COMMENTARY

Is Patient's 'Right to Try' Law All Wrong?

Kathy D. Miller, MD

Disclosures

April 06, 2015

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Hi. It's Dr Kathy Miller from Indiana University. On my way to the hospital today, I heard about a new bill that is now signed into law in Indiana,[1] to which I want to share my reaction with you and get your thoughts.

The law is known as the patient's "right to try" law. It says that if you are a patient with a terminal illness and you don't have effective available therapies that you haven't already tried, you have the right to try any medicine that has passed through phase 1 testing and continues in clinical development. This law passed through the House and unanimously through the Indiana Senate[2] and was signed quickly today by our governor.

Really, that's not a surprise. What politician wants to go on record saying, "I am against the patients' right to try when they are in a desperate situation"?

Let's think about the details here. What does this law really allow us to do?

If the drug is already approved for another indication, I already have the ability to prescribe it off-label. I do not have the ability to force an insurance carrier to pay for that medication, and this law does not require any insurance carrier to provide coverage for that therapy.

There is already a process to petition a company and the US Food and Drug Administration (FDA) for individual compassionate use[3,4] of a drug currently in clinical trials for a patient for whom a clinical trial might not be available. That process is cumbersome, and nobody likes paperwork, me among them. But the process exists, and rarely are those requests turned down by the FDA.

This "right to try" law doesn't mean I don't have to go through that cumbersome process, and it does not compel any pharmaceutical company to provide that drug to my patient, either because of that law or because I ask them to.

In reality, this law changes nothing for my patients. You would not know by the news coverage. The news coverage makes it sound like this is a great day for patients with terminal illness in the state of Indiana: They now have a host of options available to them that they didn't have before.

This law can cause real harm. Our new medicines are powerful. They may have great activity, but they also have real toxicity. And if they're in that early stage of clinical development, we simply don't yet know how to use them successfully; we don't know whether they'll be helpful; and we really don't have a way to have an honest, open, reasonable discussion with our patients.

One of my early mentors, the great pharmacologist Paul Talalay, drummed into my head: "There is no moral imperative to offer unproven therapy." Now this becomes difficult.

I am very much a supporter of patients' rights. But in this case, it ought to be a patient's right to have clinical trials available—really available, widely available—in their home community and appropriately funded, so that a patient can join those clinical trials and get access to those investigational agents as part of the investigation, because that's what will help us learn. That's what helps the patients who get those drugs, and that's what helps the patients who want those drugs. So if our legislatures really want to get this right, that should be their focus. This law is just window-dressing. It does nothing.

Now for those of you who think, "Thank God I don't live in Indiana today," you might want to take a look at the agenda of your state legislatures, because 22 other states have similar laws coming down the pike quickly.

I'd love to hear your thoughts on this. I'll be back again soon.

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