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Controversial Bioethicist Resigns From Celltex

Unknown Lamer posted more than 2 years ago | from the tweet-two-for-ethics dept.

Biotech 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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Well... how else are you gona prove them? (5, Insightful)

Kenja (541830) | more than 2 years ago | (#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.

Re:Well... how else are you gona prove them? (3, Interesting)

Demonantis (1340557) | more than 2 years ago | (#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.

Re:Well... how else are you gona prove them? (4, Insightful)

ColdWetDog (752185) | more than 2 years ago | (#39213247)

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.

Re:Well... how else are you gona prove them? (3, Insightful)

jhoegl (638955) | more than 2 years ago | (#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.

Re:Well... how else are you gona prove them? (2)

Frnknstn (663642) | more than 2 years ago | (#39213993)

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?

Re:Well... how else are you gona prove them? (3)

Misanthrope (49269) | more than 2 years ago | (#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.

Re:Well... how else are you gona prove them? (1)

nbauman (624611) | more than 2 years ago | (#39217345)

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 you need? This is one of the worst areas of medicine. It doesn't help matters when insurance companies have a financial stake in the matter. Sometimes people can browbeat insurance companies into covering a treatment (good or bad).

In New York State, the chiropractors passed a law that requires the insurance companies to cover chiropractic (I'm not sure if it's still in effect).

Second, I was surprised to find that patients do pay for treatments in medical trials. You have metastatic colon cancer, a doctor is a consultant to a drug company trying out a new drug which is approved (but not for metastatic colon cancer), he's got a grant to do a clinical trial, and he doctor says, "we don't really have a good treatment, but I can get you into a clinical trial." You pay. Sometimes the company "donates" the drug, sometimes they don't.

Re:Well... how else are you gona prove them? (0)

Anonymous Coward | more than 2 years ago | (#39213011)

Treatments are tested first for safety, then for efficacy. You can test most treatments for safety on healthy volunteers first. Most people are unaware that in most trials researchers are given wide latitude in terms of what they are permitted to test, provided that they're willing to test it on themselves first. Bottom line is that it's unethical to use someone else as a guinea pig when you're not willing to do it to yourself, especially if that someone else is in a difficult position--for instance, facing death.

Re:Well... how else are you gona prove them? (4, Informative)

Baloroth (2370816) | more than 2 years ago | (#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.

Re:Well... how else are you gona prove them? (1)

khallow (566160) | more than 2 years ago | (#39214791)

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.

Re:Well... how else are you gona prove them? (1)

Rogerborg (306625) | more than 2 years ago | (#39219705)

"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.

Re:Well... how else are you gona prove them? (1)

bacon.frankfurter (2584789) | more than 2 years ago | (#39213195)

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 isn't an option in trauma and emergency scenarios... but it's a touchy subject of willful opportunism to decide to take advantage of trauma situations, when you have to prove that you didn't decide to take advantage of emergencies for personal gain.

Or maybe they WANT to suffer and die. If you interfere with a persons wishes, and anything unexpected happens, it risks going before a judge.

Anyway, even if you save someone's life to day, and yeah, it extends their life for six months but with a far FAR more miserable death... well... is that an unsuable position? Lawyers will argue anything.

Re:Well... how else are you gona prove them? (2)

Dishevel (1105119) | more than 2 years ago | (#39213677)

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.

Re:Well... how else are you gona prove them? (1)

Archangel Michael (180766) | more than 2 years ago | (#39213783)

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

Re:Well... how else are you gona prove them? (1)

Dishevel (1105119) | more than 2 years ago | (#39214385)

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

Re:Well... how else are you gona prove them? (0)

Anonymous Coward | more than 2 years ago | (#39214985)

Personal Choice (as long as you choose the way we want) and Not Government Mandates ... wow what a concept. Welcome to the Republican Party.

Re:Well... how else are you gona prove them? (1)

Archangel Michael (180766) | more than 2 years ago | (#39215853)

Republican Party is not what you claim it to be. You guys are about to elect Obama Lite for President (Romney). If the party was where you claimed, Ron Paul would be doing so much better.

Re:Well... how else are you gona prove them? (2)

nbauman (624611) | more than 2 years ago | (#39217465)

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 "dietary supplement" that dietary supplements are not regulated.

In many countries, doctors are paid by the government and follow government guidelines, and most patients prefer it that way. If you live in the U.K., and your doctor follows NICE guidelines, you'll get pretty close to the best medical decisions in the world.

In health care, the governments of developed countries usually make the best decisions. The U.S. federal government usually makes the best decisions, except for those times when they're under pressure from the health care industry. Best example: If you get a head injury in Iraq or Afghanistan, military medicine will give you the best chance of getting home alive and with the least cognitive damage that you could get anywhere in the world. I've looked up some of the studies of results of major surgery, and the Veterans Affairs hospitals have some of the best outcomes in the country and the world.

Re:Well... how else are you gona prove them? (1)

Dishevel (1105119) | more than 2 years ago | (#39220187)

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 you and your doctor are incapable of rational though is no reason to rob me of my freedoms.

Re:Well... how else are you gona prove them? (1)

nbauman (624611) | more than 2 years ago | (#39217369)

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 different combinations of possible therapeutic effects and side effects. Decisions about therapy for early-stage breast cancer or prostate cancer, lipid-lowering medication for the primary prevention of coronary heart disease, and genetic and cancer screening tests are good examples. In such cases, patient involvement in decision making adds substantial value.

Re:Well... how else are you gona prove them? (2)

edelbrp (62429) | more than 2 years ago | (#39213393)

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, it still gets a bit more complicated than that from an ethical point of view.

And thus the mutants were born.... roxy (0)

Anonymous Coward | more than 2 years ago | (#39213445)

Giving unapproved stem cell "treatments" to unknowing patients. Sounds like a movie or a Nazi meme.
Just like the animals with the glowing skin, what unknown changes can these make to the brain? People are right to be worried about contamination caused by genetically engineered crops. This is orders of magnitude worse. And we don't even know about the secret experiments being done in other countries with ethics for sale to the highest bidders.

Re:Well... how else are you gona prove them? (1)

izomiac (815208) | more than 2 years ago | (#39213737)

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 spread disinformation about outright curing hundreds of diseases and downplay the risks to a mere "we're not liable for anything" clause.

With clinical trials (4, Informative)

pavon (30274) | more than 2 years ago | (#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.

Re:With clinical trials (4, Interesting)

ananyo (2519492) | more than 2 years ago | (#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....

Re:With clinical trials (1)

nbauman (624611) | more than 2 years ago | (#39217541)

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 found out how ethicists are paid by the pharmaceutical companies.

Ouch... (2)

SomePgmr (2021234) | more than 2 years ago | (#39212805)

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.

Re:Ouch... (1)

NicknameAvailable (2581237) | more than 2 years ago | (#39214581)

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.

Re:Ouch... (1)

interkin3tic (1469267) | more than 2 years ago | (#39215625)

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 these scam artists inject stem cell lines that your immune system instantly tears apart, but still, this is foolish.

Finally, if you use people as test subjects, you need to inform them of the facts, which in this case is that there is no data to suggest that injecting these cells will do anything that injecting salt water wouldn't (aside from maybe cause cancer). And you get volunteers, you don't make them pay for the privilege of possibly giving you data.

This is snake oil salesmanship. The only thing not shady about this is that the charlatans aren't hiding, they're doing this out in the open. I'm not sure that qualifies as the opposite of shady though, I'd say that's closer to arrogance.

Re:Ouch... (0)

Anonymous Coward | more than 2 years ago | (#39219811)

what sucks is he resigned from the wrong post, he'll probably lose two jobs now..

The REAL laws of Kama (-1, Troll)

Grindalf (1089511) | more than 2 years ago | (#39212973)

They are meddling with the forces of Nature, forces that they cannot control or understand. I believe that the Bioethicists role is designed around a misconception of why we have ethics, and as a consequence the ethics go wrong. If your ethics go wrong in a certain manner, you break as a person. Your job will fail, in other words.

Re:The REAL laws of Kama (0)

Anonymous Coward | more than 2 years ago | (#39213079)

That's one of the most nonsensical posts I have read on /. for a while.

Ironically you even brought up Karma (or did you really mean to type Kama, the Hindu principle of desire?) when yours has already been shot to hell from stupid posts like this.

Re:The REAL laws of Kama (1)

Dishevel (1105119) | more than 2 years ago | (#39213699)

And if man were meant to fly nature would have given him wings.
In other words....Fuck off.

If God meant me to fly (1)

drainbramage (588291) | more than 2 years ago | (#39214349)

He would have given me tickets.

Ethicist (1)

pitchpipe (708843) | more than 2 years ago | (#39213023)

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?

Re:Ethicist (0)

Anonymous Coward | more than 2 years ago | (#39213119)

A lot of people believe that we ought to have some standards of right and wrong. Not all of those people are religious.

Re:Ethicist (1)

JonySuede (1908576) | more than 2 years ago | (#39215427)

And some do not. I state that right and wrong is a fiction create by the projection of ours desires, needs, pains and anxiety unto others. It has no basis in Nature and that is why you can find example of successful (enough that we know about them ) civilizations that had at least one core value completely opposite to one our own (the western judeochristian one) for every core values (do not kill, do not steal, do not rape...).

The closer you can currently get to a non-Platonic definition of right and wrong are based on utilitarian calculus; calculus that has root in the consequentialist tradition. Even then there is too much subjectivity and political correctness involved for results from this form calculus to be as universalistic as it claims.

Re:Ethicist (1)

jackbird (721605) | more than 2 years ago | (#39216533)

We don't base our values on a state of nature, though. We base them on principles that we develop through consensus over time. That's how we manage to refrain from fighting and fucking for long enough to develop and maintain a technological civilization.

Re:Ethicist (2)

ColdWetDog (752185) | more than 2 years ago | (#39213307)

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.

Re:Ethicist (0)

Anonymous Coward | more than 2 years ago | (#39213629)

"Ethicist" sound like bullshit?

Yes, it does. If you need to employ people to analyze your ethics you're doing it wrong. Ethics only gets 'complicated' when there is money, power or sex involved, at which point you use a professional ethicist to create rationalizations for the unethical.

The ethics 'profession' is actually a fairly fresh turd in the universe of professional bullshit. The Association for Practical and Professional Ethics [indiana.edu] is celebrating only its 20th anniversary and is still hosted in a university account.

Give them another ten years and they'll have an office tower on K Street. Doubtless there will be a consequent improvement it ethics generally...

Re:Ethicist (1)

interkin3tic (1469267) | more than 2 years ago | (#39215749)

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.

It immediately became unquestionably unethical when penicillin got approved and the researchers prevented their patients from getting treated. There was no longer any use to the data as to how the disease affected black patients. With their heads wrapped up in their pointless study, the researchers were obviously in no position to judge the ethics. It was not pure racism either: some of the senior scientists were themselves black. A bioethicist obviously may not have solved the situation before it became a tragedy, but it would have been an additional safeguard against that happening. Maybe at the start, laying down conditions for ending the study.

Contrast that outcome with what happened with the antiviral "cocktail" for treating HIV: clinical trials were ended before they were scheduled to be completed because it became clear that they worked, and it was unethical to continue giving placebos instead of the real thing. A bioethics panel likely made that call or put the mechanism in place to ensure that. What if the disease was not 100% fatal like AIDS is? If it was 20% fatal? 5%?

At a minimum, you want bioethicists to limit the liability. Say "This study passed an internal review board, we have these standards for what is ethical study and what isn't" rather than "Well, it seemed like we should continue the study to us because... well... "

Re:Ethicist (1)

nbauman (624611) | more than 2 years ago | (#39217585)

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) like some guys sitting around a table drinking wine like Socrates and trying to figure out the good and the truth.

They're actually more like mob lawyers who are very clever and whose job is to get their clients off when they're guilty. A drug company does a study, it turns into a disaster, but they can go back in their files and say, "Our ethics committee reviewed this and said it was OK. Here's their letter. We thought we were doing the right thing."

Ethics committees used to be committees in academic medical centers. Now they've been privatized and there are actually independent private companies that do ethics reviews under contract and are paid by the drug companies.

Hoax (-1)

Anonymous Coward | more than 2 years ago | (#39213207)

The story is a hoax people. Celltex Therapeutics is fake; there aren't any stem cell companies in the US, and in particular not in Texas (where 'Celltex' is supposedly based,) because the bushies chased all the stem cell work to Europe and Asia with their fundy policies.

Also, even if Celltex existed, it couldn't possibly be engaged in anything unethical. Only the fundies were stupid enough to believe anything like that might happen, so that's obviously nonsense.

Please, stop falling for these hoaxes. Also, do spend your mod points rating Anonymous Coward a troll.

Way to go. (3, Interesting)

subreality (157447) | more than 2 years ago | (#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.

Re:Way to go. (1)

interkin3tic (1469267) | more than 2 years ago | (#39215647)

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.

jumping to conclusions? (1)

Gravis Zero (934156) | more than 2 years ago | (#39222371)

didnt read the article but is it possible he got a better offer?

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