The MMR vaccine: why it’s sensible to worry about the way it has been regulated.

02/21/2017 09:53 am ET

Jerome Burne and Sally Beck

I have a confession. I am one of those people who has been radicalised by a preacher of hate; someone in the same league as the cleric with a hook Abu Hamza. At least that is how the Times described those who attended the first UK screening of the documentary Vaxxed (about the dangers of the MMR vaccine) last week.

A large proportion of those present were parents who either believed that a vaccine had damaged a child of theirs or were agonising over whether to vaccinate or not. The preacher of hate was of course Andrew Wakefield, a doctor, who proposed a link between the vaccine and autism via the guts nearly 20 years ago. Since then Wakefield has had his license to practise withdrawn and the link declared disproved; raising the issue of safety has become a sure way to invite abuse as a believer in pseudoscience.

Top medical journal The BMJ took a different view of being critical about vaccines 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 demonise them. While evidence matters, so too do the legitimate concerns of patients.’

Demonising 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 groups 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 publicly 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 18-years 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. (Please italicise)

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 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 at:

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.

Thompson’s data is not the only unresolved issue. Another of the sources of evidence, relied on by the mainstream to deny a vaccine/autism link, is a set of studies done in Denmark by Dr Poul Thorsen working closely with the CDC. One of these looked at the suggested link between autism and the adjuvant Thimerosal (mercury) in vaccines (not used in MMR). His study found mercury not guilty because when its use was phased out across Denmark, autism rates actually went up.

However, documents reportedly leaked from CDC, showed that the data had been heavily manipulated and that the study had originally found that the autism rate decreased. To complicate matters further Thorsen has subsequently been accused of fraud, using CDC funds, intended to pay for trials, for his personal use, including buying a home in Atlanta.

Thompson made his whistle-blowing documents available in 2014 and by the end of 2016 he no longer seemed to be a lone voice. According to a report in the Huffington Post, he has been joined by a group of a dozen senior scientists at CDC who have lodged an ‘ethics complaint that the agency is being influenced by corporate and political interests in ways that short-change taxpayers.’

The group, anonymous for fear of retribution, which calls itself SPIDER (Scientists Preserving Integrity Diligence and Ethics in Research) has made public a letter it sent to the CDC Chief of Staff. They claim, like Thompson, that studies done by the agency are being doctored to produce favourable results.

For instance, there was a co-ordinated effort to misrepresent the findings of a project to cut the risk of heart disease in women to make it look as if more women were involved than was the case. The results of an internal review into this were suppressed.

The letter also claims that at the same time senior figures at the CDC were actively helping an industry whose products have been linked to heart disease. It says that there are ‘troubling’ links between Coca Cola and two top CDC officials. One of them, who directed the agency’s Division for Heart Disease and Stroke Prevention, was advising the company on how best to influence world health authorities on sugar and beverage policy. ‘This is an industry,’ says SPIDER, ‘which is linked to about 180,000 deaths a year world-wide.’

This of course is not directly relevant to the MMR/autism debate but it does show the way the agency and the industry have the kind of connections which are not reassuring if you want to be confident that the claims the regulator is making are unbiased and accurate.

What’s more, there is clearly a revolving door between CDC and the drug companies. Dr Julie Gerberding, was director of CDC between 2002 (when Thompson was doctoring the MMR studies to show there was no link between autism and the vaccine), and 2009 when she left to join Merck – manufacturers of the MMR vaccine - to become president of the company’s vaccine division.

Another example of this murky relationship can be seen in a long running court case alleging that Merck generated unreliable evidence about the effectiveness of the mumps component of the MMR vaccine.

Last week a USA district court judge gave permission for two whistle-blowers, Merck scientists who had worked on MMR, to go forward with a fraud claim against Merck on the grounds that the company had been testing MMR’s effectiveness against mumps in a way that ensured it showed up as more effective than it really was.

Again, this is not directly related to MMR and autism but it is another example of why scepticism about the reliability of drug company pronouncements is wise and why there is an urgent need for a serious investigation.

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.