This is the third installment in the Mal–FEE–sance series that I have moved up to second because of current events. In the first installment I laid out how campaign contributions to congressmen and congresswomen influence our government’s national drug policy. In this segment I’ll show you how PhRMA’s campaign contributions in combination with their lobbying efforts have moved one of our institutions – the FDA – away from their core responsibilities of protecting the American public and into the pharmaceutical industry’s profit column.
Politicians have an axiom they’ve been using for quite some time; ‘personnel is policy.’ But what exactly does this mean? In this case, it means that for any government official – whether it’s your local mayor or President of the U. S. – to accomplish their agenda, they must have key personnel placed in strategic positions within the government agencies that will be effected by and executing their policy.
Perhaps one of the finest current examples of ‘personnel is policy’ is President Obama’s appointment of Dr. Robert Califf to head the FDA. As a matter of procedure, the President appoints the commissioner of the FDA and the senate must approve his appointment before he or she can hold the office. On February 24, 2016 the senate approved Califf’s appointment over the strong objection of many of its members and watch-dog groups who say he has a series of conflicts of interest and is too friendly with the pharmaceutical industry.
Regardless if you think President Obama is too closely aligned with the Pharmaceutical industry or not, the actions he has taken are facts. Whether they’re the result of political wrangling or his preference will never be known. But what does stand undisputable is the decision itself of replacing Margaret Hamburg as head of the FDA – the government agency that regulates in excess of twenty-percent of all the products bought and sold in the United States – with Dr. Califf.
Margaret Hamburg is a Harvard University graduate who left her position at Henry Schein, Inc (the largest seller of dental products in the U.S. and a major seller of medical products) when she was tapped by President Obama to head the FDA. Hamburg was President Obama’s first commissioner appointment to the FDA.
Because of her fawning public health positions, Hamburg was greeted with open arms. But the new commissioner soon disappointed her advocates when she began working towards loosening the conflict of interest rule baring individuals and/or groups who receive health industry money from sitting on expert advisory boards regulating the very products made by the companies that paid them. She claimed the agency was struggling to fill the seats on the 50 expert panels. In response, health-care watchdogs said; ‘Balderdash’ (and other acronyms or phrases starting with the letter ‘b’ with the same effect)!
Hamburg’s stained legacy is not what her early supporters could have ever believed possible. At the objection of her advisory board (11-2) and 28 state attorneys generals, Hamburg approved the pure hydrocodone product Zohydro (5 times as much active opioid as the highest strength hydrocodone), approved Oxys for kids 11 years and older, oversaw a 50.4% increase in the production of Oxycodone, the active ingredient of Oxycontin, and streamlined the approval process making it even easier for pharmaceutical companies to get FDA approval.
Perhaps her most challenging moment came in 2012 when a pharmacy based in Massachusetts produced tainted epidural steroids that killed 64 people and sickened hundreds of others across the country with fungal meningitis. Lawmakers grilled Hamburg during a congressional hearing, accusing her of not fulfilling her duties as leader of the nation’s top drug regulatory agency. During Hamburg’s tenure, nearly 100,000 Americans died an avoidable horrible death at the hands of the very poison she was responsible to regulate, prescription opioid painkillers; yet not a peep from congress. Our lawmakers’ silence is deafening.
While many in congress have called for a change in the culture at the FDA, it appears as though they are as much, if not more, of the problem. They take money from the pharmaceutical industry and tell us that it doesn’t influence their votes. Often they’ll point to their voting record as an example of their honesty and integrity. However what they rarely point out – and what you and I will never see –
is the backroom political gymnastics our lawmakers go through for special interests to get key personal placed into a position of authority. And we don’t see or hear much about the pressure congressmen and congresswomen brings to bare on the heads of agencies on behalf of their campaign contributors. Is this how Dr. Califf found his way to the top spot in the FDA? Quid pro quo? You be the judge.
Watch-dog groups have firmly opposed the confirmation of Dr. Robert Califf. Joe Manchin, former governor of West Virginia and current Senator, suggested: “Get somebody in the FDA that’s basically conscious about what’s going on and not married up to large Pharma.” Yet with all the controversy and obvious conflicts of interest surrounding Califf, his nomination was confirmed by senate with an 89-4 vote on February 24th. From my perspective, this confirmation completely eviscerates any and all government pretenses of eliminating conflicts of interests. The frail veneer that at least gave us the faint impression that the FDA was working to keep us safe is now gone. There is no longer any conflict of interest; the FDA is now being operated solely by the very same industries they’re supposed to be regulating. The FDA will now be regulating commerce – or more accurately opening the flood gates – with little regard for public safety.
Dr. Robert Califf is the former Vice Chancellor for clinical research at Duke University. 50-60% of the research he conducted was funded by the pharmaceutical industry. During his tenure at Duke, Califf was also a paid consultant for a variety of pharmaceutical companies (as much as $100,000 a year). He says his salary was contractually underwritten in part by several large pharmaceutical companies. According to his Wikipedia page Califf was also: “the Director of Portola Pharmaceuticals, Inc. from July 2012 to January 26, 2015, Advisor of Proventys, Inc., Chairman of the medical advisory board of Regado Biosciences, Inc. and has been member of the medical advisory board since June 2, 2009, and member of the clinical advisory board of Corgentech Inc.”
Califf is not tied to Big PhRMA – he is Big PhRMA!
In 2014 Califf stated in a presentation to a group of biomedical researchers, lawyers and industry experts that “American system for developing drugs and medical devices was in crisis. The system was too slow and too expensive, and required disruption and transformation.” Towards the end of his talk, he put up a slide that identified a key barrier to change: regulation.
In an interview with time magazine Califf stated: “The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors,” He says there is “a tension which cannot be avoided between regulating an industry and creating the conditions where the industry can thrive, and the FDA’s got to do both.” He says it would be “useful to have someone [leading the FDA] who understands how companies operate because you’re interacting with them all the time.” In all that I’ve been able to read on Dr. Califf, I’ve yet to hear him mention public health and safety in any significant manner. I don’t even think it’s on his radar.
First Dr. Hamburg and now Dr. Califf – what could possibly go wrong?! America’s Second Opiate/Opioid Epidemic is raging out of control and this is the best our government can do for us – putting the fox officially in charge of the hen house?!
If you’re finding yourself in shock and a state of total disbelief, you’re not alone. Everyday that passes, I find myself trusting our lawmakers less and questioning their judgment more – and I know there are a lot of others out there that feel the exact same way. However its political season and that provides us with the rare opportunity to speak directly with lawmakers without having to hire lobbyists. I am asking you to attend the town hall meetings and question their position on drug policy and the personnel they feel best suited to execute it. If there are no meetings in your area then visit the candidate’s website. Press them and ask how they plan to end this epidemic!
John Giordano DHL, MAC is a counselor, President and Founder of the National Institute for Holistic Addiction Studies and Chaplain of the North Miami Police Department. For the latest development in cutting-edge treatment check out his website: www.holisticaddictioninfo.com