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Alzheimer's Research does not Create "New Drug"

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On February 8, 2012, Science magazine published research showing that bexarotene (Targretin®), a drug approved for use in the US by the FDA for the very specific purpose of treating cutaneous T-cell lymphoma [CTCL] that can not be treated successfully with at least one other medication, that it can reduce brain amyloidal beta protein fragments in mice breed for Alzheimer's disease, increasing social skills and the sense of smell. http://www.sciencedaily.com/releases/2012/02/120209144005.htm

The news was greeted by Alzheimer's patients and advocacy groups with a overwhelming demand that physicians immediately prescribe the drug for those suffering from this debilitating and often frustrating condition. The few drugs that have been approved by the FDA for treatment of Alzheimer's may slow progression of the disease or improve some memory loss, but none can "cure" it. Other drugs not approved by the FDA for this indication have been tried but so far, have shown little more promise than the existing treatments.

The clamor for prescribing bexarotene for an off-label use, while understandable given the devastation Alzheimer's can cause for patients, family, caregivers and loved ones, is much too early and cannot be justified at this point in time. To do so, the prescriber and a dispensing pharmacist would be entering the world of experimentation, an activity that is way beyond the bounds of acceptable off-label use. Experimental use of drugs for new indications is regulated by the FDA and requires an Investigational New Drug Application (INDA) with the approval of the Institutional Research Board (IRB) where the research might be conducted before it can ever be prescribed for humans. Off-label prescribing is only permissible only when as there is a body of evidence, usually in the form of peer reviewed literature, that there is evidences it is an acceptable practice within the bounds of reasonable standards of health care to use the drug for a non-approved use.

The evidence that bexarotene might show promise for treating some aspects of Alzheimer's in mice does not automatically translate to its legally acceptable use in humans, at least not at this point in time. It may be difficult to explain this situation to families and caregivers who demand something that is better than nothing. Pharmacists should be prepared to explain why it is not appropriate to try using this drug in patients with Alzheimer's until further research is performed resulting in data that it can be useful for this indication in humans.

The March, 2012 edition of US Pharmacist will have a more detailed discussion of this subject and try to help pharmacists understand the mark of delimitation between unlawful experimentation and permissible off-label use of drugs.

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