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Slate Pharmaceuticals Supports Testosterone Replacement Therapy for Pro Athletes.

16 December 2009 No Comment

doug-barronRobert Whitehead, the President and CEO of Slate Pharmaceuticals, released a statement defending the use of the anabolic steroid testosterone by professional athletes when prescribed by a physician to treat low testosterone levels. Slate is the manufacturer of Testogel testosterone pellets. The statement is noteworthy because it represents the first time big pharma has been bold enough to criticize the anti-doping policies in professional sports.

The pharmaceutical company CEO’s press release supported golfer Doug Barron in his lawsuit against the PGA Tour. Barron was the first golfer banned by the PGA for violating the policy on the use of performance enhancing drugs (”PGA Tour’s Suspension of Doug Barron For Doping Is ‘Dopey,’ Says Pharmaceutical Company CEO,” December 8).

“I have examined the PGA Tour’s claims and statements put forth in defending their action against Doug Barron,” said Whitehead, “and when it comes to the issue of low testosterone and how to properly evaluate it, the PGA Tour has not made a sufficiently diligent effort to achieve a medically sound decision.”

“This area of medicine is complex,” said the pharmaceutical company CEO. “Physicians recognized as leading experts in this field habitually point out that many physicians who do not specialize in testosterone frequently render poor advice as a result of not being current with scientific findings. The PGA Tour would have been better served by seeking out the opinion of at least one physician recognized as a leading expert in this specialized area of medicine.”

Doug Barron was prescribed monthly exogenous testosterone injections by his physician after being diagnosed with hypogonadism in 2005; Barron’s testosterone value was 78. The LabCorp and Quest Diagnostics reference ranges for total testosterone are 241-827 ng/dL and 260-1000 ng/dl, respectively.

Barron submitted a therepeutic use exemption (TUE) application to the PGA Tour in order to continue testosterone replacement therapy (TRT) under the PGA anti-doping policy. An independent endocrinologist requested that Barron discontinue the use of testosterone in order to confirm the original diagnosis of hypogonadism.

Doug Barron discontinued testosterone injections in October 2008. He reported testosterone values were 325 in November 2008 and 296 in December 2008. Since his testosterone level was within the “normal” range, although far from optimal, his TUE was denied in January 2009.

Furthermore, Barron was unable to provide medical documentation of clinical hypogonadism at any time during the 6 months following the denial of his therapeutic use exemption (TUE) application.

At best, Barron had low-normal testosterone levels (not optimal) with symptomalogy that caused signficant impairment and reduced quality of life. He and his physician may have been medically justified in pushing his testosterone to “optimal” levels with TRT to treat his symptoms rather than treating a lab value.

Unfortunately, the PGA anti-doping policy explicitly disallows increasing “low-normal levels” of endogenous hormones as an “acceptable therapeutic intervention.”

“[t]he use of any Prohibited Substance or Prohibited Method to increase ‘low normal’ levels of any Endogenous hormone is not considered an acceptable therapeutic intervention[.]

Yet, the question remains ‘Should anti-doping policy dictate what is acceptable medical treatment?’

Hopefully, more big pharma companies will speak out against anti-doping policies that interfere with proper medical treatment in athletes.

Excerpt from United States Magistrate Judge Tu M Pham of the US District Court in Memphis, Tennessee denying temporary restraining order preventing Barron’s suspension:

On June 23, 2008, Barron submitted his TUE application to the PGA Tour to allow him to continue taking the exogenous Testosterone. The TUE Committee that reviewed his application was comprised of doctors, including endocrinologists. The TUE Committee requested that Barron be re-examined by an independent endocrinologist, who directed Barron to stop using Testosterone so that his normal Testosterone levels could be evaluated. In November and December of 2008, the endocrinologist took samples of Barron’s blood. The November test indicated Barron’s Testosterone level was 325 and the December test indicated that it was 296. Barron does not dispute the accuracy of these tests, nor does he dispute that these levels fall within the normal Testosterone range. The TUE Committee denied his application to use Testosterone on January 21, 2009, and Barron did not appeal this decision.

[…]

Barron has not alleged in his complaint, or provided the court with medical evidence to show, that the blood tests conducted by the independent endocrinologist were inaccurate or that his Testosterone levels dropped below the normal range between January and June of 2009. Had his levels dropped during this period, Barron could have reapplied for a TUE before the St. Jude Classic, which is permitted under the Program, but did not do so. The court has not been provided with the additional information that the TUE Committee received from Barron after he tested positive in June; however, Barron has not claimed that the additional information would reveal that he had abnormally low Testosterone levels between January and June of 2009.

As for the sanction itself, it was imposed by Commissioner Finchem based on Barron’s intentional and continued use of Testosterone. In his October 20 letter, the Commissioner outlined the bases for his decision, the terms of the sanction, and Barron’s right to appeal the decision. The Program authorizes the Commissioner to impose a one-year suspension for this violation, a sanction that also appears to be consistent with the World Anti-Doping Code. The Commissioner even took into consideration Barron’s desire to compete in the 2010 Q-School, and therefore decided to make the suspension retroactive to September 20, 2009, so that Barron could participate in the 2010 Q-School. Based on this record, the court finds that Barron has not shown a likelihood of success that the one-year sanction imposed for his use of Testosterone was arbitrary, unreasonable, or unfair.

Source: Mesomorphosis.com

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