Saturday, February 5, 2011

Wakefield's own Words - Didn't have Informed Consent


Using Wakefield's own words, he doesn't qualify for the Wakefield loyalty oath.

Over 3000 names are 'signatories' to th Wakefield loyalty oath at  http://www.wesupportandywakefield.com It begins,
We declare that:
1. Dr. Wakefield is a man of honesty, integrity, courage, and proven commitment to children and the public health.


Wakefield's own evidence has him disagreeing.  Because his own words demonstrate that he didn't have what he recognized he needed to have blood taken from children at a birthday party: informed consent. That's ignoring the issue of proceeding without permission he would never have gotten.

Q You have already accepted – and I do not propose to rehearse it – the Panel will remember right at the beginning of your evidence you accepted that you were completely wrong in thinking that ethics committee approval was not required.
A That is correct. As I now know, it was required.
Day  67 page 17  
Source for this quote and others:  Transcripts retrieved electronically from a secure directory of  the GMC computer in Manchester, UK
That's an admission of error. But let us go farther.  The  previous Q and A is:

Q Did not that difficulty, which, as I say, appears to have been encountered by researchers other than yourself, indicate to you that there were ethical considerations about undertaking this procedure on normal children?
A Yes. The ethical considerations that I considered were clearly that there was full informed parental and child consent. As I have said, my understanding at that time was that ethics committees existed for the protection of NHS patients
In the real world, Wakefield knew that he needed advance ethic committee approval. He also knew that he would not get such approval.  Taking of blood from healthy children for research purposes is of zero benefit to the children. That makes is non-therapeutic research.  Getting ethics approval for taking blood from healthy children for non-therapeutic research  is extremely difficult if at all possible.


If we believe Wakefield (I did say pretend), then he needs, as he says " fully informed parental and child consent."   Pretending that a 4 year old can give fully informed consent to have blood taken at a birthday party (page18) there's not even a written record that the child's parent had consented.


Q The difficulty is, doctor, that you apparently think that a four year-old can give consent. Did you understand even the basis upon which children are consented for procedures and whether they have the capacity to consent or not?
A If it is explained in terms that are appropriate, yes.
Q Aged four?
A Yes.

And the consent wasn't given to Wakefield, but to his wife and could have been a long time before the party.

Q With regard to the other children, you have no idea at all whether they were consented properly, have you, because you were not there, as I understand it and you have no idea how their parents presented it to them?
A They were consented long in advance of the party by my wife, who knew them extremely well. Several of the parents were medical. The parent of one was a dentist. So they were in a sophisticated position to be able to make that judgment and explain it to their children. Based upon what I had told my wife and what I am absolutely certain she will have told them, then I have no doubt that the appropriate process of parental consent and child explanation and consent was obtained.
Q Doctor, you say it was done a long time in advance. How can you have been satisfied that these children were happy to do this, or, even if they were, that they were still happy when it came actually to having to stick their arms out and do it?
A Because it was entirely voluntary. They were very happy to do it. As I say, and as Professor Hull has alluded to, the children are altruistic and I think for that reason actually it was a very positive experience.

Wakefield is happy with informed consent of children and parents to draw blood for non-therapeutic use when there is no written record, he didn't obtain the consent and the consent was obtained long in advance.

For Andy Wakefield supporters  informed consent from 4 year olds, given to his wife, a long time in advance and without written record for research purposes is in keeping with the Wakefield loyalty oath.
We declare that:
1. Dr. Wakefield is a man of honesty, integrity, courage, and proven commitment to children and the public health.
Wakefield is a master with words, so it is nice to see him convict himself out of his own words.





1 comments:

  1. HI Sheldon, not sure if you are interested in the anti vax happenings from 'down under'. But in case you are, you might enjoy the work of one Meryl Dorey, and American woman living in New South Wales who runs a group (mis)called the Australian Vaccination Network. If you are on facebook you can see her work there, and the group formed to counter her, Stop The Australian Vaccination Network. The misleading medical misinformation she happily peddles will hopefully get her into legal hot water soon enough.

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