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‘Right to try’ bill would get FDA out of way of treatments for terminal patients

Wednesday, May 11, 2016 16:44

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(Before It's News)

Trickett Wendler lost her battle with ALS. Her fight for a cure lives on in a bill bearing her name. The legislation, introduced Tuesday by Sen. Ron Johnson, R-Oshkosh, would open the door to investigatory medicines not yet approved by the FDA. Photo by Youtube

TND Guest Contributor: M.D. Kittle

WAUKESHA, Wis. – Weakened from the devastating effects of amyotrophic lateral sclerosis, Trickett Wendler showed her internal strength in a 2014 video appeal.

“I have ALS. Last year I was a healthy 39-year-old and balancing a career and 10 years of marriage. And this year I am battling for my life,” the Waukesha mother of three said in 3-minute video titled “Trickett’s Story.”

It was filmed in 2014.

In March 2015, Wendler lost her courageous battle against the “nightmare disease.”

Often referred to as Lou Gehrig’s disease because of the baseball legend who died of the neurological condition, ALS is a thief. A bully. A kidnapper. A murderer. ALS doesn’t allow your muscles to take commands from your mind anymore.

“Eventually you are not able to move or breathe,” Wendler said in the video. “This nightmare disease considers everyone fair game. I was literally taking Zumba classes in March and in a wheelchair by July.”

While her husband, Tim, her three young children, the world, lost this courageous woman to ALS, the work she did to shine light on the disease lives on.

On Tuesday, U.S. Sen. Ron Johnson, R-Oshkosh, introduced the Trickett Wendler Right to Try Act of 2016. Asimilar bill was introduced in the House in 2015.

The bill aims to ensure that terminally ill patients, their doctors, and pharmaceutical manufacturers are allowed to administer investigational treatments where no approved alternative exists.

“Many of us have felt that sense of desperation – of urgency – when we learn that we or someone we love is fighting for their life,” Johnson said in a statement following a meeting with ALS patients and those affected by the glacial federal drug approval processes.

“In 2014, I met with a brave Wisconsin woman, Trickett Wendler, who was fighting ALS. Trickett passed away last year, but her spirit and her fight are among the reasons I am passionate about this issue — because I know that today, and every day, millions of Americans are fighting similar life-and-death battles to save themselves and their loved ones,” Johnson, chairman of the Senate Homeland Security and Governmental Affairs Committee, added.

There is no cure, and only one drug approved by the U.S. Food and Drug Administration modestly extends survival, according to the ALS Association.

“In an era of unprecedented medical innovation, we have to do more to ensure that patients facing terminal illnesses have access to potentially life-saving treatments,” Johnson said. “These patients don’t have the time to wait – often years and years – for the FDA to grant final approval. For Trickett, and for countless others facing terminal illnesses, now is the time to give more patients a chance to save their lives.”

Also Tuesday, the ALS Association joined U.S. Rep. Leonard Lance, R-N.J., sponsor of the Dormant Therapies Act, for a Capitol Hill press conference to urge Congress to move on the bill.

The legislation would facilitate and incentivize the development of treatments for diseases such as ALS, for which effective treatments do not exist, according to the association.

ALS advocates and representatives from the National Health Council joined the press conference on a day in which nearly 1,000 activists from across the U.S. met with their congressional representatives as part of the association’s National ALS Advocacy Day and Public Policy Conference.

“Currently, promising treatments for ALS are not being developed because they have lost patent protection or have weak patents,” the ALS Association said in a statement. “Without patent protection, there is no incentive for a treatment to be developed, no matter how promising.”

The Dormant Therapies Act would address this challenge by creating a new class of drugs called Dormant Therapies, which are treatments that show promise for treating diseases with unmet medical need and which do not have patent protection or have weak patents. The legislation would provide 15 years of data exclusivity for dormant therapies and sponsors that pursue dormant therapies would have to waive all patent rights.

“Right now, there is no treatment available that significantly slows or stops the progression of the disease. That needs to change. We need to do all that we can to speed the development of new treatments for ALS and other diseases and we need to do it now,” Lance said.

Trickett Wendler’s 2014 video shows a woman who is in the middle of losing everything. It’s heartbreaking to watch.

“It’s really the love and support I get each day that helps me get up, knowing that today is the strongest I will ever be again,” she said. “I see things differently now. Special moments happen in slow motion. Sometimes I see them through the future memories of my children.”

“I read a quote that I love that gives me hope. ALS is not incurable, it’s underfunded,” she added. “I can’t give the strong gripping hugs of my earlier days, but I can still give hugs that leave a real piece of me behind.”

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M.D. Kittle is national First Amendment reporter at Watchdog.org. Contact him at [email protected].

Watchdog.org is an online news organization that publishes articles by independent journalists covering state-specific and local government activity. The program began in September 2009, a project of Franklin Center for Government & Public Integrity, a 501(c)3 non-profit organization dedicated to promoting new media journalism. This article is reprinted with permission.