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Organon Discontinues Production of Deca Durabolin (Nandrolone decanoate) by Nelson
Vergel
We have been getting daily
emails from many people with this question. We have been able to secure generic
nandrolone decanoate, and testosterone (also in short supply) from GulfSouth,
a compounding pharmacy.
Here is the link:
http://www.appliedpharmacyrx.com
Phone (877) 729-1015
A recent study by Wanke
et al showed that as many as 29% of people with HIV in the era of HAART are
still losing weight or lean body mass, even with undetectable viral loads in
most cases.
Deca Durabolin is one of the safest, most cost-effective anabolic steroids available
worldwide. Unlike oral steroids, it does not impact liver function at the doses
used in HIV. Another product that is sometimes misused for wasting is Megace
(megestrol acetate). Question your doctor if they prescribe it to you. It makes
people gain fat, induces diabetes, blood clots and impotence.
Growth hormone costs $3000
to $6000 a month for treating HIV wasting, but it is not as effective as anabolic
steroids for building muscle. (See: Anabolic
Agent Comparison Chart )
Deca Durabolin was approved for anemia due to renal insufficiency many years
ago, so its use for HIV wasting was "off-label." It is legal for a
doctor to prescribe a drug for an off-label use, but the insurance companies
are not required to pay for the drug.
A research source told me
that Organon is planning to take advantage of the"off-label use" that
we, as a community, have been advocating for since the Dr. Walter Jekot first
prescribed it in Los Angeles in 1982 to an HIV patient for wasting. As we progressed
in our advocacy work, and our nonprofit book "Built
to Survive" was released, the sales of Deca Durabolin sky rocketed
and Organon decided apply for a New Drugs Application for HIV wasting after
several studies showed good results in men and women living with HIV (see below.)
The rumors are that they will bring it back at a much higher price for AIDS
after their study is completed and the FDA approves indication for it for HIV.
I wrote a letter to the
president of the company last week and have not heard from them, yet.
An economical and safe product
like Deca Durabolin needs to stay in the market at the current pricing levels.
A New Drug Application for wasting could mean that more third party payers could
cover its cost, but we should not tolerate any increase due to the "AIDS
cash cow effect"
History has shown this kind
of thing repeating itself. Oxandrin and Anadrol, the oral anabolics that can
affect liver function, were "dropped " by their manufacturers to later
be "picked up" by other companies that increased the price when they
marketed them to the HIV market. Oxandrin went from being a 12 cents a tablet
to $3.85 a tablet (you take 8 a day for a man for a cost of $900 a month). Anadrol
went from 70 cents a tablet to $12 a tablet (you take one a day, for a cost
of $360 a month). Deca durabolin used to be available 4 years ago as a generic
(nandrolone decanoate-made by Steris) for $16/ 200 mg. The generic was stopped
and the brand name product was last priced at $32 per 200 mg (1 cc) before Organon
stopped its sale (you may need one cc a week for 12 weeks for a low dose cycle
to increase LBM for a cost of $ 128/month, see "Built
to Survive" and the references below for more details). I hope they
are not following this trend, which would mean that Deca could come back at
an exorbitant price.
I feel very strongly that
"quality of life" drugs need as much advocacy efforts as antivirals,
specially in this era.
If you want to help the
community to let Organon know what their decision means to you,your friends
or your practice, write a letter to:
Dr. Hans M. Vemer
President, Organon International
375, Mount Pleasant Avenue
West Orange, NJ 07052
You can also call Organon Inc. Customer Service Department at:
1-800-241-8812, 8:00am - 5:00pm(EST).
Phone Tel: +1 973 325 4500
Fax: Fax: +1 973 235 4589
Website: www.organoninc.com
Here are some references on nandrolone:
Effects of pharmacological
doses of nandrolone decanoate and progressive resistance training in immunodeficient
patients infected with human immunodeficiency virus. Sattler FR, Jaque SV, Schroeder
ET, Olson C, Dube MP, Martinez C, Briggs W, Horton R, Azen S.J Clin Endocrinol
Metab. 1999 Apr;84(4):1268-76.
Department of Medicine,
University of Southern California School of Medicine, Los Angeles County-University
of Southern California Medical Center, Los Angeles 90033, USA.This nonplacebo-controlled,
open label, randomized study was conducted to test the hypotheses that pharmacological
doses of nandrolone decanoate would increase lean body tissue, muscle mass,
and strength in immunodeficient human immunodeficiency virus-infected men, and
that these effects would be enhanced with progressive resistance training (PRT).
Thirty human immunodeficiency virus-positive men with fewer than 400 CD4 lymphocytes/mm3
were randomly assigned to receive weekly injections of nandrolone alone or in
combination with supervised PRT at 80% of the one-repetition maximum three times
weekly for 12 weeks. Total body weight increased significantly in both groups
(3.2 +/- 2.7 and 4.0 +/- 2.0 kg, respectively; P < 0.001), with increases
due primarily to augmentation of lean tissue. Lean body mass determined by dual
energy x-ray absorptiometry increased significantly more in the PRT group (3.9
+/- 2.3 vs. 5.2 +/- 5.7 kg, respectively; P = 0.03). Body cell mass by bioelectrical
impedance analysis increased significantly (P < 0.001) in both groups (2.6
+/- 1.0 vs. 2.9 +/- 0.8 kg), but to a similar magnitude (P = NS). Significant
increases in cross-sectional area by magnetic resonance imaging of total thigh
muscles (1538 +/- 767 and 1480 +/- 532 mm2), quadriceps (705 +/- 365 and 717
+/- 288 mm2), and hamstrings (842 +/- 409 and 771 +/- 295 mm2) occurred with
both treatment strategies (P < 0.001 for the three muscle areas); these increases
were similar in both groups (P = NS). By the one-repetition method, strength
increased in both upper and lower body exercises, with gains ranging from 10.3-31%
in the nandrolone group and from 14.4-53.0% in the PRT group (P < 0.006 with
one exception). Gains in strength were of significantly greater magnitude in
the PRT group (P < or = 0.005 for all comparisons), even after correction
for lean body mass. Thus, pharmacological doses of nandrolone decanoate yielded
significant gains in total weight, lean body mass, body cell mass, muscle size,
and strength. The increases in lean body mass and muscular strength were significantly
augmented with PRT.
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Effects of nandrolone decanoate therapy in borderline hypogonadal men with HIV-associated
weight loss.
Strawford A, Barbieri T, Neese R, Van Loan M, Christiansen M, Hoh R, Sathyan
G, Skowronski R, King J, Hellerstein M.J Acquir Immune Defic Syndr Hum Retrovirol.
1999 Feb 1;20(2):137-46.
Department of Nutritional
Sciences, University of California at Berkeley, 94720, USA.Serum testosterone
concentrations are frequently in the low-normal range (lowest quartile, <500
ng/dl) in men with AIDS-wasting syndrome (AWS) and in other chronic wasting
disorders. The response of patients in this group to androgen treatment has
not been determined, however. Eighteen men with AWS (mean +/- standard error
[SE]: 87% +/- 1% usual body weight; CD4 count 90 +/- 24) and borderline low
serum testosterone concentrations (382 +/- 33 ng/dl) completed a 21-day placebo-controlled
inpatient metabolic ward study comparing intramuscular (i.m.) placebo (n = 7)
with low-dose (65 mg/week; n = 4) and high-dose (200 mg/week; n = 7) nandrolone
decanoate, a testosterone analogue. Nitrogen balance, stable isotope-mass spectrometric
measurement of de novo lipogenesis (DNL), resting energy expenditure, and gonadal
hormone levels were measured. Both low-dose and high-dose nandrolone resulted
in significant nitrogen retention (33-52 g nitrogen/14 days, representing gains
of 0.5 to 0.9 kg lean tissue/week) compared with placebo (loss of 11 g nitrogen/week).
This was reflected biochemically in a borderline significant reduction of high
DNL (p < .06). Serum testosterone and gonadotropins were suppressed whereas
resting energy expenditure was unchanged by nandrolone treatment. In 10 study
subjects completing a 12-week open-label follow-up phase, body weight increased
by 4.9 +/- 1.2 kg, including 3.1 +/- 0.5 kg lean body mass, and treadmill exercise
performance also improved. In summary, nandrolone decanoate therapy in the absence
of an exercise program in borderline hypogonadal men with AWS caused substantial
nitrogen retention compared with placebo, similar in extent to the nitrogen
retention previously achieved with recombinant growth hormone. It is reasonable
to expand the criteria for androgen treatment in AWS to include at least patients
in the lowest quartile of serum testosterone.
***********************************************
Safety and efficacy of nandrolone
decanoate for treatment of wasting in patients with HIV infection.
Gold J, High HA, Li Y, Michelmore H, Bodsworth NJ, Finlayson R, Furner VL, Allen
BJ, Oliver CJ.AIDS. 1996 Jun;10(7):745-52.
Albion Street Centre, Prince
of Wales Hospital, Sydney, Australia.OBJECTIVE: To evaluate the safety and efficacy
of the anabolic steroid, nandrolone decanoate (Deca Durabolin) in patients with
HIV wasting who are resistant to nutritional intervention. DESIGN: A 16-week
open trial with subjects who had lost 5-15% of their usual body weight. SETTING:
HIV/AIDS specialist ambulatory care services, both public and private, in sydney,
Australia. PARTICIPANTS: Two hundred and twenty men entered the pre-therapy
phase, and of these, 24 failed to gain weight and were enrolled. Seventeen subjects
(81%) completed the 16-week trial. INTERVENTIONS: Pre-therapy nutritional assessment
and education was conducted by the clinical dietitian. Those who failed to gain
weight (10.9%) were treated with nandrolone decanoate (100 mg/ml) by deep intramuscular
injection every 2 weeks for 16 weeks. MAIN OUTCOME MEASURES: Changes in weight
and body composition (lean body mass, total body water and nitrogen index) were
measured by anthropometry, bioelectrical impedance, and in vivo neutron activation.
Changes in quality of life were assessed by the 30-item Medical Outcomes Study
short form questionnaire. Changes in biochemistry, haematology and immunology
were also measured. RESULTS: There were significant increases in weight (mean,
0.14 kg per week; P < 0.05) and lean body mass (mean, 3 kg by anthropometry;
P < 0.005). The change in lean body mass was of similar magnitude across
all measurement modalities. Quality of life parameters, especially functionality,
increased significantly during the trial. No subject experienced toxicity. CONCLUSION:
Nandrolone decanoate has beneficial effects on weight, lean body mass and quality
of life in selected patients who have mild to moderate HIV wasting.
************************************************
Nandrolone decanoate increases
weight and lean body mass in HIV-infected women with weight loss: a randomized,
double-blind, placebo-controlled, multicenter trial.
Mulligan K, Zackin R, Clark RA, Sattler FR, Santana J, Delvers T, Currier JS.Conf
Retroviruses Opportunistic Infect. 2001 Feb 4-8;8:236 (abstract no. 641).
NIAID Adult AIDS Clin Trials
Group, Bethesda, MD.Background: Lean body mass (LBM) is not consistently restored
with potent antiretroviral therapy. Moreover, wasting persists as a prominent
complication and a factor in mortality in populations with limited access to
potent therapies, and there are few proven treatment options for women with
wasting. ACTG 329 was designed to evaluate the safety and efficacy of nandrolone
decanoate (ND), a synthetic testosterone derivative, in HIV+ women. Methods:
Thirty-eight HIV+ women with an involuntary weight loss >/= 5% or BMI <20
kg/m2 were randomly assigned to receive ND (Organon Inc; 100 mg q2 wks by IM
injection) or equivalent volume of placebo (P) for 12 weeks, followed by 12
weeks of open-label ND for all participants. Weight and body composition (BIA)
were measured under fasting conditions at baseline and every 6 weeks. Dietary
intake was also evaluated. Results: Baseline weight, body composition, and energy
intake did not differ between groups. Thirty-three women (87%) completed the
blinded treatment period (16 ND; 17 P). Those randomized to ND experienced significant
increases in weight (median + 4.6 vs. + 0.1 kg [+ 9.0 vs. + 0.3%] in ND and
P, respectively; p < 0.001) and LBM (+ 3.5 vs. - 0.4 kg [+ 8.6 vs. - 1.0%];
p <0.001). Changes in fat did not differ between groups (+ 0.7 vs. + 0.8
kg; p = 0.679). During open-label treatment, women originally assigned to P
had significant increases in weight and LBM, while those originally assigned
to ND sustained the increases achieved during the blinded phase. There were
no significant differences between treatment groups in the proportions experiencing
adverse events (clinical signs/symptoms or laboratory tests). Hoarseness, hirsutism,
and clitoral enlargement, while rare, occurred primarily in the ND group. Conclusions:
Nandrolone decanoate increases weight and LBM in HIV-infected women with weight
loss and appears to have a tolerable safety profile.
Nelson Vergel
Executive Director
Program for Wellness Restoration, PoWeR
www.medibolics.com
www.facialwasting.org
Don't Lose Your Body to HIV.
Click here to buy
the book "Built to Survive."
Click
here to join the Facial Wasting Community Discussion Group
"It is never too late to be what you might have been."- George Eliot
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