Originally created 05/26/98

The people's pharmacy: Thalidomide may usher in new era of cancer therapy

In 1960 a pediatric surgeon and cell biologist named Judah Folkman came up with a novel approach to cancer. It took him more than 10 years to get a journal to publish his theory, which was so revolutionary that most of his colleagues derided it for years.

Dr. Folkman labored in relative obscurity for more than three decades until an article in The New York Times made the implications of his research clear. His concept that cancer could be controlled by cutting off the blood supply to tumors has now made the covers of Time, Newsweek and U.S. News & World Report.

The research in mice is extraordinary. Transplanted human cancers disappear after treatment with compounds called anti-angiogenesis agents that stop the growth of blood vessels.

Despite the intense interest, however, these compounds have not yet been used in humans. Angiostatin and endostatin are hard to make and it will be years before clinical trials in cancer patients will show whether or not they are effective for people. Many cancer patients were disappointed to learn this after hearing that a cure for cancer might be on the horizon.

Ignored throughout the media frenzy of the last few weeks is another anti-angiogenesis compound that is actually poised for FDA approval. Notorious for its horrible history of crippling birth defects, thalidomide may ultimately prove to be one of the most beneficial drugs ever developed.

The very property responsible for deformed arms and legs in babies whose mothers took thalidomide while pregnant may also make this drug a blessing for people with leprosy, AIDS, cancer and a range of other serious health problems. Its ability to prevent the growth of blood vessels and modify the immune system makes thalidomide the first drug in the new class of cancer compounds that Dr. Judah Folkman's research has launched.

The Celgene Corp. will market Thalomid (thalidomide) initially for ENL (erythema nodosum leprosum), a serious skin condition associated with leprosy. We anticipate that Thalomid could reach pharmacies by the end of the summer.

The company has developed an unusual set of precautions to prevent a repeat of the thalidomide tragedies of the 1960s. Pharmacies dispensing the medication will be registered and will track patients to ensure that the drug is being used appropriately.

Female patients will be required to have a negative pregnancy test before taking Thalomid and will be tested monthly to determine that they have not become pregnant while on the drug. If sexually active, they will be advised to use two effective methods of contraception. Men will be told to use condoms, as it is not known whether thalidomide is found in semen.

Initially, Thalomid will be approved only for leprosy, but once a drug is in pharmacies, physicians can legally prescribe it for other purposes. Possible applications may include cancers of the brain, breast, colon or prostate; macular degeneration; Crohn's disease; lupus; tuberculosis; rheumatoid arthritis; aphthous ulcers of AIDS and AIDS-related wasting.

Doctors who want to prescribe Thalomid for such off-label indications will have to follow stringent guidelines and be well-informed about risks as well as potential benefits. Celgene plans to respond to inquiries from health professionals through its medical affairs department.

In addition to birth defects, thalidomide can cause numbness or tingling of hands, arms, legs and feet (peripheral neuropathy). Other side effects may include drowsiness, headache, dry mouth, constipation, thyroid problems, itching and blood sugar imbalance.

Despite its risks, thalidomide may usher in a new era of drug development and cancer therapy. Dr. Folkman's dream of curing cancer may come true with anti-angiogenesis cocktails that include thalidomide and similar drugs still being developed.

Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. Write to them at Graedons' People's Pharmacy, P.O. Box 52027, Durham, NC 27717-2027, or e-mail to PHARMACY@mindspring.com.


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