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Is the Food and Drug Administration (FDA) Protecting Us or Serving the Drug Companies?
While all of us are used to hearing that some Member of Congress has been indicted or that a local politician admitted to taking a bribe, most of us have felt that certain parts of our federal government are somehow above reproach. Particularly this has been the perception of the U. S. Food and Drug Administration (“FDA”). The FDA is non-partisan and protects us from bad food and bad drugs.
Officially created in 1906, the FDA’s mission statement says that it is responsible for “protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” The items regulated by the FDA account for 25 cents of every dollar spent by consumers.
However, there is increasing evidence that this confidence is misplaced and that the FDA is really not representing us at all.
HOW A DRUG IS APPROVED
The Center For Drug Evaluation and Research (CDER), a branch of the Food and Drug Administration (FDA), is responsible for approving new drugs. The CDER says it has the mission to assure that “safe and effective drugs are available to the American people.”
After extensive testing in the lab and in animals, some drugs are given approval for testing in humans. Because of a legitimate concern that these tests on humans be as safe as possible, the human test subjects are carefully selected and only include people who will have the least likelihood of having problems.
A drug is tested on humans in Phase I, II and III clinical trials. Phase I clinical trials normally are done on approximately 100 healthy volunteers. If this trial produces acceptable results, the company goes on to Phase II.
Phase II trials generally involve 100-300 volunteers who have the condition which the drug is intended to treat. If the results of this test are acceptable, then Phase III clinical trials are started.
Phase III clinical trials generally involve approximately 1,000 subjects and generally last from four to eight weeks but sometimes involve more people and last longer.
THE DEFINITION OF SAFE
If the FDA reviews the results of the Phase III clinical trial and determines that the drug is “safe”, then it is released to the public. When most of us hear the word safe, we think of “not dangerous” or “unlikely to cause or result in harm, injury, or damage.” According to Janet Woodcock, M.D., director of the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), safe has a different meaning to the Food and Drug Administration.
When it comes to any drug, “safe” means that the benefits of the drug outweigh the risks for the population the drug is intended to treat and for its intended use. “Safe does not mean harmless.”
So safe does not mean harmless, but the CDER has determined that the benefits of the drug outweigh the risks and that is why there are paragraphs of risk factors associated with the use of the drug. This may not be so bad, but how can you know if the benefits outweigh the risks if the test is done on a tiny percentage of the population, less than .001% of the population?
The CDER confirms this when it says, “So, the safety profile for new drugs that come on the market is never totally defined because new drugs are studied only in relatively small and homogeneous patient populations. The complete safety profile of a new drug will be defined only after it has been approved and is in use on the market.”
All of us realize that there are some illnesses, like cancer, which are often fatal, and we certainly know that a cancer drug that causes harm to some cancer patients but may help others is one, if the risk is known, that a cancer patient might choose to take. However, the key here is for someone to tell us that we are actually participating in an unofficial test of the safety of a new drug when it is prescribed by our doctor.
To compound this further, many drugs are being prescribed to treat things for which they were not approved by the FDA. This is called “off-label” use. For example, many antidepressants are being prescribed for the treatment of pre-menstrual syndrome (PMS) or elbow pain or are being used to promote weight loss. While this is legal (a doctor can prescribe a drug for any use), it is dangerous.
Dr. Randal Stafford co-wrote “Off-label Prescribing Among Office-Based Physicians”. This article was published in the May 8, 2006 Archives of Internal Medicine.
The article concluded, “Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use.”
AFTER A DRUG IS RELEASED TO THE PUBLIC
However, since the FDA is charged with protecting our safety, a reasonable person would assume that the FDA is closely monitoring the effects of these drugs in their real tests on the American public. Unfortunately, this is not the case. According to the 2003 report of the Office of Inspector General of the Department of Health and Human Services, a survey of CDER reviewers revealed that 66% lacked confidence in the FDA’s safety monitoring of marketed prescription drugs, and 18% had felt pressure to approve a drug despite reservations about its quality, efficacy, or safety.
Perhaps some of the reason for the reluctance of the FDA to make sure the American people understand the limited testing of new drugs is that the FDA does not think of the American public as its clients.
David Graham, Associate Director of the FDA’s Office of Drug Safety, in an interview that appeared in Fraud Magazine (September/October 2005 issue) stated, “FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent, it views its primary mission as approving as many drugs as it can regardless of whether the drugs are safe or needed.”
A reason for this attitude is likely the fact that more and more of the FDA’s budget is coming from “user fees.” These are fees paid to the FDA by the companies who are seeking approval of their drugs. It is natural to want to please the people who are paying your salary. The FDA no longer has to go to Congress to get a significant amount of the funding for drug approval and oversight.
In 2006, the Union of Concerned Scientists and Public Employees for Environmental Responsibility distributed a 38-question survey to 5,918 FDA scientists in order to examine the state of science at the Food and Drug Administration. The results are distressing. The scientists who responded pointed to significant interference with the FDA’s scientific work which in turn led to problems with the FDA being able to fulfill its mission of protecting public health. Here are some of the results:
- Less than half (47 percent) think that the “FDA routinely provides complete and accurate information to the public.”
- Less than half (49 percent) agree that “FDA leadership is as committed to product safety as it is to bringing products to the market.”
- One-fifth (20 percent) say they “have been asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.”
- In addition, more than a quarter (26 percent) feel that FDA decision makers implicitly expect them to “provide incomplete, inaccurate, or misleading information.”
- Two in five (40 percent) said they could not publicly express “concerns about public health without fear of retaliation.” More than a third (36 percent) did not feel they could do so even inside the confines of the agency.
- Nearly 70 percent do not believe the FDA has sufficient resources to effectively perform its mission of “protecting public health, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
Looking at the results of the Union of Concerned Scientist’s study, one recalls the words of Joseph Goebbels, Hitler’s Minister of Propaganda:
“If you tell a lie big enough and keep repeating it, people will eventually come to believe it. The lie can be maintained only for such time as the State can shield the people from the political, economic and/or military consequences of the lie. It thus becomes vitally important for the State to use all of its powers to repress dissent, for the truth is the mortal enemy of the lie, and thus by extension, the truth is the greatest enemy of the State.”
It is time for Congress to look at the Food and Drug Administration and shine the light of truth on it before it is too late. If the FDA is not looking out for us, then we need to understand this and know that it is up to us to protect ourselves by demanding full disclosure before taking any FDA-approved drug for any reason. Maybe that’s not a bad idea anyway.
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