Nelson Vergel asks for change in testosterone guidelines after another negative study

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Nelson Vergel

A new study published last week and a previous one from the Veterans Administration Hospital System (see below post) show what happens when older men are given testosterone replacement without managing potential blood level increases of factors that can affect their health.

Testosterone replacement can increase red blood cell (and hematocrit which is the total red cell volume) and estradiol production, two important factors for men's health when present in normal levels (red blood cells carry oxygen and estradiol maintains healthy bones, cognitive function and sex drive). However, due to genetic, age or other factors some men can have excessive production of both. High hematocrit and estradiol are more common in older men on testosterone since testosterone related aromatization and erythrocytosis are worse in that population. In excess, both variables have been linked to cardiovascular risks in older men. Not a single one of studies reporting higher cardiovascular risks in men on testosterone have managed either important factor.

Additionally, this latest nonrandomized study states that "No data were available on indications for T prescription, race, laboratory findings, occupational, environmental, or lifestyle factors."

Many clinics are managing hematocrit by recommending blood donation or phlebotomies to men with hematocrit over 53. They are also recommending treatment with low dose anastrozole for men with estradiol over 50 pg/mL. However, an alarming number of medical practices and research studies chose not to follow basic recommendations from the 4 current guideline groups that, in my opinion, may still need revision to add estradiol monitoring. The table below shows a summary of monitoring required by the main 4 guidelines groups in the world.

It is also imperative that future studies at least follow the minimum requirements of the current guidelines. The last few studies that concluded that testosterone may increase cardiovascular risks did not monitor or report hematocrit blood levels. Most guidelines recommend monitoring hematocrit at month 3, 6 and then annually. Are these studies liable for not following minimum guidelines and exposing their volunteers to increased risks?. I do not why I do not see discussions on this alarming fact. Institutional review boards (IRB's) need to educate themselves about this problem so that no more studies are allowed that do not properly monitor men on testosterone replacement. Would a class action lawsuit be required to change this malpractice? Some are already popping up: Testosterone Treatment Lawsuit Information

It is time to revise the current guidelines for testosterone treatment in men to include monitoring and managing estradiol with the same frequency as hematocrit. It is also time to enforce guidelines compliance in all testosterone studies.

I encourage all men currently on testosterone replacement or thinking about starting it to familiarize themselves with the table below and demand that guidelines (along with estradiol monitoring) are followed by their physicians. And, please, do not sign a study consent form if you see that they do not specify the monitoring frequency and side effect management options the researchers are offering.

I also encourage Abbvie (makers of Androgel), Auxillum (makers of Testim), Endo Pharmaceuticals (makers of Fortesta), Lilly (makers of Axiron) to wake up to this fact before they lose millions due to negligent practices that do not follow minimum guidelines.

I am looking forward to the day when a research group will perform a good study that uses a protocol that not only gives testosterone to men but also one that retests them periodically to manage dose, high hematocrit and estradiol blood levels. It should not be a difficult task and it is the only responsible thing to do to come up with conclusions that we can trust.

For options on how to prevent and reverse potential side effects of testosterone replacement: click here

Reference:Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men

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Nelson Vergel

This is a press release that describes issues with a previous study from the veterans administration hospital that also fails to monitor hematocrit and estradiol (and in which the majority of veterans were not monitored after starting testosterone). When will large medical groups get it? Identifies Major Flaws in Recently Published VA Testosterone Study

A men's health grassroots and education group advocates for better testosterone replacement therapy of veterans of the U.S. Armed Forces

Houston, TX -- (SBWIRE) -- 11/14/2013 -- Last week's Journal of American Medical Association (JAMA) published a retrospective study (1) that was performed at the Veteran's Administration (VA) hospital system. While it has long been known that testosterone replacement therapy (TRT) improves sexual function, bone density, lean body mass, and lipids, this study concluded that testosterone therapy may increase the risk of cardiovascular problems in men with a history of heart disease. It cautioned that men with pre-existing cardiovascular problems and testosterone deficiency should avoid TRT., an education website for men, identified major flaws in this study that wrongly alarmed patients, physicians and the media.

While it is commendable that the VA hospital system collected data on the use of testosterone in over 8,000 veterans with cardiovascular disease, the study highlights deficiencies in the hospital system's testosterone management protocol.

The VA study showed that 40% of patients did not have their testosterone blood levels retested after they started testosterone. This lack of follow up contradicts a review of guidelines published on 2011 by the American College of Cardiology Foundation that The Endocrine Society, the American Association of Clinical Endocrinologists, the American Society of Reproductive Medicine, and the European Association of Urology recommendations of monitoring patients' blood analysis 3 months after initiation of testosterone therapy (2) to determine TRT dose adjustments and potential side effects.

A previously study (3) also published in JAMA in 2009 showed that men with total testosterone blood levels below 550 ng/dl had a significant increase in their risk of cardiovascular disease, while men with levels above 550 ng/dl reduced their risk by 30%. Monitored participants in the VA study were only able to increase their total testosterone blood levels to 332 ng/dl, a value considered sub-optimal by all testosterone treatment medical guidelines.

Another shortcoming of the VA hospital system's TRT protocol highlighted by the study is the lack of monitoring and managing of hematocrit (red cell volume) and estradiol (a female hormone produced in the body from testosterone). TRT can increase hematocrit and estradiol is a minority of men resulting in increased blood viscosity and cardiovascular risks as documented in the previously mentioned 2009 JAMA study (4). Fortunately, both variables can be easily managed if patients are properly monitored.

The majority of participants in the VA study used testosterone patches. Once a popular method of testosterone delivery, testosterone patches are no longer used due to their poor absorption and inconvenience. This is reflected in the VA study where most of the participants continued to have testosterone deficiency and increased cardiovascular risk.

"Publishing flawed studies only increases the current misconceptions surrounding this important therapy and unnecessarily alarms TRT patients and their physicians", said Nelson Vergel, founder of "We encourage patients, physicians and the media to closely examine studies for misleading information that could increase barriers to life saving therapies", added Vergel.

"We urge the VA hospital system to revise their TRT protocol and to follow current testosterone guidelines. We want only the best for the men who have served our country", said Keith Willse, co-founder of is a peer reviewed and moderated safe platform where men can privately and securely share information and experiences about health and productivity. It is moderated daily for content and enforcement of a code of conduct and provides well organized archives of articles, forum chats, product reviews, and videos related to:

- Testosterone replacement,
- erectile dysfunction and sex drive,
- fat loss and muscle gain,
- energy boosters,
- exercise,
- nutrition,
- supplementation,
- diagnostics,
- pharmaceuticals,
- and all things related to men's health and productivity.

For more information and patient/clinician education on testosterone, visit


1- JAMA. 2013;310(17):1829-1836.
2- J Am Coll Cardiol. 2011;58(16):1674-1681.
3- JAMA. 2009 May 13;301(18):1892-901.
4- JAMA. 2009 May 13;301(18):1892-901.


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Nelson Vergel

I am very happy to see that several researchers have sent letter to the editors that support our views.

Letters to the Editor & Reply

Dhindsa S, Batra M, Dandona P. Deaths and Cardiovascular Events in Men Receiving Testosterone. JAMA. 2014;311(9):964.

Riche DM, Baker WL, Koch CA. Deaths and Cardiovascular Events in Men Receiving Testosterone. JAMA. 2014;311(9):963-964.

Katz J, Nadelberg R. Deaths and Cardiovascular Events in Men Receiving Testosterone. JAMA. 2014;311(9):963.

Jones T, Channer KS. Deaths and Cardiovascular Events in Men Receiving Testosterone. JAMA. 2014;311(9):962-963.

Morgentaler A, Traish A, Kacker R. Deaths and Cardiovascular Events in Men Receiving Testosterone. JAMA.2014;311(9):961-962.

Ho P, Barón AE, Wierman ME. Deaths and Cardiovascular Events in Men Receiving Testosterone—Reply. JAMA. 2014;311(9):964-965.
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