Recent developments means a drug called thalidomide may get a second chance. The Infectious Disease News reported that the Food and Drug Administration is considering approval of thalidomide in the treatment of certain patients with leprosy. Leprosy is a bacterial disease that causes damage to the skin on the patient's face, nose, ears, arms, legs, fingers and toes, and sometimes causing severe disfiguring damage to persons infected with the bacteria. Only 500 people in the United States have leprosy and one study has shown that thalidomide may decrease the amount of damage to these patients.
Two years ago, Gilla Kaplan, PhD, Rockefeller University in New York, demonstrated that patients suffering from tuberculosis were able to gain needed weight when given thalidomide. Kaplan's study also demonstrated that thalidomide helped patients with diseases like AIDS, rheumatoid arthritis, lupus, multiple sclerosis and cancer gain necessary weight.
Unfortunately, thalidomide causes severe birth defects. In the 1960s, the drug was licensed in Europe to prevent nausea in pregnancy. An estimated 10,000 babies were born with phocomelia, a condition caused by thalidomide that resulted in an absence of arms and/or legs as well as other bone and organ abnormalities. Thalidomide was never licensed in the United States and only 17 cases of phocomelia were reported in the U.S.
Are the benefits worth the risk? Many people may be helped by this drug. Unfortunately, many people could potentially be injured by this drug.
One answer to this problem could be to properly dispense this drug. Another drug, isotretinoin (Accutane, Roche), used in the treatment of acne also causes birth defects. To get isotretinoin, the drug stores must register with the government before purchasing the drug. The drugstores must not dispense more than a month's supply of the drug, no automatic refills could be given, and all patients must also register with the government before receiving the medication.
This could be required before a patient received thalidomide as well. Doctors and patients should also be required to go through extensive education concerning the dangers of thalidomide and female patients could be required to show proof that they are using contraception before getting the drug.
A tough issue but one that the Food and Drug Adminstration (in the U.S.) will be tackling soon. What is your opinion?
Take Care and Think Microbiologically!
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