shaw@garp.mit.edu (Alan Shaw) (11/03/89)
The Treatment & Data Digest A Review of issues addressed by ACTUP's T&D committee during its past week of activities Number 17: October 23, 1989 INCREASING THE AVAILABILITY OF ddI: It has now been a couple of weeks since Bristol-Myers started its program to distribute ddI to people not enrolled in official phase II trials. Any physician who called Bristol-Myers' 800 phone number should have received the enrollment forms and entry criteria. Moreover, some people may have already received the drug; others will be getting it shortly. Yet not everyone who needs ddI will be served by Bristol-Myers' program in its current form -- there are still some criteria which exclude too many people. Consequently, T&D is in the process of studying how the inclusion criteria can be changed to further increase distribution of the drug. The plan is to gather together a group of community based doctors and PWAs and listen to their problems in getting ddI. By hearing actual stories of why Bristol-Myers' program isn't working as well as it could be, T&D will be armed with the information it needs to begin a new round of negotiations with Bristol-Myers. Since the company has been responsive to ACTUP's suggestions in the past, there is a strong possibility that Bristol-Myers can be convinced to expand the program some more. ACTIVIST REPRESENTATION ON THE ACDDC: Before a drug is put into trials by the federal government, a group called the AIDS Clinical Drug Development Committee reviews all information on it and decides what priority it should be given for testing. Historically, the ACDDC has given highest priority to nucleoside analogues (drugs like AZT, ddI, and D4T, all of which stop HIV's activity in about the same way), and ignored drugs that work by other methods. ACTUP has been trying to get the ACDDC to give a higher priority to other types of drugs for quite some time. Our efforts may finally have some effect. In a meeting last week with Tony Fauci, head of the federal government's AIDS testing program, ACTUP got Fauci's promise to put a PWA or AIDS advocate on the ACDDC. With a strong activist voice on the committee, a greater variety of drugs should get tested. GM-CSF MAY INCREASE THE INCIDENCE OF MAI: GM-CSF is a drug that stimulates the body to produce more white blood cells, in particular a type of white blood cell called neutrophils that are very important in fighting off infections. There has been a lot of excitement around GM-CSF because people with AIDS often have low neutrophil counts as a result of chemotherapy or use of AZT or DHPG. Sometimes those therapies have to be stopped because the white blood cell counts get just too low; the hope was that GM-CSF would keep the counts high and thus allow the therapies to continue. However, some doctors have reported that their patients on GM-CSF are coming down with MAI at a much higher than normal rate. The fear is that GM-CSF is speeding up MAI's activity. There is theoretical justification for that fear: GM-CSF stands for granulocyte-macrophage colony stimulating factor. It gets its name because it stimulates colonies of blood cells -- granulocytes and macrophages in particular -- to develop at a faster than normal rate. MAI, a type of bacteria that causes severe brain infections and is very difficult to treat, lives in macrophages. Thus stimulating the macrophages could stimulate MAI. All is not lost: there is another drug that is very similar to FM-CSF called G-CSF. The difference between the two is that G-CSF stimulates only granulo- cytes, and thus shouldn't cause MAI to speed up. Moreover, not all doctors using GM-CSF have reported problems with MAI. With all that said, if you or someone you know needs to get GM-CSF contact Mark Harrington at (212) 353-8430. Mark has been in contact with Schering- Plough quite a bit recently and seems to be having good luck in getting the company to give GM-CSF to people who need it. WE NEED DATA ON OPPORTUNISTIC INFECTIONS: Since the beginning of the AIDS epidemic the Centers for Disease Control (CDC) in Atlanta has been keeping track of how many people get and die from AIDS. What the CDC has not been doing, however, is tracking what specific opportunistic infections PWAs get and die from, and as a result, the incidence rates of some infections are not accurately known. But as ACTUP has been stating for a long time, people don't actually die from AIDS, they die from specific infections -- infections that are often treatable and sometimes preventable. Yet treatment therapies can't be designed, nor research started, until scientists know which infections should be given the highest priorities. Nowhere is this more evident than in the federal government's AIDS Clinical Trials Group, the program that is meant to test promising AIDS therapies. As big as the ACTG program is -- or could ever get -- it is not big enough to test all the drugs that have been discovered to show preliminary effective- ness, not even all the drugs that are extremely promising. Given these constraints, an overall strategy must be developed to prioritize what drugs to test first. Yet such a strategy can't be designed at the present time because there are still too many holes in our knowledge about AIDS. For example, do more people die from MAI or from toxoplasmosis? What percentage of PWAs have serious CMV related problems? Neither of those questions can be answered right now. Nor a whole lot of others. But the answers need to be known in order for a comprehensive strategy to be worked out. AIDS FUNDING TO FALL SHORT OF NEEDS: Granted, the federal government has never provided enough money for the amount of AIDS education and research that is needed. Yet in the past Congress had always approved more money in the federal budget than the administration had asked for. This year that did not happen, and there is good reason to believe that Congress will get tighter with the money it gives to AIDS programs. In fact, money for AIDS is expected to plateau in the next few years, just as the AIDS caseload is skyrocketing. Why? Congress is comparing AIDS funding to other health related funding -- cancer and heart disease in particular -- and believes AIDS is getting too big a piece of the funding pie. And rather than increase all health funding, they'll simply lower the percentage of money that goes to AIDS. Money for research is expected to be particularly hard hit. This could be ACTUP's biggest challenge. Our past successes have usually come from applying pressure on a particular agency or person, and as a result we've been able to correct specific deficiencies on a case-by-case basis. With the exception of parallel track, we have not focussed too much on getting larger, more global changes into place. And we have not worked with Congress and don't have much experience in lobbying. All that needs to change. The more experience we gain, the more we discover that some problems are just too big to solve using our present methods. To deal with these issues -- issues like how to finance AIDS research (or all necessary health research more generally) -- will require new approaches. Congress must become a high priority, and we must spend more time on coalition building. SCREENING FOR ANTI-OI DRUGS: Each year, the National Cancer Institute screens thousands of substances to see if they have anti-HIV properties. Those sub- stances that show promising test tube (in vitro) results are then considered for more extensive research and trials. Currently, however, the NCI only looks for substances that show activity against HIV. No program exists to screen substances for activity against specific opportunistic infections like PCP, toxoplasmosis, CMV, or MAI. Such a program needs to be set up. There may very well already be drugs in existence that could be useful in treating those and other OIs. We'll never know unless a screening program is created. IMPORTANT NUMBERS: AIDS Treatment Registry: information about trials in the New York area: 212-268-4196. Project Inform: information on different experimental treatments: 800-822-7422. National Trial Hotline: information on trials throughout the United States: 800-TRIALSA. Bristol Myers ddI Hotline: information on how to get ddI outside of the official phase II trials: 800-662-7999. QUESTIONS? Call Stephen Gendin at (718) 636-9254 or Mike Barr at (212) 765-7127.