Wednesday, November 27, 2013

"Want information about research deaths? Show me the money!"


Have you ever wondered how many patients have died in psychiatric research studies at the University of Minnesota?   Or how many patients have been seriously injured?  There is a way to find out, under the state’s open records laws.  But if you want to make use of that law, you’ll have to send the university a fat check.  To be precise: the bill for that information will be $9,720.40, payable in advance.

Ever since I started filing open records requests last year, I have marveled at the ingenuity with which the university has managed to stonewall me.  They’ve claimed they have lost the records I requested, that they have destroyed the records I requested, and that privacy law prevents them from releasing the records I have requested.   But they have never actually asked me to pay for records -- until I started asking about deaths.

In October, I filed a number of open records requests asking for information about deaths and injuries in psychiatric clinical trials.  Two requests were about antipsychotic studies conducted by Stephen Olson – one for Seroquel, the other for an unapproved drug called bifeprunox.  But the largest part of my request consisted of “Serious Adverse Event” reports filed to the Institutional Review Board (IRB) by a number of psychiatric researchers, including Olson and Charles Schulz, the department chair.  Researchers are supposed to file these Serious Adverse Event reports whenever a subject dies or is seriously injured in a clinical trial.  So in theory, these reports should tell me whether a disproportionate number of psychiatric research subjects are being harmed.  (Of course, it is also possible that researchers are hiding deaths and injuries from the IRB, in which case they may not have even filed the Serious Adverse Event reports.)

After five weeks and repeated email reminders, I finally got a reply last week.   Susan McKinney, the university records officer, informed me that under Minnesota state law, the university may “require the requesting person to pay the actual costs of searching for and retrieving government data.”  She estimated that the cost of my requests will total $9,720.40 and asked me to send a check payable to the University of Minnesota.

That’s a pretty substantial bill.  But if the university were actually to provide the information it is promising, those records could be very revealing.  Over the next week or so I will be exploring ways of raising the money, perhaps through a crowdfunding campaign.  One model might be the Gawker campaign to pay for the video of Toronto mayor Rob Ford smoking crack, which was usefully titled “Crackstarter.”  So stay tuned.  If this proves workable, I will be the first person to make a donation.

3 comments:

  1. I will contribute.

    Should you actually end up having to pay this outrageous amount, I suggest that you request documentation for the fee charged.

    I think that it would be useful information to have when visiting the state capitol to lobby for some changes in the state's handling of freedom of information requests.

    A few years ago, I made some requests of Georgia Tech for records of salary payments to Sainfort and Jacko, the faculty couple who were paid simultaneously by the University of Minnesota and Georgia Tech. They graciously waived all fees, which were rather high considering how easy it must have been to pull them together.

    I think this behavior by the U is both telling and disappointing.

    Bill Gleason
    U of M faculty and alum

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  2. Suggest you also thoroughly explore options for objecting to reasonableness of the charges. I doubt the legislature intended to allow such nonsense.

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  3. I will contribute.

    As Bill says, request an itemized receipt. Have you explored getting the information free under FOI from the FDA? Have you talked to the folks at AdverseEvents.com?

    Have you or Leigh Turner considered trying to become IRB members yourselves?

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