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NewsTarget.com printable article

Thursday, August 25, 2005

American Medical Association calls for wholesale reforms of the FDA

There's a major development unfolding in the world of conventional medicine. As you know, I've been calling for major reform of the FDA for several years. Other pioneering doctors and natural health physicians have been voicing such calls for decades. But recently, the journal of the American Medical Association joined us in calling for comprehensive, radical reforms of the FDA. This is unprecedented in the world of modern medicine.

In these calls for reform, which were published in a strongly worded editorial in JAMA, the AMA says, "It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong." In other words, the Journal of the American Medical Association is saying that we can't trust the FDA to investigate itself. Clearly, the FDA's credibility is all but destroyed after revelations that the agency helped cover up the dangers of prescription drugs like Vioxx, which ultimately have led to the injury and even death of potentially hundreds of thousands of Americans.

The agency has quite clearly sought to protect the profits of drug companies at the expense of public health. It has ignored its own drug safety scientists such as chief drug safety researcher Dr. David Graham, who was silenced by the FDA for years as he attempted to warn the public about the dangers of Vioxx, Bextra and other drugs. The FDA clearly cannot be trusted to protect the American public. In fact, I believe the FDA's actions to this date are criminal in nature, and that the Justice Department should initiate an investigation to hold key FDA decision makers criminally responsible for the untold death and suffering they have unleashed upon the American public.

The American Medical Association hasn't gone that far, but they do state that the trust in the FDA has been all but destroyed and that it is impossible for the FDA to investigate itself. The FDA, for its part, denies that it has done anything wrong, and this indeed is part of the problem. It cannot see its own bias; it's in pure defense mode, rejecting all criticisms, claiming that it is the "gold standard" of drug safety around the world. The FDA even claims that Vioxx was handled in an ethical, responsible manner and that the agency did everything in its power to protect the public. These statements are beyond ridiculous. They represent such distortions in the mind of the FDA defenders that they can only be called psychotic in nature. It seems quite clear that these defenders of the FDA are suffering from rather serious mental disorders on their own. Perhaps they need to be on antidepressant drugs.

Aside from all of this, the FDA also has a rather lengthy history of suppressing alternative medicines such as herbal medicine, nutritional supplements, vitamins, homeopathy and other modalities that are not under the control of the pharmaceutical industry. This is something that has not received much public attention, but which may receive attention in the years ahead as the true criminal behavior of the FDA begins to unravel and be made public.

It is quite accurate to describe the behavior of the FDA and the pharmaceutical companies as that of a criminal racket similar to Big Tobacco in its efforts to market a dangerous product to all Americans including young children. The FDA, in conjunction with the pharmaceutical industry, has been and continues to be engaged in the systematic suppression and discrediting of alternative medical supplements and products that are well proven to prevent chronic disease and even treat those diseases in a much safer manner than prescription drugs. In my view, the most serious crimes of the FDA are not its handling of Vioxx, nor its censorship of its own scientists... the real crimes are much larger and still not being discussed publicly. The crimes are the systematic suppression of alternative therapies and the exploitation of the health of the American public for corporate profit. It's worse than Big Tobacco. It's worse than Enron. Because in this case we're talking about the lives of literally millions of people.

Of course, not everybody in the medical community agrees that the FDA is engaged in criminal behavior. But certainly more and more are now convinced that the FDA has lost its credibility and can no longer be trusted to monitor the safety status of prescription drugs. Make no mistake: there are certainly people within the FDA who are credible, well-informed drug safety scientists who could do a fantastic job of protecting the health of the American public. Unfortunately, those people don't call the shots at the agency. Right now, the FDA is run by power-hungry bureaucrats who silence the drug safety scientists that should be running the show!

So what are the alternatives to today's FDA? As the American Medical Association editorial suggests, it is time for us to start a new department. A department to oversee the FDA. This is precisely what I suggested many months ago when I promoted the idea of a Department of Internal Affairs at the FDA. This would be similar to IA offices in local police departments that are charged with investigating police corruption and making sure that those who enforce the law are not themselves breaking the law. Clearly, we need some kind of Department of Internal Affairs at the FDA today. And the first job of such a department should be, I believe, to investigate the behavior of FDA officials and press for criminal charges against those responsible for the actions on prescription drugs that have harmed and killed American citizens. It is only with the threat of criminal prosecution that the remaining FDA employees will come to their senses and start doing the jobs they were supposed to do in the first place, which is to regulate the pharmaceutical industry, not protect it and promote it.

At the same time, it is important that this new Department of Internal Affairs, or whatever it ends up being called, is staffed with people who do not have financial ties to the pharmaceutical companies themselves. Because that's the problem with the FDA today. The vast majority of decision makers at the FDA either have worked for drug companies in the past or are likely to work for drug companies in the future. Furthermore, it should be illegal for any person who works at the FDA to own stock of drug companies or to be on the payroll of drug companies, because if these people are being funded by drug companies then obviously it is in their financial interest to make sure that drug companies succeed financially. It is an obvious and potentially deadly conflict of interest that must be immediately rooted out and eliminated.

Overview:

Source: http://www.newstarget.com/003203.html

The next thing that should be done in reforming the FDA is to reverse some of the dangerous and poorly made decisions put in place by the FDA over the last few years. The most obvious of these is the legalization of direct-to-consumer advertising by drug companies. This decision was made in 1997 and it allowed drug companies to place ads on television, in magazines, newspapers, billboards and other media with the purported goal of "educating" consumers about prescription drugs. And yet the very premise is laughable. No reasonable person could possibly believe that drug companies should advertising prescription drugs to patients who don't have medical qualifications to even understand if they should use those drugs in the first place. The idea of pushing these drugs to patients so that they go to their doctors and request them by name is medically reckless. It has no medical basis whatsoever. It is clearly just a ploy that was approved by the FDA to financially benefit the drug companies at the expense of public health.

It is this direct-to-consumer advertising, in fact, that is largely responsible for the over-medication of people with dangerous drugs such as Vioxx. This direct-to-consumer advertising continues today, and it is adding to the problem by creating an over-medicated nation where patients think they have to make a list of advertised drugs, then go to their doctor and request them by name. Many times, patients don't even have any idea what these drugs do -- they just see these images of happy, healthy people on television who have been hired to play roles in these drug advertisements, and the patients of course think they want to feel that way too, so they go to their doctor and request these drugs.

The whole system is absurd. First of all, people who take prescription drugs aren't healthier in the long run anyway. The more drugs you take, the worse you get, because every drug has unsafe side effects as recently admitted by the FDA. Every drug you take makes you less healthy in the long run. There is no prescription drug that is as good for you as changing your lifestyle, engaging in physical exercise, and making healthier food choices to prevent chronic disease. Prescription drugs have absolutely no place as lifelong chemicals to be consumed by human beings. At best, they should only be used for short term acute disorders as stop-gap measures to help people survive while they make lifestyle changes that eliminate the underlying cause of their health problems in the first place.

The next thing that should be addressed at the FDA is the dissolution of the financial arrangements between pharmaceutical companies and the FDA. Today, pharmaceutical companies actually pay the FDA to review their drugs. This turns drug companies into customers, and the more customers the FDA pleases, the more money the agency earns, meaning it can grow its own staff and expand its power base. So of course it's going to be in the long term interests of key FDA decision makers to please its customers. Those customers are the drug companies.

This financial relationship must end. The FDA should be funded solely by taxpayer dollars, not by drug companies themselves. This would allow the FDA the neutrality and the independent viewpoint from which it could make an honest safety assessment of prescription drugs.

One more thing that needs to be addressed is the drug side effects reporting mechanism, because today there is absolutely no requirement whatsoever for doctors to report toxic side effects from prescription drugs to the FDA. In fact, there is not even a requirement for drug companies to report their information to the FDA when they learn about toxic side effects in drugs. The reporting system is 100% voluntary. And that means it's nearly a miracle when any drug accumulates enough negative information to actually be banned by the FDA, because enough people have to volunteer that information, and it has to accumulate over time to the point where the FDA can no longer ignore it. This is a poor system for protecting the public health. The reporting of side effects from prescription drugs should be mandatory. This is common sense, and drug companies should be held criminally responsible if they fail to reveal evidence they have about the negative effects of prescription drugs.

So in effect, to look at this whole situation, we have one big problem, and that's the FDA as it exists today. It is broken. It is discredited. It is operated by ethically disadvantaged individuals who deserve to be prosecuted for not just endangering, but actually killing literally hundreds of thousands of American citizens. That is not an exaggeration of the statistics. But even if we create an alternative to the FDA, we still have three big problems that need to be addressed right away.

The first is direct-to-consumer advertising. The second is the funding of the FDA. And the third is the drug side effects reporting system. These three fundamental problems need to be addressed immediately if we are to live in a nation where we aren't killing our citizens with our own products that are actually safety approved by the government itself.

To put all this into perspective, keep in mind that prescription drugs have killed far more Americans, in fact thousands of times more Americans, than all terrorists combined. If you think terrorists have committed crimes against the American people, then what do you think about the pharmaceutical industry that kills 100,000 people per year according to the journal of the American Medical Association, or as many as 750,000 people per year if you agree with the "Death By Medicine" numbers that also include medical mistakes? And now with the knowledge that many of these deaths could have been prevented had the people at the FDA been doing their jobs, or had the people at drug companies been practicing even basic human ethics, then is this not a case of crimes against humanity?

Is this not a crime against the American people that should be immediately investigated and rectified? Frankly, I've seen far more law enforcement efforts exerted towards catching one murderer who has killed one person, and yet here we have an entire agency, a group of powerful people, whose negligent actions have killed hundreds of thousands of people, and there has yet to be serious law enforcement action initiated against them. Just because these people are government employees should not immunize them from criminal prosecution. In fact, I would say that as government employees, they should be held to a higher standard of ethics and protecting the sanctity of human life, because they hold substantial power over that life. And it is precisely this power that they have abused over a period of many years in order to achieve their own selfish aims of power, control and financial profit.

If all the people who had been killed by prescription drugs were able to rise up from their graves and march on Washington right now, we would see a revolution in medicine overnight. But unfortunately, they lie in their graves unable to speak the truth about what really needs to be done, and thus it is up to us, the survivors of this chemical nightmare, to take responsibility for this situation and make sure that we and our children are no longer harmed by this reckless "Fraud and Drug Administration" that has lost sight of its mission and any sense of value for human life.

Overview:

Source: http://www.newstarget.com/003204.html

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