Terminally ill patients do not have a constitutional right to be treated with experim

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    Terminally ill patients do not have a constitutional right to be treated with experim


    Court: No Unapproved Meds For The Dying, Federal Appeals Court Says Terminally Ill Patients Have No Constitutional Right To Experimental Drugs - CBS News

    (AP) Terminally ill patients do not have a constitutional right to be treated with experimental drugs, even if they likely will be dead before the medicine is approved, a federal appeals court said Tuesday.

    The ruling by the U.S. Court of Appeals for the District of Columbia Circuit overturned last year's decision by a smaller panel of the same court, which held that terminally ill patients may not be denied access to potentially lifesaving drugs.

    The full court disagreed, saying in an 8-2 ruling that it would not create a constitutional right for patients to assume "any level of risk" without regard to medical testing.

    "Terminally ill patients desperately need curative treatments," Judge Thomas B. Griffith wrote for the majority. But "their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit."

    Food and Drug Administration approval of drugs generally requires extensive testing that can involve years of trials and thousands of patients.

    The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA in 2003, seeking access for terminally ill patients to drugs that have undergone preliminary safety testing in as few as 20 people but have yet to be approved.

    Abigail Alliance founder Frank Burroughs pledged an appeal to the Supreme Court. Burroughs' daughter, Abigail, was denied access to experimental cancer drugs and died in 2001. The drug she was seeking was approved years later.

    "What the opinion by Judge Griffith is saying is, 'We don't want to risk one life or a few lives, even at the expense of the lives of hundreds or thousands of people,"' Burroughs said. "The logic of that escapes me."

    In a sharply worded dissent, Judge Judith W. Rogers called the ruling "startling." She said courts have established the right "to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private, and to control one's own body even if it results in one's own death or the death of a fetus."

    "But the right to try to save one's life is left out in the cold despite its textual anchor in the right to life," Rogers wrote.

    Rogers was joined by Chief Judge Douglas H. Ginsburg. The case cut across party lines, with conservative and liberal judges taking both sides of the dispute.

    A spokeswoman for the FDA did not immediately return a message seeking comment.

    The court noted that there are government programs that provide access to experimental drugs in certain situations. It said the matter is not closed and said Congress might be a better venue than the courts to address the issue.

    Burroughs said he expects such legislation to be introduced this session. Both the Senate and House have considered such legislation but it languished in committee.

    MMVII The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

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    I agree to a great extent with this.

    All this is saying is, a patient cannot DEMAND an experimental drug and neither can their doctor. Only the people in control of the drug's development can decide. This is NOT saying that people CANNOT take experimental drugs, it only said the decision is up to the R&D group in charge of the drug whether or not the patient is permitted to have access.

    In that respect actually, come to think of it, I agree wholeheartedly for a number of reasons:

    1) the R&D group knows best who would benefit from it and the liklihood of success better than anyone else

    2) If a patient demands it and it is a catastrophic failure for that patient, it will be unfair negative press for that drug and may jeopardize approval due to POLITICAL reasons as opposed to the drug's actual efficacy and safety in its true target population.



    This decision basically just said "sick people are stupid and desperate and have no idea what will or will not be effective for them." Which is true.
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    the R&D only accept small numbers of patients for trials...trials which take years.

    if i am terminally ill im going to tell the R&D to go **** themselves, and do whatever i can to give myself a chance. look at it this way.

    1. you are terminally ill, and GOING (without a doubt) to die.
    2. you take an experimental drug which may or may not work, and it will either improve you situation to the point where you wont die, or at the very worst you are right back to option 1 where you started.

    simplified

    1. death
    2. possible cure, sooner death

    which would you take?
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    If I were terminally ill, do you think risk of prison is any deterrent?

    Especially being of a scientific mind, I would experiment like mad on myself.
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    Quote Originally Posted by jomi822 View Post
    the R&D only accept small numbers of patients for trials...trials which take years.

    if i am terminally ill im going to tell the R&D to go **** themselves, and do whatever i can to give myself a chance. look at it this way.

    1. you are terminally ill, and GOING (without a doubt) to die.
    2. you take an experimental drug which may or may not work, and it will either improve you situation to the point where you wont die, or at the very worst you are right back to option 1 where you started.

    simplified

    1. death
    2. possible cure, sooner death

    which would you take?

    That's the point. Terminally ill patients are desperate and stupid. They don't care that if they take a drug that isn't remotely meant for them and it kills them, it will jeopardize approval of a drug that may have saved thousands or even millions. And yes, such an action most definitely WOULD.

    Plus, this is a case of PATIENTS deciding a drug will help them. EXCUSE ME?! Since when do patients have the qualifications necessary to determine what drug is even remotely appropriate for their condition?! They don't have a ****ing clue! With experimental drugs the effects are so unknown and unfamiliar their DOCTORS aren't even going to know.

    No, I'm sorry, but this **** just screams entitlement. No. Patients have no right to demand anything whatsoever other than APPROVED medical treatment. If their doctor wants to they can see about seeking the possibility of getting experimental treatment and then it is up to the pahrmaceutical company to decide whether or not to offer it. THEN and ONLY THEN does the patient come into play; either accepting or rejecting the treatment offered.
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    Quote Originally Posted by Tiberius View Post
    I agree to a great extent with this.

    All this is saying is, a patient cannot DEMAND an experimental drug and neither can their doctor. Only the people in control of the drug's development can decide.
    No, that's not what this ruling says. The issue isn't whether people have the right to demand experimntal drugs from the R&D developers. Private citizens never have to right to demand property from other private citizens. The arguments here were constitutional.....the constitution governs the conduct of the government, not private actors.

    In this case, the issue is whether the FDA can set restrictions on the pool of potential testers that the R&D group is using. Testing is overseen by the FDA in a series of nested processes...with the FDA granting permission to conduct broader more detailed experiements after reviewing the data from the previous sets. The final stages of drug approval where testing on actual human beings is conducted is tightly controlled.

    In this case, the argument was that there should essentially be an exception to the stringent human testing protocols for people who were otherwise terminal. If the R&D group didn't want to share their drug with terminal patients, they didn't have to. It is private property after all. However, if they did (and it would seem a great pool of potential data in most cases), the FDA would have to let them.

    The en banc court ruled that the FDA was justified in saying no to terminal patients because the government had a legitimate interest in setting such restrictions and there was no constitutional right of the patients being infringed.
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    Quote Originally Posted by yeahright View Post
    No, that's not what this ruling says. The issue isn't whether people have the right to demand experimntal drugs from the R&D developers. Private citizens never have to right to demand property from other private citizens. The arguments here were constitutional.....the constitution governs the conduct of the government, not private actors.

    In this case, the issue is whether the FDA can set restrictions on the pool of potential testers that the R&D group is using. Testing is overseen by the FDA in a series of nested processes...with the FDA granting permission to conduct broader more detailed experiements after reviewing the data from the previous sets. The final stages of drug approval where testing on actual human beings is conducted is tightly controlled.

    In this case, the argument was that there should essentially be an exception to the stringent human testing protocols for people who were otherwise terminal. If the R&D group didn't want to share their drug with terminal patients, they didn't have to. It is private property after all. However, if they did (and it would seem a great pool of potential data in most cases), the FDA would have to let them.

    The en banc court ruled that the FDA was justified in saying no to terminal patients because the government had a legitimate interest in setting such restrictions and there was no constitutional right of the patients being infringed.

    I don't agree with thta but I can see a logic behind it. If they were to let them bypass the FDA, it would undermine the entire process by which the FDA approves drugs for human testing and human trials. Drug companies could potentially give the drug to people outside a clinical environment as a "test run" before getting approval for phase 1 or phase 2. This would be a big deal because it would allow them to give what they think is a therapeutic dose right off the bat instead of having to wait until phase 2.
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    Quote Originally Posted by Tiberius View Post
    No, I'm sorry, but this **** just screams entitlement.
    Sorry but desperation is a far more applicable notion than entitlement. Pretty asinine to say terminally-ill people are being a$$holes and belligerent because they MERELY want to stay alive.

    Empathy much?
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    Quote Originally Posted by Tiberius View Post
    I don't agree with thta but I can see a logic behind it. If they were to let them bypass the FDA, it would undermine the entire process by which the FDA approves drugs for human testing and human trials. Drug companies could potentially give the drug to people outside a clinical environment as a "test run" before getting approval for phase 1 or phase 2. This would be a big deal because it would allow them to give what they think is a therapeutic dose right off the bat instead of having to wait until phase 2.
    Yes it would be a big deal....but not in a negative way. If terminal people were willing to line-up for experiemnts, the drug testers very well might be able to give what they think is a therapeutic dose right off the bat. This could greatly speed-up the R&D process by pinpointing a therapeutic dose (at least in terminal patients) and allowing for backwards extrapolation to appropriate therapeutic doses for people with early stages of the disease. There are lots of potential ethical pitfalls here but the one you're gesturing at is actually a positive.
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    Quote Originally Posted by yeahright View Post
    Yes it would be a big deal....but not in a negative way. If terminal people were willing to line-up for experiemnts, the drug testers very well might be able to give what they think is a therapeutic dose right off the bat. This could greatly speed-up the R&D process by pinpointing a therapeutic dose (at least in terminal patients) and allowing for backwards extrapolation to appropriate therapeutic doses for people with early stages of the disease. There are lots of potential ethical pitfalls here but the one you're gesturing at is actually a positive.

    It's a double edged sword. What they THINK is a therapeutic dose could very very easily be extremely deadly. And since this would be outside of a clinical trial the results don't have to be fed into the FDA submission.
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    tiberius i pose a hypothetical situation to you.

    you are terminally ill and have 6 months to live. the doctors say there is no medication, except an experimental one not available to you, that can be used to treat your illness.

    are you or are you not going to do everything in your power to get your hands on that experimental drug?
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    Quote Originally Posted by jomi822 View Post
    tiberius i pose a hypothetical situation to you.

    you are terminally ill and have 6 months to live. the doctors say there is no medication, except an experimental one not available to you, that can be used to treat your illness.

    are you or are you not going to do everything in your power to get your hands on that experimental drug?
    That's a dumb thing to ask and completely irrelevent. I'd be desperate and stupid, of course I would try to get it.

    You know what? If doctors said "a researcher friend of mine has conducted a study finding that drinking battery acid may help cure your cancer." I'd do it in a heartbeat. Why? Cus I'd be desperate and stupid.

    If doctors told me that the cure for my cancer was across the street locked in a shrine guarded by Buddhist monks and the only way to get the shrine to open is to slaughter the entire lot of them and eat the heart of a child, I'd do it. Because I'd be desperate and stupid.
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    Quote Originally Posted by Tiberius View Post
    That's a dumb thing to ask and completely irrelevent. I'd be desperate and stupid, of course I would try to get it.

    You know what? If doctors said "a researcher friend of mine has conducted a study finding that drinking battery acid may help cure your cancer." I'd do it in a heartbeat. Why? Cus I'd be desperate and stupid.

    If doctors told me that the cure for my cancer was across the street locked in a shrine guarded by Buddhist monks and the only way to get the shrine to open is to slaughter the entire lot of them and eat the heart of a child, I'd do it. Because I'd be desperate and stupid.
    was that a yes?
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    Quote Originally Posted by Tiberius View Post
    It's a double edged sword. What they THINK is a therapeutic dose could very very easily be extremely deadly. And since this would be outside of a clinical trial the results don't have to be fed into the FDA submission.
    It's not a double edged sword but it does have its own complications (mostly ethical). The issue you point to could be resolved with an administrative rules that data from any testing of the product must be reported to the FDA. Regulating it certainly wouldn't be a problem.

    The real issues are:

    (1) Would companies be afraid that adverse results from people already dying might create a negative buzz around their product even if their other testing shows that it is safe and X% effective? From a marketing standpoint, most drugs aren't homeruns. They don't cure things. They just marginally improve conditions or patient outcomes. So, if I have a drug that I think will add 24 months onto the lifespan of a sick patient, do I want my drug associated with end-stage patients?

    (2) There are profound ethical issues that arise from taking advantage of vulnerable populations. In this case, a person faced with a terminal prognosis is pretty vulnerable and companies might be pretty cavalier in viewing them as an essentially disposable test population. They might do very risky things that aren't in the interest of the terminal patient but are merely a commercial advantage to the manufacturer. If this were allowed, there would have to be an entirely new type of human subjects review committee to oversee it.
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    Quote Originally Posted by yeahright View Post
    Yes it would be a big deal....but not in a negative way. If terminal people were willing to line-up for experiemnts, the drug testers very well might be able to give what they think is a therapeutic dose right off the bat. This could greatly speed-up the R&D process by pinpointing a therapeutic dose (at least in terminal patients) and allowing for backwards extrapolation to appropriate therapeutic doses for people with early stages of the disease. There are lots of potential ethical pitfalls here but the one you're gesturing at is actually a positive.
    I'd rather die on my feet , than live on my knees !

    The terminal experimenters would be heroes, they could pave the way for research into technologies that could save not just their own life but future lives.Dying while trying to save lives is the "Heroes Path" and I would take it!
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    Quote Originally Posted by anabolicrhino View Post
    I'd rather die on my feet , than live on my knees !

    The terminal experimenters would be heroes, they could pave the way for research into technologies that could save not just their own life but future lives.Dying while trying to save lives is the "Heroes Path" and I would take it!
    Well, there's the choice we would make as individuals and the choices a society makes when allocating resources among citizens. Personal decisions versus public policy decisions. I agree with your personal choice but the society does have big questions to wrestle with if it is going to allow those personal choices.
  

  
 

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