Low T Center Endorses The Joint FDA Committee Meeting on Testosterone

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Sep 18, 2014, 07:34 ET

SOUTHLAKE, Texas, Sept. 18, 2014 /PRNewswire/ -- Low T Center endorses the recommendations of the joint FDA committee meeting in Hyattsville, Maryland earlier this week. The FDA convened the meeting to assess the proper patient population for testosterone therapy (TRT), as well as to assess potential cardiovascular risk associated with TRT. Examining recent claims from studies that TRT affects cardiovascular health, the committee found that "available epidemiological studies do not provide convincing evidence that TRT is associated with adverse (cardiovascular) outcomes." The Committee also determined that only about one-half of men now taking testosterone have been diagnosed with hypogonadism, the specific medical diagnosis indicated for TRT. The Committee materials raised a concern that more than 25% of persons prescribed testosterone have not had adequate blood testing. Consequently, the Committee has proposed labeling changes to limit testosterone therapy to patients suffering from hypogonadism, confirmed by laboratory testing.

"4 1/2 years ago I correctly predicted the state of affairs for the testosterone industry. If you analyze the past abuses in pain management medicine, you could clearly see where we were headed," explains Michael Sisk, the Founder of Low T Centers. "Internet providers, inadequately trained providers, and 'diagnosis by phone' centers, created an ease of access that resulted in clear overuse," explains Sisk. "Low T Center is different. Our medical providers only treat men suffering from a medical condition. We refuse to treat over half of the men that come to our centers." Unlike many other so-called testosterone services, boosters or other non-medical providers, the physicians at Low T Center only treat hypogonadal patients whose low testosterone diagnosis is corroborated by symptoms together with comprehensive ongoing laboratory testing.

With the amount of advertising done by drug manufacturers, some feel that testosterone has become a target for plaintiffs' lawyers and negative press. Most suits involve gels, creams or topicals, which Low T Center does not utilize. "Low T Center physicians do not write prescriptions, do not permit patient self-medication, and will not treat patients who do not have a medical diagnosis of low testosterone. What the FDA has told us is what we have known all along," says Dr. William Reilly, M.D., National Medical Director at Low T Center. "There is a right way and a wrong way to diagnose and treat low testosterone. We are pleased that the FDA committee has finally recognized this difference."

"I am excited that the FDA is involved, and it's a matter of time before state medical boards weigh in, to refocus testosterone therapy on what it is intended to accomplish -- help men with a real medical condition," says Sisk. "At Low T Center, the physicians focus on the medicine and we focus on creating the perfect patient experience. You just won't get that marriage of safety and comfort from a pill, gel or internet service."

For More Information Contact:	Michael Sisk
	Low T Centers, Inc.
	[email protected]

	Dr. William Reilly, M.D.
	National Medical Director
	Low T Center
	www.lowtcenter.com

Source:

Background Documents, release September 17, 2014, Joint Meeting for Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management Advisory Committee (DSARM AC) available at www.fda.gov.

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