September 30, 2007
Professor: test more drugs on humans
Sarah-Kate Templeton, Health Editor
PATIENTS should be used as human guinea pigs in drug trials that would formerly have been carried out on animals, one of Britain's most senior scientists has said.
Professor Colin Blakemore, the outgoing chief executive of the govern-ment-funded Medical Research Council - well known for his defence of experiments on animals - says new drugs should be tested on humans sooner to cut the time and cost of developing medicines.
The proposals raise ethical issues about putting the advancement of medical science and development of new medicines before the welfare of individual patients.
Currently, drug trials involve extensive experiments to find out if a medicine can treat disease in animals before tests on humans. The numerous phases of the trials contribute to drugs costing up to 500m-pounds and taking up to 10 years to bring to market.
Blakemore said such lengthy and expensive trials were not sustainable. He believed the financial costs and time taken to bring out new medicines could be cut by up to 90%.
This could be done by trying out new drugs directly on patients instead of waiting to see whether they treated disease in animals.
In addition, he said drugs should not need to be shown to work in trials of tens of thousands of people before they were approved for prescription.
Blakemore insisted, however, that patients would not be put at greater risk because the safety of the medicine would be checked first using laboratory tests and animal experiments.
Advances in diagnostic equipment, such as body scanning, made it possible to test new therapies directly on humans, especially for diseases that had no equivalent in animals, such as mental illness.
Blakemore said: "Everybody recognises that it is now time to shift gear in the effort to find new medicines. A crucial step is moving as quickly as possible from laboratory studies and animal studies into direct experiments on people and patients.
"There are ethical issues because, in a sense, people will be acting as guinea pigs. This is the classical situation of human guinea pigs but safety standards won't be relaxed and it will be done with the full understanding and consent of the individuals. This new approach is not only for the benefit of the individual but for the broader good of the community.
"People who agree to take part in this kind of experimental medicine have to give their time and might have to undergo more tests than usual, which could be regarded as a certain element of sacrifice for the greater benefit.
He added: "This experimental medicine does not involve cutting ethical corners. The safety of potential treatments will still have to be rigorously assessed."
Blakemore said overregulation was slowing production of medicines and discouraging research into new cures. "I do have a worry that the regulatory process, in some areas, is going beyond the need to be sure that the correct thing is done, and is delaying or discouraging research," he said.
Blakemore said NHS patients ought to feel a duty to take part in medical trials that would benefit future generations of sufferers even if their own health might not improve.
"We have to try to promote more generally the idea that patients ought to help others, particularly in a socialised medical system like the NHS," he said. "This is not an obligation, people must choose, but I hope they will come to realise that this is just as much part of the contract of the NHS as paying your national insurance so that you can get access to it."
Dr Des Spence, a GP and spokesman for No Free Lunch UK, a campaign group that highlights conflicts of interest between health staff and pharmaceutical groups,
said patients who had paid for their healthcare through taxation should feel no obligation to take part in drug trials.