What NOT to do when prescribing testosterone to older men

I covered the results of the study  mentioned below in my book.

It is so strange to me that they did not even mention or monitor hemoglobin and hematocrit in these older men. It is a well known fact that older men have more testosterone to estradiol conversion and more red blood cell increases with the use of testosterone replacement.  Many doctors prescribe low doses of Arimidex to decrease estradiol and edema, and provide phlebotomy (drainage of 2-4 units of blood every 3 months) to older men to have them maximize the benefits of testosterone while minimizing side effects.  A higher than normal estradiol or red blood cell level can produce edema and increased blood viscosity, respectively. Both of these factors can increase cardiovascular risks.

In this study, cardiovascular events included everything from rapid heart beat to light headness, and most of them were not heart attacks or strokes.

Like anything else we take, if side effect management is not present, then the benefits are erased by the side effects.  Sadly, many doctors prescribe testosterone and do not follow their patients properly. Hopefully my book will help!!

www.testosteronewisdom.com

Nelson Vergel

On Thu, Dec 9, 2010 at 3:01 PM, Jules Levin <JuLev@aol.com> wrote:

Testosterone Adverse Events

Adverse Events Associated with Testosterone Administration - publication pdf attached - (12/09/10)

Testosterone Deficiency and Replacement in Older Men - Editorial - (12/09/10)

New Book : Testosterone: A Man's Guide- by Nelson Vergel

FDA denies approval to long acting testosterone injections

Endo's drug is Nebido, a long acting injectable (testosterone undecanoate) , that has been available in Europe, Mexico, and many countries for years. It requires injections every three to four mouths instead of every week or two. Too bad the FDA made this decision.

This shows how difficult it is getting drugs approved now at the FDA with review panels that do not know much about the science (review panel members cannot have any conflict of interests and be part of any data review panels for any companies,which excludes a lot of the experts in the field). Anaphylactic reactions are common side effects with all approved testosterone injectables due to bad injection technique, so it is amazing that they stopped this approval based on a side effect that is well known with currently available testosterone products in the United States. Common symptoms of anaphylactic reactions with testosterone injections are cough and dizziness that subside after a few minutes. It is believed that this happens when testosterone enters the blood stream and ends up in the lungs (injections are meant to form a "pocket" for slow release in the muscle. Some people may inject in a blood vessel and have anaphylactic reactions). I have had this reaction and found a quick solution to it: breathe into a paper bag until the cough stops.

Nelson

http://www.reuters.com/article/americasMergersNews/idUSN038783120091203

NEW YORK, Dec 3 (Reuters) - U.S. health regulators declined to approve Endo Pharmaceuticals Holdings Inc's (ENDP.O) drug for low testosterone, requesting more information about rare but serious side effects, the specialty drugmaker said on Thursday, sending its shares down nearly 4 percent.

The U.S. Food and Drug Administration wants information about anaphylactic reactions following injection of the drug, and about events when a poor injection technique leads to oil leaking into the lung, causing coughing.

In its so-called complete response letter, the agency also said Endo's proposed strategy to mitigate risks for the drug, Aveed, was not sufficient.

Endo said it was evaluating the FDA letter. The drug is sold outside the United States by Germany's Bayer AG (BAYGn.DE) and is available in more than 50 countries under the brand name Nebido. Endo licenses Aveed from Bayer.

Jefferies & Co analyst Corey Davis said Endo may choose to end its development of the drug if it cannot resolve the FDA's concerns.

"It's hard for us to imagine what the company could do to satisfy FDA concerns over exceedingly rare events that we would guess are not even product-specific in the first place," Davis said in a research note.

However, Davis said consensus estimates for Aveed sales had been "relatively modest" at $94 million by 2012.

An Endo spokesman said it was not yet clear what the next steps for the product would be. "Our goal is to work closely with the agency," the spokesman, Kevin Wiggins, said.

Aveed was one of the main products Endo acquired earlier this year in its $370 million purchase of Indevus Pharmaceuticals, a deal designed to expand its product line beyond pain treatments.

"It clearly casts a cloud on their ability to make acquisitions," said Jim Molloy, an analyst with Caris & Co. "They made it very clear they are looking to acquire more things. This one didn't go so well, so there's going to be some scrutiny on what the next one will be."

Low testosterone, also known as hypogonadism, is linked to symptoms such as fatigue, loss of muscle mass and decreased libido, and there is increasing evidence of an association with conditions such as diabetes and cardiovascular disease, according to Endo.

The Aveed action marks the second regulatory setback for Endo in as many months related to a testosterone product. In October the FDA delayed approval of Endo's Fortesta, a gel for men with low testosterone.

In September the FDA extended its review of Aveed by three months.

Endo shares fell 86 cents, or 3.8 percent, to $21.56 in afternoon trading on Nasdaq.

Comparative Analysis of HIV+ and HIV- Interaction with Testosterone on Bone Mineral Density

Thanks to Jules Levin for providing this paper

Comparative Analysis of HIV+ and HIV- Interaction with Testosterone on Bone Mineral Density



Reported by Jules Levin

ICAAC/IDSA Oct 28 2008 Wash DC



R.RAGHUNATHAN 1,2,J.SINACORE 2,K.RYCHLIK 2, J.FARANO 1,C.PACHUCKI 1,2,and N.AZAD 1,2

1 Edward Hines VA Hospital

Hines, VA 60141

2 Loyola University Health System,Maywood, IL 60153



AUTHOR CONCLUSIONS



In age-matched HIV-infected men, a lower free testosterone corresponds significantly to a lower T-score at the lumbar spine.



A normal free testosterone level was protective of bone mineral density in HIV-infected patients compared to the control population.



Among HIV-uninfected men, an increase in free testosterone level does not correspond to an increase in T-scores.


Further studies evaluating the interaction of low free testosterone and HIV infection need to be conducted to better understand the bone-related effects.


Background: Given an increasingly younger HIV population with osteopenia/osteoporosis a retrospective controlled study was conducted to investigate the effects of testosterone on bone mineral density (BMD) in HIV infected and HIV non-infected populations.



Methods: A chart review was done on a group of 80 male HIV patients and 154 male control patients. The following variables were obtained from the HIV group: age, race, employment status, smoking, body mass index (BMI), duration of HIV, CD4 levels, viral load, type of antiretroviral use, co-morbidities, use of prednisone, heroin, alcohol, methadone use, ever use of androgen, bisphosphanate use, calcium use, alpha reductase inhibitor use, phosphodiesterase inhibitor use, lipids, and biochemical markers. The same variables were obtained from the control group except those pertaining to HIV and employment status. T-scores were used in both HIV and control groups to evaluate BMD.



Results: A univariate analysis of variance was used controlling for the following factors: age, race, BMI, prednisone, heroin, alcohol, smoking, methadone, androgen use, alpha reductase inhibitor use, phosphodiesterase inhibitor use, bisphosphanate use, and calcium use.







Conclusions: A normal testosterone level was protective of bone mineral density in HIV-infected patients compared to the control population. At the L-spine, HIV patients with low testosterone had a lower bone mineral density (p < 0.05). Treatment of osteopenia/osteoporosis with testosterone in HIV patients needs further evaluation.



BACKGROUND



Prevalence of osteoporosis in HIV-uninfected hypogonadal men is reported to be 12.3% vs. 6.0% in men with normal testosterone levels1.



Among patients enrolled in the Study to Understand the Natural History of HIV and AIDS (SUN), 52% had osteopenia and 10% had osteoporosis. Among these patients 78% were men, 25% were black, and 80% of patients received antiretrovirals (ART)2.



Up to 70% of treatment-naive HIV-infected men are reported to have low free testosterone3.



Whether an isolated HIV-related hypogonadism interaction plays a role in developing osteopenia/osteoporosis is unknown.



It remains unclear how HIV itself or other known attributable factors (such as age, sex, race, duration of HIV, ART, hypogonadism, etc.) lead to the development of osteopenia/osteoporosis.



There is a renewed interest in the pathogenesis, diagnosis, and management of osteoporosis in this population.



HYPOTHESIS

We hypothesize that patients with HIV with low free testosterone levels have lower T-scores.


METHODS/STATISTICAL ANALYSIS


A retrospective chart review was performed on two groups: 80 HIV-infected men and 154 HIVuninfected men (see Table 1 for epidemiologic characteristics in each population).


HIV-specific information was obtained in those men who were HIV-infected with low and normal testosterone (see Table 2).



An analysis of covariance was done controlling for the following factors: age, race, BMI, smoking, and use of prednisone, heroin, cocaine, alcohol, methadone, androgen, alpha reductase inhibitor, phosphodiesterase inhibitor, bisphosphanate, and calcium (see Figs 1 – 3, Table 4).



The serum free testosterone (FT) levels were measured by Quest diagnostics (using dialysis method Wood Dale II). The normal FT ranges 35 – 210 pg/mL (see Fig 4 for free vs. total testosterone correlations in HIV-infected and HIV-uninfected patients).




REFERENCES

1. Fink H.A., Ewing S.K., Orwoll E.S., et al. Association of Testosterone and Estradiol Deficiency with Osteoporosis and Rapid Bone Loss in Older Men. The Journal of Clinical Endocrinology and Metabolism 2006; 91(10): 3908 – 3915.

2. Calza L., Tampellini L., Chiodo F., et al. Bone Mass Loss in Patients with

HIV Type 1 Infection. Infectious Diseases in Clinical Practice 2007; 15(3):

160 – 166.

3.Wunder D.M., Bersinger N.A., Furrer H., et al. Hypogonadism in HIV 1-infected men is common and does not resolve during antiretroviral therapy. Antiviral Therapy 2007; 12:261 – 265.

Anabolic Steroid Induced Hypogonadism

I am helping Dr Scally publish his book about how to get off anabolic steroids safely. Hopefully this information will help some HIV patients who have been using steroids since they reversed their wasting years ago, and also help people like Cansenco and other athletes. The book should be out in a month or so. I will inform everyone about where to get it. Dr Scally is, in my opinion, the country's best expert on this subject. He lives in Houston and lost his license because of using his protocol to reverse hypogonadism after anabolic use. He has made great progress convincing other doctors about his program and now will make it public in his book. We both presented a paper at the Lipodystrophy conference a few years ago on this topic.


Jose Canseco Suffering from Anabolic Steroid Induced Hypogonadism
Email
Written by millardbaker on Oct-20-08 11:23am
From: www.mesomorphosis.com


Jose Canseco admits to health problems resulting from the discontinuation of anabolic steroids in the A&E documentary “Jose Canseco: The Last Shot” premiering Monday night, October 20th.

Jose Canseco, the former baseball superstar who blew the whistle on the game’s steroid scandal, has used steroids himself for the past 24 years. Now Jose wants to finally get clean, but he’s terrified about what may happen when he goes through the process. There has been no medically documented case of someone quitting steroids after using them for so long, and the doctors have different opinions about what Jose will go through physically and mentally. Viewers watch Jose play guinea pig as he tries to end his long addiction.

Canseco has made the decision to permanently stop using steroids for whatever reason. During the documentary, Canseco describes classical post-cessation symptoms of anaboic steroid induced hypogonadism (ASIH) such as low libido and depression (”It’s broke, scared & contrite Jose Canseco in TV documentary,” October 18).

The show also follows Canseco through a series of medical appointments with Santa Monica physician Dr. Brent Michael. Canseco tells Michael he wants to wean himself off steroids for good and restore his testosterone levels, since quitting cold turkey isn’t working.

“I have no sex drive whatsoever. Zero,” says Canseco, who is filmed in one sequence meeting Michael with current girlfriend Heidi Northcott present. Canseco admits to bouts of depression and wanting to be left alone.

Our society has demonized anabolic steroids. The highly politicized steroid hysteria has led the medical community to abandon treatment for the non-prescription steroid user. Our society tells steroid users that it is imperative that they stop using steroids immediately to avoid catastrophic damage to their health. But once they stop using steroids, professionals in the medical community are clueless to the consequences of steroid cessation and are ignorant to the treatment options and necessary post cycle therapy (PCT). Then steroid users like Jose Canseco are ridiculed for the post cycle side effects after discontinuing steroids.

Dr. Michael Scally explains the abysmal failure of the medical community to recognize and treat anabolic steroid induced hypogonadism:

For the greater part of 10 years I have found that the medical treatment provided for the condition termed anabolic steroid induced hypogonadism (ASIH), is nonexistent or ignored by the great majority of medical professionals. As predicted since my entry into this field in 1995 more and more cases of ASIH would appear due to this negligence. Clear and convincing evidence of this is demonstrated by recent articles in peer-reviewed medical literature affirming concerns for the long term effects of untreated ASIH, rapidity and severity of symptoms in ASIH, and inappropriate treatment with AAS based upon a flawed clinical study design.

Anabolic steroids have known side effects. But overall, anabolic steroids are remarkably safe and have been used in medicine for over 50 years. The greatest risk is associated with untreated anabolic steroid induced hypogonadism. But the medical community doesn’t officially recognize this condition much less established a medically accepted treatment to restore endogenous testosterone levels.

In the documentary, Jose Canseco receives a testosterone gel from his physician as a treatment for his low testosterone. The average steroid using gymrat knows that testosterone is suppressive to the HPTA axis and will continue to prevent the restoration of endogenous testosterone production.

Michael prescribes a gel supplement that is “not a performance-enhancing steroid,” but after using the gel for a month, Canseco discovers his natural testosterone levels are still well below normal.

Michael prescribes a gel supplement that is “not a performance-enhancing steroid,” but after using the gel for a month, Canseco discovers his natural testosterone levels are still well below normal.

“My body forgot how to make testosterone,” says Canseco, which may explain his recent trip to Mexico.

It appears Jose Canseco has given up on the medical community. Physicians spend so much time telling people to stop using anabolic steroids. But they seem to care less about what happens to them when they stop. So Canseco, suffering from ASIH, is making attempts to take treatment into his own hands. This would explain his recent trip to Mexico and importation of human chorionic gonadotropin (hCG). HCG is often used by steroid users to stimulate their own natural production of testosterone.

I hope Jose Canseco will find a way to contact Dr. Michael Scally, founder of HPT/Axis and ASIH.net. Dr. Scally has dedicated his professional career to help steroid users restore their endogenous testosterone production after stopping the use of steroids (and has had his medical license revoked as a result of the anti-steroid crusade in the medical profession). But Scally continues to work on ways towards helping non-medical users of anabolic steroids, like Jose Canseco, return to normal physiology.