A new piece slid into the kaleidoscope view of the federal probe centered on Lance Armstrong's past U.S. Postal Service teams last week -- an alleged acquisition of an experimental drug.
Sports Illustrated, citing an anonymous source, reported that investigators are looking into evidence that Armstrong had access to HemAssist, a blood substitute tested in clinical trials more than a decade ago because it was thought to have promise for trauma patients.
Armstrong's spokesman, attorney Mark Fabiani, said the seven-time Tour de France winner denies ever using the drug and termed it "impossible" that he could have acquired it after recovering from cancer treatment and returning to cycling in 1998. "There is no indication whatsoever that anyone -- let alone Lance Armstrong -- had access to the discontinued drug," Fabiani wrote in an e-mail to ESPN.com, citing regulations imposing strict security on supplies.
HemAssist wouldn't play a part in any potential case against Armstrong unless federal prosecutors were to present far more substantial evidence. But mention of the drug does shine light on one of the most elusive parts of the doping food chain.
Anti-doping authorities have long known that athletes hoping to end-run testing obtain experimental drugs through the black market. This year, the World Anti-Doping Agency code changed to reflect that concern, adding catch-all language that bans use of "any pharmacological substance with no current approval by any governmental regulatory health authority for human therapeutic use (i.e. drugs under pre-clinical or clinical development or discontinued)."
"We're trying to ensure we have more than one arrow in our quiver," said WADA director general David Howman. In addition, WADA signed an accord last year with the International Federation of Pharmaceutical Manufacturers & Associations that includes an agreement to share information about drugs that might be appropriated for performance-enhancing purposes.
HemAssist -- developed for use on patients suffering from severe blood loss due to trauma or surgery -- is a blood oxygenator that would have fallen into that category.
The drug was tested in late-stage clinical trials in the United States and Europe from 1996-98. Tim Estep, the former vice president of research and development for Baxter Healthcare Corp., said HemAssist was manufactured in the Chicago suburb of Round Lake, Ill. and in Belgium, and distributed to roughly 50 clinical trial sites in the U.S. and Europe. He said it had to be shipped and stored frozen, and would have been packaged in clinical doses of 250 milliliters (roughly a half-pint). The drug was administered in hospital emergency rooms, and in Europe was also carried on ambulances.
The clinical trials were deemed a failure, partly due to higher mortality rates among patients, and halted in 1998. The trial sites had standard agreements with the company under which they were either supposed to send back or destroy leftover supplies of the drug, said Estep, now an independent consultant in the field.
"All of that is supposed to be documented," Estep said, adding that the company's quality assurance group tried to ensure that Baxter's procedures, as well as mandatory regulations set by the U.S. Food and Drug Administration, were being followed. "But there's no way those people can be everywhere, 24/7," he said. "At some point, you have to rely on the procedures at the different sites."
Estep said he never heard rumors or reports of any missing inventory of HemAssist, but said it could have been illegally obtained "if you were diligent enough and nefarious enough."
"To the best of our knowledge, it was taken care of properly," he said. "Baxter is a very ethical company and tried to do the right thing. But [HemAssist] was in a lot of places. You had to have it in emergency rooms around the clock."
HemAssist has no proven performance-enhancing qualities. In fact, according to Estep, when the drug was tested on rats, it actually decreased blood flow to skeletal muscles -- those closest to the bones. It had varying effects on the internal organs of human patients, and caused nausea in some. None of those side effects would seem to be particularly appealing to an endurance athlete.
But Estep said that didn't stop Baxter from worrying about whether athletes might try to get their hands on the drug, or even counterfeit versions of it. In May 2001, police conducting raids at the Tour of Italy found packages marked with the HemAssist brand name in the belongings of rider Dario Frigo, but the substance turned out to be water. There is anecdotal evidence that other riders have used blood substitutes.
After clinical trials were concluded, Baxter did retain some quantity -- Estep said he did not know how much -- of HemAssist for laboratory use as a comparative substance in the development of recombinant (genetically engineered) hemoglobin. By that time, Baxter had acquired a Boulder, Colo.-based biotech company called Somatogen and moved its hemoglobin therapeutics program there.
In early 2001, anti-doping researcher Michael Ashenden contacted Baxter to ask the company to cooperate with a group of scientists aiming to develop a test for blood substitutes. Ashenden, head of the Australian research consortium Science and Industry Against Blood Doping, was coordinating the study, which was funded by WADA. He met with Estep and secured Baxter's agreement to furnish a small amount of HemAssist, along with proprietary information on how to detect it.
"We wanted to be on the right side of this," Estep said. "We thought of [HemAssist] as a product with revolutionary implications, but it could also be abused." He said Ashenden arranged for him and a Baxter lab director to meet with Boulder resident and retired marathoner Frank Shorter, then the head of the fledgling U.S. Anti-Doping Agency.
Under the agreement with Baxter, a small quantity of HemAssist was transferred to a lab in Montpellier, France, in June 2001. Ashenden said the scientists also obtained similar blood substitutes from other companies, and manipulated tiny amounts of them at any given time. Researchers in France worked on the study for the next two years, and the group published its results in February 2004. The test was introduced in competition for the first time at the Athens Olympics that summer.
Baxter closed down its hemoglobin therapeutics program in late 2003. Company spokeswoman Deborah Spak responded to an inquiry about the drug by writing: "Given the amount of time that has passed since discontinuation of the program, we don't have much detail to provide. The product was never commercially available, and administered only through carefully controlled clinical trials within specific hospitals during and prior to 1998."
It remains to be seen whether that long-closed file has any relevance to current events.
Bonnie D. Ford covers Olympic sports for ESPN.com. She can be reached at firstname.lastname@example.org.