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Biotech Education Science

Controversial Bioethicist Resigns From Celltex 48

ananyo writes "Bioethicist Glenn McGee has resigned his position as president of ethics and strategic initiatives at the stem-cell firm Celltex Therapeutics in Houston, Texas. Yesterday, Slashdot posted a story that suggested Celltex may have administered unproven treatments to several patients. The move comes at the end of a turbulent three months, which has seen McGee blasted by other bioethicists for working at the controversial stem-cell company while also holding the post of editor-in-chief of the American Journal of Bioethics, the most cited bioethics journal in the world. McGee announced that he had resigned, effective 28 February, on Twitter last night — the move came just two weeks after the 13 February press release by Celltex announcing that he would take the position."
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Controversial Bioethicist Resigns From Celltex

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  • by Kenja ( 541830 ) on Thursday March 01, 2012 @02:25PM (#39212801)
    Frankly, I dont see the issue with administering unproven treatments to people who would otherwise suffer and die. So long as the risks are made clear to them. The idea of being told I'm going to die in a month, but they cant try a treatment that could cure me because it could kill me is silly.
    • by Demonantis ( 1340557 ) on Thursday March 01, 2012 @02:38PM (#39212977)
      There many instances of the doctor writing the individual off as almost dead when they live for years afterwards. Doctors currently can't predict how long you are going to live accurately enough to legitimize allowing them to give experimental treatment to people they think have a month to live.
      • by ColdWetDog ( 752185 ) on Thursday March 01, 2012 @02:56PM (#39213247) Homepage

        There many instances of the doctor writing the individual off as almost dead when they live for years afterwards.

        True enough, but it's the best information we have.

        Doctors currently can't predict how long you are going to live accurately enough to legitimize allowing them to give experimental treatment to people they think have a month to live.

        I would disagree. The key is informed consent. Do you carefully explain all of the relevant information? Do you explain where you could be wrong? Do you give an accurate accounting of potential benefits and potential harms? Can the patient understand all of that?

        Informed consent is hard to do, but lacking every potential bit of information is not an absolute barrier.

        • by jhoegl ( 638955 ) on Thursday March 01, 2012 @03:12PM (#39213483)
          Informed consent is hard to do, but lacking every potential bit of information is not an absolute barrier.
          Tell that to Vietnam war veterans.
        • True enough, but it's the best information we have.

          Exactly, and in this case the best we have isn't good enough, therefore administering untested treatments remains unethical.

          If the doctors themselves are not adequately informed about a patient, how could a patient ever give informed consent?

    • by Misanthrope ( 49269 ) on Thursday March 01, 2012 @02:40PM (#39213007)

      If it's unproven, your insurance company isn't going to cover it, period. So these types of companies are emotionally extorting people by charging high fees in addition to using you as a guinea pig. If the treatment was given for free, as it usually is in proper medical trials it would be a different matter.

      • by nbauman ( 624611 )

        I agree with your sentiments, but in my understanding it doesn't always work that way.

        First, insurance companies do cover unproven treatments under some circumstances. Legitimately, there are some diseases that have no proven treatments, so doctors have to do the best they can, with treatments they think will work. Some cancer is so rare that no one has ever done a controlled trial before, so they say, "It looks like a colon cancer, so let's treat it as a colon cancer."

        What's proven? How much evidence do yo

    • by Baloroth ( 2370816 ) on Thursday March 01, 2012 @02:46PM (#39213093)
      That wasn't the problem, actually. The problem was he held a position at the company simultaneous with holding a position (as editor-in-chief) with a highly regarded and influential bioethics magazine. The result was a conflict of interest: the company pushes to perform unproven operations, and it is the job of bioethics to make sure they don't go into an ethical violation with the treatments. If one person is involved in both, the safeguards against unethical behavior are called into question, whether or not ethical violations actually take place. From the second linked article:

      They argue that in holding both posts, McGee has a conflict of interest between his responsibilities to the journal [of Bioethics] and his new employer’s desire to promote the clinical application of stem-cell treatments that are not approved by the US Food and Drug Administration.

      • by khallow ( 566160 )

        and it is the job of bioethics to make sure they don't go into an ethical violation with the treatments.

        No, that's not the role of bioethics. Ethics in general is an attempt to determine what we should do and shouldn't do.

        The conflict of interest comes from the possibility that McGee could review papers that are critical of his other employer or competitors of his employer. Sounds like a rather remarkable lapse of judgment on McGee's part.

      • "Bioethics"? That's like saying you're an historian, but you only deal with the ancient Minoans. Specifically, the ancient Minoans in 3763 BCE. The 2nd week in July, to be precise. Tuesday, actually.
    • If I were a doctor, I couldn't imagine making a blanket statement that everyone would want the same thing. Whether or not the patient is healthy, in the vast majority of circumstances, you're patient will have family members, and if anything goes wrong, they WILL want to know why. No matter the life expectancy.

      Life saving, and life threatening decisions always need impeccable documentation of the circumstances. What if the patient doesn't believe you and wants a second decision? Obviously a second opinion
      • Here is a blanket statement. I would think that all people when they are the ones who are sick would want the choice to be theirs not the governments.

        • Personal Choice and Not Government Mandates ... wow what a concept. Welcome To Libertarian core principle.

          • Been here quite a while. But thanks for the welcome anyway.

        • by nbauman ( 624611 )

          There's no evidence for that and some evidence to the contrary. Jessie Gruman, who interviewed 200 patients about the way they make medical decisions, said that most patients can't and don't want to make their own decisions about health care. http://en.wikipedia.org/wiki/Consumer-driven_health_care [wikipedia.org]

          Those patients want their doctors to make the decisions. Most patients also want government regulations to protect them against bad decisions. They are surprised to find out when they get a bad result from a "die

          • Way to go.
            Just to help you out I would like to point out a small flaw in your attempt at equivalency.
            Wanting to be able to trust in your doctors decision about your medical care and neither you nor your doctor being able to make a decision about care because of what congress wants are not the same.
            If on the other hand you feel that the US government is better able to make decisions about your health care than you or your doctor I encourage you to turn your care over to them.
            But just because you feel that yo

      • by nbauman ( 624611 )

        If I were a doctor, I couldn't imagine making a blanket statement that everyone would want the same thing.

        This was discussed in the latest New England Journal of Medicine.

        http://www.nejm.org/doi/full/10.1056/NEJMp1109283 [nejm.org]

        For some decisions, there is one clearly superior path, and patient preferences play little or no role — a fractured hip needs repair, acute appendicitis necessitates surgery, and bacterial meningitis requires antibiotics. For most medical decisions, however, more than one reasonable path forward exists (including the option of doing nothing, when appropriate), and different paths entail

    • by edelbrp ( 62429 )

      There's a certain element of quality of life to be taken into consideration, too. My father died of brain cancer but participated in a study to see if an unusually higher use of chemo might improve the odds of survival. It's hard to say if the cancer or the drugs were what caused more suffering. Being really, really sick can sometimes be worse than death I would have to believe, especially if the odds for recovery are slim. So while the "why not give it a shot?" attitude has a certain bit of logic to it

    • by izomiac ( 815208 )
      It's actually rather common for new drugs to be tested on the terminally ill, for exactly the reasons you state. The thing is, though, they actually have a chance of working, hence why it's being researched. A lot of stem cell companies promise miracles to people at their most vulnerable and charge exorbitant fees for snake oil.

      Informed consent is not compatible with a profit incentive unless you have a proven treatment. I don't know if Celltex is like other stem cell companies, but most of them will
    • With clinical trials (Score:5, Informative)

      by pavon ( 30274 ) on Thursday March 01, 2012 @03:43PM (#39213839)

      You prove that this works through clinical trials. But Celltex Therapeutics isn't conducting any such trials. They have made vague comments about starting some trials sometime in the future, but that's it. They don't have any control subjects. They don't have any animal test results on which they are basing their human predictions on. They haven't even identified what ailments they are going to be testing their treatment for!

      In the meanwhile they are happy to inject anyone willing to pay the $7k+ per injection, for whatever ailment they complain about, regardless of whether there is any reason to think the treatment would help, or whether the patient would otherwise suffer and die.

      • by ananyo ( 2519492 ) on Thursday March 01, 2012 @04:09PM (#39214123)

        Yep exactly. There are two problems here.
        1. Celltex hasn't done any clinical trials of any sort. To prove a treatment works you need a double-blind trial at least - administer placebo to one group, and the cells to another and make sure the physician in charge doesn't know which one is being given to which patient. Then when you 'unblind' the trial and reveal which patient got what - that's when (if it's worked) you start charging. In the trial phase, a company should be providing the treatment free with placebo and working with the FDA. They shouldn't be charging for voodoo treatments/homeopathy.
        2. Big conflict of interest for McGee from the start - it's difficult to claim you can independently assess papers on bioethics, when many of the papers are likely to be about stem cells and trials but you're being paid by a firm that is growing stem cells.

        As the (accidentally unlinked when I submitted) Nature story [nature.com] says, McGee claimed he hoped by being inside the company, he could push them to do trials properly. When it became clear they were already treating patients and probably weren't too interested in testing the treatments, he quit. At least, that's one interpretation....

        • by nbauman ( 624611 )

          1. Celltex hasn't done any clinical trials of any sort. To prove a treatment works you need a double-blind trial at least - administer placebo to one group, and the cells to another and make sure the physician in charge doesn't know which one is being given to which patient. Then when you 'unblind' the trial and reveal which patient got what - that's when (if it's worked) you start charging. In the trial phase, a company should be providing the treatment free with placebo and working with the FDA. They shouldn't be charging for voodoo treatments/homeopathy.

          That's the way it should work but unfortunately it doesn't. In cancer, for example, many studies of new drug treatments or combinations for a particular cancer are done by doctors as part of their regular practice, who are getting paid by the drug company for the study and also getting paid by the patients for their treatment. Sometimes they get the drug free, but if it's a drug that's already approved for another indication, they charge the patient for that too.

          I always thought it was unethical. Then I fou

  • by SomePgmr ( 2021234 ) on Thursday March 01, 2012 @02:25PM (#39212805) Homepage

    So he took the position there just in time to find out the place is shady, take a bunch of heat, and resign?

    That sucks.

    • So he took the position there just in time to find out the place is shady, take a bunch of heat, and resign?

      That sucks.

      They don't actually strike me as shady. They offer untested but hopeful treatments to terminal patients with no alternatives at a time when the FDA isn't even equipped to test the safety of stem cells.

      • I think many of us cell biologists would disagree about the hopeful bit. Hopeful means "It's been proven to work," not "We don't know that this WON'T work in your specific case even though it hasn't worked before!"

        I'm not sure what you mean by "FDA isn't equipped to test the safety of stem cells" either. Stem cells can be injected into mice. If they grow tumors, that ain't a safe test. Fun fact: injecting stem cells into mice CAN cause teratomas. It evidently doesn't happen every time, and typically
  • Doesn't the job "Ethicist" sound like bullshit? Not that ethics isn't a valid field of study, it's just that it feels like more of a religion than something serious. I mean really isn't it just a way of codifying your opinion?
    • It's 'religious' in that it relies on system of beliefs rather than facts and experiment, but it it's important anyway. Not everything can be reduced to logic.

      Codifying something, be it religious, scientific, engineering or what have you has validity. It's how you start a framework for discussion.

      My karma ran over your dogma, as it were.

    • Nah, it sounds just like an esthetician, only more facials....
      http://dictionary.reference.com/browse/esthetician [reference.com]

    • If you codify opinion that pretty much everyone shares and apply it to specific technical situations, then no, that's not as bullshit. Many people fail to understand the Tuskegee syphilis experiments as 100% abhorrent. It's not as clear cut as that. At the start of the experiment, there was no treatment to syphillis, it was lethal, and there was little data on how the disease progressed in black patients. That's a significant gap in clinical knowledge. Arguably, the experiment was ethical at the start.
    • by nbauman ( 624611 )

      Bullshit indeed.

      There was an article by Carl Elliot (I think it was in the Atlantic but I can't find it right now) in which he explained that he was a philosophy professor, he had written about medical ethics, and he got calls from drug companies wanting him to work on their ethics panels. They would pay him a lot of money, and all he had to do was review their clinical trials and approve them.

      Indeed, the term "ethicist" has become a term of the art in the pharmaceutical industry. It sounds (to the naive) l

  • Way to go. (Score:4, Interesting)

    by subreality ( 157447 ) on Thursday March 01, 2012 @03:48PM (#39213883)

    blasted by other bioethicists for working at the controversial stem-cell company

    Fail. This is exactly the kind of company that we want a bioethicist working for.

    • No, we want them working for companies that have some merit. I think the critics who are upset at this would say the company in question is beyond redemption and should just be closed down completely. Get the bioethicists working for Pfizer or other drug companies, or research universities that need to stay around but stray all to often into unethical territory.
  • didnt read the article but is it possible he got a better offer?

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