Response to media inquiries about a MLB player who tested positive for a banned substance (reported to be androstenedione) and is attributing the result to his use of the dietary supplement product(s) 6-OXO or 6-OXO Extreme (January 13, 2009)
The media has reported that baseball pitcher J.C. Romero has alleged that his positive test for the banned substance androstenedione is attributable to use of our dietary supplement product, 6-OXO Extreme. Proviant Technologies is immensely proud of our quality control standards and our strict compliance with all applicable laws and regulations. We are confident that our products are untainted by any contaminants.
However, while advances in analytical testing and sensitivity in detection of metabolites have made drug testers more proficient at catching cheaters, the unintended consequence is that a perfectly legal and untainted substance can cause a positive test for a banned or illegal substance. Although little information has been released about the specifics of the alleged positive test, our preliminary investigation of these allegations has uncovered information showing that the main active ingredient in our product (androst-4-ene-3,6,17-trione; also known as 4-Etioallocholen-3,6, 17-Trione) will trigger a false positive for androstenedione.
What is a false positive?
A false positive in doping analysis happens when an athlete’s urine sample is found to contain markers that indicate the ingestion of a banned substance, even though the banned substance itself was never ingested by the athlete. There are many causes of false positives, but in the case of Mr. Romero we believe the false positive is due to a case of ‘shared metabolites’.
It is important to know that drug testers usually do not look for the presence of the drug itself in urine; rather they look for breakdown products called ‘metabolites.’ In the case of the androstenedione test, we recently learned that the metabolite they screen for is a substance called 6a-OH-androstenedione.
This metabolite happens to also be a major metabolite of the main active ingredient in 6-OXO Extreme (see Detection of androst-4-ene-3,6,17-trione (6-OXO) and its metabolites in urine by gas chromatography-mass spectrometry in relation to doping analysis; Biomed Chromatogr. 2005 Nov;19(9):689-95). Consequently, it is clearly evident that Mr. Romero received a false positive due to his ingestion of the main active ingredient androst-4-ene-3,6,17-trione which was present in the legal supplement 6-OXO Extreme. Mr. Romero’s positive had nothing to do with any alleged ‘contamination’ of the nutritional supplement.
When asked to comment after reviewing the relevant studies, world renowned anti-doping expert Mauro DiPasquale, M.D., said, “It is my opinion that the putative positive drug test for androstenedione was a result of the ingestion of the compound androst-4-ene-3,6,17-trione, which is found in 6-OXO and not a result of the direct ingestion of androstenedione.” He explained that, “In order to generate a positive test for androstenedione, a significant amount of androstenedione would have to be ingested. The trace amounts that would be present as a contaminant would not significantly alter the hormonal profile so as to provide indirect use of androstenedione.”
These findings and comments reinforce our longstanding position that while many dietary supplement products are safe and lawfully marketed, competitive athletes and others subject to urinalysis testing for banned substances should not use them. Not only do both professional and amateur athletic agencies warn athletes to beware of supplements, but our company puts explicit label warnings on each and every bottle of our 6-OXO products. Our labels read, in pertinent part: “Use of this product may be banned by some athletic or government associations (including military).”
Proviant supports Major League Baseball’s anti-doping policy and efforts to keep banned substances out of sports. We will continue to provide explicit warnings on our product labels to prevent responsible athletes from testing positive based on dietary supplement consumption. However, it is the responsibility of athletes who are subject to urinalysis testing to carefully read warning labels and diligently investigate and monitor the substances they ingest, be it food, drugs or dietary supplements, as the list of substances that are banned by various sports organizations is highly expansive and includes many substances which are safe, legal and commonly consumed by non-athletes.
James Klein, CEO
Sports Supplement Acquisition Group Inc.