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Waiting on the Government
Perhaps those at the Food and Drug Administration (FDA) who are responsible for more delays in the approval of the drug Eteplirsen were inspired by the imaginative approach of their colleagues at the Department of Veterans Affairs, who compared the long delays in treating veterans to waiting in line at Walt Disney World. It is "the quality of the overall experience" that the VA says we should consider, not the time it takes. . . . Read more

First, Do No Harm: A Few Simple Rules for the FDA
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. . . . Read more

FDA Horror Stories
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. . . . Read more

The Power of the FDA Must End
The Food and Drug Administration is a huge, unwieldy, distant and indifferent bureaucracy. After more than a century of regulation, it follows a well-established pattern in the history of the U.S. Government. It relentlessly, voraciously and persistently seeks to increase its spending, regulations, authority and staff. The result is the subordination of the best interests of patients in favor of serving the FDAs congressional and ideological patrons. . . . Read more

Asking the Government for Permission to Live
The Food and Drug Administration has gone to court to prevent the Colorado-based firm Regenerative Sciences from using stem cells developed in one part of your body (bone marrow) to repair damage in other parts of your body, such as joints. The FDA objects to the fact that these cells are chemicals, the use of which the agency has the power to regulate even though the cells are taken from your body to later be injected back into your body. . . . Read more

Freedom from the FDA
The FDA adds billions of dollars to the cost of developing new drugs and delays their use for years. Yet it is so obsessed with predicting exactly how each drug will perform for any patient—with any condition, in any dosage, for any length of time and in any combination with any other drug or combination of drugs in any dosage—that it often loses sight of safety. So a few years ago the FDA proposed the creation of a new "Drug Safety Board" to provide for drug safety. One would have thought that was the purpose of the whole agency. . . . Read more

Finding Alternatives to the Food and Drug Administration
First of all, we need to realize that neither the FDA nor anyone else can do the impossible. When a new drug comes to market, no one can know all of its side effects, nor the impact on all other medical conditions that a patient might have, nor how it might interact with any dosage of any combination of an infinite number of other drugs—nor the cumulative effect of ten, twenty, or thirty years of use. If omniscience is required, no new drug will come to market. The good news, however, is that computers and the Internet now provide excellent tools to accumulate and tabulate data on the impact of every new drug. . . . Read more

Free Markets: The Key to New Drugs at a Reasonable Price
The U.S. pharmaceutical industry spends $22 billion a year on research and development of new drugs. Unlike government-funded research—which can be spent to develop drugs that no one needs or that duplicate existing drugs—pharmaceutical companies must get results. In order to recover their investment, their new drugs actually have to work. The continuing flow of new drugs that these firms produce is the best hope we have to treat and cure our ailments. . . . Read more

A Prescription for Disaster
At a cost of $400 billion over 10 years, Congressional Republicans have agreed in Conference Committee—with the enthusiastic encouragement of a Republican president—to the greatest expansion of government in two generations. This new Medicare program can only result in what government supplied health care has always produced in the U.S. and elsewhere: fewer new drugs and a lot more government. Of course, after a few years in practice we all know the program will end up costing a lot more. . . . Read more


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First, Do No Harm: A Few Simple Rules for the FDA

By Richard E. Ralston

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.

Richard E. Ralston is Executive Director of Americans for Free Choice in Medicine.

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