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agate
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 Posted: Tue Aug 15, 2006 11:12 am Post subject: (Article) Concern in UK over major MS drug trial |
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From BBC News, July 29, 2006:
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Concern over major MS drug trial
By Linda Pressly
Reporter, Drugs On Trial
MS drugs can be expensive
Leading scientists have raised serious concerns about a major government study into the effectiveness of drugs used by thousands of people with MS.
The study was originally being conducted by an established team at Sheffield University.
But it has been switched to Parexel - a company with commercial links to three of the four pharmaceutical companies involved in the study.
The concerns are outlined in a report to be aired on BBC Radio Five Live.
There are also concerns about how much of the research will be made public.
It is feared patients currently taking expensive drugs like beta interferon may be kept in the dark even after the ten year study is complete.
The National Institute for Health and Clinical Excellence decided in 2001 not to sanction beta interferon - or another MS drug, glatiramer acetate - for use on the NHS, ruling they did not represent value for money.
However, after a sustained campaign by the pharmaceutical companies, charities and patients, the government came up with an alternative approach known as the Risk Sharing Scheme.
Under its terms, the government committed around £500 million to providing the MS drugs over a ten year period while scientists studied their long-term effectiveness.
If the study reveals the drugs are not as effective as the pharmaceutical companies say, they will have to drop the price of their products to the NHS.
The original contract to evaluate the progress of the thousands of MS patients on the scheme was given to the Sheffield team.
However, sources have told the BBC that the contract was re-tendered last year following a dispute over the university's right to publish independently on their findings.
Sir Iain Chalmers, editor of the James Lind Library, which reviews scientific research, is uneasy about the decision.
He said: "I think it's a totally unreasonable expectation, that information which may be important to patients and prescribers should potentially be suppressed because a company does not find it in its interests to see it made public.
'Not a veto'
One of the pharmaceutical companies involved in the scheme has denied that any of the research will be suppressed, even though each company in the risk sharing scheme has the right to decide if any research involving their own drugs should be published.
Pete Smith, managing director of Biogen Idec in the UK and Ireland, said: "It may look like a veto but it really isn't a veto.
"We are very confident that our drug is going to demonstrate its value here in the UK and to those patients who are in need of care and we are quite frankly looking forward to those results being published at the completion of this study."
The move to a commercial company has also dismayed one of the world's experts on multiple sclerosis whose research data was being used by the scientists at Sheffield University.
George Ebers, professor of clinical neurology at Oxford University, said: "I think you'd have to have a pretty good reason to change horses in the middle of what is a pretty rocky and rapid stream.
"One has a certain bit of worry here that you've got an academic group with a well-established and well earned reputation in this whole business and in particular MS, and then for reasons which I don't understand they're replaced by a clinical research organisation.
"I have reservations about this being a clinical research organisation that's going to be involved in determining efficacy."
Questions remain
Experts in the field of scientific research claim that any question marks hanging over the value of the MS drugs are unlikely to be satisfactorily answered by the study.
Sir Iain Chalmers said: "I think we remain, I would say, almost irresponsibly ignorant about what these drugs really do have to offer and I'm not confident that the current arrangements for so-called evaluation of the longer term effects of these drugs are actually going to produce reliable evidence."
The scheme was being overseen by a project management group that included the MS Trust charity, four pharmaceutical companies, the Department of Health and several others including scientists and academics.
However, the BBC understands that the group as a whole was not consulted about the decision to appoint Parexel, which was taken instead by the drugs companies, the Department of Health and the MS Trust.
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