From lasers to Lycra and laptops, the world is largely unrecognisable compared to the 1960s, yet our drug safety regulations have not moved with the times. Current regulations require all new medicines to be safety tested on animals before they are tried on humans. New technologies are making such tests redundant, but when will the law catch up with the science? Margaret Clotworthy addresses a new campaign that aims to shift the legal requirements.
Despite the extensive testing new drugs undergo, adverse drug reactions (ADRs) are estimated to kill 197,000 people across the EU and to cost the NHS alone £2billion annually. Whilst inappropriate prescribing and mistakes also contribute to the toll from ADRs, recent tragedies have graphically illustrated the need for improved testing. In 2006, six young men almost died in a clinical trial at Northwick Park hospital, London, after being given a new drug that had been tested at 500 times the dose in monkeys. Vioxx, an arthritis painkiller withdrawn in 2004, claimed over 100,000 lives worldwide in the four years it was on the market, despite appearing to be safe in animal studies.
The problems associated with using animals as surrogate humans to find out which products are dangerous are not confined to medicines. REACH is an EU programme to ensure the safety of 30,000 chemicals at large in the environment for which insufficient information is available. This represents a tremendous opportunity to take advantage of the myriad new technologies which are faster, cheaper & provide more human-relevant information than the standard animal tests.
In 2007, the US Environmental Protection Agency commissioned a report which was revolutionary in its scope and the strength of its recommendations. The authors expected the “paradigm shift” away from animal tests which they advocated to encounter resistance, as toxicological testing practices are “deeply ingrained” and pressure to maintain the status quo is strong.
Encouragingly, three major US agencies have agreed to collaborate to bring about this revolution. If the US EPA report is correct, what sort of policy should we look at implementing in the UK?
Safer Medicines Campaign is supporting the Safety of Medicines (Evaluation) Bill 2009 and a parliamentary petition, Early Day Motion 569, in support of it. The Bill has cross-party support and would require the Government to conduct an independent scientific comparison between animal safety tests and newer, human biology-based technologies (see Box below). A panel of drugs, for which human (and hence also animal) data are already available would be assessed in a suite of the latest human biology-based tests, and the results, from humans, animals and the newer tests, compared to see whether the newer tests more accurately predicted the side effects experienced by patients. This idea received great support from scientists attending Safer Medicines Trust’s Speed and Safety in Drug Discovery conference held at the Royal Society last November.
You can support our campaign by sending one of our postcards, or by writing, to your MP (we have drafted a sample letter for your convenience, please see our website). Please do not hesitate to contact us if you would like more information or to order postcards or information sheets.
Dr Margaret Clotworthy is Science Consultant to the Safer Medicines Trust
PO Box 62720, London SW2 9FQ.
Tel: 020 8265 2880
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