Due largely to drug makers’ aggressive direct-to-consumer advertising campaigns, testosterone replacement therapy (TRT) has become a big business projected to reach profits of $5 billion by 2017. But, huge profits should not come with a huge price to pay for consumers.
The FDA said that testosterone replacement therapy (TRT) has only been approved for treating men who have hypogonadism, a form of abnormally low testosterone caused by injury or medical illness, yet many advertisements encourage older men to use testosterone replacement therapy if they are experiencing decreased sex drive, weight gain, depression or lack of energy. While use of testosterone drugs, such as AndroGel has increased dramatically over the past ten years, concerns have emerged in recent months about serious and potentially life-threatening side effects.
In November 2013, a study published in the Journal of the American Medical Association found that testosterone drug side effects were linked to increased risks of heart attacks, strokes, and death among older men with certain pre-existing heart problems. That research was followed by another study released in January 2014 by the medical journal PLOSOne, which found that men who take such testosterone drugs are 30% more likely to experience a heart attack, stroke, or die suddenly regardless of their prior heart conditions. The study also reported that about 25% of men who received prescriptions for testosterone boosters were granted them without undergoing blood tests to check their testosterone levels.
The results of these studies raise many questions about why the drug makers did not warn consumers and the medical community after an aborted 2009 study. Additionally, why did the FDA recently approve Aveed; a drug it previously rejected three times due to safety concerns without requiring a black box warning? A black box warning, the strongest warning that the FDA requires, signifies that medical studies indicate a drug carries a significant risk of serious or even life-threatening adverse reactions.
As the FDA reviews these recent concerns, it urges health care professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program.
It’s clear that drug makers are reaping the rewards of successful marketing of testosterone treatments; they are putting profits over the safety of the consumer. All drugs have some risks and a physician and patient should balance the benefits versus the risks to decide a course of medical therapy, but when advertisements and product labels don’t mention need-to-know risks, especially those serious and life-threatening, it is pure negligence.
These products should be safe before reaching consumers. Deceitful marketing tactics show the lengths drug companies will go to make billions of dollars without considering the safety of consumers. Making a mistake is bad business; refusing to face the facts and at least warn consumers about the risks associated with one’s product is shameful. Lawsuit Financial supports all efforts to hold drug companies responsible for producing safe products and warning about dangerous ones.
Attorney, certified civil mediator, and award-winning author of the Zachary Blake Betrayal Series. Mark Bello is also a member of the State Bar of Michigan, a sustaining member of the Michigan Association for Justice, and a member of the American Association for Justice.