U.S. Passes 'Right to Try' Law Allowing Experimental Medical Treatments (chicagotribune.com) 169
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.
Interesting balance (Score:5, Insightful)
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.
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Where do you think does it improve over the current practice:
https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm
Improvement over previous practice (Score:2)
Where do you think does it improve over the current practice:
https://www.fda.gov/NewsEvents... [fda.gov]
Improvement over previous practice:
The FDA lacks compassion, of course.
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The FDA has approved 99% of requests so...
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... so there's only 1% more to go.
Plus the ones that people didn't bother to make, because they either didn't know how to make the request, or they figured they'd end up in the 1%, or they figured it would take too long to be selected to be one of the 99%, or they figured the 1% was actually a larger number. Or whatever.
Re:Interesting balance (Score:5, Insightful)
You have to be careful with laws. What it claims to do and what it actually does are not always the same thing. There's very little oversight in the law as written. There are also no safeguards against clinics who might use it as a legal justification to sell patients ineffective drugs at 'you'll die without it' prices.
I think the problem is that the bill was not motivated by acting in the interests of patients, but by people following the ideological position that all regulation is wrong and the government needs to just step aside and let industry solve all our problems.
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What kind of arsehole thinks the state never get the job done right? Are you even aware of who developed penicillin? The state, you fucking idiot.
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There is no reason why penicillin couldn't have been invented by privately funded research.
But privately funded research did not, in fact, develop penicillin. And the development of penicillin was one of the greatest scientific achievements of all time and required organisation on a scale only feasible by government.
I'd have a lot more respect for you if you lived your principles the way a vegan does and forswore all use of products and services where the meddling state has had a hand. As a bonus, you'd be dead very soon, which would please everyone bar your mum. And maybe her too.
Re:Interesting balance (Score:5, Insightful)
You have to be careful with laws.
Exactly. This really doesn't change anything as far as access to such treatment is concerned, as major drug manufacturers do not have to provide medicines and insurance companies do not have to pay for non-FDA approved treatments; especially since, per TFA, the FDA approves almost all expanded access requests. A legitimate drug company has a number of reasons to not let early stage drugs out into the market willy nilly, the least of which is teh potential for lawsuits if it tuns out they are prove to be unsafe. It does however, allow shady operators to function with minimum oversight and limits the FDA's ability to oversee or use results when determining if a drug is safe and effective. Legitimate companies I can see the real beneficiaries as shady operators who take advantage of desperate people with the money to pay for expensive and unproven treatments.
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Right to work - delegitimize unions
Patriot Act - Unconstitutional spying and removal of citizen rights
Citizens United - legal bribery, constituents no longer represented
Defense of marriage act - restrict marriage to same sex only
Internet Freedom Act - attempted to repeal net neutrality
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Citizen's United is a court case, not legislation. Its named after the organization who sued (Citizen's United vs the United States was the court case)
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noun. laws, considered collectively
synonyms: law(s), body of laws, rules, rulings, regulations, acts, bills, statutes, enactments, ordinances "pushing for stronger gun legislation" So rulings would be reasonably covered as a synonym.
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Court cases are not, and never have been, considered legislation. Legislation comes from a legislative body, for example Congress. Legislation does not and in the US cannot come from the courts. Especially in the case of this point, putting Citizen's United in the list of actual legislation and complaining about legislation having opposite names is facetious at best, as the name of a court case is not the name of legislation, and is fixed by convention to be the name of the two parties.
In addition, a syn
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Patriot Act - Unconstitutional spying and removal of citizen rights
Yep, that one's all backward.
Right to work - delegitimize unions
You have the right to work for an employer on your own terms, even if the union doesn't want you to do so.
Defense of marriage act - restrict marriage to same sex only
Defended the existing, long-standing concept of marriage from being altered.
Internet Freedom Act - attempted to repeal net neutrality
People are free to do as they like with their own networks.
Citizens United - legal bribery, constituents no longer represented
Citizens united for a purpose have the same right to use political ads that they have when they're not united (also
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People are free to do as they like with their own networks.
Except build them out in the first place. Though U.S. law bans cities from awarding cable franchises that are de jure exclusive, cities can still make them de facto exclusive by imposing a buildout timeframe on all new franchises that is prohibitively rapid for a small company.
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Except build them out in the first place. Though U.S. law...
Absolutely. Don't get me started, you'll never hear the end of it.
My only point was that if a law eliminates some regulations in industry X, then it's not oxymoronic or arcane for its supporters to call it "The X Freedom Act".
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No?
Must be bad. The crystal ball of ideology must have gotten left out of the process!
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That's lovely for you. Interestingly, quite a lot of the rest of us are keener on the idea of not dying while trying to find out whether a particular manufacturer has scammed us on the safety of their products, and are happy for the government to regulate to make this happen. In fact, so many of us think this way that not a single place exists on the entire planet that functions according to your Ayn Rand wank-fest description.
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Jesus, this is so confused it's difficult to know where to start. Let's just pick up on two points:
1. It is literally impossible for a layperson to "think" their way into knowing whether a medicine is safe and effective. You cannot even be sure that the pill in front of you is the pill it purports to be, much less know whether statistical power was reached during the trials, whether the I/E criteria were appropriate, whether that particular batch was manufactured in accordance with GMP guidance on stability
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Business doesn't exist in the absence of contract, contract doesn't exist in the absence of something to enforce that contract. The reason you can have a scalable system of 1000s of futures contracts on tons and tons of wheat is that you know someone is that the rules are enforced by a central body who has a police force and an army to back up their promises. In the end that is the essence pf what government is, it's the collectives way of stopping individuals "cheating" and gaining an advantage by failing
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Why do the drug companies get to charge for these experimental treatments at all?
Seems to me the best 'compromise' would be to 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.
The expense o
That's a very interesting idea. Might be good (Score:3)
> 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 ce
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Clinical trials just don't work like that.They have complex inclusion / exclusion criteria, need to achieve statistical power, have strict conditions for adherence, must be overseen by a PI, etc. They can't just randomly recruit various desperate patients in an uncontrolled way.
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Those criteria already existed and patients with fatal diseases already had the right to risky medication. It was passed after the events that inspired the "Dallas Buyers Club". But the FDA was still involved, using the early results of testing to help the doctor come up with a treatment plan. Oh, and 0.1% of the time, they rejected an experiment because it wasn't going to work (More often than that, they worked with the doctors on improving the dosage or other parts of the prescription plan).
All this do
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I'm not talking about drug trials. I'm talking about taking taking experimental medication for curative purposes. Oh, and that's not the FDA. This is about FDA oversight.
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On the other hand, we don't want people peddling snake oil taking advantage of desperate people.
This loophole is easily closed by a "You're not allowed to charge for this" clause.
Companies that are legitimately trying to find cures and want to test on humans get to test on humans. Humans that have no other option and will die anyway get to play the cure-lottery. Win-win all round.
Re: Interesting balance (Score:2)
I personally think that people should have the right to do as they see fit when it comes to their own body as long as they don't harm or burden others in the process.
I do think good governance is necessary when it comes to advertising a drug though. So people shouldn't be claiming untested drugs have any quality or benefit. As long as people can operate with all the available facts, I think freedom is paramount to protection.
Your fallacy is selling false hope. (Score:2)
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 (
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It's easy to maintain the balance... FORCE the balance.
Eliminate the charge for services to those who effectively become human guinea pigs.
The corporates benefit from human trials for which they aren't held accountable more than a minimum level.
The patients benefit from free treatment.
However this will not occur and I think, in practice, this will just become a new way to fleece desperate people out of everything they own for a solution which is most likely going to kill them and there will be no balance.
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Tesla, 787, e-cig (vape) exploding in pockets (Score:2)
> 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
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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.
So what is the problem they're trying to solve? (Score:3, Insightful)
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.
Re:So what is the problem they're trying to solve? (Score:4, Informative)
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.
The bill protects doctors and pharmaceutical companies from liability for giving experimental treatments to terminally ill patients, which is one of the reasons drug companies don't want to give these out. Drug company liability has gone bonkers in the last few years - people are suing because chemotherapy drugs are causing their hair to fall out, and blood thinners are causing them to bleed more easily. It's insane.
As long as the doctors and patients are fully informed that the drug is experimental I don't see a problem with this.
Re:So what is the problem they're trying to solve? (Score:4, Informative)
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.
The bill protects doctors and pharmaceutical companies from liability for giving experimental treatments to terminally ill patients, which is one of the reasons drug companies don't want to give these out. Drug company liability has gone bonkers in the last few years - people are suing because chemotherapy drugs are causing their hair to fall out, and blood thinners are causing them to bleed more easily. It's insane.
As long as the doctors and patients are fully informed that the drug is experimental I don't see a problem with this.
Doesn't sound like that's a problem [nejm.org]:
Finally, expanded-access programs could bring liability exposure. Litigation in this arena, however, has been limited to obtaining access rather than seeking redress of treatment-related harm. The lack of adverse-event lawsuits may reflect the willingness of such patients to assume risks as well as the adequacy of existing regulatory and manufacturer safeguards.
Limitation (Score:2)
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.
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Will the drug companies be liable for the use of their drug off label? The answer has been yes and that is why they do not want to do this.
Will their be data gathered by these uses? If not, that is another reason for the drug companies not to do it.
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As far as I can tell, the main goal is to pass a law called "The Right to Try", so people misinterpret the previous state of the world and they get credit for the existing right to try benefits.
A side benefit is that doctors making life-altering decisions on experimental medicine are denied the benefits of knowing the current results independent testing in progress, making accidents more likely and doctors more dependent on big pharma. Sorry, I meant to write "decrease job killing regulation"
People (espec
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The FDA is one of the toughest regulatory agencies in the world for getting a treatment approved. Thalidomide [northwestern.edu] was kept out of the U.S. by the FDA, while it was approved in Europe. While that was a huge FDA success, the long-term effect has been that the FDA tends to err far on the side of caution (you cannot have a critical failure like Thalidomide if you don't approve anything).
The problem is that there are two failure mo
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The FDA is one of the toughest regulatory agencies in the world for getting a treatment approved.
I don't think that's relevant because we're not talking about approved treatments, this is about unapproved experimental treatments.
And the FDA already has a system for allowing critically ill patients to access unapproved treatments. To the extent that people still can't access these treatments it's the Drug Companies, not the FDA, who are the problem.
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I don't think that's relevant because we're not talking about approved treatments, this is about unapproved experimental treatments.
If a treatment has been approved in one or more major markets in Europe but not yet in the United States, should it be described as "approved" or "unapproved" in discussions like this?
Not really, no... (Score:2)
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.
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How can quacks exploit the pub
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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.
Remember Fen Phen and Redux? There always be people willing to peddle miracles to the gullible if enough money is to be made. As for "exhausted every other acknowledged treatment option" I would imagine that is vague enough to drive a truckload of pills through; for example is chemo an "acknowledged treatment option" if the doctor says you have 6 months and chemo wold normally take a year?
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Sure... as long as the doctor who gave the timeline is is not the same one who has recommended the unapproved option (ie, it cannot be part of any initial opinion), and such a recommendation only done so *after* all other methods have been exhuasted, and the person is always free to seek medical advice or opinions from alternative sources before making a decision, and is further free to rejec
Holmes (Score:2)
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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.
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What about restricting people from taking life saving medication?
That's not going to hurt people?
Comment removed (Score:5, Insightful)
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Your implied claim does not apply. There are already laws against fraud, and against various forms of homicide.
You may have a duty to try, but you do not have either the duty or the right to act against me to prevent me fro
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My Body My Choice (Score:1)
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.
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There will always be vultures hanging around peddling impotent miracles to desperate people. The original intent of the law was to address that problem. There was (and still is) a real need for it to protect the desperate from exploitation by the unscrupulous.
But the law as it was written, like so many others before it, was overfly-broad.
This new legislation just seeks a better balance.
get ur crap here (Score:2)
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This is the same government that had shovel ready solutions like protected turtle road crossings, Solyndra, and studies on why lesbians are more likely to be overweight.
empathize with yourself and your family (Score:4, Insightful)
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.
Re:empathize with yourself and your family (Score:5, Informative)
The governement was already not forbidding you. They were forcing your doctor to consult with the scientists running studies to make sure you were getting the best dose. Oh, and 0.1% of the time they said "those studies are going really bad, it's not an option.
And yes, I want the government from forbidding me from getting desperate and having snake oil salesman make a bunch of pitches that won't work and I don't understand. (Again, 99.9% of the time they let the experimental treatment happen, withing 24 hours if you say its time critical.) I'm not educated enough about medicine, nor will I be thinking clearly enough.
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The governement was already not forbidding you. They were forcing your doctor to consult with the scientists running studies to make sure you were getting the best dose.
Currently US doctors cannot legally discuss or prescribe non-FDA approved drugs, such as Domperidone [wikipedia.org], which is legally available in 58 other countries, in some cases over-the-counter. (It is true that recently there was an FDA Investigational New Drug application for Domperidone, but good luck getting your doctor to properly interface with
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Given that the doctors were generally not allowed to do it by their hospitals due to regulations/liability, or were equally problematically subject to having their medical licenses pulled which is all an aspect of state authority... you're wrong.
As to what you want for yourself... you appreciate you don't speak for everyone I assume? And given that, your personal opinion... is just that.
This prohibition stuff has been a long running confession by millions as to their truly absurd hubris.
You're not banning a
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The governement was already not forbidding you. They were forcing your doctor to consult with the scientists running studies to make sure you were getting the best dose. Oh, and 0.1% of the time they said "those studies are going really bad, it's not an option.
Not true in the least. A friend of mine's grandfather was part of the phase one trials for using interferon for treating bladder cancer. That option was unavailable in the US, interferon was also reserved for AIDS patients and cases of critical immune deficiency. This was when he was living in the US, the various companies wanting to do this trial were outright refused certification. On the other hand, it was allowed in Canada. He got the treatment in Canada, he spent another ~25 years quite alive until
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You say I'm over simplifying and then say "if you want to inject some random cocktail".
Did I suggest a random cocktail?
At BEST you're over simplifying me and thus are a hypocrite.
However, that is over generous in my estimation... I think you're just strawmanning here.
Kindly don't open your comments to me with an attack on my integrity if you're going to show a greater lapse yourself immediately. Doing this just makes you look absurd and it makes it almost impossible for me to take you seriously.
Doubtless yo
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What is was is self evident and your first sentence doubled down on the same thing.
This conversation was over the instant you rendered yourself ridiculous. Kindly take your failure elsewhere as it is stinking up the place.
I said GOOD DAY, sir.
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Having no integrity whilst casting out retarded insults is not strong rhetoric.
Your argument is that because people that are not trained in medicine can do something people seeking experimental treatment should be happy receiving such treatment from people with no experience in medicine.
Naturally what the FDA considers valid treatment does not encompass the entirety of what medicine as a science considers valid treatment. And of course if one were to obtain treatment that the FDA didn't approve your best re
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If you ignore my argument, you are not rebutting my argument.
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in so far as I can tell you're all the same twit. And no, you didn't rebut me in the post where you strawmanned my position.
You started out by saying my argument was other than what it obviously was and then you took down this fictional argument that I never made.
That is what a strawman is... its invalid.
I said, GOOD DAY, sir.
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You can pretend to be 20 people all day. All I see is "AC". Listening to some guy try to elevate his position by pretending to be other people is not going to work.
As to not understanding what a strawman is, I don' think you understand what a strawman is... here is a link to explain it to you:
https://en.wikipedia.org/wiki/... [wikipedia.org]
""A straw man is a common form of argument and is an informal fallacy based on giving the impression of refuting an opponent's argument, while actually refuting an argument that was not
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You're not applying strawman correctly here, and just as before you keep going back to slinging insults and claiming that the other person is attacking you. What do you perceive yourself to have to gain by continuing with this path? You're only demonstrating that you are not interested in having a discussion on the matter. It's unfortunate that you took offense at the original AC comment when there was absolutely no evidence whatsoever that it was intended as any kind of personal attack on you.
It seems
FDA the implicit Serial Killer (Score:1)
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
Good for business (Score:1)
But probably really bad for patients. But right in line with Trump's idea of how the works should work.
Except for marijuana. (Score:4, Insightful)
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.
Conversely... (Score:1)
Their Body (Score:2)
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.
How a Bill Becomes a Law (Score:2)
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.
ok, if we ban profit (Score:2)
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.
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There's a reason there's no pharmeceutical innovation happens in Europe.
If you don't want to work for free, I'm not sure why you should dictate to others that they should work for free.
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Then you said, "Just from the development process" in your second post.
I'm not sure anyone is currently making money during the development process of drugs. Are the employees spending money on the drugs they are researching and designing? If you could identify a business model there, the world would beat a path to your door I think.
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This article was about allowing the sale of drugs that are in early stage development. They've only passed phase 1 trials which leaves them typically years from release and profit. Phase 1 is a level that says it won't immediately kill most people. The drugs efficacy and proper dosage have not been determined as well as safety across larger numbers of people.
My usage of "all levels" was referring to all levels of the distribution path from manufacturer to clinic - not to all levels of development. I was bas
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Thanks for clarifying.