Nelson Vergel
Founder, ExcelMale.com
Interview With Dr. Michael Scally- Part 1
Nelson Vergel (NV): Dr. Michael Scally is a well-known expert on men’s health in general, and specifically he’s an expert on hormone therapy and issues surrounding testosterone replacement. Dr. Scally, can you tell us a little bit about your background?
Michael Scally (MS): My education includes a double degree major in chemistry (1975) and life sciences (1975) from the Massachusetts Institute of Technology (MIT) Cambridge, MA. From 1975 to 1980, in the MIT division of Brain Sciences & Neuroendocrinology, I researched and published investigations on neurotransmitter relationships. During this time, I entered the prestigious Health Sciences & Technology Program, a collaboration of the MIT and Harvard Medical School. In 1980, I was awarded by Harvard Medical School a Doctorate of Medicine, MD. In 1983, I completed a fellowship in anesthesiology at Parkland Southwest Memorial, in Dallas. From 1983 to 1994, I was a private practice anesthesiologist. In 1984, I set up the first ambulatory, outpatient, surgery center at Houston.
In 1994, I became interested in general and preventative medicine with a focus on endocrinology. I have been active in this area since that time.
In 1995, I inquired to Wyeth Pharmaceuticals about the association between primary pulmonary hypertension and pondimin (fenfluramine). I came to learn, this inquiry later was used as evidence in the class-action suit against Wyeth and was instrumental in showing that the known adverse effects were known to Wyeth but not revealed to the public.
During 1994, I competed in the Mr. Texas Bodybuilding Championship, placing second. While exercising, I was approached by a number of weightlifters on the medical treatment to restore the hypothalamic-pituitary axis (HPTA) after stopping anabolic steroids (AAS). Many of these same individuals also used over-the-counter (OTC) supplements.
As you might know, many bodybuilders are trying to decrease their body fat and increase their muscle mass as much as they can. And with these two specific goals in their mind, they were having a hard time because they were taking this over-the-counter supplement. Within a short time later, I discovered an over-the-counter weight loss supplement containing an ingredient, tiratricol, toxic to the thyroid. The reporting of this to the federal agency, MedWatch, was instrumental in the nationwide seizure of the supplement thus avoiding a disaster to the public health and welfare. We published our findings in the peer- reviewed literature, being the first to do so.
This spurred on my interest in the field of men’s health, particularly in the field of testosterone and anabolic steroids. I recognized the use of a treatment for stopping anabolic steroids, both prescription and nonprescription, was without any scientific support. The accepted standard of care within the medical community for anabolic steroid- induced hypogonadism is to do nothing with the expectation the individual will return to normal unassisted. This is proving not to be the case and now jeopardizes the health and welfare of countless individuals.
I developed a treatment for anabolic steroid-induced hypogonadism that has been published and presented before the Endocrine Society, the American Association of Clinical Endocrinologists, American College of Sports Medicine, and the International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. The condition of anabolic steroid-induced hypogonadism is found in nonprescription and prescription AAS alike. The failure of the medical community to recognize the importance of anabolic steroid-induced hypogonadism, particularly in the research setting, is the focus of my recently published book, “Anabolic Steroids—A Question of Muscle: Human Subject Abuses in Anabolic Steroid Research.”
NV: There are lots of misconceptions when it comes to testosterone replacement in men. Will you tell us, in your opinion, what are the main misconceptions? For instance, some doctors may think that giving testosterone to somebody with low testosterone may affect the liver, or may cause cancer of the liver or prostate.
MS: There are many misconceptions regarding anabolic steroids, which include testosterone. You mentioned two of the areas: liver and prostate cancer. Other areas are enlargement of the prostate or benign prostate hypertrophy, anabolic steroid dependency, cardiovascular disease, and addiction.
I believe that many of the misconceptions come about by the politicization of anabolic steroids. As far as prescribed medicines are concerned, anabolic steroids are the only group of drugs with a law specifically aimed at their use. This has led to a lack or absence of good research. Instead, what the medical community has relied on are anecdotal and inflammatory reports.
This is probably most evident in the medical community’s steadfast refusal to accept that anabolic steroids increase muscle mass and strength. We now know that anabolic steroids conclusively do increase muscle mass and strength and athletic performance.
As far as liver effects, use of the oral anabolic steroids has been reported to cause liver dysfunction and cancer. These reports are primarily in individuals with a preexisting condition treated for extended periods. The intramuscular injections and transdermal preparations do not appear to be associated with liver problems, and routine monitoring is therefore unnecessary. In the thousands of patients I have treated with testosterone, I never even think about liver problems being a contraindication, because they just do not come up.
In non-obstructive benign prostatic hyperplasia (BPH), testosterone replacement therapy is not a concern. The prostate volumes increase in an inconsistent manner. As with any treatment, careful monitoring will alert one to a problem.
As far as prostatic cancer, there is no association. In 2004, a New England Journal of Medicine article review of over 60 studies on testosterone replacement therapy concluded that there is no causal or association with prostate cancer.
NV: But testosterone replacement seems to be getting more and more mainstream. Ever since the introduction of gels like Androgel and Testim, more and more doctors feel comfortable prescribing testos- terone. But yet, there are still a lot of fears, too. Another fear is changes in lipids and cardiovascular risks associated with testosterone. Can you expand on that a little?
MS: The available data indicate that testosterone replacement therapy within the physiologic range by transdermal or injectable testosterone preparation is not associated with worsening of the lipid profile. Studies using physiologic replacement doses of testosterone show no change, or only a slight decrease, in HDL, often with a reduction in total cholesterol. The oral non-aromatizable anabolic steroids appear to lower high-density lipoprotein (HDL) levels.
The belief that testosterone is a risk factor for cardiac disease is based on the observation that men have both a higher incidence of cardiovascular events and higher testosterone levels than women do. There is little data for this idea. Many studies suggest the opposite. There are multiple studies showing a relation between hypogonadism and an increased cardiovascular risk.
There is evidence that testosterone replacement therapy may be beneficial for men with cardiac disease. In a small study, men with chronic stable angina who were treated with transdermal testosterone replacement therapy had greater angina free exercise tolerance. Importantly, testosterone replacement therapy has not shown an increased incidence of cardiovascular disease or stroke.
NV: There are some data on hypogonadism and increased risks of cardiovascular events. Is that what you mean? Some people actually become so severely hypogonadal, they actually may be risking higher incidence of heart attacks and strokes?
MS: That is correct. There are numerous studies demonstrating the rela- tionship between low testosterone levels and adverse cardiovascular events, as well as stroke. Also, there are case study reports of people who stop anabolic steroids, and then suffer a heart attack.
In the book that I wrote, one of the studies in the published literature, looking at the effects of anabolic steroids in certain populations, for 12 weeks, did not look at the patients after they stopped the drug. If you want to look at the effects of these drugs, you need to see what happens when you stop them. I filed a Freedom of Information Act to obtain the patient records. One of the patients actually suffered a heart attack within four weeks of stopping the anabolic steroid. The details, including the original patient records, of this case are reported in my book.
NV: Should patients with an increased or elevated prostatic specific antigen (PSA) avoid testosterone? What role does testosterone replacement therapy (TRT) have on prostate cancer, if any? Is there a risk of worsening prostate cancer with TRT?
MS: You brought up a number of important and controversial issues. It is generally agreed that TRT with established prostate cancer is contraindicated.
It is known that suppression of testosterone levels causes regression of prostate cancer, and it is now commonplace for men with metastatic prostate cancer to undergo treatment designed to lower testosterone levels. The question becomes if lowering testosterone causes prostate cancer to regress, does elevating testosterone cause prostate cancer to appear?
There are case reports suggesting that TRT may convert an occult cancer into a clinically apparent lesion. These studies are wrong. One must be very careful in attributing causality to testosterone, since over 200,000 men are given a diagnosis of prostate cancer each year, and most of these cases are first detected by a rise in the PSA level unrelated to testosterone therapy. Studies have demonstrated a low frequency of prostate cancer in association with TRT. Despite extensive research, there is no compelling evidence that testosterone has a causative role in prostate cancer.
There appears to be no compelling evidence at present to suggest that men with higher testosterone levels are at greater risk of prostate cancer or treating men who have hypogonadism with exogenous androgens increases this risk. In fact, prostate cancer becomes more prevalent exactly at the time of a man’s life when testosterone levels decline.
Little evidence exists on the safety of TRT initiation after treatment for primary prostate cancer. In one very small case series, TRT after treatment of organ confined prostate cancer produced no adverse effects. There are no large, long-term studies proving that the risk of recurrence is not affected by TRT. Personally, I would be reluctant to provide TRT in prostate cancer; treatment should be left to strict research protocols.
PSA is a serum glycoprotein made by the normal prostate that is widely used as a tumor marker, because elevated PSA levels correlate with the risk of prostate cancer. A PSA value greater than 4.0 ng/mL has been the standard indication for prostate biopsy since the introduction of this test in the 1980s.
Testosterone trials have inconsistently shown a rise in PSA, typically between 0.2 and 0.5 ng/mL. A greater increase in PSA arouses concern that prostate cancer has developed. It is my practice to recommend a prostate biopsy in any patient with a yearly PSA increase of 1.0 ng/mL or more. If the PSA level increases by 0.75 ng/mL in one year, I repeat the PSA measurement in three to six months and recommend a biopsy if there is any further increase.
Interview with Dr. Michael Scally about Testosterone and Its Side Effects- Part 2
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