Expert on new Salbutamol study: ‘Not a game-changer’ for Froome case

CALTAGIRONE, Italy (VN) — For the past several days at the Giro d’Italia, there was a new, confident vibe coming out of Team Sky.

There were private comments expressing optimism about Chris Froome’s ongoing Salbutamol case. The four-time Tour de France champion even went so far as to say he thinks he will be cleared of all changes in the ongoing, controversial case.

“I haven’t broken any rules,” Froome said before the start of the Giro last week. “I’m confident that people will see it from my point of view when all the details are out there.”

On Monday, the world was clued in to why. The Times of London reported on a new study that could be a key pillar to Froome’s defense.

The report — titled “Futility of Current Urine Salbutamol Doping Control” — was published in the British Journal of Clinical Pharmacology. The authors claim that existing protocol is not viable to determine how big of a dosage of Salbutamol is in a sample based solely on one single “untimed” urine sample.

The study made some alarming claims about the current Salbutamol testing methods. By analyzing data from previous tests, the authors stated that results from existing protocol vary widely and, in some cases, can produce false positives.

VeloNews reached out to Dr. Tom Bassindale, a forensic toxicologist and lecturer at Sheffield Hallam University in the United Kingdom, for an expert opinion.

Bassindale read the report in detail and cautioned against jumping to conclusions based on the new study. He pointed out that the study is based on modeled data taken from previously published works, and is not based on real-time independent samples.

“I certainly don’t see it as a game-changer for any panel looking at this case,” Bassindale said. “WADA will back their science and have funded several research projects over the years to look at inhaled Salbutamol.”

Froome’s high-profile case casts a spotlight on Salbutamol and its use in cycling events. In 2010, the World Anti-Doping Agency removed it from its banned list when taken in spray form. A TUE (therapeutic use exemption) is no longer needed, but officials put a ceiling on allowed limits. That limit is 1,000ng/ml or, broadly speaking, about 16 puffs in a 24-hour period or eight puffs in a 12-hour period. Other uses of Sabutamol, either in pill form or as a nebulizer, remained banned.

Anything above those allowed doses can trigger an adverse analytical finding (AAF) and can result in up to a two-year ban. Froome tested for levels as high 2,000ng/ml, but that number has reportedly been reduced as the case moves forward (see below). Froome claims he did not take more than the allowed dosages.

The study reviewed data based on allowed dosages of Salbutamol, and claimed that 15 percent of the subjects (among them dogs that were used in some of the trials) go over the allowed 1,000ng/ml threshold in urine tests taken at one hour after use. At four hours after the dose, the authors also claimed that three percent would still trigger above 1,000ng/ml at four hours after use.

What’s key about the study data is it based on taking the maximum allowable dosage in one shot rather than spreading it out, as a cyclist likely would before, during, and after a race.

Bassindale said other key factors were not included in the data, such as dehydration, hematocrit, urine production, all of which could be affected by riding in the heat.

“The data has limitations, which they acknowledge,” Bassindale said. “The variability of their results is very wide. That means the top end goes up a lot higher than expected. Again, they acknowledge this.

“They did not take into account anything like the condition of an athlete in a grand tour,” he said. “What I fully agree on is that you cannot tell the [dosage] from the concentration in a urine sample. Most toxicologists I know would be uncomfortable or would refuse to do so.”

The study’s findings sent another ripple through the cycling community.

Froome’s legal team has remained quiet ever since the case was leaked to the media in December. Froome did not comment on the latest report and said last week he would “not be providing a running commentary on every new development in the case.”

Sources close to Team Sky told VeloNews last week ahead of the start of the Giro that they are hopeful there is evidence to demonstrate that Froome did not break any rules during last year’s Vuelta. They are equally hopeful he could be cleared of any wrongdoing and thus avoid a racing ban and possible disqualification of the Vuelta.

UCI officials have hinted that the Froome case might be resolved before the Tour de France starts in July.

Froome levels recalibrated

The Times’s story also reported that Froome’s reading from his AAF taken during the Vuelta has been recalibrated to lower levels.

Froome tested for 2,000ng/ml after stage 18 just days before winning the Spanish grand tour.

According to The Times, Froome’s reading has been recalibrated to 1,429nl/ml based on correcting the “specific gravity” of the urine sample by considering such factors as dehydration and urine concentration.

“By that value going down like that, it tells us his sample was quite concentrated,” Bassindale said. “As in [it was] somewhat dehydrated rather than diluted.”

Even with the lowered level, however, Froome is still above the allowed limit and above “actionable” threshold of 1,200ng/ml.

The Times also revealed interesting details of how Froome administered the inhaler during the Vuelta. It reported, “that he increased his puffs during the race under the guidance of the team doctor, believed to have gone from two puffs per day up to 10 during the last week of the Vuelta because he felt worsening asthma conditions.”