Friday, January 29, 2010

162/95 or 162-95 The Two Studies Defense of Dr. Wakefield is Nonsense

This blog entry is useful because it gathers together information on 162-95 in a neat package.  But it is wrong because 162-95, clinically indicated procedures and to some extent the discussion of 172-96 doesn't matter in determining what was and what was not medical research.
This blog entry is incorrect because it doesn't recognize that the only issue that counts in determining what was and was not medical research was the intent of the three doctors.   162-95 and the concept of 'clinically indicated' have nothing to do with the determination of what was and what was not research.

I got it wrong.  I'm certainly not the only one.
Abstract: Key to the defense of Wakefield, Walker-Smith and Murch was their nonsensical argument that any research component of their clinically indicated investigations had been approved under a different study, not 172-96. Specific details on this other study have been missing from the internet. Now you can read the application and the approval letter for 162/95. It is laughable.  It lets Professor Walker-Smith take two additional biopsies for research purposes during colonoscopies he performs. That's it.

The GMC specifically rejected this argument.

By sheldon101 January 29, 2009

The Panel has heard that ethical approval had been sought and granted for other trials and it has been specifically suggested that Project 172-96 was never undertaken and that in fact, the Lancet 12 children’s investigations were clinically indicated and the research parts of those clinically justified investigations were covered by Project 162-95. In the light of all the available evidence, the Panel rejected this proposition.

Compare two extra Biopsies to 172-96
As opposed to taking two additional biopsies during routine colonoscopies, here is the proposal submitted to the Ethics Committee in August 1996 for 172-96. and here is the proposed timetable.
Before 172-96 was approved
For most children used in The Lancet Study, this intensive regime, to use Walker-Smith's own words, the  protocol was carried out.

Perhaps out of embarrassment, specific details of 162-95 haven't been put on the internet. Thanks to a fanciful complaint to the GMC by Vaccines cause Autism groups against 5 doctors, including Dr. Michael Pegg, head of the ethics committee starting in 1996, we now have the details.

162-95 162/95  Vaccines Cause Autism Groups Complaint to The GMC

The following is all of the statements, testimony and exhibits in the complaint related to 162-95 or Dr. Pegg. Editorial comments on the meaning of the statements, testimony and exhibits has been removed.

-------------------- start exhibits, testimony and statements on 162-95 or Dr.Pegg--------------

Walker-Smith gets permission to take 2 additional biopsies for research purposes for colonoscopies he performs
On August 24, 1995, Professor Walker-Smith wrote to the Royal Free ethics committee: 

For some years at Barts during the course of colonoscopy in children we have had ethical permission to take two extra mucosal biopsies for research purposes. During colonoscopy children routinely have multiple biopsies taken for diagnostic purpose (4-6). The parents have signed a form as attached granting permission. These biopsies are used for a variety of research investigations such as cytokine production where on occasion information of direct and immediate importance to the child’s illness has been obtained as well as of research importance. 

I would be very grateful if you would grant permission for this to continue after our move to the Royal Free. 

Pegg Tr. 8-54E; Ex. 37

The September 5, 1995 response from the Secretary of the Ethics committee was: 

Re The taking of two extra mucosal biopsies for research purposes during the course of colonoscopy in children. I am pleased to be able to inform you that your recent submission to the Ethical Practices Sub-Committee has now received approval by Chairman’s Action.

This approval will be formally documented at the next meeting of the full committee and meanwhile you are free to carry out the above procedure at the Royal Free. 

Please note the code number 162-95 that the submission has been given and quote this in all correspondence.
Ex. 38.

Dr. Pegg statement on 162-95

Dr.Pegg in his statement said:
[Walker-Smith's July 15, 1996 letter to the committee] also mentioned that the team “already have research permission for taking extra biopsies in children that we colonoscope.” The reference to “research permission” is when samples are taken from waste tissue in the course of normal surgery, and is necessary to obtain patient consent for the tissue to be retained and used for research purposes. The type of consent form is standard and is often produced to all patients as a matter of course. It is my understanding that Professor Walker-Smith wanted to retain tissue samples from all of his child patients at that time, and this is very common practice. This is so that samples can be retained for research purposes. This requires patient consent but not LREC approval. In fact, prior to 1999, the retention of tissue in this was often done without patient consent and many practitioners would consider this to be acceptable practice at that time.
Pegg Stmt. ¶ 55 (Ex. 104).

Testimony of Pegg replying to questions from GMC 'prosecutor' Sally Smitg, QC

Smith (on direct): Can you explain to us, remembering again we are all starting from scratch, so in simple terms, the reference to Professor Walker-Smith saying: “We already have research permission for taking extra biopsies in children who we olonoscope”, is that - --?
Pegg: That is another study.
Smith: Can you just explain that? How does that come about? Was that a general research application?
Pegg: They had made a previous application to take extra biopsies for children who were colonoscoped, and there is an information sheet and everything for that.
Smith: Was that children who were being colonoscoped in the course of normal clinical practice?
Pegg: It was for every colonoscopy they do they to ok an extra sample, I think, but they had a permission for it and an information sheet for it.
Smith: Was that normal practice within the hospital at that time for doctors to have a general research permission in respect of their patients?
Pegg: I think it is ahead of practice at that time. I think if you go into the College of Physicians’ guidance there was a view at that time that it was not even necessary to get consent.
Smith: If you were just taking an extra sample?
Pegg: Taking extra. There was a body of opinion at that time who did not even think that approval was necessary to take extra … If you were actually doing the investigation, i.e. the patient was not having any more risk, then taking extra samples you do not even need permission for, so this was almost ahead of feelings at that time, and of course we know now things have changed.
Smith: Yes, and that is as a result of all the --- ?
Pegg: Yes, but remember this is pre the new Tissue Acts and all that sort of thing where practices were very different.
Smith: When you say it involved no extra risk for the patient, do you mean they were going to undergo ---
Pegg: You are going to have a colonoscope anyway, we are going to take one, can we take another one?
Smith: So you were taking one for clinical diagnostic purposes?
Pegg: Yes,.
Smith: And in addition to that you take an extra one for research purposes?
Pegg: Yes, with the risk being putting the colonoscope in, which you are already doing.
Pegg. Tr. 8-45E.

Testimony of Dr. Pegg on Cross-Examination by Coonan
Coonan: This grant of ethical committee approval, which is numbered 162-95, was an approval which was capable of running continuously throughout the period with which we are concerned, was it not?
Pegg: Yes.
Coonan: We see that it relates to the taking of two extra mucosal biopsies, and we see that in the main heading, two extra ones, during the course of colonoscopy in children, and the taking of those two extra for research would therefore permit histology to be taken, is that right?
Pegg: It did not state what they were going to be used for, so by inference they could be used for anything.
Coonan: Well, in the light of that answer it therefore follows logically, it is a matter of common sense, that it at least extended to histology, yes?
Pegg: Well, as I say, the ethics committee is concerned with the risk to the child, therefore it has approved the biopsies. Whatever you use them for is not going to increase the risk to the patient.
You can list a hundred things they can do with those and I will answer “Yes” to every single one of your questions, so if you give the list I will answer “Yes” to your questions.
Coonan: I will give you enormous reassurance because there are only two particular matters on my list that I want to put in front of you. The first, as I said a minute ago, is histology.
Pegg: As I said, I would say yes to that.
Coonan: The second one is immunohistochemistry.
Pegg: I will say yes to that. It does not matter what you say.
Coonan: It is just that I am using your evidence to assist the Panel.
Pegg: There is no relevance to an ethics committee as to what you do with them, because except for genetic research which was not even here in that era, we are not worried, it is no risk to the child whatever you do with those things. So that is not really our concern. It is just the taking of them that we are concerned with, so you can do what you like with them.
Coonan: Just to complete the picture on the biopsy front – just go back to volume 1 in the pro forma application at page 209, right at the bottom of the page, Dr Pegg, if you have got it, in terms of biopsies the difference between 162/95 and 172/96 is the fact that the people concerned with this study wanted to take an additional biopsy. Do you see that at the bottom of the page 209?
 Pegg: Yes.
Pegg Tr. 9-24G.

-------------------end  exhibits, testimony and statements on 162-95 or Dr.Pegg--------------

1 comment:

  1. Thanks for posting this. The fact that people are pushing this obviously false claim to defend Dr. Wakefield shows me that they aren't interested in a real defense as the GMC will obviously shoot this nonsense down (and already has).

    This is just part of the public relations effort to confuse people and salvage Dr. Wakefield's reputation in the alt-med community.


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