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one problem - to date, despite testing and clinical trials, only one HBOC was ever approved for human use, but that was revoked in 2008.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."

 Ross

"Scientific Literacy," or, "Don't believe everything you read"

Note to self:  Always remain skeptical

The whole Power Balance debate is now winding down a bit, although it is still far from over.  On the heels of their announcement, here in America New Balance finds themselves in a similar position as there are threats of a lawsuit against their WW850 "toning shoes."  The shoes, which Reebok and Skechers also produce models, make wild claims about burning more calories and toning certain muscles, but the basis of the potential lawsuit is that one consumer injured herself after using them.  Apparently Reebok and Skechers also face lawsuits.

A common theme arose in the discussion around our Power Balance posts, and that was surprise from you, our audience, that people actually believed the claims in the first place.  It seems self-evident to most of you to be skeptical and wary of these kinds of claims, because you have the training or inclination to be somewhat skeptical, and your "science filter" (or maybe your "BS" filter!) is always on.  But in the broader population this characteristic is lacking. 

We do not teach critical inquiry

Part of the requirements for my undergraduate degree were that I took a certain number of classes that were classified as "Critical Inquiry."  Those were meant to focus on "critical thinking," however you define that, but the gist of it is that we interrogate the source of information and apply some degree of skepticism before accepting statements as 100% truthful.  That was a long time ago, however, and I can tell you with some authority that these days there is no emphasis on critical thinking in higher education.  It is a huge debate that we will not get into here, but the state of affairs in most institutions is that no responsibility is placed on the students to learn the material.  Instead, a customer/provider relationship persists in which the students' demands and complaints are honored in a wholesale fashion---as in, "This class is too hard, there is too much reading," and accordingly the instructor is told to reduce the volume of material.


A great read on this is Michael Specter's 2009 book Denialism: How Irrational Thinking Hinders Scientific Progress, Harms the Planet, and Threatens Our Lives  Specter is a long time writer for the New Yorker and the book examines several cases where we have lost our scientific literacy or scientific "compass" and replace rationality and skepticism of science with ideological or unscientific irrationality.  Most fascinating is his analysis and comment on the issues of childhood vaccination and organic foods.  Most of you will know that the scientific evidence overwhelmingly supports early childhood vaccination, yet about 10 years ago the idea that those same vaccines cause autism was planted by the British medical doctor Andrew Wakefield---whose research has now been exposed as fraudulent.  But the cause was taken up by celebrities and, in Specter's words, they were winning the publicity war on the topic.  Suddenly, in spite of decades of evidence, parents stopped vaccinating their children.

It is a remarkable thing, and really forces one to see the importance of being rational and skeptical, applying some "critical thought" to new information.  So I can really suggest the book, it is a quick and fascinating read, made possible partly by Specter's engaging style but also because I think this topic will appeal to most of our readers. 

The power of marketing, or the lack of scientific literacy?

It is difficult to say which forces are primarily at work here, but certainly both are powerful currents in our society.  The marketing of the products like the toning shoes is aggressive on every single level, and one thing recent history has shown us is that marketing works.  We only need to look at the growth of the tobacco industry in the last century for a prime example of how to market a product to it maximum.


So marketing works, but surely at the same time being scientifically literate should counter those forces that compel someone to buy a product, especially when the manufacturer makes outlandish claims.  For me the question is whether or not we can teach critical inquiry, and if so then to what extent.  Certainly some individuals seem to be inherently skeptical.  I suppose it makes me an optimist, but I have to believe we can also teach people the skills to be critical of information and claims.  At least I try my hardest with my students, even though most often I am slated for being too hard because of it.


For now, please make a note to yourself to remain skeptical, interrogate the source of the information, and look to the available evidence to guide your interpretation.  I am happy to say for most people in this audience, that will not be such a hard thing to do!


Jonathan

Power balance, placebo and perceptions

"It works, who cares why?" vs "The fraud of Power Balance bracelets"

Last week a big debate started up on the Power Balance bracelets, whose holographic technology is supposed to "work with your body's natural energy field", "resonating and responding to the natural energy field" to improve balance, strength, endurance and flexibility.  Too good to be true?  Apparently, yes, because in the last week, the fraudulent advertising claims made by the company have been poked and exposed by numerous sources.

The debate began in Australia, where an advertising commission ruled that Power Balance must refund any unhappy consumers after finding no evidence.  Power Balance themselves issued a statement saying there was "no credible scientific evidence" that the bands worked at all.  That was followed by a class-action lawsuit in Los Angeles, a 300,000 Euro fine in Italy for false advertising, and an NIH conclusion that the scientific evidence was lacking.  Here in South Africa, the local newspapers have picked up the story, I did an interview or two on the radio yesterday, so at the very least, the debate has now begun. 

Prior to this, the bracelet was a sensation - the best selling item at a big local sports store in South Africa, and I'm told, a million-dollar industry.  CNBC named it "Sports Product of 2010" and it was a best-seller on Amazon.com.  Considering that you can place a bulk order for 500 bands for $475, and then sell the band for the equivalent of about $70, you can tell that someone is basically printing money off the advertising claims made by the company.  Those advertising claims and people's gullibility have set more than a few people up for life.

"It works.  And I don't care why" - the placebo effect, and why it does matter

Among its target market, opinion is divided.  Many are saying "about time they were exposed", while others are standing by their purchases.  The most common defense, of course, and one that is worth discussing, is that the bracelet seems to work, so who cares why it works?  Perception is reality, after all...

Of course, when you have paid R500, the equivalent of $70 for a piece of plastic, then you're more invested in the band than you probably want to realize.  The pricing is in fact an important part of the overall marketing strategy - you don't promise such amazing benefits and then charge only $10 for them. The more people pay, the more "effective" the band will be, and the more vociferously they will defend it, regardless of whether your advertising promise is true or not!

Scientifically, opinion is less divided - for example, our friend Inigo Mujika wrote the following on his website:  "I have no other choice but to admit that my academic education is insufficient to be able to interpret what appears to be nothing but a bunch of nonsense."  Most scientific opinions I have seen dismiss the band as a placebo effect.  The placebo effect is a phenomenon where even an "ineffective" intervention (like a sugar tablet in a medicine trial, for example) will have an effect because of the subject's belief that it will work.  For more on the placebo effect, there is a fascinating and comprehensive chapter in Ben Goldacre's book, Bad Science.  Well worth reading.

A targeted, deliberate scheme using science as the hook

But what do we make of this position that it doesn't matter why the bracelet works, as long as it does?  I think that to fully answer this, you need to understand a little about the targeting strategy and the market that Power Balance has positioned itself for.  In the early phases, when the bracelet first came out, there was a very definite "scientific" promise of what the band offered, as well as "proof" that it worked.

This proof took the form a demonstration of how the bracelet could improve your strength or flexiblity and usually took the form of a test where someone would have you stand in front of them with your arms spread wide, and they would push down on one arm causing you to lose balance.  Then, they hand you the miracle hologram bracelet, repeat the test, and magically, you were now more stable and able to resist their pressure!  There were other tests - flexibility and balance, but the principle is the same.

This "applied kinesiology" test is discussed and explained more below, but basically, what you're seeing there is clever application of force using different angles and torques, combined with your body's immediate adaptation, because it prepares for the second push.  The learning effect can't be understand - pre-activation effectively braces the body and even in the absence of deliberate manipulation by the tester, this is what is primarily responsible for the improvement in the second test (which always co-incides with holding the bracelet, of course).  But of course the conditions under which the demo is done doesn't allow this to be obvious, and the consumer is sold - seeing is believing, after all, and so actually experiencing the effect - that's highly convincing, it's marketing that money can't buy...

The point here is that many people, Power Balance's "early adopters" or "lighthouse customers", were sold the bracelet on this basis - the science was tangible, supposedly credible - they experienced it.  The placebo effect was in fact created in the consumer, because the company "proved" that it the band worked!  It's not as though people liked the look of a silver hologram and figured they'd believe that it worked - they were told, and shown, that it worked.

This first group would be followed by those who figured it can't hurt to try, who believe that if it works for them, it'll work for me.  These people are simply following, and might not even know why they're buying it in many instances.  Then, if you're Power Balance, what you really need are high-profile names to wear your band, since they are your opinion leaders.  Enter celebrities and sports stars, who are particularly vulnerable to this kind of promise - sports stars in particular lean towards superstition all the time, and the promise of better balance, strength and flexibility is too good to resist, especially if it comes without any training.

In no time at all, everyone is wearing one and so then you absolutely must follow suit, because even if you don't really believe that it works, there's a small voice that says "it might, and I'm on the only person without it".  This is why it becomes so pervasive in sport - most sports people will do something without any basis, unless there is a potential downside.  A hologram bracelet brings no obvious downside, so they wear it, and don't care whether there's scientific proof or not behind it.

So too, the majority of consumers will wear it in hope, or belief, regardless of the facts.  All of which is perfectly fine - until you trace back that the whole promise behind the bracelet is that it works as a result of some 'scientific' theory that was shown to be true using those demonstrations.  Then you realize that at its origins, your perceptions and beliefs have been manipulated in a planned, controlled strategy by a company who are making upwards of a 3000% profit margin!  If that doesn't strike you as reprehensible, then nothing will.

If I was that consumer, who had parted with R500 of my money to buy a hologram that I was told worked for a reason that was clearly false, then purely from a moral standpoint, I'd be upset to learn that science proves that claim completely bogus.  I did not spend R500 to buy something I believed worked, I did not invest in my own placebo effect.  The commercialization is part of the problem, but more than this, it is the notion that a company has promised something to me, conned me into believing "science" that does not exist that makes this so important to put out into the open.

To those who have worn it and honestly believe that they're getting more value out of their training as a result, that's great.  These later adopters, each individual, may be benefiting and they're right, it doesn't really matter why.  But if you step back and view the big picture, then it matters, because at its source, the whole market was lied to.  Science will tell you that you could just as well put a pink ribbon in your hair before you train and achieve the same result, provided you spend enough money on it to believe that it works.  Of course, if I designed an impressive website and wore a white lab-coat and staked my scientific reputation on its effectiveness, then it would help even more.

But to the individuals, even the sports stars, who wear it simply because "everyone else is" and because they believe it works, that's fine, and I don't mean to be critical of them.  The criticism should be directed at:
a) the company, who have exploited belief to make huge profits, and
b) scientists, strength & conditioning coaches and health practitioners who have sacrificed their own integrity to sell the product, to wear the bracelet and endorse what is at best 'junk science'.

The research and the testing - conspicuous by its absence

The lack of research, as I've said before, is conspicuous by its absence, saying more about the company than any study could.  I cannot stress enough how relatively simple a study on Power Balance bracelets would be.  If the company was at all interested, they would have done this study years ago, and it would have been repeated by many different research groups (all independent), and published widely in peer-reviewed scientific journals.  But there is nothing of the sort - some impromptu studies have been done to show that the effect is purely placebo, but these are not in scientific journals either - all I have are news links here and here.

Now, these studies are not published either, and that's largely because no one really has the incentive to conduct and then publish research disproving a gimmick.  The onus would be on Power Balance to prove that their product works, yet years of marketing have not seen fit to do so. Why?  Because science doesn't matter, marketing does, so they're more invested in a viral campaign that gets big names into the bracelet than actually proving the effect.  However, when it comes to promotion and advertising, then the "science" suddenly becomes important.  It is not for nothing that decades and generations have passed with this concept of "natural energy fields", yet not a shred of scientific proof under controlled conditions exists.  It's a scam, and it has cost you money.

In case Power Balance is reading this, the study you need to do to show that the bracelet works is simple - all you need is one real and one fake bracelet, a group of 50 volunteers, and a "tester", who doesn't even need to be independent.  In other words, Power Balance can send along one of their own people to conduct their "tests", and as long as that person doesn't know whether the volunteer is holding the real bracelet of the fake one, the result is blinded.  The hypothesis would be an improvement in flexibility (easy to measure), strength (equally objective) and balance (not quite as simple, but possible, provided the tester is the same each time).  Then, each volunteer has to be tested under both conditions - the real and the fake bracelet, and the order of testing has to be randomized so that half do the fake bracelet first, half the real one - this would take care of a 'learning effect' and the neural adaptation that takes place with all those tests.

This kind of double-blind study would very quickly establish whether the hologram does anything, or whether simply wearing the band is the difference.  It's so easy to do that students have done it on the fly, but Power Balance still have not.

The tests that are done, incidentally, are themselves extremely dodgy, because they're so easy to "cheat", and the video below looks at how this field succeeds at doing this.  It's a little overplayed - too much sarcasm, and long-winded (jump to just before 5:00 to see the bit about how the tests actually work, where the 'con' is exposed), but it's accurate and very interesting.



My first encounter with Power Balance bracelets was in fact observing these very tests - it was at the Two Oceans Marathon expo last year, where the company had a stand and was conducting these demonstrations on passers-by.  People were amazed when suddenly, holding a bracelet with a hologram would improve their balance or strength or stability, and the company was very clearly using science as the bait to lure the consumer in.  The video above addresses, at least in part, that method of selling the bracelet.

When the hypothesis becomes advertising without proof - enter science

Lastly, there will always be criticism when science dismisses the "unknown" - there are many things that have not been proven.  Either they can't be (too difficult to prove scientifically), or it's too early.  And it would be equally bad science to dismiss any claims simply because of a lack of proof.  But science exists for a reason - it challenges statements and hypotheses, tests them and then confirms of refutes them.  Good science is skeptical by nature, but still open minded about possibilities.

However, when a hypothesis (the bracelet improves balance and flexibility, for example) became an advertising claim, without any proof at all, then science is right to criticize it.  Especially when those claims have existed for a long time, yet still no proof exists.  It's different if a company brings out a revolutionary vest to help athletes stay cool during exercise in the heat - that's a product that is new, and should be tested.  But this kind of promise has existed for years, and no one can find proof.

Therefore, the criticism that science is being closed-minded is unjustified.  If that proof existed, it would have been found by now.  It hasn't, and short of being too open-minded, it doesn't exist.

I leave you with a video, a song by Tim Minchim.  Question everything, but don't be too open-minded, sometimes science has already spoken. 

Ross

Power balance bracelets: "No credible scientific evidence"

Power balance: "We admit that there is no credible scientific evidence that supports our claims"

The truth is, if you're reading this site, and do so regularly, then the above statement will come as no surprise.  It shouldn't, given what history has shown us about companies that make such claims about products ranging from supplements to holographic stickers.

What is different is that the above quote comes directly from Power Balance, who are responsible for making the now ubiquitous holographic bracelets that are worn by celebrities, sports stars, and members of the public in such huge numbers that if you go down to your local gym and you DON'T have one, you feel like the odd one out.

Somebody is making a fortune of what is basically a placebo effect, a psychological benefit of wearing a bracelet that initially claimed to harness the body's natural energy field to improve.  From their website, it "optimizes the body's natural energy flow", which improves strength, endurance and flexibility.  All without evidence of course.  And I would be the first to point out that the absence of evidence is not necessarily evidence of the absence of an effect.

However, in this case, the fact that not a single study exists is very telling.  Why?  Because proving whether these gimmicks work is so simple that a high-school student could conduct the study.  Yet nothing has emerged. And that's because there is no incentive to provide the science - the science does not matter, the marketing does, and so Power Balance has invested into celebrity endorsement and viral marketing, not research.  With good reason - research destroys their credibility.  I'll discuss this in much more detail in a post early next week.

For today, just the report on the findings of the Commission.  Below is the statement they issued in response to an investigation from Australia's Competition and Consumer Commission, which exposed them as a sham.  The huge verdict resulted in Power Balance admitting that they had no evidence, that they had misled consumers, and promising to refund customers who feel misled by the advertising claims.  The statement below will appear in 20 magazines in Australia.

I hope that this is the catalyst for more of the same around the world.

Many of you will no doubt be thinking "so what.  If it's a placebo effect, it doesn't matter, as long as it works".  And this is a topic certainly worth discussing.  But that's for another time, so join me next week when I'll look a little more closely at Power Balance bracelets, some of the claims they made, and how the lack of science was part of the strategy.  It's a great case study in the clash of incentives between marketing and credibility, and should stimulate some good discussion.

And finally, I have no objection to members of the public, celebrities and even individual sportspeople wearing the bracelet.  However, if you are a sports scientist, a personal trainer or biokineticist/strength and conditioning coach who works with athletes and sports teams, and you wear this bracelet, then you are unwittingly (or perhaps knowingly) endorsing the sham "science".  After all, all you have is your scientific "credibility" - it is your value to your athletes and clients.  So rather than simply following the herd, think that perhaps your endorsement strips away your own credibility.

Until next week!
Ross

Happy New Year and welcome to 2011

2011 begins.  Happy New Year!

Happy New Year everyone, from The Science of Sport!

I realise I still owe you a "Sportsman of the Year" post, which I hope to get done soon (or the award will start to overlap with 2011!)

As for the year ahead, we can only promise to do our best to bring you the same insights and analysis of the world's sporting events as we've done in the past.  I know that 2010 was an up-and-down year, some very quiet patches and some very busy ones.  I hope that 2011 will bring more consistency, but no less quality.


There are a few things I'd like to build in 2011 - more interaction through our Facebook and Twitter pages (join now!), and more videos, interviews and involvement of others on the site.  As with most of what we do, it's time-dependent, but I'll do my best in 2011!

As always, it's your site as much as ours, and we welcome your feedback, suggestions and comments.  Let's hope 2011 is a great year!


I'm not sure if you are big on New Year's Resolutions.  I'm not, but here's a suggestion:





Have a great 2011!


Ross