Notes From the Underground
The PWA Health Group Newsletter
This rant was written and sent to community activists and organizations around the country on March 14.
We met on 3/13/96 with activists and Merck & Co.'s merry marketeers, so that they could lay out for us their so-called plan to distribute, sell, and continue to study Crixivan, our newest friendly protease inhibitor. Well, they were more than willing to admit that their plan was probably unfair, totally complicated, and barely not fodder for a fabulous anti-trust lawsuit. But Merck pleaded for mercy (which some activists who attended this mini-meeting were more than willing to give), because they had to devise this so quickly, and they were being rushed, pushed by the FDA to get Crixivan into the market-I'd rush too if I could make $131,000,000 in a year like the Merckies. So, Crixivan was approved by the FDA, probably within minutes of our sorry backsides walking out the door of Merck's visitors compound in Blue Bell, PA. The only really good news is that Merck's base price is way cheaper than Norvir or Invirase-$4,380 per year ($12 per day). BUT they cut a sweetheart deal with Stadtlanders, so the retail price sucks. (see pricing).
CRIXIVAN WILL NOT BE SOLD IN DRUG STORES!!! It will be distributed only through Stadtlanders, a mail order pharmacy service, at least until October. This will happen ON A FIRST COME, FIRST SERVE BASIS. There is no priority for patients with low CD4, or high viral load. The Merckies claim, and this really burns us, that they "can't play God", and that any type of patient priority would be too complicated to be economically feasible. As if they are not already playing God by making people jump through flaming hoops for an expensive, gel-capped powder they hope might save their lives. Also, it was too late to change the plan (DUH!!! -the meeting for "community" input finished one minute before they were legally able to implement the stupid plan!!). The Merckies asked that we tell them if we hear of problems (AS IF!!! Stadtlanders doesn't accept Medicaid in 28 states, usually charges more than most drug stores, -ugghhh. Surprise, surprise, the stories are rolling in. Last week one Crixivan customer waiting for drug, was bugged for his credit card by none other than Gregg Perelman, Pres. of Stadtlanders - doesn't he have better things to do? And if they're so broke, shouldn't someone else be distributing Crixivan?)
The patient assistance program is trademarked SUPPORT , hilariously. Merck refused to tell us what the income limit is, so we can't tell you whether to apply or not. But trust them, Merck PR-types said, it will be generous. Of course we have no way to know-the info's all proprietary, you see. NOTE:you can apply for patient assistance even if your HMO, ADAP, or Medicaid has not decided yet to cover Crixivan. The Merckies claim that they're working with the VA (the US's largest health care provider to PWAs) and prison systems, but gave no detail-so we'll just have to see how much drug gets up the river in the next 4 weeks.
WHY SUCH A PAIN? Merck tells us that their (money-clutching) hands are tied. First, they don't have enough Crixivan to supply it to everyone, and they need to ensure that everyone has a steady supply to avoid speeding up HIV resistance. OK, That's serious enough. The rumor in certain circles is that Merck conservatively estimates it has enough Crixivan to continually supply 30,000 patients until their new factory is finished next Fall, when there will be enough Crixivan to feed it to the pigeons and fertilize your garden with it. Protease inhibitors, a totally new class of drug, were developed and approved by the FDA faster than any drugs in the past. Because of this, we have literally NO information about how long Crixivan works, how it works with other drugs, how long it takes HIV to become resistant to it, why and which people respond very well or not at all, and what the long term side effects of taking Crixivan are. Merck stated that they will compile "long term" safety data in a small number of people for 3-5 years, but would only commit to the first year. This data will be from patients who enrolled in phase II trials (#s 4,6,10,18,19,20,21,35) and one phase III trial (#39), for a total of "around" 800 patients. They will continue to receive Crixivan for free and get their labs, blood counts, and viral RNA counted through Merck. Horrores! Merck won't give these patients their own viral load counts on a regular basis as they are taken. Why? Could it be that Merck doesn't want people to stop Crixivan when they find out they have developed resistance? So much for the standard of care.
If you're in this long term follow-up program, you can't take any other protease inhibitors, and new experimental drugs (non-FDA approved, study drugs) will be reviewed on a case by case basis by Merckian wizards. The other 2200 people in Merckian programs, including those in their limited expanded access program (a.k.a. restricted marketing access program), will be "rolled into commercial access" (as though buying prescription drugs at the drug store is a whole new access program.)
YAY, PRICE!! BOO, DISTRIBUTION!! This distribution looks like it will be complicated, complicated, complicated, which sucks. The supply issue could have been worked out in many, easier ways, if Merck and the small group of community people who were involved in the entire development process, had acted a little earlier than two weeks before the drug was bottled up and sent out to PWAs. The people who will bear the brunt of this ugly situation are the many PWAs who need this drug the most right now: people who have outlived other antivirals, have lower T cells or high viral loads. They may not receive this drug for months and months, if ever. The vast majority of PWAs have no experience using mail order pharmacies, and if the paper trail extends too far, many doctors will be less willing to prescribe the drug-disgusting, but true. People who want Crixivan now and are unable to get it should be angry at Merck for devising this labyrinth of hooey, and should be angry at their activist community reps for not calling them on it sooner.
(Since this was written Merck has decided to provide Crixivan directly to the VA system, Federal Prison system, as well as Kaiser and some smaller HMOs. Merck has also promised enough drug for 15,000 PWAs, in France, by September, even though they confirmed on April 1, that they have Crixivan for only 30,000 PWAs worldwide, until their factory opens. Community Prescription Service and MediExpress will assist people with the paper work from Stadtlanders for access to Crixivan.)
In his Welcome-To-Stadtlanders letter, Gregg Perelman, President of Stadtlanders, writes: "We know there can be numerous obstacles for individuals who are living with challenging health conditions. When winds blow softly or the storms rage violently, we hope that the foundation of patient support we create at Stadtlanders can help to keep our customers grounded in a safe place."
Safe for whom? STADTLANDERS... Friend of the Community and PRICE GOUGER!!
For the FDA approved Crixivan dose of 2,400 mg/day, Merck charges Stadtlanders: $12/day or $4,380/year
Stadtlanders charges you: $16.50/day or $6,022/year
THAT'S AN OUTRAGEOUS 37.5% MARKUP!
Stadtlanders reps claim that their price is only 10% above the averag wholesale price ("AWP"). BUT THERE IS NO WHOLESALE PRICE. Stadtlanders is buying Crixivan directly from Merck. No wholesaler is involved. And, of course, no competition either.
Merck estimates that they can supply 30,000 people until next fall. If so, Stadtlanders' gross profit in six months will hypothetically be: 24.3 million dollars! Stadtlanders whines that they have had to hire 420 new employees! And that it's really just their usual, higher than average markup! Ahh, the joys of monopoly distribution. Remember that they don;t have a monopoly on anything else, vitamins or 3TC or Fosarnet. Get Crixivan at Stadtlanders and everything else anywhere else, preferably a place that really supports PWAs.
Hopefully, by the time you read this Stadtlanders will have done the right thing and lowered their price. But meanwhile, TAKE ACTION! Call and/or fax Stadtlanders, the "friend of the community." Rainbow flags are not enough!
Stadtlanders' Contact Information:
By Andy Young
The New Products Committee, which is made up of PWAs and doctors from our Board of Directors, met last month to discuss possible new products for the PWA Health Group. I had never attended one of these meetings and found it to be an interesting process -- something that sets the Health Group apart from other buyers' clubs. First, I compiled data, as much as there was, for the four things we were to consider: Cat's Claw, Thymopentin, Cantharadin, and Nitazoxanide. For a product to get approved by our Board, it has to be safe to take, not cost too much, and, a fact that is sometimes overlooked, it has to do some good. Side effects are defined in three ways:
Cat's Claw has interested us because it's so popular with PWAs, and because of the anecdotal data that it is a strong antiviral, antioxidant, anti-tumor, anti-inflammatory, anti-etc., herbal compound. Part of our mission is to listen to and respond to the community's voice and treatment decisions. Cat's Claw is an herbal product derived from the Peruvian root, Uncaria Tormentosa. A European version called Krallendorn is prescribed as if it were a pharmaceutical, in Germany at least, but there was no data available to back up claims made by the various marketeers who want to sell it in the US. After repeated requests, the Austrian company, Immodal, gave me reports based on one, two, six patients who took Krallendorn and said they felt better. This did not make the committee, or myself, feel any better about selling this product. The problem, as I see it, is that anyone can sell almost anything and call it Cat's Claw without having to prove what it is to anyone. Immodal was more than happy to send me info that their product had less wood pulp and no fungus in it, unlike their competitors, but they wouldn't provide us with any information that it does anything for PWAs who take it. The committee rejected it.
Thymopentin is studied clinically in the US and is available in Italy and Germany. It's an injectable extract based on hormones found in the thymus, the gland where T cells are produced. One reason for interest in this drug is that we may lose our Italian source for Thymosin alpha-1, another "thymus-stimulator", with proven activity against chronic Hepatitis B infection. A decision on thymopentin was put on hold because at the last minute we found out that we may be able to get Thymosin alpha-1 in Singapore. Results of Thymopentin trials are encouraging, in that people who used thymopentin with AZT had fewer problems with opportunistic infections and better sustained T cell levels than those who took AZT alone, and there don't seem to be any side effects. It's also very expensive.
Cantharadin is the poison from a bug called the Blister Beetle. The extract burns the skin and has been in Chinese medicine for centuries to treat warts and other skin problems. It used to be available as an ointment in the US, and was used in the sixties to treat Molluscum Contagiosum in infants. The many dermatologists I spoke with said, "Oh, yeah. I remember that. It was just pulled from the market...I don't know why." We think we can get it from Canada, to help people treat Molluscum less painfully than the endless freezing and scraping. The committee was a bit worried about Cantharadin, because in searching for info, I found many references to people who have been blinded, had heart attacks, and gotten burned terribly by swallowing the dreaded Blister Beetle. Of course this was the fault of the beetle itself, not an ointment that is 5% extract and 95% goo. But it is worth considering, huh? It also seems that some people have sold this extract as "Spanish Fly"- an aphrodiasiac (thank you Medline). Anyway, it's all pretty weird, but once we have a supply, we'll start providing it to people with a prescription, for treating Molluscum.
Nitazoxanide was discussed in the last issue of Notes as a promising treatment for the treatment of Cryptosporidia and Microsporidia. There is no effective treatment approved by the FDA for these killers, so if we could get our grubby little hands on the drug, we'd sell it in a jiffy. The problem with Nitazoxanide is that it is seemingly not for sale anywhere in the world...a significant problem. Some believe that it's an approved vet drug in Europe, but the French veterinarian I spoke to said it had been approved, but never sold. The chief researcher at the company in the US told me that I would be "sorely disappointed" if we tried to import this drug. The committee voted that we should aggressively work to get NTZ ASAP.
By Andy Young
Protease hoo-hah aside, the Retrovirus Conference at the end of January gave PWAs and doctors a lot of information about MAC (mycobacterium avium complex) prevention in the form of two large prevention studies. MAC is a bacterial infection that can cause a variety of symptoms and is difficult to diagnose. People with an active infection often run fevers, lose weight, and have no appetite, and the bacteria can be present in almost any part of the body. Two large trials compared MAC treatments and prevention regimens.
These two studies are important, because many PWAs with less than 100 T cells take Rifabutin to prevent MAC. (Rifabutin use has to be stopped or the dosage changed when used with protease inhibitors.) Rifabutin is currently the only drug approved by the FDA for the prevention of MAC.
In one study, 1200 patients with less than 100 T cells took Rifabutin, Clarithromycin, or both. 9% of patients who took Clarithromycin developed MAC, 15% of those on Rifabutin, and 7% on the combo...not very big differences (in terms of statistical significance). The key finding was that almost 30% of people who took Clarithromycin alone or in the combo developed resistance to it. Clarithromycin is the standard treatment for active MAC infections. Resistance to it before a person actually becomes sick with the monster is way bad news.
The other large trial looked at 699 PWAs on Rifabutin, Azithromycin or both in= combination. The combination was again the best preventative treatment. 2.5% of PWAs who took Azithromycin and Rifabutin together got MAC, compared to 8.8% who used Azithromycin alone, and 11.6% who took only Rifabutin. One scary thing is that 11% of people who developed active MAC infections in this study became resistant to both Azithromycin and Clarithromycin. This happens because the two drugs are so similar in chemical structure that resistance to one can be functionally resistant to both. Cross resistance between Azithromycin and Clarithromycin would leave Rifabutin alone as the treatment for an active MAC infection.
These studies tell us that there are other and possibly more effective ways to prevent MAC than just taking Rifabutin alone. The successful use of Azithromycin is really interesting because it only was taken once a week. A potential problem is cross resistance between Azithromycin and Clarithromycin, which also spells trouble in treating an active MAC infection. People do not develop resistance to Rifabutin from taking it, or from the other drugs discussed here, but it was shown in both studies to be the least succesful way to avoid a MAC infection.
As a footnote, Roxithromycin, another antibiotic in the same family as Azithromycin and Clarithromycin, that we carry here, has also been shown to work as MAC prevention and as a treatment for cryptosporidiosis. Treatment and prevention for MAC is a dicey proposition at best. All the medicines are strong and can be difficult to take, both physically and in regards to which other medicines have to be avoided. But truth be told, I'd rather make my doctor work to figure out which drugs of many I should use, than have no options to choose from.
The next piece was written by a friend of mine, who lives in New York City. It is the first of an ongoing series which looks at the treatment decisions people make. If you would like to contribute, call Andy. Thanks in advance.
By Horacio Tintos
I decided out of curiosity in, February, 1995, to participate in an HIV testing program for gay men. I knew that those who were negative stayed in the program, and those who were positive were sent to other places to get help. The day that I got the results, I left with three pounds of paper, pamphlets, folders...all of which told me "you are not alone." Besides= that, they all gave me a million instructions about legal, medical, psychological, and nutritional things. I was a wreck, alone in the US without family or anyone I was close to share the news. I was afraid of the future which seemed completely black. I was an undocumented immigrant without any health insurance, and a job where I barely got paid. What did I expect? The worst. In spite of that I decided to stay in the fight and do all that I could for myself.
Because of hospital bureaucracy, I couldn\t get a medical appointment until April, but I had an appointment with a social worker two days after I got my results, and got my blood drawn for my first T cell count. There was basically enough time before my first appointment to memorize all the information the program had given me, so I decided to learn what was known about the illness.
First, I decide to make my life last as long as possible. I'm not going to fall apart or kill myself because I have a virus in my blood. Secondly, I am infected, but don't want to be reinfected. I need to take care of myself. But more than anything, I don't want to ever infect or give this to another human being; no one deserves to carry this kind of load. Thirdly, I need to help myself in all aspects of my life - emotional, physical, economical, and social, to try to continue my life happily. It' s a big challenge, but I resolved to know how to deal with and overcome every problem that comes with the development of this disease. Since February, 1995, when I learned I was HIV positive, I decided to do all that I can to strengthen my immune system. I changed the way I ate, since it was such a disaster, so I ate as much fruit, vegetables, and cereal as I could. The binges when I would drink and stay up all night were gone. Resolute in my decisions, I started taking Cat's Claw and shark cartilage. I knew perfectly well that they were neither going to kill the virus, nor even slow down the illness. I had heard that they help the immune system. I had faith that it would strengthen my immune system, so I did it not wanting to give the virus the opportunity or room to advance quickly.
In the following months I felt well and my T4 cells were around 430, but the doctor told me that something strange was in my blood, and I would have to redo all the tests. Later, he told me that I had two other infections in my body, and then I got red sores on my skin that bothered me when I walked. The solution to this problem was 2.4 million units of penicillin for three weeks.
May was the worst; I was so tired all the time, and I lost fourteen pounds. Besides, they had taken fluid from my spinal cord to see if the infection had affected my brain. I had begun to walk more slowly and my balance was off. Because I was so nervous, my immune system was fighting against HIV and the other two infections, and I was taking so many antibiotics, my T cell count went down terribly, to around 200. The doctor told me that we shouldn't lose any more time. He said that it was imperative to start to take pharmaceutical medications. I had told him earlier that I would not take antivirals.
I perfectly remember that morning in the hospital when I had a long, serious talk with my doctor about the medicines he wanted me to start taking. The decision was to take AZT with 3TC, because, as he= explained, they had been shown to block or slow down the virus, and in the best cases, raise T4 counts. I felt like a marionette, slowly nodding my head whenever I thought I should, acting like I knew why my doctor was being so adamant. For the first week I only took AZT, three times a day. I was told to take it alone so my body could get used to it, and to begin 3TC later.
I also had to take Bactrim as a prevention against a bunch of respiratory problems that are common and devastating for HIV positive people. He told me that a high percentage of the people's bodies reject Bactrim, for reasons that were not understood. "If you seem to have an allergy to it, stop taking it and we'll find something else that you can take."
Since the first week of taking AZT, I felt like I had poured Drano into my stomach. My stomach was swollen, I was nauseous, I was sweating all the time, and I had headaches. Even so, I continued taking it for a month because I thought I would learn to deal with the side effects. I tried alternating Bactrim and 3TC, in an attempt to find out which of the two medicines was giving me the side effects. Incredibly, I had no problem taking Bactrim; no allergy to Bactrim and no side effects with 3TC.
By the fifth week of taking AZT and 3TC, my body couldn't handle it any more - I had lost more weight, didn't have an appetite, my stomach hurt all the time, I had chills, my body ached, and to top it off, I had a headache 24 hours a day. I spoke to my doctor again who told me we should half the dose of AZT, which I did for another week. I felt so physically and emotionally bad because I had put an iron faith into the combination. I only ever had heard about combinations of AZT and another antiviral. I was devastated, psychologically destroyed because some of my friends and some of my support group had or were taking AZT without any consequences. Why wouldn't my body accept it? On top of it all, my T4 cells had dropped to around 100.
After another appointment with my doctor, we opted to completely stop AZT. Although the combination of Zerit and 3TC was not very well studied, the results have been fabulous for me. I have no side effects right now. I feel perfectly well, have gained all my weight back, my other infections have disappeared, and magically, my T4 cells, which were racing downward, are increasing with each test. I still take the Cat's Claw and shark cartilage; if they are not helping me, they are at least not hurting me.
I now believe that it is important to take the antivirals even though they cannot cure a person with HIV, they can extend how long they live. I am also staying with the natural therapies that I take because I believe that they are helpful to how my body functions: how it cleans out the bad things, how it evens out the functioning of my body. I think that both things have the highest importance in my body.
By Andy Young
Happily (for novelty's sake), the PWA Health Group reports that a product we carry, Thymosin- a, has emerged victorious in a scientific brawl with the Hepatitis B Virus (HBV). In an actual controlled, randomized study with 158 patients in Taiwan, preliminary results show that 38.5% of people who injected 1.6 mg Thymosin-alpha-1, twice a week, for six months, got rid of HBV viral load, as examined through branched DNA PCR) and antigen to HBV, which measures the amount of viral replication. Liver enzyme values also came back down to normal.
The team at good old Chang Gung Memorial Hospital, in Taipei, also reported that 33.3% of people with chronic HBV infection who injected the drug for a full year, were clear. This was still the case after a year and half. This study is ongoing and data will be released this summer.
This is great news because there is no more effective-looking treatment available, anywhere, anyhow. Unfortunately, this drug is way, way expensive. If you were to take 2.6 mg twice a week, Thymosin-alpha-1, would cost you $520 each month. There aren't any side effects, as opposed to the standard chronic HBV treatment, alpha-interferon, and Thymosin is up for approval in seven countries (not the US) to treat HBV.
The US company that is developing and seeking approval for Thymosin, Sci-Clone , is also studying the drug for use in chronic hepatitis C, and HIV infection. So, we'll have to see what happens this summer, and don't forget to keep your eyes on 3TC. The successful use of 3TC and alpha- interferon in chronic HBV was discussed in Notes 31.
That'll be every Saturday, for you folks out there who prefer the relative calm of the weekend to deal with us. Heh-heh-heh!!
A hearty yo, sista to Ms. Lorna Gottesman, who by the way, ROCKSHARD, and is the spanking new coordinator of our Women's Treatment Project. She is here for you, ladies, so give her a call to join the treatment education group (which meets every other Wednesday), or have Lorna come to your organization to jam on women's treatment issues.
Hey!! In our search for new products, we have been held back by our lack of Asian contacts. Can any of you, dear readers, help us out by putting us in contact with some activist-types in Japan, Hong Kong, Taiwan, or Singapore?? Sally studied Chinese, but, hey, that was in the days of the Han Dynasty. Call Andy or email us: firstname.lastname@example.org
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
copyright 1996 by People With AIDS Working For Health, Inc.
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 1996 by People With AIDS Working For Health, Inc.
This article was provided by PWA Health Group.