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 Oxandrine, 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