COMMENTARY

Does 'Right to Try' New Drugs Really Mean 'Right to Beg?'

Arthur L. Caplan, PhD

Disclosures

December 02, 2015

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Hi. I'm Art Caplan at New York University Langone Medical Center.

A lot of states—25 at last count—have passed laws in the past year called "Right-to-Try" laws. These laws recognize that individuals who are dying ought to have a chance to use unapproved experimental drugs. These are drugs still early in the testing process, maybe just coming out of first attempts in humans with a little safety data, to drugs that are well along in the development process.

The laws say that people ought to have the right to access experimental drugs if they want. They say that there should be minimal safety data, which we call "phase 1" in regulatory terms. Basically, the laws focus on the terminally ill and focus on drugs.

What could be wrong with giving dying people the right to try? If someone wants to take a chance on something, why not let them? The problem with these laws is that they don't really give anybody a right. The rhetoric sounds good, but reality doesn't match the rhetoric. A "right to try" presumes that somebody has a duty to give you the drug. But these laws don't create any obligation or duty on the part of the drug companies. They don't put any money aside to pay for the drugs, nor do they say, "If I ask for a drug, the big drug companies or the little start-ups have to give me a drug."

Sometimes I call these "right-to-beg" laws. You have a right to request something from a company, but it does not mean that they will give you the drug. Strangely enough, we already had these rights. There was nothing to stop you from asking a company to give you or a family member an unapproved drug. The laws feel good and sound good. Legislators vote for them overwhelmingly in each state, but they don't achieve much in terms of getting people access.

They have other problems, too. A lot of folks who ask for a "right to try" aren't dying; they have chronic pain, they are going blind, they have Parkinson disease. Their quality of life is slipping, and they may want to try a drug. They are not helped by these laws. With our policies right now, if you are dying and want to try a drug, you would lose your hospice coverage or benefit in many states because the only way to get into hospice is to say that you are not going to try any last-minute therapeutic or experimental modalities. That may be bad policy, but it certainly isn't helped by laws that don't address that loophole.

What should we do? We have got to do better. People who are dying or becoming disabled have a right to get drugs that would help them. Programs to help pay for these drugs need to be created. We have debated the Obama health reform for years, but I have not heard much discussion, if any, about paying for experimental drugs for desperately ill people. Maybe we should push our legislators to think not just about rhetoric but about going into their pockets if they really want to help. People have costs for the drug, travel, babysitters, hotels, and incidental expenses. They have time lost from their job if they are helping themselves, a family member, or a child get an experimental drug.

Companies need more advice about who to give these drugs to and when. Some of them aren't going to be comfortable doing anything unless the US Food and Drug Administration says, "If someone dies, we are not going to hold this against you." Sure, we want to know if a death is attributable to a new drug, and the company would want to know that too, but we are often talking about very sick people. Adverse events and bad outcomes are likely. A lot of these drugs aren't going to help—it's a long shot. You don't want companies afraid to give something because someone getting sicker or dying—which sadly is more likely than not with experimental drugs—might slow down the drug approval process.

There are things we have to change. There are ways we could accelerate the process of giving desperately ill people better access. Even though "Right to Try" sounds like a good idea, I don't think it lives up to its name.

I'm Art Caplan at NYU Langone Medical Center. Thanks for watching.

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