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Experimental drug tests on terminal patients debated

Experts are debating in the British Medical Journal whether terminally ill patients in the US should have access to unapproved drugs

Experts have been debating in the British Medical Journal (BMJ) this week whether terminally ill patients in the US should have access to drugs which have not been approved.

The FDA announced in December 2006 that it was considering allowing experimental drugs to be given to terminally ill patients. The agency proposed expanded access to investigational drugs in such cases after phase I trials, but before final approval for marketing.

Professor Emil Freireich from the University of Texas said in the BMJ that patients should be allowed to judge the risks for themselves.

Currently, most cancer patients cannot participate in phase II trials because they are ineligible or are unable to fulfil the financial and social requirements, such as staying in the drug trial centres for the required weeks or months.

"The problem is clearly not one of safety because these drugs have completed phase I clinical trials and there is sufficient information about them to justify a phase II trial to determine efficacy," said Freireich.

Freireich argued that allowing such patients access to experimental drugs will accelerate drug development and has been demonstrated in the past when the FDA and the National Cancer Institute (NCI) allowed compassionate use of drugs.

"When patients are offered compassionate use of an experimental drug, their doctors have to collect information systematically in the research protocol and submit it to the sponsor. Information is therefore available about use of the drug outside trial conditions. For example, if patients with impaired renal function not only tolerate the drug but respond, it will assist in drug development to have that knowledge collected systematically," explained Freireich.

However, Dr Dean Gesme from the Minnesota Oncology Haemotology Professional Association argues that more than 90 per cent of drugs entering phase I trials fail due to lack of efficacy and tolerability, and, of those approved, most provide incremental improvements rather than lifesaving treatments.

"False hopes for unproven drugs can also erode the clinical trials system by substituting clinical enthusiasm and wishful thinking for evidence based medicine," warned Gesme.

Many drug firms have opted not to join current expanded access programmes for drugs in later stages of development and are opposed to providing investigational products outside of approved phase II trials, continued Gesme.

Gesme also asked who would bear the costs of open access to partially tested drugs, when no benefit has actually been demonstrated.

30th September 2008

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