HIV-related wasting can have long-term consequences

HIV-related wasting can have long-term consequences

People who suffered wasting in the past more vulnerable to frailty in later life

Michael Carter

Published: 30 November 2015

HIV-associated wasting can have a long-term impact on physical function and quality of life, according to research from the United States published in the online edition of AIDS. The research was conducted by investigators from the Multicenter AIDS Cohort Study. HIV-positive men with a wasting diagnosis were assessed an average of four years after their wasting diagnosis and compared with HIV-positive and HIV-negative men without wasting.

“The degree of impairment observed among HIV/wasting men may have significant clinical implications,” comment the authors. “HIV-wasting had a similar effect of 10 – 20 years of aging on self-reported physical QoL [quality of life].”

HIV-wasting syndrome was recognised early in the epidemic. Diagnostic criteria are involuntary weight loss of over 10%, either chronic diarrhoea or weakness and fever for over one month. Chronic weight loss and wasting are still among the commonest manifestations of advanced HIV disease. Although the incidence of wasting has declined marked with the introduction of effective antiretroviral therapy, initial weight loss may not be restored even with effective HIV therapy.

Because the long-term consequences of HIV-associated wasting are still unclear, investigators from MACS designed a longitudinal study comparing the physical function and physical and mental quality of life of HIV-positive wasting survivors with HIV-positive and HIV-negative men without wasting.

The impact of wasting on overall survival was also monitored.

Patients with wasting were assessed at least two years after they were diagnosed with the syndrome or other manifestations of severe weight loss (BMI below 18.5kg/m², sustained 10% loss in body weight, or a 1%/kg loss of body weight each year during follow-up). Men with wasting were matched with men of a similar age who were recruited to the cohort at approximately the same time. CD4 count and viral load were used for matching with HIV-positive men.

Assessments of physical function included grip strength and walking speed. Physical and mental quality of life were assessed using accredited self-administered questionnaires.

Median survival was significantly lower among MACS patients with HIV-related wasting (9.1 years) compared to HIV-positive men without wasting (11.6 years).

“We found that the occurrence of HIV-wasting by any of our tested definitions was associated with markedly shorter survival than observed among HIV-infected men without wasting or uninfected men,” comment the investigators.

The study population for the assessment of the impact of wasting on physical function and quality of life comprised 85 men with a wasting diagnosis, 249 men with HIV and no wasting and 338 HIV-negative men.

Most of the study visits (80%) took place after 1996 – the year in which effective HIV therapy became widely available.

Men with wasting were assessed a median of four years after they were diagnosed with the syndrome. During this time, they experienced a small but significant increase in total body weight. However, they still weighed between 8-9kg less than men without wasting.

“We suspect that wasting in our cohort was associated largely with losses in lean mass, with subsequent regain largely representing fat mass,” comment the investigators. “The persistent low body weight and mean gain of only 2kg over 4 years is of particular concern in regards to long-term consequences in our cohort.”

At the time of assessment, the men with wasting had more co-morbid health conditions (2 vs.1), greater levels of use of stavudine (d4T) – an antiretroviral associated with fat loss (69% vs. 54%; cumulative use 2 years vs .05 years), and greater levels of use of therapy to counter wasting (testosterone – 38% vs. 22%).  

Men with HIV-associated wasting had lower grip strength and poorer physical quality of life than HIV-positive men without wasting (p < 0.03), and poorer physical quality of life but higher mental quality of life compared to HIV-negative men (p < 0.05). Walking speed did not differ significantly between the wasting and non-wasting patients.

When comparison was limited to patients with HIV, the association between wasting and physical quality of life ceased to be significant when lowest ever CD4 count and an AIDS diagnosis were taken into account. The association between wasting and grip strength was of borderline significance (p = 0.055), a likely reflection of the small sample size.

“HIV-wasting has a negative impact on muscle strength and physical QoL, years after stabilization of body weight,” conclude the investigators. “Prior studies have demonstrated that low body weight and/or poor strength are associated with low bone density, injurious falls, fractures, frailty, and ultimately, could result in a loss of independent living.”

http://www.aidsmap.com/HIV-related-wasting-can-have-long-term-consequences/page/3014398/

Reference

Erlandson EM et al. Long-term impact of HIV wasting on physical function in the Multicenter AIDS Cohort Study. AIDS, online edition. DOI: 10.1097/QAD.0000000000000932 (2015).

Second Bioplasty Congress in Mexico- PMMA for facial and buttock lipoatrophy

I  attended the second International Congress on Bioplasty in Guadalajara last week. Here is the program in Spanish: http://www.bioplastia.org.mx/es/programa.php

Cosmetic and dermatology physicians from Mexico, Spain, Argentina, Brazil, and Colombia  came to share experiences on the use of PMMA (polymethylacrylate) to treat HIV related facial and buttock lipoatrophy and other non HIV related physical abnormalities.

Bioplasty is a technique of  inyectable implantation  done  under local anesthesia for facial and buttock lipoatrophy and for reshaping other body parts. The product usually used is PMMA (polymethylmethacrylate microspheres) and it is  usually  (but not always) injected using a micro-canula (gun like device that enables faster and smooth dispersion of the product under the skin) .  Two brands used overseas are Metacryl and Newplastic.  In the States, Artefill is the only PMMA based product approved (for cosmetic use, not lipoatrophy). 

It was confusing for me to find out that Bioplasty really is a brand name for the specific use of NewPlastic which was created by Dr Nagul in Brazil (he wrote a book on the procedure and trains doctors in Porto Alegre, Brazil).   But Bioplastic is only one of the several PMMA options available worldwide but it seems to be spreading fast around the world. More on Bioplasty here : http://www.bioplastia.med.br/bioplasty.htm 

I presented  the current status of facial lipoatrophy solutions in the United States and the challenges we still face with access and the lack of an economical permanent solution to facial and buttock lipoatrophy.  I presented the results of the 1500 people survey that people subscribed to my pozhealth yahoo group ( http://health.groups.yahoo.com/group/PozHealth/ ) helped me gather about the impact on lipodystrophy on quality of life.  They were surprised that almost half of the respondents with lipoatrophy have not done anything to treat it and that  25 percent of respondents had  suicidal thoughts in the past due to body changes ( http://bit.ly/fg4ODN )

Dr Luis Casavantes reviewed the different options available for facial and buttock lipoatrophy. Dr Gottfried Lemperle from the US reviewed management techniques for potential complications like granulomas.  Dr Marcio Serra from Brazil reviewed his experiences during the past 12 years of work. He and colleges from Brazil also described their national free assistance program for people with facial lipotrophy. Physicians in Mexico want to use Brazil's model to provide economical access to patients in Mexico with facial wasting.

The most interesting part of the conference for me was the 3 hours in which all of us got to watch 5 doctors apply PMMA (Metacryl or NewPlastic) to patients in the operating room from a giant screen. Some use a gun-like canula to inject the product and others using insulin syringes.  It was great for me to see the different techniques in person.   It was a true eye opener for me !

I was impressed with the work on Dr Suzana Barreto from  Sao Paulo, Brazil. She does a MRI on patients before she injects them with PMMA and a few months later to see how the implant behaves in people. She showed great slides on MRI results of the face and buttocks. She also compared MRIs done in patients that have had silicone injected to show how silicone migrates and shifts in tissue. I would love for her to present in the United States since I had never seen anyone who has MRI data on patients with any injectable implants.

It amazes me that in the US  we are so far behind  of all of these countries when it comes to dealing with facial and buttock lipoatrophy   in a permanent way. As I said before, the PMMA product in the US is Artefill, which is not approved for HIV lipoatrophy (only for cosmetic purposes- wrinkles, etc)  and was priced horribly high for it to be cost effective for us in HIV. Luckily, its patent expires next year, which will open the door for Brazilians to bring their cheaper option to the US. I had a meeting with a few doctors to discuss how  feasible it would be to do a study  in the United States in 2011 so that we HIV+ patients can have access to a more cost effective permanent correction.  

The two options approved by the FDA (Sculptra and Radiesse) are non permanent and not cost effective for those  with more advanced facial lipoatrophy. They both require yearly touch ups in most patients. Currently, Medicare pays for both but the reimbursement amounts are too low to entice doctors to use it for HIV patients.  Both products have patient assistance programs that are decreasing in scope with time.

The other two products  that can be used in the US for facial lipoatrophy but that are not approved for that use are Silicone 1000 micro droplets and Artefill, and both are permanent. Neither gets reimbursed and there are no patient assistance programs for them. It would be interesting to see an economic analysis of the total cost for each for a facial wasting grade 2-4 in  a 5 year period.  I would not be surprised that permanent solutions will be cheaper in the long run for some patients.  

We have a lot of activist work to do to try to get something permanent approved for lipoatrophy that is not outrageously expensive and that has a good patient assistance program for those with no insurance (ADAP patients).  Most people with facial lipoatrophy still have no access to treatments for that condition.  Let's see what happens in the long run with Medicare and insurance rates for the two FDA approved options we have now.  Unless something changes with a petition from the community, Medicare approval may actually hurt us more now since both companies are already reducing their patient assistance programs considerably after they assumed that Medicare would pick up a lot of the patients in their programs. If Medicare does not reimburse doctors properly, we will actually lose ground in this field.  Tim Murphy from POZ is writing an article on this problem after he interviewed a few doctors who are having problems with Medicare right now.

I am encouraging companies from other countries that have cheaper PMMA to start studies on facial and buttock lipoatrophy in the US soon to get ready for the time when the patent of the expensive Artefill expires next year.

I will try to post some videos I took of several presentations from the conference. I am still traveling a lot and have not had much time to download and process them.

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Background on PMMA- From www.FacialWasting.org

(collaboration with Al Benson)

The use of PMMA for medical uses dates to 1936 in as a bone cement.  PMMA has presented a good degree of bio-compatibility and as a result it has been extensively used as a soft tissue filler, bone cement, component of denture materials and tooth bond, housing for pacemakers and intra-ocular and contact lenses. The material itself was chemically synthesized in 1904.

Dr. Gottfried Lemperle developed the concept of using PMMA micro-spheres for tissue augmentation in Germany in 1989. PMMA has been available in Germany since as sub-dermal injections used to reduce wrinkles, scars and for certain larger soft tissue deficits.  

PMMA as a tissue filler was first introduced to Europe in 1991 as Arteplast and marketed as a non absorbable injected material. It was composed of microspheres suspended in a gelatin solution. It was observed that the gelatin material was reabsorbed and replaced by native collagen. Not fully recognized at the time was that PMMA itself was stimulating the deposition of new healthy collagen around the individual microspheres without causing fibrotic reactions seen in the implant of foreign materials such as siloxane. Arteplast has since been superseded by newer generations of PMMA of greater consistency in granule size and surface smoothness.  Dr Lemperle said: “because of the extensive fibrous network associated with PMMA related granulomas, intralesional corticosteroid injections are considered the best treatment. We saw an Arteplast® granuloma develop as late as 10 years after injection, which responded well to high doses of local steroids and a pulse light therapy.  After sieving and washing, the second generation Artecoll in Europe caused a significant lower number of foreign body granuloma.” 

There are several PMMA injectable products available. Among the approved and registered PMMA based products are Artecoll and Artesense®, manufactured in Holland and approved in Mexico and Canada since 1998.  Both are formulated with 20% PMMA in a vehicle composed of 79.7% bovine collagen and 0.3% lidocaine. Metracryl and BioPlastic are two other PMMA products widely used in Mexico, Brazil, Argentina and Europe.

Published safety and efficacy studies of PMMA in the United States done for FDA review dealt with PMMA use for the cosmetic correction of nasolabial deficits and concluded that “PMMA is the first soft tissue filler that demonstrates continued improvement and persistence of correction over a 5-year period post-treatment”. PMMA is now manufactured in the United States and was approved by the FDA in October 2006; marketed as ArteFill® (a new formulation of Artecoll), a compound of 20% PMMA in 80% bovine collagen and a small amount of lidocaine.

However, Artefill is extremely expensive for facial or buttock lipoatrophy correction.  ArteFill® costs medical providers $720.00 per ml prepackaged in a box containing 4 syringes of 0.8 ml of product. The professional services of the provider are often sold to the patient for double the cost of the product, thus making it impractical as a corrective for large volume tissue loss. Calculations for the cost-of-treatment climbs astronomically since quite common in the faces or buttocks of people with HIV tissue loss are deficits which can require from 30 ml to 400 ml of filler to correct. A severely atrophied buttock requiring 300 to 400 ml of ArteFill® would cost in the range of $ 200,000 to $ 300,000.

Dr Lemperle has shown that the reported complication appearing in clinical trial results of Arte-Fill has been a small number of tiny palpable nodules. The clinical experience suggests that nodules tend to develop in thin skin areas or when the product is dermally injected in a too superficial manner. These nodules often respond to treatment with Kenalog 40, a cortico-steroid and in many cases also spontaneously remiss.  ArteFill was developed and purified over several generations from the original Arteplast, the appearance of granuloma have decreased dramatically after the micro sphere surface was cleaned up of any imperfections that may have caused macrophages to attack them as foreign objects.

Dr. Luis Casavantes said that based on his experience in the past 5 years of experience with NewPlastic, a PMMA product produced in Brazil and widely used in Mexico and worldwide, does not appear to produce either palpable nodules or true foreign body granuloma, when grafted underneath the muscle fascia.  NewPlastic seems to be a lot cheaper than Artefill.  A moderate to severe facial lipoatrophy correction would cost from 2500 to 3500 depending on the volume needed.  Buttocks require a lot more volume, with costs running from $4000 to $8000 depending on the severity of wasting. Of course, no one knows how much this product would cost in the US if it gets studied and approved here.

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		What is happening to Nandrolone?? May 10, 2009 hey Nelson I enjoyed your book Built to Survive. It really helped me to realize what nandrolone could do for my health and body shape. I have been using nandrolone for 10 years without side effects and I have been able to reshape my body after lipodystrophy. But now I cannot get it anymore and compounding pharmacies are telling me that China is not exporting the raw material anymore to the United States. I really do not want to look like crap again and my energy level drops horribly without nandrolone. What can we do to get it? I am desperate Ed
>      Response from Mr. Vergel Well, it seems that China has stopped shipping nandrolone's raw material (basically powder to be mixed in oil) to the US . As most of you know, Watson, the last maker of nandrolone, dropped the product a year ago to carry Oxandrin, a drug ten times more expensive, less effective, and potentially troublesome to the liver. Compounding pharmacies picked up the market and sold nandrolone at a third of what Watson was selling it at. The Drug Enforcement Agency frequently visited several compounders unannounced and took files away for weeks for review to see if every sale had a supporting prescription from a doctor. These visits happened more and more frequently as the steroid scandal in baseball, etc heated with congress' witch hunt. A few shut down. There are few left providing the product to us, but now they are telling us that may stop. We really do not know why China stopped. My network is not that great to find out. It may have been related to the small clinical market and its off label use. Nandrolone is available cheaply in Mexico and most countries around the world. However, we cannot import it even with a HIV-related prescription because nandrolone is a DEA controlled substance (class III). For those of you long term survivors, you may remember that we used to import stuff that we used to think was going to save our lives in the 80's and early 90's and the FDA/DEA never got in the way. But asking to be allowed to import a steroid may be different. Nonetheless, I am wanting to write a petition to the FDA and the DEA to allow us to import it (3 month supply) for HIV related unintentional weight loss and frailty/fatigue . We could make a case with the FDA/DEA about the lack of supply and our needs ( I sent you guys a survey that could help me list different reasons, link below). One problem that we have is that nandrolone is not approved for a HIV indication, even though there are several well done studies of its effectiveness in increasing strength, lean body mass, and stamina in HIV+ patients (men and women) . Hopefully a company will get smart and pick the drug up and run for a NDA (new drug application) for HIV with the great available data. But that is not a sure thing yet. Anyway, do you guys think it is a feasible idea? I know the FDA and the DEA will have a big problem with this petition, but at least we are pressuring federal agencies that are funded with our tax payer money. FOR BACKGROUND INFO: http://savehivwastingmeds.blogspot.com/ HELP ME COLLECT YOUR EXPERIENCE WITH NANDROLONE: http://www.surveymonkey.com/s.aspx?sm=_2frprhdUDFuKijnWXLOfGwA_3d_3d SEE WHAT SOME PATIENTS HAVE SAID SO FAR ABOUT THE BENEFITS OF NANDROLONE IN THEIR LIVES: http://www.surveymonkey.com/sr.aspx?sm=VqCK45gHXi10L4l2eihyx4wu7TOCkZLFELVFHERJwDA_3d I hope you can help me! Nelson

World AIDS Day: Adverse Impact of Steroid Law and Steroid Hearings on Anabolic Therapies

World AIDS Day: Adverse Impact of Steroid Law and Steroid Hearings on Anabolic Therapies
Posted on 15:42 December 1st, 2008 by Millard Baker

http://www.mesomorphosis.com/blog/2008/12/01/world-aids-day-adverse-impact-of-steroid-law-for-hiv/

In recognition of World AIDS Day, we urge Congressional leaders in the United States to carefully consider the significant harm that morally-guided U.S. steroid policy has had for the life-saving therapeutic applications offered by anabolic-androgenic steroids. The criminalization of anabolic steroids and steroid hysteria perpetuated by Congressional steroid hearings has had an adverse impact on medical research and medical therapies involving anabolic steroids, particularly in the prevention and treatment of HIV+ associated wasting disease.

Anabolic steroids are one of the safest and most effective treatments for HIV associated wasting and have been invaluable in helping HIV+ patients retain, preserve and restore lean body weight and stay alive. Given that wasting is one of the most common symptoms of HIV and that HIV+ patients with wasting symptoms have significantly higher mortality rates, anabolic steroids have been an invaluable medical treatment.

Michael Mooney, of Medibolics, and Nelson Vergel, of the Program for Wellness Restoration, have spearheaded educational efforts and have extensively documented the benefits of anabolic steroid therapy for AID/HIV wasting in “Built to Survive“. Mooney and Vergel have discussed the negative consequences arising from the demonization of steroids by the Anabolic Steroid Control Act of 1990 (”Anabolic Steroid Legality and the Physician,” January 28).

The Anabolic Steroid Act of 1990 created grave misunderstandings about the legal status of “steroids as medicines” to the public and to the physicians trying to help their patients. This law states only that anabolic steroids can not be prescribed for cosmetic or athletic purposes, but the impression it created was that steroids were off limits to everyone, and that they are basically illegal for any use. This is not the case. To compound this climate of fear, it seems that when this law was passed in 1990 several of the more conservative regional governing medical organizations made doctors uneasy, giving them impression that they would become the object of scrutiny if they prescribed steroids at all.

The scheduling of anabolic steroids as controlled substances was a medical catastrophe that pandered to anti-doping crusaders in sports while ignoring the medicinal value of androgens and the life-saving therapeutic potential this category of pharmaceutical drugs offered for HIV+ patients. The regulatory agencies in charge of scheduling of drugs strongly protested the inclusion of anabolic steroids in the Controlled Substances List. Legislators ignored the scientific advisors and experts from the American Medical Association (AMA), the Food and Drug Administration (FDA), the Department of Health and Human Services (DHHS) and the Drug Enforcement Enforcement (DEA) to pass the Anti-Drug Abuse Act of 1988 and the Anabolic Steroid Control Act of 1990.

The legislators were guided by the moral condemnation of athletes that use anabolic steroids and performance enhancing drugs rather than a rational empirical analysis of steroid use and abuse and the effects of such legislation on leigitmate medical research and anabolic therapy.

Unfortunately, the steroid hysteria has continued with the Congressional steroids and baseball hearings initiated by Henry Waxman (and former chief of staff Phil Schiliro) and the passage of more draconian steroid laws in recent years. California resident Mark A. Meier outlined the impact the steroid hearings in a letter to the Nancy Pelosi, Speaker of the House (”Representative Henry Waxman’s Hearings on Steroids in Sports and the Impact on Treatments for HIV and other Medical Conditions,” March 12).

The result, then, of Representative Waxman’s hearings has been an attack on an important, powerful, beneficial and legal therapy solely because professional athletes use it improperly. Patients with legitimate medical needs should not be made to suffer because of the improper actions of a few.

Nelson Vergel of the HIV Blog explains how political pressure and steroid hysteria have restricted the availability of anabolic steroids for HIV+ patients. The moral and political pressure resulted in the discontinuation of Deca Durabolin by Watson Pharmaceutical and the discontinuation of nandrolone decanoate by compounding pharmacies like Applied Pharmacy (”Important information about nandrolone in the U.S.” March 17).

Watson stopped making [nandrolone decanoate] because… Congress and the DEA are treating anabolics like the treat crack-cocaine and are closely watching every prescriber’s and manufacturer’s move. No HIV doc has ever got in trouble since many studies have shown nandrolone’s benefit and can justify its medical use. However, inexperienced HIV doctors who have not been around long enough to know its history shy away from prescribing due to the bad publicity and misconceptions around these medicines. [...]

Applied Pharmacy stopped all production due to DEA pressure. Some compounders are making doctors sign a waiver to say they will not prescribe nandrolone for non medical uses. Some doctors feel this represents extra liability.

The effects of anabolic steroids in treating HIV+ associated wasting syndrome by preserving and increasing lean body weight has been well documented by multiple studies. Unfortunately, Congressional leaders in the United States have based steroid policy on emotional testimony and moral objections to cheating in sports rather than scientifically-guided legislative policy; this has been to the detriment of individuals with AIDS/HIV+ associated wasting syndrome. The morally-guided steroid policy has effectively limited the availability of anabolic steroids for those individuals who use steroids as a matter of medical necessity. We urge Congress to reconsider and re-evaluate the Anabolic Steroid Control Act to address the address the adverse effects of current steroid policy on the advancement of anabolic therapies in medicine.

An Anti-frailty Pill For Seniors? New Drug Increases Muscle Mass In Arms And Legs Of Older Adults

I bet this could compete with Theratecnologies/Serono's Tesamorelin eventually. But Merck is smart going after baby aging boomers

An Anti-frailty Pill For Seniors? New Drug Increases Muscle Mass In Arms And Legs Of Older Adults
ScienceDaily (Nov. 5, 2008) — Researchers at the University of Virginia Health System report that a daily single oral dose of an investigational drug, MK-677, increased muscle mass in the arms and legs of healthy older adults without serious side effects, suggesting that it may prove safe and effective in reducing age-related frailty.

Published in the November 4, 2008 issue of Annals of Internal Medicine, the study showed that levels of growth hormone (GH) and of insulin-like growth factor I (IGF- I) in seniors who took MK-677 increased to those found in healthy young adults. The drug restored 20 percent of muscle mass loss associated with normal aging.

"Our study opens the door to the possibility of developing treatments that avert the frailty of aging," explains Dr. Michael O. Thorner, a nationally recognized researcher of growth hormone regulation and a professor of internal medicine and neurosurgery at UVA. "The search for anti-frailty medications has become increasingly important because the average American is expected to live into his or her 80s, and most seniors want to stay strong enough to remain independent as they age."

Funded by the National Institutes of Health, the two-year, double-blind, placebo-controlled, modified-crossover study involved 65 men and women ranging in age from 60 to 81.

The study drug, MK-677, mimics the action of ghrelin, a peptide that stimulates the growth hormone secretagogue receptor (GHSR). Drug developers are focusing on GHSR because it plays an important role in the regulation of growth hormone and appetite. They think it may prove to be an excellent treatment target for metabolic disorders such as those related to body weight and body composition.

According to Dr. Thorner, the UVA research was a "proof-of-concept" study that sets the stage for a larger and longer clinical trial to determine whether MK-677 is effective in people who are frail and to assess its long term safety.


--------------------------------------------------------------------------------

University of Virginia Health System (2008, November 5). An Anti-frailty Pill For Seniors? New Drug Increases Muscle Mass In Arms And Legs Of Older Adults. ScienceDaily. Retrieved November 10, 2008, from http://www.sciencedaily.com /releases/2008/11/081104132902.htm

IMPORTANT INFORMATION ABOUT NANDROLONE IN THE US

QUESTION FROM SOMEONE IN MY POZHEALTH AT YAHOOGROUPS.COM LIST:

"I interpret this that once the current supply of the components tomake nandrolone are depleted, there will be no more access tonandrolone here in the US. Am I right or just the number ofcompounding pharmacies may continue to dwindle due to DEA pressures?Thanks everyone,Tom A"

MY ANSWER:


Dear Tom

The ingredients to make nandrolone are not depleted. The decision from the manufacturer (Watson) to stop making nandrolone decanoate (an effective injectable medicine to treat unintentional weight loss and to increase muscle mass) was based on economics and political pressure.

Watson stopped making it because:

1- It is a generic CHEAP drug
2- They can sell expensive Oxandrin instead. Oxandrin is approved for unintentional weight loss but costs $1200 a month and can cause liver toxicity in some.
3- Nandrolone's indication is for anemia and no doctor uses it for that purpose, so they prescribe it legally off label.
4- Congress and the DEA are treating anabolics like the treat crack-cocaine and are closely watching every prescriber's and manufacturer's move. No HIV doc has ever got in trouble since many studies have shown nandrolone's benefit and can justify its medical use. However, inexperienced HIV doctors who have not been around long enough to know its history shy away from prescribing due to the bad publicity and misconceptions around these medicines.

Compounders picked it up and are making it cheap at $13 per 200 mg (1 cc). Watson's retail price was $48 per 200 mg (1 cc). Most people do ok with 1 cc a week along with daily testosterone gel. Most are able to gain 10 pounds of muscle slowly at this dose with the use of exercise and good nutrition. This amounts to a total cost of $52 a month, compared to $1200 a month for oral Oxandrin, another anabolic prescribed and approved for unintentional weight loss.


Nandrolone is the cheapest, cleanest, most effective medicine out there to increase muscle mass, strength and functional capacity. Like all medicines, it is only advisable to use it with doctor's supervision so that your hematocrit /hemoglobin, blood pressure, free testosterone/estradiol, and PSA are monitored. It has been studied in several HIV studies and it has been shown effective and low in side effects up to 600 mg a week. It has been studied in women with HIV also.

We are losing this drug in the US because patients who use it and love it are not empowered to fight back, even with Michael's, Al's and my help. More and more HIV doctors are getting afraid to prescribe it even after prescribing it without problems for 15 years. And most patients thing it is not available anymore, so they start oral Oxandrin at $1200 a month and experience liver problems.

I am glad someone in this list wrote a wonderful letter to congress, but it will take more from you guys than that. Calling your congress people, sending letters, and talking to your doctors are all a good start.

I will keep pushing. If the day comes when we have no nandrolone, I will opt for foreign travel. I am trying to get some small companies interested in it since there are enough data to go to the FDA with a new drug application (IND) for a HIV unintentional weight loss indication (I did not say "wasting" since most people do not lose 10% of their weight anymore unless they get PCP, excessive diarrhea, or other complications)


One important development:

Applied Pharmacy stopped all production due to DEA pressure. Some compounders are making doctors sign a waiver to say they will not prescribe nandrolone for non medical uses. Some doctors feel this represents extra liability. I am attaching the letter from Medaus so that you guys can see it.

So far, we are happy with these guys in Los Angeles. They ship anywhere after receiving a doctor's prescription

www.bbpharmacy.com
(562) 866-8363

FOR BACKGROUND INFORMATION ( PRINT AND GIVE IT TO YOUR DOCTOR): http://savehivwastingmeds.blogspot.com/


This is the letter that Mark Mier from this list wrote recently. Please feel free to copy and paste text in it to write your own letter!

March 12, 2008



The Honorable Nancy Pelosi
Speaker of the United State House of Representatives
235 Cannon HOB
Washington, DC 20515

Subject: Representative Henry Waxman’s Hearings on Steroids in Sports and the Impact on Treatments for HIV and other Medical Conditions

Dear Madam Speaker:

The hearings Representative Henry Waxman has been conducting with respect to steroids in sports have had an adverse impact upon treatment for a variety of medical condition for which anabolic steroids and human growth hormones are legitimately and legally used. Among those conditions is HIV, a matter of substantial concern to many in your own district.

The manner in which these hearings have been conducted has created a level of hysteria that has painted all anabolic supplements and medications as unsavory and illegitimate. Certainly illegal use of human growth hormones and steroids in both professional and youth sports is a concern that needs to be addressed. But Representative Waxman’s hearings, as conducted, have highlighted only the negative aspects of such medicine and have not mentioned at all how they are properly and legitimately used and how controls on illegal use should be limited so as not to impact availability for proper usage. I am sure Representative Waxman appreciates the manner in which his name has been prominently highlighted in the press, but members in the HIV community have found him to have little interest in doing anything that will address our concerns in any concrete and demonstrable manner.

Anabolic steroids and recombinant human growth hormone are powerful prescriptive medicines that have been highly effective in treating cancer cachexia, MS, burns and HIV-related wasting and body changes. With respect to HIV, these treatments have been used successfully by thousands of sufferers in combating wasting, a condition which in the past was among the leading causes of death from AIDS. Since use of anabolic steroids and growth hormone to combat wasting began in the late 1980s, even before development of Highly Active Anti-Retroviral Therapy (HAART) used to combat HIV, thousands of lives have been saved.

The difficulty now is that anabolic steroids are becoming much less available legally because of Federal pressure upon producers. The anabolic steroid most successfully used over the years to combat wasting has been nandrolone decanoate. Up until recently, this product was produced by Watson Pharmaceuticals. In 2007, however, Watson stopped producing nandrolone. Instead, it is promoting Oxandrin, an oral steroid that is less effective and has more adverse side effects, but is also proprietary and therefore commands a higher price. Since then, anyone who needs to use nandrolone must go to compounding pharmacies, which will then produce the medicine on a custom order. At this time, the only anabolic steroids that may be used legally in the United States are Oxandrine and nandrolone. So the choice is Watson’s expensive, less effective, propriety product or use of the compounding pharmacies.

This situation presents two major problems for patients who need anabolic therapies. The first is that a prescription filled by a compounding pharmacy is not covered by insurance or AIDS Drug Assistance Programs (ADAPs), so use of nandrolone is an out-of-pocket expense. Many patients suffering from HIV are in difficult economic circumstance. The added expense frequently puts the medicine out of reach.

The other problem is that compounding pharmacies are now under heavy scrutiny by the Drug Enforcement Agency to ensure that prescriptions are for legitimate medical needs. In theory, this would sound reasonable, but, in practice, the added delays, pressure and bureaucratic requirements have caused many compounding pharmacies to shy away from production of nandrolone. The most popular, Applied Pharmacy of Alabama, was providing the product reliably and at a reasonable price. However, the DEA insisted that the pharmacies verify the medical necessity of each prescription. That is not the role of a pharmacy. That is the role of the doctor writing the prescription. So the DEA regularly comes into the Applied Pharmaceuticals, gathers up all their records and keeps them for an unreasonable amount of time for review purposes. This amounts to blatant harassment solely to suppress production of a legitimate medication. For this reason, Applied Pharmacy has announced that it will no longer provide nandrolone or other hormone-based products. Other compounding pharmacies have similarly so halted production, and this has caused an increase in prices among the remaining producers and confusion among HIV prescribers who wrongly assume that nandrolone is no longer available in the U.S.

The result, then, of Representative Waxman’s hearings has been an attack on an important, powerful, beneficial and legal therapy solely because professional athletes use it improperly. Patients with legitimate medical needs should not be made to suffer because of the improper actions of a few. As for young athletes, for which use of anabolic steroids is a concern, I believe that virtually all of the drugs used by them are from black market sources. Legitimate pharmacies filling prescriptions for legitimate medical needs should not be harassed into curtailing production when they are not even the source of the problem.

What I would therefore request is that Representative Waxman hold hearings on the legitimate use of steroids and human growth hormones and the need to ensure that enforcement action against illegal use does not impede appropriate and necessary supplies. I would also ask that efforts be made to publicize these hearing to the same level as those held to highlight improper usage by athletes.

For more information on the impact current actions against anabolic steroids and human growth hormones have had on HIV treatment, I would recommend contacting Nelson Vergel and Michael Mooney, coauthors of Built to Survive, subtitled, “A Comprehensive Guide to the Medical Use of Anabolic Therapies, Nutrition and Exercise for HIV(+) Men and Woman.” This book summarizes all the years of medical research using anabolics to improve health in people with HIV. Mr. Nelson and Mr. Mooney may be contacted through their web site at www.medibolics.com.

Sincerely,



Mark A. Meier




cc: Representative Henry Waxman 2204 Rayburn House Office Building Washington, DC 20515