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First, do no harm: A few simple rules for the FDA

By Richard E. Ralston
web posted May 2, 2016

Top management recently changed at the Food and Drug Administration (FDA), with a new commissioner, Robert M. Califf, in the top spot. Therefore, this is a good time to review the basic principles upon which the FDA should base its decisions.

The first principle is not that the FDA is in charge of American medicine but rather that patients and their physicians are in charge of their care.

From that follows "First, do no harm."

You and your physician should not have to ask the FDA for permission to use a medication. If you have a terminal illness, you should especially not have to ask the FDA for permission to live. Unfortunately current law says that you do.  

The U.S. Supreme Court has ruled that you must comply with that law.

Therefore, we must change current law.

The first reform at the FDA must be compassionate, early access for the terminally ill to new drugs and treatments that have cleared Phase 1 safety approval.

With a large bureaucracy like the FDA, we have to be clear about the meaning of "access." It does not mean a right to submit hundreds of pages with applications and wait for months to get approval. It means prompt access.

"Prompt" means before you die.

Organizations like Patients for Stem Cells and the Abigail Alliance have made a courageous effort to obtain access for patients to medical advances. The Abigail Alliance has cast light on the thousands of patients who have died while waiting for the FDA to clear use of many drugs that were eventually approved.

Once safety has been addressed, the study of "comparative effectiveness" should not delay compassionate use of a new drug or procedure. A vain search for omniscience should certainly not delay the availability of a drug to the terminally ill. Yet "comparative effectiveness" review has blocked approval of drugs proven to help some patients because they do not help all patients in the same way.

No drug is safe in any combination with any other drug or combination of drugs in any dosage anywhere, for every age, race or gender. The goal of the FDA should be saving lives, not publishing exhaustive research papers. Caution and careful judgment are required, but demanding absolute certainty can kill people.

The FDA must neither forbid nor subsidize new drugs because they are too expensive but allow use by individuals or firms that can afford them. Anyone should be free to use their life savings to save their own life. Their experience will provide important information that will benefit everyone.

It is vital to maintain an environment in which firms can make significant investments in research on new medications and treatments with the prospect of a return on that investment. The FDA must give no credence to those who would prefer that patients suffer and die rather than allow anyone to make money helping them. Envy can also kill.

One certain principle that the FDA must apply: If patients have the right (as they should) to use willing physicians to help them die at the end of their lives, they must also have the right to investigational drugs that may save their lives.

These and other life-saving principles must be at the foundation of the FDA and the clinical details that determine drug safety and effectiveness. In a constitutional republic based on an inalienable, individual right to life-- among other rights--patients must have the unmitigated right to drugs that may keep them alive. ESR

Richard E. Ralston is executive director of Americans for Free Choice in Medicine, Newport Beach, California. Copyright © 2016 Americans for Free Choice in Medicine. All rights reserved.





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