Vaccine safety – don’t shut down the debate

I am not an apologist for Andrew Wakefield, the doctor who proposed a link between the MMR vaccine and autism via the guts nearly 20 years ago. Since then Wakefield has had his licence to practice withdrawn and the link declared disproved.

But I do feel that we should not simply shut down the discussion about the safety of vaccines because of Wakefield’s ruined reputation. He came to the UK recently to show a film – Vaxxed – that claimed there were reasons to investigate the repeated assertion that scientific research had proved there was no link between vaccines and autism.

He has been extensively attacked in the media using quotes from the General Medical Council hearing which revoked his licence. But none of this coverage has addressed any of the new issues around vaccine safety that are now public knowledge in the States.

These are totally independent of Wakefield. The hostility towards him, however, means that parents who are naturally concerned about issues of vaccine safety can feel attacked and besieged if they even raise the issue, never mind actually turn up to see the film, Vaxxed.

The BMJ made the same point earlier in the month.

‘Many parents of children with developmental disorders who question the role of vaccines have been labelled as “anti-vaxxer”,’ wrote associate editor of journal Peter Doshi. ‘This is a form of attack that stigmatises people for merely asking an open question.

‘It is time to listen to patients’ concerns – seriously and respectfully – not demonize them. While evidence matters, so too do the legitimate concerns of patients.’

Demonizing those questioning the safety of the MMR not only creates a damaging gulf between doctors and patients but requires putting a very high level of trust in the ethical standards and truthfulness of both the pharmaceutical industry and its regulatory authorities. A degree of trust I for one am not inclined to grant them.

I have been writing about drugs – especially widely-used blockbusters – for over 20 years and the situation with the MMR vaccine is all too familiar. A best-selling drug is claimed by the company involved to be safe and effective; angry group of patients post details of damaging side effects on line; the company repeatedly denies any problems and points to large studies showing all is well; patients’ claims dismissed as anecdotes.

This is what happened with anti-depressant SSRIs and children; the reports were of suicide and addiction. In 2002 a Panorama programme revealed that not only were studies showing a raised risk of suicide being hidden but that the problems with withdrawal were widely recognised within the industry.

There have been many similar cases, such as one involving a stroke drug and another with an anti-inflammatory; large scale studies which ‘proved’ safety were subsequently shown to be highly misleading or fraudulent. There is a large literature on this which anyone rushing to the defence of vaccines by claiming trials have shown all is well should be aware of.

Dismissing researchers and others who raise concerns about drugs as believing in pseudoscience and risking patients’ lives is also familiar. Well-informed critics have consistently questioned the benefits and safety of statins; not least because the evidence said to support the drugs is hidden behind a wall of secrecy at an Oxford institute.

The country’s senior statin researcher has claimed publically that those challenging the benefit of these drugs  are not only as foolish as flat earthers but also directly responsible for the death of thousands who stop taking the drugs as a result of such unfounded claims.

The lesson from all this is the need for researchers with no links to the company involved to be able to see the raw data from trials and to take patients’ concerns seriously. Consequently Wakefield is no longer the main story here. He set a ball rolling over a decade ago which has been picked up by many others. Since then a number of new concerns about MMR have come to light and require proper independent attention.

One of these is the shocking claim at the heart of the Vaxxed documentary that the evidence relied on to declare the MMR vaccine unconnected with autism was obtained by extensive tampering with the results gathered in trials which originally showed the precisely the opposite.

The evidence was gathered and analysed in 2002 by the American Centre for Disease Control (CDC), the government body responsible for regulating the vaccine program. The documentary and other sources have now raised serious questions about bias in its findings and its close links with the industry it is supposed to oversee.

Vaxxed contains testimony from a senior CDC scientist turned whistle-blower – Dr William Thompson – who claims he was directly involved in the cover-up over research designed to disprove the autism link with MMR.

Thompson has now made public this claims that the initial results of this research showed that African American males who received the MMR were at significantly greater risk of developing autism. He and a few others were instructed to make this problems go away.

After the data had been worked on and the desired result obtained, says Thompson, he and the others had a meeting at which all the hard copy which documented the fraud was put in a large bin to be destroyed. Thompson, however, concerned he was doing something illegal, kept hard and digital copies of the documents.

The apparently doctored results were published in 2004 and have since been routinely used to deny any autism connection with the MMR vaccine.

Thompson has of course come in for sustained and aggressive attack on social media since then. An example can be seen  here. 

This very active pro-vaccine blog portrays Thompson as a lone figure who was only complaining because his personal pet result had been ignored. This was described as an ‘almost certainly spurious finding’. It was that in a sub-group of African American boys, vaccination was associated with an increase in autism.’ The blogger than asserted that the ‘increased risk was seen in no other subgroup and disappeared when proper correction for cofounders was made.’

So which account is true?  I’ve no idea and more importantly nor does any parent trying to decide what to do. The web is full of sites making claim and counter claim and without any sort of heavyweight investigation with the power to summon witnesses and documents and cross-question people under oath, parents are never going to know with any degree of certainty. What is clear is that the matter is very far from settled and there are good reasons to ask hard questions.

Other outstanding issues include:

• The most basic form of testing a drug – comparing those getting the drug with a placebo group who don’t –  has never been done on the MMR vaccine.
• There are no long term studies to investigate the effects of getting multiple vaccinations.
• One reason the original research suggesting a link between gut bacteria and the brain was dismissed was because at the time no such connection was thought possible. The microbiome is now known to be extensively connected with brain development, the immune system and inflammation.

Parents are quite rightly desperate to know the truth about the risk of vaccination, especially since the number recommended for children has increased so dramatically. The policy of asserting that all is well in the face of mounting evidence of issues that need addressing has not proved reassuring. They deserve better treatment especially since, if the critics worst fears are realised, the consequences will be catastrophic.