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Drug trial update

Martin Rosenbaum | 15:48 UK time, Tuesday, 21 November 2006

An update on my recent posting on the medical ethics committee documents relating to the TGN1412 drug trial earlier this year which went badly wrong.

As noted, the Brent ethics committee was told by an external representative that the payment was higher because it was 'a totally novel drug and mode of action'. This is a surprising argument, since the ethical basis for paying healthy volunteers to take part in such trials is that they are paid for their time; they are not being compensated for taking risks.

However, the redactions on the documents supplied under freedom of information by the ethics committee meant they did not reveal who made this remark. I have now received an email from Dr Mark Lewis (Director of Clinical Governance and Research for North West London at NHS London), which clarifies matters:

'There were representatives of both TeGenero and Parexel at the first meeting of the ethics committee (23rd January 2006) when this study was discussed. It was the trial sponsor’s (TeGenero’s) representative, not the representative of the company that they commissioned to carry out the research (Parexel), whose first comment in response to point 7 suggested that the novelty and mode of action of the drug were determinants of the level of payment.'

Dr Lewis adds: 'Parexel, the company that actually undertakes clinical research, was quite clear about the ethical position, stating that the higher fees reflected the long duration of the planned study follow up and the scale of commitment that would be made by volunteers. Before the study was considered further, Parexel supplied a detailed breakdown of the proposed payment for participation. The committee would not have approved the study if they were not completely clear that Parexel remunerated volunteers on an ethical basis.'

TeGenero, the German pharmaceutical company which made the drug and sponsored the trial, declared itself unable to continue in business in July and filed for insolvency.

Comments   Post your comment

  • 1.
  • At 05:25 PM on 22 Nov 2006,
  • james wrote:

Hi, I requested some information from my local council about the housing transfer system, in particular about the number of applicants to the list from my estate, the numbers successful in being moved and their ethnicities.

First of all, the request for information was not fulfilled until after 32 days and on top of that they refused to give me the detailed information I asked for other than very general statistics.

What can I do? Can I claim compensation for the late response by suing them?
Are they right in not answering my questions?

Thanks.

  • 2.
  • At 09:14 PM on 22 Nov 2006,
  • Martin Rosenbaum wrote:

You can ask the council to review the way they handled your request and to reconsider their decision. The letter from the council should have told you who to contact to ask for this. If it didn't, just ask the person who replied to you. If after the review you are still not happy then you can complain to the Information Commissioner.

  • 3.
  • At 01:12 PM on 24 Nov 2006,
  • Pete_London wrote:

Mr Rosenbaum

Given your area of interest, you will no doubt be aware that the BBC spent many thousands of pounds of licence payers' money trying to block the release of a report which is believed to be highly critical of its Middle East coverage. The corporation is mounting a landmark High Court action to prevent the release of The Balen Report under the Freedom of Information Act, despite the fact that BBC reporters, in cludin yourself, often use the Act to pursue their journalism.

The action has only increased suspicions that the report, which is believed to run to 20,000 words, includes evidence of anti-Israeli bias in news programming. Given your expertise, how would you go about persuading the BBC to release the Balen Report to a public which paid for it?

  • 4.
  • At 01:44 PM on 24 Nov 2006,
  • Martin Rosenbaum wrote:

Pete -
I have commented on this before. See for example comment 15 on this page: http://www.bbc.co.uk/blogs/opensecrets/2006/05/about_martin_rosenbaum.html

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