Advances in the Treatment of LEPROSY
Leprosy is an infectious disease caused by the bacteria Mycobacterium leprae with symptoms of disfiguring skin lesions and sensory loss in the skin, muscle weakness, and progressive debilitation caused by peripheral nerve damage. Symptoms can take as long as 20 years to develop. Through ancient times, leprosy was regarded by the community as a contagious, mutilating and incurable disease. Today, leprosy is treatable and curable, and we now know it is difficult to transmit.91,92
While leprosy is most common in temperate, subtropical and tropical climates, approximately 100 cases are diagnosed each year in the United States. Children are more susceptible than adults to contracting the disease.93
Erythema nodosum leprosum (ENL) is a serious inflammatory complication of leprosy that can include severe skin lesions, nerve pain, loss of nerve function, joint swelling and high fever.94
Patient Perspective: Reason for Exile in the Old World
PHARMACEUTICAL ADVANCES
Ancient, "Incurable" Disease Now Treated with "Second Chance" Drug
Nearly 40 years after thalidomide was first found to produce severe birth defects when used as a treatment for morning sickness associated with pregnancy in countries around the world, it was approved for the first time by the FDA in 1998. With tight restrictions, it is now used to treat debilitating skin sores that result from ENL.95 In clinical trials, treatment with thalidomide caused improvement in at least 70 to 80 percent of patients with ENL, compared to approximately 25 percent of patients given placebo.96
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Since the Orphan Drug Act, over 1,450 drugs in development have been designated as orphan products.97 |
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Endnotes:
91 National Library of Medicine, MedlinePlus Medical Encyclopedia, "Leprosy," http://www.nlm.nih.gov/medlineplus/ency/article/001347.htm (accessed 12 September 2005).
92 World Health Organization, Leprosy, http://www.who.int/mediacentre/factsheets/fs101/en (accessed 12 September 2005).
93 National Library of Medicine, MedlinePlus Medical Encyclopedia, "Leprosy," op. cit.
94 International Foundation of Anti-Leprosy Associations, "The Management of Erythema Nodosum Leprosum," ILEP Technical Bulletin 9 (May 1996), http://www.ilep.org.uk/documents/tb09eng.pdf (accessed 1 August 2005).
95 Food and Drug Administration, Thalidomid® Consumer Information, http://www.fda.gov/cder/news/thalinfo/thalomid.htm (accessed 3 October 2005).
96 Food and Drug Administration, "FDA Approves Thalidomide for Hansen's Disease Side Effect, Imposes Unprecedented Restrictions on Distribution," 16 July 1998, http://www.fda.gov/bbs/topics/ANSWERS/ANS00887.html (accessed 3 October 2005).
97 Food and Drug Administration, "Office of Orphan Products Development," Budget 2006, http://www.fda.gov/oc/oms/ofm/budget/2006/PDFs/Summary/Pages194thru199.pdf (accessed 7 September 2005).
