this entire 1932 paper if you’d like to read it. Thomas and his team discovered through work in dogs that there were specific cells in bone marrow that could restore hematopoiesis after lethal irradiation. one could even make burgers from a consumer’s very own stem cells creating a new form of autophagy (self-digestion) that cell biologists never imagined. The fact that meat stem cells require FBS to grow undermines the argument for animal welfare as a rationale for lab-grown meat because FBS is a product made by draining the blood from cow fetuses.I see this case as a key test of how society wants medical innovation to occur and the balance between the two types of?Practicing physicians generally support the continued need for dual new therapy discovery pathways to protect patients and advance medicine-??FDA/Pharma?? and ??Physician Innovation?? While all of our advances in drug therapy have occurred through the FDA/Pharma pathway almost all of our innovations in medical procedures have developed through physicians treating patients and outside of the RCT process Without both we would have none of the modern medical miracles we all take for grantedType 1 regulatory error occurs when we allow a harmful therapy to be widely used-FDA excels in preventing this type of error Type 2 regulatory error occurs when a beneficial therapy is disallowed-this is mitigated through the Physician Innovation pathway For example FDA??s current process is hampered by a glacially slow adoption of new therapies in exchange for obtaining high quality data supporting safety and efficacy while the physician pathway for innovation allows much quicker access to therapies but is hampered by lower quality data The FDA approach uses regulatory assurances to expose patients to mass unconsented risk (ie patients don??t sign a consent to take the newest Cholesterol drug; they assume certain safety and efficacy parameters) On the other hand medical procedures require an) No matter how you slice it applying a mass manufacture public health model to an individually consented risk makes little sense For example patients are consented for significant medical procedure risks every day where it??s often impossible to fully quantify the risk or verify the likelihood of success-just as in an autologous stem cell procedure So to answer your question I see the need for both points of view and believe FDA has just lost focus in this instance I believe when cells are mass manufactured and distributed they should be regulated as drugs because there is mass unconsented risk and that preventing type 2 error has a societal benefit The flip side of that coin is that applying mass distribution principles to autologous cells magnifies type 1 error and ignores the ICR concept-which hampers innovation Has FDA made a good decision when pursuing this case As former FDA commissioner Dr von Eschenbach recently said in the Wall Street Journal Op Ed he believed that this case has ??If Regenerative Sciences wins the case what do you believe will be the impact of the case more broadly for stem cell treatments in the US and globallyCenteno: This case will be appealed by both sides and likely end up in the Supreme Court (or not and be settled at the Appellate court level) Therefore its impact won??t be felt for several years If FDA loses this case it could lose in many ways and in many different areas As one specific example a federal judge could delete parts of 1271 as ??ultra vires?? (beyond the powers authorized by congress) In that case I expect the FDA will issue a Compliance Policy Guide (CPG) The CPG must more clearly define what is the practice of medicine and what is the manufacture of a drug If this future comes to pass I suspect you??ll see physicians using autologous stem cells alongside any ??stem cell drugs?? being produced for mass distribution In the short run this competition will lower prices for consumers and perhaps expand the number of doctors offering questionable therapies In the long-term the systems already in place to regulate physicians will respond and autologous stem cells will be regulated the same as the culture of human embryos for fertility treatments (5 day blastocyst procedure) There will be physician regulations through individual states with professional societies jumping in to provide guidelines and accreditation (like the College of American Pathologist??s IVF Accreditation program) as well as a civil court system to address malpractice claims The physician side won??t be under regulated as physicians are already regulated through a bevy of entities including medical boards public health departments Medicare hospitals specialty boards and the civil court systemSipp:In the best-case scenario it will be a complete disaster for the field By eroding the ability of the government to exert control over stem cell marketing a decision in favor of Regenerative Sciences would result in an accelelration of the race to the bottom mentality that