20 August 2020

A MLB lawsuit could call DHCMT ADRVs into question

The Major League Baseball Players Association (MLBPA) has asked Major League Baseball (MLB) to implement a Decision Limit for dehydrochloromethyltestosterone (DHCMT) of 100 picograms per millilitre of urine, after a number of players tested positive for tiny amounts of the steroid’s long term metabolite. A lawsuit challenging the test developed to detect the long term metabolites of DHCMT could have implications for many Russians ensnared by the International Olympic Committee’s (IOC) retesting programme for the Beijing 2008 and London 2012 Olympics.

DHCMT and the MLB

DHCMT, or oral Turinabol, is considered a performance enhancing anabolic steroid under section 2.B of the MLB’s Joint Drug Prevention and Treatment Program. ‘A test will be considered positive if any Steroid as defined in Section 2.B of the Program is present’, reads the MLB’s Testing Protocols. An exception is nandrolone, which is only recorded as a ‘positive’ if levels exceed 2ng/mL.

Houston Astros pitcher Kent Emanuel was suspended for 80 games on 6 August, after testing positive for DHCMT. Emanuel revealed that seven picograms of DHCMT had been discovered in his sample. A picogram is a concentration 1,000 times smaller than a nanogram. If Emanuel had tested positive for nandrolone, he would need to record a concentration greater than 2,000pg/mL in order to record a positive test. The Decision Limit for DHCMT proposed by the MLBPA would be equivalent to 0.1ng/mL.

“If you took a grain of table salt and split it in half, you would have to do that 58 million times to get to the size of a picogram”, says Emanuel in the video below. “DHCMT was a steroid created in East Germany, used by they government in a State sponsored doping programme in the seventies and eighties. It was popular with a lot of athletes, as the parent compound leaves the body rather quickly. The estimate I heard was a week’s time, so very easy to skirt around drug testing.

“However, a study conducted by a scientist named Rodchenkov discovered these metabolites that are a result of ingesting DHCMT. Starting in 2016, all of a sudden Laboratories were able to test for these metabolites that would hang out in the body for weeks, months, years after ingestion, showing that DHCMT had been in an athlete’s system.

“One thing we don’t know is how long these metabolites stay in the body. Unfortunately, there are guys testing positive years and years after ingestion, and have yet to clear the metabolite from their body. There is also a pulsing effect that scientists have noticed, where the long term metabolite will essentially lay dormant in the body and will then be detectable at other random times. So if you were to be tested every day, you might test negative one day and positive the next.

“Combining those two things is incredibly frustrating for me, because it gives me no information about as to when this could have entered my system. With all the information I have at hand, for all I know I could have ingested this as an 11 year old, or in High School as a teenager.

“Unfortunately, there is no way for us to gain much more information soon DHCMT […] DHCMT is illegal, even outside of the sporting world, so it cannot be approved for clinical trials or clinical studies. As far as I know, the only study we have of the substance is Rodchenkov’s, where it was self- administered with no other subjects.”

Twenty one MLB players have been suspended for DHCMT since 2015, reports The Wall Street Journal. On 25 July, Tres Barrera was also suspended for 80 games after a positive test for DHCMT. Like Emanuel, Barrera denied any wrongdoing and filed a lawsuit disputing his suspension. His positive test involved 10pg/mL of DHCMT.

Challenge to the DHCMT test

It is understood that Barrera’s lawsuit also attacks the validity of the test for long term metabolites of DHCMT, based on the idea that it cannot determine how long the metabolite has been in your system. It was questionable whether it is accurate that a player can test positive for a DHCMT metabolite due to a substance taken years ago – however, advances in science mean things may have changed.

“The window of detection has moved out to, typically, several weeks, and in some rare circumstances up to months after administration”, Daniel Eichner, the President of the Sports Medicine Research and Testing Laboratory (SMRTL) in Utah, told ESPN in 2016. ‘In the last several years, a new long-term metabolite, referred to as the M4 metabolite, was identified that increases the window of detection to at least 40-50 days, perhaps longer’, wrote Don Catlin, the founder of the UCLA Laboratory, in 2016. ‘The chemistry of DHCMT, however, appears to be such that after 20 days only the long-term metabolite would be detectable, while the parent and other identifying metabolites would no longer be detectable. While not many drugs in the WADA system rely on the presence of a single metabolite to demonstrate the presence of a drug, doing so is certainly acceptable.’

The above suggests that in 2016, the idea that an athlete could test positive for DHCMT years after taking the substance was incorrect. But since then, it is understood that there have been major advances in Laboratory technology enabling detection of prohibited substances in ever smaller concentrations. Under MLB’s rules, any amount of a DHCMT metabolite, however small, equals a positive test. However, WADA operates a Minimum Required Performance Level (MRPL) of 2ng/mL for DHCMT – a concentration 20 times larger than that reported by the two baseball players.

Dr. Timothy Sobolevsky and Dr. Grigory Rodchenkov published their 2011 paper, ‘Detection and mass spectrometric characterization of novel long-term dehydrochloromethyltestosterone metabolites in human urine’ in The Journal of Steroid Biochemistry and Molecular Biology during 2012. Dr. Rodchenkov was the Director of the Moscow Laboratory involved in subverting the doping control system for a number of years, and Sobolevsky was his assistant.

Dr. Rodchnkov’s book…

The paper outlined how long term metabolites of DHCMT could be detected up to six months after use. But this was using Russian Laboratory detection methods from 2011, nine years ago. In his ‘The Rodchenkov Affair’ book, Dr. Rodchenkov admits that the Moscow Laboratory didn’t purchase up to date equipment until May 2012 – in advance of the Sochi 2014 Olympics. If Emanuel and Barrera are correct, and Laboratory advances mean that DHCMT can be detected for much longer after use than in the past, then it is possible that avenues of appeal could open for the many Russian athletes sanctioned due to the IOC’s retesting of samples for the long term metabolites of DHCMT.

The number of affected athletes could be huge. In 2017, the IOC had identified approximately 80 adverse analytical findings (AAFs) for DHCMT from its retesting programme on samples taken at the Beijing 2008 and London 2012 Olympics, approximately 35 of them involving Russian athletes. This meant that in 2017, DHCMT accounted for around 70% of the 111 anti-doping rule violations (ADRVs) the IOC had reported through its retesting programme to date (exact numbers are difficult to report, as some athletes reported an AAF for more than one substance, and some athletes reported more than one AAF).

The IOC has now concluded its retesting programme for both Games, as the eight year Statute of Limitations for the London 2012 Games, which was in place at the time, expired on 12 August. In 2018, the IOC revealed that the retesting programme involved analysis of over 4,800 samples for Beijing 2008 and over 5,000 for London 2012. 

Questions have previously been raised over the methods used by Drs. Sobolevsky and Rodchenkov in their 2011 study. DHCMT is illegal in most countries, and it is understood that the 2011 paper involved administering it to Dr. Rodchenkov alone and searching for metabolites. 

Yet it would appear that the science behind the test for metabolites of DHCMT is not under question. ‘Other laboratories were involved in validating the metabolite identification method using different methods than the one used by the Moscow laboratory’, explained WADA in 2017. ‘Furthermore, each laboratory has to validate the detection method before they use it in routine analysis; and, the methods are reviewed by independent ISO accreditation bodies. The current detection method for turinabol [DHCMT] and its metabolites was validated by different laboratories using different methods and fulfils all the requirements for a routine anti-doping method as established under the International Standard for Laboratories.’

Legal headache

It is understood that Barrera is seeking to develop a class action lawsuit on behalf of players who have been sanctioned for low levels of DHCMT. This would be based on the idea that detection methods are now so accurate that a long term metabolite of DHCMT can now be detected from ingestion years ago.

It is important to point out that at 2ng/mL, the minimum reporting limit under WADA’s rules is more than 20 times larger than the 100pg/mL reporting limit proposed by the MLBPA. It is therefore questionable as to whether the same logic applicable in the lawsuit launched by Barrera would also be applicable to athletes sanctioned by the IOC.

In 2016, WADA’s addition of meldonium to the Prohibited List created widespread chaos, after it later emerged that excretion times (the amount of time that the substance takes to leave the body) were much longer than first thought. This resulted in a number of athletes being sanctioned for taking the hormonal and metabolic modulator before it became prohibited.

This isn’t the same situation, but it is similar. In 2011, it would appear that long term metabolites of DHCMT could only be detected for up to six months. But there have been huge advances in detection methods, meaning that this time length may have increased. One method of proving this could be to request a sample today from an athlete who tested positive for DHCMT over a year ago.

As such, WADA and the IOC are likely to be watching developments in the US with interest. If Barrera’s lawsuit is successful, then the IOC and WADA could face a legal headache.

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