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The Next FDA Commissioner

Conflict or Qualified? The NY Times just did a story on the recent Presidential nominee to head the FDA. The title of the article tells the summary of the story, F.D.A. Nominee Califf’s Ties to Drug Makers Worry Some.

The article starts out with a meeting in May 2014, and presentation that Dr. Robert M. Califf gave to a group of biomedical researchers,  pharmaceutical lawyers and industry experts.

His PowerPoint slides showed the importance of speeding up the pace of biomedical innovation by transforming research. Near the end of the presentation, one slide was put up that indicated one barrier to that pace: Regulation.

At the time, no one reacted to that one slide. Now, it has garnered some attention because this Cardiologist/nominee will potentially be the “Police Chief” of medications that get approved and make it to our pharmacies.

He is a renowned clinical researcher who is unquestionably qualified to lead the agency. On the other hand, he will be in charge of an agency that regulates what is responsible for about a quarter of every dollar that we spend.

This agency is now facing such issues as whether/how to regulate electronic cigarettes. Dr. Califf’s previous job was heading up Duke University’s research center, which received more than 60% of its funding directly from pharmaceutical companies. Does that make him too close to them and create a conflict; or does his familiarity with the industry make him more qualified to regulate it.

Dr. Califf personally received $215,000 as a consultant from drug companies from 2009-2015. As a side note, several years ago Frank Luntz did research on the term drug companies and advised them to start calling themselves pharmaceutical companies. Drug Company sounded bad to the public. More on that in his book Words That Work: It’s Not What You Say, It’s What People Hear.

“Pharmaceutical Companies” have always been known to have great ties to government while employing powerful lobbyists. In 2002, the Homeland Security Act that we all knew was going to make us safe as it was signed into law… also contained a provision buried deep in the legislation that protected Eli Lilly and a few other big drug companies against  lawsuits by parents who believed that there children had been harmed by thimersol.

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    So, the question really remains, when is regulation protective and when is it too restrictive? Let’s hope that Dr. Califf knows the balance. As one professor who worked with him observed, “How does he think? We won’t know until we see how he behaves.”

 

 

And for pic o’ day, a bit of surveillance:

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