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Commentary

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 FDAís 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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The Power of the FDA Must End

By Richard E. Ralston

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 FDAís congressional and ideological patrons.

In recent years, the FDAís pernicious power over drug and medical equipment manufacturers has been aggressively extended into micromanagement of the private practices of physicians and the treatments permitted for their individual patients.

The FDA, however, is not monolithic. Some FDA employees are trying to improve the health of Americans. Divisions compete with each other over policies and their own authority.

But those factors are completely overwhelmed by the inertia of bureaucrats who manipulate the political system to their own advantage and push through legislation to serve their political agenda.

The unstated principles behind the FDAís use of naked government power include:

  1. No drug or medical equipment may be manufactured without government permission.
  2. No physician may provide treatment to a patient without government permission.
  3. No terminally ill patient may have access to drugs without government permission.
  4. Nothing from a patientís body, such as stem cells, may be removed and used in their own treatment without government permission.
  5. No treatment approved for one purpose, if found effective for another purpose, may be used for the latter without government permission.
  6. No knowledge, technical skills or experience may be applied by medical specialists without permission of FDA officials, whether those officials possess such qualifications or not. (The ignorance of the government must always trump the experience of those actually practicing medicine.)
  7. No treatment found to be safe and effective in Europe, Japan or anywhere else is permitted if not FDA-approved.

In essence: no physician may continue to practice medicine, and no American may live without government permission.

The FDA bases their demand for omnipotence on their goal of omniscience—endeavoring to determine the efficacy of every new drug in any dose, for any treatment, for any patient in any condition, with any other ailments, in combination with any other drugs in any doses.

But only the experience of physicians with individual patients can assess, over time, the appropriateness of a particular drug or treatment for a particular patient—if the FDA would permit it. But they donít.

For example, the FDA restricts doctors from using a patientís stem cells or genetic information for that patientís own treatment.

A "black box" warning, the strongest the FDA may require, informs physicians and patients that a drug is safe—except when it isnít. The FDA may spend years of evaluation and hundreds of millions of dollars to assert that level of impunity while demonizing a drug that might be an effective and needed treatment for certain patients.

In many cases, by the time the FDA grants permission to use drugs or medical devices, hundreds of thousands of terminal patients have died while waiting for them. After all, the important thing is to preserve the powers of the FDA.

A lab or clinic that receives grants from a competing drug company can build a computer model to arbitrarily merge data from the research of others to claim that a drug is dangerous. Then they share their findings with the staff of a congressional committee and the press.

A political process thereby replaces a medical one, and the progress and effectiveness of personalized medicine is destroyed.

Government involvement in medical care does not ensure better care but leads to its degradation, while making it less available and more expensive. Like Obamacare, the FDA actually threatens our health. We must now begin the process of rolling back the powers of the FDA if we want to remain free and alive.

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

Copyright © 2013 Americans for Free Choice in Medicine. All rights reserved.

 

 

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