A recent announcement by the Food and Drug Administration that it has approved thalidomide for a rare complication of leprosy may seem irrelevant to most Americans. After all, only 50 patients a year suffer from the problem for which the drug is indicated.
Many people may wonder why the agency would allow thalidomide on the market at all. It is the most reviled drug in history. In the 1960s, thousands of European children were born with deformed limbs because their mothers took this sedative during pregnancy.
Despite this horrific legacy, thalidomide is one of the most promising drugs of this decade. Researchers are actively investigating its role in the treatment of cancers of the brain, breast, colon or prostate; aphthous ulcers of AIDS; AIDS-related wasting; rheumatoid arthritis; macular degeneration; Crohn's disease; lupus and tuberculosis.
Thalidomide has the ability to modify the immune system and delay the growth of new blood vessels. This is why it can have such devastating effects on a fetus, but it is also the key to scientists' current fascination with the compound.
Many cancers stimulate blood-vessel growth to feed rapidly growing tumors. Interfering with this vascular development offers a new and exciting approach to fighting cancer.
Thalidomide is not the only anti-angiogenesis compound being studied. Harvard researcher Judah Folkman electrified the scientific community earlier this year when he announced his startling results with angiostatin and endostatin. Research in mice showed these compounds to be remarkably effective against a variety of solid tumors and even leukemia.
Publicity about a possible cure for cancer encouraged many patients and their families. But their hopes were dashed when they learned that it would be years before these experimental drugs would be properly tested and made available for humans.
Most terminal cancer patients cannot afford to wait that long. Dr. Folkman has pointed out that clinical trials are already in progress with thalidomide. Though results are preliminary, this angiogenesis inhibitor has shown promise against breast cancer and some brain tumors.
Doctors are well aware that once a drug is approved for one use, it can be prescribed for other indications. That is one reason why the FDA has gone to such lengths to reduce the risks of birth defects caused by thalidomide.
Thalomid (thalidomide) will be shipped in four to six weeks, but only to registered pharmacies. To have their prescriptions honored, physicians will have to participate in the System for Thalidomide Education and Prescribing Safety. This unprecedented program includes a plea from victims of thalidomide-induced birth defects and a videotape. Physicians and pharmacists who would like to register or get more information may call (888) 423-5436.
Women will be urged to use two reliable methods of contraception, while male patients will be required to use condoms. Even with such precautions, though, there is great concern that mistakes will be made and infants will be born with tragic birth defects.
To maximize the benefits and minimize the risks of this extraordinary compound, everyone -- physicians, pharmacists and patients -- will have to exercise unprecedented vigilance and caution.
Write to Joe and Teresa Graedon at P.O. Box 52027, Durham, NC 27717-2027. You can e-mail them via their Web site (www.peoplespharmacy.com).
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