Low T Center Endorses the Joint FDA Committee Meeting on Testosterone
Posted: September 19, 2014
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 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 percent 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.
“Four-and-a-half years ago, I correctly predicted the state of affairs for the testosterone industry,” says Low T founder Michael Sisk. “If you analyze the past abuses in pain management medicine, you could clearly see where we were headed. Internet providers, inadequately trained providers, and ‘diagnosis by phone’ centers created an ease of access that resulted in clear overuse.
“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 nonmedical 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 use.
“Low T Center physicians do not permit patient self-medication and will not treat patients who do not have a medical diagnosis of low testosterone,”says Dr. William Reilly, M.D., national medical director at Low T Center. “What the FDA has told us is what we have known all along. 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,” adds 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.
Disclaimer: This article is made available for general, entertainment and educational purposes only. The opinions expressed herein do not necessarily reflect those of Low T Center. You should always seek the advice of a licensed healthcare professional.