A canna’ change the laws of physics

Scotty, The Naked Time, stardate 1704.3, Episode 7

Ignorant refusal

Posted by apgaylard on February 8, 2009

bigstockphoto_balance_32866491Jeni Barnett‘s recent deplorable on-air foray into the topic of vaccination and MMR has got me thinking about one of the most fundamental concepts in medical ethics: informed consent.

Back in 2005 Edzard Ernst discussed this in the context of the use of so-called complementary and alternative medicine (CAM). 

“The principle of informed consent means that patients need full information about a treatment before receiving it [...] Informed consent, however, is more than just agreement, it’s also about information. According to the Department of Health, the data that healthcare professionals need to provide includes “information about the benefits and risks of the proposed treatment and alternative treatments”. [emphasis mine]

Informed consent means having full information, which includes the benefits and risks of the proposed treatment; or any viable alternative.

Without full information any consent is mis-informed; the ethics of the transaction between the patient and practitioner have been compromised. 

However, what about when a patient decides to withhold their consent; shouldn’t this decision be equally fully informed?  I would contend that allowing a refusal to be made in ignorance of the facts is unethical.

Anti-MMR and anti-vaccine campaigners often talk about the importance of an individual’s undoubted right to decide when airing their views.  And Barnett is no exception, at one point she apparantly said,

“you’ve always got to hear two sides, you’ve got to make an informed decision”.

The problem with this is that truly informed decision making is not about giving a hearing to “two sides”; it is about being in possession of the full facts.  A patient needs, “information about the benefits and risks of the proposed treatment”.  A patient does not need mis-information.  It is possible that one side requires little or no consideration at all: it may be entirely spurious.

One of the problems with Barnett and her ilk is that they don’t actually support the public getting access to the information they really need.  Instead, they promote their litany of myths and misconceptions: Wakefield “wasn’t really allowed to have his say”; MMR isn’t useful because it isn’t perfect; MMR is linked to autism; Measles isn’t a serious health problem.  Anyone who disagrees with them is likely to be accused of being in the pocket of the pharmaceutical industry.

In the guise of providing people with information to help them reach a balanced decision, anti-vaccine campaigners often provide un-evidenced assertions; rely on debunked work and baseless conspiracy theories (as seen in Barnett’s reported comment, “there are all sorts of other figures that have been withheld from us, and I don’t know what they are because they’ve been withheld!” Classic). 

More than that, they studiously ignore good quality evidence which contradicts their beliefs.

They are actually advocates of ignorant refusal.  They end up supporting the right to choose only in the presence of ignorance: their public pronouncements promote continued ignorance.

So, what does the balance of evidence really say about the safety of MMR?

immunize.org provide a very helpful summary of the evidence.  It lists, “25 studies that refute a connection between MMR vaccine and the development of autism” which are balanced against, “3 studies that suggested a connection between MMR vaccine and the development of autism”.

One of the three worrying studies is, of course, Andrew Wakefield’s infamous 1998 Lancet paper.  As the summary notes, “In 2004, The Lancet published a retraction submitted by 10 of the 13 original authors. The authors stated that there was no connection between the MMR vaccine and the bowel disease/autism syndrome.”

Another is a study by Wakefield and co-workers published in 1993.  Other researchers have not been able to replicate his work – a clear indication of lack of reliability.

The final of this triumvirate is a study by Uhlmann et al. (2002), which was recently comprehensively debunked by Bustin (2008 ).  He concluded,

“This exhaustive analysis of the experimental RT-qPCR data generated by the Unigenetics laboratory [the lab used for the work reported in Uhlmann et al.] demonstrates persistent and widespread contamination with F-gene DNA. As a result there is no credible evidence for the presence of either MV genomic RNA or mRNA in the GI tracts (or blood samples) of any patient investigated by this laboratory. Consequently, this finding excludes any link between MV and, by extension, the MMR vaccine and autism. [empasis mine]

Yes, all Uhlmann et al. found were contaminants from their own laboratory.

So, when it comes down to it the score is, by this count, 25-0 in favour of the safety of MMR.  Just to drive the point home I would like to quote from Paul Offit’s excellent “Autism’s False Prophets”,

The science is largely complete.  Ten epidemiological studies have shown MMR vaccine doesn’t cause autism; six have shown thimerosal doesn’t cause autism; three have shown thimerosal doesn’t cause subtle neurological problems; a growing body of evidence now points to the genes that are linked to autism; and despite the removal of thimerosal from vaccines in 2001, the number of children with autism continues to rise.”

[Offit PA, 2008, Autism's False Prophets. Columbia University Press, p.247]

 On page 256 he makes a selection of eighteen “Studies exonerating MMR”.  Here are the references, with links to the on-line content where available. 

So what is the real balance of risks against benefit for the MMR vaccine?  The medinfo website carries the following useful information.

Complications

Risk after natural disease Risk after first dose of MMR
Fits (convulsions) 1 in 200 1 in 1,000
Meningitis / encephalitis 1 in 200 to 1 in 5,000 1 in 1,000,000
Conditions affecting the clotting of the blood 1 in 3,000 1 in 24,000
Severe allergic response (anaphylaxis)  - 1 in 100,000
Deaths 1 in 8000 to 1 in 10000 (depends on age)

0

It would appear that the natural diseases are around five times more likely to lead to fits; at least 200 times more likely to cause Meningitis or encephalitis; eight times more likely to cause abnormalities in the clotting of blood.  Finally there is no evidence to suggest that MMR causes death, whilst the rate for the natural disease is between one in eight and ten thousandOther sources quote death rates in the range of between 1 in 2,500 to 1 in 5,000 (depending on age). Neither is there any reason to suppose that MMR causes autism.

On the negative side, the vaccine can cause anaphylaxis in around one in a hundred thousand cases.

If people were fully informed about the risks and benefits of MMR, not just for their own children but other members of society, then their consent to vaccination would have real meaning .

Equally important: refusal would not be in ignorance of the real risks involved.

I am not so naïve as to think that everyone would chose to have their child vaccinated with MMR (note: a very few children cannot have MMR for medical reasons).  Neither am I arguing for the removal of informed consent or for the use of compulsion. 

What I would hope is that limiting the scope for ignorant refusal may see vaccination rates recover to a level where the damage caused by serious childhood illnesses is minimized.  After all, before the MMR scare, measles was under control in the UK.

Unwittingly Barnett provides an accurate commentary as to why measles infections are running at alarming levels in the UK,

“… if you scare-monger, people don’t know how to make clear decisions about some things”.

Quite; unfortunately it’s Barnett and people with similar attitudes who continue to “scare-monger” with the connivance of the media and some medical ‘professionals’ who ought to know better.

Acknowledgements

The Jeni Barnett quotes are taken from the transcripts generously provided on the following blogs:

  1. Science Punk
  2. The Lay Scientist
  3. Podblack Cat
  4. Sceptics’ Book
  5. Quackometer
  6. HolfordWatch

jdc325’s Weblog also has a useful summary of recent MMR related news.

Finally, please note that this site does not provide medical guidance.  If you need that go to a real doctor.  The UK’s NHS provides excellent advice on MMR in particular and vaccination in general.

Edits

8th February 2009. UK NHS death rate data included in text, along with reference to http://www.immunisation.nhs.uk/ . Thanks to jdc of jdc325’s Weblog for the reference.

[BPSDB]

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12 Responses to “Ignorant refusal”

  1. [...] Change the Laws of Physics has an outstanding discussion of the notion of informed consent: Ignorant refusal. Gaylard identifies one of the cruxes of Jeni Barnett’s misguided defence when she repeated [...]

  2. [...] Change the Laws of Physics has an outstanding discussion of the notion of informed consent: Ignorant refusal. Gaylard identifies one of the cruxes of Jeni Barnett’s misguided defence when she repeated [...]

  3. dvnutrix said

    Excellent work.

    Breaking news: Brian Deer discusses Andrew Wakefield in the Sunday Times and there are claims that

    THE doctor who sparked the scare over the safety of the MMR vaccine for children changed and misreported results in his research, creating the appearance of a possible link with autism, a Sunday Times investigation has found.
    Confidential medical documents and interviews with witnesses have established that Andrew Wakefield manipulated patients’ data, which triggered fears that the MMR triple vaccine to protect against measles, mumps and rubella was linked to the condition.

    All of which adds to your fine discussion of what was known and when. It undermines the notion that there was a strong case to answer based on Wakefield’s research.

  4. mythusmage said

    I wouldn’t call such people misinformed, but ill-informed. In some cases mal-informed, in so far as the informer was driven to provide false information to prove his point.

  5. apgaylard said

    dvnutrix: Thanks for the comment. It seems with Wakefield – if Deer is right (again) – that the more scrutiny his work gets the less it seems like a researcher making an honest mistake.

    mythusmage: Thanks for a nice lesson in fine distinctions. Your suggestions are certainly better, but I dont think that, “To [be] provide[d] with incorrect information” is too far off the mark.

  6. [...] Apgaylard har mer, blant annet en påminnelse om forskningen som er gjort på forholdet MMR-autisme i mellomtiden. Publisert av Asbjørn Dyrendal Anti-vaksinasjon, Juks og bedrag, Media [...]

  7. [...] about the safety of MMR, AP Gaylard has usefully produced a table of what Dr Paul Offit styles as “Studies exonerating MMR”, drawn from Offit’s book, Autism’s False Prophets (Gaylard has thoughtfully provided [...]

  8. [...] Change the Laws of Physics has an outstanding discussion of the notion of informed consent: Ignorant refusal. Gaylard identifies one of the cruxes of Jeni Barnett’s misguided defence when she repeated [...]

  9. pv said

    Bravo. Succinctly and to the point.

  10. warumich said

    Interesting post, thanks. Informed consent can actually be quite a tricky area in medical ethics for other reasons as well; there are very good reasons to doubt whether informed consent is an even an appropriate concept for public health issues like vaccination programs, where one person’s decision effects other people’s health.

    You may be interested in this article: (O’Neill: “Some Limitations of informed consent”, J Med Ethics 2003;29:4-7,)
    http://jme.bmj.com/cgi/content/full/29/1/4

    and specifically this quote:

    “A second limitation of informed consent procedures in medicine is that they are useless for selecting public health policies. Public policies, including public health policies, have to be uniform for populations. We cannot adjust water purity levels or food safety requirements to individual choice, or seek informed consent for health and safety legislation or quarantine restrictions.

    Vaccination polices are an interesting and possibly hybrid case: in so far as we think of them as a matter of public health policy they cannot be based on individual choice, or on informed consent. In the United Kingdom, however, we have treated vaccination only partly as a public health matter. We allow parents to refuse to have their children vaccinated without medical reason. Some have done so at little or no cost or risk to their children by sheltering behind protection provided by others’ vaccinated children. The proportion of children vaccinated with measles, mumps, and rubella (MMR) has fallen, and free riders now face a problem. They still do not want to expose their children to the risk of measles, but can no longer do so by refusing vaccination. Their current ambition—well stoked by parts of the media—is to use an alternative vaccine which they claim (evidence is not provided) would be safer for their children, but which will not provide the same level of protection for the population—including for infants below the age of vaccination. Public health policies can be undermined if their implementation depends on individual informed consent.”

  11. apgaylard said

    warumich: Thank you for the reference; it raises some valid concerns. As you noted, my post does take the current UK regulatory framework as read.

    However, I do think that the issue of MMR and public health in the UK is currently more a matter of ignorant (or perhaps better put as ill-informed or mal-informed)refusal than a problem with the concept of informed consent per se. Without Wakefield, his acolytes and a scare-mongering media it’s likely that measles, for instance, would have continued to be well-controlled.

    I do take the point that this would still leave some sheltering behind the protection affored by others without good reason – and putting more vulnerable people at risk – an ethically dubious position at best.

    My preference would be to see a conserted effort made to properly inform the public before compulsion is discussed. Perhaps strengthening the regulatory framework for the media might help.

    pv: Thanks; concision is not my strong suit; though I do try (sometimes).

  12. [...] and natural practitioners really informed? Blogger AP Gaylard wrote an interesting post titled “ignorant refusal” that is well worth reading – it covers informed consent and the need for full information, [...]

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