U.S. Supreme Court rejects GlaxoSmithKline; FDA e-cig regulations under further scrutiny


A former Commissioner of the Food and Drug Administration (FDA), Margaret Hamburg, is facing allegations of racketeering, conspiracy, and colluding to conceal possibly deadly information regarding the drug Levaquin.  Under the federal Racketeer Influenced and Corrupt Organizations (RICO) law, Hamburg could face possible prison time, and the FDA might be forced to pay nearly $1 billion in punitive damages.

Meanwhile, the United States Supreme Court recently rejected a motion to dismiss a court case against pharmaceutical company GlaxoSmithKline that claims the Big Pharm conglomerate intentionally concealed safety risks about a Diabetes medication called Avandia.  GlaxoSmithKline is accused of manipulating scientific literature, falsifying advertisement campaigns, and issuing misleading statements about the drug in order to increase sales.

The FDA and GlaxoSmithKline:  A pattern of deceptive and devious behavior

While these two cases have nothing whatsoever to do with electronic cigarettes, many in the vaping community believe that this series of new lawsuits only demonstrates a pattern of deceptive and devious behavior that is supported and encouraged within the FDA from the top down.  Mitch Zeller, organizer behind the recently announced FDA e-cig regulations, was once a political consultant for GlaxoSmithKline, which incidentally is the manufacturer of Nicorette Gum.  Pro-vaping advocates have long suspected that Zeller only pushed for the FDA e-cig regulations as an easy way of eliminating the vaping industry, the primary competitor to Nicorette Gum and other “quit smoking” products.


Margaret Hamburg:  Long history of ‘conflict of interest’

While Hamburg has never been employed by GlaxoSmithKline, her husband once ran a hedge fund named Renaissance Technologies (RT) which held tens of millions of dollars in stock in Big Pharma’s Alkermes, the manufacturer of the drug Zohydro.  In 2012, Hamburg approved the drug on behalf of the FDA even though an advisory panel voted 11 to 2 against approval due to concerns of possible overdosing by its patients. 

With the Hamburg-provided “FDA stamp of approval,” Alkermes stock prices soared, and Hamburg made millions. To add insult to injury, the company also released a second drug that treats the very same patients who would eventually become addicted to Zohydro.  In short, Hamburg approved two drugs that made her a very rich woman - one drug that addicted the millions of patients and the second drug that “cured” them.  

Sen. Ron Johnson: An unlikely ally of the vaping industry

For many in the vaping industry, the Machiavellian partnership between Big Pharma and The FDA is one that cannot be ignored any longer. Hamburg’s recent lawsuit involving the RICO charges seems to show a continuous abuse of authority that dates back as far as 1996.  And the FDA’s consistent hiring of Big Pharm ex-employees seems to indicate another significant conflict of interest, as well.

Fortunately, the vaping industry has at least one political supporter in its corner.  Sen. Ron Johnson from Wisconsin is a member of the Committee on Homeland Security and Governmental Affairs.  Since the May 5 announcement of the FDA e-cig regulations, Sen. Johnson has issued two somewhat aggressively worded letters to the FDA demanding access to the scientific research and other data that was used to write them.

Johnson is also calling for the FDA to be more “transparent and accountable in its regulatory actions.” Will “The Badger State Senator” finally be the one to uncover the dishonest business practices that seemingly run rampant throughout the FDA?  Only time will tell.  But should the vaping industry decide to take its case to the U.S. Supreme Court, the current rejection for dismissal of the GlaxoSmithKline case shows a second glimmer of hope.




  • I couldn’t refrain from commenting. Perfectly written!

  • I don’t see the difference in ecigs then flavored cigar and flavor rolling papers I started calling and got off cigs five months ago and notice I don’t half to use my copd in hailer as much drama going on with ecigs make me smoke again because you don’t no if you will be aloud to Vap are not and that should be are choice in life

    Herkie reeves
  • Perverts run amuck.!

  • Honestly I think Congress should shut down the FDA and replace it with an organization where those who the organization regulates can not intermingle. The organization employees would not be allowed to work for any organization they regulate nor hire anyone from those regulated organizations. I believe the FDA is not looking out for the best interests of the people and so it needs to go. Even when Big Pharma gets a fine it looks large to your an I but to them its just a small fine and just the cost of doing business. There needs to be more accountability. If a drug gets out on the market that was known to be bad and kills people that should be viewed as a capital offense and everyone with their hands on that drug need to be arrested and charged with a capital offense. Enough is enough how many more people have to suffer because of greed.

    Stephen Bruce
  • In truth, GlaxoSmithKline is only the license holder for Nicorette. They are manufactured by McNeil, which is a subsidiary of Johnson & Johnson, the product’s global marketer. Johnson & Johnson also owns the Nicotrol and Nicoderm brands, nicely wrapping up the whole of the brand name NRT market. And of course, Johnson & Johnson is the owner of Levaquin and one of the two companies included in the RICO case with former Commissioner Hamburg. Ironically enough, the FDA’s pursuit of vapor products started six months after Hamburg took over as Commissioner, with the agency trying to classify e-cigarettes as unapproved drug devices and seizing shipments. Hamburg admitted on record that she helped spearhead that effort.


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