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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 FDA’s 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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Get Ready for the Vitamin Police

By Richard E. Ralston

The Food and Drug Administration (FDA) is now seeking to expand its considerable powers into the regulation of vitamins and nutritional supplements.

The FDA has evidently discovered that Americans, after centuries of experience doing so, cannot now be counted on to take vitamins or dietary supplements without poisoning or killing themselves. The FDA is concerned that we have not been getting their approval first.

Perhaps a disclaimer is in order here: We should all use informed and discriminating judgment before gulping down a tonic that claims effortless weight loss—while turning us into Don Juans who will live forever. But we should not be less cautious if the bottle bears an FDA seal of approval.

If some consumers recklessly disregard such caution, no Federal agency can help them. But this is America. If consumer health is destroyed by the willful malfeasance of a vitamin manufacturer, whole armies of trial lawyers stand ready to help put those firms out of business.

Assuming that many of these products do enhance the health of Americans, we will become less healthy when the FDA starts regulating them. If the FDA record on approving prescription drugs is any indication, the approval process for vitamins will require an expensive research and application process lasting years. This usually costs a minimum of $100,000, and will result in many products coming off the market.

The FDA does not just ask for research proving that something works. They often require that the manufacturer prove a negative—that it will not or cannot do harm. That makes the whole evaluation process very arbitrary. I used to buy artificial sweeteners in Germany that had been banned in the United States; for some reason they did not cause cancer in Germany. In the United States research showed that when extremely large doses were injected into rats, the rats developed tumors. The injections were a standard research technique used to simulate the effect of consuming the sweeteners for many years. Of course the same quantity of sugar injected into rats would have killed them instantly, but perhaps the FDA did not feel it was in the position to ban sugar. Now that might have saved millions of lives, but there was a complication: this is still a free country.

One of the reasons that the FDA uses to justify regulation is the need to control the dose of each product. They state (correctly) that people have sometimes unwisely taken too much of vitamins such as A or C. But what can the FDA do about it? What is to stop you from taking two or more pills? If we follow this line of reasoning, we should immediately remove aspirin from the store shelves.

Some representatives of the pharmaceutical industry support these FDA proposals. They may want these supplements to run the same nightmare gauntlet of obtaining FDA approval that they do. That is disgusting, but it casts some light on a wider issue.

What if a Federal Vitamin Administration (FVA) had been created during the New Deal in the 1930’s, and was now employing tens of thousands of people regulating vitamins? Anyone proposing its elimination, or even a bit of deregulation would be attacked for putting our health at risk.

Today the FDA adds billions of dollars to the cost of drugs. The FDA often needlessly delays the availability of new drugs for years. With all of those employees spending billions of dollars—and requiring pharmaceutical companies to do the same, they probably have prevented some accidents. But at what cost? The first principle of medicine is “do no harm.” What is the cost to our health of keeping many drugs off the market, and adding greatly to the cost of the drugs that survive?

Americans should not be asking what vast new areas of our lives require FDA regulation. We need to be asking how much less the FDA should be doing.

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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