From: Vivien

Subject: attempts to ban animal testing of human drugs
Sept. 2005

The following is an extract from Hansard and is at http://www.publications.parliament.uk/pa/cm200506/cmhansrd/cm050912/text/50912122.htm#50912122.html_sbhd3

"New Medications (Safety Testing)
Mr. Hancock: To ask the Secretary of State for Health if she will make it her policy to end the requirement that new medications are safety tested on animals before they are given to humans. [10193]

Jane Kennedy: Regulatory and scientific requirements on the testing strategies for new medicinal products have been established at European and international levels. The "Note for Guidance on Non-clinical Safety Studies
for the Conduct of human Clinical Trials for Pharmaceuticals (CPMP/ICH/286/95)" provides guidance as to what safety tests are required before a medicinal product enters the different stages of a clinical trial program. These safety tests in animals are needed to establish the safety and toxicological profile of a medicinal product before it is used in man. As a result of these tests, a large number of potential medicinal products never make it to use in man because their toxicological profile is unacceptable. These tests serve an essential role in the development of medicines. Therefore, we will not make it our policy to end the requirement for safety testing in animals."

Jane Kennedy MP is Minister of State for Quality and Patient Safety at the Department of Health, including clinical quality, patient safety and clinical negligence. It is clear that there is serious lack of knowledge on this issue in Parliament. She is described at http://www.labour.org.uk/maps/locinfo.phtml?ctid=2363 as 'Educated at
Liverpool University' (no degree?) and 'Previously a care assistant for Liverpool City Council's social service department and residential child care officer'. So what qualifies her to speak on this vital scientific issue?

Ms Kennedy states that "a large number of potential medicinal products never make it to use in man because their toxicological profile is unacceptable."

EXACTLY! Their toxicological profile in NON-HUMANS is unacceptable. This means that many potential SAFE medicines are abandoned because the animal tests indicate that they are unsafe. In many other cases, drugs go on to be tested in humans even when the animal tests indicate that they are unsafe. And many drugs which are harmful to humans test as safe in non-humans. The use of non-humans to test medicines for humans yields results which are less accurate than tossing a coin.

When will the authorities see sense?

Vivien