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Industry links to FDA commissioner nominee are questioned

Industry links to FDA commissioner nominee are questioned

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Drug company links to Duke University researcher Robert Califf, nominated by the Obama administration to be FDA commissioner, are not hard to find. Califf has "served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech” and reports 23 financial links to drug companies including stock ownership according to published reports.He defended Merck's Vioxx behavior which cost thousands of lives and said “many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study,” on PBS.

News analysts say the nomination of Califf conveys that the administration does not have the stomach for a confirmation battle, but it also ends all pretenses of a firewall between the drug industry and the government agency that is supposed to regulate it. Why even have an FDA; why not let the drug industry police itself? 

In 2009 when Califf's name was floated for FDA commissioner along with three others, Reuters reported that medical experts asked how someone who helps drug companies market their products could possibly be considered as the nation’s chief watchdog over unsafe medications. We now have our answer.

When Margaret Hamburg was named FDA commissioner in 2009, instead of Califf, many hoped her background as deputy health commissioner for New York City could purge industry influences, especially when she appointed Joshua Sharfstein deputy commissioner who also had a public health background. But hopes were dashed when Sharfstein left within two years and Hamburg soon moved to loosen conflict of interest rules governing who can sit on advisory committees that recommend drug approvals. In fact, Hamburg appointed Califf FDA Deputy Commissioner earlier this year, before stepping down

Questions about industry ties while working for the government are not limited to Califf. Four years ago, the Chronicle of Higher Education reported that longtime director of the National Institute of Mental Health (NIMH) Thomas Insel assured the University of Miami medical school dean if they hired his friend, government money would not be denied to his school. Why would it be denied? The friend, Charles Nemerof, was found to have so much unreported drug company income after a congressional investigation, a $9.3 million National Institutes of Health (NIH) grant he managed was suspended. At the time of the cronyism and promise of flowing government funds, Insel was leading NIH efforts to stamp out conflicts of interest reported the Chronicle.

This month Insel was reported to be leaving NIMH for Google but he won't be enhancing mobile aps or tracking Google ads. Google is rapidly becoming part of Big Pharma and Insel is joining Google Life Sciences, a semi-secret research organization studying "brain diseases" which last year launched a potential $1.5 billion research partnership with drug maker AbbVie. 

With the likely new head of the FDA an unapologetic Pharma consultant, the government has solved the problem of hidden and undisclosed conflicts of interest. They are not hidden and they are not undisclosed.

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