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.
This article continues in part two