The right to try

MARY REICHARD, HOST: Coming up next on The World and Everything in It: The Right to Try.

Not the right to die, but the right to try. That is, to try alternative medical treatments when facing a serious health challenge. President Trump mentioned it in his State of the Union address back in January. It did not attract a lot of attention at the time.

TRUMP: We also believe that patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives … It’s time for Congress to give these wonderful incredible Americans the Right to Try.

NICK EICHER, HOST: It can take about a decade for a drug to win approval from the Food and Drug Administration. The Right to Try is a way around that. It’s about patient access to medication still being tested in clinical trials. In other words, treatment options the federal government hasn’t approved yet.

Right to Try is the law in a majority of states, including most of those that also have doctor-assisted suicide. Washington is one state that approved a so-called “Death with Dignity” law a decade ago, but still hasn’t gotten around to giving sick patients a different option.

WORLD Radio’s Sarah Schweinsberg files this report.

SARAH SCHWEINSBERG, REPORTER: In 2013, Trickett Wendler was diagnosed with hereditary ALS, a degenerative disease that affects nerves and muscles. Trickett’s husband Tim says it showed up on a business trip to California.

WENDLER: She was fatigued or she was tired. She had a little bit of difficulty walking long distances on this trip. So when she came back to Wisconsin, we went and visited her normal doctor. They ran some tests, couldn’t find anything, got referred to another specialist, couldn’t find anything. And it was then that the neurologist said, in my estimation, this is going to be a diagnosis for ALS.

Tim and Trickett Wendler immediately began searching for treatment options. There’s no cure for ALS and there were frustratingly few FDA approved drug options. That’s when the Wendler’s began advocating for Right to Try laws alongside Republican Senator Ron Johnson of Wisconsin, one of Right to Try’s champions.

Trickett wanted the right to access drugs that had passed phase one of the FDA’s rigorous clinical study and approval process. Tim says that’s an opportunity any patient facing a life-ending disease wants.

WENDLER: How can we wait if there is a chance for a drug to help, even if it’s a miracle. When you have no other options, you’ve exhausted your efforts to go find a treatment or cures or medicines and there are medicines in the pipeline that may help. Well, that’s all we’re asking for here.

Trickett fought for Right to Try laws until she died in 2015, three years ago this month. Since then, Tim Wendler and his three children have continued to lobby for a federal law.

WENDLER: My three kids are predisposed for the exact same disease. We’ve got to find, we’ve got to make progress right now.

In August, the Senate unanimously passed a bipartisan Right to Try bill named for Trickett Wendler. And after a failed attempt last week, House Republicans say they’ll vote on the bill again tomorrow… and this time it’s very likely to pass.

Under the measure, the FDA will no longer have to sign off if a doctor and a drug manufacturer agree to let a patient try a treatment not fully approved by the FDA. Here’s Arizona Republican Representative Andy Biggs during floor debate last week.

BIGGS: This bill gives tens of thousands perhaps hundreds of thousands or perhaps millions even the hope that they might avail themselves of medication that might prolong their life or maybe even be a cure.

Most Republicans and a few House Democrats agree. But the majority of House Democrats and dozens of advocacy groups argue that the legislation isn’t needed. That’s because the FDA already approves 99 percent of experimental prescription requests under an existing program called Expanded Access.

Caitlin Donovan is a spokesman for the National Patient Advocate Foundation, one of 40 patient advocate groups that wrote a letter to Congress opposing the current legislation. She says the legislation will cut the FDA out of the clinical trial process, placing patients in danger. She says the FDA isn’t the problem.

DONOVAN: The problem is that more patients are unaware of the avenues that exist, that there are financial barriers to access of drugs in general. The bigger problem is incentivizing drug companies to provide these drugs to patients.

Right to Try advocates say the FDA’s application process has a high approval rate because doctors only submit applications they know will be approved. The House’s version of the bill also includes stronger doctor and pharmaceutical reporting requirements to protect patient safety.

Tim Wendler’s biggest hope for Right to Try is that it will speed up research on treatments and cures for terminal diseases.

WENDLER: We want this to create a sense of urgency for everyone. We’re talking about people’s lives here and we can’t wait 20 years for another drug to get through the pipeline.

Reporting for WORLD Radio, I’m Sarah Schweinsberg.

(AP Photo/Andrew Harnik, File) This Oct. 14, 2015, file photo shows the Food and Drug Administration campus in Silver Spring, Md. 

WORLD Radio transcripts are created on a rush deadline. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of WORLD Radio programming is the audio record.

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