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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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AFCM Executive Director Richard E. Ralston's Testimony

FDA Open Public Hearing
July 30, 2007

Endocrinologic and Metabolic Drug Safety and Risk Management Advisory Committees to the Food and Drug Administration

Gaithersburg, Maryland

"Good Afternoon. I am Richard Ralston, Executive Director of Americans for Free Choice in Medicine. We are a non-profit organization providing public education on free market approaches to health care. We advocate the principles of individual rights of physicians and patients and personal choice as the only proper basis for health care policy. We support the economic and moral rights of businesses to make profits as the result of developing and producing medications, and of their investors to obtain a substantial return on their investments. We hold that this provides the best hope for the development of new drugs for America and the world.

"I need to disclose that my organization received a contribution of fifty dollars from an employee of Pfizer a few years ago which was later matched with a gift of fifty dollars from Pfizer. No other gift from a pharmaceutical firm or organization has been received, nor any reimbursement for travel expenses.

"I should also say that I have been managing my own Type 2 Diabetes for some years. I have previously taken Avandia, but now rely on insulin. I once participated in a clinical trial of Lantus.

"I have no qualifications to evaluate the safety or efficacy of any prescription drug. I am not a physician or a scientist. I do not know how to conduct a clinical trial, or how to evaluate the results of such a trial. I do not know how to evaluate a "meta-analysis" of multiple clinical trials.

"I have been told that it is possible to compile the apples of one clinical trial conducted under one set of criteria and controls with the oranges of another clinical trial conducted under another set of criteria—but exclude the grapefruits of another clinical trial because it reported no adverse events—and then somehow come to conclusions not reached by any of those who actually conducted the clinical trials.

"But I don't understand it."

"In other words, my limited understanding of these methodologies puts me at approximately the same level of competence as the Chairman and members of the House Committee on Oversight and Government Reform.

"But I was not born yesterday."

"When results of a meta-analysis claim that a drug is killing people and should be taken from the market, why is it first reviewed with the majority staff of a committee of the House of Representatives as a part of discussing "pending legislation?" On what basis did the Chairman of that committee instantaneously issue a press release evaluating the findings of the meta-analysis and describe it as "a case study of the need for reform of the nation's drug safety laws?"

"Was this press release based on the Chairman's vast clinical experience? Or on his mature understanding of the human endocrine system? If not, was his press release itself a "case study," but a case study of how to distort, manipulate and manufacture research data to support a political agenda?

"If patients taking the drug are presumably dropping in the streets from heart failure, why does a prestigious medical journal first take the time to write an editorial in pursuit of a political agenda as a part of publishing the research?

"Lastly, why would someone who has been publishing clinical research make the statement on a national television program—broadcast to the general public—that "the deaths caused by Avandia could dwarf the carnage of September 11, 2001?" As I am not familiar with the austere technical terminology of reports on clinical trials, can someone explain to me what were the exact clinical results and what were the precise metrics that justified such a statement? And from the perspective of objective peer review, what could have been the purpose of such a statement? Is there something going on here besides science?

"I am concerned that the tremendous power of the Food and Drug Administration over our health and daily lives has become a magnet for those with another agenda.

"To mention only two: there are those with so much antipathy for private business as such, that they would rather see people suffer and die for want of new medications than allow anyone, anywhere to make money from developing them.

"There are some law firms—already hovering over Avandia as a contingency fee jackpot of billions of dollars—who would prefer to see any drug driven off the market—no matter how many people it helps—if it presents an opportunity for a litigation bonanza that will only result in increased drug prices.

"My chief concern is what happens to patients in this process. What happens when patients are frightened away from drugs that are helping them? Or when physicians are intimidated from prescribing approved drugs? Do politicians issuing press releases, or researchers making polemical statements on television care about what they are doing to the countless patients that have been helped by a drug without adverse effect?

"There are two distinct issues here to which I would like to draw your attention. First is the politicization of research. Secondly, and more importantly, is what the use of such tactics implies about the core skills of the researchers and the reliability of their conclusions. Why are such tactics necessary if the science speaks for itself? When should publishing research be turned into a political and public relations campaign in the general media? And why? And do researchers who behave in this way employ the same tactics with the same zeal against the drug companies that fund their research as against those that don't?

"I am sure that I do not need to tell the members of this committee that there are those who would like to preempt or manipulate their advice to the FDA. Nor do I need to remind you that your advice must be based exclusively on sound science and the objective evaluation of clinical trials—and not on statements made on ABC's Nightline.

"Those who manipulate research for the purpose of increasing the powers of the FDA—which they can then further manipulate to achieve their political objectives—must not be allowed to control this process.

"Please rest assured that many of us realize all of these factors and how you have to contend with them.

"Thank you."

 

 

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