Pharmaceuticals

Terminal Patients Got Drugs Without FDA Approval. It Added Years to Their Lives.

The Right to Try movement, which recently became federal law, allows doctors to prescribe experimental treatments that haven't been approved for sale by regulators.

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When Marc Hayutin was 69, he was diagnosed with squamous cell thymic carcinoma, a deadly cancer that affects the lymphatic and endocrine systems. His doctor told him he likely had months to live.

That was six years ago.

He survived thanks to an experimental drug that rapidly shrank his tumors and eased his pain. What's particularly noteworthy about Hayutin's recovery was that the drug that saved his life hadn't been approved for commercial use by the FDA. That would come six years later, at which point Hayutin probably would have been long dead.

He was able to take the medicine anyway thanks to Right to Try—a legal movement that has led to the passage of laws in 41 states allowing doctors to prescribe experimental drugs (ones that haven't been approved by regulators yet) to patients suffering from life-threatening illnesses. Right to Try was engineered by the Goldwater Institute, a free-market research and litigation organization in Arizona.

In May of 2018*, President Trump signed a Right to Try bill into federal law. It was championed by Vice President Mike Pence, who had signed a version of the legislation as governor of Indiana in 2015.

Right to Try is a shot across the bow at the FDA's core mission. But what does it mean for the future of medicine?

Produced and shot by Zach Weissmueller. Additional interview by Alex Manning. Additional camera by Meredith Bragg, Jim Epstein, Lexy Garcia, Alex Manning, and Mark McDaniel.

"Smoldering," by Kai Engel, is licensed under a Creative Commons Attribution NC 3.0 license. Engel's music is available for purchase and download at his Bandcamp page.

"November," by Kai Engel, is licensed under a Creative Commons Attribution NC 3.0 license. Engel's music is available for purchase and download at his Bandcamp page.

"Cobweb Morning," by Kai Engel, is licensed under a Creative Commons Attribution NC 3.0 license. Engel's music is available for purchase and download at his Bandcamp page.

"After Midnight," by Kai Engel, is licensed under a Creative Commons Attribution NC 3.0 license. Engel's music is available for purchase and download at his Bandcamp page.

"November," by Kai Engel, is licensed under a Creative Commons Attribution NC 3.0 license. Engel's music is available for purchase and download at his Bandcamp page.

"Drop D for Sirish," was produced and recorded by Case Newsom.

"Bosphorous," by Aris Spyropoulos, was licensed under a standard license through Artisound.io.

"Hang Drum Campfire," by Aris Spyropoulos, was licensed under a standard license through Artisound.io.

Photo credits: Kevin Dietsch/UPI/Newscom

Additional stock footage provided by Pond5.

CORRECTION: This article originally stated that Right to Try was signed into law by President Trump in May of 2019. It was 2018.

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11 responses to “Terminal Patients Got Drugs Without FDA Approval. It Added Years to Their Lives.

  1. How horrible for Trump to sign a bill into law to allow this. Going against the drug lobby is something Hitler would do.

  2. “Right to Try is a shot across the bow at the FDA’s core mission. But what does it mean for the future of medicine?”

    The end of the FDA? One can hope …

    1. Yes the FDA that says they won’t approve a drug that is not safe also keeps good drugs off the market for years causing unnecessary suffering. As if one bad experience is worth and infinite number of good results.

  3. You can’t have terminally ill patients taking drugs that aren’t FDA approved! The side effects could kill them!

    1. They are terminally ill to start with. Not taking drugs that aren’t FDA approved will definitely kill them.

      Death, death, maybe.

      I vote for maybe, who’s with me.

  4. BTW, whoever wanted to understand what’s legal and illegal re CBD, I answered it in that thread many hours after you posted the question.

  5. FDA = Fucking Dumb Asses.

    1. They’re better than the Demented Egotistical Assholes or the Asshole Training Facility.

  6. Off label prescribing is well known, very legal and has gone on for many years. As many as 20% of prescriptions or advised meds are off label. It is not illegal nor outside medical standard care.

    There are many examples, Gabapentin and Wellbutrin among them. Even otc meds like aspirin are advised for non approved indications.

    For years it was known that lidocaine, approved initially only as a local anesthetic was used everywhere for certain cardiac arrhythmias. Viagra was developed and initially approved as a drug to treat heart disease.

    1. There’s a bit of a difference between off-label prescribing and terminal patients getting access to experimental treatments that haven’t been approved for ANYTHING. My understanding is that this article is about the later, not the former.

      as for off-label prescribing, there are drugs out there that are useful for treating terminal and chronic conditions that can be very dangerous if used off-label.

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