Trump signs 'Right to Try Act' aimed at helping terminally ill patients seek drug treatments

[DonViejo]

Source: CNN




By Allie Malloy, CNN

Updated 1:18 PM ET, Wed May 30, 2018

Washington (CNN)President Donald Trump signed the "Right to Try Act" Wednesday, a measure aimed at helping terminally ill patients access drug treatments that are yet to be fully approved by the Food and Drug Administration.

Trump, at a White House ceremony surrounded by patients and families who will be affected by the legislation, said his administration "worked hard on this" but said repeatedly he didn't understand why it hadn't been done before.

The bill will give terminally ill patients the right to seek drug treatments that remain in clinical trials and "have passed Phase 1 of the Food and Drug Administration's approval process" but have not been fully approved by the FDA. Some opponents of the bill argue that the legislation won't change much but could have a detrimental effect on how the FDA safeguards public health.

Trump said he thinks "hundreds of thousands" could be saved as a result of the legislation.

Read more: https://www.cnn.com/2018/05/30/politics/right-to-try-donald-trump/index.html

[Hoyt]

1. Possibly something worthwhile, finally. trump has quite a ways to go before offsetting

all the damage he’s done.

[matt819]

2. Just hang on a bit

We'll find out that there's more to this bill and that it is not good.

Big Pharma liability waived.

Extending right to try to anyone, with any drug.

Financial benefits to big pharma.

Financial benefits to trump cronies.

Just wait. We'll find out soon enough.

[Haggis for Breakfast]

59. Absolutely correct, matt819

And you don't even have to wait to see yourself victorious. This is a thinly veiled attempt to dismantle the FDA. Make NO mistake about it. We've all seen how this administration wants to gut all regulations that prevent profit, no matter what the cost to people. This will free up the administration to take apart the FDA piece-by-piece. By circumnavigating the clinical trial process, (which can take years and huge sums of money that Big Pharma puts into research and development), that evaluates medications for quality, efficacy and safety, the market will be flooded by unproven and unsafe drugs. And lost along the way will be all of the protections that are now in place to keep Americans safe from dangerous medications that would not win approval in the first place. Clinical trials are one of the things the WH wants to see obliterated. One of those protections also comes in the form of price control. Without the current regulations, Big Pharma will be permitted to charge any outrageous amount they thing they can sustain.

Without the FDA, that smirking, smug little bastard, Martin Shkreli, would have gotten away with jacking the price of daraprim 5000%.

[Calista241]

81. If a drug is experimental and you volunteer for taking it

Because you are terminally ill and have nothing to lose, i don’t have an issue with waiving liability for the drug company in this specific case.

If a drug is FDA approved and tested, there should be recourse through the courts.

[Alethia Merritt]

22. Not really new. Terminally ill patients have received waivers for experimental drugs before.

It just wasn't public and used mostly in clinical trials or in biomedical research in foreign countries. What is new with this is probably the release of liability for Pharma.

[dbackjon]

76. How is this worthwhile?

[Matthew28]

3. Great idea!

This will help a lot of people.

[jberryhill]

12. Yes, there is a lot of money to be made selling hope

[janx]

14. Precisely. n/t

[Haggis for Breakfast]

62. And a lot of gullible people

will get bilked in the process.

[oberliner]

55. Almost every House Democrat voted against this legislation

Just FYI

[dbackjon]

77. How?

Kill them quicker?

Free guinea pig status?

[Cattledog]

4. Big Pharma will be protected from lawsuits.

[BlancheSplanchnik]

5. The large print giveth

And the small print taketh away.

[Phoenix61]

6. Sounds good but I wonder if insurance will

cover it. It's hard enough to get them to pay for drugs that are FDA approved.

[Siwsan]

7. Not likely

I think they will count on people who are willing to go bankrupt, on the slim chance they will be able to buy a little more time.

Given the side effect warnings on approved drugs and treatments, this could have the potential of being pretty scary for the public while being very profitable for Big Pharma.

[Haggis for Breakfast]

60. Excellent point

And the answer is a big fat NO. Insurance companies will not approve or cover these costs.

[standingtall]

8. I think there is a hidden agenda behind this

often times people who participate in clinical trials are paid a premium for it, but now drug companies will have a new ready supply of desperate people to test their drugs on and probably for nothing.

[dbackjon]

78. And liability free!!

[Kittycow]

9. I have mixed feelings...

The dying person can sign on to be a guinea pig for Big Pharma but in most states isn't trusted enough to medically end their own life

[janx]

15. Hence the name "Right to Try" instead of "Right to Die."

Clever, eh?

[Kittycow]

36. Yeppers. Good point.

[Haggis for Breakfast]

64. Out here on the West Coast

Oregon passed an initiative called "Death with Dignity." After the vote passed into law with a healthy margin, the then Attorney General, John Ashcroft, came out west to inform the State that any doctor who assisted in the death of a terminally ill person would lose their license and be sentenced for first degree murder. So the State rewrote the bill to spell out with great clarity all of the precautions, evaluations and protections, and how many different medical doctors had to sign off on the request before it would be put in place, and again, it passed. And again, Ashcroft claimed that there would be no protections under federal law for anyone who participated. Since then, the number of terminally ill patients who have sought to use this law numbers less than 20.

[bucolic_frolic]

10. Covering up the cause of disease

you can kneel at the dispensers of medicine but not at football games

[jberryhill]

11. Headline needs correction

It should be "aimed at helping con artists rip off sick people".

[FSogol]

13. "Try to Act Right" sounds like damn good advice for Trumpy.

Too bad he is incapable of doing that.

[SwissTony]

16. Very bad idea.

Phase 1 trials look at toxicity, not efficacy.

https://respectfulinsolence.com/2018/05/29/the-cruel-sham-that-is-federal-right-to-try-has-passed-let-patients-beware/

[hatrack]

17. Bingo - from your link . . .

Consistent with their libertarian origin, right-to-try laws also strip away many protections from patients. First, there is no requirement that companies provide the drugs for free or at a reduced price. Indeed, these laws explicitly state that insurance companies are under no obligation to pay, even though such a statement is unnecessary given that insurance companies don’t reimburse for experimental therapies. As a result, the only people who would potentially be able to access right-to-try are the rich or people who are very good at fundraising. A terminally ill person trying to access right-to-try can easily spend away his estate or even go bankrupt before dying. It’s even worse than that. The language in many of these laws can be interpreted to mean not just that insurance companies don’t have to pay for right-to-try but that they don’t have to pay for medical care as a result of complications suffered from using a drug under right-to-try.

[Hoyt]

20. The bill is for when you have no other hope but painful, ugly death.

It’s optional and any physician worth a damn will lay out all the facts.

Personally, I probably would give up long before reaching that point and seek euthanasia. Some others might go for the remaining, long shot treatment.

[SwissTony]

21. But itdoesn't really offer any actual alternative.

You can have a treatment which has absolutely no evidence that it works, it'll cost you your house and your kids' inheritance, it may leave you with major medical problems (including death) and you have no claim on the treatment centre or the drug company.

What facts can the physician lay out?

[Hoyt]

24. If that's the case, you say No Thanks. Nice to have option.

Not for me, but some people will try anything when they are dying. If a drug has shown some promise even in laboratory animals, there is no reason to deny it if a person wants to try everything when the alternative is death.

No physician is going to force it upon the patient. In fact, most physicians won’t push something like this. But they will explain the options.

[jberryhill]

25. I have a guy who has some stuff that he says might work

It's really expensive to make, so it'll cost you.

But, why not mortgage the house and I'll get you some. After all, you aren't going to need the money, and your kids would rather have you alive.

In fact, most physicians won’t push something like this.

QUACKS WILL!

And they will get every dime they can out of sick and dying people.

Are you shitting me? Of COURSE there are doctors, and "alternative healers" who are going to be in high cotton.

[Hoyt]

28. Did you read the article? This bill doesn't help quacks, and I'm not chitting you.

I think the patient and family deserve to have the alternative, and many states already allow this something similar. No chit.

[jberryhill]

30. Sure it does - it creates a whole new market

Because you can go to trials on something you KNOW is bullshit, but as long as you get through Phase 1, then you can sell out the wazoo.

Things don't happen in a vacuum.

When you change the rules, you change the game.

I have boiled donkey piss, and I'm going to do an initial trial to see if it is or is not toxic in a handful of people with cancer. I don't have to give a shit whether it gets any farther than that, because next month I'm doing goat piss. The month after that I'm doing rabbit piss.

The incentive is to get things into pre-clinical and phase 1 trials, because THEN you can go to market.

[Hoyt]

32. So I guess California and many other Blue states that already have these laws are wrong.

[Hoyt]

33. The FDA doesn't allow "boiled donkey piss" in clinical trials. Christ.

[jberryhill]

37. it was a figure of speech

An aqueous solution of inorganic salts and organic compounds, including proteins, hormones, and selected metabolites.

[Hoyt]

42. By the time it gets to FDA, millions of bucks have been spent on research. Boiled pss,

or the equivalent won’t have that kind of investment and research.

[jberryhill]

44. That's because of the current ecosystem

Yes, you are correct - under the current circumstances. Of course, companies will invest a lot of research into promising remedies, because they won’t see a payoff until the remedies have been proven effective.

But this is a change to the ecosystem. If there is a prospect of a financial reward for only making it through phase 1, then the dynamics are different.

Maybe I can try an analogy. A lot of athletes train to run 100 meters very fast. If you change the rules of the 100 meter dash, so that instead of recording their time at the 100 meter mark, you say “and we will also have a prize for the first 50 meters”, then you will get some runners who are aiming to win the first 50 meters, and walk the rest of the way if at all.

Changing the rules changes the incentives. Changing the incentives changes the basis for the investment.

[Hoyt]

48. If I wanted to try my last chance, I'll focus on the science and clinicians, not what

lay people think COULD BE an abuse of the system.

I don’t think there will be a viable market for drugs that are killing people. If a doc has the first one or two patients die on the experimental drug quicker than was predicted without, they are not likely to continue mentioning it as an option.

The system sucks, but a drug that isn’t extending life or quality of life won’t last long. I’ll leave that kind of view to conspiracy theorists.

[jmowreader]

72. They already allowed boiled horse piss in clinical trials

The drug name "Premarin" is short for "pregnant mares' urine"...which is what it's made from.

[SwissTony]

27. That's the problem...

Some promise in laboratory animals...Please, no. We are not rats/rabbits/mice/whatever. What appears to work to work with rats (and let me stress - often in situations which do do correspond to situations in which humans find themselves). It very often doesn't work the same way in humans.

How can an honest physician explain the options on a treatment that has only passed through a Phase 1 trial?

[Hoyt]

29. Most patients and families have more sense than you are giving them credit

for when someone is dying.

I like the option although probably wouldn’t use it. Also, I think Jack Kevorkian is a national hero.

[jberryhill]

31. Desperate people are very persuadable

We have diseases like whooping cough coming back because families WITHOUT any terminal illness have been persuaded that vaccination is bad for them.

Physician-assisted terminal choice is an entirely different thing, and is not relevant to this particular issue.

[janx]

49. It is relevant in the way that Trump is selling it.

See my post #9. There's no question. He is once again pandering to his base. He is also going for the snake oil angle, as you have pointed out.

[SwissTony]

34. Sorry, can't agree.

Mucho dollars, no effect.

Do you have a database that is evidence against this?

[Haggis for Breakfast]

67. If I remember correctly

Kevorkian went to prison.

[Hoyt]

69. He did, because of people who don't understand dying with dignity. You ever see someone die

from cancer, dementia, etc?

[Haggis for Breakfast]

74. Yes and it nearly destroyed me . . .

Hotchkin's Lymphoma ravaged my step-Mum's body. She died weighing less than 60 pounds. She was 36 years old.

But not everyone defines "dignity" the same.

And if you're Catholic, taking your life - even under such circumstances - is a mortal sin.

It is not my place to judge.

[Haggis for Breakfast]

66. And some will be so gullible

that they will spend their entire life savings on some snake oil or sugar pill that does nothing to cure them.

[Hoyt]

70. Actually, you should read about the cost of these meds. Besides, who are they saving it for,

their Greedy kids.

Do you understand that these are people who will die within the next month or two?

[Adrahil]

40. If someone is terminal, what's the harm?

My Dad died of liver cancer. There was a drug is early trials at the that he could not take. That drug has proven to be quite effective. I don;t know that he would have survived had he taken it, but it's possible.

[Hoyt]

43. Exactly. Sorry about your dad.

[Haggis for Breakfast]

65. Great post.

This is a good link to a great post. Thank you, SwissTony. Your post put this more eloquently than all of my above statements of caution about this dangerous proposal. And as we have seen, this republican congress is all too willing to bum rush bills through with little or no debate about the merits or the scientific opinion (if it collides with what the WH wants) of a proposed law.

This will not end well.

[dembotoz]

18. CBS morning news same segment. Right to try and folks going blind from unproven stem cell eye

Treatments.
Clearly to try does not always mean cure

[hatrack]

19. And no recourse. Zero. None.

.

[Hekate]

23. Who profits?

[Yavin4]

26. A big pharm company can make a ton of money selling ineffective drugs to such patients

This is not good. Sounds good, but what incentive does a pharma corp have to make something that actually works?

[JenniferJuniper]

38. Yes, desperate, dying, vulnerable people

getting sold a ton of snake oil from big pharma.

[Yavin4]

46. And paying a ton for it.

Not good. Regretfully, people have to accept death.

[JenniferJuniper]

47. with no insurance covering anything

Big Pharma Grab. Nothing more. Lives will not be saved or extended by the snake oil they peddle. Which is the Republicans were all in favor.

[janx]

51. "Big pharm" is probably the least of it.

We're used to that expression, but if this goes into law, it will be like jberryhill's snake oil post above on (pardon the pun) steroids.

Anti-science fodder for his "base."

[Yavin4]

61. Better yet. Trump Pharmaceuticals. Cures everything.

I wish that I was joking.

[maryellen99]

35. Wonder if cutting Hospice funding is part of this bill?

[The Mouth]

39. I don't like the idea of ANYTHING being unavailable

Especially if I were dying.

Nobody's business but mine what goes in my body, period.

[LanternWaste]

73. Nice bumper-stickers. Little else.

Nice bumper-stickers. Little else, regardless of the period you reference without relevance.

[Adrahil]

41. Don;t understand the reaction of some here.

Patient: I'm dying. Please let me try that treatment!

Grouchy DUers: NO! It might hurt you!

Patient: Ummm.... I'm dying....

[Hoyt]

45. Some of it is because trump signed it, which I do get.

Any other reasons, I don’t understand. I too have had a number of family members die from cancer, dementia, heart disease, etc. Not sure any of them would have tried a long shot in early trials, but it’s good to have the option.

[monmouth4]

50. I wonder what trump's kickback will be...n/t

[Hoyt]

56. Probably not much for this. Drug companies don't charge patients for clinical trials and few charge

for “right to try” use. In California’s law and apparently the federal law, those that do charge are limited to the DIRECT cost of manufacturing and providing the drug — that is, no profit, research, clinical trials or other cost above the production cost. Thus, using the figure of speech from a poster abov — “boiled buffalo piss” — the cost would be small. And that cost has to be provided in writing to patient or guardian.

Obviously, there could be someone who games the system. But if the drug doesn’t work, that will be apparent soon enough. If it does work, someone who is likely to die in a few months, might get a treatment that won’t be available for a year after their death.

Why don’t you check on European laws. Most investigational drugs are available much earlier in Europe.

[Qutzupalotl]

79. That's what I don't get about the snake oil arguments.

A whole new segment of the pharmaceutical industry is going to spring up built solely on scamming dying people? And no one will find out about the zero success rate, not even through word of mouth? THIS is supposedly a viable business model?!

[Hoyt]

80. Exactly. The FDA would never allow them to submit another product.

Yes, I suppose there is a concern under trump admin. But even that is a stretch.

[bluestarone]

52. Only way i would even concider supporting this is

Take the MONEY completely out of it! They will make enough on it IF it actually saves lives!! I say this type of choice (last chance treatment) should be COMPLETELY FREE!!!

[Hoyt]

57. Look at what the law allows the drug company to charge. Most don't charge at all, but if they

do it is severely restricted AND the charge has to be clearly specified to patient or legal representative.

[Turbineguy]

53. Isn't that a bit like....

The NRA practicing medicine?

They could name it "secondamabub".

[oberliner]

54. Almost every House Democrat voted against this legislation

[Hoyt]

58. Senate passed it with unanimous consent. Democrats are not above playing politics either.

California passed a similar bill.

[oberliner]

63. In the House, every Republican voted in favor, and 169 Democrats voted against

22 Democrats voted with the Republicans.

[truthisfreedom]

68. It's basically a right to die law.

That’s what 45 signed. Basically, a right to die.

[Hoyt]

71. No, a right to die with dignity would allow a physician to put you under while you

still have control of your thoughts, bowels, life.

[dbackjon]

75. Horrible idea, IMHO

No, hundreds of thousands won't be saved, but the drug companies thank you for the free, liability-free guinea pigs!

[Totally Tunsie]

82. Consider there's a whole other level if this involves a sick child.

There are some parents who would mortgage their lives to save their child. Look how many have risked imprisonment by taking their child across borders to secure experimental medical care not available to them in the U.S.

With these medications not being covered by insurance (because insurance won't cover anything considered "experimental&quot , there are those parents who would bankrupt themselves in their attempt to find a cure. The residual effect on their family could be catastrophic.

It's bad enough when an ill adult/elder runs the risk. Their life savings may be gone, but hopefully the family left behind is financially established to continue on with their lives. For parents of an ill child who invests every cent and borrows more, the entire family financially capsizes.