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EXECUTIVE SUMMARY:
That elusive, vague, and shifting line that represents the balance between any drugs risks and its benefits again became a focus of controversy in August in the case of Glaxo Wellcome's newly approved Lotronex (alosetron), indicated for severe, diarrheaassociated irritable bowel syndrome.
No doubt foreseeing a re-run of its ultimately successful case against Warner-Lambert's Rezulin (troglitazone), forced from the market last March, Ralph Nader's Public Citizen Health Research Group (HRG) filed a citizen petition at the FDA to have Lotronex removed from the market.
It is an old story, stretching back many years and embracing many drugs - all of them the subjects of characteristically strident HRG demands for market withdrawal.
Citing continuing reports of ischemic colitis associated with the drug's use since its approval in February, and the FDA's decision earlier in August to make Lotronex the subject of the agency's first mandatory, patient-language Medication Guide that must be dispensed with every prescription, the HRG predicted there would be patient deaths from such a tepid regulatory response.
"There is no way," the HRG petition said, that the FDA can "justify using a minimally effective drug that is only palliative for a non-life-threatening condition, and, in the process, putting women at risk of ischemic colitis, which can be life-threatening, and its serious complications which have required intestinal surgery, including colectomy. As use of this drug spreads to less healthy and more poorly monitored populations, and prescribing extends beyond the three-month duration of the clinical trials, we will surely see a continued increase in the number and severity of adverse events, and almost certainly, fatalities."
The HRG's petition contended that past FDA reliance on tougher labeling restrictions and "Dear Doctor" letters have proven inadequate. It cited an internal FDA document on the review of Lotronex in which FDA Division of Risk Evaluation II Director Evelyn Rodriguez reported that her studies has found that labeling changes and "Dear Doctor" letters are not particularly helpful: "providers and patients are confused and do not understand after multiple re-labelings what the really important message is."
As for the imposition of the FDA's first Medication Guide requirement, the HRG petition asserted that this set an important program "off on the wrong foot, as its...