Wednesday, January 4, 2012

Translation

Vivisectors uniformly argue that medical progress is dependent on their continued access to animals. Their lobbying organizations work diligently toward more or less unfettered freedom for vivisectors to treat animals as they wish. They never make the claim so baldly, but their actions -- like the University of Wisconsin successfully lobbying state lawmakers in 2011 to exempt them from the state's anti-animal cruelty laws -- speak volumes.

How perplexed they must be when the director of NIH -- the gravy train that keeps the vivisectors in cars, boats, and vacation homes -- says that vivisection might not be all that the vivisectors themselves claim it to be.

Director Francis S. Collins understandably dances around the matter; the nation's large universities and the giant suppliers of animals, cages, and tools of torture, are a hornets nest that only the stouthearted would disturb without care. Even the director of the NIH hopes not to lose his job.

Nevertheless, it's hard to look at the gigantic failure of the American biomedical research endeavor and pretend not to notice the key detrimental role that vivisection has played.

The quotes below come from Director Collins's Commentary: Reengineering Translational Science: The Time Is Right. www.ScienceTranslationalMedicine.org 6 July 2011.

Collins: "The average length of time from target discovery to approval of a new drug currently averages ~13 years, the failure rate exceeds 95%, and the cost per successful drug exceeds $1 billion, after adjusting for all of the failures."

Collins: "The upstream component of this developmental pipeline is progressing vigorously, aided by dramatic technological advances and associated basic insights into disease mechanisms ... The downstream end—premarket clinical trials—is traditionally the strong suit of the private sector because of its considerable expertise in assessing promising interventions. However, serious problems exist in the middle zone, in which attrition rates for candidate products are horrendously high. Many of the complex steps in this middle zone have been performed in the same way for a decade or more and have not been subjected to the kind of bold innovation that has characterized other branches of biomedical science."

Collins: "Current trends are indeed disturbing. Over the past 15 years, the annual rate of approval for drugs that address a new target class has not kept pace with the substantially increased investments that have been made in research and development."

Collins: "The use of small and large animals to predict safety in humans is a long-standing but not always reliable practice in translational science. New cell-based approaches have the potential to improve drug safety prediction before use in patients."

Collins: "The use of animal models for therapeutic development and target validation is time consuming, costly, and may not accurately predict efficacy in humans. As a result, many clinical compounds are carried forward only to fail in phase II or III trials; many others are probably abandoned because of the shortcomings of the model. Building on a potentially extensive network of collaborations with academic centers and advocacy groups, NCATS will aim to develop more reliable efficacy models that are based on access to biobanks of human tissues, use of human embryonic stem cell and induced pluripotent stem cell models of disease, and improved validation of assays. With earlier and more rigorous target validation in human tissues, it may be justifiable to skip the animal model assessment of efficacy altogether." Sacrilege!

Collins: "Using as few as one or two human volunteers, phase zero trials allow in vivo testing of very low doses of appropriately labeled novel therapeutics to assess appropriate distribution to the desired target. Through access to academic research centers that received NIH Clinical and Translational Science Awards (CTSAs) and the NIH Clinical Center, NCATS can encourage further development of phase zero technologies such as positron emission tomography–ligand–assisted molecular imaging and metabolomics to provide a more direct pathway toward optimizing formulation, dosing, pharmacokinetics, and pharmacodynamics rather than depending so heavily on animal testing."

These observations can't be good news to many within the industry.

No comments: