Performance assessments on 21st century technology
Dear Department of Health and Social Care,
I read with interest the recent UK government press release announcing a £400 million public-private collaboration launched to kickstart economic growth and build an NHS fit for the future.
Can you please refer me to the advice and guidance you have provided to the MHRA with regard to the continuing use of unreliable animal tests as the back bone of pre-clinical studies by pharmaceuticals?
According to the US Food and Drug Administration, out of ten drugs that successfully pass animal tests, nine will fail during clinical trials, either as a result of adverse reactions not seen in the animals or else due to lack of efficacy in humans.
What has the Department of Health and Social Care provided as advice and indeed regulation to ensure that the the availability of modern technologies that far surpass animal tests in terms of reliability and relevance to human health such as Liver on a chip is now one of the key and expected tools in preclinical studes.
As one example, the human « liver on a chip » is far more reliable than animal tests at detecting drug induced liver injury (DILI for short). This is hugely significant because the « liver on a chip » will prevent dangerous drugs from ever reaching clinical trials, whereas animal testing is notoriously unreliable at detecting and predicting DILI.
Not only is DILI the leading cause of prescription drug withdrawal from the market, but such liver damage can even result in a patient requiring a liver transplant.
One single liver transplant costs the NHS around £ 121 000.
I attach these articles which have informed my request for information
https://www.nature.com/articles/s43856-0...
https://www.nature.com/articles/s41573-0...
Adoption of organ-on-chip platforms by the pharmaceutical industry | Nature Reviews Drug Discovery.
Can you point me to the information that is being used to not allow the implementation of the use of the Liver on a chip as a part of the pre-clinical toolkit for researchers and drug development and is this a general omission or a specific one with regard to the use of non animal methods?
Yours faithfully,
Linda Birr-Pixton
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Dear Ms Birr-Pixton,
Please find attached the Department of Health and Social Care's response
to your recent FOI request (our ref: FOI-1534130).
Yours sincerely,
Freedom of Information Team
Department of Health and Social Care
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