FDA Committee Unanimously Recommends Egrifta for Lipodystrophy

FROM POZ.COM

May 27, 2010 FDA Committee Unanimously Recommends Egrifta for Lipodystrophy A U.S. Food and Drug Administration (FDA) advisory committee has unanimously recommended that Egrifta (tesamorelin), Montreal-based Theratechnologies' experimental product for the treatment of excess abdominal fat in HIV-positive people with lipodystrophy, be approved by the agency.  Though the FDA is not required to follow the recommendations of its advisory committees, it usually does so. Several of the 16 panelists making up the Endocrinologic and Metabolic Drugs Advisory Committee, which met May 27 at the University of Maryland University College (UMUC) Marriott Conference Centers in Adelphi, Maryland, stressed that there is a need for additional follow-up studies to monitor the long-term safety and efficacy of the drug. Egrifta is a synthetic human growth hormone-releasing factor. Phase III clinical trials of the drug indicate that it decreases visceral adipose tissue (VAT)—fat deep within the belly—by about 17 percent. According to Christian Marsolais, MD, vice president of clinical research and medical affairs at Theratechnologies, who reviewed the Phase III efficacy results at today's hearing, 57.4 percent of patients taking Egrifta experienced an 8 percent or greater reduction in VAT—the primary goals of the studies—compared with 29.3 percent of the placebo group. Unlike Serostim (recombinant human growth hormone), an earlier contender for treating excess VAT, Egrifta has long been suggested to have fewer side effects when used for at least a year, including a minimal effect on blood sugar (glucose) levels. There were, however, conflicting reports at today's hearing regarding the risk of diabetes in people receiving Egrifta in the Phase III clinical trials. Graziella Soulban, MD, director of clinical research at Theratechnologies, reported higher rates of pre-diabetes and diabetes among those receiving Egrifta, compared with placebo, during the first 26 weeks of the studies. But between weeks 26 and 52 of the studies, however, the number of people with glucose intolerance and diabetes dropped.  Ali Mohamadi, MD, a clinical reviewer from the FDA, unveiled a slightly more detailed analysis. According to the FDA safety analysis reported this morning, 49.2 percent of patients receiving Egrifta had no instances of raised blood-glucose levels. However, 17.3 percent of those receiving Egfrifta had three or more increased blood-glucose measurements during the clinical trial, compared with 7.3 percent of those receiving placebo. Mohamadi also reported that 25 percent of patients in the tesamorelin group who started off as pre-diabetic eventually went on to develop frank diabetes in the studies. Among those who began treatment without a history of diabetes and had normal glucose levels, Mohamadi confirmed, the risk of diabetes during the study remains low. Increases in insulin-like growth factor 1, or IGF-1, was another safety issue discussed at length during today's meeting. Though increases in IGF-1 are considered to be an indicator of Egrifta's activity, IGF-1 has also been suggested to promote tumor growth, which can be problematic in a population of individuals—including people living with HIV—who already face a higher risk of cancer. According to Mohamadi, a third of patients receiving Egrifta had significantly elevated IGF-1 levels. However, according to Soulban, these increases were not found to be associated with an increased risk of any type of cancer in the 52-week Phase III studies. Mohamadi reiterated that decreases in decreases in VAT associated with the use of Egrifta have not been shown to decrease the risk of cardiovascular disease—an important potential benefit of any drug that treats abdominal obesity—and several panelists reiterated that future studies should explore this goal. And though the panelists were divided on the data submitted to the FDA regarding improvements in body image and body perception in the studies, many were clearly impressed by the mid-day public testimony offered by three people living with HIV—Jeff Berry of the AIDS Treatment Activists Coalition and two Egrifta clinical trial participants—who emphasized the detrimental effects of lipodystrophy in people living with HIV. As the clock approached 4 p.m., the final vote was cast by the advisory committee members, in response to a single question put forth by the FDA: Does the risk-benefit assessment support approval of Egrifta? Sixteen voted "yes"—there were zero "no" votes and no abstentions. Several panelists stressed that follow-up data should be collected to better understand the long-term risks of glucose abnormalities and IGF-1 increases. Theratechnologies noted that it is already planning a safety monitoring program that will go into effect if the FDA agrees with the advisory committee panel and approves the drug for use in the United States. A final decision from the FDA is expected within the next two months. The agency has until July 27 to notify Theratechnologies of the drug's approval status and of any post-marketing studies that must be conducted.

Vitamin and Mineral Use in HIV- Summary of Studies

 Excellent summary tables on the use of micronutrients in HIV published in

Am J Clin Nutr 2007;85:333–45. Printed in USA. © 2007 American Society for Nutrition

http://www.ajcn.org/cgi/content/full/85/2/333

Reference	Study design, location, and population	Vitamin concentrations1	Results and conclusions
Cross-sectional studies
Toma et al, 2001 (93)	Cross-sectional study in Canada. 11 HIV-positive adults (6 receiving HAART for 3 y, 5 not receiving any HIV medications).	Vitamin A: HAART (51 ± 5 µg/dL); no HIV medications (66 ± 11 µg/dL)	Mean plasma concentrations of vitamin A and retinol-binding protein were significantly lower (P = 0.03) and higher (P = 0.04), respectively, in those receiving HAART.
Rousseau et al, 2000 (94)	Cross-sectional study in France. 30 HIV-positive adults, mostly injection-drug users (23 receiving HAART for3 y, 7 not receiving HAART).	Vitamin A: total (0.66 ± 1.2 µmol/L); 24 of 30 (80%) deficient (<1.5 µmol/L); concentrations not presented for HAART and non-HAART groups Vitamin E: total (9.24 ± 3.4 mg/L); 10 of 29 (34%) deficient (<6 mg/L); concentrations not presented for HAART and non-HAART groups	Mean plasma concentrations of vitamins A and E were not significantly different between those with a CD4 count < and >250 cells/µL, between those with viral load > and <5000 copies/mL, and between those receiving and not receiving HAART.
Tang et al, 2000 (95)	Cross-sectional study in the United States. 175 HIV-positive injection-drug users (30 receiving HAART, 65 receiving dual- or monotherapy, 80 not receiving any HIV medications).	-Tocopherol2: HAART (1076 ± 468 µg/dL); no HIV medications (778 ± 209 µg/dL) -Carotene3: HAART (1.06 ± 0.01 µg/dL); no HIV medications (0.74 ± 0.02 µg/dL) ß-Carotene2: HAART (8.8 ± 3.1 µg/dL); no HIV medications (5.2 ± 0.9 µg/dL) Vitamin A2: HAART (42.0 ± 11.4 µg/dL); no HIV medications (38.4 ± 6.2 µg/dL) -Tocopherol2: HAART (238 ± 107 µg/dL); no HIV medications (202 ± 59 µg/dL)	Adjusted mean serum concentrations of-tocopherol (P = 0.0008), -carotene (P= 0.05), and ß-carotene (P = 0.02), but not of vitamin A and -tocopherol, were significantly higher in those receiving HAART than in those not taking any HIV medications; no significant differences in adjusted mean serum vitamin concentrations between CD4 cell count categories (<200, 200–499, and 500 cells/µL).
Remacha et al, 2003 (96)	Cross-sectional study in Spain. 126 HIV-positive adults receiving HAART compared with 109 HIV-positive historical control subjects from 1989 to 1992 receiving HAART.	Folate: HAART (1473 ± 1087 mmol/L), 1 of 126 (0.8%) deficient (450 mmol/L); historical control subjects (1057 ± 665 mmol/L), 19 of 109 (17.4%) deficient Vitamin B-12: HAART (402 ± 218 pmol/L), 2 of 126 (1.2%) deficient (150 pmol/L); historical control subjects (330 ± 219 pmol/L), 20 of 109 (18%) deficient	Mean concentrations of red blood cell folate and serum vitamin B-12 were significantly higher in HIV-positive adults receiving HAART than in historical HIV-positive control subjects receiving HAART. Significantly fewer HIV-positive adults receiving HAART than historical control subjects had folate or vitamin B-12 deficiencies.
Woods et al, 2003 (97)	Cross-sectional study from 1995 to 2000 in the United States. 412 HIV-positive adults (615 patient-time intervals in adults receiving HAART, 454 patient-time intervals in adults not receiving HAART).	Vitamin B-124: HAART [491 (382–667) pg/mL], 17% deficient (<350 pg/mL); no HAART [462 (369–617) pg/mL], 22% deficient	Median serum concentration of vitamin B-12 was significantly higher at the beginning of each patient-time interval in HIV-positive adults receiving HAART; multivariate analyses were not performed to account for higher intakes of vitamin B-12 (P = 0.0002) in participants receiving HAART.
Longitudinal studies
Look et al, 2001 (98)	Longitudinal study from 1997 to 1998 in Germany. 17 HIV-positive adults studied at baseline and 100 d after HAART initiation.	Vitamin B-6: baseline [11.9 (10.7–13.2) µmol/L]; follow-up [15.7 (8.8–22.7) µmol/L] Folate: baseline [3.8 (1.0–6.5) ng/mL]; follow-up [5.2 (1.8–8.5) ng/mL] Methylmalonic acid (surrogate of vitamin B-12)3: baseline [138 (100–176) µmol/L]; follow-up [186 (81–291) µmol/L]	Median follow-up serum concentrations of vitamin B-6, folate, and methylmalonic acid were not significantly higher than median baseline concentrations; however, baseline concentrations of vitamin B-6, folate, and methlymalonic acid were not significantly different from those of a cohort of HIV-negative healthy control subjects.

 Observational studies of minerals in HIV-infected persons receiving highly active antiretroviral therapy (HAART)

Reference Study design, location, and population Mineral concentrations Results and conclusions Cross-sectional studies     Batterham et al, 2001 (99) Cross-sectional study in Australia. 48 HIV-positive adults (35 receiving HAART, 13 not receiving any HIV medications). Selenium: HAART with detectable (>400 copies/mL) viral load (2.16 ± 0.54 µmol/L); HAART with undetectable viral load (2.22 ± 0.93 µmol/L); no HIV medications (2.40 ± 0.83 µmol/L) Mean serum concentrations of glutathione peroxidase (P = 0.001), lipid peroxidase (P = 0.03), and uric acid (P = 0.009), but not of selenium, were significantly different between HIV-positive persons receiving HAART and those not taking any HIV medications.     Wellinghausen et al, 2000 (100) Cross-sectional study in Germany. 79 HIV-positive adults (52 receiving HAART; 4 receiving dual- or monotherapy, 23 not receiving any HIV medications). Zinc: HAART (12.5 ± 2.8 µmol/L), 25% deficient (<10.5 µmol/L); no HIV medications (12.7 ± 2.7 µmol/L), 22% deficient Zinc concentrations were not significantly different between those receiving and those not receiving HAART. Longitudinal studies     Rousseau et al, 2000 (94) Longitudinal study from 1995 to 1998 in France. 44 HIV-positive adults, mostly injection-drug users. At baseline, none were receiving HAART, but 80% were receiving dual-combination therapy. Of 30 participants with follow-up data, 23 were receiving HAART and 7 were not receiving any HIV medications. Selenium: baseline (51.5 ± 15.6 µg/L), 77% deficient (<60 µg/L); follow-up (93.9 ± 21.6 µg/L), 10% deficient Iron: baseline (15.5 ± 5.6 µmol/L), 19% deficient (<11 µmol/L); follow-up (19.0 ± 16 µmol/L), 13% deficient Zinc: baseline (79.0 ± 22.8 µmol/L), 23% deficient (<75 µmol/L); follow-up (71.2 ± 16 µmol/L), 27% deficient Copper: baseline (149 ± 16 µg/100 mL), 98% overloaded (>140 µg/100 mL); follow-up (144 ± 95 µg/100 mL), 43% overloaded Mean serum concentrations of selenium, iron, zinc, and copper did not significantly increase from baseline; however, significantly fewer participants had selenium deficiency and copper overload at follow-up; at follow-up, mean concentrations of selenium, iron, zinc, and copper were not significantly different between those receiving and those not receiving HAART.

Intervention studies of micronutrients in HIV-infected persons receiving highly active antiretroviral therapy (HAART)

Reference Study design, population, and inclusion and exclusion criteria Intervention Primary outcomes Major findings Conclusions Nonrandomized trials     McComsey et al, 2003 (101) Nonrandomized, open-label pilot study without placebo control in the United States. 10 HIV-positive adults receiving HAART for 12 mo. 9 had lipoatrophy and 1 had sustained hyperlactemia at enrollment. Daily vitamin C (1000 mg) and vitamin E (800 IU) and twice-daily N-acetyl cysteine (600 mg) for 24 wk. Fasting glucose, insulin resistance, peripheral fat, lipoatrophy, CD4 cell count, plasma viral load Intervention significantly increased fasting glucose and insulin resistance and decreased waist-to-hip ratio compared with placebo; intervention had no significant effect on peripheral fat, lipoatrophy, CD4 cell count, or plasma viral load. 24 wk of a supplement worsened fasting glucose and insulin resistance and did not significantly improve peripheral fat, lipoatrophy, immunologic status, or plasma viral load.     Batterham et al, 2001 (99) Nonrandomized trial without placebo control in Australia. 66 HIV-positive adults enrolled and 48 completed study (32 receiving HAART, 3 receiving dual therapy, 13 not receiving any HIV medications). Exclusion criteria included taking supplements within 4 wk of enrollment, not clinically stable or with active infection, and change of HIV medication regimen within 6 wk of enrollment. Daily supplementation with either a low-dose1 or a high- dose2antioxidant regimen for 12 wk. Antioxidant defense (glutathione, glutathione peroxidase), oxidative stress (allantoin, uric acid), plasma viral load Intervention significantly increased concentrations of glutathione and glutathione peroxidase from baseline, but had no significant effect on allantoin, uric acid, or plasma viral load; no significant differences between those receiving low-dose and those receiving high-dose regimens. 12 wk of an antioxidant supplement increased oxidative defenses, but did not affect oxidative stress or plasma viral load. Randomized trials     Jensen-Fangel et al, 2003 (102) Randomized crossover trial without placebo control in Denmark. 15 HIV-positive adults receiving HAART; all with chronic nelfinavir-associated diarrhea. Twice-daily calcium carbonate (1350 mg) f or 14 d. A subset of 6 patients additionally treated with twice-daily calcium gluconate (2950 mg) and an extra 300 mg calcium carbonate. Clinical improvement of diarrhea Intervention had no significant effect on clinical measurements of diarrhea. 14 d of a calcium carbonate supplement did not clinically improve nelfinavir-associated diarrhea.     Spada et al, 2002 (103); De Souza et al, 2005 (104) Randomized, placebo-controlled trial in Brazil. 29 HIV-positive adults with CD4 count <500 cells/µL. 26 initiated HAART and 3 initiated dual-combination therapy at study enrollment. Daily vitamin E (800 mg -tocopherol) for 6 mo. Lymphocyte viability, CD4 cell count, CD4: CD8 cells, plasma viral load Intervention had no significant effect on CD4 cell count, CD4: CD8 cells, or plasma viral load as compared with placebo; intervention significantly increased lymphocyte viability compared with placebo. 6 mo of vitamin E supplementation improved lymphocyte viability, but did not affect immune cell count or plasma viral load.     Jaruga et al, 2002 (105) Randomized, placebo-controlled trial in Poland. 30 HIV-positive adults receiving HAART. Daily vitamin A (5000 IU), vitamin C (50 mg), and vitamin E (100 IU) for 6 mo. Antioxidant defense (catalase, superoxide dismutase) oxidative stress; (thiobarbituric acid–reactive substances); CD4 cell count Intervention significantly increased concentrations of catalase and superoxide dismutase and significantly lowered thiobarbituric acid–reactive substances; the CD4 cell count increased in the intervention group from baseline, whereas the mean CD4 count of the placebo group decreased, but the difference was not statistically significant. 6 mo of an antioxidant multivitamin supplement significantly increased antioxidant defenses, significantly reduced oxidative stress, and possibly improved immunologic status.     Burbano et al, 2002 (106) Randomized placebo-controlled trial in the United States. 186 HIV-positive injection-drug users (85 receiving HAART, 39 receiving dual- or monodrug therapy, 52 not receiving any HIV medications). Daily selenium (200 µg) for 2 y. CD4 cell count, hospital admissions Significantly fewer participants in the intervention group than in the placebo group had a decrease in CD4 cell count of >50 cells/µL during the study; intervention significantly reduced hospital admissions because of opportunistic infections and other HIV-related conditions; in multivariate analyses,3the placebo group had a 2.4 greater risk of hospitalization (P = 0.01). 2 y of a selenium supplement decreased large reductions in CD4 cell count and reduced the risk of hospitalization.     Kaiser et al, 2006 (107) Randomized placebo-controlled trial in the United States. 40 HIV-positive adults receiving HAART. Micronutrient supplementation twice daily for 12 wk.4 Fasting glucose, insulin, lipids, CD4 cell count, plasma viral load Intervention significantly increased absolute CD4 cell count (P = 0.03) and mean change in CD4 cell count from baseline (P= 0.01) and had no significant effects on fasting glucose, insulin, lipids, or plasma viral load. 12 wk of micronutrient supplementation increased CD4 cell count.

¹ Included 5450 IU ß-carotene, 250 mg vitamin C, 100 IU vitamin E, 100 µg Se, 50 mg coenzyme Q10, 10 mg thiamine, 25 mg vitamin B-6, 55 mg pantothenic acid, 250 µg folate, 50 µg vitamin B-12, and 5 mg Zn.

² Included 21800 IU ß-carotene, 1000 mg vitamin C, 400 IU vitamin E, 200 µg Se, 200 mg coenzyme Q10, 40 mg thiamine, 100 mg vitamin B-6, 220 mg pantothenic acid, 1000 µg folate, 200 µg vitamin B-12, and 20 mg Zn.

³ Multivariate analysis adjusted for HAART (yes or no), use of other HIV medications (yes or no), age >50 y, CD4 cell count at baseline, and plasma viral load >10000 copies/mL at baseline.

⁴ Micronutrient supplement included 1200 mg N-acetyl cysteine, 1000 mg acetyl L-carnitine, 400 mg -lipoic acid, 20000 IU ß-carotene, 8000 IU vitamin A, 1800 mg vitamin C, 60 mg thiamine, 60 mg riboflavin, 60 mg pantothenic acid, 60 mg niacinamide, 60 mg inositol, 260 mg vitamin B-6, 2.5 mg vitamin B-12, 400 IU vitamin D, 800 IU vitamin E, 800 µg folic acid, 800 mg Ca, 400 mg Mg, 200 µg Se, 150 µg I, 30 mg Zn, 2 mg Cu, 2 mg B, 99 mg K, 18 mg Fe, 10 mg Mn, 50 µg biotin, 100 µg Cr, 300 µg Mo, 60 mg choline, 300 mg bioflavonoid complex, 100 mg L-glutamine, and 150 mg betaine HCL.

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

Anal cancer is one of the top cancers in HIV

The top two cancers are HPV related

The rates of anal cancer in HIV have increased as we live longer.

Medical News: CODHy: Testosterone Improves Metabolic Syndrome - in Meeting Coverage, CODHy from MedPage Today

Medical News: CODHy: Testosterone Improves Metabolic Syndrome - in Meeting Coverage, CODHy from MedPage Today

The Forgotten Minority: HIV+ Patients With No Available HIV treatment Options

Most successful HIV medication combinations require 3 medications that are fully active, but a small portion of long term survivors with long treatment history and accumulated HIV resistance mutations do not have the luxury of constructing a viable regimen to save their lives.

Several potent antiretrovirals (ARVs) in the past 4 years have enabled many patients with multidrug resistance (MDR) to suppress their HIV viral load.

Due to several factors, there is still a relatively small number of patients that have developed resistance or toxicity to the new ARV’s

To protect them from functional monotherapy, these patients are not allowed in pre- approval studies.

Some HIV ARV’s in phase II studies may potentially help those patients, but combining them after their respective approvals may take at least 3 or 4 years.

Some of these patients may be at risk of clinical decline and death if no viable regimen is available for them before 2012

We do not know how many of these patients there are in the U.S.

I performed a physician survey with the help of some researchers and activists to find out how many patients may be present in the U.S. with HIV multidrug resistance in deep salvage (one or zero active medications to treat their HIV).

These figures summarize our findings (click on figures to enlarge):

These are the HIV medications in current development. The ones with an asterisk are the ones that may work for patients with no options left.

The closest ones to approval are Taimed's ibalizumab ( an IV once every two weeks) which may be two years away from approval, and GSK's integrase inhibitor GSK572 (2-3 years) . Avexa recently stopped the development of   Apricitabine and Myriad may follow suit with their maturation inhibitor. A combination of at least two compounds will probably not be feasible until 2013.  Efforts towards creating an expanded access program using multiple investigational agents is currently under way but it may not be a possibility until 2011.  All companies and the FDA are welcoming the concept in its early stages.  I will provide an update during the last quarter of 2010.

I wish we could help patients who need help now.

Nelson Vergel

Update on Medicare's Decision to Help People with HIV-associated Facial Lipoatrophy

I sent this email to Medicare:

Sent: Wednesday, March 31, 2010 10:53 AM
To: Baldwin, JoAnna F. (CMS/OCSQ)
Subject: From the feedback tool - 100331-000018


Regarding:Decision Memo for Dermal injections for the treatment of facial lipodystrophy syndrome (FLS) (CAG-00412N)

I have the following questions:


1- Do patients have to remain depressed to get yearly touch ups ?
2- Are Sculptra and Radiesse (the two FDA approved options) to be included in Medicare part D formularies?
3- How much will doctors get paid for every session?
4- Will there be a maximum number of sessions per year allowed?

Thank you

Nelson Vergel
Founder
FacialWasting.org

******

This the reply from the JoAnna Baldwin from CMS. As you can tell, there is still a lot of work they need to do in establishing rates, etc. I will keep following up for updates.
nelson

(Background for this email for those who have not read Medicare's decision: http://www.hivandhepatitis.com/recent/2010/0326_2010_a.html )

Dear Mr. Vergel,

I hope to be able to help with some of your questions. Please see the below responses and please let me know if you have additional questions.

1- Do patients have to remain depressed to get yearly touch ups ?
I do not know exactly how local Medicare contractors will implement the policy so there is always potential for variation in implementation when the national coverage policy is not explicit. I would venture to say that some documentation would continue to exist in the patient’s medical record that depression is a continued concern and that these conversations be had between the patient and their treating physician. But again, the policy is not explicit in this regard.
2- Are Sculptra and Radiesse (the two FDA approved options) to be included in Medicare part D formularies?
I do not believe these products fall under Part D Medicare coverage. For example, if the injections are delivered in a physician’s office, then the physician would purchase the fillers and then bill Medicare for the fillers and for administering the injections. Part B co-pays and deductibles would apply to this service just as it would be applied to any other Medicare covered service.
3- How much will doctors get paid for every session?
The payment amounts are in the process of being established. Medicare participating providers would accept the payment amount as the full payment but again, co-pays for each office visit would still apply just as any other Medicare Part B service.
4- Will there be a maximum number of sessions per year allowed?
The national coverage policy does not limit the number of sessions per year.

Table of Contents- Testosterone: A Man's Guide

Table of Contents


About the Author
Chapter 1 Introduction
Chapter 2 Testosterone and Its Replacement Therapy Options
History of Testosterone
What Is Testosterone and Why It Is Important
What Are the Symptoms of Low Testosterone (deficiency)?
Questions to Determine If You May Have Testosterone Deficiency
Causes of Testosterone Deficiency
Diagnosis of Testosterone Deficiency
Top Ten Mistakes in Testosterone Replacement Therapy
Testosterone Replacement Options
Chapter 3 Important Tests Required before Starting Testosterone Replacement Therapy
Ensuring Prostate Health
Ensuring Liver Health
Monitoring Blood Pressure
Avoiding Enlarged Breast (Gynecomastia)
Medications and Products that Can Cause Gynecomastia
Keeping Cholesterol (Lipids) in Check
Hypothalamic-Pituitary-Testicular (or Gonadal) Axis (HPTA or HPGA) Dysfunction
Other Important Hormones
Special Considerations for Women
Supplements That Claim to Have Sexual Function and/or Testosterone Improvement Claims

Resources
Appendix A: Compounding Pharmacies
Frequently Asked Questions about Compounding
Some Compounding Pharmacies I Have Used
Appendix B: Physicians Who Treat Hypogonadism
Appendix C: Interview with Dr. Michael Scally about Testosterone Replacement, Its Side Effects and Management Strategies
Appendix D: Testosterone Physician’s Desk Reference (PDR) Package Insert
Description
Clinical Pharmacology
Pharmacokinetics
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Abuse and Dependence
Overdosage
Dosage and Administration
How Supplied

From Upcoming Book: Testosterone: A Man's Guide- The top ten mistakes in testosterone replacement therapy

From my upcoming book: Testosterone: A Man's Guide (to be released in May and available on amazon.com)

TOP TEN MISTAKES IN TESTOSTERONE REPLACEMENT THERAPY

In my years of using testosterone and lecturing, I have seen mistakes being made by people who did not know better. Some mistakes really caused serious negative effects on their quality of life. I will attempt to list a few.

1. Using “street sources” of testosterone: I have met men whose doctors do not support the use of TRT, so they buy it in the black market or from someone at their gyms. This is illegal and dangerous since you need physician supervision. Also, no one knows what those street testosterone products may contain. Some may contain just peanut oil. Testosterone is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III, so it is a controlled substance regulated by the Drug Enforcement Agency (DEA). It can be legally prescribed by a doctor but it is not legal to use it without a prescription. Buying it, importing it, selling it, or even using it without a proper prescription may have legal consequences. Not having a doctor follow-up your blood work is a sure way to get in trouble! If you have low testosterone, there are hundreds of doctors who will prescribe TRT. If you are using it to increase muscle even though you have normal levels, be a smart patient who knows the legalities and research all you can. The use of testosterone or its cousin molecules (anabolic steroids) is illegal in the United States for those without a medical diagnosis that justifies their use. Be careful not to be set up by “informants” who may inform the DEA of your purchase. Read the information in this book about how stopping testosterone can cause health problems (if you are using black market testosterone, chances are that you will run out of your source eventually). In one word: Don’t do it.

2. Not exploring what TRT option is best for you: Some people are told by their doctors to use injections even if needles were a concern to them or if they had to be inconvenienced to go see their doctors every 2 weeks for an injection. Some did not know that they could learn to self-inject. Others were prescribed daily gels even if their busy lives make it difficult to have perfect compliance to the daily therapy. Others were not told about the potential transfer of testosterone from their skin (after applying gels) if they hug their wives, kids, or sexual partners. Every TRT option has advantages and disadvantages that may be more suitable for one person over another, so read the following section on TRT options.

3. Not using the right dose: People put on TRT need to have their testosterone blood levels rechecked 2 weeks or a month after they start therapy, right before they administer the corresponding dose for that day or week. This gives you information on whether you need to increase or decrease the dose. Total testosterone blood levels under 500 ng/dL that are not improving your sexual desire and energy should be increased to 500–1,000 ng/dL by increasing the frequency of injection or dose, increasing the amount or concentration of the gel, etc. Some doctors fail to retest to adjust and some patients stop using TRT because they do not feel the benefits related to a low dose or had too many side effects related to a higher dose. I have seen people getting 200 mg injections of testosterone cypionate once a month, which actually is worse than not treating them at all. See next sections for more details.

4. Cycling on and off TRT: TRT is a life time commitment. Once you start, you should assume that you will stay on it unless you have an unmanageable side effect. Some patients think that “giving the body a break” once every few weeks is a good thing. What they do not know is that when you are on TRT, your testicles do not produce testosterone, so when you stop you are left with no testosterone in your system for weeks. Depression, weight loss, lack of motivation, and loss of sex drive can appear rapidly. Some men never have their HPG axis return to normal after stopping testosterone (especially if they were hypogonadal at baseline). Read more details on “resetting the HPGA.”

5. Stopping TRT abruptly due to an unrelated signal: Some of us may be taking medications for other conditions along with TRT. Sometimes new medications can increase cholesterol and triglycerides and/or liver enzymes (I call these “signals”). Some doctors prematurely blame TRT instead of any of the new medications that the patient might have started. I have seen patients suffer because of this poor judgment of their doctors. Weeks later, they learn that stopping TRT did not improve any of these problems and by then they feel tired, depressed, and asexual.

6. Not knowing how to manage potential side effects: Luckily, this will not happen to you after you finish reading this book. I know men who have stopped TRT due to swelling in their nipple area, acne, moodiness, perceived lack of benefit, hair loss, or a prostatic specific antigen (PSA) increase that was due to a prostatic infection. Knowing how to manage these is key to long-term success so that you do not prematurely stop when you could have just readjust the dose, the delivery method, or taken a medication to counteract the potential problem. Only the best doctors who do not overreact know how to do this.

7. Having a life style that is not “testosterone friendly”: If you smoke, drink more than two drinks a day, smoke too much pot, are overweight, do not exercise, do not keep your blood sugar or lipids in control, and do not show up to doctor’s appointments, you do not have a testosterone-friendly lifestyle. Studies have shown that these factors may influence your sexual function and long-term health. Excessive alcohol can decrease testosterone. Exercise can increase it (to a certain degree if done properly). You can read more about this later in this book.

8. Not reading or being “networked” with other patients: Being in isolation when it comes to information and experiences make you a less effective patient. There are online groups of men who discuss testosterone and other issues (see the Resource section). Sharing your experiences and learning from others are keys to being an empowered and proactive patient who maximizes benefits of any therapy you are using. Many of the practical “tricks” that I have learned have been obtained via this method. The collective wisdom is more powerful than just relying on everything your doctor tells, or does not tell you.

9. Not divorcing your doctor when you have to: Divorcing your incompetent doctor can be difficult, especially if you are not a networked patient who reads a lot about your condition. Many people do not have options and have to see a certain doctor in an health management organization (HMO) setting. But most of us can search for educated doctors who do not speak down to you and who treat you as equal. Your doctor should be your partner in your health and not just an unquestionable authority. Although they are saving lives and have spent hundreds of hours in school and practice to do so, they are human beings who are exposed to myths and misconceptions similar to all of us. I have heard the most incredible things from doctors about TRT that make me question how unfortunate their patients may be. So, do your home work and find a doctor who supports you in your search for optimum health. See the Resource section.

10. Poor compliance: Forgetting when to inject or apply gels is a common complaint. Good time management and reminders are key. I use Google calendar which can be set up to send me text messages to my phone as reminders. Avoid the yo-yo effect that poor compliance causes! TRT is a lifetime and life style commitment that should be explored with care.