Comprehensive Review of Vaccines: Part 4 of 12
As a society, we put our trust in the regulatory agencies established to protect us, but are they fulfilling their duties or are they protecting someone else? Government bureaucracies are political by nature, but now add the fact that there are hundreds of billions of dollars at stake and you have a recipe for almost certain corruption. Remember, these are the gatekeepers for all drugs coming on to market and their rulings determine which drugs come to market and which don’t. In part 4 of this series we take a closer look at these agencies and see where their loyalties really lie.
Food and Drug Administration (FDA)
In addition to the president Obama nominating a commissioner with financial ties to a dozen or more pharmaceutical companies, the FDA has an even bigger existing conflict of interest that we do not hear much about. In 1992 congress passed the Prescription Drug User Fee Act (PDUFA) which allowed the FDA to collect fees directly from drug manufacturers to fund the new drug approval process. What this legislation did was allow the very companies the FDA is supposed to regulate, to become its funders. Those who fund an organization enjoy privilege and control and this is no exception. Are we to believe that with all the money we spend on frivolous items that we cannot even fund our own federal agency to make sure our drugs are safe?
Dr. Marcia Angell
As we saw in part one of this article, the former Executive Editor of The New England Journal of Medicine, Dr. Marcia Angell, is very familiar with the pharmaceutical and medical industry. Dr. Angell wrote an article titled “Taking back the FDA” in 2007 with her critique of this fundamental conflict of interest in this agency.
Here are some excerpts from article:
But in 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay “user fees” to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process.
In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.
The FDA also refuses to release unfavorable research results in its possession without the sponsoring company’s permission. Here again, it contends not to have the authority to do so, but providing evidence of side-effects or negative results would seem to be an integral part of its job. It’s no wonder that serious safety concerns about drugs such as Vioxx, Paxil, and Zyprexa have emerged very late in the day — years after they were in widespread use.
The agency’s coziness with industry is underscored by the composition of its 18 advisory committees — outside experts who help evaluate drugs.
Incredibly, many of these advisors work as consultants for drug companies. Although they are supposed to recuse themselves if there is a direct conflict of interest, the FDA regularly grants exemptions from that requirement. Of the six members of the advisory committee that in 1999 recommended approving Vioxx — the arthritis drug pulled from the market in 2004 because it caused heart attacks — four had received waivers from the conflict-of-interest rule.
“The FDA now behaves as though the pharmaceutical industry is its user, not the public.”
– Dr. Marcia Angell, Former Executive Editor for The New England Journal of Medicine
Dr. David Graham
Dr. David Graham was a senior drug safety researcher at the FDA during the Vioxx scandal. He corroborates Dr. Angell’s sentiments as well. Dr. Graham researched Vioxx for several years before coming to the conclusion that the drug was unsafe and has caused over 100,000 heart attacks since its introduction. When he went to his superiors in the FDA about his concerns, he received feedback that was quite surprising. Instead of the FDA trying to remedy the problem with Merck, Vioxx’x manufacturer, they were disappointed in him, saying “why on earth did you study Vioxx and heart attacks anyway”? Dr. Graham was told, “drug manufacturers are our client, not the public.” When Dr. Graham said he is going public with the information he was met with strong resistance. Dr. Graham went public anyway.
Dr. Graham went on PBS in October of 2005 and aired his concerns. One of the other key takeaways from Dr. Graham is that he stressed that safety is not a concern for the FDA, but that their priority is to keep their clients (drug companies) happy. This is a very troubling characterization of what is supposed to be the nation’s last line of defense in regard to food and drugs.
The FDA is Not There to Serve the Public?
Dr. Angell and Dr. Graham told us that the FDA is there to serve the drug industry, which is a very profound statement and may sound extreme. Maybe it’s just a few agents who have this ideology. Unfortunately, when we look at the recent history and behavior of the FDA, it does seem to be a systemic ideology throughout the agency. What I mean by that, is that the FDA comes down extremely hard on any homeopath or natural health practice, while letting large pharmaceutical companies get away with murder — some might say literally. If you’re an organic raw milk farmer and the FDA gets you in their sights they will roll up with a dozen or more armed tactical agents and destroy or seize your product on the spot and take all your cash. Could you even imagine that ever happening to one of the big pharmaceutical companies?
Medical error is the third leading cause of death in America and pharmaceutical drugs account for a large portion of those deaths. There is a well respected paper published by Dr. Barbara Starfield from John Hopkins School of Public Health which concludes that there are over 100,000 deaths every year from pharmaceutical drugs alone. That’s almost 2,000 people a week dying from pharmaceutical drugs. It’s a matter of public record that pharmaceutical companies promoted products they knew were dangerous to the public and many lives were effected as a result. How many people are dying from raw milk? Yet, the supposedly understaffed FDA chooses to spend its precious time raiding and harassing raw milk farmers. I use raw milk farmers as an example, but this seems to be the case with any type of natural or holistic product that comes across the FDA’s radar – they pursue them with extreme prejudice. There are many examples of this and Natural News compiled a list of FDA raids and a timeline in an article titled “Timeline of FDA raids on raw milk farmers, dietary supplement makers and natural medicine practitioners.” It is plain to see that the FDA has been bought off by the drug companies to crush any competition they see as a threat to the drug makers.
This behavior is not just limited to the FDA, we have seen similar behavior from the American Medical Association, the National Cancer Institute as well as many other allopathic agencies. All one needs to do is look at Harry Hoxsey, Max and Charlotte Gerson, or Stanislaw Burzynski, to name just a few. These agencies do not appear to have the public’s best interest at heart and seem more like allopathic gatekeepers. If it is not a pharmaceutical drug or treatment and cannot be patented, one or more of these agencies will likely be called in to intervene.
The FDA and Dr. Stanislaw Burzynski MD, PhD.
Stanislaw Burzynski is a doctor in Texas who has been treating people with inoperable brain tumors naturally with great success. In fact, the first half hour of the documentary is solely about all the patients he has cured when traditional doctors gave up on them after trying every conventional method possible. The Texas Medical Board, backed by the FDA and the National Cancer Institute, spent years harassing Dr. Burzynski by continually filing complaints against him and trying to put him out of business.
The Texas Medical Board Filed against Dr. Burzynski at least a half a dozen times and they lost every time. It got so bad that many of his patients testified on his behalf to try to keep the treatment available or their children would have died. Keep in mind that Dr. Burzynski was not allowed to treat anyone who did not use AMA approved cancer treatment first and in most cases he was these patients last hope. Dr. Burzynski is by no means the only case where the FDA aggressively pursued natural healers, but this documentary captures exactly whose side the FDA is on and it’s not the people’s side. The FDA has clearly been compromised by the pharmaceutical industry. Like Dr. David Graham from the FDA told us: the FDA is there to serve the drug and medical industry.
Professor Donald Light
Donald Light is a professor at the University of Medicine and Dentistry of New Jersey School of Osteopathic Medicine and a founding fellow of the Center for Bioethics at the University of Pennsylvania. He is currently researching the historical roots of institutional corruption in the development of prescription drugs. In 2013 Professor Light wrote an article published by Harvard University’s Edmond J. Safra Center for Ethics titled “Risky Drugs: Why the FDA Cannot Be Trusted”