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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 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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Finding Alternatives to the Food and Drug Administration

By Richard E. Ralston

Since the Federal Food and Drug Act came into law in 1906, the Food and Drug Administration (FDA) has had a century to develop their methodology for insuring drug safety. After expanding to an annual budget of $1.5 billion and a staff of 10,000, they continue to seek additional responsibilities—such as the same control and approval authority for over-the-counter vitamins and nutritional supplements that they exercise over prescription drugs. Now they announce that, whatever their other priorities are, they have not been able to adequately insure the safety of prescription drugs and want to establish an additional bureaucracy in the form of a new "Drug Safety Board" to do so. The first proposed solution to administrative failure in government, no matter how vast the agency, always seems to be more regulation, more staff, and bigger budgets.

The FDA has undoubtedly prevented much harm from unsafe drugs that might otherwise not have been vetted—although this could have been accomplished by other means. But it added enormously to the development cost of new drugs, thereby substantially adding to their price, and delaying their benefits being available to patients—sometimes for many years. It has also, with cruel indifference, prevented access to experimental drugs by terminally ill patients who are near death and willing to take some risk to stay alive. With all this control and lengthy review, we clearly still have drug safety problems, and it is time to explore options other than adding to the size and power of the FDA.

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. Unexpected consequences can now quickly be detected and dealt with. The incredible benefits to health and longevity that new drugs have achieved in recent years clearly require that we make it possible for new drugs to come to market at reasonable cost.

We need to open up the approval process for new drugs to private laboratories, both corporate and non-profit. This could take the form of both monitoring and observation of the testing by the drug companies themselves, and testing by independent research facilities in the final stages of development. Independent laboratories would be liable only for the accuracy, integrity, and robustness of their research, not for all possible future side effects of new drugs. Such research should be funded by the drug companies themselves, paid to third party institutions that would randomly assign the research to the independent laboratories that meet qualification standards.

These reforms could be undertaken over an extended period, selecting one category of drugs at a time. It could apply only to new research, so that work currently underway would not be interrupted. We should explore this and other alternatives to placing our health exclusively in the hands of omniscient and omnipotent government. The FDA cannot be omniscient, and we must not allow it to seek omnipotence.

The best protection for patients is the self-interest of drug companies. The beauty of private research is that is has to get results. Drug companies will prosper only if they bring drugs to market that are effective without unreasonable side effects—and as they maintain a reputation for doing so. In addition to whatever independent review process is used, we may also rely on the self-interest of legions of trial lawyers to pursue any malfeasance that might circumvent the review process.

Freedom is a more thorough and relentless defender of safety than layers of bureaucracy. Expanding freedom can benefit our health far more than concentrating power.

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

Copyright © 2005 Americans for Free Choice in Medicine. All rights reserved.

 

 

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