Monday, February 27, 2012

Book Excerpt: Problems Associated With Government Regulators

Daily Health Tips Newsletter February 27, 2012
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Lessons from Jon Barron
Problems Associated With Government Regulators

  
In this week's excerpt from Lessons from the Miracle Doctors, Jon Barron discusses problems associated with government regulators.

Daily Health Tip Image"It doesn't matter what country you live in, you have an FDA-type regulatory authority promoting questionable pharmaceutical solutions while at the same time limiting your access to far safer alternatives. A 2006 article in The Washington Post brings home the point that FDA approval (actually, any government approval) does not guarantee safety. It also makes it clear that approved pharmaceuticals, over-the-counter medications, medical devices, and even food products are not what you think they are.

This article highlights the findings of a 15-month investigation of the FDA following a worldwide flu vaccine shortage. In the process, investigators documented profound and disturbing indications of much more far reaching and deep-seated problems. While the motivation for the investigation was undoubtedly political, the results are inarguable. First, consider the trends revealed in the investigation:
  • In the previous five years, the number of warning letters that the FDA issued to drug companies, medical device makers, etc., dropped 54 percent to 535 in 2005 from 1,154 in 2000.
  • The seizure of mislabeled, defective, and dangerous products dipped 44 percent.
  • The biggest decline was found at the agency's device center, where enforcement actions decreased 65 percent in the five-year period of the study, despite a wave of problems with devices including implantable defibrillators and pacemakers. The most disturbing indicator in these statistics is that the research found no evidence that such declines could be attributed to increased compliance with regulations. Investigators at the FDA continued to uncover about the same number of problems at drug and device companies during the study as during comparable time periods before the study. The inquiry found instead that top officials at the FDA increasingly overruled the investigators' enforcement recommendations."

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We hope you enjoyed this week's excerpt from Lessons from the Miracle Doctors. Next week, we'll take a look at some FDA missteps. If you enjoyed this excerpt and would like to get a copy of the book for yourself, please visit one of the following resources.

Lessons from the Miracle Doctors Book

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