Safer Medicines - putting patient safety first

Putting patient safety first

EDM 475 Conservative response

Dear

Thank you for your letter regarding EDM 475: Safety of Medicines.

I am pleased that the Government wishes to minimise animal testing and to encourage the development of other in vitro methods. However, I must challenge your assertion that there are limits to the use of non-animal testing, and that without animal testing some potentially dangerous medicines might have to be tested in perfectly healthy human volunteers.

Of course it is unacceptable to test potentially dangerous medicines in healthy human volunteers. Unfortunately, this is currently standard practice, as a direct consequence of animal testing. The law requires that new drugs are shown to be safe in animals before they can be given to volunteers in clinical trials. Many technologies are available to assess drug safety in a human context, without exposing volunteers to risk – but the law does not require them to be used.

As a result, volunteers are exposed to medicines that appear to be safe in animals but for which meaningful information about safety in humans can be entirely lacking. The infamous ‘elephant man’ trial at Northwick Park Hospital in 2006 is a good example: 6 young men were given the experimental drug because it had been shown to be safe in monkeys, even at doses 500 times higher. Since 2006, simple tests using human cells have been developed which can predict the terrible effects that animal tests failed to detect.

The purpose of the Safety of Medicines Bill and EDM 475 is to protect volunteers and patients from such unacceptable risks. There is no suggestion of abolishing the most effective tests: quite the reverse. Thus even advocates of animal testing should be happy to sign the EDM. I hope you will reconsider signing EDM 475, which promises to improve the safety of medicines for volunteers and patients. I enclose an information sheet that I hope you will find useful.

Yours sincerely,

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