Opinion: Lynne Featherstone’s defence of evidence-based translational medicine is welcome

[Declaration: for the last nine years I worked in an academic research laboratory, developing therapies for inherited disorders that cause blindness. During this time I worked with animal models to help our improve our understanding of disease mechanisms and to act as a test-bed for new therapies].

The sparsely-attended adjournment debate on Wednesday secured by Conservative MP David Amess, saw a rare thing – a genuine discussion based around the merits of peer-reviewed scientific research and a robust defence of an evidence-based approach to translational medicine from Lib Dem Home Office Minister Lynne Featherstone. For a biology nerd interested in the application of scientific knowledge to public policy it had all the ingredients of a pre-Christmas gift – I can fully recommend the Hansard transcript for a full picture (yes, I am that sad…).

Mr. Amess has some track record of Parliamentary campaigning against animal cruelty, and he reviewed his contributions before getting to the core of the issue – an EU directive adopted last year that, according to Mr. Amess, threatens the high animal welfare standards found in UK scientific laboratories. In responding to these concerns, Lynne Featherstone sought to reassure the house that no such threat was posed by the Directive. Indeed the Economist article cited by Margot James MP in an intervention is, as Lynne pointed out, incorrect when it says that “the strict laws that require British scientists to consider alternatives to animal tests may be partially relaxed as a result of European reforms.” On the contrary, to quote the Directive itself,

this Directive represents an important step towards achieving the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so. To that end, it seeks to facilitate and promote the advancement of alternative approaches

and that if anything the flexibility afforded to EU states regarding welfare would be to impose stricter standards above the floor set by the EU.

Mr. Amess relied on two central arguments in his speech – one entirely reasonable, and one that he claims arises from the first but that in truth is simply inconsistent with it.

The MP for Southend West rightly pointed out that adverse drug reactions (ADRs) in clinical trials and when drugs are approved for use are a real concern, and that his Safety of Medicines Bill has garnered cross-party support which indicates the depth of said concern. There’s little doubt that the medical profession should endeavour to minimise adverse drug reactions and should consider all relevant avenues for doing so including scientifically valid tests of drug safety based on human biology/tissue, as the Bill calls for – however this reasonable position is spoilt by what follows. Mr. Amess wrongly ascribes the extent of ADRs to the use of animal models in pre-clinical research, and makes a logical leap in suggesting that the use of animals to assess drug safety is inappropriate.

The Bill appears to have originated with the Safer Medicines Trust, which describes itself s

an independent patient safety organisation of doctors and scientists whose concern is whether animal testing, today, is more harmful than helpful to public health and safety.

I don’t know enough about the Trust to judge its funding, remit and merit – but I can dispute many of the straw men that Mr. Amess raised in his speech, and can support the line that Lynne took.

Mr. Amess argued that animal models lure scientists into a false sense of security over the safety of drugs, and that because compounds found to be safe in rodents can be toxic when taken by humans that animal testing should be replaced by computer modelling, in vitro tests using human tissue and ‘micro-dosing’. He failed to grasp that the pre-clinical animal trials are an additional test, not an alternative one, to human testing; that the use of animals can be informative if scientists exercise caution in extrapolating their findings; and that thousands of successful drugs have been developed through regulated, judicious use of animal-based pre-clinical testing. These are issues I raise with post-graduate students in my lectures on the relevance of animal models in developing new drugs; Lynne made a point of reminding Mr. Amess of these facts and more in stating that

animal studies are considered to be an indispensable component in the assessment of the safety and efficacy of a new medicinal product. Without animal testing, it is highly likely that a large number of potentially dangerous medicinal products would have to be tested in healthy volunteers and patients in clinical trials. That would be quite unacceptable.

He also failed to understand that there is no single test for how well a drug will be tolerated, that the extent to which a drug will provoke ADRs when widely used cannot be predicted with any certainty even after human clinical trials.

Lynne also rightly praised the work of The National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), which works with researchers, regulators and animal welfare campaigners to ensure that animal research is only carried out when justified, in ways that minimise the numbers and suffering of animals, and supports the development of viable alternatives to animal models. The work of the NC3Rs ensures that the UK strikes the balance between animal welfare and medical benefit when it comes to animal research.

Ultimately, I’m afraid Mr. Amess’ objection to the use of animals in research stems from a misunderstanding of how medical research works. He seems to think that we use animals to determine with certainty which compounds will be both safe and effective, and that the use of animals is designed to eliminate ADRs in humans. In truth, as Lynne hinted in her response, there is an element of Knightian uncertainty when it comes to individuals reacting adversely to drugs, and even if we abandoned animals as our shibboleth we’d still face that uncertainty – indeed we’d probably have more adverse reactions tests of human cells in dishes will likely bear even less relevance to how intact humans will tolerate new compounds. Whilst the development of in vitro and in silico drug safety tests should continue, regulated and judicious use of animals will continue to be a valid method of developing safe and effective medicines for clinical use.

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This entry was posted in Europe / International and Op-eds.

One Comment

  • Robert Hamilton 12th May '13 - 8:27am

    “Without animal testing, it is highly likely that a large number of potentially dangerous medicinal products would have to be tested in healthy volunteers and patients in clinical trials.”
    “there is an element of Knightian uncertainty when it comes to individuals reacting adversely to drugs, and even if we abandoned animals as our shibboleth we’d still face that uncertainty ”
    The uncertainty seems very small if Lynne statement is accepted. For her there is a high probability that animal testing is needed. Lynne overstates her case.
    Amess does not think the experimenters seek certainty, he thinks that they, the experimenters, are more uncertain where they are going with animal testing that a scientist should be.

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