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Thalidomide -- the Story Goes On ...

By James Learned

September 1998

In mid-July, the FDA approved thalidomide as a treatment for leprosy (Hansen's disease) with the brand name, THALOMID. So begins another chapter in the complicated history of a drug with enormous clinical potential as well as dangerous possible side effects. Working with the FDA, Celgene Corporation (one of the drug's manufacturers) has developed a distribution program modeled on the program we created in mid-1995.

It was at that time that the PWA Health Group first imported the drug for PWAs suffering from aphthous ulcers (painful sores in the mouth, throat, vagina or rectum) and/or wasting (unexplained weight loss). Our rigorous standards and requirements (a 21 page booklet of necessary information with informed consent signed, supply limited to 10 days per prescription, a new prescription required with refill and one-on-one counseling session) established the blueprint for Celgene and the FDA to open compassionate use access to the drug for AIDS indications.

THALOMID's approval requires doctors and pharmacies to register with the FDA in order to provide the drug to patients. The program will help educate doctors, pharmacists and patients about the drug's pros and cons, but the intention is also to restrict and control access as much as possible. Off-label use will definitely occur, probably a lot. In other words, doctors will prescribe it to treat conditions other than leprosy, conditions for which it has shown some promising results -- AIDS-related wasting, aphthous ulcers, kaposi's sarcoma, microsporidiosis, cancer and lupus. The drug will be dispensed before your final approval is granted and it will be discontinued if your reason for use is disapproved by the FDA.

For information about how to register to prescribe THALOMID, your doctor and pharmacist should call Celgene: (888) 423-5436. Informed consent will be required of anyone before they receive the drug. Women of "child bearing age" will need proof that they're not pregnant, and each prescription, which will be limited to 28 days worth of drug, must be filled within seven days or it expires. Celgene is aiming for Oct. 1. but probably won't have THALOMID on pharmacy shelves until mid-October, 1998. If you have questions about Celgene's program please call Dr. Ken Resztak, Director of Medical Services at Celgene Corporation, (732) 805-4083.

THALOMID's approval is a victory for PWAs and others who need access to the drug. But the victory carries enormous responsibility. The birth defects caused by thalidomide forty years ago weigh heavily on all considerations of its use. Other possible serious side-effects include peripheral neuropathy, neutropenia (fewer white blood cells that help fight infections) and heavy sedation. Educational pamphlets, informed consent, and restricted access have been useful tools in the Health Group's program, and hopefully, will be enough to keep history from repeating itself. As THALOMID becomes more widely available to people with life-threatening conditions, including those that are HIV-related, we can only hope that these tools will remain successful.

The approval of thalidomide as THALOMID does not mean that clinical trials of thalidomide are now closed. Here are phone numbers to call if you or your doctor are interested in other ways to get the drug:

1) Pediatric Pharmaceuticals: (732) 603-7708, FAX (732) 632-2522.

Doctors need to get an IND from the FDA (see #5 below). Drug is shipped in bottles of 200 tablets (100mg) for $210, prepaid with a check. Cost includes $10 shipping.

2) Andrulis: (301) 419-2400.

Doctors need to get an IND from the FDA (see #5 below). This program is HIV friendly and they have the ability to help those who can't pay. Drug is shipped in bottles of 100 tablets (100 mg) for $309.

3) Clinical Trials Info: (800) TRIALS-A (AIDS trials), (800) TRIALS-C (Cancer trials).

4) The Network: (212) 260-8868 or (800) 734-7104.

The Network helps you locate experimental treatments and clinical trials information.

Sometimes things aren't as easy as they would seem. If you run into trouble with any of these programs please call us or have your doctor call us here at the PWA Health Group, (212) 255-0520. We will do everything in our power to help you get the treatment you need.

Back to the September 1998 contents page.

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