Not necessarily a good idea.

While on the face of what they are saying - without these drugs they will die anyway - it sounds ok. What will happen (as was the case with AZT and AIDS) the drugs hasten their death?

Will the drug companies (and others) be held liable if taking these drugs makes things worse?

I suspect those that are crying that the FDA is "heartless" would be the same ones who will cry that the FDA or someone should have told them these drugs would kill.

And, yes, we can make the patient sign away any or all claims against the drug companies; but, some lawyer somewhere will try to get cash from someone somehow. That, sadly, is also a part of modern medicine.

Sometimes there is nothing one can do to avoid death. We often expect too much from modern medicine. Lastly, calling access to these drugs a "right" is just plain nonsense.

The bigger issue is who is going to pay for all these unapproved drugs?

Insurance is not required to cover any treatments not FDA approved.

I can find better uses for my IRA than a last ditch attempt to extend my life for a few miserable months or weeks.

Just another meaningless government gesture, in my opinion.

.

Um... I hate to say it, but that's something that already happens, a lot.

Think about most cancer treatments that are non-surgical. They are designed to KILL cells - with cancerous cells being more susceptible to whatever particular treatment. This means that one is basically poisoning the body in a deliberate manner (this is why chemo has such nasty side effects).

Obviously, this is risky. So, who tries potential new drugs/therapies/doses/combos/etc? Pretty much just those people who aren't helped by existing therapies. That's how the clinical trial process works. They can't try it on people if it will likely do more harm than good, and poison is harmful, so there basically has to be no other alternative.

If this does anything different from what I have described, it would probably have to allow "therapies" that aren't even up to FDA approval for limited clinical trials (stage 1 trials typically have 3 participants).

This is not necessarily a bad thing. It opens the doors to certain types of abuse, but it could also help reduce the cost of getting a drug to market (if people take it voluntarily before it hits trials or is approved and it helps). We could stand to have some new classes of antibiotics...

(P.S. sorry if this posts twice, I put "cars" but it said I failed the challenge)

Isab, I presume the drug companies and the government will pick up the tab.

One of my terminally ill family members took part in a drug trial through NIH - the trial itself didn't cost her a thing (she did pay for travel, food, and lodging).

Isab, I presume the drug companies and the government will pick up the tab.

One of my terminally ill family members took part in a drug trial through NIH - the trial itself didn't cost her a thing (she did pay for travel, food, and lodging).

Posted by: Michelle at February 21, 2014 1:38 PM

Drug trials are already allowed by the FDA. In that case, you have a fifty fifty shot of ending up in a control group with no treatment at all.

So this bill is either unnecessary, or it will be very expensive for those who try and go this route.

Somebody has to pay. The drug companies are not in the philanthropy business.

If it isn't the patient paying, it is going to be you and me.

Here comes the "alternative" "medicine". Urine therapy, anyone?

You progressives are just pissed because we still treat our state like a laboratory of democracy rather than marching in lockstep on the road to serfdom with the rest of you.

I talked to a bunch of people here in AZ about this today. Not a single one brought up the question of who would pay. I can't speak for them because I didn't think to ask, but I sure never thought the government would be paying for these treatments.

"Not a single one brought up the question of who would pay."

Well, that was pretty stupid. It looks like someone thanks something is free. Nothing is free.

Meanwhile, here's a Web site which attempts to explain what happens when quackery is allowed. I wonder who will be on the hook when things go wrong?

Because some people are gullible shouldn't mean everyone is prohibited from using unapproved drugs. Those gullible people tend to see you treatment in Mexico from unapproved people.

Posted by: Amy Alkon at February 22, 2014 6:01 AM

True, but a lot of the approved drugs are a Crapshoot anyway, with marginal benefits, measured over horrendous side effects.
Mindlessly throwing a cocktail of poison at a terminally ill person, isn't going to either advance science, or help anyone.

People don't have the ability to determine cause and effect under the best of circumstances, and I really hope insurance doesn't end up paying for this idiocy,

Isab, I haven't read the bill, so I don't know the details.

In theory, drug companies invest money in drug research, which is a long term financial gamble. When a drug goes to market, the drug company has a patent that allows them to market the drug exclusively for a time, to recoup the investment. If the drug doesn't make it to market, the company has to recoup the expense through the sales of other the drugs. Capitalism - risk and sometimes reward.

My understanding is this bill will allow companies to test drugs that have not been approved for trial or use by the FDA - essentially getting the paternal FDA out if the way of dying people making one last grab at life and making a contribution to humanity.

My understanding is this bill will allow companies to test drugs that have not been approved for trial or use by the FDA - essentially getting the paternal FDA out if the way of dying people making one last grab at life and making a contribution to humanity.

Posted by: Michelle at February 22, 2014 7:02 AM

I am well aware of the patent process, and the drug approval process.
And 90 pcercent of this isnt going to be drugs in development, it will be off label uses of existing patented drugs. (Again not covered by insurance)

It is an emotional response to an intractable problem (inevitable death) and the companies will have no incentive to provide the durgs, as there will be no control group, which is necessary to further both the scientific research, and the patent approval process.

I would never sign up for this voodoo myself, or allow a loved one to do so, if I had any say in the decision.

These legislators passing this feel good bullshit, know as much about medicine as the Obamacare authors knew about insurance.

"Urine therapy, anyone?"

I was but I'm not in therapy any more.

I am all for letting people ingest what they want, with the exception of heroine and anything else that is largely instantly addictive.

If this law makes it easier for dying people to get their hands on what they want, so be it. Let us go down swinging and going for the long shot if that's the way we want to go.

If this law makes it easier for dying people to get their hands on what they want, so be it. Let us go down swinging and going for the long shot if that's the way we want to go.

Posted by: Michelle at February 22, 2014 11:52 AM

Yes, and now all the state of Arizona has to do, is figure out a way to get drug companies to donate expensive experimental drugs, while ignoring the Federal laws, that require approval from the FDA.

I am well aware of the patent process, and the drug approval process. And 90 pcercent of this isnt going to be drugs in development, it will be off label uses of existing patented drugs. (Again not covered by insurance) -- Isab at February 22, 2014 7:39 AM

Once a drug is approved by the FDA a doctor can prescribe it even for off label use. The doctor could prescribe Mentax for headaches. Now if it doesn't match the diagnosis code (ICD-9) the insurance probably won't pay for it and it goes back to the patient.

They're talking about drugs that are still in the experimental status that are barely at the testing stage.

Or there is at least one drug that is out there that is a cocktail of vitamins and nutrients that works on kids with bad intestines. The only way to get FDA approval it is a double blind study. The kids who don't get it and get the placebo are going to die. Real ethical.

I'm sure you approve of doing that study.

Some off-label uses have become so used they become "typical" if not the original use, and insurance will often cover those. In some cases it is utilizing a side effect to the patient's advantage.

For instance, I was having a bad eczema flare up. The dermatologist said, "take X" (I think it was zertec). I told him I already was. He said, "use Y as well" I again said I was. So, he goes, "Okay, keep doing that and take this too." I look at the scrip he wrote and it was for ranitadine (sp??). This is medicine for acid reflux. So, I asked why he was giving me something for stomach acid and he said it enhances the effect of whatever the first drug was.

If I didn't trust the guy I wouldn't have taken it, but I did and it worked. Insurance covered it. Also, when I was at another doctor shortly after and got the "what meds are you taking and why," I mentioned the reflux med and the doc just nodded and said something like, "stubborn allergy, huh?"

Or, for a shorter example, Rogain was originally supposed to be for blood pressure. It had this side effect that kept coming up in the clinical trial...

"Or there is at least one drug that is out there that is a cocktail of vitamins and nutrients that works on kids with bad intestines."

Change that to "a few kids" with bad intestines.

This is one of the problems with wonder drugs and other therapies. They work on a few random people, but without a control group, you don't know if it is the drug, or a placebo effect (or something else they are taking in conjunction with the therapy)

And

This mineral vitamin nutrients thing doesn't meet the definition of a drug under the FDA rules.

In short it is more hype, from scared parents, grasping at straws.

Tell me again how the state of Arizona is going to get the doctors, and the drug companies to buck the FDA?

While I agree with you that the FDA has way more power than they should have, they have big Pharma by the balls.

No drug company's lawyers are going to allow them to release experimental drugs to doctors, and hospitals for the treatment of a few terminal patients.

The Goldwater Institute should know better.

ranitadine (sp??)

Available over the counter, very cheaply, In a generic form. You didn't need a scrip.

Yes, and now all the state of Arizona has to do, is figure out a way to get drug companies to donate expensive experimental drugs, while ignoring the Federal laws, that require approval from the FDA.

Posted by: Isab at February 22, 2014 12:29 PM

Experimental drugs are drugs that have even developed - and need to be tried on human beings.

Arizona has opened the door for the drug companies to walk in with drugs they have already developed and try them on people who volunteer. This can help people who are dying and help drug companies refine their future tests & proposals to the FDA.

Less bureaucracy, more freedom to experiment, respond, and try again - funded likely by drug companies that have to treat out the drugs anyway.

Am I missing something here?

Also - "We're all gonna die" doesn't mean that every effort undertaken in light of one's dying is deluded, extravagant, or worthless.

...so many typos, so little twine...

"Am I missing something here?"

Just the fact that the State of Arizona has no authority over the FDA, and the drug companies owe their entire business to playing ball with the FDA and following FDA rules for the release of drugs onto the market.

The phama industry is not going to violate federal laws and regulations, to please the State of Arizona.

Kind of hard for big Pharma to send any drugs to Arizona, without running afoul of the FDA's ability to enforce jurisdiction over transportation via the interstate commerce clause.

In short it is more hype, from scared parents, grasping at straws. -- Isab at February 22, 2014 1:40 PM

Found it -- I was off on the details. The drug is Omegaven. It corrects for the liver damage of treatment for Microvillus Inclusion Disease.

But of course these children should die. Anyone else you want to put on the list?

Authority, no. Influence? Sure. And screw the idea of giving up influencing one's own government before trying.

It took about ten years to get the FDA to allow levonorgestrel (emergency contraception) to be sold without a prescription, but it happened.

Arizona's approach could lower costs for pharmaceutical companies (smaller, more nimble trials) and expand demand for certain drugs. I have no doubt that big pharma, people of libertarian persuasion, and those who care for the dying can collectively persuade the powers that be at the FDA.

"And even if a child gets approval for Omegaven and is doing well on it, there can be problems continuing the treatment because it’s illegal to ship non-FDA approved medications across state lines"

As usual Jim, you totally missed my point. I don't want to put anyone on any list. This is a very rare genetic disease you are talking about, with a handful of survivors, and the treatment has been effective in a few of them, at least short term.

I am just telling you that the state of Arizona cant get any of this shipped in, in spite of their law, if they get it passed,
WITHOUT THE APPROVAL OF THE FDA.

What part of "the state of Arizona cant TRUMP federal law" do you and Michelle not get?

Without FDA approval, Omegaven is available only to those who can come to Boston to take the drug in a research protocol, or at another hospital with special dispensation from the FDA, a provision called “compassionate use.”

Compassionate use is how Puder and doctors at some other hospitals, such as Texas Children’s, are providing Omegaven for sick babies. But doctors argue that the application process is difficult and wastes precious time.

“The problem with this disease is it’s so rapidly progressive that you may lose the time to be able to rescue them,” Puder said. “So, if their liver disease is bad at two months, and then it’s at four months now, now you’ve hit a point where there’s a point of no return.”

Yes, let the federal overlords determine compassionate use. Please let some fuckhead in Mordor on the Potomac say that use in my child's case is the right thing to do. But when he leaves at 4:30P on Friday I now have to wait because he wants to to go home for the weekend?

What else should our federal overlords decide? Maybe that I have to pay for the crackheads treatment? How about prohibiting alcohol. Oh, shit, that was tried by our federal overlords. It fucking failed.

Let's send all our money to Mordor on the Potomac and they can decide what we deserve to get back. Our government will never be in debt.

Please let the federal overlords decide that you shouldn't be allowed to decide what you need for health insurance because you aren't fucking smart enough and they know better than you.

Hey everybody stop saying this CAN help people who are dying.

We do NOT know for sure if it can or cannot help. That's why these drugs are still experimental for Pete's sake.

If pushed through it will allow some folks to take the drugs without control groups so we will really have no way of knowing if it was the drug that worked (or failed by doing harm) or something else.

I get it; you're dying and nothing has helped so you want to try anything, ANYTHING, with the hope that this will be the "miracle" cure.

This is feel good legislation that does nothing to advance the knowledge of the drug or necessarily help those who are dying.

AZ has a lot of retired, elderly folks who think this would be great; and that is my guess why this is being proposed there.

What part of "the state of Arizona cant TRUMP federal law" do you and Michelle not get? -- Isab at February 22, 2014 6:48 PM

BTW, have you ever read the Tenth Amendment:

The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.

Please show me the FDA without invoking the ICC and Wickard fuckup.

What part of "the state of Arizona cant TRUMP federal law" do you and Michelle not get?
Posted by: Isab at February 22, 2014 6:48 PM

State sovereignty and federalism are an ongoing wrestling match. I get it.

I think you give in too easily. Resigned? I don't know.

I see, strategically, how this could work.

Arizona just opened up a market full of old people with money. Big pharma has only to aim for that hoop (net?) and talk with the FDA - also likely full of aging baby boomers - about the obvious wisdom of letting dying people take whatever the fuck drugs they want to take. For free. Because one of the things pharmaceutical companies do to generate sales is give out free samples.

The biggest medical expenditures are incurred in the last six months of life, by people who are trying to die not just yet. Arizona has a lot of front line Baby Boomers who are well educated and know how to advocate for their interests. Drug companies, which give away drugs to drive up demand and are notoriously effective at lobbying congress, now have an entire state in which to give drugs to people who are dying and have little if anything to lose by trying unproven approaches. (I wonder if one or more of them had a hand in lobbying AZ to pass this legislation). Drug companies in turn could glean insights that inspire new thinking, new studies, new patents, new drugs, and best of all - new customers.

Have I missed something?