FDA Incompetence and Bias Lead to Poor Ratings & Results

The US Food and Drug Administration ^[1] (FDA ^[2]) is celebrating a big improvement in its public perception. This year, only 47 percent of the US residents recently polled ^[3] think the agency is doing a poor job. That’s a marked improvement for the agency, down from 58 percent of those polled expressing a “poor” rating a year ago. The public’s poor perception of FDA is based upon facts that show the agency is incapable of performing its mission and is not aligned with public health and safety interests. Unfortunately, the declining public disapproval ratings of the FDA have more to do with the amazingly short-term memory of the American public and media which is bombarded with government scandals and crises (real or imagined) on a daily basis.

In recent years, the FDA has increasingly botched its duties to protect the American public from unsafe food and medicines. It has approved dangerous medicines such as Vioxx ^[4] based upon flawed studies that should have been detected. For years, it buried studies and evidence showing widespread mercury contamination in High Fructose Corn Syrup used across the US in thousands of common products. (See our previous story High Fructose Corn Syrup is Dangerous for Many Reasons ^[5] for more details.) And it continues to behave in a biased and irresponsible fashion to advance the interests of pharmaceutical and chemical giants over public safety and health. The FDA consistently relegates the interests of the public to a distant last place after its own higher priorities. The FDA’s high priority agenda includes protecting agency interests of having studies to examine, securing funding for its operations, fighting alternative and non-US medicine to crush any threats to its domineering nature, and protecting the financial interests of the mega-companies that produce those studies and fund drug lobbies and political campaigns. The FDA knows the people in nominal control are the politicians who have oversight over FDA, and knows that the real control resides with the money that funds the politicians. In short, the agency is effectively corrupted by bias to the core. It is incapable of doing its job by its very nature. Even the FDA itself knows it.

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FDA Report Indicts the Agency As Unable to Do Its Job

In a 60-page report issued in November 2007 entitled FDA Science and Mission at Risk ^[8], the review of the agency revealed extensive flaws and inadequacies in its staff and operations. Some of the most damaging conclusions are quoted below:

1. The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
2. The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
3. The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
4. The FDA does not have the capacity to ensure the safety of food for the nation.
5. The development of medical products based on “new science” cannot be adequately regulated by the FDA.
6. There is insufficient capacity in modeling, risk assessment, and analysis.
7. The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.
8. The FDA has substantial recruitment and retention challenges.
9. The FDA has an inadequate and ineffective program for scientist performance.
10. The FDA has not taken sufficient advantage of external and internal collaborations.
11. The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.
12. The FDA cannot provide the information infrastructure support to regulate products based on new science.

FDA Believes Big Pharma Lies — Case in Point: Vioxx

The Vioxx ^[4] drug scandal involved the FDA approving a pain reliever drug based upon misleading drug studies that avoided revealing the risk of cardiovascular clotting (leading to heart attacks and strokes) caused by the drug’s inhibition of the human body generation of prostacyclin ^[9], a natural biochemical that creates an anti-clotting action in the blood and vasodilates blood vessels, also reducing clotting risk. Due to the Vioxx ^[4] drug scandal that resulted in its maker, Merck ^[10], withdrawing Vioxx from the market on September 30, 2004.

Further showing the disregard for safety and the facts by some in the drug research community, it is common practice to design and manipulate drug studies to achieve results that can be used to market drugs for new purposes for which they may not even be safe and effective. The Vioxx story again provides an example of how this happens by demonstrating how corrupt to the core FDA and the “big pharma” research they oversee is through the recent discovery of extensive research fraud.

In March 2009, a major researcher responsible for much of the drug study literature backing Vioxx and similar painkillers that are COX-2 inhibitors was revealed. Dr. Scott S. Reuben ^[11] admitted fabricating 21 clinical trials and even signatures of supposed collaborating researchers who did not know their names were being used in conjunction with the studies as they had no involvement with them. These studies were used by Reuben, Pfizer ^[12] (which provided some of the study funding), Merck ^[10], and others to advance the argument that Pfizer’s drugs Bextra ^[13], Celebrex ^[14], and Lyrica ^[15] and Merck’s drug Vioxx ^[4] were effective and safe painkillers. Reuben’s research fraud has been compared to that of Bernie Madoff’s $65 billion fraud crimes:

Excerpted from Wikipedia: Scott Reuben ^[11]:

Scott S. Reuben (b. 1958) is Professor of Anesthesiology and Pain Medicine at Baystate Medical Center in Springfield, Massachusetts. Reuben was considered a prolific and influential researcher in pain management, and his purported findings altered the way millions of patients are treated for pain during and after orthopedic surgeries. Reuben has now admitted that he never conducted any of the clinical trials on which his conclusions were based “in what may be considered the longest-running and widest-ranging cases of academic fraud.” Scientific American has called Reuben the medical equivalent of Bernie Madoff, the former NASDAQ chairman who is awaiting sentencing for his admitted $65-billion fraud.

FDA Hides Mercury Poisoning of US Food Supply

As an example of FDA’s willingness to hide food safety dangers, consider the HFCS (High Fructose Corn Syrup) mercury contamination issue. This is much bigger than many of the smaller but better-covered scandals as it affects common foods widespread throughout the nation’s food supply. Products tested from big-name manufacturers such as Minute Maid, Coca-Cola, Hershey’s, Quaker, Hunt’s, Manwich, Smucker’s, Kraft, Nutri-Grain, and Yoplait had detectable levels of mercury.

US Food and Drug Administration ^[1] (FDA ^[2]) knew about this mercury contamination problem since 2005 but suppressed the information. The 2005 study which found 45% of the samples had mercury contamination was conducted by the FDA. But the agency kept it quiet and did nothing to correct the situation even behind the scenes! In March 2008, former FDA scientist Renee Dufault retired. As a researcher on that study, she was later able to go public with the news of the HFCS mercury contamination.

“Mercury is toxic in all its forms,” said IATP’s David Wallinga, M.D., and a co-author in both studies. “Given how much high fructose corn syrup is consumed by children, it could be a significant additional source of mercury never before considered. We are calling for immediate changes by industry and the FDA to help stop this avoidable mercury contamination of the food supply.”

Yet what has the FDA done in response? Something between “absolute nothing” and “more cover-ups” seems to be an accurate statement. We cannot help but wonder if the many mini-crises of salmonella poisoning at peanut plants and other such stories that broke around the time of the HFCS mercury contamination story going public were intentionally overblown to draw fire away from a much bigger mercury contamination problem.

FDA Blocks Access to Treatments Not Backed by Financial Corruption

Furthermore, the FDA frequently ensures that Americans are unable to use medical treatments proven to work. Some of these are well-substantiated outside of the US in reputable studies. But the FDA instead puts much of its energy and resources into crushing organizations and companies that don’t feed its corruption. That such groups and their treatments may be legitimate and relatively inexpensive means to address common health care problems is viewed as a threat to the FDA. Therefore they send agents and lawyers to attack these groups, sometimes for decades. Most end up shutting down under the unrelenting assault from the FDA. A few, such as Life Extension Foundation ^[16], have managed to fight off the FDA’s corrupt attacks and survive. The end result is that American access to inexpensive and effective health care is compromised so that the FDA and its allies can financially benefit.

Replace FDA With An Honest Public Health & Safety Agency

President Obama has claimed his administration represents “change” for the better. If that’s really the case, the US FDA should be shut down, dismantled, and replaced with a regulatory system and agency that aligns itself with the public health and safety interests, not the financial interests of big pharmaceutical and chemical companies and the politicians they bribe, lobby, and fund to serve their interests.

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Further Reading

U.S. Public Lacks Confidence in FDA: Poll ^[3]

FDA Science and Mission at Risk ^[8]

A Medical Madoff: Anesthesiologist Faked Data in 21 Studies ^[17]

High Fructose Corn Syrup is Dangerous for Many Reasons ^[5]

Life Extension: The FDA Indicts Itself (July 2008) ^[18]

Consumers Against High Drug Prices ^[19]

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