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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 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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Asking the Government for Permission to Live

By Richard E. Ralston

The Food and Drug Administration (FDA) 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.

The FDA is accustomed to the process by which it requires that many years and millions of dollars be spent to approve drugs developed in a laboratory before anyone is allowed to use them. Regardless of clinical results that show use of stem cells to be highly effective, the FDA finds it intolerable to let you use the cells in your own body without prior approval by a vast and expensive bureaucracy.

It is a shame that no one told all of those who would benefit from stem cell research that the benefits of such research would not actually be available to patients. Treatment of individuals does not comply with the FDA's regulatory paradigm. Personalized medicine may work new miracles, but care for the individual must be subordinated to supervision by a multitude of administrators.

Growing government involvement in medicine, over generations, has resulted in control for the controller's sake. The most extreme example of this is the FDA's refusal, in many cases, to allow access by terminally ill patients to drugs that have passed the first phase of testing, which establishes safety. The FDA insists on protecting these patients from these drugs that have not been conclusively proven effective, taking pride in this perverse method of protecting the dead. As documented by the courageous Abigail Foundation, hundreds of thousands of these patients have died waiting for drugs already known to be safe—and which the FDA ultimately approved.

The use of stem cells, should the FDA eventually give its approval, may still have to pass many other obstacles, thanks to the wonders enacted by Congress. In 2009, Congress created the Federal Coordinating Council for Comparative Effectiveness Research and handed it $400 million as a part of the Stimulus Act. (Don't ask what that had to do with economic stimulus.) Now, anything that the FDA decides is safe and effective must run an additional gauntlet of effectiveness. It will not make a difference whether a drug is effective for some people or most people—it must be effective for everyone.

So much for personalized medicine.

In 2010, another hurdle was created with the passage of Obamacare. The Independent Payment Advisory Board (IPAB)—"independent" because it is appointed by the president—decides whether it will allow payment for any care, including use of your stem cells. If you are on Medicare and your physician accepts Medicare patients, you may not even use your own money for treatment with your own stem cells. No physician in Medicare is allowed to accept payment for anything not covered by Medicare.

Economist and columnist Thomas Sowell lamented last year that in such situations "you are not free to use your life's savings to save your life."

All this from a loving government that claims it only wants you to place your medical care and, ultimately, all of your decisions and freedom in its hands so it can take care of you.

And if that makes your joints ache, you may not be able to use your own money or your own stems cells to do anything about it.

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

Copyright © 2012 Americans for Free Choice in Medicine. All rights reserved.

 

 

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