• Margaret Hamburg Stepping Down: FDA Commissioner

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    A resignation letter shared with FDA staff this morning, Dr Hamburg said that “our collective efforts have improved the health, safety, and quality of life of the American people.” She cited such accomplishments as improving the oversight of drug compounders, speeding up the review of new drugs and devices, and protecting the drug supply chain from counterfeit, stolen, or contaminated products.

    Dr. Margaret Hamburg, the commissioner of the Food and Drug Administration (FDA), announced that she would be stepping down as commissioner at the end of March 2015.

    As one of the longest-serving commissioners at the agency, Hamburg led the FDA for close to six years. She said the heavy demands of the job as well as the length of time she’s been serving contributed to her decision to resign.

    Strong Ties to Industry from the Very Beginning…

    Hamburg entered the FDA through the revolving government/private industry door after allegedly making millions as the director of Henry Schein Inc., the largest seller of dental amalgam (mercury fillings) and flu vaccine seller as well. To get appointed, Hamburg was required to sign an agreement promising:

    1. To sell her Schein stock and stock options
    2. Not to participate in regulatory matters affecting Schein while owning these options

    Sign she did, but she apparently had her fingers crossed. Selling her …

    Industry Is Still Adding Dangerous Synthetic Trans Fats to Your Food

    According to CDC director Thomas Frieden, an estimated 5,000 Americans die from heart disease caused by synthetic dietary trans fats each year, and another 15,000 will get heart disease as a result of eating too many trans fats. Other CDC statistics suggest that as many as 20,000 heart attacks could be avoided each year by eliminating trans fats from the food supply.

    Reuters praised Hamburg for proposing “measures to improve nutrition by limiting dangerous trans-fats in food,” but they are still allowed in your food, even after a lawsuit.In 2009, Dr. Fred Kummerow, who has studied heart disease for more than 60 years, filed a citizen petition with the FDA calling for a ban on synthetic trans fats. In the petition, he noted that heart disease is often the result of trans fat deposited in veins and arteries, which can cause sudden death due to blockage.

    51 New Drug Approvals in 2014… Including Conflict-of-Interest Driven Zohydro

    Under Hamburg, the FDA approved 51 new drugs in 2014 alone, which is the most in close to 20 years. In a blog post, Hamburg called the drug approvals “innovative approaches to help expedite development and review of medical products that target unmet medical needs.” But many believe the speedy drug approvals come at the expense of safety. A prime example is the narcotic painkiller Zohydro. Dr. Sanjay Gupta discussed conflicts of interests that may have coaxed the FDA to approve Zohydro ER (Zogenix) last year.

    Three Strikes and You’re Out… Who’s Up Next?

    Mercury fillings, antibiotics overuse, trans fats… we have three-plus strikes against Hamburg. She’s out now… anyone want to bet where she’s headed? Back to Henry Schein perhaps? As for who will replace Hamburg, Dr. Robert Califf, a cardiologist and researcher from Duke University who currently oversees the FDA’s drug, medical device and tobacco policy has been fingered as the most likely successor. I’d like to say that he will be a breath of fresh air for the FDA… but Dr. Califf has an extensive list of industry associations of his own to disclose. According to author disclosures listed in the Journal of the American College of Cardiology:

    “For the period from 2010 through 2013, Dr. Califf reports receiving research grants that partially support his salary from Amylin, Johnson & Johnson, Scios, Merck/Schering-Plough, Schering-Plough Research Institute, Novartis Pharma, Bristol-Myers Squibb Foundation, Aterovax, Bayer, Roche, Lilly, and Schering-Plough; all grants are paid to Duke University.

    Whatever your health problem or health goal might be, I strongly recommend digging below the surface using all the resources available to you, including your own commonsense and reason, true independent experts' advice, and others' experiences to determine what medical treatment or advice will be best for you. Ultimately, you are responsible for your and your family's health — not me, not your physician, and certainly not any researchers or government health agencies. I cannot stress enough how important it is to become an active participant in your own care, and make sure you are making decisions that correspond with your own best judgment, knowledge, and experiences.

    The agency has also faced major public health issues during Dr Hamburg's tenure, including, most recently, the outbreak of Ebola and other infectious diseases.

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    Photo Source: Mich Bio



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