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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.
This kind of unethical medical experimentation used to be outsourced to 3rd world countries, but now lower-class America is the 3rd world country.
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
and so you bribe a few senators and congressmen, as is usually done in the just and honest America, and a law is passed. Tadaa!
Aperture Labs.
We do what we must because we can.
For the good of all of us.
(Except the ones who will die.)
But there's no use crying over every medical mistake.
Because the science gets done.
And we get a neat pill.
For the people who are still alive.
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.
This is inline with Americunt beliefs about radical individualism, and letting corporations use the most vulnerable specimens.
If the science gained by unethical experiments can be applied in civilized atheist nations, it's a worthy tradeoff.
Especially if it results in new drugs which can be made in India, ignoring Americunt (((patents))).
Only thing I'd like to see added is that there's not allowed to be any kind of cost to the patient.
This just sucks since this will hurt people. I know a lot of people upset by this, but when they voted for Trump why didn't they expect him to do what he said?
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
A phase one trial is only designed to show the drug causes no harm, so yeah, they could.
That's probably the trick. Get ineffective cancer drugs through phase 1, hit the brakes, and sell.
The good people of the Big Pharma lobby! First and foremost in their minds is their right to profit, it's pretty much that simple.
No. Phase 1 is safety and they can peddle inactive-yet-safe stuff all day.
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.
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.
My body, my right!
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
All this does is allow corp/doctor/hospital waivers on shit that has no merit.
There are experimental drug trials already.
I pity the fool(s) who fall into this "death" trap. Pun intended
I'm an adult.
Stop controlling my life and making choices for me, in the name of whatever - in this case, protecting me.
No, they also have to report side effects and complications arising from the treatment, as well as how the patient responds to the treatment.
But that's beside the point because even to get to a phase 1 trial, the drug company has to prove to the FDA that the treatment will potentially work as well or better than is what is currently available. They have provide some science for their claims, usually in the form of their research or animal testing. The only way a snake oil peddler would get past the pre-clinical trial process and onto completing a phase 1 round is if their data was completely fabricated. If that's the case, they'll be found out soon enough.
If you are going to die anyways, please help with a real study, that follows best practices around drug testing.
Single-person testing shouldn't be allowed, but groups of 20 patients or more should be allowed to fast-track something, even if 10 of the patients die like they were already going to die. Even if all 20 die, something would be learned.
I'd have a few more requirements for using this law.
* all studies and protocols must be documented and published in free journals
* no patents are allowed around the treatments.
* A panel of doctors and scientists should setup the base protocols for each study, from at least 20 unrelated companies/practices.
* If any organization is found to be profiteering, that organization will be banned, forever, from using this law.
* Doctors/nurses and practitioners failing to follow the study standards can lose their professional licenses.
They have to report side effects ONCE a year. I personally think that's too long. I'd prefer quarterly or every 6 months.
> 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.
I remember when this site was "News for Nerds". Now it's just "News for Nuts". Bye, bye.
But probably really bad for patients. But right in line with Trump's idea of how the works should work.
Most ACs are not even worth the keystrokes to insult them. Be generically insulted by this and ignored otherwise.
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!
Those are some quite specific numbers, particularly for someone describing their lack of education. Sources, please?
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.
"By this act, I bring a death into the world." Spoken in a sci-fi short story in Analog, or Asimov's, decades ago; female author, about female protagonist giving birth.
Each and every one of us has a death sentence. So, we're all facing "life-threatening illness"...
Dying patients and small clinics are not the issue.
Why would any company complete phase II trials if they can sell under this exception? Particularly if, or since, the reporting of adverse effects is so weak? They can make nominal efforts, and sell a bad drug killing people for years with no one knowing: who will do the forensics to determine that the patient died from the drug and not the fatal disease?
This essentially destroys the FDA's power over the drug companies. Every submission, every request for more information or more studies can now be met with a big "so what?" since they can just sell in this official back channel.
I would predict a huge expansion in the exception, e.g., to include accompanying treatments (anti-nausea for your chemo?), etc.
This is a windfall for the drug companies: free to sell, and free to hide bad news.
The drumbeat of Iran and North Korea hide the screams of rape as consumers and patients lose any protections they had against the corporate predators.
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.
Your implied claim does not apply. There are already laws against fraud, and against various forms of homicide.
Your implied claim does not apply either.
Those laws are too weak and full of loopholes when it comes to snake-oil salesman. The problem is in the proving - proving that the snake-oil was an intentional fraud is now harder under these new laws. Proving that someone died because of the snake-oil rather than because of their already known to be terminal disease is really hard. Especially when the person's estate is now broke because they gave all their money to the snake-oil salesman so you have to convince some lawyer to not only take the case on spec, but also find a pathologist to evaluate the corpse to find the cause of death on spec. The chances of that happening are infitesimal. The real world is not a libertarian utopia.
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.
It is sad that so many Americans are either so filled with anti-Trump hatred, or so poorly educated that they are reacting against it.
The idea that the individual has a God-given right to try medical procedures and/or medications to try to stay alive (provided they do not involve harming somebody else) is so completely aligned with the view of the nation's founders that there should be no controversy here. The Constitution specifically gives the feds authority over a andful of things (NONE of them medical) and then specifically and explicitly says everything else is left to the states and the people themselves.
Over the decades, the federal government has written law upon law and thousands of regulations on everything under the sleazy guise that anything affecting interstate commerce in any way is the purvue of congress and thus they have written a virtual mountain of laws and rules governing American medical care. If there was even ONE truly conservative judge in the country, this stuff would've been rules unconstitutional decades ago. Sadly, many current Americans have been so mentally pickled by our bloated-to-unconstitutional-scope federal government that they would allow that government to tell them that they must passively sit there and die rather than try some experimental drug.
That a Republican congress would write a new law allowing the American people to do something the founders would have thought common sense and that Trump would sign that law into effect should be a no-brainer. In an era where even half of the GOP are "never Trumpers" and dishonestly campaign as conservatives while never doing anything conservative and sharing a Democrat vision of total government control over the individual, it's rather breathtaking to see the outsider Trump shake things up this much.
> 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.
After reading some of that I don't think accusing other people of being uneducated is something you should do anymore.
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.