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Jan 27 2012- murgita.docx

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Microbiology and Immun (Sci)
MIMM 387
Robert Murgita

thFriday January 27 2012TGN1412 Company pursuing a monoclonal Ab that bound to the surface of T cells thus inactivating them Biotech companies want to make money as well they moved from the positive preclinical studies to clinical studies quickly Phase I studies were done testing safety in drugs Companies want to do this fast because they have a limited patent life on the drug So the first human trials were in 2006 In order to do so they often involve normal healthy volunteers who often volunteer for the money So in the UK they recruited a group of men and offered them money The Phase I study was designed with a large margin of safety they showed a certain dose was not dangerous in nonhuman primates Phase I designs are dose escalation experiments you gradually increase the dose until you see toxicity so you start at a dose you know is safe They started at a dose 500x lower than what they would think to be toxic based on the primate studies 6 got doses 2 got placebos they dosed patients 20 minutes apart Within 90 minutes of administering the first dose the people with the medicine developed pain Within 24 hours it was lifethreatening illness kidney failure multiorgan failure in 12 weeks One patient was hospitalized for a month Basically the MoAb had triggered a cytokine storm This gives you a picture of the questions and challenges that come up when you try to translate drugs from animals to humans You could ask if it was ethical to enrol these patients Also more globally you could ask if the risk level was at a level that we should tolerate or not should we make more stringent laws After this companies get worried about backing drugs that could trigger such a response Also people began to worry about cytokine storms The Mounting Burden for Health Care In order to mobilize social resources for illness one needs evidence Evidence In the realm of drugs this means we need evidence about the safety and efficacy of drugs before we expose patients to risk Human Experimentation 4 problems that are part of the core problem of producing evidence on human beings Next Slide Physicians are the ones doing the clinical trials They have a duty to their patients to do the best they can for them including using all resources But in medical experimentation it is mainly to advance the interest of others future patients etcNext Slide
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