevax.blogspot.com/2010/01/gmc-ruling-on-andrew-wakefield-in-and.html ).

    Excerpts from the 2nd edition of Bad Science by Ben Goldacre:

    Page 294:

    In February 1998 a group of researchers and doctors led by a surgeon called Andrew Wakefield from the Royal Free Hospital in London published a research paper in the Lancet which by now stands as one of the most misunderstood and misreported papers in the history of academia. In some respects it did itself no favours: it is badly written, and has no clear statement of its hypothesis, or indeed of its conclusions (you can read it free online if you like). It has since been partially retracted.

    Continuing later on page 295:

    What can this kind of paper tell you about something as common as MMR, and something as common as autism? Basically nothing, either way. It was a collection of twelve clinical anecdotes, a type of paper called a ‘case series’ — and a case series, by design, wouldn’t demonstrate such a relation between an exposure and an outcome with any force.

    Which is followed by a definition of a ‘cohort study’ and a ‘case-control study. Neither of which of describe Wakefield’s paper, that you so much think that should change the UK NHS’s vaccine policy. Indeed, the UK taxpayers already had wasted enough of their funds from the public legal fund on this folly. There is absolutely no reason to squander even more of the UK taxpayers money on single vaccines.

    Continuing on about the use of single vaccines on page 296-297:

    We are all entitled to our clinical hunches, as individuals, but there was nothing in this study of twelve children, or any other published research, to suggest giving single vaccines would be safer. As it happens, there are good grounds for believing that giving vaccines separately might be more harmful: they need six visits to the GP, and six unpleasant jabs, which makes four more appointments to miss. Maybe you’re ill, maybe you’re on holiday, maybe you move house, maybe you lose track of which ones you’ve had, maybe can’t see the point of rubella for boys, or mumps for girls, or maybe you’re a working single mum with two kids and no time.

    Also, of course, the children spend much more time vulnerable to infection, especially if you wait a year between jabs, as Wakefield has recommended, out of the blue. Ironically, although most of the causes remain unclear, one of the few well-characterised single causes is rubella infection itself, while the child is in the womb.

  32. tmac57on 31 Jan 2010 at 10:26 pm

    Well done ChrisH !

  33. johnmatthewsonon 01 Feb 2010 at 7:09 am

    ChrisH: “Also, you have failed to show any data that would show that the single vaccine option would be safer. Why is that? Do you have something against real science?”

    Do you have something against competent government or do you believe those in government should react like ill educated “bovver boys” and blimps? You have not tackled my basic point which is that Wakefield’s announcements could have been dealt with by competent government and need not have lead to an increase in measles.

    The ignorant, “bovver boy” approach to government would be to shout loudly that the results are doubtful and to attack Wakefield’s credibility and smear his reputation “off record”. It might well be the case that the results were indeed doubtful and Wakefield was indeed dubious but this panicky, school playground bullying approach is incompetent.

    I have spent many years doing research in British Hospitals and in the private sector. The hospital researcher is isolated and no-one cares about them. Had I done Wakefield’s research in a hospital environment it would have had to be published. All that would have mattered would have been “paper count”. I have also worked for pharmaceutical companies. Had I come up with something like Wakefield at one of these companies there would have been a meeting with senior researchers who would have come up with a plan for dealing with it. I would not have been exposed personally and would have been protected by the experience of senior scientists and managers who were wise to the ways of science and the world. Of course, these comments apply to a general piece of research, had the research involved any pharmaceutical company’s own vaccines there would have been board level involvement and a total “lock down”!

    Whatever you think of Wakefield’s research, the fact that it led to a health scare was a supervisory failure at the institution where it was performed and gross incompetence in government. After all, who paid Wakefield? The government and the hospital/medical college. All the government needed to do was get Wakefield to say that the results were provisional (after all, they were provisional) and, given that the scare was serious, to produce a leaflet that said “So you want single vaccines” in which the parent’s fears would be allayed but they would be allowed single vaccines if they filled in a detailed 5 page form and gave solemn undertakings to complete the course, perhaps with the penalty of refunding the cost of the treatment if they failed to do so.

    What can we learn from Wakefield?

    The first point is that Hospital/Medical College Research should have a management structure with shared responsibility for quality control amongst those managing the project. This would have stopped the Wakefield saga in its tracks. The appropriate people exist in Medical Colleges and Hospitals and should really be fulfilling this function already.

    The second point is that the government should talk to those scientists who are creating a serious health scare at the earliest opportunity and, if there is doubt about the work, persuade them to announce that the results are provisional and further work is needed so there is no need for alarm.

    The third point is that if alarm has spread so that it has become a danger then, to ensure public health, the government should allow some way round the problem and should not just try to bully it away.

  34. johnmatthewsonon 01 Feb 2010 at 7:22 am

    ChrisH: “In short: put up or shut up.”

    I’ve got to respond to this. I have “put up”. What I am talking about is management, not science. A collegiate atmosphere where staff such as Wakefield can find guidance, consultation between department of health and researchers and an intelligent response to the concerns of parents are management issues. It is nothing like your scary: “Are you suggesting that a “competent” government is one that has control of the media? Kind of like what is happening in Venezuela?”.

    I detect hospital consultant or other health service staff behind some of the comments here. The British NHS has bred a rather nasty competitiveness and bullying mentality in its staff. The working atmosphere is like Eastern Europe at the height of Stalinism. Thank goodness I only had to witness this behaviour, it must be a nightmare to work within such a system.

  35. SteveAon 01 Feb 2010 at 9:00 am

    “# johnmatthewson”

    You seem incapable of accepting the fact that Wakefield has been shown to be a deliberate liar. This is not a management issue. It’s one of ethics and honesty. You seem desperate to absolve this man of any responsibility for his actions and blame some ‘all powerful’ bureaucracy that somehow failed to protect him from himself.

    You seem divorced from reality in other ways. The UK government’s response to the vaccine scare should have been to…Da-da-dum!…Write a leaflet.

    A leaflet?

    A leaflet…!

    As far as naive statements go, you just turned the dial up to 11. No make that 12.

  36. johnmatthewsonon 01 Feb 2010 at 12:02 pm

    SteveA: “You seem incapable of accepting the fact that Wakefield has been shown to be a deliberate liar. ”

    I am not defending Wakefield but I am pointing out that an institutional failure also occurred. A problem became a scare and the scare risked lives. This could have been tackled and nipped in the bud if the hospital/college and department of health were not poorly managed. Do you really believe that one out of the hundreds of thousands of health workers and researchers in UK government employment will not give rise to another situation like this within a decade or two? Some simple and low cost management precautions would avoid this happening again. In fact the managers in hospitals/medical colleges/health departments should already be implementing such measures because they would improve the quality of research and the social conditions of researchers.

    What actually happens is that, whether the errant researcher is right or wrong the institutions let a scare develop then attempt to discredit the researcher (rightly or wrongly) and smear them (always wrongly).

    This smearing, bullying approach has been seen on this blog. In response to my pointing out that Wakefield’s managers are also culpable and my call for the institutions to learn a lesson from this affair I have had the following comments:

    “The call for single vaccines is incredibly stupid and unfounded”.

    “You seem incapable of accepting the fact that Wakefield has been shown to be a deliberate liar. ”

    “You seem divorced from reality ”

    “Are you suggesting that a “competent” government is one that has control of the media? Kind of like what is happening in Venezuela?”

    “By what I mean by evidence, actual scientific studies, and not government conspiracy rants.”

    It makes me wonder why people would characterise my calls for institutions to accept managerial responsibilty and to learn from these events as “conspiracy rants”, stupidity, incapacity and fascism. Obviously poor management does not deserve such avid, emotional defence – why are they doing it?

  37. daedalus2uon 01 Feb 2010 at 12:11 pm

    There is another issue in abandoning MMR and going with 3x single injections, that is cost. The MMR vaccine already produced would have to be discarded, and new single vaccines made up to replace it. Who pays for that? 3 injections will be more expensive than a single injection. The cost could easily be a few hundred million.

    Contrary to what johnmatthewson suggests, there are procedures in place to prevent what happened when Wakefield published the Lancet paper. The problem is that Wakefield deliberately circumvented those procedures.

    1.Research requires an ethics review which Wakefield did not get.
    2.Publication requires affirmation that the proper ethical safeguards were in place which Wakefield lied about.
    3.Publication requires disclosures of financial conflicts of interest which Wakefield lied about.
    4.Publication requires honest reporting of the factual details of the research which Wakefield lied about.
    5.Wakefield individually picked individual children with the individual characteristics he wanted and then deliberately lied and said these children were not individually picked.
    6.Wakefield deliberately omitted PCR data which would have proven beyond any doubt that his immunological results were simply artifact.

    If Wakefield had acted honestly and ethically, there would never have been any doubts raised as to the safety of MMR.

    What changes might governments implement to prevent such things in the future? The only thing I can think of is to reduce the presumption of honesty and the presumption of ethical behavior. I think those doubts are better raised by the media, which acted very badly in these circumstances.

  38. ChrisHon 01 Feb 2010 at 12:27 pm

    I see Mr. Matthewson has pulled variant of the Pharma Shill Gambit. I assure you, I do not work in any form of a medical field (I am a parent of a child with several health issues). He has refused to read any of the history, and is just going on “management” instead of science.

    Actually, the UK NHS did write several leaflets, and there are several web pages dedicated to showing how Wakefield was very flawed and that the MMR is safe. Somehow this did not seem to work against the tide of truly horrible media coverage of the MMR vaccine.

    Remember, the MMR vaccine introduced to the UK in 1992 is the same one that has been used in the USA and several other countries since 1971.

    It loos like Mr. Matthewson’s several years of research is the equivalent of reading Scudamore’s whale.to webiste. He deserves all the derision he has received, and I shall now ignore him.

  39. daedalus2uon 01 Feb 2010 at 12:35 pm

    Johnmatthewson, are you are suggesting that whoever was Wakefield’s “supervisor” should have exerted greater control over him? To the extent that he did have administrative supervision, Wakefield lied to those administrators and/or didn’t follow correct administrative procedures anyway. He didn’t get ethics review for doing the research. Ethics review is in place to balance the risks of research on human subjects with the value of the research questions being answered.

    A review of his research questions before he did the research might have stopped the research right then as being silly and not consistent with much that is well known about measles virus and measles vaccine virus. His real research “goal” was “how can I cast doubt on MMR so my lawyer backers funding this research can use it to scam the government into paying them legal fees to litigate this”.

    The reason that Chadwick couldn’t go public with his PCR data that refuted Wakefield’s immunological data was the control that Wakefield exerted over Chadwick’s career. Wakefield did his damnedest to thwart Brian Deer’s exposure of Wakefield’s fraud. If Brian Deer hadn’t had sufficiently deep pockets backing him up, Wakefield might have succeeded. Changing English libel laws to remove the use of libel law to silence scientific debate is (I think) important in reducing the likelihood of future Wakefield-like incidents.

    I think that fixing the legal system so it can’t be used to scam or defraud would be a valuable change. I don’t think that is going to happen because it means removing power from the legal system and lawyers and they simply won’t allow that to happen.

  40. johnmatthewsonon 01 Feb 2010 at 1:06 pm

    I have worked at a medical college and in industry. What I am saying has nothing to do with ethical committees or publication conditions. It is about management. What daedalus presented as quality controls was not about this sort of management.

    If someone wishes to do research and be paid by the government for this research the overseeing medical college should supervise that research. This happens at the beginning of a project but it should continue. A senior, academic manager in the college should be assigned managerial responsibility for the project, there should be occasional reviews, the senior member of staff should take a look occasionally, go over the notebooks, watch the procedures etc.

    When a paper comes up for publication the work (including notebooks) should be reviewed by a publication committee and the manager should sign it off and take managerial responsibility, along with the committe. This is taxpayers money that is being spent. You can bet that if a senior member of the faculty had had to sign off Wakefield’s work and take responsibility it would not even have been published.

    I remember many medics going through my lab, using our research facilities, doing “a bit of research” for their MDs or other advancement of their medical careers. Most were almost entirely unmanaged. Many were excellent but god knows what some of them were doing, certainly their “supervisors” or managers didn’t. Almost all of them would have been happier if the college had taken some interest in their work.

    Daedalus: “What changes might governments implement to prevent such things in the future?”

    Improve medical college management. Ensure that scares are managed through consultation. If required, to control a scare and protect the community, amend treatment routines so that, with effort, patients can obtain alternative treatment if they really must.

  41. ChrisHon 01 Feb 2010 at 1:57 pm

    I suspect with that logic, you probably think the US government is to blame for all the losses incurred by those who invested with Bernie Madoff.

  42. Draalon 01 Feb 2010 at 2:04 pm

    Part of the allure of academic research is independence. No one to manage you. A university assumes that a research professor is a big boy and can work independently. The hierarchy of tenor track (assistant, associate and then full professor) is a built-in mechanism for determining the quality of a faculty member. If someone is publishing crap, being unethical and/or not bringing in financial resources, then the university can fire the person. Therefore, either follow the rules or be fired. That 5-6 year process is what any full professor cuts their teeth on and earns them respect. It also builds up their ego. Once someone is a full professor, they have earned their tenor and are nationally recognized as significant contributor to their field of research.

    Not many nationally recognized professors would go along with being ‘managed’ by their department or institute. If a professor wanted to be managed, then they’d have gone into industry instead. Plus, being managed by your department has it’s problems since it involves human nature. Often, faculty members do not play nice with one another; it would be quite an issue if one’s ‘supervisor’ had a personal dislike of you. That supervisor would have the power to block any publications regardless of the quality. That job is already part of the peer review process of all quality journals.

    In addition, part of applying for funding is the requirement of submitting all the necessary legal and ethical documentation, especially if human subjects are involved. That’s meant to ensure that the research is being conducted in a proper manner. It is up to the researcher to be familiar with the ethical rules and follow those guidelines.

  43. johnmatthewsonon 01 Feb 2010 at 2:05 pm

    What are you saying ChrisH, that colleges taking an interest in research work done in their facilities is a bad idea? That government departments should talk things over with researchers before launching campaigns to discredit them is a bad idea? That being flexible at the delivery end of the National Health Service is wrong?

    Again I get a global “smear” for no apparent reason. There were serious institutional failures in the Wakefield case, I cannot understand why contributors are so anxious to gloss over these.

    I used to feel sorry for the doctors who had to perform research in a lonely vacuum but it seems that no-one else here gives a damn.

  44. johnmatthewsonon 01 Feb 2010 at 3:07 pm

    Draal, I can see where you are coming from on the subject of independence. But there is a middle path. Some of the points you raise such as:

    “Plus, being managed by your department has it’s problems since it involves human nature. Often, faculty members do not play nice with one another; it would be quite an issue if one’s ’supervisor’ had a personal dislike of you. That supervisor would have the power to block any publications regardless of the quality. That job is already part of the peer review process of all quality journals.”

    are indicators of extremely low standards of management in these institutions. What you describe does indeed happen and it is positively Victorian.

    You say : “Therefore, either follow the rules or be fired.”

    You have missed out “cause a national or even international health scare, then get fired”. How much better to get rid of Victorian standards of management and avoid unnecessary deaths. Young researchers would welcome this, old professors would lament the loss of empires.

    And then there is the adversarial behaviour of the civil service. This needs fixing

  45. Archangl508on 01 Feb 2010 at 3:25 pm

    johnmatthewson,

    You may have some legitimate points about changing of management styles and management beurocracy at academic institutions, but that certainly is not where the majority of the blame should lie. Even if you are correct, the fault of the institution is small compared to Wakefield’s responsibility. Part of the way science works is that people are expected to behave in an ethical manner (similar to the concept of “innocent until proven guilty”). Wakefield obviously behaved in a highly unethical manner. A University is not industry and academic researchers are expected to bear the responsibility and liability for their own work much more so than within industry.

    It is also important to remember that it was not necessarily just the publication that began the scare, but rather the comments Wakefield made to the press that went far beyond what was said within his paper. He made much stronger statements about his research (and continues to do so) than he could have ever gotten away with within a publication. How should the university have managed that? Do you want academic researchers required to submit all of their public statements to a university panel prior to those statements being made, as would occur in an industrial setting?

    Bottom line is, we are all responsible for our own actions. The failure of a system can only go so far as to take blame for an individual’s unethical choices or conduct.

  46. ChrisHon 02 Feb 2010 at 12:48 pm

    Now that the 1998 Lancet paper has been formally fully retracted, there is absolutely no reason to continue bleaking about “single vaccines” or what any government should do.

    Mr. Matthewson, you can now stop beating that dead horse, and banging that dead parrot on the table.

    The science has been done, the link between vaccines and autism does not exist. It is a dead link… “It’s not pinin’! ‘It’s passed on! This link is no more! It has ceased to be! It’s expired and gone to meet its maker! It’s a stiff! Bereft of life, it rests in peace! If you hadn’t nailed it to the perch it’d be pushing up the daisies! Its metabolic processes are now ‘istory! It’s off the twig! It’s kicked the bucket, it’s shuffled off its mortal coil, run down the curtain and joined the bleedin’ choir invisible!! THIS IS AN EX-LINK!! ” (hat-tip to Monty Python and the dead parrot sketch)

  47. michael0156on 03 Feb 2010 at 5:27 pm

    The original article is FILLED with the regular shill fabrications.

    I will take issue with only 2 as I know for the most part this information will fall on deaf ears.

    First, Brian Deer and the “faked data” has not only been proven to be a lie, but The Times was requested by the PCC to remove those stories related to the faked data from it’s website, which it did. That action was taken by the PCC based on a complaint filed by Dr Andrew Wakefield.
    Then in an unprecedented move, The Times reposted the stories in defiance of the PCC. The PCC, for the first time ever, backpedalled, and claimed that since the issue was part of the ongoing GMC investigation it was postponig it’s judgement on the complaint until after those proceedings. However, the GMC was not investigating any allegations of faked or fixed data regarding Dr Wakefield’s landmark study. So why did the PCC lie? To wait for the forgone conclusion of the GMC so it would havea little more weight behind denying the truth of Dr Wakefield’s complaint? Only the PCC knows for sure.

    Second, the Japan study. One of the classic mistakes made by shills is to continue to quote this study in defense of vaccines.
    The Japanese did not merely stop MMR vaccinations, they replaced them with single valent vaccines. That the author would leave that little bit of information out speaks to his integrity and desire to get to the truth. As a side note, anything with Fombonne’s or Madsen’s name on it is not admissable as evidence vaccines are safe. If you want the details I can provide them, but this is not a very hospitable environment for the truth.

    What is the truth?
    We don’t yet know what causes autism. The correlation with vaccines is obvious, through the timiing of autism’s diagnosable symptoms, through regression, through the increasing diagnosis of autism in conjunction with an increasing vaccine load… these are all indications, not proof, of an association that needs further investigation.

    The only ethical way to approach this is to create a toxin-free vaccine schedule and conduct a large long term study (5 years should suffice) comparing the progress of kids with and without vaccine toxins. Among the removable toxins are adjuvants and preservatives. These 2 substances are there to increase profit margins by; reducing expensive antigen or shipping large quantities of vaccine instead of profit robbing single doses (which do not require preservative). Other substances are non-self endotoxin and DNA fragments, expecially since adjuvants will intensify/prolong infant immune reaction to these toxins. Finally, no multi-valent injections. Only single valent doses with a medically determined safe time interval between them.

    What we should all be after is the truth, the original poster in this blog is not interested in the truth and you should all be taking him to task for it.

  48. Steven Novellaon 03 Feb 2010 at 7:32 pm

    michael – are you accusing me of being a shill and lying? You spread anti-vax propaganda and conspiracy theories, and then accuse us of not respecting the truth – rich.

    There have been multiple studies showing no correlation between MMR and autism, or vaccines and autism. The evidence is fairly solid – and there is no evidence for a correlation. (follow the link I provided)

    The timing of vaccines and autism diagnosis is a coincidence only – and not a big one as vaccines are spread out throughout childhood, and so are likely to coincide with any childhood illness.

    Plus, as we investigate autism further we are finding that the onset is BEFORE the vaccine schedule. There are subtle signs reliably detected even in infancy.

    The significance of the Japan study is for the MMR. That is how it is cited. In fact – Wakefield himself was advocating replacing the MMR with single valent vaccines (for which he had patents pending).

    Your recommendations are without scientific backing.

  49. ChrisHon 03 Feb 2010 at 11:37 pm

    Michael, have you asked yourself why no one has been able to replicate Wakefield’s study? Mady Hornig tried, and even used the same lab (after it cleaned up its procedures to avoid contamination) but did not get the same results. Why is it that he continued to use results that he was told were false positives (Dr. Chadwick testimony in the Cedillo Autism Omnibus federal court case)?

    Also, before you conduct large expensive tests on vaccines, you must first show they are causing problems. So far the many many studies in several countries show no connection. And going on your plan of only single valent vaccines would leave many children vulnerable (please read the excerpt of Ben Goldacre’s book I posted above). Multivalent vaccines include DTaP, influenza, polio, rotavirus, meningococcal, and pneumococcal. Do you realize how many additional needle jabs you are asking for?

    Michael:

    The Japanese did not merely stop MMR vaccinations, they replaced them with single valent vaccines.

    How is that working for them? From Progress Toward Measles Elimination — Japan, 1999–2008:

    . However, during 2007–2008, Japan experienced a large measles outbreak, which resulted in exportation of measles cases from Japan into countries where measles elimination had been achieved. ….. Measles continues to be endemic in Japan, with most cases occurring in children before school entry, except for 2007 and 2008, when a shift to an older age group was observed.

    Michael continued:

    We don’t yet know what causes autism. The correlation with vaccines is obvious, through the timiing of autism’s diagnosable symptoms, through regression, through the increasing diagnosis of autism in conjunction with an increasing vaccine load… these are all indications, not proof, of an association that needs further investigation.

    And it has been studied, using large populations in several countries. There really is no reason to spend more money on researching the ephemeral connection to vaccines, especially the MMR vaccine. Which has been used in the USA since 1971.

    There are some indications of genetic connections, and perhaps some exposures in utero of something (rubella is already known to cause autism!). Some papers of interest:

    Trends Genet. 2009 Dec;25(12):536-44. Epub 2009 Nov 10.
    Copy-number variants in neurodevelopmental disorders: promises and challenges.
    Merikangas AK, Corvin AP, Gallagher L.

    Expert Rev Mol Diagn. 2009 Nov;9(8):795-803.
    Autism genetics: emerging data from genome-wide copy-number and single nucleotide polymorphism scans.
    Weiss LA.

    Lancet. 2009 Nov 7;374(9701):1627-38. Epub 2009 Oct 12.
    Autism.
    Levy SE, Mandell DS, Schultz RT….

    Autism spectrum disorders are characterised by severe deficits in socialisation, communication, and repetitive or unusual behaviours. Increases over time in the frequency of these disorders (to present rates of about 60 cases per 10,000 children) might be attributable to factors such as new administrative classifications, policy and practice changes, and increased awareness. Surveillance and screening strategies for early identification could enable early treatment and improved outcomes. Autism spectrum disorders are highly genetic and multifactorial, with many risk factors acting together. Genes that affect synaptic maturation are implicated, resulting in neurobiological theories focusing on connectivity and neural effects of gene expression.

Trackback URI | Comments RSS

Leave a Reply

You must be logged in to post a comment.