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No right to save your life
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.
Posted by Alex Tabarrok on August 9, 2007 at 09:19 AM in Economics, Medicine | Permalink
Comments
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?
Posted by: robertdfeinman at Aug 9, 2007 10:52:12 AM
There is no evidence that less FDA regulation would cause problems for conducting medical trials. Manufacturers may choose not to sell new drugs before trials have been conducted. Patients in trials can be given free drugs or (heaven forbid) they could be paid to participate - indeed, this is what we do now for phase-one trials. Many post-approval trials are conducted today (see the brief, linked to above for lots of examples.) The issue of clinical trials is a red herring.
Posted by: Alex Tabarrok at Aug 9, 2007 11:05:44 AM
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.
Posted by: Yancey Ward at Aug 9, 2007 11:27:24 AM
That's what makes discussions with libertarians so futile. They dismiss the opposing position out of hand and then reiterate their original statements.
Personally I haven't formed any personal opinion on this issue, but was just trying to restate what those who supported the judge's decision have been claiming.
I don't see what paying people to participate in trials or giving them free drugs has to do with anything. The issue is an ethical one, not a financial one.
I'll try to recast it, without reference to this particular case, since there are complicating factors.
My version of the conflict:
Society imposes restrictions on people's options in society. The reasons for this vary, sometimes it is for public health (vaccinations), sometimes for self defense (the draft), sometimes for social welfare for the weak, in whatever sense you wish to interpret that, (social security), sometimes it is to maintain the public infrastructure (civil engineering), and sometimes it is to preserve public order and property (police and the legal system).
There are those who claim that any such restriction is unacceptable. I think they are mostly disregarded as being too utopian.
There are those who support the legal, police and military aspects, but draw the line there.
There are those who will also add in infrastructure.
So, ultimately, there is a degree of arbitrariness as to where any individual draws the line as to what should be done with "their" money. This varies from time to time and place to place. There seems to be no philosophical basis for where one draws the line, just preferences expressed by different social philosophers and their followers.
Since the line is somewhat arbitrary there needs to be a way to set it in practice. I prefer that it be done by means of a democratic society. The majority of people get to express their will and this gets turned into the rules of society. I'm ignoring the imperfections in the process - we are speaking of policial philosophy not street politics.
The down side is that those who are in the minority have their preferences ignored. I don't have any solution to this. This is the weakness of democracy - the "tyranny" of the majority. If anyone has a better way to accommodate the will of the majority while maximizing the wishes of the minority I'd be happy to hear their ideas.
Posted by: robertdfeinman at Aug 9, 2007 12:23:49 PM
Thanks for strawmanning Alex, Robert.
Posted by: J. at Aug 9, 2007 12:26:23 PM
unrelated but I thought this could be in the running for sentence of the day: Local news: four galaxies collide, five billion light-years from Earth
its from another blog, boingboing.com
Posted by: Paul at Aug 9, 2007 12:56:37 PM
Sorry J, I don't see "strawmanning" whatever that means to you. Show your work.
Posted by: Lee at Aug 9, 2007 12:57:10 PM
"Personally I haven't formed any personal opinion on this issue, but was just trying to restate what those who supported the judge's decision have been claiming."
They have been claiming that there is an ethical obligation to deny dying patients access to a drug deemed AT LEAST safe and POSSIBLY a treatment for their illness? There's an ethical argument IN FAVOR of that?
That's a very... interesting... system of ethics. Seems on par with watching someone drown because if you jump in the water to save them, you'll ruin your suede shoes.
Posted by: Flynn at Aug 9, 2007 1:40:10 PM
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.
Posted by: Hopefully Anonymous at Aug 9, 2007 1:47:19 PM
Flynn:
The ethical issue concerns whether people should take risks that they are not able to properly evaluate. The drugs are not "at least safe" and the whole point is that there is no evidence (as of yet) that they are useful for the particular illness at hand.
Now you can argue that people should be able to do as they wish, that's where we came in. We have many laws to protect people from themselves, libertarians don't like them, but they still get passed which means that the majority of people do.
There was a recent debate (again) over helmets for motorcycle riders. There is the never-ending debate about people being permitted to take psychotropic drugs. You have your position, but you can't dismiss the other side by claiming that they don't have an ethical argument to make.
We prevent children from doing all sorts of things because we don't feel that they have the intellectual capacity or experience to know what's best. Is there some arbitrary point when mommy knows best ceases and kiddies are allowed to do whatever they will?
It would be much more useful if libertarians would stop arguing for a vision of society which will never be achieved and instead devoted themselves to working for reasonable limits on personal behavior.
Our Puritan background makes us much more willing to adopt restrictions because of unstated religious prejudices than other advanced countries. These should be examined rationally, on both sides, rather than just assuming an inflexible stance that gets nowhere.
Posted by: robertdfeinman at Aug 9, 2007 1:51:43 PM
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!
Posted by: TGGP at Aug 9, 2007 1:52:21 PM
The ethical issue concerns whether people should take risks that they are not able to properly evaluate.
Thank God you're qualified to evaluate that for them. Now shut the fuck up.
Posted by: Joshua Holmes at Aug 9, 2007 2:05:28 PM
"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 :)
Posted by: Meisha at Aug 9, 2007 2:28:11 PM
If you saw Man in the Moon, you might remember scenes where Andy Kaufmann is trying crystals and later flying to a "healer" in the Philippines. People who are terminally ill are desperate and they sometimes turn to scam artists.
What is the ethical dilemma? The drugs have passed FDA saftey tests. If we do nothing, barring a miracle or two, 100% of the patients will die. Why shouldn't they be allowed to take medicine developed by legitimate companies?
Posted by: 8 at Aug 9, 2007 2:40:51 PM
"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.
Posted by: Erik at Aug 9, 2007 2:45:44 PM
Josh:
Thanks for raising the tone of the debate. I never said I was going to make any choices for anyone else. Do you have a point to make, or are you just always angry?
8:
"Why shouldn't they be allowed to take medicine developed by legitimate companies?"
That is exactly the question under discussion. Why don't you read the arguments that those in favor of allowing the FDA to keep it present policies used. I'm not trying to be a spokesman for them. I imagine with a bit of digging you might even find the case posted online someplace.
Posted by: robertdfeinman at Aug 9, 2007 2:48:28 PM
"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).
Posted by: Ned at Aug 9, 2007 3:19:24 PM
Robert,
The problem with saying that people should not be able to take risks "they cannot properly evaluate" is that it's impossible to know what that means. If the more important and personal a decision is, the more "difficult" it is for the individual to evaluate, then the logical extension of that is that no difficult decisions that have far reaching consequences can actually be made by individuals themselves. You see this in FDA hearings where the risks and benefits of a particular drug for a disease are made by people who actually have no experience with that disease. Not only do they not have it, they do not even deal with patients who do! Somehow, this is a better system than letting the people who deal with a disease every day of their lives make the choice. So who is less equipped to evaluate the risks? It's deeply flawed.
As for your questions about tradeoffs, I believe that it's a false dichotomy. Here's why: To say that letting people have access to drugs outside the clinical trial system means no one will participate in trials assumes a key thing: That all individuals with a given condition have the same risk preferences. This is really not true. I think that if you look at the politics and public opinion about drug safety in this country, you will see that there are relatively few people who want to just go try drugs that have hardly been tested. Most people want drugs whose risks and benefits are fairly well defined. Therefore, there will still be demand for clinical trials. Imagine a disease with basically three "tiers" of patients. Tier 1 patients are really, really, sick and have tried all available therapies without any success, and don't have a lot of time. They may want untested drugs. Tier 2 patients are fairly ill, conventional therapies are doing OK but not so good, and they want more choices, and are willing to assume risks to have them. They are ill, but still more risk-averse than tier 1 patients; they would be willing to participate in trials. Tier 3 patients are not so sick, do OK on available treatments, but still keep an eye out for new stuff that works better. They do not really wish to assume much risk. They are content to wait for trial results, and they create the demand for clinical trial data. A drug company can satisfy all these groups at the same time, with none coming at the expense of the other. In that way, the tradeoffs you speak of are not really necessary.
Posted by: LisaMarie at Aug 9, 2007 3:32:12 PM
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?
Posted by: robertdfeinman at Aug 9, 2007 4:18:50 PM
"The ethical issue concerns whether people should take risks that they are not able to properly evaluate."
The problem with using that as a basis to support the present system is the fact that the FDA is NOT taking on the responsibility to properly evaluate the risks itself. They are just sitting back and saying "NO, you cannot do ANYTHING to treat your terminal illness, until someone ELSE spends millions of dollars, and years of time proving to me that it is acceptable."
You cannot take a choice as important as the right to choose medicine away from an individual, without, at the very least, giving the individual the right to notice and a fair, individualized, hearing on the matter.
Even in cases of MENTAL ILLNESS, you have the right to notice and a hearing before your freedom can be permanently denied. Why is it different for someone who is physically ill, rather than mentally ill?
Also, we have no problem with terminally ill patients refusing any treatment at all, so why should we care if they want to try a treatment that might not work, or that we think might be unsafe? The reality is even worse, because we aren't JUST denying access to treatments that we deem dangerous, we are denying access to treatments that we haven't yet PROVEN are safe, even if we have ABSOLUTELY NO evidence that they are unsafe.
I could understand marketing restrictions, strict disclosure requirements, liability requirements for the companies selling investigational drugs, etc., but I cannot understand, nor understand how any other human being could advocate, telling a terminally ill person that they are not allowed to try something that might SAVE THEIR OTHERWISE DOOMED LIFE, unless a faceless bureaucrat with zero accountability had already approved a multimillion dollar multi-year study. It is just an inhuman thing to say, and like Erik, though I hate the word hate, I am very tempted to hate anyone who supports this kind of abomination.
Posted by: Doug at Aug 9, 2007 7:13:40 PM
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.
Posted by: Doug at Aug 9, 2007 7:24:08 PM
So let me get this straight Robert, you have just been diagnosed with pancreatic cancer. You can pretty much book it that you are soon to die. However, some company, university, or baby bio-tech firm has just created some kind of gene therapy that may be useful in curing your once thought non-treatable cancer. However, because the therapy is not FDA approved you have no legal right to access the new therapy. Remember, you have pancreatic cancer so you are soon to die. Now judging by your arguments in this post you believe that it is unethical for someone in your position to gain special exclusive access to a non-FDA approved drug? Why, what ethical right does the government have to murder someone? Why do you hold such a violent belief? A dieing person would like to live yet you would make them suffer and die? Something tells me that you have never had a serious illness. Im sorry for the emotional ranting but this is one issue where there the libertarian position clearly has ZERO weakness. There is no gray area in this matter, denying treatment to those that are soon to die is murder, plain and simple and the bureaucrats who allow this regulatory system to persist have blood on their hands.
Posted by: John Pertz at Aug 9, 2007 7:37:09 PM
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).
Posted by: robertdfeinman at Aug 9, 2007 7:57:09 PM
Janssen Pharmaceutical has brought Domperidone before the FDA several times in the last two decades, with the most recent effort in the 1990s. Numerous U.S. clinical drug trials have demonstrated its safety and efficacy in dealing with gastroparesis symptoms, but the FDA turned down Janssen's application for Domperidone, even though the FDA's division of gastrointestinal drugs had approved Domperidone.
In June 2004, the United States' main regulation agency, the Food and Drug Administration (FDA), issued a letter warning women not to take domperidone, citing unknown risks to parents and infants, and warned pharmacies that domestic sale was illegal, and that import shipments from other countries would be searched and seized.
It has been widely speculated that this action by the FDA is related to increasing drug importation from countries such as Canada.
Posted by: domperidone at Aug 9, 2007 10:35:04 PM
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:-)
Posted by: Ken at Aug 9, 2007 10:58:24 PM
