FDA should allow treatment of terminally ill patients with experimental drugs

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Matt Bellina

The Outrage Machine is a regular opinion column by voices from the left and right on Washington and politics.

Last Thursday, I testified before the Senate on a bill that could mean life or death for me. The Trickett Wendler Right To Try Act, would clear the way for drug and device manufacturers to provide investigativetherapies to terminal patients if a patient and his or her doctor thinks it might help.

In The Washington Post, columnistJoe Davidson called my testimony compelling, but decided that ultimately the Right to Tryproposal is a solution in search of a problem.

As a 32-year-old father, veteran, and terminally ill ALS patient, I can assure you we have a problem and this bill is part of the solution.

Thirty-one states have passed Right to Try laws in 24 months. When the measures are approved, its with overwhelming bipartisan support. In more than half of all states they passed unanimously, without a single dissenting vote from a Republican or Democrat. They have also been signed into law by Republican and Democratic governors.

The state laws allow terminal patients like me to work directly with their doctors and drug manufacturers to access promising treatments nowbeing safely used in clinical trials. The federal law under consideration would prevent the Federal Drug Administration or any other federal agency from blocking or interfering with the implementation of these state-passed laws.

A newfederal law is essential in order for the state laws to have a meaningful impact. Right now, many drug companies are sitting on the sidelines, waiting to see what the FDA does now that the first brave doctor has stepped forward to say that he is treating patients under his states law.

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Until doctors and drug companies know that the FDA isnt going to have them prosecuted, why would they risk providing treatments to anyone, no matter how compelling their story?

In his column, Davidson suggests that Right to Try is unnecessary because the FDA has a process called compassionate use that gives terminal patients access to treatments still in clinical trials and that the agency approves almost every request.

But this program is severely flawed.

The FDA disincentivizes doctors and companies from participating in the program by making the process onerous and by refusing to put in writing that the agency will not use any adverse events that happen outside of clinical trials to shut down a trial or delay approval.

In Thursdays hearing, much was made of the fact that the FDA itself has acknowledged these flaws by attempting to streamline the application process and proposing a new office within the agency to help dying people navigate its bureaucracy.

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Shorter forms and hand-holding bureaucrats are helpful but when youre dying, you dont have time for that.

Right to Try streamlines the process for early access to an investigative treatmentand eliminates unnecessary delay. If a patient is willing to try a promising treatment even when he or she understands the risks, a doctor thinks the treatment may help the patient more than anything else on the market today, and a company agrees and is willing to provide the treatment the federal government should not get a veto stamp.

The FDA says it approves almost all requests for access to investigative treatments. Last year, that was a little over 1,200 requests.

Dr. Razelle Kurzrock of the University of California, San Diego,told the Goldwater Institutethat when she ran clinical trials at MD Anderson Cancer Center, she would spend hours on the phone with the FDA trying to get a verbal commitment before even beginning the application process for a patient.

Its almost a self-fulfilling prophecy for the FDA to say they approve everything, because you dont even put in the application before you sort of get a verbal approval from the FDA that its worth doing.

In 2014, nearly 25,000people in France were using investigativetreatmentsthrough that governments equivalent program. If a country with one-fifth the population of the U.S. can help 2000 percent more people, we clearly have a problem.

No one advocating for the state or federal Right to Try laws thinks it is a magic pill. But it does open up new options for people like me whose time is running out.

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What is the downside of creating new pathways for the terminally ill to access promising treatments? Maybe the law wont help millions of people, or even many but for those that it does help, its a game-changer. Just ask the 78 terminal cancer patients who are still with us today because of a state version of this law.

Wisconsin Republican Sen. Ron Johnson plans to ask the full Senate to pass this bill by unanimous consent this coming week.

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If they do, they will be able to look back on that decision and know it saved lives.

Bellina is a Navyveteran who is suffering fromALS. He is collaborating with The Goldwater Institute,which is leading the federal Right to Try effort.

https://www.washingtonpost.com/news/powerpost/wp/2016/09/28/fda-should-allow-treatment-of-terminally-ill-patients-with-experimental-drugs/

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