1. #1

    Testosterone Prescriptions Declined after FDA Warning

    A new study published in JAMA found that testosterone prescriptions fell sharply after the FDA issued a warning that testosterone increases the risk of cardiovascular disease. A news article says:

    By reviewing health insurance records for almost 10 million men aged 30 and older, the investigators found that total testosterone use increased from 0.52 percent of men in 2002 to 3.2 percent in 2013. But 2013 was the year in which the "low-T" wave crested. After that, the popularity of testosterone therapy waned sharply, falling to less than 2 percent of men by 2016. The decline in overall use of testosterone appears linked to an advisory put out by the U.S. Food and Drug Administration in 2013, the researchers said. The FDA advisory warned that men using testosterone to ward off aging might be putting themselves at increased risk of a heart attack or stroke.

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    The decline is celebrated by a doctor:

    The decrease is "definitely a good thing," said Dr. Shalender Bhasin, an endocrinologist with Brigham and Women's Hospital in Boston.

    "It's a hopeful sign that educational efforts in science do matter, and people pay attention to both the science and the information from clinical studies that's being put out by scientists," said Bhasin. He chairs the Endocrine Society's testosterone guidelines committee.
    Except that in this case the science was wrong and the public misinformed.
    Last edited by Nelson Vergel; 07-17-2018 at 10:31 AM.

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  3. #2
    Member Sean Mosher's Avatar
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    Geez...........
    If having low testosterone is so normal then why did previous generations have so much higher levels..........did they all suffer/die from cardiovascular disease too??

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    A plot of TRT users from the article.
    Last edited by Nelson Vergel; 07-17-2018 at 10:31 AM.

  5. #4
    This is big pharma is pushing back, now they can sell more **** pills.

  6. #5
    Super Moderator Nelson Vergel's Avatar
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    The state of testosterone therapy since the FDA's 2015 labeling changes: Indications and cardiovascular risk



    Summary
    Objective
    A label change in testosterone (T) products in March 2015 followed a highly publicized FDA advisory committee meeting in September 2014. Changes included a warning of possible increased cardiovascular (CV) risks and restriction of indicated populations to younger men with a limited set of known aetiologies of testosterone deficiency (TD). These changes greatly impacted clinical practice and public perception of T therapy (TTh). Our aim was to review these changes in the light of subsequently published studies.

    Design
    We identified 23 studies through June 2017, including 12 clinical trials and 11 observational studies. The Testosterone Trials included 790 men aged 65 years and older with TD without known aetiology, assigned to 1‐year T gel or placebo.

    Results
    Demonstrated benefits of T included sexual activity and desire, physical activity and mood. There were 9 major adverse CV events (MACE) in the T arm and 16 in the placebo arm. No study reported increased MACE with TTh. A 3‐year RCT showed no difference in carotid atherosclerosis. Several large observational studies reported reduced CV events with TTh, including one showing progressively reduced CV and mortality risk with greater duration of TTh. Men whose serum T normalized with TTh had reduced risk of MI and death compared with men whose T levels failed to normalize.

    Conclusion
    We conclude that existing evidence fails to support increased CV risk with TTh; on the contrary, there is evidence suggestive of real‐world CV benefits. Finally, existing evidence provides benefits of TTh in older men without known aetiology for T deficiency.

    FULL PAPER

  7. #6
    Super Moderator Nelson Vergel's Avatar
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    We are seeing an increase already, especially in compounded testosterone prescriptions. The graph above does not include prescriptions from the compounding industry.

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