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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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Freedom from the FDA

By Richard E. Ralston

It took the Food and Drug Administration more than a century to grow into a massive, expensive, wasteful, inflexible, ineffective, distant and indifferent bureaucracy. It now violates a founding principle of the practice of medicine: "First, do no harm."

The FDA does a lot of harm, every day. Why do we allow that?

The FDA has kept some unsafe or ineffective drugs off the market (although a consortium of independent research organizations could have done the same thing). But at what cost? We can summarize in ten ways how the FDA threatens or does real harm to our health:

  1. The FDA adds billions to the development cost and price of new drugs.
  2. The FDA delays the availability of new drugs for years.
  3. The FDA prohibits the use of new drugs that treat conditions for which other drugs are available, regardless of how much better they might work for some patients.
  4. The FDA withholds new drugs—even those that passed initial safety tests—from terminally ill patients, in the name of preserving safety. When one of these patients wins access to the drugs by going to court, the FDA, apparently in a relentless effort to protect the health of the dead, appeals the ruling until the patient dies, at which time the appeal is of course dismissed.
  5. The FDA and Congress allow the drug approval process to be politicized to protect the interests of firms with political pull or to serve the anti-corporate political agenda of those who would rather see Americans die than allow any investors or businesses to make money developing new medications.
  6. The FDA suppresses off-label use of drugs with proven ability to treat other conditions and restricts the circulation of information about such successful off-label use of drugs that have already been approved as safe.
  7. The FDA actively seeks to extend the authority it so ineptly applies to drugs—and for which it asserts to have insufficient staff—to controlling all vitamins and food supplements. Whenever the reach of the FDA exceeds its grasp, it always tries to extend its reach.
  8. The FDA constitutes a roadblock to new developments in anti-aging drugs by refusing to consider any science that would extend healthy lifespans—because "aging is not a disease."
  9. The FDA states that it lacks the resources to ensure human drug safety but requests more resources to review veterinary medicine.
  10. The FDA now publishes lists of drugs it approved but the safety of which it questions—leaving physicians in the lurch and creating a potential jackpot for litigation.

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.

That hypocrisy is consistent with the history of the agency. Every failure to fulfill its purpose is met with a review or a study by another government-related organization hired by the FDA to make recommendations. The recommendations are always the same: more staff, more budget, more authority, more buildings, more office furniture and more regulations.

If we want the tremendous progress in the development of medications in recent years to continue, we must act to eliminate the awesome ability of the FDA to destroy that progress. The first steps in reform should be to direct the FDA to focus entirely on safety and allow physicians and their patients to determine efficacy. Research must be encouraged, not restricted, and information on that research must be open to all.

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

Copyright © 2008 Americans for Free Choice in Medicine. All rights reserved.

 

 

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