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Important Legislation With Implications for Clinical Trials At the University of Minnesota

I thank a reader for calling this to my attention.

Jeremy Olson and Paul Tosto won the Premack award this year for excellence in investigative or analytical reporting about public affairs for their series β€œThe Death of Subject 13” published in the Pioneer-Planet May 18, 19 and 20, 2008. For background see an earlier post.

The Frank Premack Public Affairs Journalism Award competition is one of Minnesota's most coveted and celebrated journalism honors. Started after the death in 1975 of Frank Premack, a reporter, city editor and assistant managing editor at the Minneapolis Tribune, the competition has recognized Minnesota media doing public affairs journalism in their community or region for more than 30 years.

From the Pioneer Planet's excellent health reporter Jeremy Olson:

Legislature approves bill limiting mentally ill patients' participation in drug trials

By Jeremy Olson

Updated: 05/07/2009 12:58:10 PM CDT

A bill before Gov. Tim Pawlenty would restrict the ability of clinical drug researchers to enroll mentally ill patients who are under court commitment orders.

The House and Senate both voted unanimously this week in favor of the bill, which was motivated by the suicide of schizophrenic Dan Markingson. Friday marks five years since his death in a group home in West St. Paul.

At the time, Markingson was enrolled in a comparative drug trial at the University of Minnesota β€” despite objections from his mother that he was coerced into the trial and should be withdrawn.

The initial legislation would have banned clinical drug trials from enrolling any patients under stayed commitments, which are court orders that keep people out of locked mental institutions but under strict conditions.

This outright ban drew opposition from the National Alliance on Mental Illness, or NAMI, which argued that mentally ill patients benefit from experimental drugs or treatments when traditional therapy fails them.

The approved bill gives court judges discretion β€” allowing patients under stayed commitments to participate in clinical trials if they have the wherewithal to make such a decision and have tried traditional therapies first.

The bill also requires that a psychiatrist enrolling a patient into a drug trial cannot be the primary treating psychiatrist for that patient.

A single psychiatrist at the U of M treated Markingson, advised the court on whether
he should be committed, and enrolled him into a study funded by AstraZeneca.
The study compared the effectiveness and side effects of three existing antipsychotics.

"There's a lot more transparency and people watching out for the patient" under this bill, said Rep. Karla Bigham, DFL-Cottage Grove, who authored the bill. "That was our goal."

Kudos to the U of M's own bioethicist, Carl Elliot, for his efforts in making this legislation possible.

Sadly, openness and transparency at the U can sometimes only be achieved by legislation.

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