Incompetent FDA Defers to Europe for Drug Safety Testing

Friday, June 10, 2011
By: Byron J. Richards,
Board Certified Clinical Nutritionist

The French and German governments have acted swiftly to protect their citizens from the blockbuster diabetes drug Actos (pioglitazone).  A French study of 155,000 people, completed on Tuesday, showed that diabetics taking Actos had a significantly increased risk for bladder cancer.  Two days later French and German drug regulators order their doctors to quit prescribing the drug.  Their swift action stands in stark contrast to the bumbling regulators at the FDA who allow tens of thousands of people to die every year as they sit on adverse-reaction drug data.  At the same time they are busy sending armed U.S. marshals into dietary supplement companies to seize their products.

Actos, like Avandia, is a class of medication called thiazolidinedione (TZD).  These drugs interfere with gene signaling at a fundamental level towards the goal of lowering blood sugar – with incredibly costly side effects.  The FDA allowed Avandia on the market after censuring its own safety regulator for insisting on a black box warning for heart failure and then turning it loose on an unsuspecting public without one.  As the heart failure cases piled up and people died, the FDA was mostly silent.  It wasn’t a government study that even brought the problems to light – it was private research that had to buck the system.  After a decade of people dying the FDA finally curtailed sales of Avandia but left Actos still readily available as they considered it less of a heart failure risk.  Well, the latest study out of Europe1 based on its citizens using the drugs shows that Actos and Avandia both have major risks for heart failure.  And now the French have conclusively proven that Actos causes bladder cancer.  Expect the FDA to continue to drag its feet as more people are needlessly injured.

I have been following the Actos and Avandia scandal for years.  Here are some of my articles on the topic:
What Does it Take to Get a Black Box Warning? – June 7, 2007
Thousands Die While FDA has Mud on Its Face – June 11, 2007
The FDA – Culture of Corruption – July 26, 2007
Common Diabetes Drug Causes Bone Loss – Medical Profession in a Funk – December 4, 2007
Western Medicine Fails Tim Russert – June 18, 2008
Common Diabetes Drugs Double Fracture Risk – December 10, 2008
Avandia Linked to Heart Failure – FDA to Blame – August 26, 2009
Diabetes Drugs Actos & Avandia Increase Bone Fracture Rate – February 17, 2010
Avandia is Killing Americans, FDA Negligence Comes Front and Center – February 22, 2010
Avandia and Actos Increase Fracture Risk – August 6, 2010
FDA Management Escapes Culpability for Avandia Debacle – September 24, 2010

Because the FDA eventually singled out Avandia, in 2010 it sales dropped to 521 million while Actos continued blockbuster business at 3.4 billion.

The FDA is reluctant to act for several reasons.  If it takes a drug off the market, then massive litigation follows, and rightfully so.  However, the FDA has demonstrated in multiple similar circumstances over the past decade that they act in concert with large drug companies to help them minimize their legal liability – rather than protect the public from danger. 

Actos and Avandia represent the next generation of drugs that work by powerfully altering gene signals, rather than just dumping something toxic on cells and hoping for the best (older drugs).  The problem is that these drugs alter the gene signals everywhere in the body, not just in the desired area (such as lowering blood sugar).  And in other areas of the body the genes, if excessively activated, cause major problems.  Thus, when drugs like Actos and Avandia fail, it is a major blow to next-generation drug development which at this time has no clue how to safely manipulate genes.

In stunning contrast, nutrition actually regulates the same genes without the side effects.  This is because our bodies have millions of years of experience using the nutrients to facilitate health.  For example, the fish oil DHA regulates the same gene signal that Actos and Avandia are targeting, but is a powerful cardio-friendly nutrient and helps prevent cancer.  The new gene science is actually proving the extreme intelligence of nutrition to behave healthfully in the human body – both in terms of preventing and treating disease.

So the gutless cowards at the FDA are now going after dietary supplement companies who dare to say so – with armed U.S. marshals.  Unfortunately, as with any industry, it’s not that all dietary supplement companies are run by good people.  There are drug-tainted products out there and everyone is in favor of the FDA going after such thugs. 

However, the FDA is abusing their regulatory power by going after companies that try to explain the legitimate science that supports their high-quality products – a far cry from shysters selling tainted goods.  The FDA tries to brand such claims as illegal drug claims and use armed force to seize products – a new pattern of behavior under the Obama FDA.  In fact, the FDA adamantly does not want you to know that fish oil DHA is much better for you than Actos or Avandia.  This is all about being a police force bully for Big Pharma.

Furthermore, the FDA fails to protect the public because of its own gross incompetence and highly dysfunctional corporate culture.  After all, the FDA let these drugs on the market in the first place, often with slanted data using a pathetic standard of biomarkers to determine effectiveness (not if a drug can actually cure something).  Once on the market the FDA goes on cruise control, rather than ensuring the follow up studies are done that prove safety and effectiveness. 

Rest assured, FDA execs are meeting this very minute to figure out a damage-control strategy for Actos – public safety is far from their top concern.  The FDA should either be disbanded or completely overhauled.

 


Referenced Studies:
  1. ^ Actos and Avandia Have Heart Failure Risks  BMC Clinical Pharmacology  Stephanie Berthet , Pascale Olivier , Jean-Louis Montastruc , Maryse Lapeyre-Mestre.

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