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Old 01-25-2008, 06:57 PM   #1 (permalink)
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Should dying patients be allowed to take experimental drugs

Quote:
Terminally ill patients have no constitutional right to gain access to experimental drugs that have yet to win federal approval, the US Supreme Court ruled Monday.

The top court refused to hear a case brought by the Abigail Alliance for Better Access to Developmental Drugs, which accuses the government's Food and Drug Administration (FDA) of violating the legal rights of the patients.

As is customary when the court declines to take up a case, the nine justices gave no explanation of their reasoning.

The decision let stand an August ruling by the federal appeals court in Washington, which said the FDA was right to refuse access to drugs that have yet to go through the lengthy process of clinical trials.

"Although terminally ill patients desperately need curative treatments ... their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit," the appeals court had said.

Steven Walker, who co-founded the Abigail Alliance in 2001, had urged the Supreme Court to give patients suffering incurable disease a legal redress against the "unelected, tenured career bureaucrats" of the FDA.

Source
I think that experimental drugs are fine, as long as they are ready for human trials. The families and the patient have to be fully informed of the risks. If drugs aren't thoroughly trialled, then they will never become FDA approved. If there's a drug to potentially cure me, I'd want the option of taking it and being made aware of the risks.
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Old 01-25-2008, 07:04 PM   #2 (permalink)
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Here's my simplified answer: I'm dying, but the Supreme Court and FDA say I can't take this drug because it might kill me.

Joseph Heller, do you have anything to add?
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Old 01-25-2008, 07:09 PM   #3 (permalink)
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Pfft, and put all those poor drug-testing animals out on the street?

...

I'm all for humans testing their own medicines.
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Old 01-25-2008, 07:13 PM   #4 (permalink)
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If I were going to die without the drug, possibly sooner/later/not at all with an experimental drug, I would opt for the experimental one.

It's funny how, as a terminally ill patient, you can't opt for an experimental drug that might hasten your death, but you can get a prescription for drugs that will hasten your death (doctor assisted suicide).
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Old 01-25-2008, 07:24 PM   #5 (permalink)
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Yes, we need better medical research.

Just don't let the same thing happen that occured in the movie 'I Am Legend'.
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Old 01-25-2008, 07:56 PM   #6 (permalink)
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Maybe we could tie this drug testing in with the welfare thread above.....

Just think of the possibilities!

But seriously folks I keed...

While I think it makes sense for if you ARE going to die then you should be allowed to volunteer for whatever new or wacky treatment you like, there are still ethical considerations to make. Like what is exactly terminal, the medical world is full of people who have had 6 months to live for the last several years. Also do you have controls? Just think how great it would be to be dying and then given the control placebo.

Also there are waves of liability to be avoided in todays sue you society. "They told me John had 2 months to live, and he died right after taking the experimental drug, they stole my last two months with my husband". Yea its stupid but juries are stupid.

I know this IS done at times, but I'm not sure what the current requirements are.
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Old 01-25-2008, 08:13 PM   #7 (permalink)
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Quote:
Originally Posted by ASU2003
Just don't let the same thing happen that occured in the movie 'I Am Legend'.
...I was saving that bacon.
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Old 01-25-2008, 09:53 PM   #8 (permalink)
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Every sane adult should be allowed to take experimental drugs. If it's your life, it's your decision.
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Old 01-25-2008, 10:28 PM   #9 (permalink)
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Quote:
Originally Posted by inBOIL
Every sane adult should be allowed to take experimental drugs. If it's your life, it's your decision.
People are stupid.

Stupid people sign up for experiments that pay money.

Stupid people then find out they have cancer or the like from said drug.

But stupid people signed a release form, so its all good right?

Many laws are to protect stupid people. I don't agree with this because I enjoy reading Darwin awards, but thats how it is. If this were allowed then stupid people would sooner or later be exploited by taking something that turned out to be very bad for them but sounded good in the lab.

I think the FDA could do a lot to speed up how these things go, but right now you won't see anything where just anyone can sign up for an experimental drug without a LOT of prior testing.
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Old 01-26-2008, 01:17 AM   #10 (permalink)
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Quote:
Originally Posted by Ustwo
Also there are waves of liability to be avoided in todays sue you society. "They told me John had 2 months to live, and he died right after taking the experimental drug, they stole my last two months with my husband". Yea its stupid but juries are stupid.
I am pretty sure there would be sufficient paperwork to sign. While people usually don't sign documents with so many skulls and crossbones, if they haven't got anything else to loose, they'll sign anything. Which is the only problem I see with it- they are using the desperate to further science...

Besides, I am sure medical companies can spare the chump-change to have their lawyers gangbang a legally binding document with the dying patient and the dying patient's family.

... Actually strike this, I have a lot of hatred towards the medical treatment of prisoners. Give them this option of being used in medical science as well.
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Old 01-26-2008, 01:53 AM   #11 (permalink)
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[QUOTE=Augi]While people usually don't sign documents with so many skulls and crossbones, QUOTE]

But skulls and cross bone are pretty!

no, seriously now. I think if your dying, you should pretty much be able to do whatever the hell you want if it doesnt hurt others. In my opinion, if your in the hospital on your death bed, you should be able to pull a Rodney Dangerfield and spark up a dooby if you damn well please. Hell, if you want to take a vein full of heroin and mouthfull of whip-its on your death bed, i think you should be able to. but thats just me.

as for experimental drugs...why not? your going to kick the bucket soon anyways.
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Old 01-26-2008, 03:52 AM   #12 (permalink)
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I'm for all people taking experimental drugs, I don't care if they need them or not. As long as they know the consequences It's all good in my book. If the little Release form I gotta sign says may cure cancer or grow Quato on your stomach then whatever. I have no reason to complain when it happens.


edit: BTW http://www.michaeldavy.com/gallery/2_quato.html
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Old 01-26-2008, 04:02 AM   #13 (permalink)
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As long as there are safeguards to ensure that the patient is taking a properly informed decision, I don't see the problem.

What about grey areas such as where the patient is in a coma etc?
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Old 01-26-2008, 05:35 AM   #14 (permalink)
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The problem is that if you take it and then die soon there after. People fighting against that said drug will use your death as a tarnish against it.

It ruins the statistics for the drug, and that is a high risk of losing money and funding.

My feeling on the matter, its your body, and as long as you're paying do what you will.

If you're feeding off the state or "the peoples" money, don't waste it on an experiment.
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Old 01-26-2008, 05:41 AM   #15 (permalink)
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Quote:
Originally Posted by allaboutmusic
As long as there are safeguards to ensure that the patient is taking a properly informed decision, I don't see the problem.
That is the problem with business ethics now a days. It is really impossible to ensure an informed consent since only the expert will truly grasp the possible effects. Even if they client/family "knows" death is a possibility, they still just don't get it...

They first need to sign a wavier that says:
Quote:
I, [YOUR NAME] ____________________________, don't really understand shit about what the doctor/engineer/researcher is actually talking about especially when it is written in lawyer-speak. I sign this agreement here so that in the event of everything my doctor/engineer/researcher warned me about with simple terms/words/charts/pictures/cartoons drawn in crayon I won't call the first lawyer I can think of in order to sue.

________________________________

Quote:
What about grey areas such as where the patient is in a coma etc?
Then I guess they can't consent, but families can.
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Old 01-26-2008, 06:06 AM   #16 (permalink)
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Quote:
Originally Posted by Augi
They first need to sign a wavier that says:
Hey, you copied that from the Department of Defense and changed the theme!
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Old 01-26-2008, 06:23 AM   #17 (permalink)
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Cognitive liberty.
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Old 01-26-2008, 06:38 AM   #18 (permalink)
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Quote:
Originally Posted by Ustwo
People are stupid.

Stupid people sign up for experiments that pay money.

Stupid people then find out they have cancer or the like from said drug.

But stupid people signed a release form, so its all good right?

Many laws are to protect stupid people. I don't agree with this because I enjoy reading Darwin awards, but thats how it is. If this were allowed then stupid people would sooner or later be exploited by taking something that turned out to be very bad for them but sounded good in the lab.

I think the FDA could do a lot to speed up how these things go, but right now you won't see anything where just anyone can sign up for an experimental drug without a LOT of prior testing.
If they're stupid do we need them around?

If we had to deal with survival of the species we'd have a lot less stupid people running around, messing things up for the rest of us. I seriously think that stupid people are costing the non-stupid people in terms of all sorts of bad habits/decisions including the impact on health care from poor health habits as an example. Or driving 8 mpg SUVs with no one but themselves inside.

Why should we protect stupid people if they can't protect themselves? And I think many laws are around to protect companies from stupid people, not to protect the stupid people. Who cares if someone spills hot coffee in their lap. Do you really need protection from that? Or the warning signs on ladders that tell you you might get hurt if you fall. That's liability, not protection of the stupid!

And back to the original point of this thread: if I'm dying and there's even a slight chance that a new drug will help me, I'd bettter have the right to fork over my own money to experiment. I mean, what are they going to do - give me the chair? It's my business, my life and my money covering the cost.
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Last edited by thingstodo; 01-26-2008 at 06:41 AM..
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Old 01-26-2008, 06:42 AM   #19 (permalink)
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Sure - sign the waivers, get informed, then take anything you want. Experimental drugs, heroin for pain relief, suicide pill, whatever.
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Old 01-26-2008, 08:42 AM   #20 (permalink)
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One of the actual reasons that the drug companies do not want unfettered access to research drugs is that the research controls tightly who gets the drugs to make sure that it is the right person, disease, and timing for the drug. Those researchers are generally in small groups and VERY busy dealing with the information and processes they have to follow to ensure that their (seriously, these guys designed the drug, it's theirs and on their conscience if anything happens to patients) drugs reach the market soon and safely. Just imagine if they were suddenly bogged down with millions of requests for their drug, which they would then have to screen and deal with. Could they charge for it, if so how much? How much money would they have to spend coming up with the legal consent forms? What doctor would be willing to give them the drugs? I pledged the Hippocratic oath, and personally would have objections to assisting a patient with this. The simple fact is, allowing this access would actually delay drug development by allowing a bunch of desperate people unfettered access to drugs we don't know a thing about. In the end, researchers would likely start hiding their research so that they wouldn't have to deal with the onslaught.

I've had several discussions on this exact topic with physicians here in medical school and this has always been the conclusion, based on the actual questions posed in the trial.
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Old 01-26-2008, 09:03 AM   #21 (permalink)
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Quote:
Originally Posted by thingstodo
If they're stupid do we need them around?
We need enough or else we wouldn't have random things to laugh at. /leans back too far in chair/

Also what if the drug makes stupid people much much smarter... or even more interesting, very smart and homicidal?


Quote:
And back to the original point of this thread: if I'm dying and there's even a slight chance that a new drug will help me, I'd bettter have the right to fork over my own money to experiment. I mean, what are they going to do - give me the chair? It's my business, my life and my money covering the cost.
Again the only thing I see the problem with is that we are using the desperate to further research. They can tell you whatever you want to hear, while they are testing whatever they need to test. I imagine someday there will be a difference between those two ideas.

For the record, I would probably take anything that claimed to cure what fatally ailed me.

@ basmoq:
Then why not restrict this as one way: the medical company looks for patients instead of doctors contacting the drug companies. More work I'd think. Or the companies send out a list of requirements for those near death to become one of the subjects.
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Old 01-26-2008, 09:04 AM   #22 (permalink)
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That's useful info, basmoq. In that light, I agree.
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Old 01-26-2008, 09:08 AM   #23 (permalink)
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Quote:
Originally Posted by basmoq
One of the actual reasons that the drug companies do not want unfettered access to research drugs is that the research controls tightly who gets the drugs to make sure that it is the right person, disease, and timing for the drug. Those researchers are generally in small groups and VERY busy dealing with the information and processes they have to follow to ensure that their (seriously, these guys designed the drug, it's theirs and on their conscience if anything happens to patients) drugs reach the market soon and safely. Just imagine if they were suddenly bogged down with millions of requests for their drug, which they would then have to screen and deal with. Could they charge for it, if so how much? How much money would they have to spend coming up with the legal consent forms? What doctor would be willing to give them the drugs? I pledged the Hippocratic oath, and personally would have objections to assisting a patient with this. The simple fact is, allowing this access would actually delay drug development by allowing a bunch of desperate people unfettered access to drugs we don't know a thing about. In the end, researchers would likely start hiding their research so that they wouldn't have to deal with the onslaught.

I've had several discussions on this exact topic with physicians here in medical school and this has always been the conclusion, based on the actual questions posed in the trial.

This information is helpful. Thanks for sharing your knowledge with us. Sadly, I think most people (myself included) labor under the opinion that the reasoning behind these denials are insurance companies' unwillingness to pay for what might be very expensive treatment.

We've become quite cynical.
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Old 01-26-2008, 09:18 AM   #24 (permalink)
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Consider it an advance upon a donation of my body to science. I do not know if I would wish to make that decision but if I there is no sliver of a doubt that my condition is terminal I would want to be able to make that decision. Not only would this be for myself but also for any future victims of the same disease condition.

The only limitation that I feel would need to be enforced is that there can be mention made of the option but no pushy drug companies pressing me for a decision. It must be made completely without any pressure whatsoever.
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Old 01-26-2008, 10:19 AM   #25 (permalink)
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Yes. It is common sense to do this.Animal testing is unreliable.
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Old 01-26-2008, 12:13 PM   #26 (permalink)
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I think this is meant more as a protection to keep people from being used as lab rats. Imagine a drug company is developing a drug and gives it to a dying person without having done any prior testing and then discover that the drug not only doesn't work, but may cause other, possibly painful, side effects. Now this person is still dying, but now has to suffer even more by a treatment that doesn't work.

This explanation may seem a bit out there, but I have been in a similar situation. Three times in my life, I was given experimental chemotherapy treatments. Obviously, two of them failed I nearly died many times as a result of both. With one, it cause serious and painful permanent nerve damage to my lower legs and feet that's not likely to ever go away. The third time was successful and had relatively few complications.

That said, I think patients should have the option of being able to receive treatment if they're terminally ill as long as everything has been explained to them. I don't think doctors or the drug companies would be willing to go for it unless some liability waiver is signed first though.
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Old 01-26-2008, 02:55 PM   #27 (permalink)
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Funny how the government will stop people from potentially trying to save themselves or have a better quality of what life they have left, but do nothing about aspertame for example in diet soft drinks and food products that is showing up as the direct causes of diseases such as MS, diabetes and a host of cancers tied to major organs.
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Old 01-26-2008, 03:11 PM   #28 (permalink)
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Quote:
Originally Posted by Crompsin
...I was saving that bacon.
Still cracks me up.

Would it make sense to include this decision in our Living Will?

Yes, certain medications might take some time to cure (or potentially hurt), but if a patient is diagnosed as terminal, they should be given the option to start experimental treatment immediately or anytime that the medical practitioner and patient feel appropriate.
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Old 01-26-2008, 10:29 PM   #29 (permalink)
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Quote:
Originally Posted by JumpinJesus
This information is helpful. Thanks for sharing your knowledge with us. Sadly, I think most people (myself included) labor under the opinion that the reasoning behind these denials are insurance companies' unwillingness to pay for what might be very expensive treatment.

We've become quite cynical.
And you say that like its a bad thing.

Experimental drugs usually fail and can be very expensive. Worse you would open the door to quack treatments like shark cartilage for cancer treatment as something insurance companies should pay for, after all its experimental.

Now maybe you want to write those checks, but my insurance premiums are high enough.

And before someone cries socialized medicine, there are times you don't get PROVEN treatments in those systems in a timely fashion due to costs, so don't even dream that you will see extensive use of experimental drugs there.
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Old 01-27-2008, 12:07 AM   #30 (permalink)
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I absolutely think it's my right to try out an "experimental" drug, especially if it carries the possibility of curing my terminal illness. I'm gonna die anyway, right? Who the hell are *YOU* to tell me I can't do something to save my life?
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Old 01-27-2008, 08:48 AM   #31 (permalink)
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Quote:
Originally Posted by percy
Funny how the government will stop people from potentially trying to save themselves or have a better quality of what life they have left, but do nothing about aspertame for example in diet soft drinks and food products that is showing up as the direct causes of diseases such as MS, diabetes and a host of cancers tied to major organs.
Or high fructose corn syrup and hydrogonated oils!
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Old 06-07-2008, 05:24 AM   #32 (permalink)
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the right to control what goes into our body

The government already has too many "orifice laws" all aimed
at regulating or taxing anything we might wanna put in our
mouths, twats and asses - food, drink, drugs, cocks, whatever ...

We all have the right to take any drug we want, experimental or not!
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Old 06-07-2008, 04:09 PM   #33 (permalink)
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the answer to this is an unequivocal yes.

My dad died two and a half weeks ago after having a degenerative muscle disease for almost 2 decades. He was 62. No cure for this disease (inclusion body myositis if you're curious), you just slowly waste away. He was at the point where he was in a power wheelchair full time. He really only had slight use of his right hand and that was it. Just enough to move the chair's joystick. Mom had to do everything for him. Everything. Dress him, bathe him, lift him onto the toilet, clean him off when he was done, lift him back into his chair, put his deodorant on him, shave him. . Everything that you and I take for granted, he couldn't do.

He hadn't slept in a bed in years because it was just easier to recline his wheelchair.

He finally got aspirative pneumonia because even the muscle in the throat that closes off your windpipe when you swallow (pharyngeal sphincter) was failing. He breathed in his own saliva and it got infected. When he got to the hospital his oxygen sats were at 42. The goal is 90-100. They tried an oxygen mask, but it didn't get him oxygenated fast enough so they had to put him on a ventilator.

When you go on a ventilator, your diaphragm atrophies because it isn't doing any work -the machine is doing it for you. Normally you just rebuild the muscle once they wean you off of it, but his disease meant he couldn't do that - he would have to have been on a ventilator for the rest of his life. That's no way to live. Instead, he made the decision to pull the ventilator. He died 9 hours later. I was there the whole nine hours and watched him die. It's not something I would wish on anyone.


There's a drug out there that they think might not only stop his disease, but reverse its effects. Been out there for several years, but the FDA won't let it be given to humans yet because it might not be "safe." So, instead of possibly having a life saving treatment, he died, all in the name of the FDA protecting him. From my view, that's just stupid, wrong, and a complete waste.
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Old 06-07-2008, 04:33 PM   #34 (permalink)
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I absolutely don't think so. The potential for vultures in this area is far FAR to great for me to be comfortable with. I could sell distilled urine to terminal cancer patients for $5000 a vial, and when it doesn't do anyting, oh well, it was experimental.
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Old 06-07-2008, 07:09 PM   #35 (permalink)
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Quote:
Originally Posted by twistedmosaic
I absolutely don't think so. The potential for vultures in this area is far FAR to great for me to be comfortable with. I could sell distilled urine to terminal cancer patients for $5000 a vial, and when it doesn't do anyting, oh well, it was experimental.
If there's a valid scientific reason that a treatment could work, this will be minimized. You can't eliminate the vultures entirely, but "protecting" patients by eliminating their last hope for effective treatement doesn't make sense.
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