EDITORIAL

What’s Wrong with
“Good Intention” Laws

We were the first that ever burst into that silent sea.
— Samuel Coleridge

T he spirit of the explorers evoked by Coleridge animates his longest poem, The Rime of the Ancient Mariner, wherein a journey into the unknown is recognized as a natural expression of human energy. This exploration is a compelling expansion of human awareness. Although creativity is fraught with risk, where would we be without it?

The health of a nation is dependent upon constant exploration and discovery. Yet it can be said that Federal drug, food, and supplement regulations don’t take good care of us because they penalize and thwart creativity. Indeed, this is much the opposite of what is said by those who feed at the Federal trough, whether directly or indirectly. In their opinion, if it wasn’t for the government’s wisdom, protection, and compassion, the population would continually suffer the horrors of thalidamide-drugs, tainted meats, and toxic vitamins.

Cui Bono?

Who ends up fabricating the Federal drug, food, and supplement regulations? And who benefits (cui bono, in Latin)? Bureaucrats write the regulations, but who writes the laws? Congress does, and always with alleged good intentions, wherein lobbyists—especially the high powered ones with the biggest expense accounts—exercise the greatest influence over the structure of the regulations before they are turned over to the bureaucracy. In order of their influence, the pharmaceutical industry is overwhelmingly at the top. Cui bono?

FDA Drug Oversight Impotence

In a startling appearance on November 18, 2004, Dr. David Graham gave testimony before the U.S. Senate Committee on Finance. Dr. Graham had spent his career at the FDA studying the safety of drugs. The subject of the hearing was Merck’s withdrawal of the popular anti-inflammatory drug Vioxx the previous month because of serious safety concerns. In testimony, Dr. Graham affirmed his personal belief that FDA policies were insufficient to protect the public from drugs which carry unacceptable risks. He said “I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.”1 In the seven years that have passed, has anything changed? We doubt it.

In a massive self-analysis in 2007 (probably an attempt to gain a bigger budget), the FDA proclaimed that it lacked the competency and capacity to keep up with scientific advances.2 Among the major findings of this analysis:

  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

Isn’t that enough? Well, there’s more. In January of 2009, a letter was sent to the highest levels of United States government by FDA scientists and doctors accusing top FDA officials and attorneys of violating laws, suppressing and altering scientific findings and conclusions, abuse of power and authority, and retaliation against those who’ve spoken out.3 While the FDA finally acknowledged the letter’s authenticity, to date nothing has been done.

Indeed, the FDA has gotten so out of control and corrupt that it has totally lost its focus on what exactly it should be doing for public health. It is more than conjecture that the current system is most definitely broken, and must eventually be abolished if we want to regain both our health and our freedom, which are inseparable from one another.

Preventing Tainted Meat

To beat the drum, today the FDA, like other agencies in Washington, is hopelessly corrupt. Tyson’s Food, the largest producer of meat in the world, has also been a major contributor to both Republican and Democrat candidates over the years and was a major player in the rise of Bill Clinton. Yet, Tyson employees have ended up as hires by the FDA, the very agency that is supposed to regulate them. Can you believe that they are treated the same way that, say, the far smaller General Sausage, Inc. is?

Imagine a J.D. Power and Associates—an overall consumer product and service rating company—stamp on a package of meat. You can readily grasp that the involvement of private companies would transform the meat industry. Privatizing the whole process of the FDA’s regulatory activities would muzzle the cozy relationship between the agency and the industry it is supposed to regulate and this could make all the difference in the world.

The War on Supplements

As you know, supplement availability and affordability is currently being attacked on two fronts. On one hand is Senator Durbin’s bill, which grants the FDA power to arbitrarily ban supplements that have been safely used for many years, even without the need for any evidence that the supplements are actually dangerous. Then, on the other hand, are the FDA’s regulatory guidelines (in transit) that would cripple supplement innovation by turning an existing notification system for new supplements into a de facto pre-approval system.

None of this was intended by the Dietary Supplement and Health Education Act of 1994, passed because of a “perfect storm” of confluent political forces at the time. Yet, Congress never intended to make it increasingly difficult for newer and better supplements not to be developed. Nor did it conceive that all supplements marketed since 1994 would be retroactively jeopardized at some time in the future, even if they did not have a perfect record of safe use.

Challenging the Idea of “Good Intentions”

“Good intentions” are no substitute for the justice of the marketplace, where everyone has the opportunity to choose for him- or herself. Under the Precautionary Principle advocated by many bureaucrats, only 100% proof that a product will do no harm is acceptable to permit a product to be marketed. In the Brave New World where that is enforced, no drug, no food, and no supplement will pass scrutiny, and the world of creativity and innovation will come to an end. Rise up and let your voice be heard.

References

  1. FDA failed public on Vioxx, scientist says: Congress probes agency on arthritis drug safety warnings. http://www.msnbc.msn.com/id/6520630/ns/health-arthritis/t/fda-failed-public-vioxx-scientist-says/#.TvtvCfK7OuI. Updated November 19, 2004. Accessed December 28, 2011.
  2. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf
  3. Mundy A, Favole JA. FDA scientists ask Obama to restructure drug agency. Wall Street Journal, January 8, 2009.

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