Thalidomide usage grow in the underground
Thalidomide is spreading very far away from the supervising eye of the authorities. AIDS-groups have their own networks to get access to the drug.
A search at the
WWW-web gives thousands of hits on the search string "thalidomide." Plenty of the links ends at sites run by support groups for people with AIDS and cancer. Food and Drug Administration, FDA, in USA tried to limit the accessibility of the drug in the mid 1990s. But large scale trafficking of thalidomide from Brazil and Mexico dashed FDAs hope of getting control of the usage.
Brazil consumes only Brazil consumes only 400 kg = 881,848 lb = 62,989 stone of the 1200 kg = 2645,544 lb = 188,967 stone thalidomide produced in the country each year. Two thirds of the drug is either exported - legal or smuggled - or sold on the Brazilian Black Market.
FDA decided to open the gates to their emergency investigational new drug program ( IND ) that provides access to thalidomide for the treatment of ulcers and wasting. In order for a patient to be approved for the emergency IND, a physician must submit information to the FDA regarding (1) location of the ulcers (2) duration of the ulcers (3) all previously tried therapies (4) a recent negative herpes culture (5) a biopsy report (6) a negative history of peripheral neuropathy (7) documented weight loss.
Processing the IND takes 24 to 48 hours. Once an emergency IND for thalidomide is approved, the FDA ships a free one-month supply of the drug. Physicians ordered the drug directly from the manufacturers, Celgene Corporation or Andrulis. Paediatric Pharmaceuticals is the third company that is licensed to market thalidomide in USA . Paediatric Pharmaceuticals provides the drug for $1 per 100 mg pill. (Celgene charges $6.56 per 100 mg pill).
Access via "Buyers clubs"
A more unofficial way of getting the drug is via "Buyers clubs." Buyers clubs supply experimental medications for people with AIDS and have made thalidomide available through underground sources. A few years ago did three buyers clubs still advertise thalidomide on their web-sites: PWA health group in New York , Healing Alternatives in San Francisco , and Life Link near Santa Barbara ? When these lines were written, Healing Alternatives did still supply thalidomide on their site.
The actions from various buyers clubs forced FDA to take a more liberal attitude towards the use of thalidomide. FDA realised that thalidomide could never be totally stopped.
The price for thalidomide also varies greatly between buyers clubs. The price for thalidomide at PWA Health group is $2.25 per 100 mg pill or $22.50 for a bottle of 10 — a ten-day supply. This compared with Life Link, which sells the drug in 50 mg. capsules for $60 a bottle.
No side-effects?
Side effects are naturally not on the top of the bill on AIDS-related
WWW-sites. They mention though, that some allergic reactions can result from taking thalidomide, especially at higher doses (300 to 400 mg daily — which is well over twice the daily dose when used as a sedative). In the trial conducted in Thailand , six patients on thalidomide developed rashes as a result of the drug. Other reactions may involve high fevers, and extreme flu-like conditions.
Researchers have also found that long term use can cause peripheral neuropathy. But there is no need to worry, according to these sources. Peripheral neuropathy can easily be avoided by just starting at a low dose; 100 mg daily, (50 - 100 mg/day was the dose recommended in the 1960s) or discontinuing the drug if necessary. And as an extra relief, it can be noted that Dr. Gilla Kaplan of Rockefeller University states in web-sites belonging to AIDS and cancer support groups, that people who are infected with HIV and being treated for TB do not seem to experience the allergic reactions.