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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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July 23, 2012

A Total Mess At the FDA

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Posted by Derek

As expected, there's a lot more to the story about the FDA and its monitoring of whistleblowing employees. Steve Usdin at BioCentury has details (PDF, free access), and good grief, what a mess. Read the whole thing; you'll be amazed.

It looks like the agency's Center for Devices and Radiologic Health has devolved into a cross between "Dilbert" and some ministry in Pyongyang. The employees that the agency has been monitoring have been accusing their superiors of approving screening devices based on flawed (even fraudulent) data, while the agency seems to think that they're out of line and off on their own crusade. At issue is whether the reviewers or their bosses really have the expertise to make regulatory decisions, and there seems to be a real, uh, divided opinion on that question. To put it lightly.

As it turns out, any time an employee at the FDA logs on to a computer, the following warning pops up: "You have no reasonable expectation of privacy regarding any communica- tions or data transiting or stored on this information system. At any time, and for any lawful government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this information system." This case shows that they're not kidding about any of that, since the employees in question found everything they did being keylogged, screen-captured, etc., without (of course) their knowledge.

The CDRH higher-ups were treating this primarily as a criminal case by this point. But legitimate whistleblowing is a tricky grey area in this regard - with varying values of "legitimate" often decided years later - and the Office of Special Counsel is now investigating the FDA's own steps for their legality. No one is going to come out of this looking good, is my guess.

There's even more reason to think that, because (as it turns out), several of the CDRH employees were simultaneously filing suit (!) against the manufacturers of the devices that they were arguing about inside the agency:

While FDA reviewers were publicly working to persuade the agency to with- draw approval of computer-aided detection (CAD) mammography and CT colonoscopy devices, they also were secretly pursuing a lawsuit against the products’ manufactur- ers. The suit included a request that a substantial share of any financial awards go directly to the plaintiffs. . .

The suit was filed “under seal,” so the defendants were not aware that the FDA staff reviewing their products were also asking a court to levy potentially billions of dollars in civil penalties against them.

Under the False Claims Act, private individuals can file a suit under seal and invite the U.S. Department of Justice to join the case. If the federal government joins the case, it takes responsibility and foots the bill for prosecution, and the individual plain- tiffs can be awarded a portion of the civil penalties.

The FDA employees requested in the suit that they be awarded “at least 15% but not more than 25% of the proceeds of any award or settlement” if the government joined the suit, and more if the government did not join.

No, this whole business is a stink bomb. I really don't see how the CDRH can be operating effectively at all with all this sort of stuff going on. Is the rest of the FDA this hosed up, or is this just a particularly dysfunctional branch? Who knows?

Comments (19) + TrackBacks (0) | Category: Regulatory Affairs


1. NoDrugsNoJobs on July 23, 2012 11:50 AM writes...

I had read in the WSJ that one of the intended "whistleblowers" has scored lucrative settlements from prior employers on similar matters. Do we not have enough litigation in the US already? Do we really need to further incentivize litigation in the US?

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2. MIMD on July 23, 2012 11:53 AM writes...

CDRH doesn't want to touch political "hot potatos" that really do need regulating.

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3. MIMD on July 23, 2012 11:56 AM writes...

@1 NoDrugsNoJobs

I had read in the WSJ that one of the intended "whistleblowers" has scored lucrative settlements from prior employers on similar matters. Do we not have enough litigation in the US already? Do we really need to further incentivize litigation in the US?

Nah, we should just let people be maimed and die due to product defects, unapproved experimentation, etc. After all, it's for the good of the people. So say we all!

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4. alig on July 23, 2012 12:59 PM writes...

So they are using confidential information that the company had provided to the FDA to sue the company for personal financial gain? I guess they FDA was right to be tracking the employees computers.

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5. Chemjobber on July 23, 2012 1:46 PM writes...

Look at the claptrap that Prof. Cronin's sales job is spawning (link in my handle):

"The Guardian has a great interview with a Scottish professor named Lee Cronin who is working on developing a system to create pharmaceuticals through 3-d printing. Which is to say that he wants to make downloading and manufacturing medicine as simple as printing a web page...

...By contrast, the advantages of 3-d printing in places with limited transportation, manufacturing and distribution networks are enormous. That's the insight, for example, behind the Coke Freestyle, an increasingly common coke machine that can mix more than 100 different flavors of soda, despite being no bigger than a traditional vending machine. In effect, Coke decided that rather than spend a lot of money running trucks full of bottles between places and wait for transportation to get better, they could instead just find a way to produce soda at much smaller scales.
And that's the idea here--that by rethinking production, a lot of various but critical barriers, such as transportation and distribution networks, become far less imposing."

Yes, because synthesizing and formulating bioavailable drugs is somewhat equivalent to mixing flavoring, CO2 and sugar water.

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6. Chemjobber on July 23, 2012 2:15 PM writes...

Ooops, wrong thread.

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7. Hap on July 23, 2012 2:33 PM writes...

But I didn't think it was just their employees' computers they were monitoring but other "enemies" of the FDA as well. I also had thought that they monitored not only internal but other computers of employees. If either was the case, someone stepped well outside the bounds of permissible monitoring to catch leaks. If your tactics seem to come from Watergate, perhaps second thoughts are in order.

I wonder how dense you need to be to think that receiving money from suing people using confidential information from your employer is not going to be a conflict of interest. Of course, that would also apply to a wink-and-nod relationship between FDA managers and companies submiting devices for approval.

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8. Grad Student on July 23, 2012 3:52 PM writes...

There is no talk on the actual science of the CAD devices. Does the science actually support Smith's claim? Or is he just a litigious lawyer without any scientific understanding?

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9. Norman Yarvin on July 23, 2012 4:08 PM writes...

The underlying technical issue here is that CT scans (any CT scan, not just these ones) pump a lot of radiation into the patient. CT scans operate by taking X-rays, but not by just taking one X-ray, but rather X-rays from all different angles, which the computer then combines into a 3D image. So the patient gets something like 180 X-rays' worth of radiation rather than just one. Why the dissenting FDA employees are exercised about these particular CT scans is unclear to me, but it may have to do with them being sold for screening purposes, where you're giving the CT scan to healthy people, and so the expected upside is relatively small.

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10. Captain Ned on July 23, 2012 6:16 PM writes...

That pop-up warning upon login is standard issue on all Federal computers. I have to deal with a Federal laptop in the day job (financial regulation, not drug approval) and it's there as well.

As I said in an earlier thread on this subject. Any Federal employee whistleblowing from their work computer is an idiot.

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11. johnnyboy on July 23, 2012 8:25 PM writes...

From having worked in both the pharma and the device industry, I would say that the CDRH branch has always struck me as particularly amateurish, compared to CDER. From reviewers focusing on totally irrelevant study data, to badly written draft guidance documents that include totally off-the-wall recommendations and that never get finalized anyway, the whole branch gave off a whiff of underfunding, undercompetence and total improvisation.

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12. Anonymous BMS Researcher on July 23, 2012 9:27 PM writes...

At my workplace, and probably many other pharma companies, all the computers have regular pop-up messages warning us not to have any expectation of privacy when using company systems. I post here from a computer that I own, via a network connection for which I pay. If ever I felt the need to blow the whistle -- which to date I haven't -- I would certainly not do so using my workplace computer and network connection. I'd use either the hardwired connection at my residence or my cell phone (which, like many phones nowadays, can be used to send and receive email messages).

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13. Watson on July 24, 2012 3:33 AM writes...

All you need to do to thwart such intrusive measures is to place a Faraday cage around the computer you use at work. It works much the same as a tinfoil hat.

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14. Jonathan on July 24, 2012 9:55 AM writes...

Captain Ned is 100% correct, anyone using a government device on the .gov network (or even at home on their own network) has absolutely no expectation of privacy, and I think recent court cases hae meant that applies to anyone using a corporate computer at their place of work (even if they're accessing private webmail accounts etc).

If you want to whistleblow, don't do any of it on corporate IT assets; take pictures of documents with your own camera or phone and use disposable email accounts that you don't log into (ever) at work. Or accept you're going to get busted.

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15. NJBiologist on July 24, 2012 11:53 AM writes...

@1 NoDrugsNoJobs, @3 MIMD--They had a history of suing, but not a history of winning. The only win was a retaliation claim--won after the initial lawsuit was dismissed.

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16. johnfg on July 24, 2012 2:00 PM writes...

So am I the only one who read this and thought to myself "have these people never seen a movie involving whistle blowing in Washington". You don't send emails from work computers.
You need the following things to properly "blow the whistle": a memory stick, a bike, a hooded sweatshirt (or baring that a ball cap you can pull down low), a pair of dark sunglasses, a laptop, a messenger bag or backpack, a cute nickname as part of gmail account, and a random internet cafe or coffee shop with free wifi.(Note that pre-paid cellphones are optional these days)
Once you have these assets the rest should fall in place for you no problem

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17. Mary Peed on July 28, 2012 7:17 AM writes...

I've given that exact same warning (nearly word for word) at a University I used to work at... to incoming freshmen.
"You have no expectation of privacy. That means if you do something stupid from a university computer, we don't need your permission to find out about it. So don't do anything stupid. Because no matter how good you are, we've got better... and we will find out... and you will blow your entire future for something stupid."

Sounds like someone should have had that conversation with FDA employees.

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18. Joe Protandem on August 1, 2012 12:48 AM writes...

Its all about the money - FDA isn't always out to protect you they are out to protect their own pockets.

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19. BELI on September 25, 2012 6:35 PM writes...

When I found I was so frustrated with what had recently happened. There were two of us in line for a great promotion at work. However, I was not willing to “fix the books” like my manager wanted so I did not get the promotion… the other guy did. I really needed that to survive as I was barely getting by on my measly pay. I found your site and knew what I wanted… I wanted my manager to finally be caught, along with the guy that now had the promotion, wanted them both to get what they deserved. A week after requesting the ramshackled finances revenge spell our company was audited, the accounting discrepancies were found and the people responsible were let go and brought up on fraud charges. I now have my ex-managers job and don’t expect my employees to “fix” anything other than their mistakes.

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