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Wednesday, January 19, 2011

The drug of 2011? HemAssist and Armstrong

HemAssist:  A drug you'll never use, but you'll be hearing more about

A few weeks ago, as part of my Year in Review series, I gave the somewhat tongue-in-cheek award (though the repercussions were serious) for Drug of the Year to Methylhexanamine, a stimulant that was responsible for a slew of positive tests and sanctions.

2011 is barely two weeks old, and already a new drug name is hitting the news in a big way, thanks to a piece by Selena Roberts and David Epstein of Sports Illustrated.  That drug is Diaspirin Cross-Linked Hemoglobin (DCLHb), or HemAssist.  It is a Hemoglobin-based Oxygen Carrier (HBOC), part of a class of drugs that is engineered to carry oxygen.

A drug that "doesn't exist"

Only one problem - to date, despite testing and clinical trials, only one HBOC was ever approved for human use, but that was revoked in 2008.  Which means that this is a drug you'll probably never be given (hopefully you never need it - it's used in trauma cases where substantial blood loss has to be treated), and you probably would not have heard about it unless you followed cycling very closely.

So why then are we even discussing a drug that for all practical purposes "doesn't exist"?  Well, because this is the drug that Sports Illustrated have alleged that Lance Armstrong was able to obtain and use in the late 1990s, after clinical trials on the drug had been discontinued for ethical/safety reasons.  If true, it could be the drug that powered him to Tour de France titles (apart from EPO, corticosteroids and others, all of which he has been accused of using).  The rumor of Armstrong using a "designer" drug, undetectable, is not new - I've actually heard it from pro-cyclists directly, as well as other sources.  However this is a specific allegation, one which may have evidence enough to prove.

The entire article by Roberts and Epstein is worth reading - many of the allegations of doping discussed in it are not necessarily new, but they are framed differently, but the real interest will be in some of the new allegations, and there are more than a few.

Don Catlin's involvement with Armstrong, and his team, as well as alleged cover-ups by the USOC, and Armstrong's alleged use of HemAssist are likely to be among the lasting effects of the piece.  Catlin and the USOC come off pretty badly, and the deception and denial, if only 50% true, is startling.  19 Olympic medalists between 1984 and 2000, allowed to compete despite failing doping tests.  Lost samples, unconfirmed positives...the list goes on.  Spain and Italy have often been accused of having state-supported doping programmes, but this article points the spotlight squarely back on the USA.

Of course, the allegations remain to be proven, and some may never be.  But given the extremely litigious nature of Armstrong and his response to these kinds of allegations, and the fact that this story has been in the works for a long time (rumors on Twitter began a month ago), you can be sure that SI have checked, double and triple checked everything.

Also, Twitter chat from NY Velocity has suggested that some parts of the article were removed under threat of litigation, so I am pretty confident that whatever has remained has pretty substantial supportive evidence - remember, you don't even need a smoking gun to convict for murder.  And to repeat, if even a few of the allegations are proven, then few can doubt the depth of the deception is startling.

The science of HemAssist

For more on the science of HBOC and HemAssist in particular, I highly recommend this article by Joe Lindsey, who outlines the studies on HemAssist, the problems in the clinical trials, the reasons why HBOCs are so attractive to cyclists, and previous cases of cyclists trying to use HBOCs.  He also explains, very succinctly, what the implications of this allegation are, not only for Armstrong, but for the clinical trials process for pharmaceutical companies.  His is a far better job than I could do in so short a time, so spend some time on that article for "outsourced" Science of Sport!

I'm struck by the sophistication of the whole process, where a sportsman can learn of a drug with potential benefits, then seek to acquire it when it is illegal to use.  Does that come about via a tip-off, is there a team who are proactively searching the medical market for the "edge"?  That is a little more calculating than an athlete being opportunistic about a drug that exists on the market, or giving in to pressure to dope from team-mates or management. 

As for the next step, in Joe's words:
"Why, goes one of Fabiani’s (an Armstrong spokesman) best lines, is the FDA of all people interested in some European bike races from a decade ago?

Well, the response now goes, because one of the most famous sportsmen of the last half-century stands accused of buying stocks of a tightly controlled investigational drug – manufactured by an American pharmaceutical company and intended for use only in clinical trial settings under the regulation of the FDA or its European counterparts and which is illegal to use for any other purpose, or even for a private citizen to possess, much less transport internationally – to pull off a monumental sporting fraud.
I think that subject is well within the FDA’s investigatory wheelhouse. And I eagerly await Fabiani and Armstrong’s explanation for why it’s not."