Some MPs are responding to requests to sign EDM 400 with a standard letter that ignores up-to-date medical knowledge.
We have drafted a template letter for you to respond with – below – simply cut and paste it into an email, or contact us if you need additional help.
We appreciate that our text is a little on the long side, but this issue is too important to reduce; every aspect needs to be there. Please remember to sign off at the close and include your address!
TEMPLATE LETTER for MPs who are refusing to listen to current scientific evidence:
Thank you for your letter in response to my request for you to sign Parliamentary EDM 400, which calls for fair, properly moderated public scientific debate between opposing scientists, about claims that animal experiments can ‘predict’ the responses of human patients.
With the confidence you present in your scientific position, surely it would be appropriate to sign the EDM in order to prove your opponents wrong? After all, the debate conditions for the EDM’s called for scientific hearing protect both sides, and are endorsed as “well set out and fair” by Michael Mansfield QC. In signing the EDM you could perhaps make a public statement that you support animal models on medical and scientific grounds, and that you wish your supporting evidence to be heard in public.
I should add, however, that this EDM has a purely scientific focus and must not, therefore, be confused with ethics about animals – including the 3Rs which you highlight in your letter. The National Centre for 3RS exists to implement ‘humane experimental technique’ on animals. Although humane animal ethics is unquestionably of equal significance and value, ethics about animals can never enter a debate about medical science, which – as such – can only ever be about objectively verifiable, factual evidence.
Parliamentary EDM 400’s sole focus is scientific: namely the question of the claimed ‘predictive’ value of animal experiments for human patients. Scientists in the wider community – outside the vested interests of animal-based research – acknowledge the failure of animal models of humans, as reported by the British Medical Journal ‘s Editor’s Choice, June 2014, titled How Predictive and Productive is Animal Research? This article concluded by quoting from the paper it cited:
“If research conducted on animals continues to be unable to reasonably predict what can be expected in humans, the public’s continuing endorsement and funding of preclinical animal research seems misplaced.”
If your claim is true – that animal models still play ‘a small but important role in providing vital safety information for potential new medicines’ – then surely your support of the EDM, with its reference to the ‘Concordat On Openness On Animal Research’ (which proclaims to be committed to developing communications with the media and public), would encourage a senior scientist from the animal experimentation community to agree to debate his/her scientific position?
You are absolutely correct: ‘a large number of potential new drugs never get as far as being tested in humans’ – and that is because of the failure of animal models; indeed the National Cancer Institute has said we have lost cures for cancer because studies in rodents have been believed. However, your statement that ‘some aspects of the toxicological assessment of new human medicines cannot be adequately assessed in humans, and animal data will be the only kind available’ is now opposed by up-to-date scientific understanding, as highlighted by the BMJ demonstrating unequivocally that animal data actually poses a serious threat to human health [2-3].
Animals – promoted as intact testing systems – have now been proven a consistent disaster for the prediction of responses in human patients. Drug manufacturers openly acknowledge this fact and write about it often in the scientific literature; please visit this link for extensive quotes from pharmaceutical companies. It is incorrect of you to state that ‘a large number of potentially dangerous new medicines would be tested in healthy human volunteers and patients in clinical trials’. Current science has developed tiered testing, human biology-based strategies which begin with simple cell culture (2 dimensional) and move on to 3D cell culture; 2D or 3D co-cultures (e.g. organ slices); ethically sourced stem cells that are programmed to behave like differentiated cells (e.g. liver cells, neural cells, etc); toxicogenomics; pharmacogenomics; microfluidic organ on a chip and non invasive or minimally invasive clinical and imaging studies (e.g. pharmaco-magnetoencephalography). All of this means, at the very least, that the correct physiological system is being presented with a potential new chemical, thus avoiding an entirely wrong intact system, which offers no predictive value whatsoever.
In today’s world of gene-based medicine, new treatments are being targeted to individual patients’ and their personal genetic profiles. Science now understands that even identical twins suffer differently from illnesses, and require entirely treatments that are unique for their genetic profiles. As the BMJ states: the continued funding of animal models is entirely unacceptable in this current scientific climate.
The definition of ‘prediction’ in science
The definition of prediction in science is precise because it has life and death consequences for humans. For a test to be accepted as predictive in medical practice – in our hospitals and at our GP surgeries – it has to get the answer correct at least 90% of the time, otherwise it is abandoned . And as you correctly point out, the Predictive Toxicology project shows that animals predict correctly in human patients less than 50 % of the time: this is not ‘prediction’ in medical science when human lives depend on the outcome: it is less than the value of a coin toss .
Finally, you mention that ‘animals are only used when there are no suitable alternatives’ but the word ‘alternative’ is highly misleading when employed within this context. In reality there is no such thing as an ‘alternative’ to a method that is now demonstrated to have never existed. Animal models are now proven to have never held predictive value for humans. The correct scientific term for human-based research is ‘viable’ or ‘valid’ – this is not an ‘alternative’, it is quite simply the opposite.
Some MPs are still under the influence of the vested interests, namely those who make money directly from animal models falsely claimed as ‘predictive’ for humans. It is certainly worth mentioning that such animal experiments were first institutionalized in 1847, by Claude Bernard who went on to reject the Theory of Evolution! Please visit this link for more on this vital historical perspective.
I’d like to conclude my letter by inviting your support and interest for the scientific evidence which illustrates EDM 400, it is provided by the leading medical Board in its field who represent the new initiative Patients Campaigning For Cures, highlighted in the EDM. These experts are available to speak with you at any time. But certainly, at the very least, please sign the EDM to encourage the ‘Concordat On Openness on Animal Research’ to agree to submit a scientist to debate their position, in a fair public hearing – including evidence reported by no less than the British Medical Journal.
(your name and address)
- 1. BMJ2014;348:g3719 [available here http://www.bmj.com/content/348/bmj.g3719 ]
- 2. Shanks N, Greek R, Greek J:Are Animal Models Predictive for Humans?Philos Ethics Humanit Med 2009, 4:2.
3. Shanks N, Greek R Animal Models in Light of Evolution Boca Raton: Brown Walker Press; 2009.
4. FDA panel reviews Diabetes Drug linked to dozens of deaths [available here: http://edition.cnn.com/HEALTH/9903/25/rezulin.review/index.html?iref=allsearch ]
5. Heywood R. In: Animal Toxicity Studies: Their Relevance for Man.Lumley CE, Walker S Lancaster, Quay, editor. 1990. Clinical Toxicity – Could it have been predicted? Post-marketing experience; pp. 57–67.
Referenced quotes from pharmaceutical companies, available here
Referenced document citing fifty failures of animal experiments that have led to human deaths, available here
The science-based campaign For Life On Earth http://www.forlifeonearth.org
Patients Campaigning For Cures http://www.patientscampaigningforcures.org
Americans and Europeans for Medical Advancement https://www.afma-curedisease.org/tsmt.aspx