The FDA indicts itself

Life Extension, July, 2008 by William Faloon

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Some people enjoy saying "I told you so." I cannot under these circumstances. What you are going to read is too barbaric for me to brag that we knew it was going on all along.

Back in the early 1980s, Life Extension predicted horrific tragedies if government control over health care was not abolished. The heartbreaking fact is that tens of millions of Americans have needlessly suffered and died because of FDA incompetence. and the FDA now admits its own incompetence!

These tens of millions of lives lost are not statistics of strangers. Virtually everyone reading this column has family or friends who have been victimized by dangerous drugs or denied access to life-saving ones.

Rather than boasting that every flaw we identified about the FDA is now a documented reality, I instead view it as a failure that we could not persuade Congress to abolish the FDA's totalitarian powers decades ago. We certainly tried.

FDA UNCOVERS ITS OWN INADEQUACIES

I have appeared on hundreds of talk shows to expose how the FDA, in collusion with pharmaceutical giants and conventional medical orthodoxy, is the leading cause of suffering and death in the United States.

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Back in the early days, the FDA would defend its position by proclaiming that it served to protect the public's health. An endless number of well-publicized scandals have caused the FDA itself to admit that it is incapable of carrying out its mission. (1-10)

If all the FDA did was act so cautiously that it almost never approved a dangerous drug, then at least the agency could point to some consumer value it provides. Instead, we are plagued by an antiquated regulatory agency that stifles the development of novel life-saving medications, while allowing a slew of drugs to be sold that have cumulatively cost millions of lives.

Americans thus suffer the "worst of both worlds" as they are poisoned by FDA-sanctioned prescription drugs, but denied the fruits of novel approaches to disease prevention and treatment.

THE FDA'S INDICTMENT OF ITSELF

In response to a barrage of criticisms, FDA commissioner Dr. Edward von Eschenbach requested that a special committee assess whether the FDA is capable of doing its job. The premise for the FDA's massive audit of itself was the fear that "the nation is at risk if FDA science is at risk." (11)

The following are exact quotes from this 60-page report, titled FDA Science and Mission at Risk: (11)

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.

Most appalling is the FDA's own finding that it "cannot even keep up with the advances in science." (11) Said differently, this means that the FDA cannot keep up with scientific breakthroughs that could cumulatively save millions of human lives!

RESPONSES TO THE FDA'S DAMNING REPORT OF ITSELF

The Wall Street Journal wrote an editorial titled "The Real FDA Scandal" and quoted the following about the FDA's admitted statement:

"Particularly in complex and specialized fields like genomics and biotechnology medicine, the FDA lacks the basic competence 'to understand the impact of product use, to maintain ongoing currency with their evolution or to evaluate the sophisticated products produced' and 'to support innovation in the industries and markets that it regulates.'" (12)

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The Wall Street Journal further wrote, "Think about that: We live amid a revolution in biology, but the FDA still thinks like it did when Sputnik launched." (12)

Dr. David Kessler was the most publicly recognized FDA commissioner of all time. Dr. Kessler is still sought out by the media as a proponent on FDA issues. In response to this horrific report, however, Dr. Kessler stated, "The problems are way bigger than one commissioner. I'm not sure how anybody could do this job now." (13)

FDA commissioner Eschenbach stated, "I think to do what we need to do requires substantially more dollars than what has been invested in the FDA so far. This is a systemic overhaul that must go on for years." (13)