The FDA Flexes Its Muscles on Testosterone

by Karen Solomon, Bioethics Program Student

In 2002, Solvay Pharmaceuticals developed a new marketing strategy that characterized the natural decline in testosterone production associated with normal male aging as a medical problem, termed low-T. The ultimate objective was to encourage physicians to prescribe testosterone to otherwise healthy patients to combat the effects of normal male aging, such as low energy and libido.

This marketing strategy worked. In the last decade, testosterone use in men has increased by over 300%. Over 2 million men are now being treated with testosterone in the US, earning pharmaceutical companies a great deal of money. In 2012, US testosterone sales hit $2 billion, up from a “mere $324 million” in 2002. Although the US leads the world with testosterone prescribing, a significant and steady increase in testosterone use has been seen across the globe.

However, safety concerns over testosterone use by otherwise healthy men are mounting. One observational study revealed that within three months of starting testosterone, heart attacks doubled in men over 65, and in younger men with heart disease. Another study found that among older men with low testosterone undergoing coronary angiography, many with heart disease, there was a 30% increase of “stroke, heart attack, and death” among those being treated with testosterone.

Earlier this year the FDA took notice, asking an Advisory Committee to provide recommendations on licensing and use of testosterone as an anti-aging panacea. That committee has since recommended that the Agency place additional restrictions on the ability of pharmaceutical companies to promote testosterone for low-T. The panel also recommended that researchers conduct additional clinical trials designed to better understand the frequency and severity of side effects associated with testosterone use.

It is encouraging to see an FDA Advisory Panel argue for greater caution with the use of prescription drugs in otherwise healthy individuals. As demonstrated with testosterone, FDA drug approval does not mean that all potential safety issues had been vetted. When drugs are prescribed with larger and more diverse populations than those studied in clinical trials, new safety concerns can arise. Once physician prescribing habits become established for off-label uses, drug manufacturers may not have an incentive to pursue additional studies to demonstrate whether such use is effective or safe.

Hopefully this will change. Until recently, manufacturers profited from increased sales while questions about whether off-label use was safe or effective were left unanswered.

In 2007, however, the FDA was given new authority under the Food and Drug Administration Amendments Acts (FDAAA), to require manufacturers to conduct post-marketing studies, as new safety information becomes available. The FDA now has the option to flex new regulatory muscles, as they have done with testosterone manufacturers, instead of negotiating for voluntary action with little promise of an end game. This can only be a win for patients.

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

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