Wednesday, November 11, 2015

The Right to Try: How the FDA Is Killing Americans



The Right to Try: How the FDA Is Killing Americans
by Ben Shapiro10 Nov 2015
This week, Darcy Olsen, president of the Goldwater Institute, released a vital and fascinating new book, The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They NeedIt’s a must-read rebuttal of the left’s number one argument for big government: the Food and Drug Administration (FDA) protects us from evil capitalists who would alternatively poison us or toss us into meat grinders for the viewing pleasure of Sinclair Lewis. Olsen argues persuasively that the federal government kills Americans with its useless bureaucracy and counterproductive belief that the government must protect sick Americans from making their own decisions regarding their sickness.

The book begins with a description of Ted Harada, a young father diagnosed with Lou Gehrig’s Disease (ALS). ALS is a death sentence; it has a 100% death rate, and the only question is whether death will come in five years or two. But Harada had an experimental stem cell surgery at Emory University that reversed his symptoms completely – until the FDA stepped in to stop him from having further surgeries. Harada’s surgery is also unavailable to the approximately 24,000 people who have died since Emory’s clinical trial began.

Olsen points out:

In 2012 … there were just 940 requests for experimental drugs approved in the entire country under the FDA’s compassionate use program. According to the American Cancer Society, that same year about 1,638,910 Americans were diagnosed with and about 577,190 died from cancer alone. Millions more are diagnosed each year with other terminal diseases. Clearly, the system is failing to help the vast majority of Americans who are fighting to save their lives.

Olsen advocates for the Right to Try: the right to attempt to preserve your life so long as that attempt hurts no one else. Right to Try legislation – legislation preserving the rights of terminally ill patients – has now succeeded in states all over America.

The book is an eloquent tome on behalf of this Right to Try. The stories in the book break your heart. Take, for example, the story of Jenn McNary and her two sons, Austin and Max, both of whom suffered from Duchenne muscular dystrophy. One of her sons, Max, received a lifesaving drug, while the government banned the other son from receiving it. Jenn says Austin “doesn’t understand why the grown-ups in his world can’t figure this out and make things happen faster for him.” Jenn tried to work with a company called Sarepta, but the FDA held them up, over and over again, despite the passage of a new law that should have fast-tracked the development of the necessary drugs. In the end, the FDA still has not invited Sarepta to apply for approval of the necessary drug. That decision has left 12,000 to 16,000 boys out in the cold.

The FDA’s decision-making process is so problematic that families are moving overseas to avoid its tentacles. Diego Morris, 11, contracted osteosarcoma, a rare bone cancer. His parents wanted to put him in a clinical trial for Mifamurtide, a biological therapy “that stimulates the immune system to attack cancer.” Despite the fact that trials worked wonders with the drug, the FDA met its application with hostility. In Europe, however, drug approval moved smoothly. It has become standard care in countries from the United Kingdom to Israel. Morris’ family ended up helping to push Right to Try legislation through the Arizona legislature to fight the FDA.

The book isn’t just stories. It explains how companies have had to battle with the FDA, and how individuals have had to pay a massive price in health and cash to fight the agency. It explains how the FDA’s so-called “compassionate use” program hasn’t fulfilled its promise to Americans. Polls of doctors show that physicians feel that medical specialists are hindered by the FDA’s processes when it comes to treating terminally ill patients.

This is a bipartisan issue, says Olsen: “We are the 99 percent. We demand change, and we will get it.” They call on Americans to use social media to fight for Right to Try – social pressure, says the Goldwater Institute, is the key to moving the agenda forward. “When patients and parents know a drug is working,” writes Olsen, “they are not going to sit back and wait years for the FDA to satisfy itself with near-100 percent certitude about the efficacy of a drug. Patients are demanding action.”

So should we all. And picking up a copy of The Right to Try would be a great first step.

Emory University
John G. Rice is a trustee at the Emory University, and a board member for the CDC Foundation.

Note: CDC Foundation is a foundation for the Centers for Disease Control and Prevention (CDC).
Jeffrey P. Koplan was a director at the Centers for Disease Control and Prevention (CDC), and is the VP for the Emory University.
David Satcher is a board member for the CDC Foundation, was a director at the Centers for Disease Control and Prevention (CDC), and the surgeon general for the U.S. Department of Health and Human Services (HHS).
Margaret A. Hamburg was an assistant secretary for the U.S. Department of Health and Human Services (HHS), a commissioner for the U.S. Food and Drug Administration (FDA), and is a VP for the Nuclear Threat Initiative (think tank).
Donald Kennedy was a commissioner for the U.S. Food and Drug Administration (FDA), and a trustee at the Carnegie Endowment for International Peace (think tank).
Carnegie Endowment for International Peace (think tank) was a funder for the Nuclear Threat Initiative (think tank).
Jessica Tuchman Mathews is a director at the Nuclear Threat Initiative (think tank), was the president of the Carnegie Endowment for International Peace (think tank), a director at the American Friends of Bilderberg (think tank), an honorary trustee at the Brookings Institution (think tank), and a 2008 Bilderberg conference participant (think tank).
Ed Griffin’s interview with Norman Dodd in 1982
(The investigation into the Carnegie Endowment for International Peace uncovered the plans for population control by involving the United States in war)
Foundation to Promote Open Society was a funder for the Carnegie Endowment for International Peace (think tank), the Brookings Institution (think tank), the Harlem Children's Zone, and the Aspen Institute (think tank).
George Soros was the chairman for the Foundation to Promote Open Society, and a benefactor for the Harlem Children's Zone.
Mark B. McClellan was a senior fellow at the Brookings Institution (think tank), a commissioner for the U.S. Food and Drug Administration (FDA), and an administrator of Medicare and Medicaid for the U.S. Department of Health and Human Services (HHS).   
Michael R. Bloomberg was a benefactor for the Harlem Children's Zone, is the founder for the Bloomberg Family Foundation, and the founder of Everytown for Gun Safety.
John J. Mack was a benefactor for the Harlem Children's Zone, is a director at the Bloomberg Family Foundation, and an advisory board member for Everytown for Gun Safety.  
Bloomberg Family Foundation was a funder for the Aspen Institute (think tank), and the CDC Foundation.
CDC Foundation is a foundation for the Centers for Disease Control and Prevention (CDC).
Bloomberg Philanthropies is an umbrella organization for the Bloomberg Family Foundation, and was a funder for the Global Polio Eradication Initiative.
Jeffrey P. Koplan is a board member for the Global Polio Eradication Initiative, the VP for the Emory University, and was a director at the Centers for Disease Control and Prevention (CDC).
Everytown for Gun Safety is a “Gun Saftey, Gun Control” group for guns.
Warren E. Buffett is an advisory board member for the Everytown for Gun Safety, and an adviser for the Nuclear Threat Initiative (think tank).
Margaret A. Hamburg is a VP for the Nuclear Threat Initiative (think tank), was an assistant secretary for the U.S. Department of Health and Human Services (HHS), and a commissioner for the U.S. Food and Drug Administration (FDA).
Carnegie Endowment for International Peace (think tank) was a funder for the Nuclear Threat Initiative (think tank).
Donald Kennedy was a trustee at the Carnegie Endowment for International Peace (think tank), and a commissioner for the U.S. Food and Drug Administration (FDA).
Mark B. McClellan was a commissioner for the U.S. Food and Drug Administration (FDA), a senior fellow at the Brookings Institution (think tank), an administrator of Medicare and Medicaid for the U.S. Department of Health and Human Services (HHS), and is a director at Research!America.
John Edward Porter is a chair for Research!America, and was an honorary trustee at the Brookings Institution (think tank).
John R. Seffrin is a director at Research!America, and the CEO for the American Cancer Society.
Tenley E. Albright is a director at Research!America, and a director at the Bloomberg Family Foundation.
Bloomberg Family Foundation was a funder for the Aspen Institute (think tank), and the CDC Foundation.
CDC Foundation is a foundation for the Centers for Disease Control and Prevention (CDC).
Bloomberg Philanthropies is an umbrella organization for the Bloomberg Family Foundation, and was a funder for the Global Polio Eradication Initiative.
Jeffrey P. Koplan is a board member for the Global Polio Eradication Initiative, the VP for the Emory University, and was a director at the Centers for Disease Control and Prevention (CDC).
John G. Rice is a trustee at the Emory University, and a board member for the CDC Foundation.

No comments: