Extended Cut: Should the terminally ill have the right to try non FDA approved drugs?

Howard Baetjer,

Release Date
April 30, 2015



What do you think about these questions? Let us know in the comments!
Should terminally ill patients have the right to try risky, non FDA approved drugs? Or should they have to wait on the FDA approval process, which can take several years, in order to get access to potentially life-saving drugs? What if patients are just sick, but not terminally ill—should they have access to experimental, non FDA approved drugs? Economics Professor Howard Baetjer went to Towson University in Baltimore, Maryland to ask students what they think about these tough questions.
He asked them to consider:
Why should we prevent patients who are already going to die from taking medication which could save them, or at least ease their suffering? What harm could it do?
Should we treat everyone equally? Or should we treat terminally ill patients differently from patients who are just sick?
The FDA’s approval process takes years–this means that thousands could die waiting for the FDA to approve the drugs that would save them. How does it make you feel that people who want to try these risky, but potentially life-saving drugs, can’t get access to them?

Should we be allowed to sell…? (Video): Professor Peter Jaworski asks campus students whether they should be permitted to sell hugs, sex, and kidneys.
FDAreview.org (Website): An extensive collection of FDA Research including a detailed history of the FDA, a review of the major plans for FDA reform, and more.
Is the FDA Safe and Effective” (Video): An informative and enjoyable lecture from Dr. Alex Tabarrok.
Goldwater Institute (Database): A compilation of recently published stories on healthcare and “Right to Try”

Prof. Howard: Do you think it should be legal for the terminally ill to try risky, non-FDA approved treatments?
Speaker 2: I mean I don’t think every person knows what goes behind FDA testing.
Speaker 3: If they really need it and that’s the only option, I think it should be legal to save a life.
Speaker 4: They’re not approved by the FDA, they’re not safe.
Prof. Howard: Okay.
Speaker 4: At least that’s what we’re told.
Speaker 5: I think what it comes down to is it’s your life. If you want to try. If you want to try anything you know how it could end. Do it. It’s your life.
Prof. Howard: The FDA is cautious. They aim never to release an unsafe drug as they did with the birth defect-causing [inaudible 00:54]. Caution takes time. Time the very ill may not have. The longer the FDA takes to approve a drug, the longer sick people must wait to use it. Though taking an unapproved drug may be risky, not taking a potential cure is also risky.
Look at this chart. Sometimes the FDA is so cautious that it delays approving drugs that turn out to be life saving, including drugs that have already been approved for use in other industrialized countries. That caution can kill. That caution means thousands of people die waiting for the FDA to act. It’s an admittedly difficult trade off, so I asked students on my campus what they think about this problem.
Maria: Hello.
Prof. Howard: I’m Howard.
Maria: Maria.
Prof. Howard: Maria. Umer?
Umer: Yes.
Prof. Howard: Umer and?
Matt: Matt.
Prof. Howard: Matt. What’s your name Miss?
Cecelia: Cecelia.
Prof. Howard: Should it be legal for the terminally ill to try risky non-FDA approved treatments?
Cecelia: In the end it’s that person’s choice. For example if I was sick and I want to be treated, I would take it.
Speaker 10: I feel like they shouldn’t be able to use it if it’s not approved because if it’s not approved it doesn’t sound too healthy.
Speaker 2: I mean I guess they are dying but what if it makes it worse?
Speaker 12: If the patient is aware that they are dying and this is a last ditch effort, I see no reason to prevent them from receiving medical care.
Speaker 13: I happen to have an immunodeficiency disorder.
Prof. Howard: Oh really?
Speaker 13: If that was presented to me and I was at a terminally ill point in my life I think I should be allowed to not only choose my treatment, but choose that if I wanted to end my life like Oregon offers, I think it’s absolutely the individual’s discretion.
Prof. Howard: What’s your feeling about the fact that you can’t?
Speaker 13: I’m all for government regulation and intervention when I think it could pose a health crisis to other people and my decision effects other people and other people of the country, other citizens, but if it only effects me and my consequences involved in my life, then it should be out of the hands.
Speaker 14: People should be informed, so it’s like it should be legal but as long as the person’s informed then it should be up to them.
Speaker 4: I think if a treatment that we found is working maybe in other countries, the FDA should probably try to test it out.
Speaker 16: In my opinion, they’re going to die they should be able to do whatever they want. It doesn’t bother me if they, an old woman with terminal cancer was smoking cannabis or if it was some experimental drug, clinical trial or anything like that.
Speaker 17: I say yes.
Prof. Howard: You say yes? Okay, jelly votes yes. Becca is still thinking.
Becca: I’m going to vote no because a patient doesn’t really know everything that goes into a drug and their doctor should be the one to tell them whether it’s for them or not.
Speaker 19: I think if they’re terminally ill then they should definitely be able to try the risky non-FDA approved treatments because that might be the only chance that they have to live.
Prof. Howard: What was interesting too was how their responses changed when we revealed the second board hidden behind the first. Check this out. Can I ask you a followup question?
Speaker 20: Yes.
Prof. Howard: How about this one. How about people that aren’t terminally ill, but they’re sick? They also want to try a non-FDA approved treatment. Should they be allowed to do that or not?
Speaker 21: No, not at all.
Speaker 22: That’s a tough one.
Becca: No, I’d say yes to this one.
Prof. Howard: You’d say yes to this one?
Speaker 17: I actually have a question for this one.
Speaker 12: I want to say yes, but at the same time I feel like the FDA does a lot of good work to keep things that aren’t safe from getting to consumers.
Speaker 22: Let’s say you’re not that sick and they say the FDA approved this and it helps you, but maybe you’ve done your own research and you say I don’t like some of these side effects. There’s a promising new drug that doesn’t have this side effect. That’s why I’m kind of on the fence about it. I’m going to go with yes.
Prof. Howard: All right. Why would you deny terminally ill patients the choice, but allow just sick people the choice?
Becca: I don’t know. Maybe it’s because I have more of a personal connection to this because when my uncle had brain cancer he couldn’t try things that weren’t FDA approved and that could have saved him. I feel like there’s more of a chance with this to be saved and with that you’re going to die anyways, so why should it be legal to try something that’s not been tested.
Speaker 24: To me terminally ill and sick is two way different things because if you’re terminally ill then you can’t really recover from that. If you’re sick there’s always a time in the future where you can …
Prof. Howard: Okay, so you’re a no on that one.
Speaker 17: You said they’re not terminally ill so.
Prof. Howard: Just sick.
Speaker 17: Okay, so isn’t there a medication already then?
Prof. Howard: Yes, there are various medications, but there are some, the medications aren’t doing so well for them and there’s something else that maybe a pharmaceutical company is testing that looks promising and they’d say, “Well, I’d like to try that,” but it’s not approved yet.
Speaker 17: Will this medication still have the same risk as this one?
Prof. Howard: Yeah, let’s assume it’s just as risky because we don’t know what the side effects are.
Speaker 17: I say if the patient discusses it with the doctor and they know the risks and stuff like that and if they are consenting I would say they should ave the right to consent to what they want to consent to.
Speaker 25: They know the risk before I guess before they even take it.
Maria: They’re not terminally ill though. They can still survive without the treatment.
Speaker 25: They could probably survive with it.
Maria: You don’t know that because it’s not FDA approved.
Speaker 19: I think they should be able to try it.
Prof. Howard: Yeah. Well how does it make you feel that they can’t now?
Speaker 19: I guess it’s, I’m kind of desensitized to people being not allowed to do things, exercise what they want to do.
Prof. Howard: Yeah. Students on my campus have very diverse views on letting individuals test drugs for themselves. This shouldn’t be surprising. We all view risk differently. Moreover each individual would weigh the situation differently if he or she or a loved one had to choose between the risk of taking an experimental drug and the risk of losing the fight with disease. Both choices are risky. Should we have a one size fits all policy for Americans about this trade off? What role should individual choice play? Got an opinion? Join the conversation at Learn Liberty. We’d love to hear from you.