The FDA Indicts Itself

William Faloon

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 1980’s, Life Extension predicted horrific tragedies if government control over healthcare were 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 lifesaving 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.

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 a 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. 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 is 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 incompetence:  

“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

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 publically 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 what we need to do require 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

Problems are worse than what FDA admits

In doing the research to write this editorial, I uncovered many recent reports from outside organizations harshly critical of the FDA. These reports made national news for a day or two and were then quickly forgotten.14-24

We at Life Extension cannot pretend these problems disappear the day after the news reports them. That’s because we are on the front lines every single day battling to keep our aging members alive and in good heath.

Our greatest impediment to saving human lives is an incompetent and corrupt federal bureaucracy that is strangling medical innovation, especially in the areas of genomics and biotechnology where breakthroughs in anti-aging medicine are most expected.

I routinely talk with scientists about methods to significantly extend our life spans, but the problem with “the FDA” inevitably arises. If the FDA’s bureaucratic roadblock is not torn down, we may all succumb to a disease that liberated scientists could readily prevent or cure.

Please know that there is not a magic immortality pill that the FDA is directly suppressing. Instead, the FDA is restraining the ability for medical science to progress. This is no longer just my opinion. The FDA themselves admit they cannot keep up with advances in science. So discoveries that could save human lives are not getting approved by the FDA and the cost is thousands of American lives being lost each day.

What can be done to stop this carnage?

There are a number of proposals to turn around this lethal barrier to medical progress called the Food and Drug Administration (FDA). Some politicians say throw more tax dollars at the problem, while other politicians refuse to reward an agency with so much documented incompetence.

We at Life Extension look at the hard science and the free market as the best solution to quickly end this bureaucratic abomination. Unlike scholars who leisurely debate the best way to reform the FDA, Life Extension is obligated to represent the health interests of our aging members today!

The FDA’s own report makes it clear that scientific innovation is suffocated by bureaucratic red tape and incompetency. Yet a medical renaissance is needed if our generation is to achieve dramatically extended life spans.

The only way to liberate scientific ingenuity is to allow Americans to obtain therapies that are clearly marked “Not approved by the FDA”. Under this free market scenario, those who want the so called “protection” the FDA previously pretended it provided could continue doing so.

Enlightened individuals and their doctors, on the other hand, would be able to choose novel therapies that are clearly labeled “Not approved by the FDA”.

Since it costs so much for a new drug to be approved, therapies that did not have to go this arduous (and antiquated) approval process would cost less than outlandishly priced “approved” prescription drugs.

Don’t let medical innovation be held hostage to FDA bureaucracy!

Back in year 2003, Life Extension initiated a poll on a website that has about 400,000 new visitors each month.26 The people visiting this site are not part of any anti-FDA group, nor were they exposed to anti-FDA propaganda. These people were asked a simple question as to whether terminally ill cancer patients should have the right to any drug that might save their life. After 22,506 votes were tabulated, the results were:

Terminally ill cancer patients:

• Should have access to any drug that might save their life: 89%
• Should only have access to drugs approved by the FDA: 11%

We live in a constitutional republic where the people's wishes are supposed to be adhered to (as long as they don't infringe on the rights of others). If 89% of the American public thinks terminal cancer patients should have access to any drug that could save their life, then there is no reason for the law not to be changed to allow Americans to access therapies “Not approved by the FDA”.

Companies that engaged in fraud could be prosecuted under consumer protection laws that already exist. The FDA could post its opinion about the safety and efficacy of unapproved therapies on their website (www.fda.gov). The civil litigation risks to companies that knowingly sold bogus products would preclude large-scale unsavory activities that some are concerned with. The greater fear Americans face is being diagnosed with a lethal disease only to find out that a cure is no where in sight.

Email your Congressional Representative and the Presidential Candidates

American citizens deserve the right to choose what goes into their bodies. Those who prefer therapies that are “Not approved by the FDA” should be allowed to do so, especially now that the FDA has come to the conclusion that it is too incapable and incompetent to keep up with scientific advances.

For longer life,

William Faloon