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Posted on 12/08/2007 8:29:53 PM PST by neverdem
If laws banning the use of force are relaxed when an intruder crawls in your window and you’re home, shouldn’t stringent F.D.A. regulations bend when you’re backed into a dark corner by a terminal illness? That was the gist of an argument made by the U.C.L.A. law professor Eugene Volokh in the May issue of The Harvard Law Review. Citing the concept of “medical self-defense,” Volokh contended that a dying American should have the right to buy any drug that has passed the F.D.A.’s preliminary safety tests. Currently, the F.D.A. insists that most terminally ill patients await, like everyone else, full proof of a drug’s safety and efficacy.
Volokh’s inspiration for the article was a court decision. In 2006, a panel of the United States Court of Appeals for the District of Columbia Circuit ruled 2 to 1 that the terminally ill ought to be able to buy drugs that have passed Phase 1 F.D.A. testing (of three phases). One judge in the majority was a staunch conservative, the other a Clinton appointee. The full Court of Appeals, however, set aside the panel decision and then, in August, ruled 8 to 2 against the plaintiff, the Abigail Alliance for Better Access to Developmental Drugs. The court agreed with the F.D.A.’s arguments that the government has a strong interest in protecting even the terminally ill from brutal side effects and a premature death, and that only the full testing regimen can do that. The court also stressed that the states’ efforts to regulate drugs dated to 1736 and observed that the Supreme Court had rejected a “medical necessity” argument in the case of medical marijuana. And it wondered where the right to self-defense would end — could a dying patient force a drug company to hand over drugs? In a vigorous...
(Excerpt) Read more at nytimes.com ...
I agree with the end-state of your argument, but to jump back to the analogy of self defense, lots of people who hate guns would nevertheless accept the legality of blowing someone away who was just about to kill you ... and if they do, you could then argue that, well, that means you need to be able to keep guns at home, and for that matter carry them with you, because the attack might not occur at home, and next thing you know, you’re talking about Vermont carry. Your end-state is the Vermont carry of medicine, but all Volokh is asking for is keeping a gun at home, in the analogy (which the FDA doesn’t presently allow, apparently).
Where to begin
OK, I can see relaxing standards for care in terminal situations. A morphine drip is acceptable if someone’s life is ending.
However
could a dying patient force a drug company to hand over drugs?
The operative term is force
A person may have a gun and use it against an intruder
I am not obligated to sell / give you a gun to do so however
Forcing drug companies to release drugs prior to effective testing
is a dangerous precedent
Were the drug company to choose to do so, is it's own business
Father Catches Bird Flu That Killed His Son
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Nicely said.
Generally, I could be accused of being a libertarian on this issue. I see no rational reason, once a patient has been certified terminal by two independent physicians, that they may not purchase any experimental treatment or protocol out there that would not harm public health (as in antibiotics).
Thanks for the ping. Off topic but let’s give terminally ill patients the right to all of THEIR money THEY poured into social security. Economic self-interest.
If a patient is terminal and poor, do you believe the hospital should be allowed to harvest their organs as payment?
“Since the patients are terminal, do you believe the drug companies should be allowed to pay them to test their experimental drugs? Even if the experimental drugs have nothing to do with their disease?”
No, is messes up the quality of the tests. Clinical tests need to be highy controlled and financial incentives.
“If a patient is terminal and poor, do you believe the hospital should be allowed to harvest their organs as payment?”
No, but that’s because I have, for a long time, advocated a program of
“In order to get you have to be willing to give” providing organ transplants only to those previously registered as potential donors.
Why don't we leave that up to the manufacturer? Maybe they want to test a new acne cream that may cause facial paralysis. I see no reason why they couldn't test that on a terminal cancer patient. You?
Or a Vitamin C replacement that may cause insanity. A new eye shadow that may cause blindness. Hey, if the patient is terminal and is going to die anyways ...
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As I said, I’d let terminal patients have access to whatever they want.
Unfortunately, it does not work for clinical trials which must be double blinded. That means that neither the patient nor the doctor knows if they are getting the treatment. (for instance, dummy pills are handed out, but the person giving the pill to the patient doesn’t know if it is the real thing or not). In addition “intention to treat” is controlled for by having a group get no treatment. That’s because it’s been found that thinking they might be being treated lifts the patient’s mood and can impact the results.
For the most part, it's the government, the FDA, forcing them not to release them, even to the terminally ill.
Terminate the FDA.
Nothing wrong with that! I've had "organ donor" on my license since I was 16 (28 years), and have been waiting for a kidney for the past 2-1/2 years...
Best wishes to you. A few years ago my kid sister was told her kidney function was around 30% and at 1% less they’d put her on the list. Amazingly, she’s managed to recoup a bit of function, but I am able to see how it’s no fun living on the edge.
There was an article called “The Rest Are Simply Left to Die” ...around 40 years ago ... it’s tragic that such a simple solution is so hard to get into the public eye.
A terminally ill patient could plead and plead for treatment, but doctors and hospitals will deny it if they've determined the patient is too far along (or too "old") and that the treatment itself might possibly kill them. (ESPECIALLY if those doctors/hospitals have made a mistake they want to cover up.)
And, if a doctor does decide to treat a terminally ill patient, the hospital ethics committee will come after them. How do I know? That was exactly what happened to my father when he was terminally ill, so I'm speaking from personal experience. Also, I've spoken with many other people who came up against the same brick wall when they were pleading for treatment. One rushed her mother to seven different doctors before one would agree to treat her for cancer. Her mother is alive today because only one doctor was willing to try something.
The argument of medical "self-defense" is an interesting one. Maybe the case would have a different outcome if the fight for treatment for terminally ill patients began with the "fully approved" drugs first.
I’m not sure, but I believe most doctors now are employees, usually of HMOs, or get paid by Medicare or insurance companies.
Aside from not getting caught in a malpractice, the doctors also have to justify themselves to these gatekeepers with $igns for eyes.
We discovered that doctors have a lot more leeway with insurance companies than we knew. Insurance companies often make decisions based on the opinions of doctors.
Example: Following recovery from a surgery that went horribly wrong, my father would’ve qualified for physical rehabilitation in the hospital’s state of the art facility. The hospital said the insurance denied it. But, it turns out, the insurance company denied it because the surgeon wrote in my father’s records that he was too sick to handle it. Otherwise, the insurance would’ve covered it.
Also, we discovered malpractice suits aren’t as commonplace as medical malpractice is. The vast majority of medical malpractice claims are denied. No lawyer would represent my father’s case because he was deemed “too old” (at 72) and “terminally ill, anyway.”
So, if a patient is terminally ill, anyway, and hospital mistakes are going to be shrugged off for terminally ill patients, why not try a treatment? Maybe the reason is hospice. A recent thread here on FR spelled it out much better: Terminally ill patients are pushed into hospice earlier and earlier today because it’s a big money maker.
bmflr
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Why the smart money is on Duncan Hunter
http://www.freerepublic.com/focus/f-news/1926032/posts
Thanks for the ping. Interesting. Thanks for informing. Education/life BUMP!
You are aboslutely correct on all but one count. That’s one reason I get irritated by the tort refom crowd. For every malpractice award that gets made, dozens of legitimate cases go nowhere.
The hospice movement, however, filled a desperately needed hole, and makes it possible to treat pain in patients who would otherwise be subject to dying in agony in hospitals. The fact that many of the “terminally ill” patients fail to die “on time” is probably due to simple fact that relieving pain reduces the stress on the body and the patient can put those resources toward recovery.
Like the "right to keep and bear arms", the bureaucrats and politicians will hold the government power to "regulate commerce" superior to that right as long as the USSC lets them.
Believe it or not, 30% function is still pretty good. There are still issues that need to be addressed (phosphorous, parathyroid hormone, anemia, etc), but at least they can be managed with meds and diet. Of course, it depends on the root cause of the kidney failure, but I had 8-10% function for over a year before I needed dialysis.
Good luck to your sister. Hopefully, she’ll get a transplant before needing dialysis.
I meant to say that hopefully she won’t need a transplant, but if she does, that she gets it pre-emptively (before needing dialysis).
Iatrogenic ... serious medical melpractice. Too much to summarize, but basically too many of the wrong meds for too long plus serious, untreated medical conditions easily diagnosed from extant lab work.
No, didn’t qualify for malpractice suit.
Thanks for your good wishes, she’s in great hands now.
If we can ever get the “in order to get, you have to be willing to give” program going there will no longer be a shortage of organs. Folk who worry that they’ll get less good care because the doctors will want their organs couldn’t be wmore wrong, we’ll be swimming in options
I see medical deregulation as being the big sleeper issue of 2008. How it will play out depends on whether a Republican latches onto it first as a "patient right to shop around in a free market", or a Democrat who runs against the "corporate medical monopolists". Third-party payments papered over the problem for a long time, but healthcare now costs too much for even the largest mass payers.
Maybe. I suspect that at the end of the day, ther’ll be some ephemeral “patient right to shop around in a free market”, but the bottom line is the bureaucrats in DC will still decide where you can shop and what you can buy.
I agree that the "bureaucrats will decide" scenario is the highest-probability scenario, the one we will get in 2009 when Hillary bestows single-payer upon us. The existing system will not service because all parties have run out of money to pay for it. What I'm saying is that the GOP has one last chance to forestall this meltdown by agreeing to a market approach.
The bureaucrats already decide what drugs you can and cannot buy, and which ones your doctor can prescribe for what. As long as the GOP clings to the New Deal philosophies and the idea that Congress has the authority to regulate anything they can "find" that "substantially affects interstate commerce" they can't do anything except damage control, and then it's only going to be temporary.
The problem is, in order for terminally ill patients to receive the hospice (palliative) care that they need, they must agree to forego any life-saving treatments. For example, a cancer patient predicted to live six months or less will not receive chemotherapy if he elects to go into hospice care.
However, there are a couple of insurance plans today that cover what is called "open access" hospice: Patients receive round-the-clock palliative care, but they aren't denied life-saving treatments, either. I hope that idea will catch on.
All it would take to catch on is to allow the patient to decide if they want palliataive care while in the hospital. IOW get rid of the nonsensical business of regulating pain meds that might addict a 70 year old cancer patient.
Just let the patient sign a informed consent form for the degree of palliative care they want.
Full disclosure: I generally would like to stop regulating any drug that is not a stimulant. Stimulants precipitate violence, pain meds, hallucinogens, “downers” hurt no one but the user if mishandled. So do potato chips.
Why, then, the "terminally ill" restriction?
Because politics is the art of the possible.
All it would take to catch on is to allow the patient to decide if they want palliataive care while in the hospital. IOW get rid of the nonsensical business of regulating pain meds that might addict a 70 year old cancer patient.
We've found hospitals are more than willing to OVERmedicate with palliative (noncurative) treatment, even if it hastens a patient's death, but are not as willing to provide life-saving treatment (unless you're young and pretty, I guess).
Today, hospice (palliative care) is big business in hospitals. Most have a separate ward for hospice patients, where they supposedly make them more comfortable. And doctors will push hospice on patients and families who don't want it, even to the point of involving the ethics committee.
I agree that the choice should be the patient's, although I don't think doctors should go against the hippocratic oath. That is, if a patient refuses life-saving treatment and requests to die, I don't think a doctor should kill him. The doctors should make him as comfortable as possible. But when a patient is pleading for life-saving treatment (such as chemo), give him the treatment. What does he have to lose?
Believe it or not - and this was a surprise to me, too - not all terminally ill cancer patients can handle pain relieving medications. For example, if a patient's liver is compromised (with cancer tumors, for example), medication like morphine or dilaudid or even Tylenol will not make him more comfortable. Instead, it will cause continuous agitation, sleeplessness, etc. Not all cancer patients have pain, which was a surprise to me, too. But, with the exception of internal medicine, the other doctors and nurses will PUSH the pain-relieving medication onto patients, anyway. They'll argue with the patients and their families over it.
What I'm trying to say is that, hospitals aren't denying pain relieving treatment at all. They're overusing it. They're pushing it. The life-saving treatment is what they're withholding.
As to currently illegal drugs, I don't see why something like morphine is used legally and other drugs aren't. I agree the WOSD is ridiculous, if that's what you're saying.
Thanks to all contributors to this thread.
life
My sympathies. You clearly have seen a monstrous hospital experience.
I suspect that many hospitals have what are basically attitude problems, and which attitude may depend on the individual hospital.
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