And now, the House Committee on Government Oversight and Reform is investigating the FDA surrounding a sensational episode in which several current and former agency employees have charged in a lawsuit that they were harassed and dismissed after complaining about device reviews to Congress.
In a letter yesterday to FDA commish Margaret Hamburg, committee chair Darrell Issa raises the same concerns that Chuck Grassley, the ranking member of the Senate Judiciary, outlined in his own missive to the agency two weeks ago (read here). Like Grassley, Issa wants Hamburg to turn over documents and spell out agency policy on handling employees who have a right to disclose info.
For the record, the employees accused the FDA 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). And their lawsuit charges the FDA repeatedly attempted to initiate formal criminal investigations and harmed their reputations.
They were motivated by alleged problems. The employees, who are all scientists and doctors, charged three devices could have missed signs of detecting breast cancer, according to the paper. Other examples: one device risked falsely diagnosing osteoporosis and an ultrasound device could malfunction while monitoring pregnant women in labor.
In his letter, Issa points out that federal law prohibits managers from initiating personnel actions against employees in response to protected whisteblowing. And he accuses the FDA of engaging in unlawful activity by retaliating against the employees (here is his letter).
pic thx to katerha on flickr
6 Comments
Good for Congressman Issa,making this a truly bi-partisan issue. Glad to see it's not just Senator Grassley out there.
Would that the FDA would turn their investigatory guns on the real targets in industry who should stop harming the public with falsified information, defective devices, and lethal prescription drugs.
I think this is great. everyone knows the managers are from big pharma and plan to go back to big pharma. THe employees are the ones that care and they are harassed when they try to do their job and charged with criminal misconduct. THat is what big pharma likes to do to their employees who whistleblow internally. THen they hope they leave. Charge them with a crime after asking them to help with an investigation. Talk to any whistle blower from Pfizer and that is what the will tell you. Fantastic for Congress to be opening their eyes. I hope they end up with criminal charges on the managers!
I hope congress will fully investigate and protect the rights of these courageous whistle-blowers and punish these corrupt FDA managers. Sometimes whistle blowers are the only way the wrong-doings of the drug companies and the FDA are revealed.
@company insider who wrote, "Charge them with a crime after asking them to help with an investigation."
Roger that - it was SOP not just at Pfizer. It was industry-wide and definitely was worse at CROs. And when they couldn't pin anything on you after the incessant psychological harassment to become one of them - they sent you to *anger management* seminars or some other bs - anything and everything to rip you apart. It was pure evil.
And the data from a decade of this crap is crap. So we have a broken link in how advances were made in hundreds of years of honorable medical research because the information was not collected honestly nor stored honestly in databases.
The argument made now for not being concerned about broken links in knowledge is because it's all about DNA manipulation. Really? The decision back in the 1970s was made on science-driven points - that DNA manipulation could not be done, ever, SAFELY, because there is no *gold standard* for immune systems, that it was not needed because bad genes were still subject to natural elimination through breeding, and that the broken genes created by polluted environments could not be mitigated by ramping-up industries that added greatly to the pollution stream.
There is lot of delusional inwesting going on and completely irrational behavior replacing self-regulation. It's a mess.
"Good for Congressman Issa,making this a truly bi-partisan issue. Glad to see it’s not just Senator Grassley out there."
They're both Republicans
If you are a Seinfeld fan you may remember this one: George; Newman what do you do? Newman; I work for the post office. George: Isn't that the place where employees walk in and shoot everyone? Newman: Sometimes. One wonders that such things happen "only" in the post office but not in many other work environments that may be even worse. Pfizer is not the only co that just loves when their whistleblowers do it internally and then do a number on them. They all do it. Novartis is as notorious. According to their NP4 codes of conduct, every emplyee must whistleblow internaly on anyone they know of doing any type of misconduct. That is their solem duty and are guaranteed in NP4 absolute security and protection. Yes, but the guarantee expires the moment they fleece you of what you know and have in evidence. The moral of the story: collect your evidence, file it and when you have enough go externally and do the right thing, whistleblow the way it is ment to be done,to the law.You may even walk away with nice reward that will "protect" you from need for any job let alone in bigpharma. And that is the real protection for real heros outside the real battlefield.