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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
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
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.
> 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.