Researchers Co-Author Editorial on Testosterone Drug Risks

Two medical professors at the Dartmouth Institute for Health Policy and Clinical Practice — and the co-chairs of the steering committee of Preventing Overdiagnosis, an international conference that will be held at the National Institutes of Health in September — recently co-authored an editorial on testosterone drug risks that appeared in The Washington Post on June 7th.

Steven Woloshin and Lisa M. Schwartz wrote that seven years, at least 25 million prescriptions and $9.7 billion in sales too late, the U.S. Food and Drug Administration is finally starting to regulate the over-prescribing of testosterone products. In response to new FDA rules last month, testosterone manufacturers released new instructions for doctors prescribing these products, making it clear they are not approved for “low T.” Companies are now required to warn doctors about a possible increased risk of heart attack and stroke for men who take these drugs.

FDA acknowledges testosterone drug risks

In March, the FDA acknowledged an awareness that testosterone is being used “extensively” to help men relieve symptoms who have low testosterone for no reason other than aging. The Agency noted that the benefits and safety of the use of testosterone products for this reason have not been proven.

The researchers noted a nearly tenfold increase in testosterone therapy prescriptions, dating back to 2007 when Abbott Laboratories (now AbbVie) launched its successful “Is It Low-T?” disease awareness campaign. The promotion encouraged middle-aged men who wanted to lose weight, build muscle, increase their energy levels and become more sexually satisfied to ask their doctors if low testosterone could be to blame for weight gain, depression and feeling fatigued after meals.

In May, a quiz on the “Is It Low-T?” website was removed, which Woloshin and Schwartz believe may be positive sign. The site even included suggestions for how men could approach their doctor with the question. The researchers note that company-funded disease awareness campaigns frequently cross the line between important public health messages about diseases and infomercials designed to sell a drug.

“The problem is that it’s not about getting the right men (and boys) diagnosed, such as those who have low testosterone because of trauma, chemotherapy, genetic abnormalities, undescended testes or some other serious underlying problem,” Woloshin and Schwartz state. “These patients need testosterone to develop normally or to restore “malenesss” and sexual function. They don’t need an awareness campaign, because treating them is standard medical practice.”

Researchers question why campaign wasn’t stopped earlier

The FDA now acknowledges that the advantages and disadvantages of treating men for signs of “low-T” caused by aging are uncertain. For many, the symptoms covered in the ads may not even be caused by low levels of testosterone. The FDA’s endocrine advisory committee has questioned whether “low-T” is even a disease at all. The Agency notes that the drastic rise in testosterone use is overwhelmingly in men with “low-T” of aging. The researchers question why the campaign wasn’t stopped years ago if testosterone use is not approved for these men.

While the FDA admits to receiving complaints about the campaign, it told the endocrine advisory committee that it could not act. The Agency claims it can only take action to regulate a disease awareness campaign if it specifically mentions a drug by name. However, the researchers note that it can govern campaigns when an unnamed drug is uniquely identified, as is the case with “low-T.” The campaign specifically mentioned all available forms of testosterone, as the recommended treatment for the disease.

Woloshin and Schwartz note that the FDA could refer the issue to the Federal Trade Commission if it were powerless, but that did not happen.

Meanwhile, dozens of men who took Low T supplements and suffered heart problems, blood clot-related injuries and stroke have brought testosterone lawsuits against manufacturers, claiming they were not adequately warned about the products’ risks.

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