What is Human-Based Research?
Human-based research covers a wide range of exciting bio-technologies which are human relevant because they use advanced current biological knowledge of the human species to study human diseases and develop drugs which are safe and effective in humans. HBR already has a track record of success as effective 'predictive' tools yet their potential is constrained by regulatory restrictions and their adoption by govt regulators together with funded development.
With appropriate public funding and updating regulations which are 70 years behind current science, HBR will accelerate the development of effective drugs and the discovery of cures for killer diseases and crippling conditions.
How Human-Based Research benefits patients
Hyped News Headlines of Promising Cures 'News of a medical breakthrough inevitable raises our hopes that a new treatment will become available. But, as people waiting for new treatments know only too well, drugs that look promising in early research rarely reach the phamacists' shelves. For every 100'000 chemicals researched, only four are eventually licensed for prescription. This low outcome is often because early results in test tube experiments or in animal models do not translate into results in humans, despite all those optimistic headlines'.
(Making sense of drug safety science. Chapter 01. Page7. produced with support form Medical Reserach Council.)
Why Human-Based Research is essential to protect clinical trial volunteers
The replacement of pre-clinical animal testing with modern human-based safety tests are essential in preventing harm to human volunteers in clinical trials. The 70-year old law mandating animal testing in pre-clinical trials as a safety stage was intended to protect people in clinical trials for new drugs but in the light of current scince it's now recognised that the unreliability of the data from tests on aniamls exposes human volunteers to substantial and serious harm. Examples can be cited to illustrate this example in 2006 at Northwick Park six healthy men were left fighting for their lives due to organ failure during a routine clinical trial. They were all admitted to intensive care, two became critically ill, the worst affected lost his fingers and toes, and all were subsequently informed they would be likely to develp cancer or auto-immune diseases early in life as a resut of their exposure to the drug. The pre-clinical tests on animals of the drug TGN1212 prior to the clinical trial showed NO signs of organ failure.
Where as if the pre-clinical trial had used the human-based safety test Skimune, developed by a team at Newcastle University, according to Professor Anne Dickinson: "Our Skimune test would have predicted the terrible outcome at Northwick Park in 2006. Then six men taking part in a clinical trial had severe reactions to a monoclonal antibody resulting in organ failure. Previous laboratory and animal research gave no indication that this was likely to occur. Our test would have picked up the risk because it is a skin-based model of the human immune response. It uses real human skin and Immune cells to show any reaction such as a rash or blistering indicating a wider immune response within the body' ...and 'eliminates the risk of adverse reactions to new drugs, cosmetics and household chemicals.'
Professor Richard Stebbings, Principle Scientist at the National Institute for Biological Standards and Control (NIBSC) praised Skimune for its superior scientific efficacy compared to animal experiments condemning the latter as " ...poorly predictive of human responses."
This is just one example of why it's a scientific necessity to replace animals with modern technologies not just an ethical one.
Why increased Human-Based Research will boost the UK economy
'If we are to remain competitive, we must up our game in the UK...Everyone agrees that the challenge is to put human clinical disease studies back at the heart of medical discovery, where they have always belonged... If we can become better at recognising and rewarding innovation; ensure that good ideas don't get lost; and adopt them more quickly and efficiently across the NHS, then we can deliver better patient outcomes at home and take a leading role in life sciences globally.'
How Human-Based Research enhances the reputation of UK Universities
With appropriate funding for innovation in medical research, the reliance by UK universities on income streams will shift from out-dated invalid animal testing to funding human-based research methods in bio-sciences.