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The medical community has been hit by a wave of testosterone education courses in recent years, which a recent investigation has discovered are funded by medical manufacturers most likely to profit from increased testosterone drug sales.
An investigative series by MedPage Today and the Milwaukee Journal Sentinel found that major testosterone manufacturers are backing physicians teaching continuing medical education (CME) courses that tend to tout the benefits of testosterone replacement therapy, while failing to adequately warn about the risks. The education efforts often encourage doctors to ignore treatment guidelines in favor of widespread and liberal testosterone drug prescriptions.
In 2007 and 2009, Congressional investigations found that pharmaceutical and medical device companies were supporting CME courses, which some saw as a form of off-label marketing designed to sell drugs for uses that are not approved by the FDA.
It is illegal for drug and medical device manufacturers to promote drugs and devices for uses not approved by the FDA. However it is not illegal for doctors to prescribe them for non-approved purposes. By paying doctors to conduct CME courses, it allows manufacturers to have a go-between promote their drugs and devices for unapproved uses in an attempt to get around FDA regulations, critics say.
This latest investigation found that testosterone manufacturers are at the “forefront” of such efforts. Investigators looked at 75 courses that were funded by the pharmaceutical industry and found that 65 of them had a faculty member who already worked for the company that funded the course as speakers, consultants or advisors.
The report found that the courses were part of an aggressive marketing scheme that has helped push testosterone sales to blockbuster status.
Over the past decade, testosterone drugs like Androgel, Testim, Axiron, Androderm, Depo-Testosterone and other similar medications, have grown from a niche treatment to an industry that generates more than $2 billion in sales per year. However, serious testosterone concerns have emerged over the past 18 months, following reports that suggest the drugs are widely used by men with no real medical need and amid studies that indicate testosterone medications may increase the risk of heart attacks, strokes, blood clots and other injuries.
Testosterone Safety Concerns
On March 3, the FDA issued a drug safety communication to announce that it is requiring new warnings for the drugs, which indicate there is evidence of a possible link between testosterone replacement therapy and heart problems. The agency also urged doctors not to prescribe testosterone drugs to patients who had not been confirmed as having hypogonadism through serum testosterone blood tests.
According to the FDA, testosterone drugs are meant to treat men suffering from hypogonadism, which causes abnormally low testosterone levels. The condition usually comes due to injuries or problems with the testicles or certain parts of the brain. The only way to confirm whether someone suffers from hypogonadism is through a serum testosterone blood test.
Following recent studies that have identified a link between low T drugs and heart attacks, the FDA has pushed doctors to ensure that testosterone medications are only prescribed to men who have been properly tested.
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.
As the debate over the safety of testosterone replacement therapy continues among some in the medical community, a growing number of Androgel lawsuits, Axiron lawsuits, Testim lawsuits, Androderm lawsuits, Depo-Testosterone lawsuits and other product liability cases against manufacturers of “low T” drugs continue to be filed, alleging that inadequate research was conducted before marketing the drugs and that inadequate warnings were provided for consumers and the medical community.