Key Questions, and Some Answers, About Stunning New Report on A-Rod PEDs

Will Carroll@injuryexpertSports Injuries Lead WriterJuly 2, 2014

Alex Rodriguez was using testosterone. This is hardly news, having first been outed a few years ago and then again as part of the Biogenesis case. Instead, the fact that MLB sanctioned his use by granting him a therapeutic use exemption (TUE) in 2007 is a bit of a stunner to those of us that have been following MLB's continued chase to get performance enhancing drugs (PEDs) out of the game.

Major League Baseball was forced to comment after the excerpt was released, saying: 

The TUE process under the Joint Drug Program is comparable to the process under the World Anti-Doping Code. The standard for receiving a TUE for a medication listed as a performance-enhancing substance is stringent, with only a few such TUEs being issued each year by the IPA. MLB and the MLBPA annually review the TUE process to make sure it meets the most up-to-date standards for the issuance of TUEs.

That's hardly enlightening. We're left with a lot of anti-Rodriguez hysteria, but not a lot of answers as to what this means. Even all the acronyms will get confusing! There are more questions than answers on this, but let's take a look at some of the bigger ones raised by this report. 


What does it mean that Rodriguez was able to use testosterone legally?

Rodriguez was reportedly granted a therapeutic use exemption during the 2007 season, per Bob Nightengale of USA Today. Tim Elfrink, one of the Miami New Times writers that broke the Biogenesis case, published in an excerpt at that Rodriguez was given a TUE by MLB's independent program administrator (IPA), Dr. Bryan Smith. Rodriguez was also granted a TUE for Clomid, another banned substance, in 2008. 

It is unclear if Rodriguez requested or was granted a TUE for testosterone in 2008 or any other season, though MLB did discuss only the 2007 TUE at Rodriguez's grievance hearing for his most recent suspension. 


Why would MLB grant this type of waiver for anyone?

It is known that several players have been granted TUEs for a condition known as hypogonadism. In several of these cases, the player was a survivor of testicular cancer. Former Red Sox third baseman Mike Lowell has admitted use of several drugs, such as testosterone, as he was trying to have children after his cancer treatments. 

In cases such as this, the treatment is truly testosterone replacement (or TRT). A player would be brought back up to a normal level of testosterone for a man of his age and size. 

Other substances also require a waiver. The largest number of waivers are granted for drugs to control ADHD. These drugs are powerful stimulants, such as Adderall and Modafinil. MLB has a strict procedure for granting these waivers, and in almost all cases, they require the diagnosis to be made in childhood. 

The NFL, NBA, NCAA and Olympics all have similar procedures for waivers. Most are based on the World Anti-Doping Agency (WADA) standard, though MLB's procedure goes above and beyond the requirements of WADA. The NFL has never clarified its TUE procedures, but it is believed that an athlete only requires a prescription there without an IPA clearance. 


Why would MLB grant this type of waiver for Rodriguez?

This is the one I don't have an answer for. Rodriguez would have had to make a very compelling case to Dr. Smith in order to be granted the waiver, but I know from work I did at the time that MLB was very much against granting any waivers for TRT due to the level of scrutiny on the sport. The only known exceptions were for testicular cancer survivors. 

There were questions about whether Jason Giambi was granted any waivers for his treatment for a pituitary tumor in 2004, but neither Giambi nor MLB has ever commented on this. 

I cannot speak for Dr. Smith, but I cannot comprehend any circumstance where he would have granted this waiver aside from a clear medical necessity. Smith may have granted the Clomid exemption in order to take Rodriguez down from his TRT, but even this would be unusual. 

Dr. Smith was replaced as MLB's IPA in 2012, though I was told at the time that there were no performance issues. Dr. Smith was simply moving on with his career. MLB has not seen significant movement in the number of TUEs, which it reports every year, since Smith left. 


How does a TUE work in terms of testing and therapy?

A player with a TUE is still subject to MLB's drug testing procedure. Nothing is different and the collector and lab do not know about the waiver at any point. In fact, the test will show up as a positive for testosterone (or other waived drug) and will be reported to MLB just as any other positive would be.

At that point, MLB's IPA would match the player against an in-force waiver and stop the process if an exemption exists. This is not reported to teams or the player. However, teams do know that a player has a TUE because they are involved in the process of getting one approved.

One thing to note is that a TUE is made for therapeutic purposes. Players that test positive for dosings that are excessive to therapeutic use can be disciplined. For someone like Rodriguez, this means that he could use testosterone to return levels normal for a man of his age and size, but not to use massive anabolic doses to gain muscle mass.


Why would this waiver process be necessary at all in sports?

There are valid medical reasons that a banned substance would need to be used. Many asthmatics use drugs that are considered stimulants. Players with ADHD have a valid medical need for drugs that are banned. Propecia, a drug used to combat hair loss, is banned in international competition and has resulted in positive tests for players who failed to get exemptions. 

Drug policies are designed to stop the abuse of drugs in sports. TUEs are necessary in order to allow medical use of some of these drugs as necessary. In some cases, especially ADHD, MLB has required some players to attempt to switch to non-banned drugs such as Strattera in their therapy.


Why doesn't MLB publish the list of players that have received TUEs?

MLB is prohibited by HIPAA and other laws to violate a player's medical privacy. A player may elect to discuss his medical condition, but  the waiver that a player signs that allows a team to speak to the media and others about medical conditions specifically excludes the discussion of medications.


Is the waiver process abused or a failure?

Many, including those in Congress, have discussed whether the TUE process can be abused. It is often discussed in terms of the numbers of athletes that have been diagnosed with ADHD. In 2013, 119 TUEs were given with the vast majority being for ADHD drugs.

While some will argue that number is high, it is statistically in line for an all-male, active group. (Anecdotal studies of grade school athletics show the number nearer to 20-25 percent of participants.) Unless MLB is simply going to remove the waiver programs and force players to go off their medications, this seems to be about the standard level. 

Unfortunately, no other major sports publish their numbers, so it is impossible to compare. 


Could a player today get a similar waiver?

It is possible, though it is difficult to get any waiver. Players are put through a series of tests, not only by their own physicians, but by MLB approved physicians before being judged by the IPA. As seen above, MLB seems to have a very consistent number of TUEs for ADHD and other drugs. 


What would testosterone do for Rodriguez or other players?

Testosterone is the male androgenic hormone. It is what differentiates men from women on an endocrinological level. It is also the basis for all anabolic steroids. The body converts these steroids into some analog of testosterone in the body. All anabolic steroids are compared to testosterone, which is the "gold standard" of this class of drugs.

For baseball players, testosterone supplementation could give them greater muscle mass, better recovery and other positive effects. There are negative effects as well, but in TRT these are offset by the low doses and the use of other drugs such as Clomid. If held at strict TRT levels, Rodriguez and others would be at the same levels of testosterone in the body as a normal man.

In other words, the therapy should have been used to make Rodriguez have the same testosterone level as Derek Jeter, for example.


Is there a difference between the testosterone used here and similar prescription testosterone substances like Androgel and Axiron?

Remember the "Is It Low T?" ads you saw wall to wall during the last couple playoff telecasts? That's testosterone—and at a very similar level to what Rodriguez would have used. These are very popular prescription drugs used to help men with low testosterone levels.

While there is great controversy about not only the overuse but the marketing of these drugs, they are out there and widely used. For Androgel alone, sales were well over a billion dollars last year, making it the 35th-most used prescription drug in the U.S. and a big profit center for Abbott Labs. 

People may not like that Rodriguez used TRT, but if you looked around the average workplace in America, there's likely to be a number of people using Axiron, Ritalin or another drug that would require a TUE. Expecting more from athletes than the general population seems hypocritical. 


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