Tags: testosterone | Low T | FDA | Brownstein | flawed | studies

Doctor: FDA Targeting of 'Low T' Treatments Based on Flawed Studies

By    |   Friday, 19 Sep 2014 06:54 PM

Federal regulators got it partly right when they said this week that it is time to start cracking down on testosterone supplements, but they could go too far in restricting what is a safe and life-improving treatment for many men, a family practitioner of holistic medicine told Newsmax TV on Friday.

David Brownstein told "MidPoint" host Ed Berliner that a pair of studies linking heart attacks to therapies for so-called "low T," or low testosterone levels, led to Wednesday's nonbinding vote by a U.S. Food and Drug Administration advisory panel calling for new limits on testosterone replacement therapies.

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The panel said that low-T remedies such as pills, patches, and gels — which have become a $1 billion annual business — should be restricted to men with actual disorders that impair testosterone production, and not be given to people whose lower testosterone levels occur naturally with aging.

FDA officials have not yet decided whether to follow the panel's advice and give it regulatory force. But Brownstein questioned the research behind Wednesday's vote.

"The trigger was two recent studies which seem to point out that men who took testosterone therapy had more heart attacks as compared to men who didn't take testosterone therapy," he said. "However, those two studies were very flawed studies."

Brownstein said the two recent studies "go in the face of hundreds of studies before" that show the opposite — that lower testosterone levels are associated with higher risks of heart disease.

Brownstein said he's been prescribing testosterone supplements in his practice for more than 20 years, and that "when it's used appropriately. it's a safe and effective therapy for men."

But he also credited the FDA with "a reasonable argument that we need to have a little better control on this," given that an estimated 25 to 30 percent of the men taking low-T medicines have never had their testosterone levels checked.

"That is the way it's being handed out by a lot of doctors, but that doesn't make it right," said Brownstein, "and that's why the FDA has looked into this situation. And the doctors who are prescribing it that way should be brought down to task and be told that's not the way to do it."

"Now, I don't prescribe testosterone in that way," he said. "Men need to have their levels checked beforehand, and their levels correlated with a physical exam and a history, and then that decision needs to be made between the doctor and the patient whether testosterone therapy is useful or not."

He said another needed measure is to curtail the low-T advertisements that blanket mass media, and he didn't stop there: Brownstein said to "get rid of direct consumer marketing ads for pharmaceutical drugs," period.

"We're one of only two countries that allows that, and we spend more on drugs than any other country in the face of the earth, and yet we rank last amongst every indicator from the World Health Organization," he said, adding that "too much marketing is causing a lot of problems with testosterone."

But he said that when used properly, testosterone replacement can be a "useful" and even "wonderful" therapy, with benefits including better recovery from heart disease as well as heart-disease prevention.


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Federal regulators got it partly right when they said this week that it is time to start cracking down on testosterone supplements, but they could go too far in restricting what is a safe and life-improving treatment for many men, a family practitioner said.
testosterone, Low T, FDA, Brownstein, flawed, studies
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2014-54-19
Friday, 19 Sep 2014 06:54 PM
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