Testosterone Replacement Therapy cont.
Bhasin, along with three other expert endocrinologists, recently applied to the Institute of Medicine (IOM) for a grant to fund a large-scale clinical trail into the issue, but were turned down. Instead, the IOM panel recommended a series of smaller trials that would first establish whether or not testosterone therapy had real health benefits before moving on to a large trial focused on its safety.
While he understands that decision, Bhasin said, "the practical consequence of this is that studies demonstrating the risks of testosterone supplementation won't even be initiated in the coming decade."
In the meantime, increased media attention and an aging population have led thousands of American men to turn to supplemental testosterone use in the absence of good scientific data, he said.
"Testosterone sales have been growing exponentially," Bhasin said. "In each of the past four years sales have doubled, and they are projected to have exceeded half a billion dollars this past year. Some of these sales are for unapproved indications, and in the age of the Internet, getting androgen products isn't very difficult."
On the other hand, this surge in demand indicates a legitimate and growing need among older men, he said. "People are living longer, and older men and women are interested in having a better quality of life," Bhasin said. "And that's not unreasonable."
Cunningham points out that declines in testosterone vary widely between individual men, and replacement therapy is certainly not for everyone. "I think only those men who have a testosterone deficiency should be considered for replacement therapy," he said. "And if men who are 40 or 50 choose to be on treatment, they should be followed carefully."
"There's tremendous polarization of opinion," Bhasin said. "There are proponents who almost recommend putting testosterone in the water supply, and then there are opponents who believe treatment would be tantamount to malpractice. And the fact is that we just don't know."