“Low-T” Drug Ads and Unnecessary Prescriptions Need to be Curbed by FDA, Experts Say

If government regulators want to stop unnecessary testosterone prescriptions, they need to go after the aggressive direct-to-consumer ads from pharmaceutical companies, which encourage men to seek medical treatment for “low T” if they are suffering symptoms consistent with the natural drop of testosterone levels as all men age, according to some experts. 

In an editorial published last week in the Washington Post, professors Steven Woloshin and Lisa M. Schwartz called for the FDA to do more than require label warnings about potential “low T” drug side effects. Instead, they said the agency needs to act against ongoing advertisements that lead men to believe their natural low testosterone levels are a problem.

In March, the FDA issued a testosterone drug safety communication, announcing label changes that would include warnings that there is evidence of a link between low T drugs and heart problems. In addition, the agency required warnings that the medications should only be used by men with diagnosed hypogonadism, which causes unnaturally low testosterone levels, and encouraged doctors not to prescribe the drug for so-called “life-style” reasons, such as addressing decreased energy levels or sexual drive.

Professors Woloshin and Schwartz said that the warnings came at least seven years, 25 million prescriptions, and $9.7 billion in sales too late, and asked why the FDA did not put a stop to AbbVie’s “Is it Low-T?” ads years ago, which helped turn Androgel into a blockbuster treatment, even though testosterone replacement therapy was initially expected to be a niche treatment.

The professors say the campaigns have urged men to get checked for testosterone levels if they experienced such commonplace symptoms as gaining weight, feeling sad or grumpy, or got sleepy after meals.

The editorial says the FDA claimed it was powerless to stop the ads, which the professors dispute. They also point out that the FDA could have referred the issue to the Federal Trade Commission if the agency did not have the regulatory power to interfere with the ad campaign.

The campaign was one of many by pharmaceutical companies which were clear violations of laws forbidding “off-label” promotion of drugs for uses not approved by the FDA, according to the professors. They urged the agency to go after any “disease awareness” campaigns that were stealth off-label promotions.

Last month, European researchers called for changes to the clinical guidelines used in testosterone testing, saying that current testing procedures were inaccurate. The concerns were raised after a study presented at the European Congress of Endocrinology in Dublin, Ireland, found that some symptoms identified with hypogonadism by current testing procedures led to misdiagnoses of men who did not suffer from the problem, which is caused by injury or damage to the testicles or certain parts of the brain.

The researchers concluded that men with low but natural testosterone levels were being misdiagnosed and unnecessarily placed on testosterone drugs.

Low T Drug Heart Risks

The editorial comes amid continuing concerns over the potential heart risks with testosterone replacement therapy, as several recent studies have suggested that certain men may be more likely to experience a sudden heart attack, stroke, blood clot or death while using the popular low T drugs.

In November 2013, research published in the Journal of the American Medical Association (JAMA) found that older men who began taking testosterone drugs following coronary angiography were more likely to suffer cardiovascular events, such as a heart attack, stroke or death.

That study was followed by additional research published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.

In January 2015, another study published in the medical journal Pharmacotherapy found that first time testosterone users may be 40% more likely to have a heart attack when compared to men who did not use the drugs.

Over the past year, a steadily growing number of men nationwide have filed an Androgel lawsuit, Testim lawsuits, Axiron lawsuit or other low T drug lawsuits after suffering a heart attack, stroke, pulmonary embolism, deep vein thrombosis or other injury allegedly caused by use of the drugs.

All of the complaints involve similar allegations that drug makers manufactured the disease of “low T” through aggressive marketing, resulting in men using the prescription drugs when they had no real medical need. Plaintiffs claim that if the manufacturers had warned about the risk of testosterone health problems, severe and sometimes fatal injuries may have been avoided.

In the federal court system, the testosterone litigation has been centralized as part of an MDL, or Multidistrict Litigation, for coordinated pretrial proceedings.

A small group of Androgel cases are being prepared for trial. Known as “bellwether” cases, a series of six trials are scheduled to begin about one-per-month between October 2016 and April 2017, to help gauge how juries may respond to certain evidence and testimony that is likely to be offered throughout the litigation.