Albendazole is the only known treatment for microsporidiosis, a common infection in PWAs that often causes severe, debilitating diarrhea. It's available in Europe and most developing countries, but has yet to be approved here. In the meantime, there is SmithKline Beecham's compassionate use program, known as Protocol 030. The program has been open for quite a while, but it has been creatively disorganized and cumbersome. Hopefully, that will change soon. Folks from AIDS organizations in NY and Philly have been meeting with SmithKline (SKB) for the past year with some positive results. Of course, it's been very much like pulling teeth.

Things your doctor may not know: Getting in does not require a colonoscopy. SKB will also ask for a stool exam or a small bowel biopsy, but does not require either. The only requirement for compassionate use is that your doctor tell SmithKline that you need albendazole for micro. Also new: your doctor can now use a national IRB, called Western IRB, rather than seeking approval from her or his individual hospital. For many doctors, this will be enormously helpful.

Of course, there's a down side-a few down sides. First, the compassionate use dosage starts at 800 mg a day with monthly incremental increases up to 2400 mg a day. Obviously, different people need to use different dosages. But, according to what SmithKline representatives said in a Dec. 12th meeting, if you and your doctor agree to a different dosage, that can easily be worked out. Secondly...Beware! The paperwork is frightening. According to more than one doctor, the paperwork is as cumbersome as that of any compassionate use program they know. And it needs to be filed every twenty-eight days. This is a big reason why doctors may not suggest this program. But we're continuing to work to make the program more accessible and streamlined.

The main reason you may not know about compassionate use is that SmithKline has been pushing their clinical Trial 029 at the expense of compassionate use. A poorly designed, placebo-controlled trial, 029 has been very slow to enroll for over a year. Getting in requires invasive procedures, and most people suffering from months of diarrhea and weight loss don't want to take the chance of receiving a placebo. Whether or not you qualify for 029 has nothing to do with your eligibility for compassionate use. You do not have to fail to get in the trial in order to get albendazole for free. It really is your choice, so don't let your doctor or SmithKline confuse you about that.

Please call us here at the Health Group and let us know your experiences with the compassionate use program, good or bad. We're keeping score. SmithKline needs to be held accountable for an ethical, accessible program, and the only way we can help achieve that is to know what's going on out there. SmithKline has a successful track record of wearing down people until they give up, tired and disillusioned doctors, patients, and researchers alike. This has happened to many folks trying to enroll in the compassionate use program: they've been put on hold, sent from extension to extension, waited for a return call.

SKB officials brought a flow chart to a September meeting with activists which detailed the hoops you and your doctor have to jump through in order to have albendazole arrive at your doorstep. They claimed that the whole process takes 24-48 hours after the first call, providing your doctor has completed the paperwork. But the SKB person who actually processes the applications at SmithKline says that it should take no longer than a week¾way too long. Asked about these contradictory claims, SKB officials said that the doctors' paperwork is processed immediately, but delays happen because so many company officials have to sign the papers, and that frequently they get incomplete or incorrect information on the mountain of forms. Good luck! Hopefully, this situation will improve, but we need to know about your experiences so we can help.