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LE Magazine December 2008

Vindication

By William Faloon

Where Life Extension Disagrees With the “Harvard Experts”

Most of the recommendations in Testosterone for Life closely follow what Life Extension long ago published.

There are some exceptions, however, that paint an interesting picture of how differently mainstream medicine thinks when analyzing the exact same scientific data.

Life Extension has dedicated many articles to the disease-prevention potential of testosterone replacement therapy. One study, for example, showed mortality levels 88% higher in men with low testosterone, compared with men who had normal testosterone.10

Testosterone for Life acknowledges all these studies, but does not believe these studies provide enough substantiation to warrant men replacing their testosterone for the purposes of living longer. They specifically state that if a man with low testosterone has no signs or symptoms of deficiency, then he should not restore his testosterone.

We at Life Extension vehemently disagree with this line of thinking. Our position is that low testosterone contributes to the degenerative diseases of aging such as chronic inflammation,11-15 neurologic decline,16-22 diabetes,23,24 and atherosclerosis.6,25-29 Most of us take our nutrient supplements not because we suffer “signs or symptoms” of deficiency, but because we want to prevent the onset of age-related disease.

It is fascinating that the “experts of Harvard Medical School” have such a different philosophy about this critically important issue of disease prevention, though they admit they are leaning towards recommending testosterone for longevity purposes if more confirmatory studies are published.

Testosterone for Life defines low testosterone as free testosterone blood levels below 15 pg/mL. We at Life Extension suggest that aging men maintain their free testosterone at a level of 20-25 pg/mL to more closely resemble that of a healthy 21-year-old.

“Clearly, many men feel more energetic, vigorous and alive with testosterone therapy, not to mention having more interest in sex and improved sexual performance. These men feel better, enjoy their lives—and their partners—more, and tend to have a better outlook on life.”

—Abraham Morgentaler, MD, FACS, Associate clinical professor,
Harvard Medical School

There are a number of delivery methods available for aging men to restore their testosterone levels. Both Life Extension and the “experts at Harvard” suggest topically applied testosterone creams or gels as the most efficient way of delivering testosterone into the body. While the Harvard experts acknowledge that patients using compounded testosterone creams achieve desired blood levels, they heavily recommend FDA-approved testosterone cream drugs 'because they believe these to be more reliable.

Life Extension has found that testosterone made by compounding pharmacies consistently elevates free testosterone, and that the recommended follow-up blood tests can verify that an individual using testosterone from a compounding pharmacy is achieving youthful levels.

What the Harvard people neglect to discuss is cost. The FDA-approved testosterone cream drugs can cost over $220 a month (or $2,640 a year). Compounded testosterone, on the other hand, can be obtained for around $20 a month (or $240 a year). For whatever reason, Testosterone for Life chooses not to discuss the cost differential issue.

FDA-approved testosterone drugs are unaffordable to many aging men. We at Life Extension do not hesitate to enlighten our readers that they can obtain the same benefits by spending $20 a month, as opposed to $220 a month for FDA sanctioned testosterone drugs.

Interesting Tidbits

Testosterone for Life makes compelling arguments for aging men with low testosterone to take corrective action. In rebutting critics who claim nature should not be interfered with, author Abraham Morgentaler, MD, FACS, asks whether aging people should be deprived of their eyeglasses, since visual decline is also a normal manifestation of aging. He questions why doctors who prescribe thyroid hormone drugs criticize testosterone replacement. Why, he asks, is it OK to treat low thyroid but not low testosterone?

Building muscle mass and bone density while reducing abdominal fat are well-established improvements in body composition observed in response to testosterone therapy.30-32 Testosterone for Life relates recent data showing that testosterone not only helps increase the strength and size of each muscle cell, but also influences nearby cells into becoming muscle cells.33,34

Perhaps the most detailed descriptions in Testosterone for Life are the sexual-enhancing effects that occur when this hormone is restored. Dr. Morgentaler relates numerous case reports of patients who had lost interest in sex, were unable to perform satisfactorily, and/or who no longer experienced youthful fulfillment. In most cases, these patients reported that within weeks of testosterone levels being restored, they experienced more youthful sexual urge, performance, and pleasure.

“As you know, my sex drive came back quickly. What I hadn’t expected though, was how much better I would feel… within a couple months of treatment, I felt better than I’d felt in years. I’ve started two new businesses and I’m helping a colleague with the creation of a nonprofit educational company. I’m now excited to wake up every single day.”

—Testimonial of a 52-year-old male patient who had his testosterone restored to a youthful level.

Saving Our Healthcare System

Be it the public or private sector, the United States of America does not have the economic resources to pay the health care costs of its rapidly increasing aging population.

For the past three decades, we at Life Extension have advocated free market approaches that would slash medical financial outlays by maintaining aging people in youthful states of health.

Based on an enormous amount of published scientific data, testosterone deficiency is a major risk factor in the development of expensive-to-treat degenerative diseases in the male population.

If most men restored their testosterone, the savings to Medicare alone in hospital and other medical service expenditures would be incalculable.

How to Safely Restore Youthful Testosterone Balance

Since most doctors still don’t know how to properly prescribe testosterone, I will make the following recipe as simple as possible:

1. Have your blood tested for free testosterone, estradiol, and prostate-specific antigen (PSA), along with complete blood counts and blood chemistries. These blood tests are all included in the comprehensive Male Panel Blood Test that most members have performed annually.

2. If your blood test results reveal free testosterone below 20-25 pg/mL, find a doctor with experience in prescribing natural testosterone cream. Life Extension maintains lists of doctors who have knowledge about male hormone restoration. To locate a doctor in your area, log on to www.LifeExtension.com/doctors

3. To obtain natural testosterone cream at the lowest price, ask your doctor to write a prescription for compounded natural testosterone cream. An example of how a doctor can write a prescription for a two-month supply of natural testosterone cream appears below. The exact dose you need is based on your blood test results, body mass, and later may be based on your rate of absorption and internal metabolism. Your doctor will determine what dose of testosterone cream is most appropriate for you.

Natural Testosterone Cream Prescription Example

4. If your estradiol level is over 30 pg/mL, your doctor may also prescribe a very low-dose aromatase-inhibiting drug such as 0.5 mg of Arimidex® twice per week. This will usually bring estradiol into the optimal range of 20-30 pg/mL.

5. Within 45 days, have your blood re-tested to verify proper testosterone dosing and rule out prostate cancer. These blood tests also enable you to guard against excess red blood cell production and excess conversion of testosterone to estradiol, as well as to ensure that liver enzymes are in normal ranges.

Life Extension members have the advantage of requesting their blood to be drawn ahead of time so their doctor can properly prescribe them testosterone during their first visit. To order the Male Panel that includes all these blood tests and a lot more at a new lower price, call 1-800-208-3444.

Compounded testosterone cream can be obtained for as little as $40 for a 60-day supply. There are also non-prescription methods that restore free testosterone to youthful ranges in some men. To inquire about these, call a Life Extension Health Advisor at 1-800-226-2370.

Will Testosterone for Life Become a Best-Seller?

Testosterone for Life is not the first book to reveal the profound age-reversal benefits observed when testosterone levels are properly restored.

A decade ago, Jonathan Wright, MD, authored a similar book called Maximize Your Vitality and Potency (Smart Publications; 1999). This book was based on the impressive clinical results Dr. Wright obtained in the 1980s when youthful testosterone levels were restored in his male patients. As some of you will remember, the FDA spent a tremendous amount of taxpayer dollars trying to destroy Dr. Wright’s medical practice.

As we move forward towards 2009, it is unlikely the FDA will repeat its ludicrous abuse of scientific reality again.

Additional Biological Inputs to Assess the Presence of Prostate Cancer

There are additional diagnostic tools beyond a one-time PSA blood test reading to more optimally assess whether or not prostate cancer is present. These include:

Serial increases over time of the PSA, despite levels in the so-called normal range of 0.0-4.0 ng/mL. Prostate cancer may be present if such increases point to a PSA velocity of 0.3 ng/mL/year or higher, or to a PSA doubling time of less than 10 years, or to a rising PSA slope or abnormal natural logarithm of the PSA slope.
A free PSA percentage of 15% or less.
An abnormal PCA3 urine test after attentive digital rectal exam.
A PSA density (PSAD) of 0.15ng/mL/cm3 or higher.

In other words, before subjecting a man to transrectal ultrasound-guided biopsies to rule out prostate cancer prior to testosterone supplementation, look at the biological declarations that declare a problem with prostate cancer is likely. The tests mentioned in this section, in all, are far more scientifically sound approaches to direct a man to an invasive procedure or to lead him away from one. Men with low testosterone may not feel compelled to do prostate biopsies prior to the use of testosterone supplementation because a biopsy.

Is a sampling of only a portion of the prostate,
Is very much dependent on the skill of the ultrasonographer
Depends on the nature and quality of the ultrasound equipment.

Once testosterone therapy has been initiated, tests as frequently as once a month are optimal until a trend indicating a flat PSA response is clearly discerned. Afterwards, reducing the frequency of PSA testing to every three to four months is reasonable, and pending those findings a further reduction in the testing interval is justifiable.

With the endorsement of doctors from Harvard Medical School, perhaps the aging male population will awaken to the fact that they have an opportunity to restore youthful mental and physical functions, while adding decades of healthy life span, just by restoring their free testosterone blood levels.

It is my sincere hope that Testosterone for Life becomes a bestseller. It may be the greatest vindication of anti-aging medicine that the establishment has ever admitted to.

Any Life Extension member who has a question about natural testosterone restoration therapy is free to call our Health Advisors at 1-800-226-2370.

For longer life,

For Longer Life

William Faloon

Important Notes to Prostate Cancer Patients Treated With Drugs That Block Testosterone Production

Testosterone replacement therapy provides broad-spectrum anti-aging benefits that include boosting energy, improving mood, building muscle mass, reducing abdominal fat, and restoring sexual function and desire. Testosterone is also essential for maintaining bone density and protecting endothelial function.

Prostate cancer patients, on the other hand, are often prescribed drugs known as luteinizing hormone-releasing hormone agonists (such as Lupron® or Zoladex®) that block testicular production of testosterone. A side effect from these drugs is a severe testosterone deficiency that creates a constellation of serious problems characterized as the “androgen deprivation syndrome.”

Prostate cancer patients prescribed these drugs should review the Prostate Cancer chapter in the Disease Prevention and Treatment textbook (also available online at www.lef.org) that provides therapeutic suggestions to counteract androgen deprivation syndrome. More comprehensive information about protecting against side effects relating to androgen deprivation syndrome can be found in a book titled, A Primer for Prostate Cancer (Stephen Strum, MD and Donna Pogliano) available by calling 1-800-544-4440.

When luteinizing hormone-releasing hormone agonists are first prescribed, there is a temporary flare of testosterone production that may last for 30 days before testicular testosterone production shuts down. Drugs like Casodex® or Flutamide®, when prescribed five to seven days before the luteinizing hormone-releasing hormone agonists are administered, can help block this temporary testosterone flare from affecting prostate cancer cells.

The book Testosterone for Life cites some studies that seem to indicate the temporary testosterone flare in response to luteinizing hormone-releasing hormone agonists prescribed alone does not pose a problem for prostate cancer patients. Life Extension’s experience and those of its advisors indicates otherwise, and we urge prostate cancer patients undergoing luteinizing hormone-releasing hormone agonist drug therapy to:

Block the testosterone flare using a drug like Casodex® five to seven days prior to this therapy being administered and
Follow all steps to protect against “androgen deprivation syndrome” as long as testosterone levels are being suppressed.

References

1. Rhoden EL, Averbeck MA, Teloken PE. Androgen replacement in men under-going treatment for prostate cancer. J Sex Med. 2008 Sep;5(9):2202-8.

2. Morgentaler A. Testosterone replacement therapy and prostate cancer. Urol Clin North Am. 2007 Nov;34(4):555-63.

3. Miner MM, Seftel AD. Testosterone and ageing: what have we learned since the Institute of Medicine report and what lies ahead? Int J Clin Pract. 2007 Apr;61(4):622-32.

4. Raynaud JP. Prostate cancer risk in testosterone-treated men. J Steroid Biochem Mol Biol. 2006 Dec;102(1-5):261-6.

5. Tan RS, Salazar JA. Risks of testosterone replacement therapy in ageing men. Expert Opin Drug Saf. 2004 Nov;3(6):599-606.

6. Gooren L. Androgen deficiency in the aging male: benefits and risks of androgen supplementation. J Steroid Biochem Mol Biol. 2003 Jun;85(2-5):349-55.

7. Schatzl G, Madersbacher S, Thurridl T, et al. High-grade prostate cancer is associated with low serum testosterone levels. Prostate. 2001 Apr;47(1):52-8.

8. Hoffman MA, DeWolf WC, Morgentaler A. Is low serum free testosterone a marker for high grade prostate cancer? J Urol. 2000 Mar;163(3):824-7.

9. Marks LS, Mazer NA, Mostaghel E, et al. Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2351-61.

10. Shores MM, Matsumoto AM, Sloan KL, Kivlahan DR. Low serum testosterone and mortality in male veterans. Arch Intern Med. 2006 Aug 14; 166(15):1660-5.

11. Available at: http://health.ucsd.edu/news/2007/6-5-Testosterone.htm. Accessed August 17, 2008.

12. Tang YJ, Lee WJ, Chen YT, et al. Serum testosterone level and related metabolic factors in men over 70 years old. J Endocrinol Invest. 2007 Jun;30(6):451-8.

13. Maggio M, Basaria S, Ceda GP, et al. The relationship between testosterone and molecular markers of inflammation in older men. J Endocrinol Invest. 2005;28(11 Suppl Proceedings):116-9.

14. Laaksonen DE, Niskanen L, Punnonen K, et al. Sex hormones, inflammation and the metabolic syndrome: a population-based study. Eur J Endocrinol. 2003 Dec;149(6):601-8.

15. Cutolo M, Seriolo B, Villaggio B, et al. Androgens and estrogens modulate the immune and inflammatory responses in rheumatoid arthritis. Ann NY Acad Sci. 2002 Jun;966:131-42.

16. Lu PH, Masterman DA, Mulnard R, et al. Effects of testosterone on cognition and mood in male patients with mild Alzheimer disease and healthy elderly men. Arch Neurol. 2006 Feb;63(2):177-85.

17. Cherrier MM, Plymate S, Mohan S, et al. Relationship between testosterone supplementation and insulin-like growth factor-I levels and cognition in healthy older men. Psychoneuroendocrinology. 2004 Jan;29(1):65-82.

18. Moffat SD, Zonderman AB, Metter EJ, et al. Free testosterone and risk for Alzheimer disease in older men. Neurology. 2004 Jan 27;62(2):188-93.

19. Hogervorst E, Combrinck M, Smith AD. Testosterone and gonadotropin levels in men with dementia. Neuro Endocrinol Lett. 2003 Jun;24(3-4):203-8.

20. Moffat SD, Zonderman AB, Metter EJ, et al. Longitudinal assessment of serum free testosterone concentration predicts memory performance and cognitive status in elderly men. J Clin Endocrinol Metab. 2002 Nov;87(11):5001-7.

21. Cherrier MM, Anawalt BD, Herbst KL, et al. Cognitive effects of short-term manipulation of serum sex steroids in healthy young men. J Clin Endocrinol Metab. 2002 Jul;87(7):3090-6.

22. Gouras GK, Xu H, Gross RS, et al. Testosterone reduces neuronal secretion of Alzheimer’s beta-amyloid peptides. Proc Natl Acad Sci USA. 2000 Feb 1;97(3):1202-5.

23. Traish AM, Saad F, Guay AT. The Dark Side of Testosterone Deficiency: II. Type 2 Diabetes & Insulin Resistance.J Androl. 2008 Sep 4.

24. Chandel A, Dhindsa S, Topiwala S, Chaudhuri A, Dandona P. Testosterone concentrations in young patients with diabetes mellitus. Diabetes Care. 2008 Jul 23.

25. Debing E, Peeters E, Duquet W, et al. Men with atherosclerotic stenosis of the carotid artery have lower testosterone levels compared with controls. Int Angiol. 2008 Apr;27(2):135-41.

26. Khaw KT, Dowsett M, Folkerd E, et al. Endogenous testosterone and mortality due to all causes, cardiovascular disease, and cancer in men: European prospective investigation into cancer in Norfolk (EPIC-Norfolk) Prospective Population Study. Circulation. 2007 Dec 4;116(23):2694-701.

27. Muller M, van den Beld AW, Bots ML, et al. Endogenous sex hormones and progression of carotid atherosclerosis in elderly men. Circulation. 2004 May 4;109(17):2074-9.

28. Zmuda JM, Cauley JA, Kriska A, et al. Longitudinal relation between endogenous testosterone and cardiovascular disease risk factors in middle-aged men. A 13-year follow-up of former Multiple Risk Factor Intervention Trial participants. Am J Epidemiol. 1997 Oct 15;146(8):609-17.

29. Hak AE, Witteman JC, de Jong FH, et al. Low levels of endogenous androgens increase the risk of atherosclerosis in elderly men: the Rotterdam study. J Clin Endocrinol Metab. 2002 Aug;87(8):3632-9.

30. Isidori AM, Giannetta E, Greco EA, et al. Effects of testosterone on body composition, bone metabolism and serum lipid profile in middle-aged men: a meta-analysis. Clin Endocrinol (Oxf). 2005 Sep;63(3):280-93.

31. Moretti C, Frajese GV, Guccione L, et al. Androgens and body composition in the aging male. J Endocrinol Invest. 2005;28(3 Suppl):56-64.

32. Wang C, Cunningham G, Dobs A, et al. Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men. J Clin Endocrinol Metab. 2004 May;89(5):2085-98.

33. Choong K, Lakshman KM, Bhasin S. The physiological and pharmacological basis for the ergogenic effects of androgens in elite sports. Asian J Androl. 2008 May;10(3):351-63.

34. Bhasin S, Taylor WE, Singh R, et al. The mechanisms of androgen effects on body composition: mesenchymal pluripotent cell as the target of androgen action. J Gerontol A Biol Sci Med Sci. 2003 Dec;58(12):M1103-10.

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