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A new study suggests that the overuse of testosterone replacement therapy drugs, which has raised concerns about unnecessarily exposing men to serious and potential life-threatening health risks, was largely driven by aggressive advertising by pharmaceutical companies, which encouraged men without any actual testosterone deficiencies to seek treatment for “Low T” if they experience common symptoms associated with aging.
Television advertisements and other drug marketing in recent years have encouraged men to speak with their doctor about the use of low testosterone treatments if they experience decreases in energy, strength, sex drive or other symptoms that are linked to natural drops in testosterone levels as all men age.
However, as a number of studies have highlighted the risk of heart attacks, strokes, blood clots and death that maybe caused by side effects of testosterone treatments, health experts have suggested that the medications have been widely overused in recent years by men with no real medical need.
Testosterone replacement therapy, which includes blockbuster drugs like Androgel, Testim, Axiron and others, were initially expected to be a niche treatment for men suffering from testosterone deficiency caused by a medical condition, known as hypogonadism. However, as men receive prescription of the drugs for life-style reasons, the industry grew to generate more than $2 billion in sales annually in recent years.
But the new study warns that those tests are less likely to happen in areas heavily targeted by testosterone advertising campaigns.
A study published this week in the Journal of the American Medical Association (JAMA) highlights the increased use of testosterone drugs in recent years, including among men who did not get the prerequisite blood tests in areas targeted by heavy direct-to-consumer marketing.
Researchers with Johns Hopkins, the University of North Carolina and the University of Chicago reviewed data from 75 large designated market areas in the United States, and looked at monthly testosterone advertising ratings and testosterone use data from 2009 through 2013.
The findings indicate that, while advertising varied in intensity and geographic region, the southeastern United States was the region most bombarded with testosterone drug ads.
In the earlier years, many of the ads did not even include specific brand-named drugs. Rather, the marketing was designed to raise awareness about “Low T”, which is not an actual medical condition, but a marketing term created by the drug makers.
The data suggests that the more households in a region were exposed to testosterone advertisements, the more likely there was to be new testosterone testing, new prescriptions, and new initiation of testosterone treatment without testing in that area.
According to the study’s findings, every time a testosterone commercial aired on television, it generated 14 new tests, five new testosterone prescriptions, and two prescriptions without men being tested for every 1 million men who saw that commercial.
In an accompanying editorial, Dr. Richard L. Kravitz, with the Division of General Medicine, at the University of California in Sacramento, said that physicians did not know how to handle the sudden onslaught of men clamoring for testosterone treatment in response to the advertising.
“The industry’s campaign was startlingly effective. Physicians were ill prepared to respond, as practice guidelines at the time were ambiguous,” Kravitz wrote. “Between 2000 and 2011, testosterone use increased at least 3-fold in the United States. Many men who were treated with these products did not undergo appropriate testing for testosterone deficiency or meet diagnostic criteria for hypogonadism.”
Last year, the FDA required new warnings about the potential risk of heart attacks and strokes from testosterone replacement therapy, urging doctors to only prescribe the drugs to men diagnosed with hypogonadism backed up by laboratory testing.
The study comes as thousands of men are now pursuing Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone prescription lawsuits, indicating that the drug makers failed to adequately warn that they may face an increased risk of suffering a heart attack, stroke, blood clot or death while using the medications.
According to allegations raised in the testosterone prescription litigation, pharmaceutical companies marketing the drugs withheld important safety warnings from consumers and the medical community, while promoting the widespread use of the medications among men without a true need for testosterone treatments.
Given the similar allegations raised in the lawsuits, more than 6,000 cases filed throughout the federal court system have been consolidated for pretrial proceedings as part of a multidistrict litigation (MDL), which is centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.
As part of the coordinated proceedings, a series of Androgel trials are expected to begin between April and November 2017, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.
If testosterone injury settlements are not reached following bellwether trials in the MDL, the drug makers may face hundreds of individual trial dates in U.S. District Courts nationwide over failure to warn about the heart risks associated with their medications.