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Is 'Right to Try' Right for New Hampshire?

Sharon Morrow
/
flickr, creative commons

Terminally ill patients in New Hampshire may soon have the right to request experimental drugs that haven’t gotten federal approval.

Supporters of the so-called “Right to Try” bill say it give patients with only months to live a way to go around the FDA approval process in the hopes of getting potentially life-saving drugs.

The bill passed the New Hampshire House last month, and is now awaiting action in the Senate.

But there are critics of this idea in the medical community.

One of those opponents is Lisa Kearns. She’s a research associate at the NYU Langone Medical Center’s Division of Medical Ethics.

She joined NHPR’s Morning Edition.

In an op-ed in the Concord Monitor last month, you called on lawmakers here to reject this bill. What are your biggest concerns with this type of law?

I think the biggest concern is that the bills don’t do what they purport to do. They’re called “Right to Try” bills, but they don’t require pharmaceutical companies to actually grant the drugs that the terminally ill patients are seeking. The whole “Right to Try” movement is premised on the fact that these are life-saving, miracle drugs that are going to bring people back from the brink. Anybody who has just a cursory knowledge of the drug development process knows that just can’t be true.

You actually said this law offers “hollow promises” to very sick people.

Yes. There was a sad case in the St. Louis Post Dispatch last year of a family moving to Missouri and being thrilled it was a “Right to Try” state because the grandfather in the family had ALS. He petitioned the company and his neurologist petitioned the company and the company said no. The “Right to Try” law does not require the manufacturer to provide the drugs being sought. The quote from the daughter in the article was can you imagine the hope felt.

We spoke with the bill’s sponsor – Representative Frank Edelblut, a Republican who’s running for governor – and he had this to say in response.

“To call it the right to beg I think is disingenuous. These are people who have exhausted all possible medical therapies. They have no hope. So you’re saying this is a right to beg. I’m saying this is a right to try to hang on.”

So how do you respond to that?

The right to beg is a right that they have already. Unfortunately, to a have a “Right to Try” through these laws would mean that when they ask for this drug from the pharmaceutical company, the company has to give them the drug; they don’t have to do that. All this “Right to Try” allegedly does is give patients the right to ask for this drug. Because the drug company can say no, there is no right conferred on the patients.

The FDA already has a Compassionate Use program for terminally ill people, but “Right to Try” supporters argue government red tape gets in the way of people accessing these drugs in a timely manner.

Do you see any truth to that?

Well, it’s a common refrain. The way the approval process works is that if say these laws were to work they were intended, the patient would ask the pharmaceutical company for the drug, the pharmaceutical company would say yes, and then they would have to go the FDA. It is not the FDA that is the obstacle, it is the pharmaceutical company. The FDA doesn’t get involved until the pharmaceutical company agrees to provide the drug in the first place.

Do you see these laws in any way undermining the research that goes into developing these drugs?

I do. “Right to Try,” if it were to do what it said, could threaten the clinical trial process. That’s the three phases on which drugs actually get to the public, the way they get drugs out to help people. If people could access drugs through “Right to Try,” they may not be inclined to enroll in a clinical trial. If there were an adverse outcome because of “Right to Try,” that could threaten the whole clinical trial that’s going on.

Have we seen any instance of that yet?

The whole "Right to Try" movement is premised on the fact that these are life-saving, miracle drugs that are going to bring people back from the brink. Anybody who has just a cursory knowledge of the drug development process knows that just can't be true.

Well, we have seen no substantiated instances of anybody getting anything because of “Right to Try,” so I would have to say no.

Half of states now have “Right to Try” laws; Maine became the 25th state last week. And these have all been passed in the past few years.

Given all the concerns you’ve raised, how do you explain the momentum behind this movement?

I think it’s an easy movement to get behind. Everybody would like to help terminal people I imagine there’s no one drawing breath who hasn’t been touched by a devastating illness. So there’s no surprise that these are very popular among citizens and among legislatures. This is not an adversarial relationship we’re trying to make between ethicists and patients. We’re all working to support patients and their families. But our research shows that the “Right to Try” movement isn’t really going to help them. We should develop efforts to promoting policies that will.

Beyond these “Right to Try” laws, do you see any areas where there could be reform or improvements in the way terminally ill people are able to access experimental treatment?

Yes, and I’d say it’s to the FDA’s credit that they have responded to this overwhelming movement of “Right to Try.” They are making it easier for physicians to apply for emergency access for their patients. It’s been talked about how they’re streamlining the process down from 100 hours, which is not quite an accurate figure, but down to about 45 minutes for the form is expected to be finalized in the coming months.

Other steps that could happen are companies could make policies about “Right to Try,” compassionate use, and expanded access transparent and easy to use on their website, even if that policy is we have no policy on expanded access. Protections could also be put in place to protect companies from adverse events. 

Morning Edition reached out to Gov. Maggie Hassan for her position on the bill, and her office provided this statement:

"Governor Hassan understands the need for patients with severe and potentially terminal illnesses to have access to potentially life-saving treatments in a timely manner, and she will carefully review the specifics of this legislation."

For many radio listeners throughout New Hampshire, Rick Ganley is the first voice they hear each weekday morning, bringing them up to speed on news developments overnight and starting their day off with the latest information.
Michael serves as NHPR's Program Director. Michael came to NHPR in 2012, working as the station's newscast producer/reporter. In 2015, he took on the role of Morning Edition producer. Michael worked for eight years at The Telegraph of Nashua, covering education and working as the metro editor.
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