MMR and autism fruad: 25 years on

[Sheilbh]

Grim anniversary.

I remember watching a show about Wakefield - I think before covid. It was pretty dispiriting that he was on tours speaking to anti-vax/anti-pharma groups in the US, France, Poland etc after he'd been drummed out of the profession in the UK where his fall was covered in quite a loot of detail. Feels like one of the first international grifters causing huge damage to people's lives

(It is also why I'm always a bit at the Lancet given that the editor who published the first piece and stood by it for 12 years is still editing the Lancet and still popping up to regale us with his views):

25 years after the MMR vaccine autism fraud, we're still dealing with the consequences
AnalysisThe MMR scare was based on a fraudulent study. What have we learned since it was published?

Investigative journalist Brian Deer, right, confronts Andrew Wakefield, centre, author of the infamous MMR-autism study, in 2010 (Photo: Shaun Curry/AFP)
author avatar image
By Stuart Ritchie
Science Writer
February 28, 2023 9:30 am(Updated 2:01 pm)

We've reached a very ignominious anniversary. Today, the infamous study that claimed to link the MMR vaccine to autism, published in the prestigious medical journal The Lancet in 1998, is exactly twenty-five years old.

The study, led by the British doctor Andrew Wakefield, was a report of twelve children aged 3-10 years who'd shown regressions in their social and language skills – characteristics of autism. Eight of them had apparently displayed these symptoms just after being given the MMR – the vaccine against Measles, Mumps, and Rubella. The children also had a variety of gut-related complaints. Wakefield's theory was that there was a new condition, called "autistic enterocolitis": the MMR vaccine caused intestinal disturbances that were toxic to the developing brain.

But the study was fraudulent. An investigation by the journalist Brian Deer showed that Wakefield had misstated the medical history of several of the children, who had begun to show symptoms before their MMR vaccine, or a long time afterwards ("no case was free of misreporting or alteration," stated Deer). Not only that, but Wakefield had subjected the children to invasive medical procedures for no good reason, and had a serious conflict of interest since he was being paid by lawyers preparing a case against the vaccine-makers.

In between the publication of the study and its eventual demise – it was only retracted from the scientific literature in 2010 – enormous damage was done to the public's trust in vaccination. The Wakefield affair stands as one of the worst and most damaging incidents of scientific fraud in recent history, as well as a harsh indictment of our scientific, medical, and media establishments.

After twenty-five years, what have we learned?

The Wakefield fraud

It's not true to say that Wakefield's study was the start of worries about vaccines, or even the start of worries about vaccines and autism. Anti-vaxxers have been around for as long as vaccination itself, and concerns about a preservative used in vaccines, the mercury-containing thimerosal, had been buzzing around all through the 1990s.

But the 1998 study – accompanied by a febrile press conference at the Royal Free Hospital a few days prior to publication – kicked off a media storm. Reports of side-effects, a useful indicator of how much public concern there is about a vaccine, began pouring in. MMR rates in the UK collapsed immediately after the study was published, to nearly as low as 80 per cent – a far cry from the 95 per cent required for "herd immunity", where vaccination rates are high enough that even those who don't or can't take the vaccine are still protected.

Years later, we saw the inevitable measles outbreaks – thankfully these have resulted in only a few deaths in the UK, but other countries haven't been so lucky (and even outside of deaths, measles can have severe complications, including causing deafness and intellectual disability). 2019 also saw an unusually-high level of mumps infections, often in students and other young adults – potentially because they were the right age to have skipped the MMR during the scare.

And for what? Was there anything behind the fears? Is there actually any evidence – beyond Wakefield's fraudulent study – that the MMR vaccine causes autism?

The MMR vaccine and autism

The computer programmer Alberto Brandolini came up with "Brandolini's Law": The amount of energy needed to refute nonsense [he used a harsher term] is an order of magnitude bigger than that needed to produce it. It's very easy to make people panic on the basis of false information; it's much harder to calm that panic with sober, high-quality research.

There was never any good evidence for Wakefield's MMR-autism link. But now, a quarter-century later, we can be as certain as we are about any medical question that there's no relation. When the panic first hit, researchers began running a variety of different kinds of study to check the link between symptoms of autism and the vaccine. A Danish study in 2002 looked at vaccinated and unvaccinated children, testing whether autism rates were higher in either group. They were just about the same. A 2004 study from the UK looked at things the other way around: they took children with and without autism, and checked whether one group were more likely to have been vaccinated with MMR. Again, there were no differences to speak of.

Perhaps you might think it's something to do with predisposition. Perhaps it's not that giving the MMR vaccine to anyone will cause autism, but that it might for those with a higher familial risk. Not so: a study in 2015 compared children who had older siblings with and without autism – the MMR wasn't linked to autism in either group. And an even larger 2019 study, including more than 650,000 children in total, confirmed this result.

What about Wakefield's suggested link between autism and disorders of the bowel? For this one, there is actually some evidence: autistic people are more likely (according to a 2021 review of eight studies) to have inflammatory bowel disease, ulcerative colitis, and Crohn's disease. But there are two important things to bear in mind: first, this is just a correlation and we don't know why the bowel disorders would be linked to autism; and second, given all the evidence we saw above, it's vanishingly unlikely that it has anything to do with the MMR vaccine.

Lessons learned?

There's some good news. MMR rates have ticked up back to a high level in the UK – evidence consistent with the public being reassured by the resounding proof of no links between the vaccine and developmental disorders. And Wakefield himself, unlike many scientific frauds, has been punished: he was struck off by the General Medical Council in 2010, meaning he can no longer practice medicine in the UK (Wakefield himself still stands by his research).

He's still around, of course: during the Covid-19 pandemic, he continued his anti-vaccine stance by falsely arguing on social media that the vaccines change the DNA of those who take them. But he's had his day: he's been eclipsed by a range of new anti-vax figures.

One of the object lessons of the Wakefield affair was that that even well-spoken, well-credentialed experts writing in authoritative, peer-reviewed scientific journals can lie. Just because something's published in The Lancet doesn't make it true – or even worth discussing. And although many mainstream media sources have learned to be more careful with claims relating to vaccines, the "alternative" media is a different story. Popular podcasters and YouTubers, often with millions of listeners and subscribers, were taken in throughout the pandemic by a series of shysters and fabulists – modern Wakefields – who spread demonstrably untrue claims about the dangers of vaccines to their massive audiences.

The Lancet, too, has been stung again and again by scientific fraud, multiple times since Wakefield. During Covid-19 pandemic, the journal had to retract a Harvard study after two weeks after the authors admitted they could "no longer vouch for the veracity of the primary data". Two weeks is a lot shorter than the twelve long years it took for Wakefield's paper to be retracted, which represents progress. But the fact that the paper was published in the first place (another by the same authors appeared, and then was also retracted, from the prestigious New England Journal of Medicine) speaks to serious, still-remaining failings in our scientific peer-review system.

Vaccines are different

The great tragedy of vaccination – one of the greatest ever inventions in the history of medicine – is that there's something about it that always inspires fear in some subset of the population. Maybe it's the invasive nature of the needle; maybe it's the fact the vaccine contains some part of the disease it's aiming to prevent; maybe it's the fact we have to decide whether or not to give the shot to our young and vulnerable children.

Whatever it is, something makes vaccination particularly susceptible to overblown fears. The number one lesson from the saga of Andrew Wakefield's fraudulent study is that the idea of vaccination is such a tinderbox that even the smallest spark – a study with a sample size of twelve, with barely any details and the most tenuous of theories to link the jab to autism – and create a huge blaze of false and dangerous claims.

But it can only do so if it's given oxygen to burn. The Lancet, the Royal Free Hospital, and innumerable journalists made huge errors in giving Wakefield the publicity he craved.

History repeats itself. Post-Covid, anti-vaccine movement is experiencing something of a resurgence, with wildly misleading claims about the mRNA vaccines, often based on highly questionable studies, being repeated in the media and by politicians and celebrities. Upsettingly, there's some evidence that the general atmosphere of vaccine fears that arose during the pandemic has produced more worries about MMR specifically. The twenty-fifth anniversary of one of the worst scientific frauds of the modern era gives us an opportunity to reflect on where things went wrong – and try not to make the same mistakes again.

[The Brain]

Which persons did the peer-review? Hard to say exactly why the reviewers accepted it (assuming they in fact did accept it and The Lancet didn't play dirty) without that information. I haven't read the article itself, but my impression is that it contains weak parts that shouldn't have passed muster. Of course, peer-review doesn't generally catch fraud.

Peer-review is great and all, but it doesn't review the article for truth. If you're a scientific journal you can't JUST do peer-review, you also have to do normal review to detect fraud. Peer-reviews don't check if you have actually done what you claim to have done, or that the results are what you claim they are. The article can look completely fine, and seem like good science, but if you don't check the actual facts presented then you just have some guy's word for it.

[The Minsky Moment]

It will be interesting to see what kills more people in the 21st century: wars or anti-vaxxers.  Right now the latter have been building up a powerful lead, despite Putin's best efforts to keep up.

[mongers]

It will be interesting to see what kills more people in the 21st century: wars or anti-vaxxers.  Right now the latter have been building up a powerful lead, despite Putin's best efforts to keep up.

 

But what if Putin uses biological weapons against Ukraine/The West, what will that do you you're metric? 

[Josquius]

I thought his conflict of interest was that he was pushing a standalone vaccine for one of the three? Or am I thinking of a different guy?

[crazy canuck]

I thought his conflict of interest was that he was pushing a standalone vaccine for one of the three? Or am I thinking of a different guy?

This is the guy who fabricated data in his studies to claim vaccinations are not safe.  That study got a lot of publicity and is a root cause for the anti-vaccine/hesitancy movements we have today.

It's now a case study in how badly things can go off the rails in public health related fields.

[Valmy]

I thought his conflict of interest was that he was pushing a standalone vaccine for one of the three? Or am I thinking of a different guy?

This is the guy who fabricated data in his studies to claim vaccinations are not safe.  That study got a lot of publicity and is a root cause for the anti-vaccine/hesitancy movements we have today.

It's now a case study in how badly things can go off the rails in public health related fields.

He didn't even do that. He just claimed that some parents said that their kids started being autistic after getting the vaccine. No follow up in the study, just a random unsubstantiated statement.

But facts play little role in politics. You just need an emotionally resonant enough narrative for people to believe it.

[Sheilbh]

He didn't even do that. He just claimed that some parents said that their kids started being autistic after getting the vaccine. No follow up in the study, just a random unsubstantiated statement.

But facts play little role in politics. You just need an emotionally resonant enough narrative for people to believe it.

But it was published in a leading medical journal who refused to retract it for 12 years.

[crazy canuck]

I thought his conflict of interest was that he was pushing a standalone vaccine for one of the three? Or am I thinking of a different guy?

This is the guy who fabricated data in his studies to claim vaccinations are not safe.  That study got a lot of publicity and is a root cause for the anti-vaccine/hesitancy movements we have today.

It's now a case study in how badly things can go off the rails in public health related fields.

He didn't even do that. He just claimed that some parents said that their kids started being autistic after getting the vaccine. No follow up in the study, just a random unsubstantiated statement.

But facts play little role in politics. You just need an emotionally resonant enough narrative for people to believe it.

I am not sure where you got your information. He published an academic article in a journal with falsified data.

[Valmy]

I thought his conflict of interest was that he was pushing a standalone vaccine for one of the three? Or am I thinking of a different guy?

This is the guy who fabricated data in his studies to claim vaccinations are not safe.  That study got a lot of publicity and is a root cause for the anti-vaccine/hesitancy movements we have today.

It's now a case study in how badly things can go off the rails in public health related fields.

He didn't even do that. He just claimed that some parents said that their kids started being autistic after getting the vaccine. No follow up in the study, just a random unsubstantiated statement.

But facts play little role in politics. You just need an emotionally resonant enough narrative for people to believe it.

I am not sure where you got your information. He published an academic article in a journal with falsified data.

I read what I thought, and was told, was the article in question, it wasn't even about autism. It was just an aside he said and there was no data attached referring to that specific issue.

But maybe I read the wrong article.

[Sheilbh]

This was the paper?
https://briandeer.com/mmr/lancet-paper.htm

As I say it took them 12 years to retract (including the "interpretation" section).

It was definitely more than just parents hearsay in his study - one of the reasons he was disbarred by the GMC was around the testing of those kids:

Andrew Wakefield found 'irresponsible' by GMC over MMR vaccine scare
Doctor's research triggered a furore and was direct cause of slump in take-up of MMR, which has led to outbreaks of measles in some parts of the country
Sarah Boseley, health editor
Thu 28 Jan 2010 20.34 GMT

Andrew Wakefield, the doctor who claimed to have discovered a link between measles virus, bowel diseases and autism and thereby sparked widespread fear of the combined MMR jab, conducted unnecessary, invasive tests on children, the General Medical Council found today.

Branding him a dishonest, irresponsible doctor, the GMC disciplinary panel, which has sat and heard evidence for 148 days over two and a half years, finally found a long array of charges against him proven. But there were shouts of protest and dismay from the doctor's supporters.

Wakefield and two other doctors at the Royal Free hospital in London were brought before the GMC over the paper they published in February 1998 in the Lancet medical journal.

On the basis of case studies of just eight children, it suggested that measles virus might be linked to inflammatory bowel disease, which in turn might play a role in autistic spectrum disorder.

The paper conceded that the doctors had not found a definite link, but Wakefield, in a press conference, told the world he believed the measles, mumps and rubella vaccines in the MMR jab should not be given in one combined shot, but in single doses, preferably a year apart. It triggered a furore and was the direct cause of the major slump in take-up of MMR which has led to outbreaks of measles in some parts of the country.

The GMC found that Wakefield had flouted the rules in pursuit of his theory – and profit. At the centre of the case against him is the ethical conduct of the trial which resulted in the Lancet paper. The panel found he had subjected 11 children to invasive tests such as lumbar punctures and colonoscopies that they did not need, without ethical approval.

But investigations revealed more. In June 1997, before the paper was published, he filed a patent as one of the inventors of a vaccine for the elimination of measles virus and for the treatment of inflammatory bowel disease.

In February 1998, the same month as the Lancet paper, he applied for ethical permission to run a trial of a new potential measles vaccine and set up a company called Immunospecifics Biotechnologies Ltd which would produce and sell it. The father of one of the children he had seen with developmental problems and bowel disease would be the managing director. Wakefield tried out the new vaccine on the child, without mentioning it in the medical notes or telling the child's GP. He was also found to have unethically arranged for his son's friends to have blood samples taken from them during his birthday party – for which he paid them £5 each.

Wakefield hit on his theory after seeing children with bowel disease who also had developmental problems. The crucial third step in the hypothesis was the timing of the MMR vaccine: the first shot is given at around 18 months, which is also when autistic spectrum disorders start to be noticed.

In front of the GMC with him were two doctors who were at the time colleagues in the department of paediatric gastroenterology at the Royal Free, Prof John Walker-Smith and Dr (now Prof) Simon Murch. The GMC decided they shared responsibility for the ethical conduct of the trial, although neither one was said to have acted dishonestly.

The trial that Wakefield proposed troubled the ethics committee of the Royal Free. It is a fundamental principle in paediatrics that no child should be subjected to more than a blood test unless it is necessary for their treatment. But Wakefield proposed a barrage of invasive procedures. Dr Evan Harris, the Liberal Democrat spokesman who complained to the GMC, believes the committee should have sought advice from an independent paediatrician. Instead, it asked a gastroenterologist colleague of Wakefield.

The committee gave its conditional approval. The GMC panel decided that those conditions had been flouted – and that the trial had been unethical.

The GMC looked into the cases of eleven children who were entered into the trial. Many rules had been broken. Wakefield's contract was for "experimental gastroenterology" and he was not allowed to treat children, but he ordered tests and procedures that were not necessary for their health. In the interests of proving Wakefield's theory, children were given lumbar punctures in the spine, colonoscopies and barium meals – all significant procedures. Children were enrolled who did not fit the strict criteria for entry to the trial and they had not come from a GP who was referring them because they needed treatment.

Wakefield, now based in the US, has also been found not to have been open with the Lancet. He did not tell them that £55,000 funding for the study came from the legal aid board. Wakefield was advising Richard Barr, a solicitor who wanted evidence to sue the vaccine manufacturers on behalf of the parents of children with autism. It was a clear conflict of interest and should have been declared.

All three doctors will now come back before the panel in April, where the GMC will decide if they are guilty of serious professional misconduct, which could end in one or more of them being stripped of their licence to practise medicine.

Harris said Wakefield's reputation and that of his campaign was "in tatters and it is sad that it has taken so long for this to be demonstrated.

"That the GMC has found Wakefield guilty of unapproved and unnecessary invasive tests, including spinal taps, on young children, is the most damning indictment possible. The findings of failure to declare financial interest are a secondary consideration."

Dr Shona Hilton, of the Medical Research Council, said the scare had a huge impact on parents, undermining their trust in MMR vaccination. "Thankfully confidence is returning and the uptake of MMR vaccine is increasing," she said. "We need to continue rebuilding trust with parents that MMR vaccination is safe and ensure that those parents caring for children with autism do not blame themselves."

Wakefield, who was not at the hearing but spoke outside the GMC offices minutes after the ruling, said he was "extremely disappointed" by the outcome. He said: "The allegations against me and against my colleagues are both unfounded and unjust ... and I invite anyone to examine the contents of these proceedings and come to their own conclusion."

He went on: "It remains for me to thank the parents whose commitment and loyalty has been extraordinary.

Thousands of people, mainly parents of autistic children, have continued to support Wakefield. Panel chairman Dr Surendra Kumar was heckled by parents as he delivered the verdicts in central London this afternoon. One woman shouted: "These doctors have not failed our children. You are outrageous."

[crazy canuck]

I thought his conflict of interest was that he was pushing a standalone vaccine for one of the three? Or am I thinking of a different guy?

This is the guy who fabricated data in his studies to claim vaccinations are not safe.  That study got a lot of publicity and is a root cause for the anti-vaccine/hesitancy movements we have today.

It's now a case study in how badly things can go off the rails in public health related fields.

He didn't even do that. He just claimed that some parents said that their kids started being autistic after getting the vaccine. No follow up in the study, just a random unsubstantiated statement.

But facts play little role in politics. You just need an emotionally resonant enough narrative for people to believe it.

I am not sure where you got your information. He published an academic article in a journal with falsified data.

I read what I thought, and was told, was the article in question, it wasn't even about autism. It was just an aside he said and there was no data attached referring to that specific issue.

But maybe I read the wrong article.

Whatever you read, it did not contain accurate information.  Which is ironic given the subject matter being discussed.   

[grumbler]

I've not seen anything that indicates that the first report (the one in Lancet) actually contained false data.  The report was erroneous because the subjects of the test that it was documenting were not selected properly, and because the conclusions went beyond the data.  There were ancillary aspects of the study that were also condemned, but the problem with the study itself seems to be not falsified data, but unscientific data collection and analysis.

Valmy is correct, IMO, and his accusers simply wrong.

[crazy canuck]

I've not seen anything that indicates that the first report (the one in Lancet) actually contained false data.  The report was erroneous because the subjects of the test that it was documenting were not selected properly, and because the conclusions went beyond the data.  There were ancillary aspects of the study that were also condemned, but the problem with the study itself seems to be not falsified data, but unscientific data collection and analysis.

Valmy is correct, IMO, and his accusers simply wrong.

The researchers, amongst their sins, preselected their test subjects in order to obtain the results which proved their hypothesis and then passed it off as being statistically significant findings when they knew that their data was entirely invalid.

That is a textbook case of fraudulent data collection, and is taught as such in research ethics courses throughout the world.

[grumbler]

I've not seen anything that indicates that the first report (the one in Lancet) actually contained false data.  The report was erroneous because the subjects of the test that it was documenting were not selected properly, and because the conclusions went beyond the data.  There were ancillary aspects of the study that were also condemned, but the problem with the study itself seems to be not falsified data, but unscientific data collection and analysis.

Valmy is correct, IMO, and his accusers simply wrong.

The researchers, amongst their sins, preselected their test subjects in order to obtain the results which proved their hypothesis and then passed it off as being statistically significant findings when they knew that their data was entirely invalid.

That is a textbook case of fraudulent data collection, and is taught as such in research ethics courses throughout the world.

Exactly.  Not falsified data, but rather data that did not demonstrate what they claimed it did (and what they said in the paper was nothing about autism).  Valmy was correct on this.