Right to Try: New Book Argues the FDA Has the Blood of Millions on its Hands

The U.S. Food and Drug Administration is needlessly stretching out the approval process for new, experimental drugs that have a proven history of success in clinical trials and that have been approved in other Western countries.

By Rachel Alexander Published on January 14, 2016

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. Everyone knows that the FDA has a problem with delaying the approval of drugs. But most do not realize just how bad the situation is  — hundreds of thousands of people, including children, may 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 problem is getting worse, because the FDA keeps increasing the delays. The agency 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 and responds variously to medications. Another problem is treating a variety of related diseases as identical. Peter Huber of the Manhattan Institute notes, for example, that scientists “have discovered at least ten distinct variations” of breast cancer. Indiscriminately testing one drug on all breast cancer patients is going to have mixed results.

In some cases, the FDA isn’t even delaying approval in order to establish the safety of a drug, but merely to measure its effectiveness. As Darcy puts it, people with terminal illnesses like Lou Gehrig’s disease (ALS) or cancer would rather have a 50 percent fighting chance than a 100 percent chance of dying. 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 terminal illnesses who went to great lengths despite the FDA to obtain these groundbreaking treatments. Some moved overseas. 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 they finally received the treatments and saw their illnesses diminish or even disappear.

Perhaps most disturbing of all are high numbers of children who die every year of terminal illnesses, children who might have been saved. Adding insult to fatal injury, the clinical studies themselves are cruel to children. Some parents drive their children hundreds of miles every month or so for the chance 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.”

One of the new methods that are used to treat 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 reverse leukemia. Other drugs in the works will combat depression, traumatic brain injury, schizophrenia, PTSD, mesothelioma and Alzheimer’s. Positive results have been achieved already treating Lou Gehrig’s disease, leukemia and more. But virtually none of these drugs used in these treatments 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.

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.

Left to right, Thomas and Emily Whitehead attend the Stand Up To Cancer Press Conference at the American Association for Cancer Research Annual Meeting on Sunday, April 7, 2013 in Washington, DC. Stand Up to Cancer is an initiative of the Entertainment Industry Foundation which funds Dream Teams of scientists to accelerate progress in cancer research .

Left to right, Thomas and Emily Whitehead attend the Stand Up To Cancer Press Conference at the American Association for Cancer Research Annual Meeting on Sunday, April 7, 2013 in Washington, DC. Stand Up to Cancer is an initiative of the Entertainment Industry Foundation which funds Dream Teams of scientists to accelerate progress in cancer research.

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 disappeared and she has been in remission ever since. My brother died from leukemia in 2009; had he had one of these non-FDA approved options, he might still be with us today. 

Fortunately, considering how dry of a topic this could be, Darcy has written the book 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 this tragic problem, but for helping readers learn how to obtain these prohibited lifesaving treatments. 

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