Waiting on the Government
First, Do No Harm: A Few Simple Rules for the FDA
FDA Horror Stories
The Power of the FDA Must End
Asking the Government for Permission to Live
Freedom from the FDA
Finding Alternatives to the Food and Drug Administration
Free Markets: The Key to New Drugs at a Reasonable Price
A Prescription for Disaster
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.
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