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Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: something bizarre and impractical on January 15, 2008, 04:01:44 am
Links: http://news.yahoo.com/s/afp/20080114/ts_alt_afp/ushealthcourt
http://abcnews.go.com/Health/CancerPreventionAndTreatment/wireStory?id=4131494
http://www.cbsnews.com/stories/2008/01/14/health/main3709741.shtml

Lazy (this is a joke, calm down):
Discuss.

------

Just kidding.

Basically, the Supreme Court has 'decided' that patients whom are terminally ill have no right to try experimental drugs which could have life-saving effects.

The problem here is that these drugs ARE NOT approved by the FDA, and could have toxic, even lethal, or other unknown effects as they have not gone through proper human trials yet.

I think any terminal patient, whom demonstrates mental competency, should definitely be able to have access to these drugs. It should be that patients right to live and to fight for that right to live if they so choose. Once they have exhausted all over sources are they just supposed to sit by and accept their death knowing that there are potentially life-saving medicines available which are being held up by cold bureaucratic nonsense?

Does anyone understand any argument AGAINST this?
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Mateui on January 15, 2008, 04:07:41 am
Well, let's see. The hippocratic oath requires doctors to do no harm to their patients. Providing patients access to unapproved, potentially lethal drugs with unstudied side effects violates this oath and I can see why the court ruled as they did.

No health professional or ethics committee member would ever vote in favour of allowing patients to experiment with developmental drugs that haven't undergone drug trials for approval, regardless whether they are healthy or terminally ill.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Doktormartini on January 15, 2008, 04:09:16 am
I agree with you Catslacks I can't say much else.  If they are terminally then they are going to die so they should have the right to make their own choice.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: something bizarre and impractical on January 15, 2008, 04:12:19 am
Well, let's see. The hippocratic oath requires doctors to do no harm to their patients. Providing patients access to unapproved, potentially lethal drugs with unstudied side effects violates this oath and I can see why the court ruled as they did.

Okay, but moving from that. It's like saying they shouldn't do blood work because they have to poke you with a needle and it hurts. Or they shouldn't do skin grafts. Or... et cetera.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: xanque on January 15, 2008, 04:15:11 am
...What?  I'm confused.  So are experimental drugs currently allowed, but they're trying to say they shouldn't be, or is it the other way around?
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: something bizarre and impractical on January 15, 2008, 04:16:02 am
...What?  I'm confused.  So are experimental drugs currently allowed, but they're trying to say they shouldn't be, or is it the other way around?
The drugs are not approved by the FDA and are not being allowed to the patients (whom are terminally ill).
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Marcus on January 15, 2008, 04:16:41 am
I never understood why America is always torn between two extremes and there's NEVER any middle ground.

Fact of the matter is, a terminally ill patient is going to die regardless.  People have the free will to choose how they want to live their lives but as soon as they agree to something that isn't "government approved" the legal system steps in and tells them NO.  It's not like experimental drugs would be FORCED on someone, but they're being wasted on lab rats and guinea pigs. 

I don't understand how allowing someone, who is going to die, the right to choose what drugs they take will have disastrous affects on the world at large.

But fuck, it's the American legal system.  What more can I say.

Quote
No health professional or ethics committee member would ever vote in favour of allowing patients to experiment with developmental drugs that haven't undergone drug trials for approval, regardless whether they are healthy or terminally ill.

And yet we're still battling to give family members the rights to pull the plug.  If I'm going to fucking die then I don't want a potentially life saving device to go untested.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Moriason on January 15, 2008, 04:43:15 am
It seems fitting that even on our deathbed, for the average tax-paying citizen choice is still just an illusion.

Go Supreme Court, horrible ruling.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Artis Leon Ivey Jr on January 15, 2008, 04:44:26 am
Well, let's see. The hippocratic oath requires doctors to do no harm to their patients. Providing patients access to unapproved, potentially lethal drugs with unstudied side effects violates this oath and I can see why the court ruled as they did.

No health professional or ethics committee member would ever vote in favour of allowing patients to experiment with developmental drugs that haven't undergone drug trials for approval, regardless whether they are healthy or terminally ill.

bingo!

sorry kids but you don't get to violate the hippocratic oath just because some fuckabee in a suit wants to see what happens when you inject herpes into a patient and some poor doofus doesn't know what the fuck that means so he signs his dick away to more pain.

It seems fitting that even on our deathbed, for the average tax-paying citizen choice is still just an illusion.

Go Supreme Court, horrible ruling.

refusing to hear a case is not a ruling.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Hempknight on January 15, 2008, 10:37:41 am
No health professional or ethics committee member would ever vote in favour of allowing patients to experiment with developmental drugs that haven't undergone drug trials for approval, regardless whether they are healthy or terminally ill.

HOWEVER - Doctors and other 'health professionals' prescribe drugs that have been FDA approved, but not for the thing they were prescribed for all the time - Aspirin for Cardiac Health? Beta Blockers for Migraines and other Psychiatric Purposes? Steroids for Cancer? ETC.

The FDA never dreamed of approving any of those drugs for those reasons, yet they're prescribed for them every single day... Without any sort of Drug Testing. Kinda weakens the concept of "FDA Drug Trials and Approval".

This isn't about preventing harm, it's about trying to boost the publics faith in the FDA, instead of showing what a ridiculous, ineffective agency it is, where drug lobbies can convince them to approve a new erection pill or anti depressant in 2 years, while promising treatments for things that actually kill people can take 15 to 20.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: dom on January 15, 2008, 11:12:13 am
i hope you guys realise that dying is NOT the worst thing that can happen when taking a developmental drug so 'theyre gonna die anyway' is a terrible argument

HOWEVER - Doctors and other 'health professionals' prescribe drugs that have been FDA approved, but not for the thing they were prescribed for all the time - Aspirin for Cardiac Health? Beta Blockers for Migraines and other Psychiatric Purposes? Steroids for Cancer? ETC.

The FDA never dreamed of approving any of those drugs for those reasons, yet they're prescribed for them every single day... Without any sort of Drug Testing. Kinda weakens the concept of "FDA Drug Trials and Approval".

This isn't about preventing harm, it's about trying to boost the publics faith in the FDA, instead of showing what a ridiculous, ineffective agency it is, where drug lobbies can convince them to approve a new erection pill or anti depressant in 2 years, while promising treatments for things that actually kill people can take 15 to 20.
where's your tinfoil hat???

it doesn't matter if they haven't been 'FDA approved for the specific use' only that they have been FDA approved - if its FDA approved it means that it's not going to cause major adverse effects (such as death.) that means you can generally take it for any reason.

aspirin is useful as an anticoagulant which is why it lowers the risk of heart attacks. this was no doubt discussed by the FDA as an effect of the drug and deemed, obviously, safe.

please name a promising treatment for things that can actually kill people that has taken 15 to 20 years to reach the public.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: JohnnyCasil on January 15, 2008, 12:49:39 pm
Okay, but moving from that. It's like saying they shouldn't do blood work because they have to poke you with a needle and it hurts. Or they shouldn't do skin grafts. Or... et cetera.

Wow, just wow.

I don't understand how allowing someone, who is going to die, the right to choose what drugs they take will have disastrous affects on the world at large.

Because what if that one person takes the drug, and it cures him, but only him due to some specific circumstance in his body.  This is unknown of course, because the only thing the media sees the is the miracle drug that saved a man's life.  Other terminally ill patients rush to get this new 'miracle' drug.  Turns out the vast majority of these people do not have the specific bodily circumstance and for every 1 person that is cured, 100 die overnight from the drug.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Mince Wobley on January 15, 2008, 03:27:05 pm
Dr. House would just ignore them and do it anyway

But why test them with people when we have animals to do that?
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Artis Leon Ivey Jr on January 15, 2008, 03:31:27 pm
HOWEVER - Doctors and other 'health professionals' prescribe drugs that have been FDA approved, but not for the thing they were prescribed for all the time - Aspirin for Cardiac Health? Beta Blockers for Migraines and other Psychiatric Purposes? Steroids for Cancer? ETC.

The FDA never dreamed of approving any of those drugs for those reasons, yet they're prescribed for them every single day... Without any sort of Drug Testing. Kinda weakens the concept of "FDA Drug Trials and Approval".

This isn't about preventing harm, it's about trying to boost the publics faith in the FDA, instead of showing what a ridiculous, ineffective agency it is, where drug lobbies can convince them to approve a new erection pill or anti depressant in 2 years, while promising treatments for things that actually kill people can take 15 to 20.

hahaha you're kidding.

where did you come up with this shit.

do you understand that doctors who prescribe that shit might be doing it because they work and have been tested? like...what are you saying? aspirin does shit to the blood which affects the heart, beta inhibitors are well tested on mental condition, steroids are often used on cancer patients because of muscle atrophy among other things.

jesus christ you even posted it like a big pharma nutjob.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Fatboys #4 on January 15, 2008, 03:33:00 pm
Does anyone understand any argument AGAINST this?


The problem here is that these drugs ARE NOT approved by the FDA, and could have toxic, even lethal, or other unknown effects as they have not gone through proper human trials yet.

I think any terminal patient, whom demonstrates mental competency, should definitely be able to have access to these drugs.

Yeah. My argument is you're an ass.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Mince Wobley on January 15, 2008, 03:41:40 pm

it doesn't matter if they haven't been 'FDA approved for the specific use' only that they have been FDA approved - if its FDA approved it means that it's not going to cause major adverse effects (such as death.) that means you can generally take it for any reason.


http://en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration#Criticism:_FDA_approves_unsafe_drugs

Quote

Troglitazone is a diabetes drug that was also available abroad at the time the FDA approved it. Post-marketing safety data indicated that the drug had dangerous side-effects (in this case liver failure). The drug was pulled off that market in the UK in 1997, but was not withdrawn by the FDA until 2000, before which time it is claimed that thousands of Americans were injured or killed by the drug.

Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Cray on January 15, 2008, 03:50:11 pm
all I can say is that if I was a terminal patient and there is a drug tested on animals but not on humans that "could" cure me, I would want to be able to take it.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: EvilDemonCreature on January 15, 2008, 05:06:43 pm
This is the abortion issue all over again.

Except it involves the lives of people who are at the potential end rather than the potential beginning.

The people arguing pro-choice are the ones in support of extended life at the risk of lost livelyhood! It's like i'm in fucking bizarro world!
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: crone_lover720 on January 15, 2008, 05:40:18 pm
hahaha you're kidding.

where did you come up with this shit.

do you understand that doctors who prescribe that shit might be doing it because they work and have been tested? like...what are you saying? aspirin does shit to the blood which affects the heart, beta inhibitors are well tested on mental condition, steroids are often used on cancer patients because of muscle atrophy among other things.

jesus christ you even posted it like a big pharma nutjob.
he is right about prescribing drugs against what they're designed and tested for. drugs can be prescribed off-label, and sometimes it has some pretty terrible consequences. I think one drug was neurontin, used as a painkiller for people who had like shattered feet or something that'd cause them a lot of pain daily. neurontin is normally a drug that is used to stabilize mental health, and that is what it had been FDA tested for. however, many patients noticed that it also acted as a strong painkiller, and after a while some doctors started prescribing it to peope whose pain couldn't be ameliorated by any other drug

as it turns out, when used by people without the mental health issues neurontin was intended for, neurontin can cause deep depression, often leading to suicide. There's a scholarly article out there somewhere about this guy who told his wife to take their daughter out of the house and headed into the basement to kill himself. his daughter realized what was going on and stated crying and screaming, and it was only because he heard this that he couldn't pull the trigger. it was a pretty cool article iirc I don't know if it's still around or on gs but it was an interesting read

edit:
Quote
abortion
I don't think so, I'm against this and pro-choice. there are other issues involved here
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Artis Leon Ivey Jr on January 15, 2008, 05:50:12 pm
he is right about prescribing drugs against what they're designed and tested for. drugs can be prescribed off-label, and sometimes it has some pretty terrible consequences. I think one drug was neurontin, used as a painkiller for people who had like shattered feet or something that'd cause them a lot of pain daily. neurontin is normally a drug that is used to stabilize mental health, and that is what it had been FDA tested for. however, many patients noticed that it also acted as a strong painkiller, and after a while some doctors started prescribing it to peope whose pain couldn't be ameliorated by any other drug

as it turns out, when used by people without the mental health issues neurontin was intended for, neurontin can cause deep depression, often leading to suicide. There's a scholarly article out there somewhere about this guy who told his wife to take their daughter out of the house and headed into the basement to kill himself. his daughter realized what was going on and stated crying and screaming, and it was only because he heard this that he couldn't pull the trigger. it was a pretty cool article iirc I don't know if it's still around or on gs but it was an interesting read

well I mean, obviously doctors can be stupid but aside from having nothing to do with the FDA, his examples were bizarre as shit and completely irrelevant since very few would cause the example you or Cheetos brought up. we know what aspirin, steroids, and beta blockers do, and their side effects on normal people.

also yeah the FDA should probably undergo an overhaul but saying something like "doctors can prescribe FDA approved drugs without anything why can't they stick any old can of drugs into some AIDs patient" is a leap that I'm not willing to make!

also also do you all saying "I want anything that can help" not at least see the ethical dilemma of essentially experimenting on patients? this idea of consent is ridiculous, considering the example Render just brought up of doctors prescribing bad drugs and the patient not knowing anything about it. also none of these will be like TEARS OF THE VIRGIN MOTHER INSTA-CURE, and these people will die regardless, but with no knowledge of the sideeffects prior to testing in most cases. imagine taking one of these drugs and the pain getting worse.

this mistaken belief that "oh they consented please...why would you let them die instead of take that chance..." seems really strange to me because you're assuming they know enough to make an educated consent and this isn't at all going to lead to bad practices of scientific testing!

edit: also about abortion: abortion advocates look at the reality of the situation, such as in Argentina where abortion was outlawed but more abortions are done (and all back alley) than in nations with legalized abortion because the abortion movement is more about a false sense of morality than BABBY DEATH, and also that cells!=people and all that stuff. similarly, you look at the reality of this situation and if you think this will have magic cures that these poor dying people will somehow be saved by, you're completely bonkers.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Wash Cycle on January 15, 2008, 07:57:56 pm
what I'm still not understanding

is why... we care what terminally ill people want to do with their bodies. or why we should tell them what they can and cant do for that matter. If they understand all the risks associated with their choices then why tell them no you cant do that fuck you. they're going to die anyway ffs, but I would hope it to be illegal to force these types of things on people so yeah

someone please help me straighten this issue out
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: dada on January 15, 2008, 08:16:02 pm
Because what if that one person takes the drug, and it cures him, but only him due to some specific circumstance in his body.  This is unknown of course, because the only thing the media sees the is the miracle drug that saved a man's life.  Other terminally ill patients rush to get this new 'miracle' drug.  Turns out the vast majority of these people do not have the specific bodily circumstance and for every 1 person that is cured, 100 die overnight from the drug.
I think I get what you're saying, but this is a very far-fetched story, man.


Anyway, I think that the problem with this is that patients might not be educated enough to make such a decision. The thing about untested treatment is that it can cause undefined effects. You're opening Pandora's box by allowing people to judge for themselves whether they want to take such medication, which makes it very difficult from an ethical point of view. While it may save a life, it probably carries too many unnecessary risks.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: JohnnyCasil on January 15, 2008, 08:34:07 pm
It is far fetched, you are right, but the point I was trying to make is everyone here is thinking that by allowing a terminally ill patient to take the drug, only that person will see consequences.  When really there is a much larger picture here.

By allowing terminally ill patients to just take whatever experimental drug they please opens all kinds of ethical and medical cans of worms.  Steel spoke on the ethical side of it a lot, and I agree with him on it.  He touched on what I meant by my original post, but said it in a much more realistic way.

Without knowing the side effects who really knows what these drugs could do to anyone?  While people may not be dropping dead left and right in my above scenario, it could be that side effects do not appear at first when the first "specimens" start treatment with the drug.  It could appear that the drug is effective at first, but really be causing some other problems.  Which I think is a much more realistic scenario.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: dada on January 15, 2008, 08:39:04 pm
By allowing terminally ill patients to just take whatever experimental drug they please opens all kinds of ethical and medical cans of worms.
Yeah, I agree with this.

Besides, does anyone remember those Britons who took part in a certain testing program for a medicine that was supposedly safe and then died after their bodies swelled up to like two times the normal size? I do!!
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Randy Moist on January 15, 2008, 09:13:24 pm
I don't know a whole lot about the FDA, it's definitely a bureaucracy that I hear a lot of criticisms about though. Maybe I'll spend some time reading up on it and the process by which is oks a drug.

But uh with what little I know about it I see it as pretty important to have. And so without some sort of FDA reform (I dunno if it needs or not) the current process is probably the best decider of whether any drug should be available, as without it the flow of miracle cures to the market would be absurd. And I see why terminally ill patients might want an exception (and might be able to make a compiling moral case) to use experimental drugs but they don't have a constitutional claim to it, so yea whoever said this is better suited for congress is right as they classify drug categories if I'm not mistaken and could create legislation to allow terminally diagnosed patients access to experimental drugs.

for someone who knows something about the FDA, how long is the process of getting your drug approved assuming you have evidence? Is it months or years? I assume after you bring it to the FDA they run their own test (A double Blind or whatever it's called) and if the results match it becomes available and if not then it goes back to your lab to improve it.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: something bizarre and impractical on January 15, 2008, 09:17:43 pm
Yeah. My argument is you're an ass.

Thank you for this meaningless flame. It contributes greatly to the conversation at hand!

How am I an ass? Because I want to test unapproved drugs on terminally ill patients? No, because that is not the reasoning behind my position. Yes, these drugs could have unpredictable effects, and I'm sure, believe it or not, that many of these terminally ill patients (whom might be in terrible pain anyways) are quite aware that there could be negative effects that go along with the drug.

The only problem I see is that it could give them some sense of false hope, and they may be exploited by drug companies as fast-forwarded human tests. Which I wouldn't like to see happen, despite, "BEING AN ASS."


...You fucking shit-head.

The point is I do recognize that there is some emotional distress going on here, but that once the patients have exhausted all other sources they are left with nothing but to accept their own death while keeping in mind the fact that there are medicines which could potentially help them. Please do not spew forth your retarded comments unless you are going to at least expand upon them.

EDIT: I am not suggesting we pump every terminally ill patient full of random medicines of which we have no human trials yet.

Also, I find it interesting that mankind tends to justify its morality based on old texts or ideas. We have a tendency to not what to evolve our morality. Hmm!
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: dom on January 15, 2008, 09:22:30 pm
The point is I do recognize that there is some emotional distress going on here, but that once the patients have exhausted all other sources they are left with nothing but to accept their own death while keeping in mind the fact that there are medicines which could potentially help them.
potentially. however it is far more likely that these medicines will make their life even worse.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: something bizarre and impractical on January 15, 2008, 09:23:42 pm
potentially. however it is far more likely that these medicines will make their life even worse.

Yes, that's why I said potentially. Congratulations you're on your way to becoming a dictionary.

EDIT: And I'm a little tipsy on this one, but almost all of you would just accept you were dying in that case and not try to fight it? I mean, really?
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Kaempfer on January 15, 2008, 09:29:42 pm
I understand that you don't want patients taking new and completely untested drugs, even on their deathbeds. But what about drugs that are ending their testing cycle and just waiting on the final FDA approval? What about drugs approved abroad (not really experimental!)?

There is a big difference between letting patients take "whatever experimental drug they please" and drugs that are (let's just say) that have a year on their twenty year testing period left. I think doctors should have the ability to, in extreme circumstances and under the scrutiny of some pre-existing control board, be allowed to prescribe "nearly there" drugs to terminal subjects.

This isn't just anyone in the health care system and it isn't just any old drug off the street, it's someone on their deathbed and a drug that has a good chance of helping them (maybe!). It's sort of like Marcus said about a complete lack of middle ground; a drug isn't poison until the FDA says otherwise (at which point it magically becomes completely safe).
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: something bizarre and impractical on January 15, 2008, 09:34:39 pm
Thank you, Kaempfer. That was a good post.

And, I agree. Especially consider it isn't any stretch of the imagination that these drugs are held up far longer than the should be in a bureaucratic nightmare. The longer they are held up, the longer the patients have to wait for them (and these patients don't have time!). As, Kaempfer said, just because some drugs are held behind a wall of paper doesn't mean they are INSTANTLY POISON and will simultaneously give you Alzheimer's, HIV, and liver failure.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Vellfire on January 15, 2008, 09:51:50 pm
I don't know if this has been mentioned, but I can see at least one reason why "why does it matter what they want to use to try to keep living" doesn't work--say they let the patient take that experimental drug, and it kills them way faster than they were supposed to die.  The family then goes berserk whether the patient chose it or not because they just see it as WHAT A TERRIBLE DOCTOR GIVING THEM THAT DRUG WHY DONT THEY REGULATE THESE THINGS YOU KILLED MY FAMILY MEMBER

It's not the doctor's choice, but the doctor is going to be blamed if something goes wrong.  The medical field is INCREDIBLY sensitive, and you have to be VERY careful what you let through.  If we weren't so quick to always blame the doctors, I could see this MAYBE being something we should be letting them choose (although JohnnyCasil's points are dead on about giving others false hopes because one person might have had good luck with it), but if anything happened wrong, no matter whose choice it was that doctor is going to be in trouble.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Randy Moist on January 15, 2008, 09:52:09 pm
I understand that you don't want patients taking new and completely untested drugs, even on their deathbeds. But what about drugs that are ending their testing cycle and just waiting on the final FDA approval? What about drugs approved abroad (not really experimental!)?

There is a big difference between letting patients take "whatever experimental drug they please" and drugs that are (let's just say) that have a year on their twenty year testing period left. I think doctors should have the ability to, in extreme circumstances and under the scrutiny of some pre-existing control board, be allowed to prescribe "nearly there" drugs to terminal subjects.
http://www.allp.com/drug_dev.htm
I found this link with just a random search so I don't know how accurate it is, but I'm going to assume it is fairly close. So according to this the process includes a patient testing period that if the drug is in fact a good one, will be helping some 1000 to 3000 people inflicted people, many probably terminally ill. This is only a few years into the study, not 17 years or whatever you were suggesting.

As for a board or whatever to grant special permissions, that's something handled through congress not the supreme court. How the FDA operates might be suspect but I choose to believe it is designed intelligently at some level and more bad medicines are stopped than good ones lost (actually no good medicines should fail to make it to the market unless some other influence is involved but that's not what's in question).

Edit: I don't agree with Johnny. From what I've been reading this 1 person saved only thing would be pretty remarkable and labs can pick up on it for the most part. Also they can figure out what created the special circumstances and continue work with that in mind. But yea his main point is that having the process is important to create certainty.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: ATARI on January 16, 2008, 12:20:06 am
Wow, just wow.

Because what if that one person takes the drug, and it cures him, but only him due to some specific circumstance in his body.  This is unknown of course, because the only thing the media sees the is the miracle drug that saved a man's life.  Other terminally ill patients rush to get this new 'miracle' drug.  Turns out the vast majority of these people do not have the specific bodily circumstance and for every 1 person that is cured, 100 die overnight from the drug.

It's I am Legend all over again
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: Kaempfer on January 16, 2008, 12:30:38 am
http://www.allp.com/drug_dev.htm
I found this link with just a random search so I don't know how accurate it is, but I'm going to assume it is fairly close. So according to this the process includes a patient testing period that if the drug is in fact a good one, will be helping some 1000 to 3000 people inflicted people, many probably terminally ill. This is only a few years into the study, not 17 years or whatever you were suggesting.

While I admit the 17 years was way off (whoops), it still sits in the hands of the FDA for 2 and a half years before they release it to people outside the specific test group. 2.5 is a fairly long time for a patient labelled terminal, and even still only 1 our of every 5 compounds/drugs/druges makes it through the FDA. What happens if one of those rejected four, one of those that have passed trials and have shown to have side effects (but not as bad as death, one would hope) meets the requirements of the illness better than the one that is passed?

I am pro-FDA (or something like it) and think that their definitely (obviously) needs to be government oversight into the manufacture of pharmaceuticals for general consumption. But when you run into people who definitely are going to die and are willing to live with migraines and diarrhoea and possible liver failure in thirty years, then you have to be willing to create special legal and medical circumstances, otherwise you have failed as a health system.

I understand the legal complexities ("he died even though/because they gave him "experimental" drugs, I want a law suit!") but make them sign a waiver or something and try your damnedest to help, otherwise part of the onus is directly on you.
Title: Supreme Court Refuses Experimental Drugs to Terminal Patients
Post by: something bizarre and impractical on January 16, 2008, 12:46:07 am
A waiver that states that these drugs are not approved by the FDA would obviously be needed. It would need to be signed probably by the patient, the doctor, some person on an FDA board, and maybe someone willing to sign to say that they agree the patient is in a stable emotional condition and appears lucid in his thinking. This should eliminate most of the possible court cases that could be brought up against this practice, ideally. Obviously not entirely though, as no system is without flaw.