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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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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 dont 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 Executive Director of Americans for Free Choice in Medicine.

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