Monthly Archives - April 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!

Living Positively With HIV

Lecture in Detroit , Michigan

Sponsored by the Midwest AIDS Prevention Pro ject (MAPP)

Practical Health Tips from a Long Term Survivor Expert

May 6th from 6:00 pm to 8:00 pm
Como’s Restaurant & Pizzeria

22812 Woodward Ave
Ferndale, MI 48220

Free dinner and a free raffle for an IPOD Shuffle

For reservations call MAPP at 248-545-1435
You must register to attend

Nelson Vergel

HIV positive survivor for two and a half decades, Nelson,
a key national leader in HIV treatment advocacy, is the
founder of the Program for Wellness Restoration (PoWeR),
the HIV non-profit agency. For more information about
Nelson’s work, visit www.powerusa.org.

Nelson has co-authored Built To Survive, the guide to living
healthily with HIV, founded the Body Positive Wellness
Center in Houston and has spoken to thousands of his peers
and medical professionals on HIV treatments, side effect
management, salvage therapies and quality of life issues.

Committed to Living
Continuing Education Series

Nelson Vergel’s Lecture in Chicago

Nationally known
Treatment advocate,AUTHOR,
Fitness&Nutrition guru

Wednesday May 7 , 2008

7-9pm

Location to be announced

Learn why exercise is so important in fighting HIV.
Learn fitness routines you can do at home.

Be prepared to get out of your seat and move around!

Funded by
Illinois Department of Public Health

Please RSVP to TPAN reception at
773-989-9400 by May 5

PoWeR Releases Groundbreaking Lipodystrophy Resources for HIV-Positive People

CONTACT: Nelson Vergel, Director
powertx@aol.com
713-539-1978

Houston, April 8, 2008- Program for Wellness Restoration, PoWeR, released the results of the largest online patient surveys performed to date on lipodystrophy options and resources along with a free Spanish translation of their book :”Built to Survive”. The 776- people survey summarizes the main therapeutic options used in the HIV community along with a list and ratings of providers who specialize in reconstructive procedures for HIV-related body changes.

Ten years have passed since the first report of lipodystrophy at an HIV conference. The excitement and hope for a longer life that accompanied the arrival of Highly Active Anti-Retroviral Therapy (HAART) has been tempered by accounts of humps, bellies, and facial wasting. A decade on, many unanswered questions and misconceptions about HIV associated lipodystrophy persist with only a limited number of treatment options available. Frustrated and tired of waiting for answers from the medical community, many people living with lipodystrophy have turned to the internet for advice, treatment and support in hopes of reversing some of the devastating effects of this stigmatizing syndrome.
Lipodystrophy is a condition of abnormal fat redistribution that can lead to either lipohypertrophy (fat accumulation in specific areas of the body such as the neck, belly, upper torso, and breasts) or lipoatrophy (fat loss in the face, buttocks, arms and legs).
“I am very happy that we have been able to provide this key information to the HIV community”, said Nelson Vergel, founding director of PoWeR. “People have been wanting this important health resource for 10 years after the first report of lipodystrophy was reported at an HIV conference”, added Vergel.

The results of the survey can be found at: Survey Results

A list of providers with comments from patients can be found at : Survey Results

A free PDF (Adobe Acrobat Reader format) copy of the Spanish translation of the book Built to Survive can be downloaded from : http://powerusa.org/pdf/Fortaleceteysobrevive1.pdf

Another distressing and negleted issue related to HIV lipodystrophy is wasting of the buttocks. Currently, there is no research being performed in the US or abroad on this debilitating problem that can cause pain and discomfort in patients who have to sit down for extended periods of time at work or school. PoWeR gathered all available anecdotal and research information on the subject and made it available in their new web page: http://facialwasting.org/buttock_wasting.htm

PoWeR is a national non -profit all-volunteer organization that provides patient-friendly educational information to HIV-positive people and their clinicians about ways to improve HIV treatment response, side effects, and quality of life. More information can be found at www.powerusa.org

For an update on where we are after ten years of lipodystrophy, please visit http://thebody.com/content/toparts/art45454.html