How does the FDA treat employees who blow the whistle? US Senator Chuck Grassley, a long-standing agency nemesis, wants to know. And so he has written FDA commish Margaret Hamburg to explain the circumstances surrounding a controversial episode in which several current and former agency employees say they were harassed and dismissed after complaining about device reviews to Congress.
Their charges were contained in a sensational lawsuit filed last month, in which they accused the agency of secretly reading their personal email accounts, while the agency maintained they illegally disclosed confidential business information after writing to Congress to complain they were being coerced to approve devices that posed unacceptable risks (back story).
For instance, the employees, who are all scientists and doctors and worked in the Center for Devices and Radiological Health, charged three devices could have missed signs of detecting breast cancer; one device risked falsely diagnosing osteoporosis, and an ultrasound device could malfunction while monitoring pregnant women in labor.
Their lawsuit charges the FDA repeatedly attempted to initiate formal criminal investigations and harmed their reputations, which has angered Grassley. "It is troubling me to see your agency actively pursue the dismissal of an employee against the advice of the OSC (US Department of Health & Human Services Office of Special Counsel) - not because they violated procedure and leaked genuinely confidential classified information - but simply because you "cannot trust him," he writes Hamburg.
Moreover, he charges that the actions taken by the FDA contradict testimony from Hamburg before Congress in which she maintained that whistleblowers "serve a very important role in government in surfacing critical issues and concerns and making sure they're addressed. As leader of FDA, I would very much want to create a culture that all enables all voices to be heard."
Grassley goes on to note that interfering with a Congressional inquiry - the letter from the employees sparked Congressional interest in the review process - is a federal crime, as is preventing employees from providing information to Congress. And so, he wants Hamburg to explain not only how this episode occurred, but any steps the agency has taken to avoid a repeat (here is his letter).
pic thx to katerha on flickr
4 Comments
This is ugly for sure but from an IT standpoint I used tell employees all the time this is the company computer, yours is at home, so think about what you do on a personal level at work and do not expect privacy.
There are abuses and on this side of the coin IT has to track them down and occasionally monitor and find employees doing some wrong things. I have had to do it and had one example to where an employee was looking at clients addresses, then going to Zillow to see how much their houses were worth. Sounds stupid but the employee was looking for a new husband and was looking at their potential wealth and trying to get chummy with certain clients until one got mad and called and reported it. I know stupid story but we all do stupid stuff at some point in life.
You also have to maintain a very high level of privacy here and have good reason to look into such items and and IT person will always have a good audit trail to show what "we" access by all means as there's abuse from folks on that end too who just snoop. As a professional too you do have to realize that your opinion will change about that person when you find things out of the normal realm too, as cold hard data changes perceptions.
Hopefully the FDA will have this and the substantiated documentation as to the what's and why's from that side of the coin. Again, I still tell people this is the company computer and yours is at home so think twice about accessing certain personal email accounts, etc. at work.
Medical quack-- your on a different topic. It is obvious managers were only looking at these individuals. ANd were after them simply because they were doing their job, protecting us citizens from harm. I say go Grassley, I love that guy!!!!!!! No body else has the guts to do the honest thing.
Ditto to company insider, and how disappointing to read this of Hamburg. Perhaps this and other positions she has taken help explain why Jonathan Sharfstein left so abruptly - no integrity at the top of the FDA?
The only comfort here is to know that there are still some within the FDA who are trying to do what the agency is supposed to stand for - to protect the public health.
Just take a look at Levaquin... So many devistating side effects reported. 0 ACTION!
That place needs to be cleaned out...