Friday, November 29, 2013

Show me the money - Markingson case



Show me the money!



Dr. Carl Elliot writes on his excellent blog, Fear and Loathing in Bioethics:

(emphasis mine - please see link for complete piece)


"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.

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.

Dr. Elliot notes earlier in his piece that his previous requests for information under the open records law were fulfilled without charge, but that this one is somehow different:

"...they have never actually asked me to pay for records -- until I started asking about deaths."



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