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As discussed in Chapter 4, it is reassuring to see that there has been a slight decline in non-medical use patterns for marijuana since 1996 on both state and national levels even though there has been massive publicity about successful state initiatives legalizing marijuana's medical uses. Of course, it cannot be determined whether these slight declines would have been even larger in the absence of the substantial amounts of information in the media about the medical uses of marijuana. Regardless of what the actual net public health impact would be of advertisements about the medical use of psychedelic psychotherapy, FDA is powerless to prohibit the ads. Any regulations on advertisements of psychedelic psychotherapy would need to be the subject of a voluntary agreement between FDA and the sponsor. Voluntary agreements can still be enforced, with companies with products in the development pipeline being especially unlikely to try to renege or violate agreements with FDA. Regulatory Design by Analogy The next section of this chapter will focus on the regulation of methadone, thalidomide and electroconvulsive therapy ECT ; . The regulation of these medical treatments will be analyzed in an effort to derive lessons from those cases that may prove instructive in the design of a regulatory system for psychedelic psychotherapy. These lessons will be used as a basis for the elaboration of a regulatory system for psychedelic psychotherapy that will follow the analysis of these cases. Restrictions on Medical Practice: The Methadone Exception The major exception to the limitations in FDA and DEA authority to regulate the practice of medicine is the unusually detailed and intrusive regulation of the medical use of methadone in the treatment of narcotic addiction.1467 Virtually every aspect of the use of methadone in the treatment of narcotic addiction has been regulated, including specific restrictions on dosages, patient selection and retention, time limits for short-term and longterm detoxification, criteria for take-home dosages, facilities for distribution, organizational structure, training of staff, staff patient ratios, frequency and type of urine or blood testing of subjects, required counseling and health services, recordkeeping, HIV counseling requirements, and so on. The legal justification for this exceptional set of regulations is that FDA and DEA are acting under special authority granted by Congress to the Secretary of Health and Human Services and the Attorney General, as part of the Controlled Substances Act of 1970.1468 The relevant section of law was very simple, stating that "The Secretary of Health and lansoprazole.
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Principal Investigator: Dr Roger A Barker Institution: Cambridge Centre for Brain Repair, Cambridge Start date: October 2003 Completion date: December 2006 Award: 123, 960 Introduction Cell transplantation to replace dopamine-producing neurons that are lost in Parkinson's is a promising clinical therapy. To date, the most successful transplants have involved harvesting the tissue from the foetus of the same species at the time that the dopamineproducing nerve cells are normally developing in the case of humans this involves collecting foetuses that are between 69 and 812 weeks old. This technique is, however, limited for practical reasons by the need to collect large numbers of foetuses. Furthermore, the transplant only works if placed where dopamine normally works, namely the striatum, and not where the dopamine-producing nerve cells are lost in Parkinson's, namely the substantia nigra SN ; . This is because dopamine-producing nerve cells transplanted to the SN cannot send fibres to the distant striatum. Finally, these transplants only treat those symptoms attributable to the loss of dopamine-producing nerve cells from the SN, and do not help for symptoms that may relate to cell losses at other sites. Aims of Project The purpose of this study was, therefore, to find cells that can be readily obtained; have the potential for generating long fibre projections; and can migrate to all areas of cell loss and damage. One such cell that may have all these properties is the foetal neural xenografts i.e. tissue that is derived from the developing brain of a different species to the host ; . Key findings from this project The results of this study have shown that.
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