In the New York Times today, a former top FDA official shines the spotlight on a stunning revelation: that the mega consulting firm McKinsey was working with Purdue Pharma at the very same time it was getting paid by the Food and Drug Administration to help organize its offices overseeing the safety of opioids and other medications. This is an egregious conflict of interest, one that McKinsey didn’t bother to disclose to the FDA at the time, according to Dr. Joshua Sharfstein, the principal deputy commissioner of the Food and Drug Administration from 2009 to 2011.
McKinsey’s work on behalf of the drug company most responsible for our current opioid epidemic was apparently uncovered during an investigation by the Congressional Committee on Oversight and Reform, which released its report on McKinsey’s double-dealings a few weeks ago. The report found that not only did McKinsey not disclose its work for Purdue at the time it was advising the FDA, but it “also used its government consulting work to solicit more business from opioid manufacturers and tried to influence government officials to advance the interests of its private sector opioid clients.”
As Sharfstein notes, independence from the companies that sell regulated products is essential to the F.D.A.’s effectiveness and credibility.” Yet such disturbing conflicts of interest are nothing new. As I revealed in my first book, Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, the pharmaceutical industry had enormous sway over the FDA since much of the agency’s money was coming from industry fees (and not from independent Congressional appropriations, as it should have been). But even beyond that, it was a well-known fact that there was (and still is) a revolving door between the FDA and the drug industry; government officials who worked for the FDA and did the industry’s bidding could always count on landing a cushy job in the private sector once they left the government.
As Dopesick, the riveting Hulu series, makes crystal clear, the FDA made little effort to curb the overprescribing of OxyContin and other opioids. One can’t help but wonder whether McKinsey’s work for Purdue Pharma contributed to our government’s failure to stem the opioid epidemic. I personally find it hard to believe that some FDA officials didn’t know that McKinsey was working with Purdue at the same time it was on their own payroll. This very day, McKinsey is testifying before Congress in response to the oversight committee’s report on its conflicts of interest. I hope the committee gets some answers from the consulting firm about what it did or did not do to disclose these conflicts. But even more importantly, I pray that Congress doesn’t stop there. As Sharfstein writes in his Times essay:
Congress should also, at a minimum, prohibit individual consultants at firms like McKinsey from working for agencies and regulated companies at the same time, and require firewalls to block the sharing of information between public and private sector arms of consulting companies, with strong penalties for violations.
Hear hear!
This blog is also posted on medium.com.
