The Right to Die Trying to Live

Should dying patients have access to experimental, lifesaving drugs? What if those drugs could kill them? It's a tough question, but yesterday the U.S. Court of Appeals for the D.C. circuit made the right decision:

Saying that dying patients have a basic "right of self-preservation,," the court held that drugs that have passed the first phase of FDA review -- which determines whether a product is safe -- should be made available if they might save someone's life.

The 2 to 1 decision by the U.S. Court of Appeals for the District of Columbia Circuit overturned a lower court's ruling. The judges sent the case back to the district court for a full hearing and possibly a trial.

The FDA is being sued by the family of a woman who spent the last years of her life battling for access to experimental cancer drugs before dying at 21. Her father's 2001 Congressional testimony is here.

Comments

[KipEsquire]

Why is it a tough question?

[SR]

"Why is it a tough question?"

Because most "bioethicists" are evil people who delight in human misery and suffering and therefore believe you should withhold potentially life-saving drugs from terminally ill people if there's a chance that the drugs might on occasion kill someone early.

[Timothy]

If you've a P(Death)=1 without the treatment and a P(Death)

[Kevin O'Reilly]

There *is* another side to this argument. Many drugs are safe to take but not necessarily effective (or, more effective than a placebo). If the FDA creates a special "safe-only" category for experimental, life-saving drugs, the agency fears it could create a haven for charlatans intent on, essentially, defrauding desperately ill people.

I don't agree with that argument, but let's not pretend it doesn't exist.

[Evan]

There's a special place in hell for any cocksucker who thinks he should withhold possibly lifesaving medicine from a dying human being because it might be "dangerous".

It's right nextdoor to the spot that's reserved for those evil bastard SWAT fucks who chased that puppy back into the house that they set ablaze and watched it wimper and die inside.

[Mr. F. Le Mur]

Because most "bioethicists" are evil people who delight in human misery and suffering...
Perhaps, but I'd phrase it as "because polticians and FDA members are evil people who delight in controlling other people regardless of the consequences to those people." It fits a lot more shoes.

...the court held that drugs that have passed the first phase of FDA review...
Pretty half-assed. Someone who's dying should have access to whatever they can afford, no ifs ands or butts. So should everyone else.

[MP]

Please tell me they had the courage to ground this decision on the Ninth Amendment and not Substantive Due Process.

[Joe]

This is only tangentially on topic, but it's itneresting and not the sort of thing you're likely to see on Hit and Run:

From today's NY Times

Study Says Older Americans Are Less Healthy Than British

By ALAN COWELL
Published: May 3, 2006
LONDON, May 2 ? Americans 55 and over are much sicker than their British counterparts even though the United States spends more than twice as much per person on health care as Britain, researchers said Tuesday.

Writing in The Journal of the American Medical Association, researchers from University College, London, also seemed to confirm stereotypes tossed across the Atlantic, concluding that Americans are prone to obesity while Britons drink too much.

The conclusions followed an inquiry that used data from American and British health surveys to compare the relative health of people ages 55 to 64 and how their health varies as a result of social and economic status.

The researchers wrote that "health insurance cannot be the central reason for the better health outcomes in England because the top socioeconomic-status tier of the U.S. population have close to universal access but their health outcomes are often worse than those of their English counterparts."

[Evan]

"If the FDA creates a special "safe-only" category for experimental, life-saving drugs, the agency fears it could create a haven for charlatans intent on, essentially, defrauding desperately ill people."

There could be some kind of minimum threshold of effectiveness that could be shown the research. Not to mention the obvious fact that these charlatans could be weeded out pretty quickly after their drugs repeatedly fail.

[ChicagoTom]

Other than a liability issue for the company producing the drug (which could be dealth with via waivers, contracts, etc) I dont see why people shouldn't be allowed to take the medication if they believe it's their only hope.

Don't people in these situations usually get invited into to participate in the clinical trials / testing -- or is phase 1 too soon for that?

[h-dawg]

"Not to mention the obvious fact that these charlatans could be weeded out pretty quickly after their drugs repeatedly fail."

I think you're over-estimating the clinical rationality of people desperately clinging to life. Even so, in the choice between dealing with hucksters or bureaucrats, I'd choose the hucksters.

[Mark]

Joe, the reason middle aged Americans are more unhealthy is that even though you spend twice as much on healthcare, you spend seven times as much on tacos. And unlike the healthcare, tacos actually work e.g hello fatty.

I have no idea about the states but a ruling to allow people to take potentially fatal drugs would shake up contract law in the UK as presumably it would include a clause to sign away your life, which at present we do not allow.

[Dave W.]

I don't know, Joe2. When I point out that the US has a poor healthcare spending to lifespan ratio, people here at HnR defend against the undesirable implications of that fact by saying that there are differences outside of economic ones to explain the apparently poor ROI. This study supports that position, and seems to be some nice persuasive evidence on that point.

I wonder what they sweeten the soda with in Blighty?

[John]

You can't get access to drugs that might save your life because they may kill you, but if you are terminal you always have a right to get access to drugs to kill yourself or have your doctor kill you if you are incapacitated and your adulterous, abusive spouse tells him you would have wanted it that way. Great system we have.

[P Brooks]

I have here a pill which will cure whatever is wrong with you. Anything. Unfortunately, there is a one-in-three chance that the pill will kill you.

Would you take it for a headache?

Would you take it for insomnia?

Would you take it for chronic debilitating pain?

Would you take it for Lymphoma?

Would you take it for an inoperable tumor on your brain?

These (whoever they might be) boneheads who either cannot comprehend the notion of risk analysis, or cannot grasp the idea that any individual should be free to assess and accept risk on his own account...

I will provide them, free of charge, with three of my pills.

[Evan]

H-dawg,

I'm not talking about the rationality of the patients. I'm talking about the FDA or some other rather benign oversight agency keeping tabs on how their medicines do. If several of their experimental medicines fail, and none of them succeed, then I think it's reasonable for that oversight body to demand more clinical proof from that company for future submissions.

[Evan]

H-dawg,

I'm not talking about the rationality of the patients. I'm talking about the FDA or some other rather benign oversight agency keeping tabs on how their medicines do. If several of their experimental medicines fail, and none of them succeed, then I think it's reasonable for that oversight body to demand more clinical proof from that company for future submissions.

[anon2]

Timothy,

P(death) = 1 for everyone living.

P(death) = 1 for a specific cause of death is true for nobody living, because there's always a chance that someone will die of something else before whatever cause of death looks exceedingly likely.

I agree that the policy prohibiting terminally ill people from experimenting is a bad one, but your reasoning's overly simplistic.

This isn't a minor nit, because when you add in things like probability of dying from a specific disease in a particular time span, you introduce the possibility of people arguing against experimentation in cases where the patient should be allowed to experiment.

For example, someone may have a high probability of dying within a year from a specific disease and want to experiment with a drug that (we'll pretend we can know this) has a two thirds chance of killing the person instantly and a one third chance of completely destroying the disease. If your argument is that it's only justified when the probabilities favor it, someone other than the patient has to come up with a utility function to determine if the justification threshold has been reached.

In case it's not obvious why someone other than the patient has to come up with the utility function, when the patient comes up with the utility function, it's called allowing the patient to decide, without taking probabilities into account.

[Evan]

Then again, if these experimental drugs work as well as the H&R comment engine, I might just prefer death...

[Timothy]

Anon2: Point taken.

I think I was trying to make the same general point that you are, unfortunately the comment server ate a bit of my text. I was getting at that if your P(Die This Year)=1 then anything that reduces that at all is a good damn bargain. The regulatory agency should definitely let the patient decide as everyone has different levels of risk aversion, etc. Maybe I was a bit symplistic, but I pretty much agree with your point.

[Rex Rhino]

This is an ideological issue. You either believe one of two things:

1. A person's body is their own property, and they should be allowed to consume whatever they want.

2. A person is owned by the government (or perhaps, owned by "society" as embodied by the government), and that government (or "society" - but when people say "society", they usually mean "the government), should control what people are allowed to consume.

Those that believe that people own their own bodies, will naturally be hostile to government regulation on drugs. Those that believe that people are owned by other people, will naturally like the idea of government regulation of drugs.

[anon2]

Rex,

There are several other things people can believe in.

For example, they can believe in the social contract, under which people voluntarily agree to allow various laws to be made in the interests of society. I don't believe in the social contract theory, but others do.

Social contractors believe that people's body is indeed their own property, but that they (and everyone else in the country) have voluntarily decided to abide by laws that are passed, including ones that may limit what they can do with their own bodies. This is a distinct belief that is different from the two you have proposed.

Not only are there beliefs other than the two you proposed, the second one you threw up is an extremely uncommon belief. By your implied definition of "owned", people who believe in speed limits don't own their cars. In essence, you've co-opted the word "own" to make your ideology more appealing.

It's unlikely to work, because even people who don't immediately think "false dilemma" when reading your argument will still sense that something's incorrect. You're in good company, though.

[Jason Ligon]

"If the FDA creates a special "safe-only" category for experimental, life-saving drugs, the agency fears it could create a haven for charlatans intent on, essentially, defrauding desperately ill people."

We already have this. It is called "alternative medicine".

[Robert]

Actually it's already legal for a patient to obtain items like that in question and use them as drugs. The only prohibition is on their marketing -- intrastate by state pharmacy laws, interstate by the FFDCA.

[Rex Rhino]

Social contractors believe that people's body is indeed their own property, but that they (and everyone else in the country) have voluntarily decided to abide by laws that are passed, including ones that may limit what they can do with their own bodies. This is a distinct belief that is different from the two you have proposed.

Social Contractors believe that people have voluntarily given up ownership of their body... but clearly, they have given up ownership.

By your implied definition of "owned", people who believe in speed limits don't own their cars.

No, the speed limit analogy is completly incorrect.

I can go out to the local auto track, and for $50 an hour drive as fast as I want LEGALLY!!! (or, as fast as my Ford Focus will go, which is not that much faster than the speed limit 🙂 ) I only need to obey a speed limit when I am on public property. Speed limits only apply to public roads. If the FDA were banning drugs in government clinics or hospitals, that would be reasonable. But the FDA is banning even private clinics and hospitals, were it would be no danger to the general public, from using drugs. The idea is not to protect the general public under some social contract, but to protect people from themselves.

[jeffiek]

Not only are there beliefs other than the two you proposed, the second one you threw up is an extremely uncommon belief.

What luck it must be to find another one who believes it.

By your implied definition of "owned", people who believe in speed limits don't own their cars.

People who believe in those limits aren't yielding ownership, just following their beliefs.

In essence, you've co-opted the word "own" to make your ideology more appealing.

Not so. Go here: Ownership
for a nice, unbiased, discussion on ownership.
Note the phrase "exclusive possession or control". Ownership of your body, technically, is an either-or proposition. Simply limiting exercise of ownership to what medicines are permitted does not negate the reality of that ownership.

[anon2]

Rex,

If you claim that Social Contractors believe that people have voluntarily given up ownership of their body, and everyone else-including the Social Contractors, people who think the Social Contract is a sometimes useful analogy and people who think the Social Contract is complete bunk-thinks differently, we have a failure to communicate.

You're right; there are things you can do with a car when it's on private property that you can't do when it's on a public road. However, by your tortured definition of ownership, the state owns your car while it's on the road. That's a silly definition of ownership that will just make it hard to communicate with you.

jeffiek,

I don't understand your comment. I think you're agreeing that few people believe that the government own's people's bodies. That's the straw man that Rex included as number 2 in his post.

His is a false dilemma, not because people don't own their own bodies, but because there are indeed people who believe that they own their own bodies, but should not be allowed to consume whatever they want.

Personally, I believe I do own my own body. I also believe I should be allowed to consume whatever I want. However, I think bad reasoning is a liability, so I speak up occasionally when I see it.

[jeffiek]

I don't understand your comment. I think you're agreeing that few people believe that the government own's people's bodies. That's the straw man that Rex included as number 2 in his post.

I agree that few people believe that the government owns people's bodies.

His is a false dilemma, not because people don't own their own bodies, but because there are indeed people who believe that they own their own bodies, but should not be allowed to consume whatever they want.

The "belief" that the government doesn't own your body doesn't mean that you do. All the government needs to do is break the "exclusivity" part of the definition. Once this is broken the individual is no longer the owner. So, if anyone's co-opted the word "own", it's those people, since not being allowed to consume whatever they want contradicts the definition of ownership.

Strictly speaking, the government also doesn't have ownership of your body, since there are many things they can't control (that exclusivity thing again).

My conclusion is that, in American society, no one owns you, not even yourself. That sound better?

[Rex Rhino]

anon2,

Maybe I should simplify. Some people love authority, conformity, and being told what to do. Those people tend to support strong regulation of drugs by the government. Some people are anti-authority, hate being told what to do, do not like to conform, and these type of people tend to be against government regulation of drugs. Some people fall in between those extremes.

But how you feel about drug regulation probably has more to do with how you were potty trained, or if you were spanked as a child, or whatever it is that makes you a conformist/obedient or non-obedient/non-conformist.

Some of us are just naturally predisposed to to think that people should make decisions for themselves, and some people are naturally predisposed to think that people should obey authority. And the arguements about drug policy are really just a reflection of our inate attitudes.

Libertarians tend to find obedience to authority, and conformity, and fear of risk, to be disgusting and deplorable. Our feelings against drug regulation are more governed by these emotions than logic. And authoritarians tend to find obedience to authority has noble, and to find risky behavior and not agreeing with the majority to be disgusting and deplorable. Chances are they are going to agree with drug regulation because of the authoritarian, conformist, nature of it, more than any logic reason.

Debate between libertarians and authoritarians are hard, because libertarians tend to have knee jerk support for freedom, and authoritarians tend to have a knee jerk reaction to rules and punishment.

[mommsen]

Former FDA Commissioner Alexander Schmidt: "In all our FDA history, we are unable to find a single instance where a Congressional committee investigated the failure of FDA to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them. The message to FDA staff could not be clearer."

Pretty much tells it all, doesn't it?