BioTE's Dr. Donovitz Challenges FDA Panel

DALLAS, Oct. 2, 2014 /PRNewswire/ -- Dr. Gary Donovitz, founder and medical director of BioTE Medical, today challenged the recent FDA panel recommendations regarding testosterone replacement therapy.   BioTE Medical is the nation's leading provider of natural, bio-identical hormone replacement therapy to physicians in the US. Dr. Donovitz called the FDA panel's recommendations well-intentioned but misinformed. 

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The FDA panel voted recently to tighten use of testosterone replacement drugs and require drug makers to conduct tests aimed at determining a drug's risk of heart attack or stroke, according to Bloomberg News.   

Donovitz called recent studies linking testosterone therapy to an increased risk of heart attacks misleading and inaccurate. He added, "Both of the recent studies that have been covered by the media have significant issues which make their findings invalid. The recent PLOS study looked at 55,593 men retrospectively. The study was limited to men using testosterone gel and creams and some synthetic testosterone injections.  It did not consider data for men receiving subcutaneous bio-identical testosterone pellet therapy. Furthermore, there was no lab data regarding pre or post therapy."      

According to Donovitz, a recent Veterans Administration study (reported in The Journal of the American Medical Association 2013), contained misstated data. He added, "In the VA Study, cardiovascular events occurred in 21% of males not taking testosterone and 10% of those males on testosterone. In addition, the males with testosterone levels in excess of 300 ng/dl were excluded from the study. Many of these males were clearly hypo gonadal and would have benefitted from appropriate therapy." 

Donovitz said that numerous studies have shown that natural testosterone pellet therapy can reduce the risk of heart disease, type 2 diabetes mellitus, Alzheimer's disease and osteoporosis. Donovitz added, "A key component of this treatment is an accurate interpretation of a patient's laboratory values. In the PLOS One study, this data was not considered.   Bio-identical testosterone pellet therapy also includes the optimization of each patient's hormone levels to achieve a level that is above a discriminatory zone that reduces heart disease and the other diseases noted above. Dosage optimization is not possible with creams and gels."

There have been multiple studies demonstrating that testosterone administered to men will result in an increased blood flow to the coronary arteries and a decrease in plaque and inflammation in the coronary arteries. Based on BioTE Medical data from the treatment of over 10 thousand male patients and after optimization of testosterone levels in hypo gonadal males from 35-78 years of age, with or without heart disease, there was no increased risk of cardiovascular disease.

Donovitz said he supports the FDA's recommendation for more thorough blood tests.  He stated, "At BioTE Medical, we believe that measuring a patient's blood levels is essential to successful treatment.  The BioTE Method includes blood tests during both pre and post treatment to ensure the highest possible accuracy in dosing. To the extent that the FDA is recommending that treatment modalities adopt similar testing, we would support the recommendation." 

The FDA panel called for more research studies into testosterone replacement therapy. Donovitz said he supports more research but only if it is unbiased and includes the study of natural hormone replacement. He added, "There have been a number of issues concerning the veracity of research studies relating to hormone therapy. Because of this, I believe there needs to be an agreement on how future research is being carried out to ensure that the research is thorough, objective and statistically sound.  Furthermore, it is clearly time for bio-identical hormone replacement methods such as The BioTE Method to be included in the research. Only then, can a complete and true story be told." 

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SOURCE BioTE Medical

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