The First AIDS Treatment

Dear Marty

I am glad to see people honoring who you are and what you have done for us in the HIV community. As you know , you inspired me to get crazy about treatment information and give lectures when I first saw you in Houston in the 80's. I realized back then that a "non-doctor" could know as much or more than doctors in HIV, and that made me lose my fears about not having enough qualifications to educate patients. Because of you and your work on importing hopeful therapies for dying patients back then, I was also inspired to help create a buyers club in Houston that is now only one of the few left after years of operation. You have been a great mentor to me and I love how you always have a peaceful attitude even when some of us are losing our cool.

I am honored that I have worked with you and got to see you in action in the great work that you have done for all of us living with this bug. I really hope you have many years of health so that you can keep mentoring those of us who do not live in the east and west coast and that may not be networked enough to be truly effective in our activism. You are a endangered species and we need to clone you!

Thanks for all you have done for me and all of us.

Nelson


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The First AIDS Treatment Activist

Last night, Marty Delaney was honored at an event in Washington, DC. Marty is one of my heroes. He was the founder of Project Inform, and has been an AIDS treatment activist longer than anyone I know.

Back in the late 80's, when ACT UPers like myself starting pushing the government and big pharma to move faster in finding treatments for people living with HIV/AIDS, we quickly discovered that a great deal of groundwork had already been laid by Marty and one or two other gay men (notably Jay Lipner, a Manhattan-based lawyer -- see his NY Times obit). They had the smarts and patience to teach themselves about the scientific process and the inner workings of the bureaucracies involved in AIDS research.

They created AIDS treatment activism. I’m alive today because of gay men like Marty.

In addition to AIDS bigwigs like Robert Gallo, AIDSmeds.com’s very own David Evans paid tribute to Marty last night, with these wonderful remarks:

They say if you want to get to know someone well, you should spend several hours in a car with them. Since 1993 I’ve taken hundreds of car trips, dozens of plane rides and even spent a few hours in an indigenous canoe in the Caribbean just off the coast of Panama with Marty. I’ve come to know him well. It would take 100 hours to go into even half of it, but I’ve only got a few minutes and I want to take this time to tell you a few things about him that others may not know or mention.
There is a political Marty. He’s definitely left leaning, but he’s rarely partisan -- particularly when it comes to HIV. He’s equally generous with his criticism and praise of both Republicans and Democrats. This isn’t Machiavellian political gamesmanship. Speaking the truth is very important to him, and damn the politics, and damn what’s expedient or polite. This hasn’t always made him popular with politicians, government officials, or pharmaceutical executives—or even other AIDS activists. In fact I’ve watched him get beat up over his work many times, both publicly and privately.

Marty is not a typical activist. He’s unlikely to get arrested in front of the New York stock exchange or the Capitol building. Yet he repeatedly risked arrest and prison in the late 1980s, smuggling in drugs from Mexico that we once hoped would effectively treat HIV. He helped with the founding of the first buyers clubs that worked on quasi-illegal generic formulations of AIDS drugs in development. Marty will gladly buck authority and break the rules when he believes that there’s no other rational way to accomplish his goals.

Marty isn’t much of a yeller and screamer. When he sees a problem his first instinct is usually to figure out who is the person with the most power to effect the change he wants and then to pick up the phone and call that person, and to keep calling until he gets what he wants. This means that his advocacy work is often private, rather than public, and that much of his work has gone unnoticed and unacknowledged.

When I first met Marty in 1991 I had no idea who he was. I was a Project Inform volunteer and he was a guy with a briefcase who swooped in and out of the office once or twice a week. I didn’t get to know him well until we went on a road tour together of town-hall style meetings in 1993. We hit about fifty cities a year over the next three or four years. I’d do the legwork - fly in, rent a car, find a map – this was way before online driving directions or GPS – and get things set up. I’d pick Marty up at the airport the next day and we’d spend the next two to five days together, sometimes doing meetings in three or four towns in a row.

All of this began soon after the depressing results of the Concord study, which found that AZT all by itself didn’t increase survival. They were lean years, with far too many funerals. But Marty, privy to the earliest exciting data on the protease inhibitors in development saw it as his personal mission to keep people hopeful and healthy long enough for the drugs to become available. From 1993, until protease inhibitors became available at the end of 1995, Marty spoke in front of thousands of people, some of them terribly ill, and urged them to hang on just a little longer. Though he’s not a religious man, and thinks with the intellectual discipline of a scientist, he’s often said that when hope is lost, the body usually follows. When all we had to offer was hope, that’s what he strived to give people.

But his roadshow was just the warm up to some of the most intense, private work that took much of his personal time. At the end of each town meeting people lined up to talk to Marty. Most just wanted to thank him, or follow up on something he’d said in his talk. But there were always a few who faced profound problems -- sometimes life threatening problems –everything from doctors who kept them on a failing and toxic regimen for too long, or who failed to catch an opportunistic infection early enough, or problems accessing a needed treatment. It was then, with each one of these people, when Marty went into action, usually giving people his private home number so that in the coming days, and nights and weekends, they could together navigate those problems and find solutions. I imagine there are a few of you in this room tonight who are alive because of the direct help Marty gave you.

Marty’s a complicated person, and like any human being he’s not always right, or even in the best mood. But he’s always, always tried to live by a set of principles that include compassion, honesty, responsibility, fairness and what’s right and true.

For each of one of us who’s born witness to the horror and tragedy of this microscopic virus, it’s hard to imagine what it would have been like without Marty’s guiding hand. He’s indirectly helped tens of thousands of people by shaping clinical trials, the development of HIV drugs, and policies affecting treatment access and the price of drugs. And much more personally he’s helped thousands of people one-on-one. He prophesized hope when there seemed none. And more important still he stood with one person after another, taking it on himself to solve problems, overcome obstacles and ensure care in such a way that many came to see him as a kind of healthcare guardian angel. It’s important to honor his achievements, but it’s also important to honor his humanity, and that’s what I hope you will do.

U.S. Should Lift HIV/AIDS-Related Travel Restrictions

U.S. Should Lift HIV/AIDS-Related Travel Restrictions, Opinion Piece Says
[Jun 25, 2008]
Since 2003, the U.S. through the President's Emergency Plan for AIDS Relief has "extended a helping hand to" HIV-positive people living outside the country, Sens. John Kerry (D-Mass.) and Gordon Smith (R-Ore.) write in a Washington Times opinion piece. "Unfortunately, as we open our wallets to fund lifesaving treatments to those living with HIV/AIDS overseas, we will not open our doors," the authors write, adding that HIV is the "only medical condition that renders people inadmissible" to the U.S. The U.S. is "just one of 12 countries" -- including Libya, Russia, Saudi Arabia and Sudan -- that "prohibit, almost without exception, HIV-positive noncitizens from entering the country," according to Kerry and Smith. They add that such a "discriminatory policy has no basis in public health, let alone common sense."

According to the authors, they have introduced a bill that would "overturn this unfair policy." There is "no excuse for a law that goes out of its way to stigmatize a particular disease and separate parents from children, sisters from brothers, and people of all stripes from their work, travel and dreams of a better life," they add. "Actions matter," Kerry and Smith write, adding, "Leading by example in the fight against HIV/AIDS has left millions in the developing world grateful to America for our lifesaving help." It is "time we sent the same message by finally ending our needlessly discriminatory laws penalizing those with HIV/AIDS," the authors conclude (Kerry/Smith, Washington Times, 6/25).

Michael Mooney Speaks About Steroids in Deleted Scene from Bigger Stronger Faster

You can watch the video here:
http://www.mesomorphosis.com/blog/2008/06/14/hiv-activist-speaks-about-steroids-in-bigger-stronger-faster


Michael Mooney Speaks About Steroids in Deleted Scene from Bigger Stronger Faster
Posted on 02:26 June 14th, 2008 by Millard Baker

HIV activist Michael Mooney speaks about the therapeutic applications of testosterone and anabolic steroids for HIV wasting in a deleted scene from “Bigger Stronger Faster.” Mooney is the co-author of Built to Survive (along with Nelson Vergel) and wrote about steroids and HIV for the anabolic steroid and bodybuilding magazine Muscle Media 2000.

I still meet people who obviously have a serious problem with testosterone deficiency who have all the old AIDS symptoms and the doctor will not give them testosterone because their doctor is so afraid of the legal implications. Thousands of people have died because their doctor wouldn’t prescribe testosterone or anabolic steroids for their HIV.

Even though Mooney’s segment was regrettably not included in the final version of the film, Bigger Stronger Faster did include a very powerful segment with long-term HIV+ survivor Jeff Taylor about the life-saving medical applications of steroids. Al Benson wrote an excellent review of this segment for Nelson Vergel’s HIV Blog.

The angle I was most interested in was of course the application of these drugs to people living with AIDS, but I had not actually believed that it would be covered except in the most general way.

Was I wrong! About a half hour into the film , who should I see but the handsome, Smith Bros. bearded face of our friend and long term HIV survivor, Jeff Taylor.

Jeff spoke at length on two segments of his initial experience with the life saving effects of his steroid use, noting that he was able to rise up out of his death-bed, gain 30 pound in 6 weeks and gain 300 T-cells in the same 6 weeks.

[…]

I decided to question the director why they chose to spend so much time on ‘the Jeff Tailor segments”. And they said that they had read Built To Survive by Nelson Vergel and Michael Mooney and elaborated that Steroids were powerful lifesaving medications and that needed to be shown.

Please take the opportunity to check play dates for Bigger Stronger Faster and support this highly recommended steroid documentary.

Taking Care of Men

Taking Care of Men
Noted physician and author Frank Spinelli, who speaks in Houston this month, has plenty to say on gay men’s health.

By Nelson Vergel

Nelson Vergel, well-known local AIDS educator, advocate, and author, speaks to Frank Spinelli, M.D., by telephone, in advance of Spinelli's June 30 Houston appearance at an event hosted by Legacy Community Health Services. Spinelli, who maintains a private practice in the Chelsea neighborhood of New York City, is the author of the recently published Advocate Guide to Gay Men's Health and Wellness (Alyson) and writes a health column for Instinct , the gay man's answer to Cosmo.

Nelson Vergel: Could you give us a very brief background of who you are and what you do in New York?

Dr. Frank Spinelli: I've been living in the city for over 12 years. I'm from New York, originally. I'm a Brooklyn boy. And I was raised in Staten Island. I ended up in private practice in Manhattan, in New York, about eight years ago. So I've been in solo private practice in internal medicine with a sub-specialty of HIV in the gay community.

And what made you decide to write a book about gay men's health?

I've always wanted to write. I've always kept journals. Even when I was in practice, even in early periods, I would write into the local gay magazines. I would write in questions and answers, and see if they had many health columnists, and if they were interested, and how would I apply. They were very receptive. So I was attached to certain publications, like New York Blade and then HX. Then finally, I ended up with Instinct magazine, and I've been doing a Q&A for them.

Ultimately, I was feeling the same thing would keep coming up. It was these feelings of isolation and depression and loneliness. I thought, even though we are speaking now in 2008, it's amazing to me how we can still feel so isolated from our community, even being within our community. So I started to look beyond that and say, “What's going on? What are these key points that I want to address?” And that was internalized homophobia, HIV, and what that meant as a gay man. And why would gay men's health be different than men's health?

Nobody wants to talk about a few things that really concern gay men, especially aging gay men. In your book, you mention the higher suicide rates and depression and issues with GLBT youth. I really wonder what we can do as the older generation to mentor the younger generation of gay and lesbian and transgender youth to make their lives a little easier.

What I wanted to do is organize ourselves as a group and to reach out to the younger gay men, and even the older gay men, because we have a real big disparity there. The HIV epidemic really did inflict itself upon us, and it did wipe out a generation. There has been that devastation that occurred, and I think we're all kind of just wallowing in the aftermath of that. I want to say to the younger guys—because there are so many issues with complacency, where they think there [are] these new one-pill, once-a-day [treatments], and HIV is not so bad. They don't remember what the epidemic was like at the height of the epidemic. So you have to be able to address them without scaring them, because you don't want to become frightening. You want to attract your audience.

The other thing is how we deal with the older population, especially those over 50 who are breaking up with boyfriends and then going back and doing crystal meth or going back into the life of singlehood and dating. There are so many opportunities. I wanted to really explore them on a case-by-case basis. That's one of the things I'm going to do when I come to Houston. I really want to talk about these personal stories that I think are indicative of what's going on across the country.

You mention in your book that 800,000 men per year are raped or assaulted by their partner. I was really shocked by that number.
This week, I had a patient who had been attacked viciously outside his apartment, and he's in the ICU. He almost lost a kidney from being kicked and the result of what we thought was maybe a gay bashing . . . well, we researched further with the police and the investigators. We found out that it was his partner, his lover. Domestic violence—it still exists.

And you say it's very under-reported because of shame issues.


Because of shame and guilt of isolation. Because as gay men, we feel we don't have the cause to say, “Oh, I've been violated” or “I've been attacked.” There's a lot of disparity when we talk about men being attacked—like we should take care of ourselves. It's really sad, because men can be victimized, and that needs to be addressed, definitely.

Something that you also talk about a lot is our over-compulsion, our body consciousness. We get bombarded by the media — not only gays but straights, women, men — to consume more and then feel a lot more inadequate so we can consume more. How do we take care of our bodies while keeping the balance?

I was like a chubby kid when I was in school. I wasn't good at sports, and I hated to go to gym. So here I was, a gay kid. I was fat. I didn't want to go to school because I didn't want to have to play sports. . . . In the gay community, we do it to ourselves. It's like high school all over again. When I went to the bars, everybody was like, “Oh, you've got to be pretty. You've got to look good.” And I was thinking, Oh, my God. I gotta go to the gym! It comes right back down to your sense of self, who you are, and who you want to be in the community—and not just some image or some stereotype that's depicted on television, or to the camera in magazines.

You also address the sexual addiction and compulsion. We're always wondering, How much sex is too much sex? What is a healthy sexual appetite versus an unhealthy one? That's always a hot topic.

A healthy sexual appetite is great. I think sex is great. I recommend it highly. But I think anything can become an addiction when it interferes with your regular, routine life, when it just really becomes part of your routine and you cannot function without it. So when men are on the phone, texting men to arrange for sex, and they are not even talking to you at the table because they're arranging for sex afterwards, then there's a problem.

Sexual addiction speaks to something deeper. Is there underlying depression? Or is there isolation? There again, what is the void you're filling? We speak of the necessity to fill the void with sex or food or drugs or alcohol or smoking. The addictive potential for gay men is incumbent upon the fact that maybe they just feel really hollow inside because they don't accept who they are. So I wanted this to be an inspirational book for men to say, “We're gay and we should be very proud that we are here.” I hope that I put a face to gay men's health and we can just be here for one another.

In talking about meth addiction . . . I'm seeing a lot of problems not only in 20-somethings, but like you said, older gay men.

Oh, it's a huge concern. I'm going to actually speak at the Gay and Lesbian Center in New York next week. And we're talking about crystal meth. You know, crystal meth has not gone away. It's here. And it's actually very pervasive because of the way it's made and the fact of what it does to you. We talk about the effects it has on the reward system, and that it's like 50 times more powerful than cocaine. The addiction potential is so high, and what that leads to ultimately is unprotected sex and HIV. We don't talk about it enough. And I think it's like one of those things where we have to approach it in different ways, because it just gets tiresome—because everybody's like, Well, I don't want to talk about crystal meth anymore. But it still exists, and it's still around.

Something else I'm concerned about — because I've been working in the HIV field for a long time as an educator — the fact that we're still not talking enough about anal cancer, and issues with the human papilloma virus. People are not getting themselves checked. Fortunately, we now have two doctors now trained in Houston for anoscopies. Hopefully, you can talk to us about this when you come to Houston.

Yeah, well, who wants to talk about that? It's scary. I mean, I'm scared just to hear the word anus. Now, everybody is scared. You say the word anus —everybody runs. But you know what? We have got to talk about the anus. You have got to be in touch with your body. People think I'm crazy because I'm, like, You have to get a mirror. I grew up with women, so I feel very in touch with the feminine side. Do you remember in an episode of Sex and the City when they tell her [the character Charlotte] to look at her vagina in the mirror? I recommend that men look at their anuses in the mirror! Look at your body. You really have to know everything there is to know about your body.

If I had it my way, I'd have a bathroom with mirrors on every wall, so I can see everything that's going on, all over me. Because I want to know what's on my back, on my tushy, on my foot—everything. And instinctively, I examine myself all the time. But when you don't know what you're looking for, you're afraid and you ignore it. So how scary is it to find something going on in your butt? That would be frightening. So I just give in the book some tips on how to take care of yourself, because obviously this is being used as a sexual organ. We're not talking about it enough, but it is.

I don't think a lot of primary-care doctors are well-trained on doing Pap smears in men. Sometimes even the gay doctors don't want to deal with it. So it's kind of embarrassing and a problem that when it is diagnosed, it is usually in later stages that require chemotherapy or radiation.
Wait till I come to Houston with a big picture of an anus.

You are funny! Can't wait to listen to your lecture! Let me see what else I have here. Can you tell us more about what dysthymia means? Because I think a lot of us may be walking around with that underlying depression and not really know it.

I think there's a lot of underlying depression and anxiety across America period. People neglect to think that we're going through a war right now, and this has an effect on us, the economy, and everything. Add to the fact that you might be a minority, or gay, and how that influences your life, your decisions. It's a lot just to get up in the morning. That's tough.

I think addressing one's health is breaking it down into “How do I just find me? What works for me?” What I really wanted in this book was for someone to just look through it and say, “Look, I read this book and I have some questions.” That's what I wanted—to provoke a discussion between you and your doctor.

Frank Spinelli speaks on June 30, 6–8 p.m., at the Ensemble Theatre (3535 Main). There is no admission charge for the event, which is underwritten by Abbott Laboratories. Legacy will serve complimentary hors d'oeuvres, soft drinks, wine, and beer at the event.

Nelson Vergel is the co-author of Built to Survive! (with Michael Mooney) and edited the book How to Manage Side Effects, published by the Houston Buyers Club. He writes frequently on health and HIV/AIDS issues for the media, including for TheBody.com , the New York-based HIV information website. Vergel is the founder of PoWeR, the Program for Wellness Restoration, a nonprofit organization that provides educational information for HIV-positive people, and the founder and moderator of Yahoo.com PozHealthGroup, an HIV listserve.

Bigger, Stronger, Better

From Al Benson


Last night, my partner and I went to the film Bigger, Stronger, Better. The story of steroid use in America as refracted off the lives of an American family from Poughkeepsie ,NY. Its core belief is that steroid use is rampant in the US because it is an essential component of the American mentality of being a winner. It was a very well done documentary that surprised me by its open forthrightness in discussing the subject from every angle.

The science was correct and explained in a way that was useful to everyone watching, from the total indi/IFC buff to educated consumers like my partner and myself.

The angle I was most interested in was of course the application of these drugs to people living with AIDS, but I had not actually believed that it would be covered except in the most general way.

Was I wrong! About a half hour into the film , who should I see but the handsome, Smith Bros. bearded face of our friend and long term HIV survivor, Jeff Taylor.

Jeff spoke at length on two segments of his initial experience with the life saving effects of his steroid use, noting that he was able to rise up out of his death-bed, gain 30 pound in 6 weeks and gain 300 T-cells in the same 6 weeks.

Since we went on opening weekend, there was a Q&A with the 3 principle filmmakers. The crowd at the movie house was mainly indi types with a scattering of industry people. I thought it was odd that Tony and I were the only ‘big guys’ with the AIDS, there on opening Saturday Night.

I decided to question the director why they chose to spend so much time on ‘the Jeff Tailor segments”. And they said that they had read Built To Survive by Nelson Vergel and Michael Mooney and elaborated that Steroids were powerful lifesaving medications and that needed to be shown.

They eviscerated the congressional hearing and made Waxman look like a dottering idiot and Joe Biden look like an irrational angry man. Although, Joe Biden was the only actual congressman who attended the DC screening and said it was an excellent film.

I told them that they had made an excellent film and the only problem I say was the advertising for it. I had only known about the film from a conversation I had almost two years ago with somebody that they had interviewed and was lying on the cutting room floor, I guess.

In short it’s a film worth seeing, especially since it treats the issue of HIV and takes on some of the demonizing myths surrounding steroid use in America. Changes are that it will come to your town during the rollout, but you won’t hear about it, so you need to make the effort to search it out. It won’t be out in DVD for a long time so I recommend that everyone who can should make an effort to see it.

Al Benson

Buttock Wasting Options

I just wanted to let everyone know that a revised buttock wasting page is up at facialwasting.org

This is the only page out there that focuses on this undressed issue.

http://facialwasting.org/buttock_wasting.htm

Facial Wasting Reconstruction Options- Summary Table

CLICK ON THE TABLE TO MAKE IT LARGER

SHOULD EVERYONE TAKING STATINS BE TAKING ANTIOXIDANTS?


If I was on statins, I would take extra Coenzyme Q 10 ( statins lower it : http://www.cholesterol-and-health.com/Coenzyme-Q10.html )
and antioxidants to lower any chances of age-related macular degeneration (http://www.eyecareamerica.org/eyecare/treatment/alternative-therapies/antioxidant-supplements-amd.cfm ). You can read more about macular degeneration here:
http://www.macular.org/disease.html



Statins Associated With Increased Progression of AMD, but Caution Is Urged
Charlotte Libov
Medscape Medical News 2008. © 2008 Medscape




April 30, 2008 (Fort Lauderdale) — A new study shows that the use of statins is associated with the progression of age-related macular degeneration (AMD), but the authors urge caution, saying that other causes may be the reason for the findings.

The authors presented the results of their study here at the Association for Research in Vision and Ophthalmology 2008 Annual Meeting.

"We are not saying that statins are a risk factor in the progression of age-related AMD. There are a lot of confounding variables. But what this study shows is that they don't seem to have a beneficial effect," lead author Catherine Cukras, MD, PhD, medical retina fellow at the National Eye Institute, Bethesda, Maryland, told Medscape Ophthalmology.

Using data from the Age-Related Eye Disease Study (AREDS), the researchers followed 1266 subjects for 11 years. The patients had AMD — either neovascular AMD or central geographic atrophy (CGA) — in 1 or both eyes. The patients also were documented statin users.

The researchers found that 481 patients developed advanced AMD; of this number, 323 patients developed neovascular AMD and 233 developed CGA. Using multivariable analysis, statin use was statistically significantly associated with the development of advanced AMD (odds ratio [OR], 1.43; 95% confidence interval [CI], 1.12 – 1.83), but in analyses for types of advanced AMD, use of the drug was only linked with the development of neovascular AMD (odds ratio, 1.76; 95% CI, 1.34 – 2.30).

The researchers concluded that in AREDS, statin use was associated with patients developing advanced neurovascular AMD However, previous studies have found an inconsistent association with cardiovascular risk factors, such as elevated cholesterol. Because statin use may be confounded with such conditions, no causal relationship should be drawn from this study's data.

Frederick L. Ferris III, clinical director of the National Eye Institute, pointed out, "We don't want patients to be concerned about the effects of statins on their eyes. [The drugs] have a beneficial effect on their life."

In an interview with Medscape Ophthalmology, John T. Thompson, MD, clinical associate professor at the University of Maryland, concurred: "The significance here is that there have been conflicting reports as to whether statins are protective, and this study says that they are not. There need to be further studies to sort this out."

The study did not receive commercial support. The authors and commentators have disclosed no relevant financial relationships.

Association for Research in Vision and Ophthalmology 2008 Annual Meeting: Abstract 3772. Presented April 30, 2008.

Is the Answer to HIV-Associated Diarrhea Found in South America’s Rain Forest?
By Nelson Vergel, BsChE, MBA



As more and more shamans (traditional healers) in the Amazonian rain forest die as they age, the new generations of indigenous people are moving on to jobs in cities, forgetting valuable medicinal knowledge gathered through centuries. Recognizing this potential loss in key know-how a small team from a company called Shaman Pharmaceuticals in South San Francisco went searching for medicinal plants in South America’s rain forest by working hand-in-hand with local shamans. With the help of ethnobotanists and physicians who worked with the traditional healers to document the therapeutic qualities of the foliage, Shaman Pharmaceuticals created a library of 2,600 medicinal plants.



“Indigenous people led us to a situation where we could make and improve a safe and effective pharmaceutical product and give back to the population that provided the information," said Lisa Conte, founder of Shaman.



“We ensure that medicinal plants are cultivated with replanting that requires careful management and conservation in conjunction with the indigenous and local peoples who reside in the forest where it grows,” added Steven King, PhD, Vice President of Sustainable Supply, Ethnobotanical Research and Intellectual Property, one of the main experts involved in the search for medicinal plants in South America.

One of their earliest targets was Sangre de Drago ( “Dragon’s blood” or Croton lechleri), a plant with a blood-like sap (properly called ‘latex’) that has been used by indigenous people for centuries to treat wounds, diarrhea, stomach problems, and other ailments (Jones 2003.) Shaman’s researchers isolated and purified the main component from the latex, named “crofelemer”, and formulated crofelemer into standard oral medication. The company produced a supplement called “Normal Stool Formula” that was widely used in the HIV community in the 1990s to successfully treat diarrhea.

“It was our best seller for diarrhea,” said Fred Walters, founding director of the Houston Buyers Club, a Houston-based non profit that provides supplements at cost to people with HIV nationwide. “We were sad to see Shaman close its doors due to financial difficulties back then, so we are glad to see Napo Pharmaceuticals acquiring the rights for the pharmaceutical-grade of the product for new research and potential FDA approval,” added Mr. Walters.

“In our country and most other western countries, there are only two anti-diarrhea medications, both approved over 30 years ago and both work about the same way – they slow or stop the movement of the gut. Crofelemer works differently and we see an exciting opportunity to study crofelemer for HIV-associated diarrhea and many other diseases where diarrhea is a major, sometimes fatal symptom of other infections,” said David Golman, PharmD, Senior Director of Clinical Operations of Napo Pharmaceuticals. An estimate by the World Health Organization suggests that worldwide, everyday 6,800 children die from diarrhea and its complications (Guerrant 2002.) “Clearly, there is the need for a more effective and widely available treatment for diarrhea,” added Dr. Golman



Diarrhea associated with HIV infection is still very much an issue to many. In a survey performed by POZ magazine in September 2007 with a total of 941 responders, 21 % said that side effects were the primary reason that they switched antiretroviral regimens in the past. Diarrhea, nausea and vomiting were the number one side effects that make a person switch meds. In a recent prospective study of 163 HIV+ patients performed by Dr. Uzma Siddiqui, 28.2% of patients reported having 3 or more bowel movements per day but only 14.1% reported use of anti-diarrheal medications (about ½ of those with chronic diarrhea) (Siddiqui 2007).



Before the widespread availability of highly active antiretroviral therapy (HAART) in 1995, most HIV-infected people developed progressive immuno-supression and opportunistic infections (OIs); and many OIs were in the gastrointestinal track causing diarrhea. After the introduction of HAART, there was a dramatic decrease of OI-associated diarrhea, however, non-infectious causes appear to have become more dominant. In a review performed by Stephanie Call, MD (Call 2000) it was shown that between 1995 and 1997, while the use of HAART increased, non-infectious causes of diarrhea increased from 32% to 70%. One prominent cause of non-infectious diarrhea among HAART- treated patients is the antiretroviral medications themselves. Since their introduction in the market, we have learned that protease inhibitors like Viracept®, Norvir®, Kaletra®, Aptivus®, Lexiva®, Prezista®, and others can cause significant, even serious gastrointestinal problems in people taking those medications (Physicians Desk Reference 2008).



Another potential cause of HIV-associated diarrhea is the virus itself. In an interview for the newsletter HIVhealth, Calvin Cohen, MD, Research Director of the Community Research Initiative of New England, said that the HIV virus itself can increase the risk of diarrhea since HIV attacks the lymph nodes in the intestines. This may lead to a condition called enteropathy which can result in diarrhea and other diarrhea symptoms.



Currently, there are no drugs approved by the FDA for HIV-associated diarrhea in the U.S. but it remains a serious problem for many people. “Chronic diarrhea not only has a significant negative impact on quality of life, but it can also affect HIV treatment and adherence, decreasing the effectiveness of medications,” said Shannon Schrader, MD, a leading physician in Houston. “Diarrhea may also lead some of us to switch their patients to other HIV medications, reducing treatment options later on when the patient might need them more,” added Dr. Schrader.



“I have lived with HIV for over 15 years and deal with diarrhea weekly, even though my immune system has improved with HIV medicines,” said Al Benson, a patient and activist living in Los Angeles. “I am glad we have drugs like Imodium® and Lomotil®, but I am concerned that they give me a yo-yo effect from constipation to diarrhea returning with a vengeance. I certainly believe that we need another option that is more gentle on the gut,” added Mr. Benson.



Crofelemer is believed to work by a different mechanism of action. The common anti-diarrheal drugs such as Imodium® and Lomotil® are absorbed into the blood, distribute throughout the body, and work by slowing down the flow of material through the intestines, they are called “anti-motility” drugs. While this stops diarrhea, it also allows toxins to remain in the body longer. Crofelemer is thought to act locally in the gut, and because it is not absorbed the potential for systemic adverse drug effects and interactions are minimized. Crofelemer does not affect motility; instead it reduces the abnormal excessive flow of water into the gut that is the root cause of many diarrheas. In clinical studies crofelemer has been very well tolerated, and constipation in particular has not been commonly reported (Napo Pharmaceuticals, data on file).

“Crofelemer works by normalizing water flow in the gut. It is not absorbed into the blood, but acts in the intestines to treat diarrhea and reduce the chances for dehydration. Because it is not absorbed and acts locally, it has a favorable safety profile,” explained Pravin Chaturvedi, PhD, Chief Scientific Officer of Napo. The drug’s capacity to treat diarrhea by blocking the secretion of chloride ions, and still allowing bowel movements, makes this useful for treating chronic diarrhea,” explained Dr. Chaturvedi. “This is a novel mechanism of action for the treatment and management of diarrhea, and it has been brought to us by indigenous knowledge,” added Dr. Chaturvedi.

A study published in 2004 found that Viracept®, a commonly used protease inhibitor used to treat HIV, stimulated chloride ion secretion and may explain its high rates of diarrhea in HIV-positive patients (Rufo 2004). Crofelemer’s mechanism of action could provide an answer to drug induced secretory diarrhea.

Crofelemer has been tested in clinical studies involving approximately 1,700 patients with diarrhea of various causes. Its novel mechanism is important to people living with chronic diarrhea, so much so, that the U.S. Food and Drug Administration (FDA) granted Napo a fast-track designation for the crofelemer drug for use in treating HIV-related diarrhea (Napo Pharmaceuticals, data on file.) Napo is currently conducting a clinical study in HIV positive individuals with chronic diarrhea. More information can be found on the company’s web site (www.napopharma.com).

References:

Call, S. et al. The Changing Etiology of Chronic Diarrhea in HIV-infected Patients with CD4 Cell Counts Less Than 200 cells/cc. The American Journal of Gastroenterology 2000; Volume 95 (11): 3142-3146.
Guerrant, R. et al. Magnitude and Impact of Diarrheal Diseases. Archives of Medical Research 2002; Volume 33 (4): 351-355.

Jones, K. Review of Sangre de Drago (Croton lecheri)- A South American Tree Sap in the Treatment of Diarrhea, Inflammation, Insect Bites, Viral Infections, and Wounds: Traditional Uses to Clinical Research. The Journal of Alternative and Complementary Medicine 2003; Volume 9 (6); 877-896.

Rufo, PA. et al. Diarrhea-associated HIV-1 Aspartyl Protease-inhibitors Potentiate Muscarinic Cl- Secretion by T84 cells Via Prolongation of Cytosolic Ca2+ Signaling. Am J Physiol Cell Physiol 2004; Volume 286: 998-1008.



Siddiqui, U. et al. Prevalence and Impact of Diarrhea on Health-related Quality of Life in HIV-infected Patients in the Era of Highly Active Antiretroviral Therapy. Journal of Clinical Gastroenterology 2007; Volume 41 (5); 484-490.

Can Facial/Buttock Wasting Reconstruction Costs be Deducted from US Income Taxes?
Someone was nice enough to do some research on this topic for me (from my list pozhealth at yahoogroups.com)


Hi Nelson,

To our friends in other countries - ignore this message! It's about US tax.

As is usual with tax, there's no simple yes/no answer to your question. My answer boils down to - it SHOULD be deductible, and it's worthwhile trying, but if you are audited, there's a good chance that it will be reversed and you will be billed for tax and interest, and possibly penalty.

Deductibility of medical expenses comes down to "medical necessity." Internal Revenue Code section 213(a) says this:

"There shall be allowed as a deduction the expenses paid during the taxable year, not compensated for by insurance or otherwise, for medical care of the taxpayer, his spouse, or a dependent ..., to the extent that such expenses exceed 7.5 percent of adjusted gross income."

In other words, you add up all your allowable medical expenses, and if they are more than 7.5% of your adjusted gross income (also called AGI - the last line of page 1 of your Form 1040), then the excess is allowed as an itemized deduction. If your AGI is $100,000, and your total medical expenses are $10,000, your itemized deduction will be $2,500. Your total itemized deductions have to exceed your "standard deduction" to get any benefit. The standard deduction for a single person in 2007 is $5,350.

By the way, as for medication, section 213(b) says "An amount paid during the taxable year for medicine or a drug shall be taken into account ... only if such medicine or drug is a prescribed drug or is insulin."

So, no deduction for aspiring or cough syrup.

Now, in the tax code, you always have to look for the definition of everything. Section 213(d)(1) says "The term 'medical care' means amounts paid for the diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purposes of affecting any structure or function of the body ..." And then it goes on to also allow deductions for certain medical-related travel expenses, for long-term care, and for medical insurance premiums.

It sounds from the above like facial and buttock reconstruction would be covered - it mitigates disease (effect of the treatment of a disease, which amounts to the same thing), and does affect bodily structures.

However, section 163(d)(9) says "(A) The term 'medical care' does not include cosmetic surgery or other similar procedures, unless the surgery or procedure is necessary to ameliorate a deformity arising from, or directly related to, a congenital abnormality, a personal injury resulting from an accident or trauma, or disfiguring disease. (B) ... The term 'cosmetic surgery' means any procedure which is directed at improving the patient's appearance and does not meaningfully promote the proper function of the body or prevent or treat illness or disease."

We have two problems, then. First, anything that can ALSO be cosmetic, is very hard to prove as being medically necessary - it's the same reason we have trouble getting our insurance providers to cover the treatment. The IRS is extremely skeptical of such deductions. In addition, the IRS is very skeptical of any treatment that addresses a mental/emotional problem, as opposed to a physical problem. So if you have your butt fixed because it's painful to sit, that's a physical issue. If you have your face fixed because you can't even recognize yourself in the mirror and it throws you into a deep depression - the IRS may not be sympathetic.

This is a heavily-contested subject - not lipoatrophy treatment, but deduction of cosmetic treatment.

There is no requirement that treatment be provided in the US, and if you can show that it cost less because you had it done elsewhere, that may help, although it also may look to suspicious to examiner, particularly if it was done in a place that is also a vacation spot (hmmm, Baja Mexico, Brazil) ... and the regulations related to medical travel expenses mention that a "vacation for to improve general health" is not deductible so you'll need to be ready to defend against that.

The IRS has a publication on Medical Expenses called Publication 502. Here's what it says about cosmetic surgery:

"Generally, you cannot include in medical expenses the amount you pay for unnecessary cosmetic surgery. This includes any procedure that is directed at improving the patient's appearance and does not meaningfully promote the proper function of the body or prevent or treat illness or disease. You generally cannot include in medical expenses the amount you pay for procedures such as face lifts, hair transplants, hair removal (electrolysis), and liposuction.



"You can include in medical expenses the amount you pay for cosmetic surgery if it is necessary to improve a deformity arising from, or directly related to, a congenital abnormality, a personal injury resulting from an accident or trauma, or a disfiguring disease."


Here's the link to the on-line version of Publication 502: http://www.irs.gov/publications/p502/index.html

If you want to download it: http://www.irs.gov/pub/irs-pdf/p502.pdf


So, you need to be able to prove that you meet this definition. A letter from a doctor will be a necessity here. Discuss all this with your own tax provider. Large medical expenses are a red flag for audit, so if you have other stuff in your tax return you don't want them asking questions about, then you'll want to think twice about taking this deduction.



I hope this helps!