Congressional Sting Bites IRB - Who Benefits?

In March of this year, independent Coast IRB discovered what appeared to be a fraudulent clinical trial that had been submitted in 2008 for review by the IRB. According to Reuters, upon receipt of proof of the fraud, Coast ordered a halt to the clinical trial, alerted the appropriate state and federal authorities and instituted internal measures to prevent a recurrence. And that, Coast thought, was that.

Not so fast. Within days it was revealed that not only was Coast in fact the intended target of a fraud, but said fraud was perpetrated by the United States government in the form of the Government Accountability Office, whose website banner contains the words 'integrity' and 'reliability' to go along with 'accountability'. So instead of being the victim of a crime, Coast found itself in the dock before the U. S. House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce on March 26th, answering charges that it had failed in its duty to protect human subjects from potential harm in clinical research.

As it turns out, the GAO created a fake protocol for a fake device, which they falsely claimed was FDA approved for sale, manufactured by a fake company in Virginia, developed a fake curriculum vitae for a fake investigator and submitted these documents to 3 different IRBs to induce them to perform reviews. The purpose of this elaborate sting was to "gather evidence to form the basis for arguments critical of the FDA and in favor of greater regulatory oversight" (Reuters, 11Mar09). Other components of the sting that did not involve Coast IRB were: establishing a fake IRB and advertising its services on the web, inducing a company to seek approval to add a site to an existing approved ongoing study (not to approve new research, which according to the regulations receives a different level of scrutiny than ongoing research); and submitting the fake name and qualifications of a fake IRB to the Dept. of Health and Human Services to receive an assurance approval number and be listed on HHS's directory of IRBs that review federally funded research.

Following review by 3 different IRBs of the fake device protocol and other documents, according to the GAO's report, 2 of the IRBs returned such extensive feedback that the GAO determined they 'did not have the technical expertise' to respond, and withdrew its applications. By contrast Coast IRB conditionally approved the protocol after a full board review, and contacted the 'sponsor' via the email address set up by GAO and sought at least two different interactions: one for proof of the medical qualifications of the proposed investigator, which the GAO provided by supplying a forged medical license number from the Commonwealth of Virginia. In another request Coast asked the 'sponsor' to modify the informed consent to make the language understandable at the 5th grade reading level. The GAO modified the informed consent as requested and resubmitted it, whereupon full board approval was granted.

I have requested of the GAO copies of the fake protocol and other submission documents for use in developing a teaching module on this episode, and so that we private citizens in the business can determine for ouselves whether the IRB met its obligations. I have yet to receive a reply.


After the truth of the scam came out at the Subcommittee hearing on March 26th, the FDA, in a response that can be filed under Closing the Barn Door After the Cows Have Gone, issued a warning letter to Coast IRB finding fault with them for not, among other things, determining that risks to subjects had been minimized, for not determining whether the FDA approval of the fake device was valid, failure to ensure that basic elements of informed consent were included in the consent form, and failure to determine whether the proposed research is acceptable under applicable regulations and law.

Nobody in Congress or the FDA seems to be the least bit concerned about the acceptability of perpretating a fraud upon a private organization without any prior suspicion of wrongdoing, of Kafka-esque harassment and eventual ruination of said company without due process, potentially in violation of several federal and state wire fraud and mail fraud laws, as well as state laws against false credentialing. According to Reuters, under the auspices of the Department of Jutice or pursuant to a court order, these practices would have been lawful. However this operation was performed at the behest of the legislative branch, not the judicial or executive.


On April 14th, Coast agreed with the FDA to submit itself to severe restrictions in its operations and to completely revamp its procedures to ensure full compliance with FDA regulations. However as of April 29th Coast has raised the white flag and will close its operations for good after transitioning all its active research projetcs to another IRB. The entire staff has been or will be laid off.


I am as concerned about patient safety as the next person and have a long track record of teaching students that no matter what their role in clinical research may be, however great or small, their first duty is to ensure patient safety above all else, including timelines, profit, and cost. So I question just who has benefitted by this targetting of a specific IRB - who had never received an FDA warning letter before - when it would have been so much simpler, and at the same time legal, to simply audit their files and determine through above-board means whether or not they were meeting their obligations to patients under the regulations. I do not see how patients are better protected when the government itself perpetrates fraud to create a new problem, when many profressionals believe the real problem lies in the fact that there are simply not enough good IRBs to cover all the research being conducted. Taking a potentially good IRB, at least once they had developed a procedure for identifying fraud, out of the equation does not seem to me to be the answer.

Risotto as a Metaphor for Life

I made my first risotto last night, pictured here, with green garlic and leek from the farm coop. The recipe is here. Making risotto is not quite as fearsome as one often hears, but you do have to commit to about 30 minutes of very frequent stirring once you start. And you do need to mise en place. Seriously. You don't have time to chop, wash or prepare anything once the first cup of broth goes in, or at least I didn't. I served the risotto with some fresh red snapper sauteed in a little butter, seasoned only with salt and pepper. Hard to go too far wrong. Everybody took seconds.

I had a conversation this week with someone who told me about Janus the god of beginnings and endings, whose face looks both forward and backward. She related this to people entering middle age and coming to realize that not only do people die, but I will too, and looking to make sense of what has come before to make the best of what comes next. That sounds like a good idea.


I got to thinking about the nature of motivations. If I want to make a big change what is my motivation? To explore new challenges? To have more control of my future? To engage my brain a little more? Does destiny have a role? Or is it just about luck, and are they actually different?

I know I am supposed to blog about my visit in Germany with family. There is so much to tell there, it is hard to get started. Soon, soon...

Life as a locavore

Here is the bag of vegetables from my farm coop last week: beets, leeks, carrots, artichokes, chard, fava beans, broccoli, apples and green garlic. This was the third week of the season, our first in a farm coop and I am starting to get the rhythm of it: pick up a huge bag of produce on Thursday after work, cook like a fiend for the next several days trying to use as many ingredients as possible each night, start casting about for unsuspecting neighbors to palm off any remaining veggies that I either couldn't figure out what to do with or we didn't like, clean out the fridge by Thursday and start the process all over again. One change is already in place: we are eating out a lot less. Which is kind of a bummer because I liked going to the local Indian restaurant on Thursday night after everything was done - Thursday is kind of like a Friday for me because I work from home on Fridays - but now I think about all this minutes-from-the-ground produce aging in my refrigerator, and so I cook instead. Lucky for me, the Minimalist (Mark Bittman of the New York Times) has been writing about the same foods so I've had a new source of recipes. Last night I made his carrot, spinach and rice stew, adding green garlic and cup-up chicken thighs, and heated up some roti for bread - absolutely delicious.

A couple of weeks ago Passover sort of snuck up on us, like everything seems to these days. All of a sudden I realized we hadn't planned anything, so I hastily prepared the ceremonial foods (from my farm coop bag, natch) and invited one of Rob's constantly hungry riding partners and managed with some help from Sean to get the entire meal on the table in about 2 hours - blazing speed for a Seder. I used Sydnee's homemade Seder plate, here.