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U.S. Passes 'Right to Try' Law Allowing Experimental Medical Treatments (chicagotribune.com)
schwit1 shared this article from the Washington Post:
The House on Tuesday passed "right to try" legislation that would allow people with life-threatening illnesses to bypass the Food and Drug Administration to obtain experimental medications, ending a drawn-out battle over access to unapproved therapies. President Trump is expected to quickly sign the measure, which was praised by supporters as a lifeline for desperate patients but denounced by scores of medical and consumer groups as unnecessary and dangerous...
The FDA would be largely left out of the equation under the new legislation and would not oversee the right-to-try process. Drug manufacturers would have to report "adverse events" -- safety problems, including premature deaths -- only once a year. The agency also would be restricted in how it used such information when considering the experimental treatments for approval. Patients would be eligible for right-to-try if they had a "life-threatening illness" and had exhausted all available treatment options. The medication itself must have completed early-stage safety testing, called Phase 1 trials, and be in active development with the goal of FDA approval.
One Congressman opposing the bill argued that eliminating FDA oversight would "provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients," noting that the bill is opposed by over 100 patient advocacy and consumer groups.
The FDA would be largely left out of the equation under the new legislation and would not oversee the right-to-try process. Drug manufacturers would have to report "adverse events" -- safety problems, including premature deaths -- only once a year. The agency also would be restricted in how it used such information when considering the experimental treatments for approval. Patients would be eligible for right-to-try if they had a "life-threatening illness" and had exhausted all available treatment options. The medication itself must have completed early-stage safety testing, called Phase 1 trials, and be in active development with the goal of FDA approval.
One Congressman opposing the bill argued that eliminating FDA oversight would "provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients," noting that the bill is opposed by over 100 patient advocacy and consumer groups.
This is a topic I've thought about before and I see two sides to it.
On the one hand, a person who is going to die of fatal illness should be allowed to try something that might save their life. "Proven safe and effective" is a good standard for headache medicine, but if you're almost certain die without it, "20% chance it might work" is worth a try.
On the other hand, we don't want people peddling snake oil taking advantage of desperate people.
The criteria in this law, fatal illness, a treatment that has already completed phase 1 trial, and is actively moving through the FDA approval process, sounds like a reasonable compromise between two opposing interests.
It sounds like a great idea, give patients a last chance they'd otherwise lack, but according to the article:
The measure, championed by Sen. Ron Johnson, R-Wis., is designed to give patients an alternative way to obtain drugs not approved by the FDA. Currently, there are two options for patients seeking experimental medications: enrolling in clinical trials if they are eligible or participating in the FDA's "expanded access" program. The agency has said that it approves almost all such requests to that program.
and
Critics also note that drug companies, not the FDA, are the main obstacle to seriously ill patients getting unapproved drugs outside clinical trials. Manufacturers sometimes don't have large enough supplies to provide drugs outside trials or don't want to risk a safety problem involving a drug that has not yet passed FDA muster.
It doesn't sound like anyone is denied effective treatment in the current system (unless they end up control in a clinical trial) so I'm not sure what the new bill is going to do other than potentially open the doors to snake oil sellers.
I stole this Sig
If "right to try" is only available to patients who have *already* exhausted every other acknowledged treatment option that exists, I'm not sure how this concern would ever arise, in practice.
File under 'M' for 'Manic ranting'
Right now Elizabeth Holmes is reading this somewhere and thinking to herself, "I'm back!".
Laws are rules for the court, but merely a bottom bar to hit for life. Think beyond laws in your actions always.
Struggling to pass common sense laws about things the government should not be involved in is just a protracted way to further cement government power over everything in your life. The debate is always focused on a tangent. The goal which is always accomplished is for everyone to look to government to bless everything.
If you are dying what right does anyone else on this planet have to say about what treatments you can try? Ethically, no one.
I object to power without constructive purpose. --Spock
At least they would be hurting themselves and we can keep our nose out of it.
I object to power without constructive purpose. --Spock
You werent allowed to try before because the treatments are usually free or cost next to nothing.
I object to power without constructive purpose. --Spock
That's at the current limited level. Once the program becomes more widespread, the odds of litigation shoot up. The drug companies have pretty much come out and said explicitly that this is a main factor in their reluctance to participate in these programs.
My Other Computer Is A Data General Nova III.
It's really sad that these days people are shocked when a politician keeps their campaign promises. Maybe now people will pay more attention to what candidates say during elections.
If I'm terminally ill, why shouldn't I be allowed to try whatever experimental treatment options are available if all the other traditional ones have failed? Fuck this nanny state shit.
Here come the cancer curing bowel cleanses
if you or someone related to you were dying... would you want the government forbidding you trying something that might work?
Yes?
No?
A lot of things the government presumes to dictate are none of its business.
I've decided to stop wasting my time responding to AC trolls/sockpuppets... so if you want a response from me... login.
It always seemed wrong to prevent folks from trying expermental stuff in the end. As long as its approved by a doctor of good standing, there really only gain. Hope, learnings maybe extending life
> allow these experimental drugs to be administered, with limited liability so long as the drug has passed stage 1 approval and is seeking further trials, to patients with terminal illnesses that would otherwise die and for which no approved treatments exist... but that the drug companies offer these treatments for free to such patients as a part of their clinical trials.
> And this would completely eliminate snake oil and hope peddlers looking to turn a quick profit on unregulated medication.
That's certainly an interesting idea. A person wants to try something that might save their life. Drug companies want more data to know what dosage has what effects and side effects. Cool, just can't charge them for it, so that seems like it would largely eliminate snake oil salesmen.
> The expense of making drugs, after all, is constantly claimed to be about the regulatory hurdles.
Certainly the more regulation, the more expensive it is. (And hopefully safer). Also, the vast majority of new drugs never get approved. Something seems promising, so they spend $10 million on research and development, but it doesn't pan out. The pharmaceutical companies might go through that ten times before they hit on one that works well and has a large market. So while they spent $18 million directly on that medication, they spent $100 million to find the one that ends up being good.
You can try some random crap made up by a guy in a lab coat if you think it will help ... unless it's marijuana. You can't try that, it's far too dangerous for you.
Or LSD, that's also been defined to not ever be useful for medical treatment under any circumstances. It's so not useful for medical treatment that you can't even research whether it might be useful.
But on the plus side, it will provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients for profit!
I think the title stinks. It makes it sound like people using faith healers and snake oil. This is about a new drugs and treatments for people already dying. The drugs or therapies are past stage one testing and are intended to get FDA approval unlike fly by night snake oil. If your dying you should be able to take whatever the f*** you want. I think though that there should be regulations about how much can be charged for an unproven therapy.
EditorDavid needs to watch the classic cartoon, "How a Bill Becomes a Law", because he doesn't seem to understand the difference between the two.
Where do you think does it improve over the current practice:
https://www.fda.gov/NewsEvents...
Improvement over previous practice:
The FDA lacks compassion, of course.
You do not have the right to prevent me from finding a cure to my illness.
Get together with fifty of your friends to form a mob, and you still don't have the right to stop me.
Get together with ten thousand people and call the group a government, you still do not have the right to prevent me from trying to help myself.
Neither might nor numbers make right.
Contribute to civilization: ari.aynrand.org/donate
How many people would die if all drug companies stopped making drugs? Do you think that giving people a way to stay alive is morally wrong? Do you expect people who support human live to do so at a loss to themselves?
Contribute to civilization: ari.aynrand.org/donate
if you're almost certain die without it, "20% chance it might work" is worth a try.
The problem is that 20% chance is way too high. If you look at the number of drugs going through clinical trials, far fewer than 20% end up working in a full phase 3 trial, and even far fewer actually work well. I went to a pharmaceutical conference once and someone put up a slide listing 150 different drugs that had been in trials for lung cancer. All failed.
The reasons patient groups and the FDA opposed this bill are (1) there is already a method of getting very sick people into clinical trials, and (2) it just sells false hope to a lot of people. Unfortunately Republicans are very good at selling snake oil to the American people.
> The Federal Government is screwing the American population with their ever-increasing bureaucracy and it increasing demand for paperwork.
Perhaps so. We've added more new laws in the last 20 years than the entire 200 years before that.
> It took 6 months longer for the Feds to approve the rechargeable batteries than the actual hearing processor.
> What a Crock!
That sounds like a great example. Then you think about all the new technology and manufacturing processes and everything that went into the Boeing 787. What safety problem grounded the planes? The rechargeable batteries tended to spontaneously catch fire. This isn't a gentle, fairly cool fire like a wood fire either - it's so hot that the metal is on fire, burning. Tesla has a lot of cool tech. They've had two major safety problems - autopilot that isn't, and rechargeable batteries that spontaneously catch fire. You've probably seen reports of vape devices (e-cigs) exploding with burning metal in people's pockets. Because the rechargeable batteries caught fire.
I would dare say that putting newer, high energy-density rechargeable batteries in your ear is more dangerous than the audio processing done by the chip. It could very well be argued that's where regulators SHOULD have focused their concerns.
Most of the problems with this law would be corrected if you ban or severely limit profit off of it at all levels from clinic to manufacturer. Require that it be provided at cost of production, shipping, and administration of the therapy. Do not allow any fraction of R&D costs to be billed, and do not allow clinical profits that would cause clinics to push it.
Drug companies would still support it for the sake of their development process.
This will hurt people?
What about restricting people from taking life saving medication?
That's not going to hurt people?