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Pharma industry could benefit from elephant man report

First-in-man trials to be conducted in hospital

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The recommendations published in the wake of the disastrous drug trial that left six young men hospitalised could actually benefit some parts of the UK pharma industry, according to one expert.

A report by the Expert Scientific Group into the trial has just been published. Though the report has been called a whitewash by lawyers acting for the men, Louise Fullwood, a lawyer specialising in life sciences at Pinsent Masons, the law firm behind OUT-LAW, denied that claim, and said it could benefit UK companies and universities.

"This is a sensible report, it is not a whitewash," she said. Fullwood said the report will benefit hospitals, bringing in additional much needed testing and research funding.

"He is saying that when drugs are being given to people for the first time it should be done in centres that are based either in hospitals or in private sector units but based within or very close to a hospital, so that you have intensive care and treatment facilities and you need to have 24-hour medical cover there.

"Some of the private sector sites that are not necessarily that close to a hospital are not necessarily the places to do first-in-man testing, so that's good news for hospitals in this country that have on site testing facilities or an ability to do it in their own labs and their own wards because that's extra business for them," she said.

"First-in-man studies of higher risk medicines should always be conducted in an appropriate clinical environment supervised by staff with appropriate levels of training and expertise, with immediate access to facilities for the treatment and stabilisation of individuals in an acute emergency, and with pre-arranged contingency availability of ITU [intensive care / therapy unit] facilities in reasonable proximity," said the report. First-in-man studies are those in which a medicine tested on animals is given to humans for the first time.

According to Fullwood, clinical research is a vital element in research funding of hospitals and universities. "It's a big revenue generator and it very much helps funding pure blue skies scientific research in this country because researchers can get funds by carrying out these trials which they can then use to carry out perhaps more interesting pure research," she said.

The report dealt with the case of six young men who submitted to voluntary tests of the drug TGN1412 at a private testing facility at Northwick Park Hospital earlier this year. The test was carried out by Parexel on behalf of TeGenero, a German firm that has became insolvent because it was not fully insured against the adverse affects of the test.

The drug was designed to treat rheumatoid arthritis, leukemia and multiple sclerosis, but it caused a horrific reaction in all six healthy men. They swelled up, in one case to three times his normal body size, and some lost numerous fingers and toes. The men have been warned that they have a greatly increased chance of developing cancer and immune system disorders in later life.

The body responsible for the regulation of the sector is the Medicines and Healthcare Regulatory Agency. "Clinical trials in general have an excellent safety record, but it is important that we learn the lessons from the TGN1412 incident," said its chief executive Professor Kent Woods.

The Expert Science Group was appointed by the government to investigate the process. Chaired by molecular medicine expert Professor Gordon Duff, it found that a total overhaul of existing rules was not needed, and that some of the problems in the Northwick trial related to failures to follow existing rules.

"They did pick up on some problems with the trial itself but they were where people were ignoring or not conforming with existing regulation so it's arguable we don't need additional regulation we just need people to pay attention to the ones that are already there," said Fullwood.

The report is vital for the pharmaceutical testing industry, a major UK industry that is seen as being reluctant to embrace further regulation.

"The UK clinical research and pharmaceutical industry is one of the best regulated in the world, it has very high standards, that's why it takes 10 or 15 years to get a drug to market," said Fullwood. "If the regulator were to slap on a whole new set of regulations and make it even more regulated then there's a risk that pharmaceutical companies would say it's no longer cost effective to carry out research work in the UK, let's take it to Latin America or somewhere that's less regulated and that would be very bad for UK hospitals, universities and clinical research organisations."

See: The report (110 page/1.4MB PDF)

Copyright © 2006, OUT-LAW.com

OUT-LAW.COM is part of international law firm Pinsent Masons.

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