May 2, 2006
The Food and Drug Administration (F.D.A.) has recently given the go-ahead for clinical trials of a new drug derived from marijuana, says Henry Miller, a doctor and fellow at the Hoover Institution.
In January 2006, the F.D.A. approved advanced clinical trials of the mouth spray Sativex -- which contains an equal ratio of two cannabinoids (bioactive substances found in marijuana). The composition of the drug and the manner in which it is delivered ensure that its active ingredients can be medically effective without causing the "high" that many patients view as an undesirable side effect, says Miller:
- It has already been approved in Canada for the treatment of neuropathic pain associated with multiple sclerosis, and it is available by prescription (though not yet fully licensed) in Spain and Britain.
- According to GW Pharmaceuticals, the British company that makes the drug, more than 1,500 patients in those three countries are using Sativex to alleviate pain, muscle spasticity and other serious problems.
- But for Sativex to be marketed in the United States, it must first be judged safe and effective by qualified experts, and that judgment requires the review of scientific evidence.
However, smoked marijuana cannot be subjected to careful, well-controlled trials, because it does not come in a standard, reproducible formula or dose, and cannot meet the accepted standards for drug purity, potency and quality, says Miller.
Furthermore, F.D.A. officials must ensure that the testing and potential approval of cannabinoid-containing drugs are not hindered by political agendas or other nonscientific considerations. For the benefit of patients in need, this is something about which the F.D.A., the parts of our government waging the "war on drugs" and other interested parties should be able to agree, says Miller.
Source: Henry I. Miller, "Reefer Medicine," New York Times, April 28, 2006.
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