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).

[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.