A Federal court overturned last year’s shocking decision from the DC Circuit Court of Appeals saying that dying patients have
a due process right to access drugs once they have been through
FDA approved safety trials. In January I wrote:
Unfortunately, I do not think that the Abigail Alliance can win the
case; recognizing the rights that the DC Circuit of Appeals recognized
would be too big a blow to our nanny state.
Thus I am a little disappointed but not surprised. I am pleased that the brief prepared by Jack Calfee, Dan Klein, Sam Peltzman, Benjamin Zycher and myself was cited in the dissent. The majority also avoided the sweeping policy generalizations that we wrote the brief to
discourage, thus I think we won a rear-guard victory and can keep up the battle on other fronts.
Thanks to Ted Frank for the pointer and his work behind the scenes.
This is a tricky ethical issue. On one side is the “right” of a person to do whatever they wish with their body.
On the other, is the practical problem that for many orphan drugs the pool of potential people who can participate in trials is very small. A typical drug in this class might only be able to round up 100-150 people. If those who might be candidates for the pool self select then it becomes even harder to run tests of efficacy because the population is no longer random.
People are asked to sacrifice their lives for the “greater good” all the time. Sometimes it is voluntary like in Iraq, but sometimes it is compulsory like in Vietnam.
I don’t think anybody would go along with the medical establishments position if they stated in baldly as in:
“We need to test this drug for the benefit of society at large and thus your personal well being must be disregarded”. But this is part of the truth of the situation.
The other issue is whether those who are desperately ill have some special rights that preempt the established regulations. First, one must question their ability to make rational choices when in such distress and second, they (and their doctors) don’t have any scientific data on which to make a rational decision. So they are just grasping at straws.
In those cases where a trial shows early successful results it is quite common for the study to be stopped early and those being given a placebo to be given the drug immediately. So the only cases where there may be a question are those where the benefits have yet to be determined and/or are modest at best.
The medical profession is not trying to deny treatment, but they have to balance the competing demands of scientific advancement and safety and efficacy.
Presently the number of people affected by this ruling remains small, which doesn’t change the ethical issues, but does alter the practical effects.
It’s the old five people on one track vs one person on the other track dilemma. Do you do nothing and kill five or throw the switch and kill one?
The argument that this is necessary for the greater good is complete nonsense. In this case, we actively create the scenario where we throw we throw the switch to kill one to save five. If one wishes to take the drug rather than the placebo, we are in no ethical position to deny him this. At best, we are allowed to pay him more to enter the double blind portion of the study. Any other position is almost nothing better than murder.
As for the argument that we have to deny terminally ill people this choice because they may not be behaving rationally- on it’s face, this argument is also complete nonsense. It is not irrational to try to survive, especially when your actions can hurt no one else. A dying person is left with no options other than to “grasp at straws”, and in these particular cases, not all of these straws are going to be worthless.
Thanks for strawmanning Alex, Robert.
Sorry J, I don’t see “strawmanning” whatever that means to you. Show your work.
Isn’t it a bit silly to use belief-as-cheer/belief-as-attire phrases like “nanny state” on a blog of this calibre? I think it brings down the quality of discourse here. I think here we’re looking more for a deconstructiona and analysis of sloganeering than a subjection to it. This is an academic blog not dailykos or thecorner.
People are asked to sacrifice their lives for the “greater good” all the time. Sometimes it is voluntary like in Iraq, but sometimes it is compulsory like in Vietnam.
Don’t be an atomistic individualist. After all, if we never sacrificed the individual for the “greater good”, we never would have gone into Vietnam or Iraq!
“That’s what makes discussions with libertarians so futile. They dismiss the opposing position out of hand and then reiterate their original statements.”
Yeah–libertarians sure have a monopoly on that
“The ethical issue concerns whether people should take risks that they are not able to properly evaluate.”
No, that is not the case at all. The question is who should make the evaluation and come to a conclusion. There’s a risk whatever you do – the medicine could work and there will forever and ever have existed a cure for what killed you at that point in time. That’s a risk. You argue that state bureacracies should make the evaluation and take the deicision. I would argue that this is means losing my dignity as a human being. It’s like living in a zoo. If I’m dying of cancer I don’t gove a shit about what you or anyone else feel about the matter, I want that treatmant if I can afford it. You’re spitting me in the face. It’s big words but I sincerely hate people like you.
“robertdfeinman”, I have to agree with some other posters that the arguments you state in defending the FDA are sheer nonsense: I think that the shortest I can make this point is to say that none of the “imposed restrictions† you enumerate apply here. The drugs are safe. The companies would like to provide them to patients. The patients want to use them. The reason this is not allowed is that it diminishes the power of FDA bureaucrats. The trials would still go on, in fact, it may be easier to find more participants if the total number of enroller patients is not limited (i.e., all patients taking the drug would be involved in a trial). Self-selection, which you mentioned, is also present in current drug trials.
Let’s put libertarian bashing aside for a moment – please state any benefit of the current situation, in light of what I wrote above (aside from the benefits to the FDA, of course).
Ned:
I can’t find out who the other parties to the suit were besides the FDA who may have filed amicus briefs, so I don’t know what other arguments were offered. We know that bureaucracies like to defend their turf, but without actual evidence in this case it’s hard to make your claim. I think there were some other groups which sided with the FDA. It would be useful to know what their arguments were.
LisaMarie:
I think you misread one of my points I didn’t say: “To say that letting people have access to drugs outside the clinical trial system means no one will participate in trials”.
What I said was that allowing people access to drugs that were still undergoing trials would make it harder to gather a representative group of participants. Self-selection makes getting a random selection harder and for some drugs the pool is small to begin with. This is just a statistical effect.
By the way I didn’t bring up cost, since we are supposed to be discussing ethics. Many new drugs are quite costly. A single anti-cancer course of treatment can cost $100,000. Now if those who are unlikely to be helped by this treatment get it who pays? If it is covered by insurance that this drives up the course for everyone else. So which is better to spend the money on an unproven desperation attempt to prolong life or to use the money to provide health care to people that can be helped.
There is a debate on this issue right now. A new,very expensive, prostate cancer drug has been shown to extend life by 2-3 months. Is it worth it? Who decides?
The opinion in this case highlights the principal problem in constitutional law today. The ninth amendment makes it clear that the default state in this nation is freedom, NOT regulation. The onus should not be on the individual to go back and prove that terminally ill patient’s access to investigational medicine was a historically important right, it should be on the government to go back and prove that the regulation of a terminally ill patient’s right to engage in an experimental treatment was one of the specifically enumerated powers that the people intended to confer on the state when the Constitution was ratified. If it was not, then the right was reserved by the people in the ninth amendment.
No one ever seems to pay attention to this anymore, and sadly, the default state is now that the government can regulate anything it wants, so long as it is not specifically prohibited by some pre-defined right. This is exactly what the ninth amendment was intended to prevent, but the courts continue to ignore it to their own shame and the detriment of the entire nation.
Is the issue that people don’t believe that the FDA specifically is doing a good job, or is there a belief that any government body shouldn’t have the ability to regulate society?
I can’t say if the FDA is doing a good job, that’s up to the medical fraternity to determine. As for whether the government should or does have the ability to control people’s behavior, as I keep saying that is the nub of the issue. Libertarians want to see this kept to a minimum.
In our particular society the majority of the people have expressed a desire otherwise. That’s why I keep going back to the fact that this is a democracy and in a democracy not everyone gets everything they want.
PS – John Pertz, you said: “what ethical right does the government have to murder someone?”
I don’t know about the ethics of the situation, but in the US the government murders people all the time or sends them into harms way in the military. What is your position on this?
Why doesn’t anyone want to talk about democracy? The only type of person who advocated total liberty were the early Anarchists like Bakunin. His ideas didn’t turn out to be too practical (or coherent for that matter).
Robert,
The issue is that the case was dismissed because all the signatures on bringing the case are dead. We are not talking about people who have a while to live and fight an illness. We are talking about people dying within months. Not one of the posts you’ve written discusses this.
There is no one to protect. These people are going to die. What are you protecting them from? As many have mentioned before, these are drugs that are at least safe by FDA standards. It’s just that the efficacy testing has not been completed.
Libertarians, as I am one, are not fools parroting the same argument over and over as you suggest. The argument is that we live in a limited republic (not a democracy as you seem to think) and that there must be clear benefits to any restriction on personal freedom. Read the declaration of independence and the constitution, in particular, the tenth amendment. Then reread the tenth amendment. The reread it again. Then write an essay on what it means for the federal government to have ONLY the powers specifically enumerated in the constitution. Now look around you and ask yourself just how much over the line is the federal government ON LEGAL GROUNDS alone, from the founding document from which ALL laws must flow.
Now answer the following question. What are the benefits of saying: I know you are about to die. We have drugs that will not make you any worse off. But they haven’t been proven to make you better. Therefore you can’t use them.
Now fair is fair. I’ll answer one of your questions: who pays? The answer: whoever is willing to shell out the money. If the insurance companies think it’s a good idea, let them. If the patient has the money, let them. If people want to donate the money, let them. Your posts seem to implicitly imply the state should pay. The government should only pay for those drugs that work, reimbursement style and after the fact. I’m even will to let your favored FDA do the cost benefit analysis.
Regards,
Ken
PS: I agree with Josh:-)
Nathan Benedict:
Thank you, an honest libertarian. Libertarian/anarchy is the exact opposite of democracy (I don’t think the distinction about a “republic” is significant).
The libertarian ideal is some combination of a philosopher-king, enforcement of personal property rights and relatively unlimited personal freedom. This is not the type of government we have, however.
Those who are unhappy with the present system are stuck. I have no advice to give them as to how to achieve their aims. The history of our (and every other industrialized) society for the past several hundred years has been that the power of the central government has increased, the amount of social services provided by government has also increased, but so has civil rights.
We used to have slavery, disenfranchised women, explicit jim crow laws and a variety of other nasty policies. Most of these have been abolished. This is “libertarian” progress.
No modern society allows people to opt out of the burdens of citizenship that they don’t like. To hope for something else is utopian folly.
By the way economist Dani Rodrik has an ongoing debate with libertarians over his ideas for industrial policy. You might want to visit his site and see what he has to say.
Henry Evans:
You are making the specific argument, rather than the general one. The specific one is that the FDA is not doing a good (or appropriate) job. The general one is that the market should decide things not government agencies.
Regulatory agencies were set up in response to a variety of scandals similar to the ones we are now seeing with Chinese products that occurred around the beginning of the 20th Century. Read Upton Sinclair’s “The Jungle” as a typical example (about meat packing).
The people wanted oversight agencies, staffed by experts. They delegated this function. Congress’s role is to provide the enabling legislation and funding. The agency is to set the detailed rules. Oversight is only needed to see that the agency is fulfilling its mission and that there is no malfeasance taking place. I’m not sure what you mean by:
“not that they respond to popular sentiment”.
We don’t run our country by direct democracy, it’s too big to be manageable. That’s why we delegate. This is democratic in a practical sense, even if it’s not “pure”.
Now as to whether the FDA as it is currently operating can be trusted to make the right decisions. As I said previously this should be discussed by those with the expertise to evaluate their performance. This includes not only congress, but the groups within the health professions that can make informed evaluations. I’m sure there is always room for improvement.
Notice it was the courts that reaffirmed that the FDA was following congress’s instructions. Do you also have a quarrel with them? If you do, how do you propose we solve such legal issues?
Robert,
The founding fathers of this country recognized that there are TWO principals that form the basis of our government, DEMOCRACY, and LIBERTY. They also recognized that those two principals sometimes conflict (though I don’t believe they are polar-opposites). The whole point of the constitution is to STRIKE A BALANCE between democracy and liberty, so that the majority may not tyrannize the minority.
Its not about letting citizens “opt out” of whatever they want, it is about using your brain and a little compassion to strike a balance. We are human beings, not robots. The people in the FDA are human beings, not robots, and the judges are human beings not robots. What is wrong with telling them to act like it? What is wrong with saying that the government may not impinge on a fundamental matter of an individual’s right to life and to choose medical treatement without some showing of GRAVE harm being caused by that individuals’ specific decision? I don’t think that goes quite as far as unlimited personal freedom, or the destruction of democracy.
If you are really willing to take the arguement you are making seriously, why should we have ANY of the rights that are not specifically enumerated in the Bill or Rights? Abortion? Privacy? Freedom of association? They don’t appear anywhere in the bill of rights, but we have no problem telling the government “hands off.” If we can do it there, why not here?
Isn’t the question really about using your brain to reach a compromise between liberty and democracy, and aren’t the people in power FAILING to use their brains in THIS SPECIFIC CASE? (By the way it IS your job to judge the FDA… Like you said, this is a democracy, and if you cede your DUTY to evaluate the government, and take steps to replace it when it acts against your interests, special interest groups whose interests do NOT align with the public good will take that duty on for you)
Who said anything about a philosopher king? I’m sorry, but what the h** are you talking about?
The point of the post, and most of the comments is that the FDA’s policy is a horrible horrible policy that should never have been implemented, and should have been stricken down by the courts when it was challenged. I don’t see anyone claiming that a philosopher king should arise and strike down the FDA–not even Nathan.
The thing that gets me, is you have totally backed off your initial position of “this is a tricky ethical issue,” to now saying “there shouldn’t be philosopher kings,” which is a complete non sequiter. No one (besides Nathan, perhaps) is advocating anarchy, we are simply saying that IN THIS CASE, the FDA policy is irredeemably bad, the FDA has too much control over an intensly personal decision, and we should reduce the amount of control it has by whatever lawful means are at our disposal. I.E. we are criticizing our government, just as you acknowledged we have the right to do.
You initially defended the policy as being a “tricky ethical issue,” and instead of either acknowledging your mistake on that count or continuing to defend it, you devolve the argument into an absurd proposition that no one is arguing.
So back to the point, do you still consider the policy to be a “tricky ethical issue,” or is it simply an indefensible policy, which is what most of the other commentators ARE saying?
(also, regarding your comment about the founding fathers, you may want to re-read the opinion. The opinion itself is based on historical notions of fundamental rights. All I am saying is that if you are going to base an opinion on historical notions of fundamental rights, then you need to do so ACCURATELY, which would require the court to acknowledge the fact that historically speaking, the people have reserved ALL POSSIBLE RIGHTS, except those impacted by the specifically enumerated powers of the government. Accordingly, in order to determine what a historically protected right is, you do not need to determine what was specifically regarded as a right in the past, you need to examine whether or not the power being exercised by the government over the individual was one that was historically intended to be enumerated in the Constitution. If the court does not wish to go down that path, then it should not invoke a discussion of historically fundamental rights, and should instead ask whether people TODAY would consider that the right of a terminally ill patient to choose his own treatment is fundamental. If the Court was honest, I believe that either one of these approaches would have led the court to conclude that there WAS a fundamental right being infringed.)
No, you continually ask how the rights of the minority could be better served in our existing framework, but ignore the answers you receive because they do not fit your preconceived notions of a “libertarian’s” response.
I explained in my post two alternative lines of reasoning that the court could have used to reach a result that would have better served the minority in our existing framework. Thus I suggested, and am advocating for an approach that fits within our existing framework, that you just ignored. I also stated that the FDA should never have implemented the policy. That is another useful suggestion of how the rights of the minority could be better preserved in our existing framework. Again you ignored it.
You seem to be arguing that some reasonable amount of regulation is necessary, and our system is the best we have for determining that amount. I am with you so far. But then you act as if one cannot question whether the amount of regulation we have is UNREASONABLE and should be REDUCED, without arguing for the complete overthrow of the system. I am not, and I believe most here are not arguing for the complete overthrow of the system, we are arguing that the amount of regulation is currently unreasonable and should be reduced USING THE MECHANISMS AVAILABLE IN THE CURRENT SYSTEM. How is that not useful?
“The only theme that I keep bringing up (see the thread about poverty) as that in a democracy not everyone gets what they desire all the time.”
Yeah, o.k. point taken… SO WHAT??? Does that mean the people who don’t get what they want should just sit down, shut up and take it? Or should they engage in dialogue, and argue their point, and attempt to pursuade others that the regulation in question is unfair and should be repealed or stricken down? Isn’t that how the system works? When they do, do you really think it is a valid mode of arguing to just say “sometimes you don’t get what you want,” and refuse to take a position on the particular issue, even though under the system you’re talking about YOU THE VOTER are the one who has to make the decision?
Finally, I never said that you saying it was an ethically tricky issue meant that you supported it or opposed it. I said that was your initial position, and I and others argued that it is NOT ethically tricky, but is in fact clear-cut and indefensible. That is what this thread is really about, not “philosopher kings.” Several people made points regarding your initial claim, which you ignored by “generalizing” the discussion into one about philosopher kings. While you did not retract your initial statement, you completely ignored the arguments against it, and instead raised an absurd non sequiter about philosopher kings. I’m sorry, but I consider that backing off. If you still cling to your claim that it is ethically tricky, then try addressing the arguments set forth above that it is not ethically tricky, without generalizing the discussion to absurd arguments about anarchy and philospher kings.
How very odd…
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