The cruel coldness of bureaucracy is never more apparent than when the Food and Drug Administration (FDA) keeps potentially life-saving drugs out of reach of terminally ill patients, even after deeming them safe. The Goldwater Institute, based in Phoenix, Ariz., is driving a new national conversation around access to treatments for the terminally ill with its Right to Try Initiative, which has been named one of six finalists for this year’s prestigious $100,000 Templeton Freedom Award, which will be awarded at Freedom Dinner 2016. With this initiative, the Goldwater Institute is forcing movement on policies that promote the access to a fundamental but overlooked human right: the right to save your own life.
“Before Right to Try, the FDA was content to say its ‘compassionate use’ process — a narrow exception for patients seeking pre-approval access to potentially lifesaving treatments — was working,” said Le Templar, the Goldwater Institute’s director of foundation relations. “But only roughly 1,000 people made it through the costly and cumbersome application process each year. Because the 29-state Right to Try movement has publicly exposed the difficulty — and, in some cases, impossibility — patients face in securing treatments through the compassionate use process, the FDA has been forced to acknowledge the program is too complicated and unworkable for dying Americans.”
Life-saving reform long overdue
The last time the FDA overhauled policies that give dying Americans access to promising treatments was at the height of the AIDS crisis in the 1980s. Far too much time has passed without additional reform, so the Goldwater Institute is using a combination of groundbreaking legal research, field investigation, and model legislation to lead a surging nationwide chorus demanding that sick patients be given the right to try life-saving treatments.
“Right to Try was first adopted in Colorado in April 2014,” Templar said. Today, thanks to its legislative victories in 31 states, with additional states pending, patients are finally beginning to access new medicines before it’s too late. “As the issue has been taken up in state after state, it has passed with overwhelming bipartisan support. In fact, in two thirds of states that have adopted the law it has passed with a unanimous vote of both the House and Senate.”
In November 2015, HarperCollins released The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need, by Goldwater Institute President Darcy Olsen. The book has been well-reviewed by book critics, political pundits, health care industry leaders, and fellow free-market advocates.
“The president and CEO of the Goldwater Institute makes a convincing case that the slow pace of the [FDA’s] development and approval process for new medications is needlessly costing lives,” wrote the influential Kirkus Reviews. “The author presents case histories of patients fortunate enough to be enrolled in FDA-approved trials, many of whom experienced remarkable cures. For terminally ill patients, the odds that an experimental drug will help, though as low as 20 percent, may still be attractive. Olsen’s organization is leading a bipartisan campaign to pass Right to Try legislation allowing patients and their doctors to bypass FDA regulations in deciding whether or not to try experimental treatments and for drug companies to make them available on a compassionate basis. High-quality advocacy certain to stir debate.”
Widespread mainstream news coverage
The Right to Try Initiative has received coverage from an average of eight mainstream news stories every day during the past two years, the Goldwater Institute reports. The organization’s astounding efforts to drive this new conversation about access to life-saving medicine has transformed the public debate, changing policy and increasing access to promising drugs for millions of Americans.
“Before Right to Try was introduced, the FDA hadn’t changed its compassionate use process in nearly three decades, and the only federal reforms that had been introduced were those that gave the FDA more latitude in granting early access to investigational drugs,” Templar said. “Even though the FDA was given this authority, it is rarely used. Right to Try has gone far beyond influencing how the FDA thinks about its own process and state lawmakers. It is influencing elected federal policymakers and the highest levels of the health care policy and legal community.”
Additional reforms to come
The Goldwater Institute is also pursuing several additional potential reforms that would speed access to promising treatments for the terminally ill, such as allowing for reciprocal drug approval with other developed countries and encouraging the use of “adaptive clinical trials” that incorporate promising treatments into the control group at the first signs of efficacy. In the end, the most significant result of the Right to Try Initiative will be the stories of people’s lives that have been saved through early access to promising drugs. It’s too early to tell their stories publicly, but the institute reports that at least 40 patients with terminal pancreatic cancer have been treated with a drug that already has completed its final clinical trial stage but is awaiting final FDA approval.
The Goldwater Institute was named as one of eight finalists for Atlas Network’s 2014 Templeton Freedom Award, for its work advancing education savings accounts in Arizona and Florida. Unlike school vouchers, education savings accounts create the maximum possible choice for parents and opportunities for competition among government schools, private schools, and other education providers.
About the Templeton Freedom Award and the additional 2016 finalists
Awarded since 2004, the Templeton Freedom Award is named for the late investor and philanthropist Sir John Templeton. The award annually honors his legacy by identifying and recognizing the most exceptional and innovative contributions to the understanding of free enterprise, and the public policies that encourage prosperity, innovation, and human fulfillment via free competition. The award is generously supported by Templeton Religion Trust and will be presented during Atlas Network’s Freedom Dinner on Nov. 10 in New York City at the historic Capitale. The winning organization will receive a $100,000 prize, and five additional finalists will receive $25,000 prizes. In addition to the Goldwater Institute, other nominees for the 2016 Templeton Freedom Award include:
- Centre for Justice, based in Stockholm, Sweden, for its Litigating for Liberty project
- FIRE (Foundation for Individual Rights in Education), based in Philadelphia, Penn., for its Legislative and Policy Project
- The Foundation for Government Accountability, based in Naples, Fla., for its Restore the Working Class project
- Israel Center for Social and Economic Progress, based in Mevaseret Zion, for its economic reform campaign
- Lithuanian Free Market Institute, based in Vilnius, Lithuania, for its Economics in 31 Hours textbook