The trouble with Ostarine: Jimmy Wallhead’s
16th March 2018
Nobody likes to be called a cheat in any walk of life. More specifically, nobody likes to be unfairly labelled as a cheat. Even more specifically, nobody who has worked hard for years in order to achieve success in a particular area likes to be unfairly accused of cheating their way to that success. It’s human nature to react against such allegations.
As you might have already guessed, this applies to athletes, but also to companies involved in the production of sports supplements. It becomes especially complicated when athletes accused of cheating blame supplement companies for cheating in order to get the results that athletes demand.
In 2016, two South African athletes competing in two different sports returned a positive test for exogenous testosterone. Both athletes blamed their positive test – or adverse analytical finding (AAF) – on contamination of the same product. Gordon Gilbert and Demarte Pena were Brand Ambassadors for Biogen, and blamed their AAFs on its Testoforte product.
In both cases, the South African Institute for Drug Free Sport (SAIDS) accepted that tests conducted by both athletes proved that Testoforte contained 4-Androstene-3, 17-dione, which it ruled gave rise to the AAFs reported by the athletes. The SAIDS rulings also made it clear that it took the view that both athletes had not intended to cheat.
Both athletes declared a number of supplements on their doping control forms (DCFs). As The Sports Integrity Initiative reported, Gilbert did not declare the use of Testoforte on his Doping Control Form (DCF), and so was sanctioned with a six month ban. Pena did declare Testoforte on his DCF, and escaped with a reprimand.
In June this year, the Court of Arbitration for Sport (CAS) upheld an appeal by the World Anti-Doping Agency (WADA) against the SAIDS rulings, and increased the bans applicable to both athletes to four years. The CAS rulings in both cases are included below, but are also publicly available on the SAIDS internet site.
As we shall see, Gilbert and Pena remain adamant that they didn’t intend to cheat, and assert that Biogen’s Testoforte is to blame for their AAFs. WADA is adamant that they did intend to cheat and they haven’t proved that Biogen’s Testoforte is to blame. Biogen is adamant that neither AAF was caused by Testoforte. At first glance, it may appear that somebody is not being truthful, but it would appear that the real story is a little more complicated.
In both cases, WADA’s contention is that the concentration of 4-Androstene-3, 17-dione in Biogen’s Testoforte is too small to have caused the concentrations of exogenous testosterone reported in the athlete’s urine samples. In other words, WADA contends that both athletes intentionally cheated. If that were the case, then a four year ban is applicable under the World Anti-Doping Code.
Both athletes declared a variety of supplements on their doping control forms when giving the samples that led to their AAFs. The table on the right shows which substances were declared by the athletes, which were analysed, and which tested positive for prohibited substances that were not listed on the label.
Not all the supplements were tested due to the limited financial resources of the athletes concerned. Pena escaped a civil war in Angola to become a mixed martial arts (MMA) fighter based in South Africa. He is the wealthier of the two athletes, and the jurisprudence in this case reveals that he earns approximately R15,000 (€854) per month, which covers payment of rent, petrol and food for himself and his wife. Yet he is considering an appeal against the CAS ruling, despite the risk that such a course of action would present to these earnings.
Gilbert says he spent £25,000 on his case, and he has run out of money for appeals. Like Pena, is furious at being labelled a doping cheat. As mentioned in our original article, Gilbert is an amateur athlete and was tested due to a ‘tip-off’. At the CAS hearing, it emerged that this ‘tip-off’ constituted a photo of Gilbert with an person who had been accused of an offence in an unrelated matter, and was therefore disregarded.
Under the World Anti-Doping Code, all anti-doping decisions must be notified to the World Anti-Doping Agency (WADA), which has a right to appeal1. As such SAIDS, the Results Management Authority in both cases, would have provided its decisions in the Gilbert and Pena cases to WADA.
When asked for the reasons why it decided to appeal both SAIDS rulings, WADA referred to its Appeal Brief. ‘The AAF seems to be compatible with the administration of a pharmacological dose of androstenedione several hours prior to the doping control’, it reads in both cases. As Professor Luigi Fumagalli, the sole CAS Arbitrator in both cases, puts it: ‘WADA’s contention […] is that the amount of this contaminant is too small to have been the cause of the positive test, inferring that Mr. Gilbert and Mr. Pena must have ingested or injected steroid hormones in some other form’.
“I have been a professional athlete for 13 years”, explained Gilbert, who is a former professional footballer, when we spoke to him in July. “Do they think that I am so dumb that I would take an illegal substance on the morning of a race, knowing that there is a chance I could be tested?”
As clarified above, WADA’s argument is that both athletes were intentionally doping. A glance at either ruling reveals WADA’s argument in support of this position is that neither athlete has scientifically proven that their testosterone AAF was caused by trace findings of 4-Androstene-3, 17-dione in Biogen’s Testoforte. Again, on this point, the athletes and WADA disagree.
‘Of the four contaminants that were actually found in minute traces in the pills, only one of them viz. androstenedione can have any effect on the IRMS [Isotope Ratio Mass Spectrometry] values for testosterone’, reads a WADA submission based on evidence from Dr. Irene Mazzoni, a WADA Research Manager and staff member2.
In short, WADA’s contention is that Gilbert and Pena would have to have taken a massive dose of Testoforte – the equivalent to approximately 300 tablets – in order to have returned the concentrations of testosterone reported in their AAFs. This is disputed by the defence for both Gilbert and Pena. ‘Dr. Mazzoni based her calculations on the stated composition of only one tablet’, argues Estée Maman, counsel for Pena. ‘Since there is no certainty regarding the individual composition of the tablets, the calculations are imprecise and must be rejected’3.
Fortunately for Biogen, but unfortunately for the athletes, Prof. Fumagalli, agreed4 with the interpretation of WADA and its staff. In Pena’s case, he also agreed with WADA’s contention that there could not have been an interaction with other substances the athletes had been taking, despite the fact that not all of them had been subjected to testing.
The sole CAS arbitrator also agreed with WADA that Gilbert and Pena had failed to establish that a daily intake of 10.6 meg of androstenedione would have an effect on the steroid profile of the athletes. In Pena’s case, Prof. Fumagalli ruled: ‘It is not established that the daily intake of 10.6 meg of Androstenedione, even over a prolonged period of time, would have an effect on the steroid profile of the Athlete (which passed from a T/E ratio of 1.1 on 11 July 2015 and a T/E ratio of 1.3 on 28 July 2016 to a T/E ration of 5.5 on 11 November 2016) and produce an alteration in the IRMS of the magnitude shown in the Athlete’s case’.
Prof. Fumagalli does admit that in late April 2016, when Gilbert ‘claims’ to have used Testoforte (words from the CAS judgment), the relevant batch number of the bottle in question was ‘several months’ past its expiry date. However, it does not appear to have been considered whether this could have had an impact on the urinary concentration of testosterone reported in Gilbert’s sample.
Gilbert and Pena’s defence also refers to the ‘Rivier Declaration’, a document submitted by Dr. Laurent Rivier, a former Director of the Swiss Laboratory for Doping Analysis (included below) in support of Gilbert’s case. It was dismissed as irrelevant to both cases by the sole CAS arbitrator. ‘The Rivier Declaration, in that respect, is of no support, since it only states that doses of Androstenedione much lower than those indicated by WADA (50,000- 150,000 meg) can affect the steroid profile and produce alterations detectable by IRMS (albeit “for just a few hours”), but does not state that 10.6 meg of Androstenedione can affect the steroid profile and produce alterations detectable by IRMS’, reads both decisions.
Prof. Fumagalli would only admit the Rivier Declaration as evidence ‘in support of the examination of Dr Mazzoni, and therefore only to the extent it addressed issues considered by Dr Mazzoni, and not in the portions relating to different issues’. However as can be seen from the Declaration, one of its main arguments is that the chain of custody regarding Gilbert’s sample was not adhered to.
Gilbert’s urine measured a pH of 6.8, which although high is not unusual in sport, where dehydration can affect pH balance. ‘Such a high pH value is usually the consequence of some biological degradations in the urine due to microbial proliferation after some abnormally high temperature applied to the sample during transportation and storage’, reads the Declaration.
Gilbert’s sample was taken on 13 May 2016. On 9 June, it was analysed by the Doha Laboratory, which WADA said indicated the presence of prohibited substances in the A sample. In his declaration, Dr. Rivier says that the Doha Laboratory reported Gilbert’s sample as ‘Negative’ in the Anti Doping Administration and Management System (ADAMS) used by WADA; however in the CAS decision, it is outlined that the Doha Laboratory was not accredited to perform IRMS analysis on the sample, so it was sent to the Rome Laboratory. On 17 January 2017, the Rome Laboratory reported an AAF for exogenous testosterone upon analysing Gilbert’s sample. Gilbert was notified on 2 March.
This means that eight months had passed between Gilbert’s sample being taken and an AAF being reported, and almost ten months passed between Gilbert’s sample being taken and receipt of notification about his AAF. In contrast, Pena’s test was on 11 November 2016, his AAF was reported by the Ghent Laboratory on 16 December, and he was notified on 15 February 2017.
‘Was the pH measured again at the Roma laboratory and, if yes, how was it compared to the Doha value?’, continues Dr. Rivier’s Declaration. ‘How have these high values influenced the IRMS determinations?’ The CAS decision in Gilbert’s case doesn’t appear to consider these key questions.
It also doesn’t consider whether the sample’s chain of custody had been correctly recorded; the possibility that sample degradation may have affected readings; or the fact that an expired batch of Testoforte could have affected the testosterone concentration in Gilbert’s sample. Although these arguments were not presented as a line of defence in either case, Prof. Fumagalli would have been aware of them, as they are outlined in both rulings, which also made it clear that he had read the Rivier Declaration.
The CAS decision in Pena’s case outlines his weight cutting regime5, as well as a genetic mutation6 which was argued could have had an effect on the levels of testosterone he excreted in urine. Pena also submitted evidence contradicting the findings of Dr. Mazzoni7, but these were disputed by WADA, who argued that ‘in view of the misleading information, remarkable coincidences and the scientific impossibility of the explanation provided by the Athlete, it is difficult to avoid the inference that the supplements were spiked with the prohibited substance precisely in order to explain the analytical results’.
Prof. Fumagalli ruled that he did not find Pena’s arguments convincing, and outlined that there was no scientific evidence in support of them8. He ruled that Pena did not demonstrate, on the balance of probability, that Testoforte and Test Freak were the products responsible for his AAF.
Also, as previously mentioned, neither athlete could afford to analyse all of the substances that they were taking. This involved seven supplements in Gilbert’s case and around ten in Pena’s case (as he listed ‘tribulus’ and ‘testo booster’ instead of the actual supplement names). In Pena’s case, the potential cumulative effect was mentioned by the defence, however a request to conduct a pharmacokinetic study (CPKS) was rejected by Prof. Fumagalli on procedural grounds.
The decisions reveal that Estée Maman approached Dr. Marthinus Johannes, Director of the Bloemfontein Laboratory, on the advice of Dr. Harris Steinman and Dr. Ross Tucker to conduct a ‘controlled, clinical test to determine whether the source of the positive urine tests returned by the Athletes, may have been the result of ingested supplements, contaminated with steroid precursors’. However Prof. Fumagalli refused to further delay the hearing in order to allow the study to be conducted, concluding that ‘no exceptional circumstances’ existed under R56 of the Code of Sports Related Arbitration to allow the admission of new evidence after the Appeal Brief had been filed.
The fact that Pena listed ‘Tribulus’ on his Doping Control Form (DCF) perhaps indicates that he was seeking a natural boost to his testosterone levels. Gilbert also listed Biogen Tribulus 400 on his DCF, and argued that he suffered from irritability and anxiety, hair loss and low testosterone. The irony is, as Sloan Teeple’s case proved, male athletes suffering with low testosterone can apply for a Therapeutic Use Exemption (TUE) to use the substance.
Tribulus terrestris is a plant, but a simple Google search for ‘tribulus testosterone’ reveals many supplements containing the ingredient boasting that they will increase natural testosterone production. It is also worth mentioning that tribulus terrestris is also marketed as a libido booster for both men and women.
A 2014 Study found that tribulus alone, without additional components, doesn’t boost testosterone unless combined with other pharmacological components. As both athletes did combine tribulus products with other components, you would be forgiven for assuming that this is key, but it does not appear to have been fully considered in either CAS ruling.
A 2016 Study found that serum testosterone levels increased significantly in male rats subject to overtraining after three to four weeks of tribulus treatment. A 2018 Study found: ‘The urinary testosterone/epitestosterone (T/E) ration was also measured in weeks 0 and 6, and no differences were found between or within group. This test is used to detect abuse of substances with androgenic properties prior to professional competitions. The use of doping agents by professional athletes is strictly prohibited and such awareness is of utmost importance.’
However the same Study (PDF below) also noted: ‘Ma et al.  showed no significant changes in plasma testosterone and DHT levels between and within group, along the 10-week period of the study. Contrarily, Salgado et al.  observed a significant increase in serum DHT levels; however, there were no changes in serum DHEA and testosterone levels, as per treatment with T. terrestris. In a previous study, Adimoelja and Adaikan  demonstrated that daily administration of 750 mg T. terrestris extract, for a period of 3 weeks, significantly increased serum DHEA concentrations, in diabetic and non-diabetic men. These data combined indicate that the existing evidence in the literature is still controversial and requires further investigation. Thee potential role of T. terrestris in promoting the endogenous production of steroid hormones is of great interest, due to the subsequent expected effects on muscle hypertrophy and lean mass gain.’
‘The efficacy of supplementation with T. terrestris in combination with a healthy diet and routine physical activity, with the purpose of gaining muscle mass and losing body fat, is still unclear’, the Study concluded. ‘Further robust randomized controlled trials with strict inclusion criteria, larger sample sizes and longer periods of duration are warranted’. In other words, it would appear that the scientific jury is still out regarding:
• whether tribulus is effective in boosting testosterone; and
• whether use of tribulus results in increases in urinary concentration of testosterone; and
• whether tribulus combines with other components to increase testosterone/the urinary concentration of testosterone.
Yet as explained above, the sole CAS arbitrator rejected, on procedural grounds, the possibility of conducting a Study examining these anomalies in order to ascertain how Gilbert and Pena had reported an AAF for exogenous testosterone. In both cases, it was argued that such a rejection was sufficient grounds for the Swiss Federal Tribunal intervene, as such a pharmacokinetic (CPKS) study would be likely to have a bearing on the outcome of the cases.
The Gilbert and Pena cases were both heard on 15 March in Johannesburg. Both athletes blamed Biogen’s Testoforte for their AAF and insist that they did not intend to cheat. In such unusual circumstances, it is perhaps inevitable that a number of allegations have been made by both sides. After all, both athletes were Biogen Ambassadors and talked to each other. In short, the important ones are outlined below, and will be dealt with in turn:
• That Biogen’s Testoforte is ‘contaminated’ with substances not listed on the label;
• That Biogen offered Demarte Pena R100,000 (€5,700) ahead of the CAS hearing to stay quiet about his case;
• That both athletes were advised to take Testoforte, and were given Biogen products – including Testoforte – by representatives of the company;
• That Gilbert was advised against and cautioned about using certain products ahead of his AAF;
• That Biogen representatives met with Ross Wenzel, WADA’s Counsel, ahead of the 15 March hearing in Johannesburg;
• That Gilbert only mentioned using Testoforte after appointing Pena’s lawyer, Estée Mamann;
• That after the cases, Biogen put warning labels on Testoforte advising athletes not to use it.
“The very product I took came back with three types of steroid in it”, said Gilbert. “Then I bought two other bottles, which were dated 15 months older than the one which I took, they also came back as positive for the exact same stuff. They argue that there wasn’t enough of the prohibited substance in the product to report an AAF. That’s at WADA’s discretion and they wouldn’t allow me to prove otherwise. So how can they go forward on that premise?”
‘We disagree on the term “contamination”’, read a written statement supplied by Biogen, which argues that Testoforte is a libido booster, not a sports supplement. The company’s statement outlines that it only recommends its sport supplement range as safe for athletes to use, as is tested via Informed Choice and Informed Sport.
‘To a general layman, most would not appreciate the difference between “contamination” and a trace “finding”’, continues the written statement. ‘“Contamination” is when a manufacturer has a batch specific issue of products that are tainted or “contaminated” with a banned substance, in the sense that a foreign ingredient found its way into the product. This is not the case with Testoforte.
‘Biogen Testoforte and Tribulus Terrestris is a complex herbal/botanical ingredient and as such, certain batches may give rise to trace findings of prohibited substances in sport, but that are safe for consumption to any consumer. This will be consistent with many other tribulus based products that we have seen will show similar trace findings. It is inherent to a testo-boosting type product that comprises complex herbal botanicals. The levels are usually at nanogram level, or one billionth of a gram.
‘To give a comparison, these ‘nanogram’ levels can easily be compared to examples of food sources containing prohibited substances include phenethylamine in chocolate and octopamine and synephrine in marmalade. In this case, the consumption of chocolate would not be labeled as the cause for a doping violation for phenethylamine. It is not on the label, as it is inherent and at a trace level, because it is a byproduct of the food, not a specific or an intentional formulation design. Furthermore there are other reports on the internet that confirm that herbal products containing Tribulus have been shown to show trace findings for Testosterone metabolites.’
However, as previously reported, the Advertising Standards Authority of South Africa (ASASA) upheld complaints about two Biogen adverts in August 2012. The adverts claimed that Testoforte:
• Increases testosterone within natural ranges;
• Maintains lean muscle;
• Heightens energy levels, sex drive and physical performance;
• Increases stamina, performance and desire naturally;
• The ingredients were used by Chinese physicians for up to 2,000 years as a sexual enhancer;
• Increases male libido.
An August 2015 advisory (PDF below) issued by the Clay Target Shooting Association of South Africa (CTSASA) about Testoforte lists its ingredients, one of which is ‘BioPerine™’ (undisclosed mix of ingredients). Therefore, although Biogen claim that Testoforte is not marketed at athletes, the two ASASA rulings above show that Biogen was forced to withdraw Testoforte advertising claiming that it increased testosterone; heightens physical performance; increases stamina and performance. In addition, the CTSASA ruling shows that it contains a trademarked unknown ingredient.
Pena alleges that ahead Biogen offered him money to stay quiet about his case, ahead of the 15 March CAS hearing. This allegation is not explored in the CAS ruling, but is highlighted by Pena in paragraph 76(ii) of his ruling; and in paragraph 82(g) of the Gilbert ruling. Pena specifically alleges that Biogen offered him R100,000 (€5,700) on page 27 of his ruling.
Biogen deny offering Pena money to stay quiet about his case. However it is easy to see how the deal which it does admit offering Pena could be interpreted as a bribe to stay quiet.
Biogen dropped Pena as a Biogen Brand Ambassador with a year left on his contract, but offered him the remaining value of his contract, had it continued. The company says that this offer initially comprised a ‘combination of cash and product’. The value of a Biogen Brand Ambassador contract, seen by The Sports Integrity Initiative, is outlined at R100,000 per year.
Biogen alleges that Pena – perhaps understandably – indicated that he would prefer to receive the cash value of the products that were due to him under his role as a brand ambassador. Biogen said it agreed not to pursue the case if Pena acknowledged that he was using multiple testosterone-based and tribulus-based products, and if he acknowledged that Biogen was not solely responsible for his AAF. Pena refused, as he considers Testoforte responsible for his AAF.
Gilbert also alleges that he promised Biogen he would stay quiet if they offered him compensation, as well as putting out a press release acknowledging that there was an issue with Testoforte that had caused his AAF. It has been alleged that before WADA announced it would be appealing his case, Biogen told Gilbert that his case would be appealed in the same way that Pena’s was, if he continued to press for compensation. Biogen deny this.
As previously mentioned, both athletes were Biogen Brand Ambassadors, and both allege that they were given products by Biogen. Both athletes had store-based accounts enabling them to collect Biogen products. Biogen admits that prior to this arrangement, it did supply products to athletes, but argues that this was four or five years ago, prior to Gilbert and Pena’s AAFs.
Gilbert alleges that he was advised to use Testoforte by Brandon Fairweather, a Biogen employee. Complicating the matter is the fact that Gilbert and Fairweather were friends. Gilbert claims that Fairweather advised him to use Testoforte to combat personal symptoms caused by low testosterone. In other words, he argues that Fairweather advised him to use the substance in a context unrelated to sport.
Fairweather denies advising Gilbert to use Testoforte. The CAS ruling reveals that Gilbert initially alleged that Fairweather supplied him with Testoforte in October/November 2015, however that he had previously bought it for his brother in law in September 2015. Fairweather argues that Biogen noticed that Gilbert had bought Testoforte in September 2015, and suggested that he avoid it.
Fairweather also claims that Gilbert was formally warned against use of Tribulus-based products ahead of his AAF. Gilbert admits that he was warned, but states that this was after the Pena February 2017 AAF, based on Pena’s November 2016 test. Gilbert was tested in May 2016, but was not informed of his AAF until 2 March 2017. “Only after the Demarte Pena AAF did I receive an email from Biogen telling me not to use products not recommended by Informed Sport”, he argues.
Biogen also allege that based on his store account usage records, Gilbert adhered to its 2015 warning. However, the company also admits that a ruling was sent out after both rulings to Biogen’s existing athletes. “Certain athletes – Mr. Gilbert in particular – we gave the warnings, told them what to use, and they still didn’t listen”, said Fairweather in a Skype interview. This statement appears to contradict Biogen’s claim in its written statement that Gilbert adhered to its 2015 warning, which Gilbert says was only issued to him after Pena had reported his AAF.
Fairweather said that Biogen doesn’t have the 2015 warning email sent to Gilbert, but it does have the updated contracts that were issued to its brand ambassadors that year. It did not supply them to The Sports Integrity Initiative, but Gilbert did. The contracts warned athletes that they should only use Informed Choice or Informed Sport products, but Gilbert didn’t read or sign the contract, which he says was sent to him in November/December 2015.
Gilbert has a picture of him holding a bottle of Testoforte, which he says was taken on 6 March 2016, before Pena sent his substances off for testing. He argues that before November 2015, Biogen would load his store-based account with money to spend on Biogen products. He argues that he was either given Testoforte by Biogen or bought it using his store account, but because this occurred during a transition period from one system to the next, he cannot remember which it was.
Pena’s records verify that he did collect Testoforte via his Biogen account from a local store. Pena alleges he was advised to use Testoforte by Rory Diesel, a Nutritional Advisor at CrossFit 4E, and states that he was also given Biogen products by Fairweather “a number of times”, an allegation Fairweather also denies. Diesel did not respond to requests to contribute to this article, and was not called as a witness by either party in the CAS hearing.
Both Gilbert and Pena allege that Brandon Fairweather gave them Biogen products to use – in Gilbert’s case, that he specifically advised him to use it. Fairweather is a Marketing Manager for Biogen. He argues that although he used to arrange deliveries of supplements to athletes who were Biogen brand ambassadors, this approach was discontinued four or five years ago in favour of athletes collecting their own products from store-based accounts.
An August 2016 Instagram photo (see right) shows Fairweather pictured with Demarte Pena and MMA trainer Themba Gorimbo. ‘Just received our @biogensa products’, reads a caption. ‘You can get yours at any discherm [sic. Dischem] outlets nationwide’, it continues, also showing a number of Biogen products. As mentioned, Pena says that Fairweather gave him products “numerous times”. Fairweather argues that the image was taken as part of a video shoot, for which he has proof.
“Biogen say that they warned me against the product before my AAF”, says Gilbert. “This is bullshit. Why would a legitimate company warn me against a product that they have put on the shelf?”
Brandon Fairweather says that he personally drafted Gilbert’s sponsorship contract, which was sent to him in December 2015, six months prior to his AAF. ‘During 2015, he was also cautioned against the use of tribulus products’, states Fairweather’s statement. ‘I have a voice note from him reminding me of this fact. Based on his product usage records, it appears that caution was adhered to, despite his claims. Why would we caution him against using a product and then give it to him?’
Fairweather’s statement argues that he has no record of Gilbert using or collecting Testoforte from his store account, either in November 2015 as he claims, or in the months leading up to his May 2016 AAF. ‘He has been completely dishonest here, I am afraid’, Fairweather alleges in his written statement.
Perhaps understandably, Gilbert disagrees. “The CAS ruling points out that there is no record of me having bought Testoforte in 2016”, he says. “That is because I bought it in 2015 and kept it in my cupboard”.
As already mentioned, Gilbert has a picture of him holding a bottle of Testoforte, taken on 6 March 2016. He argues that before November 2015, Biogen would load his store-based account with money to spend on Biogen products. He argues that he was either given Testoforte by Biogen or bought it using his store account, but because this occurred during a transition period from one system to the next, he cannot remember which it was.
If this is correct, then Biogen would have no record of Gilbert’s use of Testoforte, as it would have not been recorded under the store-based account that later formed part of his Brand Ambassador agreement. Also, as explained, Gilbert didn’t read or sign the contract sent to him in 2015, and alleges that he was only warned after Pena’s AAF which – of course – came before he was notified about his own AAF.
“Prior to the hearing in Sandton, Johannesburg, my lawyer told me to meet him at a cafe just down the road”, states Gilbert. “I saw Ross Wenzel standing with the two representatives of Biogen”.
Wenzel said he met Fairweather on the day of the hearing. “It is completely normal to have contact with witnesses at a hearing, especially ones requested by me”, he said. “If not, they wouldn’t know any details about the hearing – for example where the hearing was due to take place. I sent Brandon Fairweather correspondence to meet at the venue and he turned up at the beginning of the hearing. He had two other people with him, who may have been from Biogen.”
However, Fairweather says he met with Wenzel the day before the hearing. ‘Yes, I met Ross the day before the hearing, with our lawyer to answer some of his questions around the cases’, reads his written statement. ‘Important to stress here that at NO stage throughout this process did Biogen ever initiate contact with WADA regarding the initial outcomes. WADA attorneys contacted us after WADA had received the SAIDS outcomes and were not satisfied with the original verdict.’
In Gilbert’s case, WADA argues that Gilbert initially claimed that the testosterone detected in his sample was endogenous (naturally produced – i.e. not external), filing a medical statement from Dr. Pierre Van der Walt. WADA argues that Gilbert only changed his position after appointing the same lawyer at Demarte Pena, after which he argued that Testoforte bought in 2015 and used it from late April 2016 until 4 May 2016 was the source of his AAF. As previously explained, Biogen and Fairweather deny this.
“I was unaware what it could be”, explains Gilbert. “I was told that there was no way it could have been any of Biogen’s products”.
Biogen assert that Gilbert’s modification of his position illustrates that he was scratching around for an explanation as to what might have caused his AAF. ‘In the first few weeks of March 2017 (after finding out about the AAF), the ongoing messages to myself made it very clear that he had no clue what could have caused his AAF’, reads Fairweather’s written statement. ‘But then, on 22 March 2017, he changed legal counsel and notes specifically that he was “Bringing another lawyer on board – She used to work for SAIDS” – (incidentally the same counsel as Mr Pena). After this, he suddenly requested information on “Testoforte and tribulus” – for the first time, not having eluded to this once prior. Our view is that Mr Gilbert was not using Testoforte and has been dishonest in this regard.’
Gilbert doesn’t dispute the idea that he was initially unsure about what had caused his AAF, but argues that he had used Testoforte and laboratory analysis confirmed that this was the cause of his AAF. As previously explained, the sole CAS Arbitrator ruled that he had not proved this.
“The first thing that Biogen did when they found out that their products were contaminated was to put a big yellow sticker on their product to label it as not suitable for professional athletes”, said Gilbert. “They didn’t take it off the shelves, because that would show weakness. They never did anything about it. How is that OK? There are three types of steroids in a product that is herbal and botanical, and considered safe.”
Biogen admits it put out a warning about Testoforte after Gilbert and Pena’s case, but argues it was a reminder about the dangers of tribulus based products. ‘Through our exclusive retailers, signage was placed up in front of all tribulus based products as far back as 2014’, reads its written statement. ‘There was also a massive multimedia campaign that ran for about six months ongoing in 2014, and for which signage, POS [point of sale] warning signs and flyers that remain in stores to date’.
This may be true, but it may also be true that Biogen was forced to do this by the two 2012 ASASA rulings previously mentioned. These complaints focused on a Testoforte advert entitled ‘Why testosterone is the male driver’, which also contained the claim that the supplement was scientifically formulated – i.e. not a botanical and herbal product, as Biogen and Fairweather claim.
“This product sits on the vitamins and herbal aisle”, argues Fairweather. “We have never, ever, labelled it as a sports supplement”. That may also be true, but as the ASA rulings suggest, it was marketed as a scientifically-formulated supplement that ‘maintains lean muscle’ and ‘increases stamina, performance’. Therefore, although it was not labelled and marketed as a sports supplement, historically it was advertised using language that might appeal to athletes.
Both athletes were taking various supplements. Both reported an AAF for exogenous testosterone. Both had been taking Biogen’s Testoforte and had some of the supplements they had been taking analysed to see if they could have caused the AAF. Separate analysis of separate batches of Testoforte by Gilbert and Pena revealed different concentrations of 4-Androstene-3, 17-dione, which is understood to be consistent with the AAFs, which both revealed the presence of testosterone and one of its adiols.
As shown above, there are inconsistencies in the evidence on both sides of both cases. Biogen argue that Testoforte is not a sports supplement and only contained trace findings of prohibited substances. The company argues that similar trace findings for prohibited substances are present in foods such as marmalade and chocolate.
Most forms of testosterone feature as a ‘specified substance’ on Prohibited List. This means that WADA recognises that such a substance can enter an athlete’s body inadvertently, however the burden of proof is on the athlete to establish how that happened. Biogen doesn’t dispute that Testoforte contained prohibited substances, only that the levels in its product were too low to cause the AAFs reported by two of their Brand Ambassadors.
The Doping Control Form (DCF – see right) asks athletes to list ‘any prescription/non-prescription medications or supplements’ that they have been taking. As Gilbert explains, he didn’t list Testoforte, as he didn’t consider it a medication or supplement. If trace findings of specified substances can turn up in food, are athletes also supposed to list what food and drink they have consumed as well? SAIDS was prepared to give the athletes the benefit of the doubt and accept that they hadn’t intended to dope. WADA was not, and maintains that both athletes intentionally doped. Why?
WADA spent money pursuing these athletes, and held a hearing was specially convened in South Africa in order to convict them. The CAS was prepared to take the word of a supplement company employee over both athletes. A casual observer could be forgiven for assuming that the supplement company employee has just as much to lose as the athletes.
Both athletes had a history of problems associated with low testosterone, as their supplement intake indicates. Most elite athletes – and many amateur athletes – take some form of supplementation. If trace findings are possible from non-supplements that athletes consume, how are athlete supposed to know what to list on their DCF?
Biogen admits that complex herbal products designed to target symptoms of low testosterone, which include ingredients such as tribulus, are considered high risk. It concedes that it is not uncommon to find metabolites of prohibited substances in such formulations. It was proven that a prohibited substance at a trace level was present in one of Biogen’s supplements, and the athletes were taking other supplements. Yet it maintains that Testoforte was in no way responsible for Gilbert and Pena’s AAFs. It is hard to see how the company can know this for sure unless the cumulative effect of everything that Gilbert and Pena were taking on the excretion of testosterone in their urine – adjusted for the impact of extreme exercise and dehydration – is measured.
In cases where athletes are taking a variety of supplements but none of them give rise to that AAF one their own, a scientific study might be considered a reasonable precaution in order to determine how such an AAF might have arisen. It might also inform future cases. Yet CAS rejected the possibility of conducting such a study after WADA objected on procedural grounds. Why?
As the title suggests, this article explains how the arbitration system set up to resolve doping disputes has failed Gilbert and Pena. Both are now subject to a four year ban, which under the World Anti-Doping Code is a penalty reserved for ‘intentional’ dopers. WADA is arguing that SAIDS is wrong in its judgement that both athletes had not intended to cheat, and asserts that both athletes intentionally doped.
Irrespective of whether Biogen or its employees gave the athletes products, it was almost impossible for the CAS to acquit Gilbert or Pena. The CAS is set up to adjudicate sporting disputes, and the anti-doping justice system requires athletes to prove, on balance of probability, how a prohibited substance entered their system.
As a comment to Article 10.4 of the World Anti-Doping Code puts it: ‘No Fault or Negligence would not apply in the following circumstances: (a) a positive test resulting from a mislabeled or contaminated vitamin or nutritional supplement (Athletes are responsible for what they ingest (Article 2.1.1) and have been warned against the possibility of supplement contamination); (b) the Administration of a Prohibited Substance by the Athlete’s personal physician or trainer without disclosure to the Athlete (Athletes are responsible for their choice of medical personnel and for advising medical personnel that they cannot be given any Prohibited Substance); and (c) sabotage of the Athlete’s food or drink by a spouse, coach or other Person within the Athlete’s circle of associates (Athletes are responsible for what they ingest and for the conduct of those Persons to whom they entrust access to their food and drink). However, depending on the unique facts of a particular case, any of the referenced illustrations could result in a reduced sanction under Article 10.5 based on No Significant Fault or Negligence.’
In shorter terms, you can be sanctioned for an ingredient that isn’t on the label of a supplement; if you are given something to eat or drink; if your food or drink is sabotaged. The sole CAS Arbitrator did not accept that either athlete had proved that Testoforte was the origin of their AAFs, so had little choice but to sanction them with four year bans. In anti-doping cases, athletes are guilty unless they can prove that they are innocent. Gilbert and Pena are guilty of not proving that they are innocent.
So we are faced with a situation where in order to preserve the justice system it has created, WADA is forced to pursue a case against two low profile (apologies…) athletes. Had WADA let the SAIDS rulings pass, they may have set a precedent where athletes reporting an AAF could blame trace findings in everyday products, without conclusively proving the exact source. Such a finding would have undermined the ‘strict liability’ principle on which the anti-doping system is founded.
Both athletes maintain that they didn’t intend to cheat, and prohibited substances did not feature on any of the labels of the products they were taking. Yet both have been hit with maximum bans for intentional doping, because they do not have the money to prove the exact source of their AAF. It isn’t hard to see how the athlete have concluded that they have been unjustly treated.
For example: they didn’t have the money to argue that the hair of frozen mummified inca children had tested positive for a metabolite of cocaine, thereby proving that positive tests for the substance predated its 1859 isolation. They didn’t have the money to commission a Nobel Prize winner to conduct studies into arguments that could be presented in order to ensure that CAS has no choice but to dismiss their cases.
Unfortunately, Gilbert and Pena are not alone. British weightlifter Sonny Webster, who competed at the Rio 2016 Olympics, was sanctioned with a four year ban by UK Anti-Doping (UKAD) in December last year.
‘I was offered on two occasions to admit to knowingly taking ostarine in exchange for a 50% ban reduction’, said Webster in a statement. ‘You may think that that was a stupid offer not to take, but I was never going to admit to something that I had not done intentionally regardless of the consequences. I was prepared to do everything in my power to prove the truth.’
Webster says that he spent his life savings attempting to discover the source of the ostarine, which he argues could have been due to contaminated supplements or salt tablets. ‘The UKAD analyst testified that the amount of ostarine found in my body was the lowest that has ever been reported (4 nanograms/ml) which would make it near impossible to establish the source’, reads his statement.
Beth McKenzie accepted a two-year sanction issued by the World Triathlon Corporation (WTC), which agreed that her ingestion of ostarine was unintentional. However, she could not definitively prove that her ostarine AAF was due to contaminated salt tablets. Laboratory evidence could not prove the contamination through testing of other packets from the same supplier. It is hard not to find sympathy with her extensive tale of woe, which you can read about in her blog post. Another triathlete sanctioned for ostarine, Lauren Barnett, has taken legal action against Classified Nutrition, alleging that three separate laboratory results confirmed that Neurolytes capsules contained concentrations of ostarine at approximately 150 nanograms per capsule.
Chris Froome was permitted to conduct a pharmacokinetic study (CPKS), but Gilbert and Pena were not afforded the same privilege. Froome’s case showed that producing a CPKS proving that salbutamol concentration in urine at above levels permitted by WADA is consistent with inhalation below WADA’s limit is close to impossible, thereby rendering such limits inapplicable. As Gilbert and Pena’s hearings were held in South Africa to save both athletes money, the CAS refused to delay their hearing to conduct a similar CPKS on how tribulus based products affected testosterone concentrations in urine.
It is possible that such a study may have come to a similar conclusion to that reached in the Froome case, which would again have been disastrous for the anti-doping system. Pena argued that such a refusal is grounds for an appeal to the Swiss Federal Tribunal, but again, this costs money. It is worth noting that none of the athletes listed above are particularly high profile except for Froome, and he had the financial resources to prove that the test that led to his AAF was unworkable.
Under the anti-doping justice system that sport has created, it is easier for WADA to argue that both athletes were intentionally doping, irrespective of whether this is accurate. The alternative is a long drawn out and expensive case, which if WADA loses, may result in it having to admit that it sought a four year ban against inadvertent dopers in order to preserve the strict liability principles of the anti-doping system.
Such an admission would give the lie to WADA’s claim that it respects the rights and integrity of clean athletes, as if this were to happen, WADA would be revealed as seeking a maximum ban against unintentional dopers. Unfortunately, it would appear that Gilbert and Pena are scapegoats for preserving sport’s perverse anti-doping justice system. This is where arbitration has failed them.
1. This is outlined in Article 14.2 of the Code, and in rule R47 of the Code of Sport Related Arbitration. ‘The RMA [Results Management Authority] must notify the Athlete, IF [International Federation], NADO [National Anti-Doping Organisation] and WADA of all results management, ADRV and appeal decisions, as these organizations have a right of appeal’, outlines WADA’s Guidelines on the 2015 Code. ↩
2. WADA also argued: ‘5-alpha and 5-beta androstenedione are metabolites of androstenedione and do not convert to testosterone; similarly, boldione (also known as 1,4 androstadiene-3,17-dione) may convert to boldenone but not to testosterone […] The fact is that no pill had more than 3 mcg of androstenedione in it (and most had significantly less) and that is the only contaminant that could have affected the testosterone IRMS. As Dr. Mazzoni has stated, a dose of 50,000 mcg would have been required to affect the IRMS values.’↩
3. ‘The “Estimated concentration of compounds in Supplements Tested’ (Exhibit 12 to the answer of Mr Demarte Pena in the Demarte Pena Arbitration) and the LGC Report justify a calculation that the total quantity of the five contaminants contained in the tablets ingested amounted to 11.7mcg (=11,700 ng) for the daily dose of Testoforte taken by the Athlete, and scientific studies show that “this is more than sufficient to alter the steroid profile and raise urine concentration levels significantly”. Together with other precursors such contaminants would have cumulatively the effect to alter the steroid profile and the urine levels also after 9 days; Dr Mazzoni’s statement regarding an alleged administration of a pharmacological dose of steroids several hours prior to the doping control is incorrect and unsupported by actual evidence: the Rivier Declaration states that doses of Androstenedione much lower than those indicated by WADA (50,000-150,000 meg) can affect the steroid profile and produce alterations detectable by IRMS, albeit “for just a few hours'”; “it is non sensical to even suggest that there is a pharmacological dose “extra” when the exact compounds found in the contaminated bottled of the Testoforte … are exactly what appear in the urine of the athletes”.’↩
4. ‘It is not established that 5 contaminants leading to an AAF for Testosterone were detected by the Bloemfontein Laboratory and by the LGC Laboratory in the contaminated product used by the Athlete’, reads the CAS decision in Pena’s case. ‘Indeed, based on the scientific evidence on file, or referred to by the Parties, the Sole Arbitrator is satisfied that the only relevant precursor of Testosterone found is 4-Androstene-3,17-dione (Androstenedione), while the other substances either do not affect the biosynthesis of Testosterone (5a-Androstanedione, 5p-Androstanedione and 1,4- androstadiene-3,17-dione) or were an internal standard added by LGC for analytical purposes (D3-19 Androstenedione). Such circumstance has the following effects:
• the calculation of the amount of prohibited substance (Androstenedione) ingested daily by the Athlete leads to 10.6 meg (=10,600 ng), based on the maximum amounts of Androstenedione found in the tablets of Testoforte and of Test Freak, multiplied by the standard daily dose of those products; and
• there is no “interaction” with other “unqualified” precursor, which could have amplified the effects of the daily intake of 10.6 meg of Androstenedione.’↩
5. ‘Mr Pena competed in a MMA event, for which he had to reduce his body weight in order to qualifyfor the weight division in which he competes (Mr Pena had to cut approximately 10 kilograms in the weeks leading up to the competition in question). His weight cuttingprocess involves strenuous exercise, intake of excessive amounts of water, culminating in dehydrating practices, salt baths and saunas, two days before weight in, at which time he continued to take the supplement. He also attended at the hyperbaric chambers six times and took both supplements a few hours before being tested. This all was within a reasonably short period prior to the competition.’↩
6. The ‘genetic mutation of Mr Pena, in the Monoamine oxidase gene (MOA) code for enzymes called monoamine oxidases (being enzymes that are involved in the breakdown of neurotransmitters such as serotonin and dopamine (linked to testosterone our emphasis). The levels of these MAO’s in brain and other tissues are important because the levels of the MAO’s determine just how quickly metabolism of these neurotransmitters occurs or whether metabolism occurs at all, MAI Review, 2009, 2, Target Article by G Raumati Hook and which Mr Pena is a level 3 MOA as was handed to the panel, can not be disregarded at all. A level 3 with be overly sensitive to exogenous compounds or at times not sensitive at all.’↩
7. ‘Be that as it may in the scientific paper … it states “Reduction in A4 of boldione results intheformation5aand5B-isomersof1-androstenedione((5a)-l-androstenedione, M6, and (5’ft)-1-androstenedione,M7). Further reductions of the 17-keto group of M6 and M7produce (5a)-I-testosterone (M8) and (5(3)-1-testosterone (M9), respectively”. From my understanding and research, this is opposite to what has been stated on page 6-7 of Dr. Mazzoni second report and then leads to a whole lot of other things that are contained therein to infact be opposite to her theories. Boldione itself likely does not have any significant anabolic or androgenic value. However, after interaction with the 17b-HSD enzyme, boldione is converted to the illegal anabolic steroid boldenone. Boldione can also be converted to 1-androstenedione (1- AD) and/or 1-testosterone after interaction with the 5a-rednctase enzyme. These metabolites are where they gets most of their effects. Since boldione is a dione, conversions to the more powerful metabolites (such as those that are in the contaminated tablet), are then expected to be near 15-20% higher.’↩
8. ‘i. there is no scientific evidence that the MAO enzyme plays a role in the biosynthesis of Testosterone (let alone in the way that could explain the AAF);
ii. no link between the weight cutting process and the use of hyperbaric chambers, on one side, and the causation of the AAF because of the use of contaminated products, on the other side, has been established: the Athlete makes a simple reference to the efforts he made to lose weight inn order to fight in his category, but does not explain how this actually affected in his body the positive IRMS following the daily intake of 10.6 meg of Androstenedione;
iii. it is suggestive, but not entirely correct, to say that the AAF showed the presence in the Athlete’s body of exactly the same substance which contaminated the products he was using. Indeed, those products contained Androstenedione, while the AAF was reported for the presence of Testosterone and its “downstream” metabolites, and the presence of Testosterone of exogenous origin (undisputed) could well be the result of the administration of Testosterone itself and not necessarily of Androstenedione.’ ↩
Twenty three athletes from ten countries, competing in ten sports, were involved in anti-doping proceedings...
Twenty nine athletes from five countries, competing in ten sports, were involved in anti-doping proceedings...
Fifteen athletes from nine countries, competing in nine sports, were involved in anti-doping proceedings that...