Want Safe Medicine? An End To Vivisection? E-mail your MP today to ask them to sign EDM 569

If you have not yet asked your MP to sign EDM 569,in support of the Safety of Medicines (Evaluation) Bill 2009, please do so at www.writetothem.com

EDM 569 is a chance to make history by statistically evaluating animal tests for medicine safety for the first time ever.

NEWS RELEASE: 00.01AM MONDAY 26TH JANUARY

MPs demand action on safety testing of medicines to slash unacceptable death toll.

A cross-party group of MPs (see their quotes below) today launched the Safety of Medicines (Evaluation) Bill 2009, to tackle the escalating problem of adverse drug reactions, which hospitalise one million Britons and cost the NHS £2 billion every year.

Clearly, in order to improve these shocking figures, better methods of safety testing need to be introduced. Currently, animal tests are the major safety screen before drugs are tested in humans for the first time in clinical trials. However, safety tests in monkeys led to the Northwick Park clinical trial disaster in 2006 and, according to a new paper in Molecular Pharmaceutics [1], safety tests in rats and mice led to the thalidomide tragedy fifty years ago.

Ironically, today's legal requirement for animal tests was intended to prevent another thalidomide: yet the Vioxx painkiller tragedy [2] dwarfed thalidomide many times over, despite appearing to be safe - even cardioprotective - in animal tests.

Many studies have shown that animal tests – even in dogs and monkeys – are no more predictive for humans than tossing a coin: e.g. Journal of the Royal Society of Medicine 2008; 101: 95, British Medical Journal 2007; 334: 197.

Meanwhile, a dazzling array of technologies is now available to test the safety of medicines in a human context (see www.drugtestingconference.com). Leading scientists agree that the best model for human drug development is human beings. Indeed, this is the motto of many companies that focus on human biology-based technologies, e.g. York-based microdosing company Xceleron (www.xceleron.com: 'the best model for human drug development - the human being'), Glasgow-based Biopta (www.biopta.com: 'Proof of concept in man'), Newcastle-based Aeirtec (www.aeirtec.com: 'Human disease-based drug testing accelerates drug development') and US-based Hurel (www.hurelcorp.com: Human-relevant).

Astonishingly, the effectiveness of animal testing has never been compared with these newer methods, despite the fact that all four inquiries into animal testing in recent years called for an assessment of the value of animal tests.

The Safety of Medicines (Evaluation) Bill calls for an unprecedented comparison of animal tests with human biology-based methods: an idea strongly backed by MPs. 250 MPs signed Early Day Motion 92 in its support in 2006. ‘There is a great variety of impressive technologies to assess drugs in humans: the species in question. They deserve to be given a fair trial against animal tests, to find out whether they could do a better job of protecting patients' - co-sponsor of the Bill, Dr Ian Gibson MP (Labour), Chair of the All-Party Parliamentary Group on Cancer, member of the Select Committee on Innovation, Universities and skills, the all-Party Parliamentary Patient Safety Group and many other science and health groups.

‘This comparison is an idea whose time has come. If animal tests could be replaced to benefit drug safety, who could fail to be happy?’ – co-sponsor of the Bill, David Amess MP (Conservative).

'It is astonishing that animal testing has never been scientifically evaluated. The process is long overdue’ - co-sponsor of the Bill, Mike Hancock CBE MP (Liberal Democrat).

Notes to Editor

[1] See: http://www.sciencedaily.com/releases/2008/11/081110181711.htm and

http://www.thenational.ae/article/20081201/FRONTIERS/821454234/1036/FOREIGN

[2] Vioxx caused approximately 320,000 heart attacks and strokes
worldwide, as calculated from Merck's own estimated 20 million 'at-risk'
patient exposures and 16 excess adverse cardiac events/1,000 exposures,
calculated by Topol et al, New England Journal of Medicine
2004;351:1707-9. Approximately 120,000-140,000 of these events were fatal.

Safer Medicines Campaign
www.safermedicines.org
Putting patient safety first

D. Telegraph, 26.1.09 "TEST DRUGS ON HUMAN TISSUE, SAY MPs" The use of human tissue in medical drug tests instead of using live animals, should be investigated as a priority. MPs are proposing this in
a Parliamentary Bill. New technology needs greater support said Dr. Ian Gibson, a member of the Commons Innovation, Universities, Science & Skills Committee. Dr. Gibson is proposing the Safety of Medicines (Evaluation)Bill. He is hoping MPs will sign his Early Day Motion.

http://www.telegraph.co.uk/scienceandtechnology/science/sciencenews/4339... Sunday Telegraph.25 January 2009.Human alternatives to animal testing should be investigated,MPs say.By Stephen AdamsThe use of human tissue in drug tests, instead of liveanimals, should be investigated as a priority, MPs are topropose in a parliamentary bill.New technologies that avoid the need for vivisection should begiven greater support, said Dr Ian Gibson, a member of the Commons' Innovation, Universities, Science and Skills Committee. However animal testing tends to continue because it is the tried and tested approach, he added.Dr Gibson, who is proposing the Safety of Medicines(Evaluation) Bill, said: "There is a great variety
of impressive technologies to assess drugs in humans: the species in question. They deserve to be given a fair trial against animal tests, to find out whether they could do a better job of protecting patients."He added: "These new technologies coming through - using human tissue cells - mean we don't need to go straight to animal testing."Dr Gibson, a former chair of Science and Technology Committee and the Labour MP for Norwich North, said: "We have got locked into animal experiments as the only way. It's still very important that we do that, but sometimes we don't look at
the alternatives." One possible option is "microdosing" - the practice of administering drugs in such low quantities that the effect can only take place at a cellular level, rather than on the organ or body as a whole. The dose is often administered to a tissue culture extracted from a human volunteer.In 2006, 250 MPs signed an Early Day Motion (EDM) that called on the Government to "facilitate an independent and transparent scientific evaluation of the use of animals as surrogate humans in drug safety testing and medical research".Dr Gibson said: "We are going to put a new EDM down and I think there will be lots and lots of MPs who will support it."The bill will also call for an assessment of the effectiveness of animal testing. 'the best guess for the correlation of adverse reactions in man and animal toxicity data is somewhere between 5% and 25%' Animal Toxicity Studies: Their Relevance to Man, Lumley and
Walker (eds) (Quay, 1989), 57-67

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