Researchers don’t normally like to pull the plug on multi-million dollar studies. But when the death rates among the treatment group due to stroke, heart attack and sudden death spike by 30%, “pulling the plug” makes all the sense in the world.
A 2009-2010 study on the health benefits/risks of testosterone therapy in older men made national headlines. Researchers at University of Texas’s Southwest Medical Center in Dallas hoped to find proof that Low T therapy saved lives or, at the very least, improved the quality of the lives of men receiving treatment.
Instead, they unearthed an association that sent ripples across a billion dollar industry.
The researchers had been following 8,700 + older veterans, who were taking testosterone replacement therapy to treat a variety of conditions. The conventional wisdom at the time had been that Low T drugs could cause side effects, but that the benefits of replenishing testosterone outpaced the drawbacks by a lot. Thus, the “cost benefit analysis” generally favored intervention.
However, researchers found themselves staring at a shocking statistical reality – the patients on testosterone therapy were 30% more likely to suffer from cardiovascular disease.
That stat forced researchers to shut down the trial at once and prompted a surge of consumer anxiety. Sadly, the study neither ended industry bad practices, nor did it even slow the growth of the Low T therapy movement. In fact, most doctors who prescribed Low T drugs in the U.S. never heard about the University of Texas study.
Why not? Why does the Low T industry continue to expand? What can be done to regulate this industry?
One might think that a drug associated with a dramatic increase in heart disease would be either pulled off the shelves immediately or at least very closely monitored.
Consider, for instance, the converse situation. Imagine if a drug maker created a medicine and gave that drug to 8,700 men. Follow up studies then showed that the treatment group enjoyed a 30% reduction in cardiovascular events and strokes. Undoubtedly, the pharmaceutical industry (and the medical establishment) would not hesitate to call such a medicine a “wonder drug” and begin prescribing it by the metric ton to the ever-worried American populous.
A 30% increase (or decrease) of a serious illness across a wide swath of a patient population should be newsworthy. Yet the University of Texas study’s headlines came and went. Millions of American men continue to take their testosterone therapy, obliviously. And the Low T drug makers continue to rake in billions of dollars of profits every year.
How did this all happen? What can good science actually say about the real “cost benefit analysis” of testosterone therapy? Furthermore, how can patients and their families – who have only limited medical knowledge of the complex scientific debate – advocate for themselves, given all the conflicting medical and scientific opinions on this topic?
First things first, we need to establish basic facts about testosterone therapy and get a clear understanding about the science behind the drug. The next post will dive into those details.
For insight into your Testosterone case, call the Davis & Crump team now at 800-277-0300 or email us at email@example.com.