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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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Medical Progress Requires Freedom of Information

By Richard E. Ralston

Sometimes drugs developed to treat a specific condition can have unanticipated results for the treatment of other conditions. Sometimes this is discovered by patients and their physicians as an accidental byproduct of monitoring the effectiveness of the medication. This in turn leads to more clinical research on these benefits, which confirm in a demonstrable way the benefits of the drug for other conditions. This is very useful information for physicians in need of new and effective treatments for their patients. It is natural that results of such clinical research are published in medical journals.

Unfortunately the Food and Drug Administration and many members of Congress take a dim view of providing copies of such journal articles to specialists most likely to need the information. It is often forbidden, even when the FDA has determined a drug that it approved for one illness has been used safely by many patients. Drug companies are not allowed to provide physicians with such research published in established medical journals.

It would be bad enough for the FDA to make it illegal for doctors to treat patients with an FDA-approved drug that was not specifically approved for the prescribed purpose (i.e., "off-label" use). But forbidding the dissemination of published information is worse. It basically asserts that free speech and freedom of the press are concepts that do not apply to medicine. That is ominous, as the forbidding of the publication of such journal articles is but a short step away. What happens to medical science if researchers cannot share the results of their research without prior government permission?

The FDA should not have the regulatory authority to outlaw plain common sense. When you try a new over-the-counter pain killer for a headache, you might discover that it relieves the pain from your arthritis more effectively than other medication. You are free to take it again to help deal with your arthritis even if the information that comes with the product talks only about headaches.

If a physician has patients who report unanticipated benefits from taking a drug, and if there is substantial published clinical research indicating that the new use of the drug is beneficial—and if the physician is allowed to read it—he should be free to make a professional decision to prescribe the drug if and when he sees fit to do so. That decision must be as informed and as cautious as any other prescription.

One of the reasons off-label prescriptions have become more important is the FDA's expensive and time-consuming approval process for new drugs. In many cases it is not worth the cost for a drug manufacturer to take a drug through that process a second or third time. That is especially the case if the relatively short term of their patent on the drug will soon expire. It will be even more unlikely under proposed measures that would require approved drugs to go through yet another lengthy review for "comparative effectiveness" with other drugs. (Soon a drug that is more effective for you may not be allowed if another drug is just as effective for other patients.)

We all have the right to expect our physicians to use their best judgment and make informed decisions—based on all information and research available—in prescribing drugs that are proven safe and have a well documented expectation for effectiveness. That right requires the unrestrained freedom to publish and disseminate information that physicians need to prescribe the on- or off-label use of approved drugs in the best interest of their patients.

We must remain free to protect our health and comfort without prior government permission.

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

Copyright © 2009 Americans for Free Choice in Medicine. All rights reserved.



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