ATLANTA — Studies raise concerns about synthetic testosterone drug
A medicine developed in Georgia to treat men's middle-age fatigue is now the focus of a federal investigation and a string of lawsuits.
Androgel is a form of synthetic testosterone, and the number one selling drug of its kind. Its maker coined the phrase "Low-T."
"The marketing was like it was a glorious drug," said Charles Littleton of Douglasville.
Littleton is a lifelong athlete and fitness enthusiast who began using the drug having complained to his doctor about fatigue after age 50.
Littleton had seen an ad for the drug on television. The doctor who prescribed it was a general practitioner and not a hormone specialist.
"He didn't say there was any risk at all, of anything, you know? None at all," Littleton said.
Nine months later, Littleton survived a heart attack. A cardiologist found a lesion in his right coronary artery.
On a hunch, Littleton quit the drug and started researching.
"To know what you know now, compared to what you were told in 2010, are you angry?" Strickland asked.
"Yeah, I am. I would have never taken it," said Littleton.
Three controversial studies have found testosterone therapy comes with an increased risk of heart attack. One study in 2010 was halted due to the heart trouble experienced by some participants.
"This case is not about the doctors, it's about the manufacturers and their failure to warn," said Decatur attorney Roger Orlando.
Orlando is helping lead a national legal team representing thousands of men who believe they're victims of a risky drug and the marketing machine behind it.
"They created a lifestyle disease for men to seek this drug, and without warning of the harm it could cause," he said.
One of Androgel's sales tools was a 10-question survey called The Low-T Quiz. Among its queries: "Are you experiencing a lack of energy?" "Are you sad or grumpy?" "Do you fall asleep after dinner?"
"What do you think of that quiz?" Strickland asked endocrinologist Dr. William Bornstein.
"A lot of men are going to answer those questions in a way that suggests they have a testosterone deficiency and most of those men will not," he said.
Bornstein is Emory Healthcare's chief medical officer. He's concerned that, according to the pharmaceutical industry's own figures, 60 percent of testosterone prescriptions are written by primary care doctors, not specialists.
Consulting firm IMS Health has predicted sales to hit $5 billion by 2017.
"There's an element of it that's out of control," said Bornstein.
"They're basically looking for a wider market, and when they think they've found one, they push it," added Kennesaw family practitioner Edward Spilker, MD.
Strickland noticed that Spilker's office still has the free Androgel tape dispensers a salesman gave out. He decided earlier this year to take more than 100 men off the drug.
"You've cut out 99 percent of the prescribing for this particular medication?"
"Probably"
"Are you that worried about it?"
"Yes."
The FDA now requires manufacturers to include a general warning about the risk of venous blood clots on all approved testosterone products.