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IMPORTANT INFORMATION ABOUT NANDROLONE IN THE US

Posted Dec 18 2008 7:28pm
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
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