oxygen in a pill
  • foobar

    Interesting, Astellas sponsors a cycling team in the US. Wonder if they are the guinea pigs?

    • I very much doubt it. While non-medical EPO usage was reputedly a large proportion of EPO sales (and thus profitable for Amgen) no company whose bread and butter is legit pharmaceutical sales would want ties to illegal usage to be too obvious. It opens the management and board up to all manner of legal and financial risks.

    • I very much doubt it. While non-medical EPO usage was reputedly a large proportion of EPO sales (and thus profitable for Amgen) no company whose bread and butter is legit pharmaceutical sales would want ties to illegal usage to be too obvious. It opens the management and board up to all manner of legal and financial risks.

      • The AMGEN Tour of California notwithstanding, then?

      • Sean Doyle

        I understood that non-medical use was a small percentage to normal use so it wasn’t a consideration for pharmas to worry about. Funny how we all get a different picture. I’m not saying your wrong or anything just that we hear/read different things.

    • Dave Christenson

      Yeah funny how these drug companies end up involved in pro cycling…http://www.astellascycling.com

  • Nick

    Well written – good work.

  • 53Phil

    Thanks for these articles on PEDs, very interesting. I would also like to know how the anti doping controls work, chemistry-wise. For example how is EPO tested for? Why do tests for new drugs take a long time to develop? Do the manufacturers of these drugs put some kind of marker in to detect them if the actual chemistry of the drug is undetectable once consumed? If not, why not? It would be interesting to know the answers to these sort of questions. Thanks!

    • The trouble with relying on a chemical marker to detect the drug is that there’s nothing (aside from intellectual property law and the difficulty of synthesising the drug) preventing another lab cooking up the same drug without the marker.

      • A grizzly bear

        I just looked up the structure and that does not look like a terribly difficult molecule to make. there are published synthetic routes (the reactions and purification methods) for molecules only 1 or 2 simple reactions away from Fg-4592. So yeah, third party labs could make this relatively easily.

    • The trouble with relying on a chemical marker to detect the drug is that there’s nothing (aside from intellectual property law and the difficulty of synthesising the drug) preventing another lab cooking up the same drug without the marker.

    • Anonymous

      My understand is that there is more of a move away from detecting the chemical and trying to observe the performance benefit gained. So rather than trying to detect FG4592 you would try and observe the improvement in red blood cell count and reconcile it to what would be considered as “normal” or to a baseline of some kind. However I could be totally off the mark there.

      I could imagine that pharma companies couldn’t be bothered manufacturing markers into their drugs if it cost them more for no financial gain.

      • echidna_sg

        they certainly do use markers is their high value products, at least while they are under patent protection (20 years) or exclusivity (5-7 years depending on class)…. but once on the market for X years, the entire manufacturing process is released into the public domain and anyone with the know-how can start making it…

      • Rodrigo Diaz

        They did with CERA! Remember that weird TdF?

    • echidna_sg

      highly variable and depends on the mode of action and also what is left behind – ie plasticizers leach from the plastic bag into the blood during storage and then end up in your blood after transfusion. There is no simple test to determine if some one “spiked” their own blood with more of the their own blood, so it was determined that a test be developed that measures the levels of the plasticizers as a type of marker or indicator of use.

      Other forms of cheating (such as banned drug use) leave metabolites behind in your urine, blood or hair for varying time periods post use so you are really never testing for the presence of the drug itself, more for its by-products, metabolites or even contaminants left behind (in the case of plasticizers in blood transfusions). These metabolites are often found at levels in the ppb/ppt level which is right at the limits of detection for the available technology and hence far harder to detect than say % or ppm level of the active components in a tablet or injection.

      The reason it takes so long to develop the test methods is due to the rigor expected and required by the anti doping authorities in order to accept that a test method is accurate, precise, reliable and repeatable across multiple samples on multiple days in multiple labs on multiple instruments when conducted by multiple analysts and still stand up to examination in a court. This process can take years due to peer reviews, waiting for atechnology to be developed that can detect the substances in the first place and last but not least the fact that there are political and financial forces at work that do not want the drugs to be detected in the first place!

      it certainly is nothing like an episode of CSI where a sample goes in one end and the results spit out the other within 2 seconds ;-)

      yep, I actual work in pharmaceutical method developments as a job *sigh*

      • echidna_sg

        hmm needs editing, but you get the point hopefully!

  • Rosco

    Great article

  • Notso Swift

    Great article, good for the site to have these cutting edge topics
    I heard about this stuff in Horse Racing late last year but didn’t know it was so far advanced in trials

    How naive is the un-identified chemist “I would be very surprised if anyone is using this compound or was going to use it…” Mate, where is is money or ego people will do it, even if it is of doubtful benefit.

  • CB

    These articles are important. Not just as part of informing us, the fans of what is next in terms of doping, but getting the conversation going whereby new, non-approved medications, with potential performance enhancing properties still in the clinical trial phase, are identified and tests can develop (where possible) in parallel with the drugs development. No more of the lame ‘we didn’t even know it was being used” excuses by sports governing bodies.

  • CB

    These articles are important. Not just as part of informing us, the fans of what is next in terms of doping, but getting the conversation going whereby new, non-approved medications, with potential performance enhancing properties still in the clinical trial phase, are identified and tests can develop (where possible) in parallel with the drugs development. No more of the lame ‘we didn’t even know it was being used” excuses by sports governing bodies.

    • Guest reader

      Prophetic words! Applicable 2 years ago and now.

  • Paolo

    A number of anti-doping expert had not heard about it, but we get to read an article about it? You can bet your house on the fact that it’s used in high level sports already.

    • mzungu

      Hahah… Not surprised that anti-doping guys are on the reactive side of things. A really good idea for an article on doping… would be to ask some top sports doctors out there ….”Hey, Doc. If you and I were to cheat on that “Bio-Passport” thing, How would we do it?”

      • Guest reader

        Didn’t this article just do that? 2 years in advance!

  • Michael Hyde

    Riding against the wind here…

    First, well done, well written article. Informed. Credible. Concise. Kudos.

    But.

    These articles do nothing for Cycling Tips, serve only to associate our sport increasingly with drugs (legal, in trial, or otherwise), and don’t have anywhere near enough photos or, heaven forbid, a tip. In short they disappoint.

    Sorry, to me, i read this site for the pleasure of cycling, to be inspired, to be excited and left envious. I see these kind of articles and i’m off to Velominati for a laugh, or Steephill for some photos…

    Just saying,
    mike

    • Nick

      Isn’t the whole article a tip? It’s explaining about a new drug…

      • Guest reader

        As much a tip for antidoping officials to get their act together!

    • Mike, I see where you’re coming from, but I think it would be naive of us to bury our heads in the sand and only talk about the positive side of cycling while things like this lurk. I find these things interesting, informative, and real.

    • dcrainmaker

      For me, I think these are the most interesting articles. It explains the still-present reality of the sport, and does so in a way that most other sites don’t. If the light isn’t directed towards stuff like this – then it or the next newest things will continue.

    • mzungu

      There was always that “Bicycling” magazine,… I think they only mentioned doping and Armstrong no more than once a decade, it’s fill with all kind of “positive” and inspiring advertisement too that you’ll like. :D

  • Mike Allen

    What are the drug company’s responsibilities in controlling the distribution of their products – especially those not yet approved for human use? It’s mind blowing that it is possible to purchase this stuff in any market grey, black or otherwise.

    • Anto, NZ

      If it is going to a stage III trial it will be probably mutli-centred, multi-national and require one, if not two or more, factories to be producing the pills. I had a quick look but I can’t tell where their factories are, but everything can fall off the back of a lorry. Those pills could be from a generic company that has manage to synthesise their own version, but I doubt that, or its simply a con.
      If this stage III trial is succesful then they are sitting on a gold mine and this drug will be everywhere. This type of anaemia is very common and chronic renal failure of this type is going to increase dramatically in the next decade, especially in India and China with their growing rates of type II diabetes (most common cause currently of chronic renal failure). This stage III trial will probably report in the major journals in the next three years and if it works, like it’s suggesting it might, then this drug will be in every pharmacy in every town in the developed world within five years. At this point, getting it will be extremely easy!!

  • Sue S

    Oh Dear. The UCI had better update on this new drug quickly. EPO was in the developing stage when it was first used by athletes. I think the drug companies that were involved were Amgen and Johnson & Johnson. Companies do not worry about ethics, only budgets, so it will be up to the UCI to nip this in the bud. If this new drug is effective, then it will be a break through for those who really need it to enjoy a full, healthy lifestyle but it would be heartbreaking for athletes to use it, who are too lazy to put in the hard yards training.

  • PT

    Use of any prescription drug is the responsibility of the prescribing dr. The same goes for unregistered drugs ( ie, per- marketing or drugs in evaluation). Moreover, pharmaceutical logistics are tightly controlled and part of their licensing requirements. If there is a gap where drugs are able to be accessed outside of these elements then its probably a criminal activity, not part of a legitimate business. The case is even more so for an unregistered compound like this. The ASADA investigation in Australia is as focused on the infiltration of organised crime into sports medicine as it is on the dopers themselves for this reason. It’s not a new problem, pharmaceuticals have been able to be sourced and used outside indication for decades. Nevertheless, it’s a problem and the solution is not as simple as catching offenders. There are illicit businesses behind this.

  • Finally! It’s been a while since you’ve dished out a decent TIP!

  • donncha

    Given that it works by continued production of red blood cells, isn’t its use already going to be caught under the existing bio-passport?

  • Anonymous

    Come back to me when they put Jean-Michel Jarre’s ‘Oxygene’ in a pill!

  • OverIt

    How does a drug that is only sanctioned fo use in clinical trials, so easily get onto the black market? Most if not all of this stuff cant be simply cooked up by ‘anyone’. Maybe it’s about time these drug companies became more accountable for where what they makes goes? Isotope markers etc could be added perhaps to trace back where and offender got his/her stuff?

    • Dave

      “How does a drug that is only sanctioned fo use in clinical trials, so easily get onto the black market?”

      $$$$$$
      €€€€€€
      ££££££

    • Arfy

      I’m not in the drug industry so I don’t know specifics, but I see similarities to what happens in hardware technology. A lot of primary research is carried out at research institutions like Universities, and papers are submitted for peer review, so these are not hard to get hold of if you know where to look. Also, patents have to spell out pretty much what your IP is to ensure no-one can copy it and sell it into legitimate markets, and large companies have large legal departments to firstly ensure the patents are water-tight and secondly to take legal action when patents are breached.

      However, patents do not stop anyone copying your product if they intend to sell through illegitimate channels, and there’s quite a few well-heeled and well connected organised crime syndicates that make money on the black market. There were some recent press articles about the Australian Embassy in Italy taking on a mafia boss’s son for work experience who then had access to confidential documents, and how this timing related to mafia court cases in Australia, so we can only imagine how they may behave if there’s money to be made from new drugs.

  • Neuron1

    There is already a test for this drug. To quote from a Cyclingnews article:

    “FG-4592 is a compound that is still in phase 3 clinical trials and has not yet been commercialised. Also known as Roxadustat, the drug was developed jointly by FibroGen and AstraZeneca. Unlike EPO, which directly stimulates the production of red blood cells, FG-4592 is taken orally, and stimulates natural production of EPO in a manner similar to altitude training.

    This class of compounds is banned under the WADA code.

    Taborre is the second cyclist to test positive for the drug this year. At the Pan Am Games in Toronto, Carlos Oyarzun of Chile was found positive for FG-4592 and kicked out of the competition.

    Drug makers are increasingly cooperating with the anti-doping authorities to stay one step ahead of cheaters. The drug companines began creating detection methods for drugs which may enhance performance before the compounds reach the market, because athletes were getting hold of drugs while they were still under development.”

    They testers are way ahead of us on this.

    • Guest Reader

      Mate this piece was written 2 years ago!

      • Neuron1

        Funny that. It’s dated July 31, 2015. Must have been a time warp.

        • Whippet

          That’s because it was reposted mate. It is two years old.

  • Peter Van Eenoo

    Sorry guys, but you didn’t really contact true anti-doping experts/scientist. Probably guys claiming to be one.As for Dr Faber…he is not exactly a person that is recognized as an anti-doping expert, but rather as a provocateur looking for a place in the spotlights who claims to be an expert…

    The substance has been spotted as a potential doping agent years ago and was/is in methods of several WADA accredited labs. Hence the positive cases… These are the experts.

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