Low T: Separating Fact from Frenzy

Low T: Separating Facts From Frenzy | MedShadow
http://medshadow.org/features/low-t-separating-facts-from-frenzy/[2014-03-08, 8:37:13 AM]
Low T: Separating Facts From Frenzy
By Jane Langille
Two new studies suggest millions
of men may be risking a heart
attack, stroke or premature death
by using testosterone
replacement therapy. Based on
these studies, the FDA issued a
safety announcement on January 31, 2014, saying that they are conducting
an investigation and cautioning health-care professionals to carefully weigh
the pros and cons of testosterone medications before writing prescriptions.
The news is surprising, and the media frenzy has added fuel to the flames
of what one men’s health expert has called “hormonophobia.”
So should you or someone you care about be using testosterone
replacement therapy? The short answer is maybe, if it really is low T, and
after a careful assessment of total health. MedShadow took a close look at
the new studies and spoke to two men’s health experts to separate the
facts from the frenzy.
The testosterone replacement market
The overall market for testosterone replacement drugs was worth about $2
billion in 2012 and is projected to grow to $5 billion in 2015. The FDA-
approved products include a topical gel, transdermal patch, buccal system
(an adhesive, tablet-shaped patch applied to the upper gum or inner
cheek) and injection delivery formats.
Available only by prescription, testosterone drugs are approved for use in
men who have low testosterone (low T) and an associated medical
condition, such as a failure of the testicles to produce testosterone due to
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chemotherapy, genetic problems, or conditions affecting the hypothalamus
and pituitary gland, the brain structures responsible for controlling
testosterone production by the testicles.
How many men have low T?
Testosterone levels decline with age, starting when a man is in his 30s, but
the incidence of low T varies depending the source. The FDA estimates that
4 to 5 million American men have low T, also called testosterone deficiency,
but that only about 5 percent are treated. One U.S. study in 2006 found a
rate of 39 per cent among 2,162 men age 45 and older, classifying men as
having low T if their total T level was below 300 ng/dL (nanograms per
deciliter). Scaling that incidence rate up to the general population would
mean that 13.8 million men might have low T. The researchers also found
that for every 10-year increase in age, the risk of testosterone deficiency
increased by 17 percent.
Symptoms of low testosterone
Low libido or erectile dysfunction are hallmark indications, but only some
men with testosterone deficiency will have symptoms. The Endocrine
Society’s Clinical Practice Guideline for Testosterone Therapy in Adult Men
provides an overview of signs and symptoms:
More specific signs and symptoms of low T:
Incomplete or delayed development of sexual characteristics
Reduced libido and activity
Decreased spontaneous erections, decreased ability to maintain
erections
Breast discomfort from gynecomastia (swollen breast tissue)
Loss of axillary and pubic hair, reduced shaving
Very small or shrinking testes
Low sperm count
Loss of height, low-trauma fracture, low bone mineral density
Hot flushes, sweats
Less specific signs and symptoms of low T:
Decreased motivation, energy and self-confidence
Depressed mood
Poor concentration and memory
Sleep disturbances
Mild anemia
Reduced muscle mass and strength
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Increased body fat and body mass index (BMI)
Decreased physical performance
The benefits of testosterone replacement therapy
The health benefits of testosterone replacement therapy go beyond
improving sexual function. Correcting testosterone deficiency can increase
lean muscle mass, decrease body fat, and improve bone density, blood
sugar, energy levels and mood.
Dr. Abraham Morgentaler, a urologist at Harvard Medical School who has
been treating men with low T for more than 20 years, and director of Men’s
Health Boston, says in his book Testosterone for Life that many men who
are originally referred to him for some form of sexual dysfunction, report that
they experience improvements in mood and energy levels, their partners
find them less irritable and their workouts at the gym are improved.
Testing 1-2-T
Filling out an online checklist at a drug manufacturer’s website is not
sufficient to diagnose testosterone deficiency, though it may encourage
men to speak to their doctors about symptoms. Blood work is needed to
determine actual hormone levels, and this test must be separately
requested in addition to the usual blood work for an annual health
screening.
The trouble, though, is that there is no medical consensus on the level of
testosterone that indicates a need for treatment and different labs use
different ranges to define ‘normal.’ The Endocrine Society states that the
threshold level to decide if therapy will address symptoms is not known, but
that men are more likely to be symptomatic below a total T level of ~300
ng/dL. Dr. Morgentaler (@DrMorgentaler)says men are likely to be
experiencing symptoms when total T is less than 350 ng/dL. Dr. Florence
Comite, an endocrinologist practicing precision medicine for age
management at ComiteMD (@ComiteMD) in New York, considers a total T
below 350 ng/dL to be worthy of further investigation and says that men are
usually symptomatic when total T is less than 280 ng/dL.
Importantly, both experts agree that looking at total testosterone is not
enough. “Lots of physicians are fooled by just looking at total T. They
should also look at free T, because most testosterone is bound up with a
protein called SHGB and is not biologically available to bind to receptor
sites,” says Dr. Comite. She advises that free T should fall within 150-250
pg/mL (picograms per milliliter), but the ranges and the calculation

methods vary, so ask your doctor to explain your results. Another important
consideration: “Men may be symptomatic at different levels of decline,
depending on what was normal for them in their earlier years,” says Comite.
It May or May Not Be Low T
Testosterone levels can provide insight about a man’s health, but it’s
important for doctors to look at a patient’s full health picture. Many signs
and symptoms of low T can be associated with other health conditions,
including erectile dysfunction, obesity, metabolic syndrome (a cluster of
cardiovascular risk factors), type 2 diabetes and depression. The odds of
having low T is significantly higher for men with high blood pressure,
elevated blood fats, diabetes, obesity, prostate disease and asthma or
chronic obstructive pulmonary disease than it is among men without those
conditions. A complete health evaluation is the only way to confirm each
individual’s precise challenges and underlying conditions.
Side Effects of Testosterone Therapy
Increased red blood cell count: The National Institute of
Health’s Medline notes that the average range for males
is 4.7 to 6.1 million cells per microliter (cells/mcL) while
Dr. Comite cites 5.1 million cells per microliter as high in
her patient examples.
Gynecomastia
Prostate enlargement
Serious health risks for children and women
Consider the example of veteran Livingston A. Miller Sr., a personal trainer
who was experiencing a lack of energy, frequent fainting episodes that
resulted in trips to the ER, symptoms of frequent urination and thirst, and
had abdominal fat that was hard to shake in spite of a diligent fitness
program. He consulted Dr. Comite when he was 52, after a VA medical
center was unable to find any health issues. Dr. Comite discovered he was
diabetic, had suffered a silent heart attack and also had low T.
She designed a personalized treatment plan to address his total health,
including shifting his workouts to focus more on cardiovascular fitness, a
better diet to get his blood sugar in control and testosterone therapy. As a

result, Miller dropped 30 pounds, trimmed excess abdominal fat, reversed
the diabetes, and improved his heart function. Now 61, he is still taking
testosterone therapy as part of his overall health maintenance plan and
continues to work as an energetic fitness trainer, free of diabetes and heart
problems.
Side Effects of Testosterone Therapy
Testosterone therapy may help improve the health of men with testosterone
deficiency, but there are some side effects that need to be carefully
considered and monitored.
Increased red blood cell count. Since testosterone therapy can trigger
an increase in the number of red blood cells, it’s important to measure
hematocrit and hemoglobin levels in follow up blood tests at least
within three months of starting medication and at regular intervals. Left
unchecked, a high red blood cell count can lead to blood clots and a
risk of stroke.
Gynecomastia. Breast tingling or enlarged breasts may occur if some
testosterone converts to estrogen. This can be addressed by lowering
the dose, switching from a skin delivery system to an injection format,
or by taking another drug called an aromatase inhibitor, which can
block the conversion.
Prostate enlargement. Testosterone therapy can spur prostate
enlargement, leading to benign prostate hyperplasia. PSA tests
should be done at regular intervals to monitor reactions to therapy.
Studies have been unable to confirm a link between prostate cancer
and testosterone therapy.
Serious health risks for children and women. AndroGel and Testim gel
have carried FDA-mandated black-box warnings since 2009 in
response to reports of worrying adverse effects in children who were
exposed to the products. Children who have contact with the products
can show early signs and symptoms of puberty, including an
enlarged penis or clitoris; early development of pubic hair; increased
erections or sex drive; and aggressive behavior. For women,
testosterone contact may produce changes in body hair and a large
increase in acne, and can seriously harm an unborn or breast-feeding
baby. The medication guide contains specific instructions for
application and what to do if accidental contact occurs. Switching to
another drug format can reduce these risks.
The Facts Behind the Frenzy About Cardiovascular Risks
The FDA announcement was based on two recent studies, which were both

observational, retrospective studies that compared historical data for
prescriptions filled with historical data about adverse cardiovascular events.
Neither study measured testosterone levels to confirm that the men actually
took the drug, or if their testosterone levels changed, during the time period
tracked. Neither study was a prospective, randomized, controlled trial, so
no causal link can be concluded from the findings.
Dr. Morgentaler, the original men’s health expert who coined the term ‘low
T’ long before it was co-opted by drug companies, says, “The overall
increased reported risk in both studies is very small. People have looked at
cardiovascular risks with testosterone in over 200 studies over 20 years.
This is not a brand-new field. Nor did these studies provide some
fantastical new and powerful way of looking at this topic. For that reason I’m
surprised and somewhat dismayed at some of the comments that have
been made about this. I think that the reason that these two relatively weak,
highly statistical retrospective studies have generated so much media
attention is because they tap into the hormonophobia that we last saw
around women and hormones.”
PLOS ONE: Increased Risk of Non-Fatal Myocardial Infarction
Following Testosterone Therapy Prescription in Men. Finkle WD, et al.,
January 29, 2014, DOI: 10.1371/journal.pone.0085805.
JAMA: Association of Testosterone Therapy with Mortality, Myocardial
Infarction, and Stroke in Men with Low Testosterone Levels. Vigen, R.
et al. November 6 2013, correction January 15, 2014; 310(17):1829-
1836. doi:10.1001/jama.2013.280386.
Both studies have serious drawbacks in how they were designed and how
conclusions were drawn. Neither study provides the quality of evidence that
we should expect to inform medical decisions. A further issue is that the
JAMA paper was corrected since original publication, so many mainstream
media outlets ran with stories based on incorrect original language that
presented figures as absolute rates of occurrence. Refer to our blog post,
The Low T Story: Hunting for the Truth, to read in depth about the
drawbacks of each study and how it can be difficult to draw fair
conclusions from retrospective, observational studies, especially when they
rely on high-level statistical calculations.
On the bright side, there may be more reliable information soon. The
National Institute of Aging and collaborating partners are currently
conducting The Testosterone Trial in Older Men, a randomized, placebo-
controlled prospective trial among 800 older men with low T levels.

Researchers at 12 sites across the U.S. are studying whether testosterone
treatment (AndroGel) results in favorable changes in physical function,
sexual function, vitality, cognition and anemia as well as cardiovascular risk
factors and bone mineral density. The study began in November 2009 and
completion is expected by July 2015. As a randomized controlled trial
among men using testosterone therapy who will have blood work and other
health variables tracked as the study progresses, this approach promises to
deliver the quality of evidence needed to make informed medical decisions.
In the meantime, The Endocrine Society is advising doctors to discuss
potential risks of adverse cardiovascular events with patients and to
continue monitoring patients carefully. Patients who have been using
testosterone therapy should not stop their medication without consulting
their health-care provider. Side effects from prescription testosterone
products should continue to be reported to the FDA MedWatch program.
Additional Reading
Testosterone for Life: Recharge Your Vitality, Sex Drive, Muscle Mass
& Overall Health by Abraham Morgentaler, MD, associate clinical
professor of urology, Beth Israel Deaconess Medical Center, Harvard
Medical School and director of Men’s Health Boston.
Keep It Up: The Power of Precision Medicine to Conquer Low T and
Revitalize Your Life By Florence Comite, MD, endocrinologist
practicing precision medicine at ComiteMD in New York City.
Testosterone Information
Testosterone Therapy for Men – Medline Plus
Testosterone Topical Gel – Medline Plus
Testosterone Buccal System – Medline Plus
Stephen Colbert Weighs in on Low-T Medication
Low-T & Low-O
Cheating Death – Low T
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Testosterone Usage Soars: When Doctors Relent to Patient…
The Low T Story: Hunting for the Truth
5 Ideas to Make Prescription Drugs Safer
Cholesterol Management – Statins

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Last updated: March 8, 2014
Copyright © 2014. MedShadow Foundation. All rights reserved. | Terms and Conditions
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Bio Latest Posts
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Jane Langille is a health and medical writer based near
Toronto, Ontario. Jane writes about health news and
medical innovations for media publications and health
care providers
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The Low T Story: Hunting for the Truth | MedShadow
http://medshadow.org/medshadow_blog/low-t-story-hunting-truth/[2014-03-08, 8:42:56 AM]


By Jane Langille
March 6, 2014
Truth and things that sound like
the truth are not the same,
especially for health news moving
at the speed of the Internet. It can
be pretty easy to believe stories in
major media publications where
studies from reputable journals
are cited.
While I was researching Low T: Separating Facts From Frenzy, I read many
stories about the testosterone therapy news, like these at The New York
Times, NPR, Los Angeles Times, Yahoo! Health and The Wall Street
Journal.
The news about low T caught fire recently when two new studies suggested
that millions of men may be risking a heart attack, stroke or premature
death by using testosterone replacement therapy. Both studies were
observational and retrospective, so I knew that any headlines or editorials
suggesting a causal link were just click bait. Reputable outlets were careful
to not overstep there.
Dr. Abraham Morgentaler, one of my story sources, took me through each
study, confirming my issues and pointing out several more. He is Director of
Men’s Health Boston and an Associate Clinical Professor of Urology at
Harvard Medical School, Beth Israel Deaconess Medical Center. He
lectures nationally and internationally, teaching physicians the latest
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information about the diagnosis and treatment of conditions affecting men’s
sexual and reproductive health. He is also the men’s health expert who
originally coined the term “low T” many years ago, long before it was co-
opted by drug manufacturers.
It takes much longer than 90 days to develop atherosclerosis
that leads to a heart attack. “Looking at events within three
months of data is an unusually short period of time to evaluate
cardiovascular risk. It takes many years to develop enough
atherosclerosis in the coronary arteries to produce a heart
attack,” says Dr. Morgentaler.
In the most recent study, published in the peer-reviewed journal PLOS ONE
on January 29, 2014, researchers looked at prescription data and health
records. The study compared heart attack rates in 55,593 middle-aged and
older men with a total T level below 300 ng/dL in the 90 days following their
first testosterone prescription with rates during the year before they
received the first prescription. Researchers reported that within 90 days,
men age 65 and older taking testosterone therapy showed more than
double the incidence of heart attack compared to a comparison group
taking erectile dysfunction drugs and state that the risk was nearly tripled
for younger men with existing heart disease.
Here are the issues with the study:
There is no way to know if the men actually took the drug or if
their levels of testosterone changed or normalized over the time
period evaluated. The study data came from insurance information,
not clinical blood work. Researchers looked at rates of heart attack in
men with low T levels, defined as less than 300 ng/dL at the
beginning of the study period and then compared reported rates for
heart attacks. To their credit, the study authors do state in the
discussion section: “We were also unable to examine whether this
excess (elevated heart attack rates) was related to indications such as
level of serum testosterone or hypogonadism,” but you have to read
carefully to find it.
There is no control group, i.e. a group who did not take
testosterone therapy. The study authors compared cardiovascular
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events for men who filled testosterone prescriptions with men who
filled erectile dysfunction prescriptions. “I think this is nonsensical,”
says Dr. Morgentaler. “This would be like taking men with diabetes
and looking at the effect of one of the agents to lower blood sugar,
and comparing it to men with COPD and treating them with a COPD
respiratory medicine, and claiming that one represents an adequate
comparison group to the other. You’re changing every variable with
the two comparisons.” Indeed, a ‘comparison’ group is not the same
as a ‘control’ group. Not by a long shot. Yet this post on in the Los
Angeles Times says, “Men in both of those two groups tend to be of
similar age, have similar health problems and complain of similar
symptoms, and so are comparable.”
It takes much longer than 90 days to develop atherosclerosis that
leads to a heart attack. “Looking at events within three months of
data is an unusually short period of time to evaluate cardiovascular
risk. It takes many years to develop enough atherosclerosis in the
coronary arteries to produce a heart attack,” says Dr. Morgentaler.
The researchers tracked patient data longer but did not report
findings for other follow-up time periods. Why not? What were the
heart attack rates at a 6-month or 12-month interval? Why did they not
compare a 12-month period to a 12-month period?
The overall rate of increase in the heart attack rate is actually very
small. Taking the figures in Table 1 of the study, the actual difference
in heart attack rates between the testosterone prescription group and
the no prescription group is 1.27 per 1,000 person years. If we
assume the men live up to 85 years on average, that rate would mean
there would be about one more heart attack per three hundred person
years in the prescription group. The absolute numbers make for a far
less compelling story than reporting double and triple the risk. “So
when The New York Times editorial claims that this is a major public
health issue, I don’t know what they’re talking about,” says Dr.
Abraham Morgentaler, “I think that editorial was irresponsible.”
As with the PLOS ONE study, there is no way to know if the
men actually took the drug or if their levels of testosterone
changed or normalized over the time period evaluated.

The second study, originally published in the peer-reviewed journal JAMA
on November 6, 2013, looked at data for more than 8,000 veterans with low
testosterone (under 300 ng/dL). For a subgroup of 1,223 men who had
coronary angiography, a heart test, they tracked data about heart attacks,
strokes and death over a three-year period.
Here are the issues with this study:
The absolute rate of heart attacks was incorrectly reported in the
original paper and has since been revised. The original paper
published on November 6, 2013 said “the absolute rate of events was
19.9% in the no testosterone therapy group vs. 25.7% in the
testosterone therapy group, with an absolute risk difference of 5.8%
(95% CI, −1.4% to 13.1%) at 3 years. But those numbers were
actually rates after a complicated, high-level statistical analysis that
adjusted for 50 variables, not absolute rates. (Eureka! I had been
trying to calculate those percentages from the raw data provided to
no avail!) The paper was revised on January 15, 2014 to state that
those figures were “Kaplan-Meier estimated cumulative percentages
with events.” Many media outlets are not aware of this correction.
As with the PLOS ONE study, there is no way to know if the men
actually took the drug or if their levels of testosterone changed or
normalized over the time period evaluated.
The study authors do not explain how they calculate their
findings, which were based on a high-level statistical manipulation of
over 50 variables. A plain language explanation would help, because
if you add up the raw numbers provided, you end up with the
complete opposite result — a lower rate of heart attacks, strokes and
death for the testosterone prescription group compared to the no
prescription group.
1,132 men who had testosterone therapy prescribed after a heart
attack or stroke were excluded from the study data. Why were they
excluded? How would their results have changed the study findings?
“One of the dangers for the average educated reader, medical or
otherwise, is that these studies have now become so technical and
statistical that we’ve lost contact with whether something makes sense or
not,” says Dr. Morgentaler.

Share this:
I’m looking forward to see the results of the National Institute of Aging’s
study, The Testosterone Trial in Older Men. As a randomized, placebo-
controlled prospective trial among 800 older men, this study promises to
deliver the quality of evidence we need to make informed medical
decisions. The study is expected to be completed by July 2015.
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Last updated: March 7, 2014
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Breaking: The Low-T Story: Hunting for the Truth, Part 2 | MedShadow
http://medshadow.org/medshadow_blog/low-t-story-hunting-truth-part-2/[2014-04-06, 8:44:13 AM]

Breaking: The Low-T Story: Hunting for the Truth,
Part 2

By Jane Langille
March 31, 2014
In a startling new development
about the low-t therapy
controversy, more than 130
physicians and scientists and 7
professional societies from around
the world have determined that
the original Journal of the
American Medical Association
(JAMA) paper about increased cardiovascular risks for men taking
testosterone replacement therapy contains major errors and should be
retracted from the journal.
In addition to the issues detailed in my first post, the March 14, 2014
petition cites newly disclosed, glaring errors, and states that “the quality
and magnitude of these errors in values indicate gross data
mismanagement and contamination to a degree that the reported results
are no longer reliable.”
Here’s a synopsis of the background. The original JAMA paper was
published on November 13, 2013. On March 5, 2014, the journal published
several letters of criticism from leading testosterone experts including a first
response by Dr. Abraham Morgentaler, Associate Clinical Professor of
Urology at Harvard Medical School, Beth Israel Deaconess Medical Center
and Director of Men’s Health Boston.
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The journal also published the study authors’ correction, where they clarify
that the “30% increase in the risk of stroke, heart attack and death” for men
who had been prescribed testosterone therapy was not a raw figure, but
based on Kaplan-Meierestimates, a statistical manipulation of the data as
detailed in my earlier post, The Low T Story: Hunting for the Truth.
In the authors’ response to further criticism though, there were startling new
revelations that prompted testosterone experts around the world to call for
retraction of the entire paper.
The study authors say that they made an “incorrect notation” about the
numbers for two groups of men who were excluded from the study.
According to the petition signatories, this “incorrect notation” translates to
an 89% error rate in the number of men excluded from the study who
received a testosterone prescription after experiencing a heart attack or
stroke, and a 44% error rate in the group who were excluded due to
coronary anatomy irregularities.
Beyond those errors though, for me, this one takes the cake:
“Astonishingly, 100 women were now identified among the original group of
1,132 individuals, meaning that one out of eleven “men” in the study were
actually women.” Dr. Morgentaler says to MedPage Today, “They found that
almost 10% were women in an all-male study, so why should we believe
any of the other data?”
Can you imagine Jon Stewart right now, saying “Whaaaaaaaat? No wonder
their T was low!”
“It’s dismaying since this paper came into field where people have looked
at cardiovascular risks with testosterone in over 200 studies over more than
20 years. The caliber of scholars and clinicians who have signed on this
petition for retraction is like nothing I’ve ever seen. It speaks to how strongly
these experts each believe the article represents false information and has
hurt the cause of medical science,” Dr. Morgentaler told me via email.
It will be interesting to see if and how swiftly this paper is retracted. For a
complete discussion about separating the facts from the frenzy, an
informative discussion of symptoms, side effects and correct testing for
testosterone deficiency in men, check out our feature story: Low T:
Separating Facts From Frenzy.
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More information:
Group Wants Testosterone Study Retracted – MedPage Today
World Experts and Androgen Study Group Petition JAMA to Retract
Misleading Article on Testosterone Therapy – PR Newswire
Incorrect Number of Excluded Patients Reported in the Text and
Figure – JAMA
Related Posts:
Early Alert on Side Effects from the Web

Last updated: April 4, 2014
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JAMA Refuses to Retract Paper on Testosterone Risks - MedShadow
http://medshadow.org/medshadow_blog/pressure-on-jama/[2014-05-25, 8:35:15 PM]

JAMA Refuses to Retract Paper on Testosterone
Risks

By Jane Langille
April 10, 2014
Pressure is mounting as 25
international societies have now
joined the Androgen Study
Group’s petition to the Journal of
the American Medical Association
(JAMA) to retract a misleading
paper about cardiovascular risks
for men taking testosterone
therapy. These professional societies, including the American Society for
Men’s Health, the International Society for Men’s Health and the
International Society for the Study of the Aging Male, are dedicated to
education and research in men’s health, endocrinology, andrology and
sexual medicine. By signing this petition, they join more than 160 leading
experts from 32 countries.
The press release says that a failure to retract amounts to “medical
literature malpractice.” “This is the first time in history a worldwide
community of distinguished researchers, scholars, and clinicians has united
to demand removal of a study from the literature,” stated Abraham
Morgentaler, Chairman of the Androgen Study Group, which submitted the
petition to JAMA. “This unprecedented action is a complete repudiation of
the false information published by JAMA that has harmed public health,
distorted medical science, and violated the trust between medical journals
and the consumer. Although science must always be open to new
information and ideas, the wholly unreliable data in this study by Vigen et
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Hunting for the Truth, Part 2
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al. categorizes these results as misinformation.”
For background, my first post outlined the major study errors not
recognized by mainstream media and my updated post detailed the original
petition by the Androgen Study Group on March 25, 2014. The original
petition outlined additional glaring errors in the testosterone study, such as
error rates ranging from 44-89%, and the mind-boggling disclosure that
one out of eleven “men” in the study were actually “women.”
Now, more bad news surfaces as more than two-dozen additional societies
add their names to the call for retraction. According to the press release,
JAMA sat on corrected results for two months before publishing the
correction that raw risk rates were actually complex, statistically
manipulated figures. “People find it hard to believe that JAMA would
publish a study in which the percentages of men who suffered an adverse
event was lower by half in men who received testosterone than untreated
men, yet results were reported as if the opposite were true, thanks to
absurdly complicated statistical manipulations of the data,” stated Andre
Guay, MD, Clinical Professor of Endocrinology at Tufts Medical School.
“Now we find out this is the gang that can’t shoot straight. In my 40 years in
medicine I’ve never before seen a paper that says, ‘Here are our data, give
or take a thousand individuals.’ There is nothing believable in this study.”
Why are all of the study errors significant? Because misinformation can lead
to damages for both patients and doctors.
In the press release, Mohit Kera, MD, Associate Professor of Urology at
Baylor Medical College, states, “This article has caused enormous damage.
This article created an unfounded negative perception of testosterone
therapy. Physicians discontinued treatment for men who were benefitting
from treatment. It harmed physician-patient relations, as patients ask why
their physicians placed their health at risk. And a new field of medical
malpractice has sprung up overnight, with plaintiff attorneys in the US
advertising nationwide for patients who suffered a stroke or heart attack
after receiving testosterone. And it’s all based on pure nonsense.”
Litigation is certainly springing up quickly. A mere four days after the FDA’s
safety announcement in January, 5 men filed a lawsuit in federal court in
Chicago, where four claim they experienced heart attacks and one says he
had a stroke after taking AndroGel. A petition to consolidate federal
AndroGel lawsuits in Illinois was filed just this week.
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“JAMA has been complicit in creating a media frenzy regarding false risks,
and is directly responsible for the new wave of medical malpractice cases
against physicians. For the good of consumers, physicians, and science,
JAMA should retract the article before it causes even more harm,
accompanied by a letter explaining how its editorial process failed and
steps taken to correct it,” stated Dr. Morgentaler.
How long will it take JAMA to respond? JAMA has not answered my request
for comment and Dr. Morgentaler tells me that JAMA has not responded
directly to the petition. He says their first response to journalists a few
weeks ago was that they were not retracting the study but more recently
indicated they were considering it.
Time will tell if JAMA responds to the stiff opposition from this
unprecedented action. *UPDATE: JAMA responded to my request for
comment, saying that they are declining to retract and confirming that it is
rare for JAMA to retract any papers: “It depends on the circumstances, but
there is a thoughtful review by several editors and follow up with the lead
author of the paper. This group wrote to us on March 25, and JAMA is
declining to retract.”
In the meantime, if you or someone you care about is considering using
testosterone therapy, find a complete discussion about considerations and
links to additional resources in my feature story, Low T: Separating Facts
From Frenzy.
Additional Information:
• Twenty-Five Medical Societies Join Androgen Study Group to Petition
JAMA to Retract Misleading Testosterone Study – PR Newswire
Related Posts:
Update: The Low-T Story: Hunting for the Truth, Part 2
How many middle-aged men need HRT?
Jane Langille

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Last updated: April 16, 2014
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