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.
In recent years, the FDA’s 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 FDA’s 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 patient’s 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 don’t.
For example, the FDA restricts doctors from using a patient’s stem cells or genetic information for that patient’s own treatment.
A “black box” warning, the strongest the FDA may require, informs physicians and patients that a drug is safe–except when it isn’t. 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
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