There is apparently already a system in place and working fine.
It sounds like this is one of those laws with a false name. It doesn’t change people’s right to try; it only changes other things. But calling it “The Relieve Drug Companies Of Their Responsibility To Their Customers Act” just isn’t as catchy somehow.
I don’t see anything offensive in there at all. Whatever intent there was in it’s creation and passing it does not reflect in the bill itself. It is rather well written for a product of the US Congress. The belief that this somehow weakens the FDA’s ability to protect us from unsafe drugs (already a rather limited ability due to political corruption) is simply a pipe dream. The critics need to explain on what basis the FDA can deny any potential life saving treatment to someone who has been sentenced to an imminent death by the universe.
It’s not good, but it is bad for the reasons you acknowledge in the “possibilities” part.
The FDA has been reasonably regulating the drug market for years to good effect. This law forecloses the possibility of the FDA imposing reasonable regulations on these cures. Why is this better?
Generally agreed, although this might weaken the FDA a lot.
This isn’t entirely true. The law says that the FDA can’t stop the patient from trying but the drug companies still can. If the drug company scientists don’t want to sell you a drug, the drug company isn’t going to sell it.
I think giving drug companies immunity for liability for drugs they sell is a terrible idea. Doesn’t that sound bad to other people?
Oh, you say, “the immunity liability only applies to drugs that don’t have FDA approval.” How is that better? “Here are some of the worst and least effective drugs we have. The FDA thinks they are useless, so they won’t approve them. But this one cures your untreatable cancer, maybe, we swear! ;). You can buy them from us for $1 million per treatment course and you can’t sue us if it kills you, maims you, or otherwise proves as effective as a Drano enema.”
This is a license for unscrupulous drug sellers to come into the market with untested snake oil and fleece consumers. It actually discourages doing the testing necessary to determine whether a given treatment might work. We all benefit from the information gained by testing drugs for FDA approval. This bill undermines those information benefits for all of us.
I understand this sentiment but the issue is that people facing death don’t always make rational decisions. Sometimes better decisions are made for them by better informed people people with a more objective viewpoint. If I were terminally ill, I’d want to ability to make the decisions myself. I’m probably better off not having it, because with that power, I’d have to weigh the value of every possible treatment in the world myself rather than relying on experts who have also done their level best to evaluate those opportunities for me.
We won’t know enough about the drugs to fully inform people about the consequences of taking them. If we could fully inform them, the FDA would have the information necessary to approve or disapprove the drug and the rule wouldn’t be necessary. The rule means that the drug sellers don’t even have to try to fully inform consumers and they can’t be held responsible for failing to even try to inform consumers.
The structure of the bill isn’t intended to permit fraud but I can assure you it does. I will not describe the mechanisms to enable fraud here because it’s against the board rules and because I don’t want to draw a road map for fraud. But, please take my word for it, this bill fully enables tremendous amounts of fraud and has the potential to empower unscrupulous drug sellers to cause tremendous amounts of harm with no redress for the injured. Given enough time and just a few bad people in the world, I don’t see how this ends any other way.
I’m not aware of anything in the bill that requires insurance to pay for these treatments. Ironically, that’s another strike against it. If, in the unlikely event that this bill helps give patients access to some effective treatment, insurance companies probably won’t pay for those treatments. This will just mean that access to effective treatments is less fairly distributed than it is now. If drug companies are making enough money on a given treatment through this mechanism, they will have no reason to seek FDA approval so insurers might never have to pay for anything for these drugs. Keeping treatment for costly conditions out of insurance coverage is just a sneaky way of reintroducing pre-existing conditions exclusions back into the insurance marketplace.
Agreed, and there are no strict controls. We are really just relying on the good faith and demeanor of any charlatan who can propose a drug.
I’m not an expert but I understand that the state laws aren’t effective without the federal law, so putting the federal law in operation is what will make the state laws work. States might still be able to regulate to protect their residents but desperate people will seek services across state lines if they have to and states will generally lack the expertise to effectively regulate in place of the FDA. Is suspect that many states, rather than protecting their residents, will instead move to follow the federal government’s path and empower charlatans to poison their sickest residents and/or use them as guinea pigs for money.
I consider weakening the FDA’s regulatory power to be a bug in the law, not a feature. FDA regulation has been imperfect but everything produced by man is imperfect. On the whole, FDA regulation has tremendously improved the quality of medical treatments in the U.S. and across the world. The solution to the FDA’s imperfections is to try to incrementally improve it, not to undermine it and hope that the return of quacks and dark-ages snake oil cures will be better.
Agreed.
If you’re definitely going to die without it, and are consenting to it even if it might result in an agonizing death, I say go for it.
Tired and Cranky, et al, I posted a link to the bill. Did you read it?
I read it earlier this week as part of my job.
Sincerely,
Et Al.
This is one of those “bad for the majority, but to the minority who need it, it’s all the world” measures. The cons will no doubt outweigh the pros, but to a terminally ill patient who truly has nothing to lose, you can’t blame them for telling the government, “You have no right to order me to consign myself to helpless death in the name of public good.”
Awesome! Now there’s a whole new category of drugs I can produce and get to market without progressing beyond a phase 1 clinical trial or approval by the FDA! Sure makes my process as a drug developer/manufacturer cheaper. Maybe I’ll sell these drugs more cheaply now that the Big Bad Gov’t has eliminated some of the expensive red tape!
Also, ditto to everything that wonky has said.
How does this apply in a **death **situation? The patient literally is facing death and experts (in your paragraph) who are telling him that “the better decision, made by us better-informed people, is that you should die.” This isn’t like getting a medication for a skin rash where maybe a doctor can say, “No, this ‘alternative treatment’ is quite toxic, you really shouldn’t do this.” In the situation here, the “experts” are telling the patient “Just die.”
Velocity, I did read the bill and I am also relying in part on news accounts of how the exemption works. Are there any parts of my opinion that you believe are inconsistent with the bill’s text?
Spending all your remaining time and money to pursue a worthless therapy hurts you even if, in the end, you just die either way. It’s also worse if the treatment hastens your death or makes your remaining time on earth more painful. The bill also hurts the public because it will reduce incentives to proceed beyond a stage 1 clinical trial. If this exemption takes off, we may get to the point where we barely bother learning what works and what doesn’t.
It sounds on its face like a nice idea but it isn’t.
So what are you complaining about? That the FDA will no longer have the power to a person who is on the verge of death the ability to try extreme measures to stay alive? The law requires the approval of an independent physician for remedies the FDA is considering for approval. What are the undesirable consequences of this law save for a conspiracy theory about taking away all of the FDA’s authority?
Medical marijuana laws also required an independent physician to prescribe it. Do you believe that medical marijuana has never been obtained by people for purely recreational purposes?
I don’t care in the case of marijuana, and it’s readily available without the help of a physician. But let’s say marijuana was seriously harmful to people, why would you care if someone about to die used it?
This is my concern also. My Favorite Uncle has cancer, but the Doctors said he had a very good chance with surgery- but he’d have to wear a “bag”.
So he went to Mexico for a "cure’ and died in pain.
I am illustrating that there is a ready supply of independent doctors who will prescribe medically worthless treatments because patients want them. That is really the only limit on quack prescriptions in the bill.
I don’t care if people smoke marijuana. I care a lot if sick and vulnerable people spend all their remaining money on treatments that may harm them rather than help them. Your view isn’t much different than saying, “well, they’re going to die anyway so let’s just let them jump in a wood chipper. We can charge them for the privilege.”
I don’t see this as any difference with the situation prior to this law where bad doctors can do great harm to patients with the wrong treatments, often done for profit.
Now I hope some critic can answer the question of what gives the FDA the right to deny a terminally ill patient their right to try any means to survive. This has been a cornerstone of our rights and the law going back centuries.
The interstate commerce clause and the FDA’s enabling legislation.
I posted, I think quite clearly, what I am complaining about. You do not have to agree with me, obviously, but that does not mean that I have been unclear.
This law will very likely not lead to anything good.
This law will very likely lead to things that are bad.
This law mostly is intended to weaken the FDA.
This law is a solution in search of a problem.
So you wouldn’t have a problem with the FDA banning proven and reliable treatments for a terminal disease you have? You’ll have to point out to me where the commerce clause denies you such a basic human right.
So the problem with this law is your personal opinions and your ability to foretell the future. That part is quite clear.