Monday, January 11, 2016

Right to Try: The FDA Has the Blood of Millions of Americans on its Hands

Darcy Olsen, CEO and President of the Goldwater Institute, has written a must-read book for anyone facing a serious ailment, The Right to Try: How the Federal Government Prevents Americans from Getting the Life-Saving Treatments They Need . It is common knowledge there is a problem with the FDA delaying the approval of drugs. But until now, most Americans did not realize just how bad the situation is  — hundreds of thousands of people, including children, needlessly lose their lives every year because new, breakthrough drugs that have worked in clinical trials and are legal in other countries are not approved here. In fact, the number of people dying is increasing, because the FDA keeps increasing the delays — despite its false claims that it approves drugs faster than it really does. The FDA continues to demand more data and statistical certainty from clinical trials, making them “larger, longer and more complex.”

The agency insists that unless a treatment has a high success rate, it should not be approved. But everyone is different; some people respond differently than others to medications. Peter Huber of the Manhattan Institute explains, “There is no such thing as breast cancer,” because scientists “have discovered at least ten distinct variations.” Therefore, indiscriminately testing one drug on all breast cancer patients is going to have skewed success results.

The FDA isn’t even delaying approval in order to establish the safety of a drug, merely to measure its effectiveness. This is cruelly unfair. As Darcy puts it, people with terminal illnesses like Lou Gehrig’s disease (ALS) or cancer would rather have a 50 percent chance of being cured than a 100 percent chance of dying from it. One doctor sarcastically stated, “These people would be happy to go to their own funeral five years from now rather than a year from now.”

Darcy relays the stories of several people with different terminal illnesses who went to great lengths despite the FDA to obtain these new groundbreaking treatments. Some moved overseas, while others persisted until they were allowed to participate in the clinical trials. Most of them were not rich so it was a difficult, uphill task, but the treatments ultimately worked.

Read the rest of the article at Townhall

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