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Friday, June 29, 2007

Unexplained Medical Syndromes

The Feb. issue of FASEB Journal (Vol. 21, pp. 299-301) had an
interesting editorial by Gerald Weissman entitled "'Chronic Lyme' and
other medically unexplained syndromes." Here is one excerpt:

[TW]
Groups of patients and advocates march against medical science under the
banners of "chronic fatigue syndrome," "myalgic encephalitis,"
"irritable bowel syndrome," "total chemical allergy," etc. There is no
question that patients suffer—and often terribly—from conditions to
which these labels have been given. There is also no question that their
disability is real. Skeptics worry, however, that the hallmark of these
"diseases" is that diagnosis requires the complete absence of objective
physical or biochemical derangement. They wonder whether such patients
are not really victims of a complex set of socially and medically
constructed diseases—much as the "railway spine," "chronic
appendicitis," or "female hysteria" favored by 19th century clinicians.

Full text available at:
http://www.fasebj.org/cgi/content/full/21/2/299

___________________________
[D-]

Pfizer announced (June 22, 2007) that the FDA approved Lyrica [Pregabalin] for the management of fibromyalgia. According to the company, in the 2 clinical trials with more than 1800 subjects, Lyrica demonstrated rapid and sustained improvements in pain compared with placebo. Lyrica’s approval for fibromyalgia represents the eighth Pfizer treatment to receive “priority review” status from the FDA over the past two and a half years, the company said. http://www.fdanews.com/newsletter/article?articleId=94987&issueId=10352

A Priority designation is intended for those products that address unmet medical needs. http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm

Pregabalin is a schedule IV controlled substance (low potential for abuse) and was initially approved in December 2004 for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Pregabalin is also indicated as an adjunctive therapy for adult patients with partial onset seizures. More than 5 million patients worldwide have been prescribed the drug, according to Pfizer.

So, not only do we have a medical condition that is defined in the absence of objective physical or biochemical derangement, we have a drug to treat it that has "priority" FDA approval in the absence of an understood mechanism of action. I really think a third study arm should have used gummy bears.


dras

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