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Low T: Separating Facts From Frenzy
By Jane Langille
Two new studies suggest millionsof men may be risking a heartattack, stroke or premature deathby using testosteronereplacement therapy. Based onthese studies, the FDA issued a
safety announcement on January 31, 2014, saying that they are conductingan investigation and cautioning health-care professionals to carefully weighthe pros and cons of testosterone medications before writing prescriptions.
The news is surprising, and the media frenzy has added fuel to the flamesof what one men’s health expert has called “hormonophobia.”
So should you or someone you care about be using testosteronereplacement therapy? The short answer is maybe, if it really is low T, andafter a careful assessment of total health. MedShadow took a close look atthe new studies and spoke to two men’s health experts to separate thefacts from the frenzy.
The testosterone replacement marketThe overall market for testosterone replacement drugs was worth about $2billion 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 innercheek) and injection delivery formats.
Available only by prescription, testosterone drugs are approved for use inmen who have low testosterone (low T) and an associated medicalcondition, such as a failure of the testicles to produce testosterone due to
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chemotherapy, genetic problems, or conditions affecting the hypothalamusand pituitary gland, the brain structures responsible for controllingtestosterone production by the testicles.
How many men have low T?Testosterone levels decline with age, starting when a man is in his 30s, butthe incidence of low T varies depending the source. The FDA estimates that4 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 arate of 39 per cent among 2,162 men age 45 and older, classifying men ashaving low T if their total T level was below 300 ng/dL (nanograms perdeciliter). Scaling that incidence rate up to the general population wouldmean that 13.8 million men might have low T. The researchers also foundthat for every 10-year increase in age, the risk of testosterone deficiencyincreased by 17 percent.
Symptoms of low testosteroneLow libido or erectile dysfunction are hallmark indications, but only somemen with testosterone deficiency will have symptoms. The EndocrineSociety’s Clinical Practice Guideline for Testosterone Therapy in Adult Menprovides an overview of signs and symptoms:
More specific signs and symptoms of low T:Incomplete or delayed development of sexual characteristicsReduced libido and activityDecreased spontaneous erections, decreased ability to maintainerectionsBreast discomfort from gynecomastia (swollen breast tissue)Loss of axillary and pubic hair, reduced shavingVery small or shrinking testesLow sperm countLoss of height, low-trauma fracture, low bone mineral densityHot flushes, sweats
Less specific signs and symptoms of low T:Decreased motivation, energy and self-confidenceDepressed moodPoor concentration and memorySleep disturbancesMild anemiaReduced muscle mass and strength
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Increased body fat and body mass index (BMI)Decreased physical performance
The benefits of testosterone replacement therapyThe health benefits of testosterone replacement therapy go beyondimproving sexual function. Correcting testosterone deficiency can increaselean muscle mass, decrease body fat, and improve bone density, bloodsugar, energy levels and mood.
Dr. Abraham Morgentaler, a urologist at Harvard Medical School who hasbeen treating men with low T for more than 20 years, and director of Men’sHealth Boston, says in his book Testosterone for Life that many men whoare originally referred to him for some form of sexual dysfunction, report thatthey experience improvements in mood and energy levels, their partnersfind them less irritable and their workouts at the gym are improved.
Testing 1-2-TFilling out an online checklist at a drug manufacturer’s website is notsufficient to diagnose testosterone deficiency, though it may encouragemen to speak to their doctors about symptoms. Blood work is needed todetermine actual hormone levels, and this test must be separatelyrequested in addition to the usual blood work for an annual healthscreening.
The trouble, though, is that there is no medical consensus on the level oftestosterone that indicates a need for treatment and different labs usedifferent ranges to define ‘normal.’ The Endocrine Society states that thethreshold level to decide if therapy will address symptoms is not known, butthat men are more likely to be symptomatic below a total T level of ~300ng/dL. Dr. Morgentaler (@DrMorgentaler)says men are likely to beexperiencing symptoms when total T is less than 350 ng/dL. Dr. FlorenceComite, an endocrinologist practicing precision medicine for agemanagement at ComiteMD (@ComiteMD) in New York, considers a total Tbelow 350 ng/dL to be worthy of further investigation and says that men areusually symptomatic when total T is less than 280 ng/dL.
Importantly, both experts agree that looking at total testosterone is notenough. “Lots of physicians are fooled by just looking at total T. Theyshould also look at free T, because most testosterone is bound up with aprotein called SHGB and is not biologically available to bind to receptorsites,” says Dr. Comite. She advises that free T should fall within 150-250pg/mL (picograms per milliliter), but the ranges and the calculation
Low T: Separating Facts From Frenzy | MedShadow
http://medshadow.org/features/low-t-separating-facts-from-frenzy/[2014-03-08, 8:37:13 AM]
methods vary, so ask your doctor to explain your results. Another importantconsideration: “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 TTestosterone levels can provide insight about a man’s health, but it’simportant for doctors to look at a patient’s full health picture. Many signsand symptoms of low T can be associated with other health conditions,including erectile dysfunction, obesity, metabolic syndrome (a cluster ofcardiovascular risk factors), type 2 diabetes and depression. The odds ofhaving low T is significantly higher for men with high blood pressure,elevated blood fats, diabetes, obesity, prostate disease and asthma orchronic obstructive pulmonary disease than it is among men without thoseconditions. A complete health evaluation is the only way to confirm eachindividual’s precise challenges and underlying conditions.
Side Effects of Testosterone TherapyIncreased red blood cell count: The National Institute ofHealth’s Medline notes that the average range for malesis 4.7 to 6.1 million cells per microliter (cells/mcL) whileDr. Comite cites 5.1 million cells per microliter as high inher patient examples.GynecomastiaProstate enlargementSerious health risks for children and women
Consider the example of veteran Livingston A. Miller Sr., a personal trainerwho was experiencing a lack of energy, frequent fainting episodes thatresulted in trips to the ER, symptoms of frequent urination and thirst, andhad abdominal fat that was hard to shake in spite of a diligent fitnessprogram. He consulted Dr. Comite when he was 52, after a VA medicalcenter was unable to find any health issues. Dr. Comite discovered he wasdiabetic, 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, abetter diet to get his blood sugar in control and testosterone therapy. As a
Low T: Separating Facts From Frenzy | MedShadow
http://medshadow.org/features/low-t-separating-facts-from-frenzy/[2014-03-08, 8:37:13 AM]
result, Miller dropped 30 pounds, trimmed excess abdominal fat, reversedthe diabetes, and improved his heart function. Now 61, he is still takingtestosterone therapy as part of his overall health maintenance plan andcontinues to work as an energetic fitness trainer, free of diabetes and heartproblems.
Side Effects of Testosterone TherapyTestosterone therapy may help improve the health of men with testosteronedeficiency, but there are some side effects that need to be carefullyconsidered and monitored.
Increased red blood cell count. Since testosterone therapy can triggeran increase in the number of red blood cells, it’s important to measurehematocrit and hemoglobin levels in follow up blood tests at leastwithin three months of starting medication and at regular intervals. Leftunchecked, a high red blood cell count can lead to blood clots and arisk of stroke.Gynecomastia. Breast tingling or enlarged breasts may occur if sometestosterone converts to estrogen. This can be addressed by loweringthe dose, switching from a skin delivery system to an injection format,or by taking another drug called an aromatase inhibitor, which canblock the conversion.Prostate enlargement. Testosterone therapy can spur prostateenlargement, leading to benign prostate hyperplasia. PSA testsshould be done at regular intervals to monitor reactions to therapy.Studies have been unable to confirm a link between prostate cancerand testosterone therapy.Serious health risks for children and women. AndroGel and Testim gelhave carried FDA-mandated black-box warnings since 2009 inresponse to reports of worrying adverse effects in children who wereexposed to the products. Children who have contact with the productscan show early signs and symptoms of puberty, including anenlarged penis or clitoris; early development of pubic hair; increasederections or sex drive; and aggressive behavior. For women,testosterone contact may produce changes in body hair and a largeincrease in acne, and can seriously harm an unborn or breast-feedingbaby. The medication guide contains specific instructions forapplication and what to do if accidental contact occurs. Switching toanother drug format can reduce these risks.
The Facts Behind the Frenzy About Cardiovascular RisksThe FDA announcement was based on two recent studies, which were both
Low T: Separating Facts From Frenzy | MedShadow
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observational, retrospective studies that compared historical data forprescriptions filled with historical data about adverse cardiovascular events.Neither study measured testosterone levels to confirm that the men actuallytook the drug, or if their testosterone levels changed, during the time periodtracked. Neither study was a prospective, randomized, controlled trial, sono causal link can be concluded from the findings.
Dr. Morgentaler, the original men’s health expert who coined the term ‘lowT’ long before it was co-opted by drug companies, says, “The overallincreased reported risk in both studies is very small. People have looked atcardiovascular risks with testosterone in over 200 studies over 20 years.This is not a brand-new field. Nor did these studies provide somefantastical new and powerful way of looking at this topic. For that reason I’msurprised and somewhat dismayed at some of the comments that havebeen made about this. I think that the reason that these two relatively weak,highly statistical retrospective studies have generated so much mediaattention is because they tap into the hormonophobia that we last sawaround women and hormones.”
PLOS ONE: Increased Risk of Non-Fatal Myocardial InfarctionFollowing 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, MyocardialInfarction, 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 howconclusions were drawn. Neither study provides the quality of evidence thatwe should expect to inform medical decisions. A further issue is that theJAMA paper was corrected since original publication, so many mainstreammedia outlets ran with stories based on incorrect original language thatpresented figures as absolute rates of occurrence. Refer to our blog post,The Low T Story: Hunting for the Truth, to read in depth about thedrawbacks of each study and how it can be difficult to draw fairconclusions from retrospective, observational studies, especially when theyrely on high-level statistical calculations.
On the bright side, there may be more reliable information soon. TheNational Institute of Aging and collaborating partners are currentlyconducting The Testosterone Trial in Older Men, a randomized, placebo-controlled prospective trial among 800 older men with low T levels.
Low T: Separating Facts From Frenzy | MedShadow
http://medshadow.org/features/low-t-separating-facts-from-frenzy/[2014-03-08, 8:37:13 AM]
Researchers at 12 sites across the U.S. are studying whether testosteronetreatment (AndroGel) results in favorable changes in physical function,sexual function, vitality, cognition and anemia as well as cardiovascular riskfactors and bone mineral density. The study began in November 2009 andcompletion is expected by July 2015. As a randomized controlled trialamong men using testosterone therapy who will have blood work and otherhealth variables tracked as the study progresses, this approach promises todeliver the quality of evidence needed to make informed medical decisions.
In the meantime, The Endocrine Society is advising doctors to discusspotential risks of adverse cardiovascular events with patients and tocontinue monitoring patients carefully. Patients who have been usingtestosterone therapy should not stop their medication without consultingtheir health-care provider. Side effects from prescription testosteroneproducts 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 clinicalprofessor of urology, Beth Israel Deaconess Medical Center, HarvardMedical School and director of Men’s Health Boston.Keep It Up: The Power of Precision Medicine to Conquer Low T andRevitalize Your Life By Florence Comite, MD, endocrinologistpracticing precision medicine at ComiteMD in New York City.
Testosterone InformationTestosterone Therapy for Men – Medline PlusTestosterone Topical Gel – Medline PlusTestosterone Buccal System – Medline Plus
Stephen Colbert Weighs in on Low-T MedicationLow-T & Low-OCheating Death – Low T
Related Posts:Is testosterone the new estrogen?Testosterone Usage Soars: When Doctors Relent to Patient…The Low T Story: Hunting for the Truth5 Ideas to Make Prescription Drugs SaferCholesterol Management – StatinsHRT Increases Breast Cancer
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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]
The Low T Story: Hunting for the Truth By Jane Langille March 6, 2014
Truth and things that sound likethe truth are not the same,especially for health news movingat the speed of the Internet. It canbe pretty easy to believe stories inmajor media publications wherestudies from reputable journalsare cited.
While I was researching Low T: Separating Facts From Frenzy, I read manystories about the testosterone therapy news, like these at The New YorkTimes, NPR, Los Angeles Times, Yahoo! Health and The Wall StreetJournal.
The news about low T caught fire recently when two new studies suggestedthat millions of men may be risking a heart attack, stroke or prematuredeath by using testosterone replacement therapy. Both studies wereobservational and retrospective, so I knew that any headlines or editorialssuggesting a causal link were just click bait. Reputable outlets were carefulto not overstep there.
Dr. Abraham Morgentaler, one of my story sources, took me through eachstudy, confirming my issues and pointing out several more. He is Director ofMen’s Health Boston and an Associate Clinical Professor of Urology atHarvard Medical School, Beth Israel Deaconess Medical Center. Helectures nationally and internationally, teaching physicians the latest
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information about the diagnosis and treatment of conditions affecting men’ssexual and reproductive health. He is also the men’s health expert whooriginally 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 atherosclerosisthat leads to a heart attack. “Looking at events within threemonths of data is an unusually short period of time to evaluatecardiovascular risk. It takes many years to develop enoughatherosclerosis in the coronary arteries to produce a heartattack,” says Dr. Morgentaler.
In the most recent study, published in the peer-reviewed journal PLOS ONEon January 29, 2014, researchers looked at prescription data and healthrecords. The study compared heart attack rates in 55,593 middle-aged andolder men with a total T level below 300 ng/dL in the 90 days following theirfirst testosterone prescription with rates during the year before theyreceived the first prescription. Researchers reported that within 90 days,men age 65 and older taking testosterone therapy showed more thandouble the incidence of heart attack compared to a comparison grouptaking erectile dysfunction drugs and state that the risk was nearly tripledfor 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 iftheir levels of testosterone changed or normalized over the timeperiod evaluated. The study data came from insurance information,not clinical blood work. Researchers looked at rates of heart attack inmen with low T levels, defined as less than 300 ng/dL at thebeginning of the study period and then compared reported rates forheart attacks. To their credit, the study authors do state in thediscussion section: “We were also unable to examine whether thisexcess (elevated heart attack rates) was related to indications such aslevel of serum testosterone or hypogonadism,” but you have to readcarefully to find it.
There is no control group, i.e. a group who did not taketestosterone therapy. The study authors compared cardiovascular
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events for men who filled testosterone prescriptions with men whofilled erectile dysfunction prescriptions. “I think this is nonsensical,”says Dr. Morgentaler. “This would be like taking men with diabetesand 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 COPDrespiratory medicine, and claiming that one represents an adequatecomparison group to the other. You’re changing every variable withthe two comparisons.” Indeed, a ‘comparison’ group is not the sameas a ‘control’ group. Not by a long shot. Yet this post on in the LosAngeles Times says, “Men in both of those two groups tend to be ofsimilar age, have similar health problems and complain of similarsymptoms, and so are comparable.”
It takes much longer than 90 days to develop atherosclerosis thatleads to a heart attack. “Looking at events within three months ofdata is an unusually short period of time to evaluate cardiovascularrisk. It takes many years to develop enough atherosclerosis in thecoronary arteries to produce a heart attack,” says Dr. Morgentaler.The researchers tracked patient data longer but did not reportfindings for other follow-up time periods. Why not? What were theheart attack rates at a 6-month or 12-month interval? Why did they notcompare a 12-month period to a 12-month period?
The overall rate of increase in the heart attack rate is actually verysmall. Taking the figures in Table 1 of the study, the actual differencein heart attack rates between the testosterone prescription group andthe no prescription group is 1.27 per 1,000 person years. If weassume the men live up to 85 years on average, that rate would meanthere would be about one more heart attack per three hundred personyears in the prescription group. The absolute numbers make for a farless compelling story than reporting double and triple the risk. “Sowhen The New York Times editorial claims that this is a major publichealth 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 themen actually took the drug or if their levels of testosteronechanged or normalized over the time period evaluated.
The Low T Story: Hunting for the Truth | MedShadow
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The second study, originally published in the peer-reviewed journal JAMAon November 6, 2013, looked at data for more than 8,000 veterans with lowtestosterone (under 300 ng/dL). For a subgroup of 1,223 men who hadcoronary 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 theoriginal paper and has since been revised. The original paperpublished on November 6, 2013 said “the absolute rate of events was19.9% in the no testosterone therapy group vs. 25.7% in thetestosterone therapy group, with an absolute risk difference of 5.8%(95% CI, −1.4% to 13.1%) at 3 years. But those numbers wereactually rates after a complicated, high-level statistical analysis thatadjusted for 50 variables, not absolute rates. (Eureka! I had beentrying to calculate those percentages from the raw data provided tono avail!) The paper was revised on January 15, 2014 to state thatthose figures were “Kaplan-Meier estimated cumulative percentageswith events.” Many media outlets are not aware of this correction.
As with the PLOS ONE study, there is no way to know if the menactually took the drug or if their levels of testosterone changed ornormalized over the time period evaluated.
The study authors do not explain how they calculate theirfindings, which were based on a high-level statistical manipulation ofover 50 variables. A plain language explanation would help, becauseif you add up the raw numbers provided, you end up with thecomplete opposite result — a lower rate of heart attacks, strokes anddeath for the testosterone prescription group compared to the noprescription group.
1,132 men who had testosterone therapy prescribed after a heartattack or stroke were excluded from the study data. Why were theyexcluded? How would their results have changed the study findings?
“One of the dangers for the average educated reader, medical orotherwise, is that these studies have now become so technical andstatistical that we’ve lost contact with whether something makes sense ornot,” says Dr. Morgentaler.
The Low T Story: Hunting for the Truth | MedShadow
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I’m looking forward to see the results of the National Institute of Aging’sstudy, The Testosterone Trial in Older Men. As a randomized, placebo-controlled prospective trial among 800 older men, this study promises todeliver the quality of evidence we need to make informed medicaldecisions. The study is expected to be completed by July 2015.
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Breaking: The Low-T Story: Hunting for the Truth, Part 2 | MedShadow
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Breaking: The Low-T Story: Hunting for the Truth,Part 2 By Jane Langille March 31, 2014
In a startling new developmentabout the low-t therapycontroversy, more than 130physicians and scientists and 7professional societies from aroundthe world have determined thatthe original Journal of theAmerican Medical Association
(JAMA) paper about increased cardiovascular risks for men takingtestosterone replacement therapy contains major errors and should beretracted from the journal.
In addition to the issues detailed in my first post, the March 14, 2014petition cites newly disclosed, glaring errors, and states that “the qualityand magnitude of these errors in values indicate gross datamismanagement and contamination to a degree that the reported resultsare no longer reliable.”
Here’s a synopsis of the background. The original JAMA paper waspublished on November 13, 2013. On March 5, 2014, the journal publishedseveral letters of criticism from leading testosterone experts including a firstresponse by Dr. Abraham Morgentaler, Associate Clinical Professor ofUrology at Harvard Medical School, Beth Israel Deaconess Medical Centerand Director of Men’s Health Boston.
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The journal also published the study authors’ correction, where they clarifythat the “30% increase in the risk of stroke, heart attack and death” for menwho had been prescribed testosterone therapy was not a raw figure, butbased on Kaplan-Meierestimates, a statistical manipulation of the data asdetailed in my earlier post, The Low T Story: Hunting for the Truth.
In the authors’ response to further criticism though, there were startling newrevelations that prompted testosterone experts around the world to call forretraction of the entire paper.
The study authors say that they made an “incorrect notation” about thenumbers for two groups of men who were excluded from the study.According to the petition signatories, this “incorrect notation” translates toan 89% error rate in the number of men excluded from the study whoreceived a testosterone prescription after experiencing a heart attack orstroke, and a 44% error rate in the group who were excluded due tocoronary anatomy irregularities.
Beyond those errors though, for me, this one takes the cake:
“Astonishingly, 100 women were now identified among the original group of1,132 individuals, meaning that one out of eleven “men” in the study wereactually women.” Dr. Morgentaler says to MedPage Today, “They found thatalmost 10% were women in an all-male study, so why should we believeany of the other data?”
Can you imagine Jon Stewart right now, saying “Whaaaaaaaat? No wondertheir T was low!”
“It’s dismaying since this paper came into field where people have lookedat cardiovascular risks with testosterone in over 200 studies over more than20 years. The caliber of scholars and clinicians who have signed on thispetition for retraction is like nothing I’ve ever seen. It speaks to how stronglythese experts each believe the article represents false information and hashurt 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 acomplete discussion about separating the facts from the frenzy, aninformative discussion of symptoms, side effects and correct testing fortestosterone 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 TodayWorld Experts and Androgen Study Group Petition JAMA to RetractMisleading Article on Testosterone Therapy – PR NewswireIncorrect Number of Excluded Patients Reported in the Text andFigure – JAMA
Related Posts:The Low T Story: Hunting for the TruthTestosterone Usage Soars: When Doctors Relent to Patient…Is testosterone the new estrogen?Low T: Separating Facts From Frenzy5 Ideas to Make Prescription Drugs SaferHRT Increases Breast CancerEarly Alert on Side Effects from the Web
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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 TestosteroneRisks By Jane Langille April 10, 2014
Pressure is mounting as 25international societies have nowjoined the Androgen StudyGroup’s petition to the Journal ofthe American Medical Association(JAMA) to retract a misleadingpaper about cardiovascular risksfor men taking testosterone
therapy. These professional societies, including the American Society forMen’s Health, the International Society for Men’s Health and theInternational Society for the Study of the Aging Male, are dedicated toeducation and research in men’s health, endocrinology, andrology andsexual medicine. By signing this petition, they join more than 160 leadingexperts from 32 countries.
The press release says that a failure to retract amounts to “medicalliterature malpractice.” “This is the first time in history a worldwidecommunity of distinguished researchers, scholars, and clinicians has unitedto demand removal of a study from the literature,” stated AbrahamMorgentaler, Chairman of the Androgen Study Group, which submitted thepetition to JAMA. “This unprecedented action is a complete repudiation ofthe false information published by JAMA that has harmed public health,distorted medical science, and violated the trust between medical journalsand the consumer. Although science must always be open to newinformation and ideas, the wholly unreliable data in this study by Vigen et
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Update: The Low-T Story:Hunting for the Truth, Part 2The Low T Story: Hunting for theTruthTestosterone Usage Soars:When Doctors Relent toPatient…Low T: Separating Facts FromFrenzyHow many middle-aged menneed HRT?5 Ideas to Make PrescriptionDrugs SaferIs testosterone the newestrogen?
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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]
al. categorizes these results as misinformation.”
For background, my first post outlined the major study errors notrecognized by mainstream media and my updated post detailed the originalpetition by the Androgen Study Group on March 25, 2014. The originalpetition outlined additional glaring errors in the testosterone study, such aserror rates ranging from 44-89%, and the mind-boggling disclosure thatone out of eleven “men” in the study were actually “women.”
Now, more bad news surfaces as more than two-dozen additional societiesadd their names to the call for retraction. According to the press release,JAMA sat on corrected results for two months before publishing thecorrection that raw risk rates were actually complex, statisticallymanipulated figures. “People find it hard to believe that JAMA wouldpublish a study in which the percentages of men who suffered an adverseevent was lower by half in men who received testosterone than untreatedmen, yet results were reported as if the opposite were true, thanks toabsurdly complicated statistical manipulations of the data,” stated AndreGuay, 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 inmedicine I’ve never before seen a paper that says, ‘Here are our data, giveor take a thousand individuals.’ There is nothing believable in this study.”
Why are all of the study errors significant? Because misinformation can leadto damages for both patients and doctors.
In the press release, Mohit Kera, MD, Associate Professor of Urology atBaylor Medical College, states, “This article has caused enormous damage.This article created an unfounded negative perception of testosteronetherapy. Physicians discontinued treatment for men who were benefittingfrom treatment. It harmed physician-patient relations, as patients ask whytheir physicians placed their health at risk. And a new field of medicalmalpractice has sprung up overnight, with plaintiff attorneys in the USadvertising nationwide for patients who suffered a stroke or heart attackafter receiving testosterone. And it’s all based on pure nonsense.”
Litigation is certainly springing up quickly. A mere four days after the FDA’ssafety announcement in January, 5 men filed a lawsuit in federal court inChicago, where four claim they experienced heart attacks and one says hehad a stroke after taking AndroGel. A petition to consolidate federalAndroGel lawsuits in Illinois was filed just this week.
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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 has been complicit in creating a media frenzy regarding false risks,and is directly responsible for the new wave of medical malpractice casesagainst 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 andsteps taken to correct it,” stated Dr. Morgentaler.
How long will it take JAMA to respond? JAMA has not answered my requestfor comment and Dr. Morgentaler tells me that JAMA has not respondeddirectly to the petition. He says their first response to journalists a fewweeks ago was that they were not retracting the study but more recentlyindicated they were considering it.
Time will tell if JAMA responds to the stiff opposition from thisunprecedented action. *UPDATE: JAMA responded to my request forcomment, saying that they are declining to retract and confirming that it israre for JAMA to retract any papers: “It depends on the circumstances, butthere is a thoughtful review by several editors and follow up with the leadauthor of the paper. This group wrote to us on March 25, and JAMA isdeclining to retract.”
In the meantime, if you or someone you care about is considering usingtestosterone therapy, find a complete discussion about considerations andlinks to additional resources in my feature story, Low T: Separating FactsFrom Frenzy.
Additional Information:• Twenty-Five Medical Societies Join Androgen Study Group to PetitionJAMA to Retract Misleading Testosterone Study – PR Newswire
Related Posts:Update: The Low-T Story: Hunting for the Truth, Part 2The Low T Story: Hunting for the TruthTestosterone Usage Soars: When Doctors Relent to Patient…Low T: Separating Facts From FrenzyHow many middle-aged men need HRT?5 Ideas to Make Prescription Drugs SaferIs testosterone the new estrogen?
Jane LangilleJane Langille is a health and medical writer based near
JAMA Refuses to Retract Paper on Testosterone Risks - MedShadow
http://medshadow.org/medshadow_blog/pressure-on-jama/[2014-05-25, 8:35:15 PM]
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Toronto, Ontario. Jane writes about health news andmedical innovations for media publications and healthcare providers
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