A study released last week in the Journal of the American Medical Association found that among men with previous heart troubles and low testosterone levels, 'low-T' therapy drastically increased the risk heart attack, stroke, and death.
Researchers looked at the medical records of over 8,700 men at age 60 or above with low testosterone levels who underwent coronary angiography at Veterans Affairs hospitals from 2005 to 2011. The angiographies were used to evaluate the condition of the patients' hearts.
Of 7,500 men who did not take a testosterone replacement, 1 in 5 had negative cardiovascular outcomes like stroke, heart attack or death. Of the 1,200 men who did take testosterone therapy, 1 in 4 had negative outcomes, an increased risk of almost 30%.
Previous studies have shown that while men younger than 50 with classic hypogonadism benefit from replacement therapy. But in a 2010 study, the New England Journal of Medicine found higher rates of cardiac, respiratory and skin problems in men over 65 who were prescribed hormone replacement. Another worry is increased rates of prostate cancer.
Unfortunately, there's been no large, comprehensive study like the Women's Health Initiative that discovered dramatic spikes in breast cancers caused by hormone replacement therapy in post-menopausal women. It is not clear yet whether the same risks apply to younger, healthier men.
The F.D.A. has approved testosterone gels "for use in men who either no longer produce the male sex hormone testosterone or produce it in very low amounts." It is unclear what exactly constitutes a "very low" amount.
Dr. Eric Topol, a cardiologist and chief academic officer at Scripps Health in San Diego, quoted in a New York Times article about "low-T marketing efforts, is alarmed by the high percentage of patients he sees who use the roll-on prescription products, achieving testosterone levels that he described as "ridiculously high."As CBS reported, Dr. Steve Nissen of the Cleveland Clinic says it may be a bad idea to treat low testosterone levels in older men like a disease, because better studies are needed to assess the benefits and risks of testosterone therapy.
A survey of physicians this year by CMI/Compass found that more than half think pharmaceutical advertising to consumers should be scaled back, and 63 percent said it misinformed patients.
Nevertheless, testosterone therapy has grown very popular even with young men. One famous example is blogger Andrew Sullivan, who began taking supplemental testosterone at 35. He has claimed to have more energy, to be leaner, and to have more muscle mass, along with a laundry list of other physical and mental benefits. His essay, "The He Hormone", helped to popularize the drug when it was published in the New York Times Magazine.
And of course there are also the commercials on TV that discuss "low-T", with just one manufacturer, Abbott Laboratories, spending $80 million advertising AndroGel last year alone. As a result, doctors report that they have men asking for the drug, but who are maybe "a little low but not truly hypogonadal." In fact, the number of men seeking treatment for low testosterone has risen considerably during the last five years, especially at 65 and older. There has been a 90 percent increase in prescriptions for the hormone, according to IMS Health, and sales have reached $1.9 billion worldwide. As a result, some physicians believe that "low-T" is basically an invented condition.
In a recent report titled "Global Testosterone Therapy Market": Trends & Opportunities (2013-2018)", focused on the US testosterone therapy market, sales of testosterone products were said to have increased globally and it is expected to increase even further in coming years. The U.S is the main market, with gels replacing injectables, pills, and patches. The most popular new products include: Axiron, AndroGel 1.62% and Foresta.
With the market growing, key players such as AbbVie Inc, Actavis Inc, Eli Lilly & Co. and Auxilium Pharmaceuticals Inc are certain to keep promoting their testosterone replacements despite the possible risks. Axiron, Eli Lilly's testosterone gel, sells for more than $500 a month retail, $400 with coupons. Sales of prescription testosterone gels that are absorbed through the skin generated over $2 billion in American sales last year, a number that is expected to more than double by 2017.
Drug companies are defending their advertising efforts. According to Morry B. Smulevitz, a director of communications for Lilly, the company does not condone the use of medicine for purposes other than those approved by the F.D.A., but it encourages "patients to talk to their physicians to weigh the risks and benefits." David Freundel, director of public affairs for AbbVie said his company's "low testosterone efforts" were "developed to educate men who may be at risk for, or have, low testosterone, so they can have the appropriate dialogue with their physician to determine if testing and treatment may be appropriate."
If you have suffered a heart attack or other serious cardiac event while using testosterone replacement therapy, the attorneys at JONES WARD PLC would be happy to discuss your rights with you. Please contact attorney R. Lauren Horner at email@example.com for more information.