The FDA has the blood of millions of Americans on its hands
By Rachel Alexander
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.
Perhaps most disturbing of all is what I think should really be called child abuse. Darcy lists the high numbers of children who die every year of terminal illnesses, who could have been saved had they been given these treatments. Even the clinical studies are cruel to children. Some are driven by their parents hundreds of miles every month or so for the chance of just a handful to participate in a trial, only to be part of the placebo group that does not receive the real drug. Darcy calls this "morally unacceptable."
It is fascinating learning about the new treatments. One of the new methods that is working effectively to kill cancer and other serious illnesses involves sending a virus into the patient's body to infect the cancer cells. If the virus doesn't kill the cancer cells first, the body's immune system will kick in and kill them. Thus, HIV is being used to cure leukemia. Other drugs in the works will combat depression, traumatic brain injury, schizophrenia, PTSD, mesothelioma and Alzheimer's. Positive results have been achieved already reversing Lou Gehrig's disease, leukemia and more — but virtually none of these drugs have been approved by the FDA.
Most Americans don't know about these successful but unapproved new treatments, because their doctors aren't telling them. One pediatric doctor told Darcy that most of them are too afraid of retaliation to stand up to the FDA.
In order to get around the FDA, Darcy and allies have worked to get Right to Try legislation passed at the state level. So far, 24 states have approved of the legislation, which lets terminally ill patients try new drugs before the FDA has approved them if they meet certain minimal criteria.
One way Darcy recommends reforming the FDA is to implement "a policy of regulatory reciprocity with countries that have a proven record of approving safe and effective drugs — including the European Union, Canada, Japan and Australia." People from Britain are surprised when they learn they have access to drugs that Americans can only dream of having years down the road.
It is heartwarming to think of all the Americans who will read this book and use it as a guide to figure out how to obtain these prohibited lifesaving treatments. My brother died from leukemia in 2009; had my brother had one of these non-FDA approved options, he might still be with us today. In 2012, a seven-year-old girl named Emily Whitehead sought experimental treatment for leukemia. Doctors "genetically engineered her own blood to kill cancer," known as T-cell immunotherapy. The leukemia completely disappeared and she has been in remission ever since.
Fortunately, considering how dry of a topic this could be, Darcy has written it as a series of human interest stories about the patients involved, making it impossible to put down. She should be commended for not only shining light on one of the most horrific problems in society, but for saving many lives. Dr. Jonathan Bell, an award-winning scientist at the Center for Innovative Cancer Research at Ottawa Hospital Research Institute in Canada, perhaps summarized the problem the best: "It's unethical to withhold these treatments if there's a potential there."
Rachel Alexander and her brother Andrew are co-Editors of Intellectual Conservative. She has been published in the American Spectator, Townhall.com, Fox News, NewsMax, Accuracy in Media, The Americano, ParcBench, and other publications.
Buy Right to Try at Amazon.com for only $19.88