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Notes From the Underground

June/July 1997

One Lump or Two

By Halley Low

The FDA has issued an important notice to all people taking, or considering taking, any of the four approved protease inhibitors. For unknown reasons, protease inhibitors may cause diabetes or hyperglycemia (elevated blood sugar levels). As of May 12, eighty three cases of diabetes/hyperglycemia had been reported to the FDA. These are only the reported cases as of that date. (We at the Health Group know of other cases not yet reported.)

Diabetes and hyperglycemia are serious. If unrecognized and untreated they can lead to coma and death. What are the main symptoms? Fruity-smelling breath, excessive thirst, excessive hunger, increased urination (peeing), fatigue, sudden weight loss, and dry-itchy skin. If you are taking protease inhibitors and are experiencing any of these symptoms, see your doctor immediately!!! If you are taking protease inhibitors and are not experiencing these symptoms, discuss this important matter with your doctor, and have your blood sugar level checked to be on the safe side. It seems to happen most often between 2 and 3 months of starting therapy.

You ask: if the FDA knew about 83 cases by May 12th, why did they wait until June 17th to release the information? How many more cases have been reported to them since May 12th? It might have been wise for the new anti-viral guidelines to call for routine testing of blood sugar levels for people on combination therapy. Apparently they didn't think so. In a related letter published in the June 14th issue of Lancet (a British medical journal), two California doctors reported that two of their patients have developed "acute pancreatitis and acute renal (kidney) failure in conjunction with combination therapy". Pancreatitis is an inflammation of the pancreas, the organ that produces insulin which our bodies use to break down sugar during digestion. Pancreatitis is characterized by severe abdominal pain, can damage the pancreas, and can lead to diabetes. Fortunately for those two patients, combination therapy was stopped, and in time they recovered. Their doctors think it is important for all doctors treating people with HIV to be aware of this potentially life-threatening complication. We think patients should also be aware.

Following on the heels of the California doctors, comes a study from the National Institute of Diabetes, Digestive and Kidney Diseases. It reports that Indinavir (aka Crixivan) can cause "crystal formations" in the kidney and bladder, which can cause painful urination, kidney stones, and possible renal failure. Twenty precent of 142 people tested showed evidence of abnormal crystal formation. It was reported that "increasing fluid intake" (drinking more water) helped some people in the study, because it flushed out the kidneys. Others had to be taken off Crixivan. Concern was expressed that doctors may misdiagnosis flank pain and/or painful urination as signs of infection, and incorrectly treat with antibiotics. If you are taking Crixivan be sure to discuss this with your doctor, and act like a sponge and soak up the water.

1592 -- Where Are You?

Glaxo Wellcome has been promising a tiny program for their strong new drug, 1592 (Abacavir), since last fall. For PWAs who've gone through every antiviral, 1592 may be their only hope. (Early trials report severe nausea.) Glaxo's penny-pinching program will offer drug to 2,500-5,000 people worldwide, including 250 kids, 250 PWAs with dementia, and 100 adults per week in the US, all starting sometime this summer. Good news: it will be available for kids (viral load over 100,000 & CD4% less than 15). Bad news: no one, not even Glaxo, seems to know when these programs will open, including the "spring '97" pediatric program.

To get 1592, your doctor should call 1-800-501-4672. We do not know when this "Dispassionate Abuse Program" (thank you, Richard) will actually open. To qualify, you have to have less than 100 T-cells (CD4 count), viral load over 30,000, have either taken two nucleosides and one protease, or have failed all anti-virals (which would amount to 1592 monotherapy), and, of course, win the weekly 100 person lottery. Also the adult program is only at 60 research sites, so if you don't live near one of them, you're out of luck.

Friendly operators are now standing by at the 800 number, and quick to acknowledge they know virtually nothing about the "open label program." (For more information on these programs - call us.) Since Glaxo's plans for a larger program sometime in 1998 look equally abysmal, it's fair to say that many, many people who might benefit from this drug will not be able to get it in time. Opinions about this? Call Glaxo:

Jennifer McMillan, Health Care Coalitions
(PR): (919)4832987,
Robert Ingram, President & CEO
(919) 248-2100,

If you're particularly ambitious,
Sir Richard Sykes, Chief Executive (in London): 011 44 171 408 0228.

There are a lot of people working to create better access to 1592 and other new drugs -- and we could use your help. Please call to join the fight to restore fair access to compassionate use programs.

Whatever Happened To Expanded Access?

What is "expanded access"? A general term for company programs that distribute new drugs before FDA approval, to people who need them. Before AIDS, getting new drugs was rare. A doctor had to call the manufacturer. Then the doctor had to call the FDA, fill out hours of paperwork, and wait months to get enough drug for one person. If another patient needed the same drug, the doctor had to start all over again and go through the same process.

Thanks to people with AIDS, this changed. PWAs organized: learned the regulations, met with industry and government officials, and drew up proposals. By 1988, FDA Commissioner Frank Young and company CEOs alike agreed there was a problem, but nothing changed until PWAs started demonstrating in the streets. New FDA regulations allowed companies to open programs as soon as there was minimal safety data. Big company programs opened (see chart):

1989-91: DDI reaches 23,000 people, based on data from 100 people [Bristol-Myers]
1990-91: DDC reaches 5,186 people in the first "parallel track" program [Roche]
1992-94: D4T reaches 12,477 people [Bristol-Myers]
1995: 3TC reaches over 32,000 people, the largest program ever [Glaxo Wellcome]

Back to the future!

In 1996, expanded access all but disappeared. Why? AIDS hadn't changed, lots of drugs were in the pipeline, and company profits were climbing. In fact, the more money drug companies made, the smaller and shorter the programs got (see chart). In 1996, marketing replaced compassion for PWAs with no other options. Companies designed programs as public relations stunts, getting their brand name out, not the drug. How could they offer lotteries for life-saving drugs?

1995 (July): Roche's Saquinavir lottery (lottery!) offers 2,000 slots, but starts drug delivery in September; 2,000 new slots open in October, but the program closes at the end of October with FDA approval.
1995 (Aug): Abbott's Norvir lottery has 2,000 slots, reaches 1,480 PWAs in Dec-Jan, and closes two months later in March with FDA approval.
1995 (Aug): Merck's Crixivan lottery has 1,500 slots, reaches 1,100 PWAs by the end of January, and closes three months later in April with FDA approval. 1996: Viramune "expanded access" reaches 325 people, because almost all PWAs are excluded [Boehringer-Ingelheim].
1996-97: Upjohn's Delavirdine reaches 1,527 people.
1996-97: Agouron's Viracept program reaches a few hundred PWAs until just before approval, when the entry rules are relaxed. Agouron claims 3,100 people got the drug before the program closed two months later. Their well-publicized pediatric program reaches only 33 kids.
1997: Glaxo Wellcome plans to offer 1592 to 2,500 people worldwide by July. It's July, and neither this nor the spring program for kids is anywhere to be seen.

Drug companies are the most profitable sector of the American economy. Yet the better their AIDS drugs get, the stingier they get. Especially with resistance to their early drugs, early access is as critical as ever.

Like it or not, drug companies are not the same as other corporations. They are part of our health care system. They make products that can save lives. They have a responsibility to society, not just their investors. All over the world, drug prices are regulated, preserving both profit and access. But not in the US, where government officials support corporate health over public health. Expanded access is a real way for companies to honor their community role, offering hope and collecting critical safety data. Expanded access programs are not required. They cost money. In 1989, the urgency of PWAs pushed companies to be generous. AIDS in 1997 is just as urgent. Once again, we need to organize, get noisy and push for fair, early access for all of us who need this chance.

My First Major Treatment Choice -- Hope or Hype? (A Conversation With Myself)

By Mark Niedzolkowski

1. Lately, it seems more and more, that we're supposed to believe the world of HIV/AIDS is full of hope and wonder. I can't deny my wonder at all that's happening, and I want to believe in the hope. But no sooner do I scratch the surface of the hope than I find a lot of hype. How do I figure it out?

-- Now the really difficult work begins. Somehow, we have to see through all this public hype and find ways to salvage a little private hope. Somewhere out there is the perfect combination of knowledge, data, and desire for our situation. But the pressure is on us, not the drug companies, to make sense out of it. We have lots of choices and no clear directions to guide us.

2. It's hard sifting through all this information about new tests and new drugs. Everyone seems to have an opinion, and I keep trying to put it all into a simple and coherent statement, but I can't. Can you?

-- I'll try. The present popular theory suggests taking a cocktail of drugs intended to lower the active virus in our blood. This is seen as a good thing, because having little or no virus in our blood may indicate little or no virus in our body. There are new blood tests that measure the amount of virus in our blood, and three catagories of approved anti-retroviral drugs. These drugs, when used in combinations called cocktails, show promise for eradicating the virus from our blood, at least as far as the new tests to measure it can show. Of course, this is only if we happen to be one of the people for whom these new drugs work. There, I did it.

3. But I still have questions.

-- And I worked so hard at boiling it all down....Oh alright, tell me what you don't understand.

4. What do you mean if they works for me? I thought these were miracle drugs?

-- There aren't any miracles with AIDS, but if you tolerate the drugs, they'll lower the amount of virus in our blood, in some cases to the point of undetectable by current technology.

5.How do I find out if the new drugs might work for me?

- You have to try them to find out for sure, but the response rate in clinical trials ranged from 60% - 80%, depending on what was studied. Of course, trials pre-select for ideal candidates, since drug companies want their products to appear in the best possible light.

6. What are the chances of having these drugs work for me?

-- Well, I guess if you're an ideal candidate and follow all of the rules and have no trouble tolerating them, we have a 60% - 80% chance of lowering the amount of virus in our blood to undetectable.

7. What happens if I'm not the ideal candidate?

-- Then I guess we're up the creek...but seriously, there's no real data on that. Remember, these trials are set up to look at the best case scenario. What happens in worst case scenarios is left to speculation and anecdotal reports. It has been suggested that if you aren't the "ideal candidate," you may want to wait to start the difficult-to-comply-with drugs until you have the ability to follow all of the rules. If these drugs are your only option, then you do yourself a favor if you work hard on your own self-discipline. I'll help.

8. This viral load, is it like a T-cell count -- the higher the better?

-- No, just the opposite. The new model of care for HIV suggests that we want our viral load to be so low that the test can't even find it. This level is called undetectable. But there's a considerable debate going on as to how important it is to get your viral load down to undetectable. Some people will tell you that keeping your viral load below 50,000 is good enough; others will tell you that below 10,000 is good enough; and still others insist that any number above undetectable is unacceptable. The new guidelines for antiviral therapy suggest 20,000 is a good cutoff. It'll be a while before we know if they're right.

9. What rules do I have to follow if I want these drugs to work for me, and what if I can't follow them to the tee?

-- Most important, take your drugs consistently, following your doctor's directions. There are now eleven antivirals, each with distinct and specific rules -- with or without food, twice a day, three times a day, etc. If you can't follow the rules, the speculation is that we may become resistant to the drugs, meaning that these and any other similar drugs coming in the near future might not work for us. It's suggested that consistent pressure against the virus is best, and this is best achieved by taking drugs exactly as prescribed. But then there's no hard data on that, just speculation. It makes a lot of sense though.

10. You mentioned something about tolerating these new drugs. What's that all about?

-- Well, side effects. As with most drugs, there are side effects, and with these new drugs they can be very serious. It's not like with the old drugs, you can't play around with your dosing schedule because you feel sick or bored. In fact, if you do, you run the risk of building resistance. The last thing we need is a resistant strain of the virus, thank you very much.

11. So, how do I figure out if these new drugs are going to work for me?

-- There are blood tests which look at the genetic make-up of your virus. In other words, they may predetermine if you're resistant to the drugs you're considering. These tests are risky business. Many people are concerned about their accuracy. The labs that do the tests are really expensive. (Ed. note: occasionally Medicaid will reimbruse.) Hopefully in the near future the price will come down, the accuracy will improve, and every lab will do the tests. Until then, it seems that drugs have to be chosen by trial and error. What works for the most people will hopefully work for you.

12. It can't really be that complicated, can it?

-- Yes, it can.

13. Okay, how am I supposed to know if I need to take any of these drugs?

-- Conservative wisdom recommends that before you start therapy you have more than one viral load test over a two to four week period, to determine your baseline viral load count. It's never recommended that treatment decisions be made on the results of a single blood test. Once you know your baseline count, you and your doctor can begin discussing whether or not it's the right time or even a good idea for you to consider drug therapy.

14. So how high can my viral load go before I have to worry about getting sick?

-- Here's where we start to get into semantics. Viral load doesn't predict when you will get sick. Viral load is a tool to help our doctors determine our "rate of disease progression." In other words, they've created a statistical model by taking a group of people who share similar viral load counts and following their progress over time. They found that the average progression to disease for a person with X viral load count happened in Y amount of time. Now remember this statistical model is based on an average. It's important to know that some progress much faster and some don't progress at all. But the statistical model would have us believe that the lower our viral load, the better our chances are of having longer, on average, before we progress to a disease state. To date, I haven't been able to get anyone to tell me specifically how much healthy time I might have ahead of me given whatever my viral load might be. No one is willing to make that kind of prediction.

15. But how does all of this apply to me?

-- It's hard to talk about the individual in any of this, because all of the information is skewed to relate to the average or mean statistic which is unpredictably altered by the introduction of human variables. So, if you're just the average Joe, the statistical model might really speak to you. But if you're a unique individual, it's not going to be so easy to fit yourself into these limited parameters. I'd like to give you an example of the extremes which can exist outside of this model: a friend of mine got his first viral load test done over a year ago. He'd been on anti-virals for a long time, his T-cell count had been below 100, and he'd been prophylaxing for as long as I'd known him. He always amazed me with his energy and humor -- he owns and maintains his home and car, works two jobs and volunteers in his spare time. That's not bad for a man whose first viral load count was 3,000,000 -- that's right, 3 million. He's slowed down a bit since then, but that's more from the side effects of the new drugs he's on than from anything else. He fell into a depression when he first got the news; he, too, believed the hype that said he would very, very quickly progress to disease, possibly within months. But with the new drugs his viral load is way down, to 450,000, and it's now well past a year without any illness. So his outlook on the future is much improved. As a matter of fact, right now he's on a cruise ship off the coast of Alaska having the time of his life.

16. Then I don't have to pay such close attention to my T-cell counts if my viral load is low?

-- Not so fast. Your T-cell (T4) count is very important as a marker for your susceptibility to opportunistic infections (OIs). If your T count has gone below 200 (some say 250) it's important, imperative, for you and your doctor to have a serious talk about prophylaxing to prevent OIs. Your viral load doesn't give anyone any idea of when you might be susceptible to OI's. It doesn't matter where our viral load is; if your T-cell count is below 200 we should definitely be doing something (prophylaxing) to avoid OIs.

17. If I start on one of these anti-viral combo cocktails, my viral load goes to "undetectable," and my T-cell count jumps from 150 to over 300, can I stop with the prophylaxing?

-- NO! The general consensus is that once your T-cells have dropped below 200 you are and will continue to be in danger of developing an OI. Lifting your T-cells above the 200 mark is probably good and may represent an improvement in the health and vitality of your immune system. But it's been shown that T-cells may not protect against OIs once they have dipped below the magic 200 mark. Contrary to the hype, anti-virals like protease inhibitors do not work to enhance the health of the immune system. They were developed solely to fight viral replication, and the rise in T-cells is only a happy side effect. So, do everything you can to keep your T-cell count above 200; but if it drops below, be prepared to prophylax indefinitely, even if it rebounds to above 200. To stop prophylaxing after you've started is to gamble with our health.

18. I'm beginning to feel a little overwhelmed by all of this. What's the point of trying? It feels like if I make a wrong move I die, and if I make no move at all I die. If I start too soon I can ruin our chances down the line, but if I wait too long, I'm up the creek! How do I figure this out? How am I supposed to know what to do? I don't have a medical degree.

-- You don't need a medical degree, but you do need a doctor you can trust and who's willing to take the time to talk with you about all of this stuff. A good relationship with your doctor is the best place to start. Besides, a medical degree doesn't automatically give you all the answers; it does, however, give you the ability to deliver those answers with authority. Your job isn't to have the answers, it's to have questions. Next, don't panic. In most situations there's time to research your options and make an educated decision about what you want to do. Some community-based organizations will help you with your research, and sometimes in an unbiased way. There's a lot of hype out there about all of the new drugs and the all important "combo" therapies, and most of it is anecdotal. Look at all of the documented information you can find and compare the results. Look for studies with participants whose entry statistics are similar to yours (if you can find any). The results from these studies might accurately predict what your response might be. Studies with large numbers of participants seem to produce more reliable data than studies which use low numbers of participants. And remember, when you look at the data presented, the end results often don't take into account the participants who've dropped out of the study.

19. How in the hell am I supposed to figure that out?

-- You may have to do your own math to get accurate results. An example: the Ritonavir/3TC/AZT study enrolled twelve participants and it reports that 100% of the participants had a viral load below 500 after sixteen weeks of therapy. These results look stunning and wonderful, until you read all of the information and realize that 25% of the participants dropped out at some point. There's no explanation for the dropout rate - it could be because they couldn't tolerate the combo, or maybe they weren't responding and decided to try some other combo. Who knows, maybe they got bored. If you redo the math you find out that the study started with 12 people, and at the end 75% of the original participants had a reduction in viral load to below 500 after 16 weeks. That's only nine people, or a 75% response. It's hard to expand these results to a large population and have an accurate estimate of what the results might be. It's also important to look at the length of the study. Sixteen weeks isn't a long time when you're looking at the possibility of being on these drugs for the rest of your life.

20. I think the real problem for me is that I feel all this pressure to do something and to do it now. It used to be that waiting to make a decision was okay, but now I feel that if I don't make a decision right now I will have completely missed the boat and there'll be no chance for me in the future. It's as though the choice is no longer about when to start therapy but only about which therapy to start. I hate this pressure!

-- Well, I have a theory. Mind you it's just a theory, and it's only my theory, nothing scientific about it. I believe that just as the death toll from AIDS has relentlessly grown over the last 16 years, so has each doctors' sense of helplessness. Imagine that you're a doctor who's been averaging 20 patient deaths a year from AIDS. But this year the information you're receiving indicates that if you start your patients on these new drug combination therapies you can cut that death rate by 50%, maybe even 70%. Isn't it a natural human response to try to get all of your HIV/AIDS patients onto these drugs? How can you blame anyone for trying to save the lives of their patients? And so much of the early information indicates that early intervention is a good thing. But these suggestions and decisions are being made based on early information, not on final data. I can't blame my doctor for pushing early drug intervention on me. His suggestions are as good as the information he has.

21. But...

-- But nothing. This is where I believe it's important for us to live up to our responsibilities as informed patients and exercise our right to make decisions for ourselves. Right now doctors are so caught up in their own need to save lives that they don't see or understand the kind of pressure they're putting on us. Now more than ever we must not panic and in the confusion make bad choices. Now is the time we should be fighting for more information so that we can work even closer with our doctors to make the best decisions about our medical therapy. I'll be much more open to the idea of drug therapy when I believe that it's being recommended because of my individual circumstance. I won't consider it as long as I believe that it's the recommendation everyone gets based on the doctors' need to lower his/her patient death rate. This isn't about lowering the number of AIDS deaths my doctor has to deal with every year. It's about me getting the very best medical treatment and advice available. I'm stubborn and selfish. I want my doctor's priority to be me and my health.

22. Suddenly I feel I'm in good hands, my own.

-- Thanks. There's hope for you yet.

Dancing in the Dark: Dan & Tom

By Mark Niedzolkowski

National HIV Testing Day brought a bizarre publicity stunt: the head of AIDS Action Council, Daniel Zingale, and Rep. Tom Coburn, author of the lock 'em-all-up HIV Prevention Act of 1997, publicly taking an HIV antibody test together at the Capitol in Washington. What a lark! Public testing (anyone can do it, it's easy - even with your enemy) belittles the tender complexity of deciding to take the HIV test that people living with HIV and AIDS know so well. And the politics -- "Let's agree to disagree" with someone who strongly believes in mandatory testing, partner notification, tracking, and no confidentiality. That sure is tough advocacy from the "the nation's foremost AIDS advocacy organization, representing all Americans affected by HIV/AIDS, and over 1400 community-based organizations." Well Dan, thanks but no thanks on behalf of one organization staying committed to the idea that HIV testing is not a political playground. Besides, we suspect that sleeping with the enemy is never as much fun as some in Washington would have you think .

Please Accept our Apology

To all of you who've been wondering where we've been for the last few months....we've been here, we've been busy, and we've been short handed since Andy left in January. It has taken until June to find a new editor for Notes. We look forward to more regular communication.


I'd like to introduce myself, my name is Halley and I am the new editor for Notes. Formerly, I worked as the counselor for the Staten Island AIDS Task Force, where I designed and coordinated the HIV Resource Room. Previous to that I was a sexuality educator for the Association for the Help of Retarded Citizens, and also I have extensive experience with dementia. Now I am happy to be part of the good work that is the PWA Health Group. Your questions and comments are important and help in determining future subjects for Notes to explore, so please call or write with them.

Dip Tip

Hummus can harm you, well, not really. However, you should avoid hummus and other salads and dips made by Cedar's Mediterranean Foods, Inc. because these foods may be contaminated with Listeria. Not Listerine, Listeria Monocytogenes, a nasty little bug that can make you very very sick. Sometimes it can be fatal. So don't buy or eat Cedar's products. If you have purchased any of their products you may return them to place of purchase for a full refund. Or call the company at 1-800-963-3668.

Pennies from Heaven

If you have stopped by the office in the past few months, you may have noticed our penny bucket in the entry-way. It collects those pennies from Heaven that fall out of your pockets. Those pennies add up and help the Health Group to continue our mission to inform and empower. Presently the bucket is very low and in need of your coinage. If you are stopping by the office any time soon, please shower our bucket with copper blessings, or if you can with silver blessings (dimes and quarters, after all darlin's it is 1997). Recently the bucket was full, and when we counted it up there was almost 200 dollars. See how those pennies and dimes add up! To all of you who have jingled your jangle into our pot, we thank you for your support!

A Few Good Volunteers:

For a special research project investigating additives in medications and possible relation to diarrhea. Call (212) 255-0520, ask for Susan or Lorna.

NOTES FROM THE UNDERGROUND is published six times a year by People With AIDS Working for Health, Inc., a non-profit buyer's club doing business as the PWA Health Group, and reports on issues pertaining to underground AIDS treatment and access.

Articles in this publication are for informational purposes only, and in no way constitute an endorsement of any particular treatment regimen or strategy. We do not consider ourselves qualified to offer medical advice, and encourage people to consult with their physician prior to taking any medications.

copyright 1997 by People With AIDS Working For Health, Inc.

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This article was provided by PWA Health Group.