Analysis of more than 200 learns conducted since 1950 determines no validity to medicine industrys portrait of testosterone as akin to a miracle drug for ageing men
A little more than a year ago, the Food and Drug Administration threw the brakes on a massive push by drugmakers to marketplace testosterone therapies to the average middle-aged boy. A multimillion-dollar advertising campaign had portrayed the medicine as having extraordinary power to combat symptoms of ageing. But the FDA had become concerned about the potential for testosterone to increase nerve perils.
The benefits and safety of testosterone therapies, the agency said in the order that ground the marketing campaign to a halt, have not been established.
Now, a group of researchers have announced that they have established the benefits: none.
The prescription of testosterone supplementation for low-T for cardiovascular health, sex role, physical role, feeling, or cognitive role is without support from randomized clinical trials, reads a new study, which was published on Wednesday in the open-access periodical Plos One.
The study is an analysis of more than 200 others conducted since 1950 which compared testosterone with a placebo. And it is a sharp rebuke to an industry which expended times portraying testosterone as akin to a miracle drug for men feeling the ordinary effects of ageing.
We dont need to do farther trials, told Adriane Fugh-Berman, a professor at the Georgetown University Medical Center and one of such studies authors. Fugh-Berman is also the director of PharmedOut, a Georgetown research group that scrutinizes medicines it suspects are over-diagnosed, often putting it at odds with the pharmaceutical industry, and she briefly acted as an expert witness in testosterone litigation. The evidence is very clear that testosterone does not assistance mens health. And the real risks of testosterone outweigh the illusory benefits.
The study is likely to deal a further jolt to marketings for testosterone supplements, which just three years ago topped$ 2bn annually. Driving those marketings was a big advertising campaign: from 2012 to 2013, the drugmakers AbbVie and Eli Lilly expended more than a quarter-billion dollars extolling testosterone therapies for men with a diminishing libido or low energy.
Critics watched an effort to set the medicine in as many hands as possible with little weight of evidence. A popular test to identifies boys with low-testosterone or low-T which Fugh-Berman at the time blamed as a test that everyone will fail asked men if they found themselves feeling grumpy and becoming tired after dinner. Physicians committed out 2.3 million prescriptions for testosterone in 2013 alone, the FDA procured up 75% from 2010.
But amid the boom, some experts raised concerns that benefits of testosterone were unproven for men experiencing the normal effects of ageing. Furthermore, there was evidence that testosterone therapies posed threats to cardiovascular health.
In late 2014, the FDAs advisory panel recommended the agency to revise testosterone medicines labeling. The FDA followed though in March 2015. Eli Lilly and AbbVie had already slashed their ad spending by nearly 40% and appreciated a 10% drop in sales of the medicines. Now, the FDA had effectively barred them from targeting any more ads at otherwise healthy men who were simply get old.
But the FDA simply regulates the marketing of a drug. Physicians may continue to prescribe testosterone to ageing boys off-label if they feel the therapies would be beneficial.
So health researchers Samantha Huo of Tulane University, Fugh-Berman and a team from Georgetown, and researchers from the University of South Florida, the University of IllinoisChicago, and toxicology consulting group set out to determine what the FDA hadnt: exactly what we the benefits, if any, of regular testosterone supplements?
The researchers deliberately included in their review many low-quality learns that procured a benefit from testosterone therapies, Fugh-Berman told. We wanted to give it the highest possible chance of coming out with positive effects, and it didnt.
Still, some of the areas where testosterone was found to have no impact were surprising. In bodybuilders, which the study omitted because they take testosterone in very high dosages, testosterone is shown to enhance muscle mass and strength. So researchers were puzzled when their findings included no proof that testosterone increased strength for men diagnosed with low-T, even though it increased their muscle mass.
Another surprise arrived when researchers concluded the medicine had no effect on sex role. Everybody presumed it was helpful for erectile dysfunction, and we were astounded to find out it merely isnt, told Fugh-Berman. There wasnt good evidence for this.
The study published on Wednesday did not include the small subset of men whose torsoes do not render any testosterone. In these people, who may have been born without or suffered damage to their testicles, testosterone care can be necessary to prevent bone loss. The study likewise omitted trans boys, who take testosterone in high dosages to help their bodies become more masculine.
So why doesnt testosterone care operate?
One big reason may be that there are no agreed-upon parameters for what counts as normal and low testosterone for different age ranges. While degrees tend to wane as boys grow older, told Fugh-Berman, theres a broad range for normal at every age.
I think this question is determined, Fugh-Berman told. Theres no such thing as the fountain of youth.
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