FDA horror stories
By Richard E. Ralston
You may think you have the right of access to drugs that could save your life. But at the urging of the Federal Drug Administration, the U.S. Supreme Court does not agree.
The FDA has vigorously defended its power to deny drugs to the terminally ill, and it has been successful. Apparently, you have no right to the use of any drug without government permission, no matter how long it takes to get it, if ever. And the FDA has no sense of urgency about anything except the preservation of its own powers.
Every year, forty thousand Americans die of pulmonary fibrosis. In 2010, a clinical trial of the new drug pirfenidone indicated improved lung function after use of the drug. The FDA's outside scientific advisory committee recommended immediate approval of its use.
Unfortunately, the results of another, inclusive trial were not statistically satisfactory for the FDA, so the drug was not approved.
While Americans continued to die every year, pirfenidone was approved for use in Mexico and China and such medically reckless places as Canada and Europe.
In May, another trial reported stronger results from treatment with pirfenidone, so the FDA may reconsider approval in a few months.
It seems that there is no need to hurry--if you don’t have pulmonary fibrosis.
The pirfenidone case reflects standard operating procedure for the FDA. For a century, the FDA has denied terminally ill patients access to new drugs that have passed the safety phase of testing but require final approval. The Abigail Alliance documents 19 medications for which it sought access on behalf of the terminally ill and which were approved by the FDA eventually. Many thousands of these patients died while waiting.
Uncounted Americans have died of skin cancer in the last 15 years while the FDA has failed to approve sunscreens used widely throughout the rest of the world. Acting U.S. Surgeon General Boris D. Lushniak issued the Surgeon General's Call to Action to Prevent Skin Cancer, but even he cannot act without FDA permission. He is only the surgeon general and a dermatologist--what does he know?
You may want the stem cells produced by your body injected into your knee by an orthopedic surgeon. But the FDA has successfully defended in federal court its exclusive power to regulate the use of stem cells. Your only hope is to leave the country and get the treatment elsewhere--if you can afford it. (Another excellent advocacy organization, Patients for Stem Cells, is fighting for the freedom of these patients to receive treatment.)
The FDA has given terminally ill patients a slim hope of survival by admitting them to clinical trials of new drugs to which they are otherwise denied access-- but half of them (the control group) are given a placebo instead.
When the FDA evaluates new devices, it turns the patients into a placebo by performing only "sham" surgery on half of them--pretending to implant new medical equipment, thereby providing only the risks of the surgery.
The FDA's behavior constitutes a dangerous and life-threatening pattern.
As the courts will not protect us from such outrages, our only options are legislation to allow dying patients access to new drugs and the complete replacement of the senior management of the FDA at the earliest opportunity.
Our lives depend on it.
Richard E. Ralston is the executive director of Americans for Free Choice in Medicine, Newport Beach, California. Copyright © 2014 Americans for Free Choice in Medicine. All rights reserved.