from the lame-shall-walk-and-blind-shall-see dept.
Trump signs 'right to try' drug bill
President Trump signed a bill Wednesday allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration (FDA). Dubbed "right to try," the law's passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans.
"Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time," Trump said at a bill signing ceremony at the White House, surrounded by terminally ill patients and their families.
Trump thanked lawmakers sitting in the audience who sponsored the bill, including Sen. Joe Donnelly, a vulnerable Democrat up for reelection in Indiana.
Also at CNN.
Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Texas Sanctions FDA-Unapproved Stem Cell Therapies
Drug Approvals Sped Up in 2017
Also submitted by mrpg
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President Trump will likely nominate Dr. Scott Gottlieb as head of the FDA. Though he is presently a resident fellow at the conservative American Enterprise Institute and a partner at a large venture capital fund, he used to be an FDA deputy commissioner known for advocating dramatic reforms in the process to approve new medical products.
According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials. Other potential reforms include the possible quick adoption of new devices that could be used to improve the kind of medtech Apple, Verily and others have been working on.
Gottlieb is viewed very favorably within the pharmaceutical industry as a regulatory reformer but not destroyer. If nominated, he will have been chosen over another high-profile name on the short list: Jim O'Neill.
The close associate of Peter Thiel, O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works. That left many fearing that Trump intended to toss out the regulatory framework for new drug approvals, raising fears that his idea of competition would allow de facto placebos to compete for market share.
Texas has approved a "right-to-try" law that will allow patients access to experimental treatments as a last resort, but without FDA oversight:
Texas Governor Greg Abbott yesterday signed a bill allowing clinics and companies in the state to offer people unproven stem cell interventions without the testing and approval required under federal law. Like the "right to try" laws that have sprung up in more than 30 states, the measure is meant to give desperately ill patients access to experimental treatments without oversight from the U.S. Food and Drug Administration (FDA).
In a state where unproven stem cell therapies are already offered widely with little legal backlash, bioethicists and patient advocates wonder whether the state's official blessing will maintain the status quo, tighten certain protections for patients, or simply embolden clinics already profiting from potentially risky therapies.
"You could make the argument that—if [the new law] was vigorously enforced—it's going to put some constraints in place," says Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, who last year co-authored a study documenting U.S. stem cell clinics [DOI: 10.1016/j.stem.2016.06.007] [DX] marketing directly to consumers online, 71 of which were based in Texas. But "it would really be surprising if anybody in Texas is going to wander around the state making sure that businesses are complying with these standards," he adds. Either way, Turner says there's "powerful symbolic value" in "setting up this conflict between state law and federal law."
But are the rights of stem cells being protected?
New drug approvals hit 21-year high in 2017
U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light -- more than double the previous year -- while the figure also rose in the European Union.
The EU recommended 92 new drugs including generics, up from 81, and China laid out plans to speed up approvals in what is now the world's second biggest market behind the United States.
Yet the world's biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies. Consultancy Deloitte said last month that projected returns at 12 of the world's top drugmakers were at an eight-year low of only 3.2 percent.
Many of the drugs receiving a green light in 2017 were for rare diseases and sub-types of cancer, which often target very small populations, although they can cost hundreds of thousands of dollars. Significantly, the U.S. drug tally of 46 does not include the first of a new wave of cell and gene therapies from Novartis, Gilead Sciences and Spark Therapeutics that were approved in 2017 under a separate category.
Food and Drug Administration Commissioner Scott Gottlieb has indicated that it might be time to revise the Orphan Drug Act of 1983.
(Score: 3, Informative) by Anonymous Coward on Friday June 01 2018, @02:31AM (3 children)
Your current Lord has thrown you a crumb.
(Score: 1, Flamebait) by SpockLogic on Friday June 01 2018, @03:00AM (1 child)
I'm OK with the right to try as long as it's the right to try the orange shitgibbon for high crimes and misdemeanors.
Overreacting is one thing, sticking your head up your ass hoping the problem goes away is another - edIII
(Score: 2) by SanityCheck on Friday June 01 2018, @02:13PM
Stop it man, you are putting Americans working in the table-salt industry out of work!
(Score: 0) by Anonymous Coward on Friday June 01 2018, @05:45PM
uhh, real americans don't go to doctors.
(Score: 4, Informative) by Gaaark on Friday June 01 2018, @02:34AM (27 children)
Makes sense: if your going to die by not trying, then trying can't really hurt you. Even if it causes you pain, you can just kill yourself.
End result is you die or you live.
As it stood before, you were both dead AND alive.
--- Please remind me if I haven't been civil to you: I'm channeling MDC. ---Gaaark 2.0 ---
(Score: 0) by Anonymous Coward on Friday June 01 2018, @02:41AM (17 children)
While ibprefer the right to try for myself, there is a real concern that some resesrcher will push experimental treatments that are statistically against the patients best interests.
(Score: 4, Interesting) by Runaway1956 on Friday June 01 2018, @02:48AM (13 children)
Informed consent. The doctor, researcher, or village quack who withholds critical information can be put on trial for fraud. All this bill seems to do, is to give the patient the right to decide.
(Score: 0) by Anonymous Coward on Friday June 01 2018, @02:51AM (9 children)
Definitely nothing that can go wrong with a patient that thinks there is no hope, being handed a 276 page tome in 7pt font all caps and told: "sign here in the next 5 minutes or you no longer qualify to be trying this thing; this is your informed consent form"
Definitely nothing that can go wrong there... no sir-ee...
Aren't you the same guy who keeps railing about people who get fsck'ed over by farcebook after not reading the TOS and how it's all their own fault?
(Score: 4, Informative) by qzm on Friday June 01 2018, @02:54AM (2 children)
So, you would rather the national legal system blocked the Terminal patients right to decide?
You are certain that a single one-law-fits-all solution 'is in the best interestes of the individual'?
Interesting...
Of course this is more likely a 'The Chinese are steamrollering us on medical research, so we need to loosen things up a bit' Bill, but hey.
(Score: 2, Insightful) by Anonymous Coward on Friday June 01 2018, @03:08AM (1 child)
I wouldn't like a system where the law blocks a patient's right to decide as such. I would like to see more safeguards built in for abuses that have been committed in the past in schemes that are similar to this and for which we have good historical data that they will happen again.
Those safeguards were not in place before this bill was signed (this isn't about D vs R), but more crucially they also are not introduced with this bill which opens up the possibilities and -dare I say- probabilities of those abuses.
This bill just opens the door to the west going: "Hey you guys, just go and grab some land over there and feel free to shoot anyone that stands in your way"
There for sure are beneficiaries of this bill, terminal patients aren't it. They will be used as cheap lab-rats without any form of protection because "they signed this X hundred pages of legalese that now shows they gave /informed/ consent". It's that "being used as cheap lab-rats" that I am very, very worried about...
(Score: 0) by Anonymous Coward on Friday June 01 2018, @05:51AM
I remember about 20 years ago people were pushing hard for something like this. I guess people can push to take it away. Whatever.
Sucks to have a long memory
(Score: 2, Troll) by Runaway1956 on Friday June 01 2018, @02:58AM (3 children)
You haven't described "informed consent" - you have however described coercion and probably fraud. Which part of "informed consent" are you having problems with? The typical terminal illness takes months or years to run it's course. There is time to research, if one wishes to research.
(Score: 1, Informative) by Anonymous Coward on Friday June 01 2018, @03:20AM (2 children)
When was the last time you read the little piece of paper that comes with your meds (and unfolds to something the size of your mattress)? When was the last time you actually read the piece of paper you get when you go to a doctor in the US that says you consent to treatment? When was the last time you read FB's TOS?
You're muddying the water suggesting that I do not understand 'informed consent' but that's not the point here... Farcebook users also give 'informed consent' but that means jack crap in practice. And it's this "in practice" that we need to protect against. Sure, they can check the boxes and be 'within the law' but that still doesn't make the behavior ethical.
We have a multitude of past behaviors where these types of schemes that involve 'informed consent' have been exploited by those in the power position and there is no protection against that in this bill.
I could be testing cyanide pills on people and bury the fact that there is a 99.9% mortality rate with partaking in the experiment, deep, deep in the informed consent document and I would literally get away with murder in this case... and you would be there going "yeah, this person should go scott-free" because the people gave 'informed consent'.
What's so wrong with the current state of affairs? Why do we need more bodies (literally and figuratively) earlier and earlier in this process of drug approvals? Let me tell you: because it's expensive to do so and it bloody well should be. These are things where I want people to dot the i's and cross the t's. It is cost for drug manufacturers that is driving this, not 'helping the terminally ill' or providing them with hope... they want to lower that cost with cheap lab-rats.
(Score: 3, Insightful) by jmorris on Friday June 01 2018, @04:23AM
When they prescribe something for the first time. Don't you RTFM? Some of those drugs can KILL YOU if you don't read and pay heed to those warnings. Are you a fricking End User or something? You are what is wrong with America! You want somebody to do your thinking and deciding for you. Freedom is too much responsibility.
Never, no FB account. But I know a TOS or EULA ain't worth squat legally so I don't really bother with them generally. Tech companies are going to screw you regardless of what they say anyway, any information you give them will be used against you and you have zero recourse unless you have a few hundred thousand dollars lying around without a better use than a likely pointless legal exercise.
But yeah, I support this bill. It takes a minimum of a decade to get a drug through the FDA's normal path. Everybody obsesses over people who die from a drug that doesn't work because they can see those dead bodies, see they died as a result of a bad drug, people can be sued, lose their jobs over it, etc. The FDA does likewise, taking a nobody will get fired for ordering another round of clinical trials just to be extra sure stance. But everybody is forgetting the unseen piles of bodies, those who died waiting. Take the next big drug approval, listen to them talk about how many lives per year it will save. Now consider that for every year that could have been saved in the approval process that many people could have been saved, that many people died waiting.
Yes, many drugs fail in testing, some in really splashy and embarrassing ways that can end the pharma company responsible for the failure. So yes we do need an approval process, we need testing, we need to make sure stuff really works before going from the lab to widescale production. We also need to keep the people who are dying from these diseases in mind as well. Especially when we are talking about terminal conditions with no current treatment. It isn't the end of the world if the next big wiener pill gets delayed, but cancer kills people. F*ck cancer.
(Score: 2) by Runaway1956 on Friday June 01 2018, @03:02PM
The first line of Jmorris' reply is apt here. I read medical brochures, the warnings, etc. I read them sometimes before I became a parent. When my little boys were due for inoculations, I started reading those things diligently. I was involved, and felt that I really needed to be informed. That has carried over into my more mature years. Doc wants to give me oxycodone? I've read that a few times - and I've turned it down a couple times. "Hell, Doc, I'm not really hurting. I'll just get some aspirin, or tylenol, or something." I've still got a bottle of etodolac, I guess it's a generic for Lodine. Shit makes me sick, so I didn't take them. Of course, the warnings actually warned about that. Take 'em on a full stomach, or suffer the consequences. Problem was, soon after I took the pill, I had an empty stomach again. I read.
I understand what you are saying about sneaky "contracts", but we also have a judiciary system that has ruled against those iron clad contracts sometimes.
Granted, this isn't the best of times in America's history to challenge unjust contracts, but it has happened, and it will happen again. You've noticed all the activists, up in arms against Farcebook, and others? The pendulum swings in both directions, and Trump isn't going to stop is swinging. Slow it down a little, if he really tries, but he ain't stopping it.
(Score: 1, Funny) by Anonymous Coward on Friday June 01 2018, @03:01AM (1 child)
I suspect that you may be an ancient Greek alchemist or some such. Today we have "volumes", rather than tomes.
(Score: 1, Funny) by Anonymous Coward on Friday June 01 2018, @03:24AM
I'm chiseling as fast as I can on this tablet...
(Score: 0) by Anonymous Coward on Friday June 01 2018, @03:29AM (2 children)
I find your signature concerning. Have you considered talking to a professional about this virtue signaling of yours?
(Score: 0) by Anonymous Coward on Friday June 01 2018, @04:30AM
(psst! The wimangry pills did not work. Ascii art of firearms is all that is left of his manhood. Have some mercy!)
(Score: 2) by Runaway1956 on Friday June 01 2018, @03:08PM
Your concern is a "good thing". Stay concerned. And, no, I won't be talking to any "professionals", thank you very much. Maybe you will feel better with a nice, new, comfy T-shirt https://www.gruntstyle.com/products/i-am-the-weapon [gruntstyle.com]
(Score: 1) by Ethanol-fueled on Friday June 01 2018, @02:49AM (1 child)
You You die when you die. [youtube.com]
(Score: 1, Insightful) by Anonymous Coward on Friday June 01 2018, @03:17AM
People die the same as they lived. Some die stupid.
(Score: 2) by arslan on Friday June 01 2018, @04:04AM
You must be new to the whole drug/experimental treatment industry. New researchers that push experimental treatments in first countries like the U.S. are numb nuts.
Everyone knows the best way is to go to a 3rd world country where the laws are laxed and/or the law enforcers are easily bribed, sell your drug/experiment like its a privilege and see the rote learning middle class folks pay exorbitant amounts to get their hands on them drugs/treatments. Marketing slogans like "Latest treatment from the U.S. used by celebrities" seems to always do the trick.
(Score: 1, Informative) by Anonymous Coward on Friday June 01 2018, @02:45AM (3 children)
> Even if it causes you pain, you can just kill yourself.
Can you though? I'm pretty sure that Republicans are against euthanasia, and consider even bringing it up as something that needs to be illegal. Remember "death panels"?
(Score: 0) by Anonymous Coward on Friday June 01 2018, @02:58AM
I am pretty sure the spyocrats hold england up as an example of that not happening. http://observer.com/2017/05/chris-gard-connie-yates-baby-charlie-mitochondrial-depletion-syndrome/ [observer.com]
(Score: 2, Troll) by realDonaldTrump on Friday June 01 2018, @03:05AM (1 child)
When there's just you it's not a panel, it's an individual choice. MAGA!
(Score: 0) by Anonymous Coward on Friday June 01 2018, @10:38AM
It'll have to be you shooting yourself in the head with a gun you hid behind your hospital pillow, because a doctor mentioning or discussing that option *was* the entire "death panel". Try again, dipshit.
(Score: 0) by Anonymous Coward on Friday June 01 2018, @02:31PM (1 child)
"End result is you die or you live."
Or you continue to live, still completely afflicted by whatever was slowly killing you, but now your jaw bone has died from the poisons that were injected into you so you can live the remaining years complaining online about your inability to whine in RL.
(Score: 2) by Gaaark on Friday June 01 2018, @02:51PM
and then you die.
--- Please remind me if I haven't been civil to you: I'm channeling MDC. ---Gaaark 2.0 ---
(Score: 3, Insightful) by All Your Lawn Are Belong To Us on Friday June 01 2018, @03:02PM (2 children)
I do not agree. One can do a LOT more harm by trying something that is wrong than doing nothing. Which is why we have an FDA in the first place. Even then there were rules for making exceptions that were very liberally granted, and those rules were tweaked in the last five years to minimize the time required of a physician to get an exception.
"But they're terminal!"
Yep. And you can make the suffering of a terminal person worse than what it would have been. You can also give false hope, which is what Trump was blathering on about.
This sig for rent.
(Score: 0) by Anonymous Coward on Friday June 01 2018, @05:49PM (1 child)
authoritarian scum.
(Score: 0) by Anonymous Coward on Friday June 01 2018, @08:04PM
clueless idiot
(Score: 3, Insightful) by takyon on Friday June 01 2018, @03:10AM (1 child)
Will the patient be allowed to try LSD, shrooms, peyote, MDMA, etc. on their death bed? Or at any other point? No? Fuck it.
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 0) by Anonymous Coward on Friday June 01 2018, @03:27AM
If they try any of these, DEA will make sure that wherever they were when trying it, that this place turns into that individual's deathbed...so there's that.
(Score: 0) by Anonymous Coward on Friday June 01 2018, @04:34AM
Next thing, you only have to dilute your "right to try" through several dilutions, and it will become even more powerful through wishful thinking! Ben Carson's friend has approved this! Republicans, more of them dead from quack medicine? How is this not a good thing for the Country? Even the World! Cannibus Oil, anyone? Electric Universe? Dinesh D'Souza Miracle Pardon Cure? Anybody? Bueller?
(Score: 5, Informative) by pTamok on Friday June 01 2018, @07:48AM
On the 'Respectful Insolence' blog.
The cruel sham that is federal right-to-try has passed. Let patients beware! [respectfulinsolence.com]
While 'right to try' sounds great, in reality it allows charlatans to prey on the ignorant by offering treatments with no evidence base at high prices to people desperate enough to grasp at the false hope offered. I cannot find words enough to convey my disgust at the immorality of people who prey on the innocent in such a way.