Mainstream Doctors’ Ineptitude Put on Display

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Interesting . . .

From: lifeextension@...(Life Extension) Date: Sat, Jul 31, 2010,

7:56am (CDT+1)

Mainstream Doctors' Ineptitude Put on Display in The New England Journal

of Medicine

A study published in the June 30, 2010 edition of The New England

Journal of Medicine confirms how little conventional doctors know about

prescribing testosterone to aging men.

The Life Extension Foundation® (and its medical advisors) long ago

recognized that maturing men have a propensity to convert (aromatize)

testosterone into estrogen. When you see an overweight man growing

breasts, it is not directly because he eats too much. This phenomenon is

instead caused by the testosterone he converts to breast-enlarging

estrogen.

When men are prescribed testosterone gels or creams, they sometimes have

to take an aromatase-inhibiting drug (like Arimidex®) to prevent their

estrogen (measured as estradiol in the blood) from climbing to dangerous

levels.

Optimal estradiol blood levels in men are between 20-30 pg/mL. Elderly

males can have much higher estradiol levels that place them at

substantial risk for developing coronary atherosclerosis and thrombotic

stroke.

If elderly men are prescribed large doses of topical testosterone gel or

cream, their estradiol blood levels have to be tested and properly

controlled. Failure to manage estradiol in men receiving high-dose

testosterone gel or cream can result in a catastrophic estrogen surge

that increases vascular disease risk and premature death.

Enormous tax dollars squandered on flawed testosterone study

The Federal government provided a financial grant to an armada of

doctors to evaluate the effects of high-dose testosterone on men that

were so severely debilitated that they struggled to climb more than 10

stairs or walk the equivalent of two city blocks.

These men suffered numerous risk factors such as obesity, diabetes,

hypertension, and elevated blood lipids that placed them at higher risk

for cardiovascular events. Obese men tend to produce loads of estrogen

in their abdominal fat — and typically have higher estradiol levels

than thinner men.

The men with the worst vascular risk factors (such as highest

triglyceride levels) were placed on a dose of topical testosterone that

is TWICE the standard starting dose. These debilitated men were given

testosterone in a way that is more likely to aromatize through the skin

into estrogen.

Men with fewer vascular risk factors were given a placebo gel.

It should be no surprise to learn that this study was halted prematurely

because the debilitated men given the high-dose testosterone (with no

aromatase inhibitor) suffered more " atherosclerosis-related events " such

as heart attack, stroke, and sudden death.

The official title of this study is " Adverse Events with Testosterone

Administration. " A more accurate title may have been: " Elevated Estrogen

Leads to Cardiovascular Events in Older Men. "

Click here to read Life Extension®'s recent review about the dangers

of estrogen imbalance in aging men, click here

Life Extension writes a letter to these doctors

The day this study was published, Life Extension wrote the doctors who

conducted the study asking if there was any data regarding baseline and

post-baseline blood estradiol levels. We have waited over four weeks,

and the authors of The New England Journal of Medicine study have not

responded to our repeated requests as to whether estradiol levels were

ever measured.

From what was written in the paper, it does not appear that any

attention was paid to the estrogen levels in these debilitated men. The

authors wrote in the discussion section of the paper, " Testosterone and

associated increases in estradiol may promote inflammation, coagulation

and platelet aggregation. " Yet these doctors don't appear to have done

anything to evaluate estradiol levels in the unfortunate study subjects

given double-dose testosterone with no aromatase inhibitor to suppress

the expected estrogen surge.

This study had numerous other flaws

Leaving aside the failure to manage estradiol levels in men given

high-dose testosterone gel, there were numerous design flaws that call

into question any conclusion that can be drawn from this study.

As mentioned earlier, the testosterone group at baseline was at greater

risk for cardiovascular events as manifested by a greater proportion of

men in the testosterone group with dyslipidemia who were undergoing

statin and antihypertensive drug treatment.

In addition, triglyceride levels (higher) and HDL levels (lower) were

trending against the testosterone group. Clearly, the baseline

cardiovascular risk for the testosterone group was higher than the

placebo group. The authors claim that a sensitivity analysis, as well as

controlling for cardiovascular risk factors, did not change the results,

but the small sample size and relatively short trial duration serve to

magnify, not minimize, differences due to chance.

The study was not designed to systematically assess for cardiovascular

events, and given the small sample size, lack of consistent pattern of

events, diversity of serious events, and small number of serious adverse

cardiac events (10 vs. 1) in the two treatment groups before study

stoppage in this short duration trial strongly suggest that the results

are due to chance. Another explanation of course is that the adverse

vascular events were caused by the uncontrolled conversion of the

topically-applied testosterone to estradiol in men who were already

likely to have dangerously high estradiol blood levels to begin with.

Fodder for the media

The published scientific data documents low testosterone as being an

independent risk factor for heart attack and a host of other age-related

ailments.

The authors of this study acknowledge the benefits the testosterone

group obtained from the drug and openly admitted the limitations of this

study in providing guidance about the effects of testosterone on

different population groups.

The media, however, has a propensity to publicize one negative study

while ignoring hundreds of positive ones. We will not be surprised to

see this horrifically flawed study used for decades to discredit the

safety and efficacy of properly prescribed testosterone cream and

aromatase-inhibition therapy.

Importance of blood testing in men supplementing with testosterone

In response to overwhelmingly favorable studies, record numbers of aging

men are rubbing testosterone creams or gels on to their skin each day to

restore this vital hormone to youthful levels.

Within 45-60 days of initiating testosterone replacement therapy, the

following blood tests should be done to ensure safety and efficacy:

PSA (prostate specific antigen) – To rule out prostate cancer

Estradiol – To make sure testosterone is not converting to estrogen

Free & Total Testosterone – To make sure enough testosterone is being

absorbed

CBC/Chemistry – To make sure liver enzymes are normal and red blood

production has not increased too much

These tests can be done at your doctor's office, or you can order them

all directly from Life Extension by calling 1-877-354-6513 (24 hours a

day) and asking for the Male Testosterone Panel (item LC100001). These

tests can retail for over $500.00 at commercial labs, but Life Extension

members pay only $125.00. Order your blood tests now!

To review Life Extension articles describing benefits of testosterone

replacement in aging men, click here:

Optimizing Testosterone Levels in Aging Men, Vindication.

Summary of 5 recent peer-reviewed studies noting adverse cardiovascular

effects associated with elevated estrogen in aging men:

1) After adjustment for age, hypertension, diabetes, adiposity,

cholesterol, atrial fibrillation, and other characteristics were made in

a group of 2,197 men aged 71 to 93 years of age, men with the highest

blood levels of estradiol had a 2.2-fold greater risk of stroke compared

with those whose estradiol levels were lower. {Reference: Abbott RD,

Launer LJ, BL, et al. Serum estradiol and risk of stroke in

elderly men. Neurology. 2007 Feb 20;68(8):563-8.}

2) In a study of 313 men whose average age was 58, carotid artery

intima-media thickness was measured at baseline and then three years

later. After adjusting for other confounding risk factors, higher levels

of estradiol were associated with thickening of the carotid artery wall.

Researchers concluded, " Circulating estradiol is a predictor of

progression of carotid artery intima-media thickness in middle-aged

men. " {Reference: Tivesten A, Hulthe J, Wallenfeldt K, et al.

Circulating estradiol is an independent predictor of progression of

carotid artery intima-media thickness in middle-aged men. J Clin

Endocrinol Metab. 2006 Nov;91(11):4433-7.}

3) In an angiographic trial of coronary atherosclerosis in a group of

men with stable coronary artery disease, significant positive

correlations between estradiol levels and other known atherosclerotic

risk factors was observed. Researchers concluded, " Our results indicate

a possible role of estradiol in promoting the development of atherogenic

lipid milieu in men with coronary artery disease. " {Reference: Wranicz

JK, Cygankiewicz I, Rosiak M, et al. The relationship between sex

hormones and lipid profile in men with coronary artery disease. Int J

Cardiol. 2005 May 11;101(1):105-10.}

4) In another angiographic trial of coronary atherosclerosis in men aged

40-60 years, compared with healthy age-matched controls, men with

coronary atherosclerosis had higher levels of estrone and a low level of

testosterone in the presence of a high level of estradiol. Researchers

concluded, " Low levels of total testosterone, testosterone/estradiol

ratio and free androgen index and higher levels of estrone in men with

coronary artery disease appear together with many features of metabolic

syndrome and may be involved in the pathogenesis of coronary

atherosclerosis. " {Reference: Dunajska K, Milewicz A, Szymczak J, et al.

Evaluation of sex hormone levels and some metabolic factors in men with

coronary atherosclerosis. Aging Male. 2004 Sep;7(3):197-204.}

5) In a study of men having suffered an acute myocardial infarction

(heart attack), a prior heart attack, and patients with normal coronary

arteries, the results showed significantly higher levels of estradiol in

both groups of heart attack patients compared with those without

coronary disease. {Reference: Mohamad MJ, Mohammad MA, Karayyem M, Hairi

A, Hader AA. Serum levels of sex hormones in men with acute myocardial

infarction. Neuro Endocrinol Lett. 2007 Apr;28(2):182-6.}

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