Saturday, August 1, 2015

Seroquel in the oatmeal at the sex offender facility: Schulz replies

Dr. Charles Schulz apparently does not feel he was treated fairly by The New York Times, so he has explained his grievance in the American Journal of Psychiatry.

If you recall, in April the Times reported yet another mismanaged clinical trial in the U's Department of Psychiatry.  Two sex offenders were recruited into a clinical trial of Seroquel for Borderline Personality Disorder, despite the fact that they did not actually have the disorder. Then one of them slipped his study medication into the oatmeal at the facility where he was housed.

According a report from Alpha House, the sex offender facility:

Some residents noticed pink particles in the oatmeal. After eating breakfast the residents and staff reported feeling sedated and some were "knocked out’ for the remainder of the day. Staff asked X if he had put the study medication into the oatmeal and he denied it. After failing a polygraph test X was re-imprisoned.

According to many experts, the status of these men as prisoners should have prohibited them from being recruited into the study.  Here is what the Times had to say.

Under guidelines governing federally funded clinical trials, the men would have been considered prisoners and their participation given special scrutiny, several outside ethics experts said. Although the trial was not federally funded, many universities follow similar rules for research involving human subjects. (The university asserts the men were not prisoners.)

Other concerns about the study were raised even before the oatmeal drugging. The study’s safety officer, Dr. Scott Crow, noted in a memo that not a single patient had failed the screening process for enrollment in the study, even though outside experts said it was unlikely that everyone who applied would meet the criteria. Dr. Schulz said the failures were not recorded because the patients were formally screened only after undergoing initial telephone interviews that eliminated unlikely candidates.

“What a sloppy trial,” said Nancy Dubler, a bioethicist who served for years on the Institutional Review Board, or I.R.B., at Montefiore Medical Center in the Bronx. She is an expert on the inclusion of prisoners in clinical trials and said closer attention should have been paid to the events at Alpha.

However, what Schulz wants readers of the AJP to understand is this: the University of Minnesota provided a statement to the Times that there had been no misconduct by any university investigator, and the Times neglected to print it.

You can read the full letter, from Schulz and Donald Black, in the August 1, 2015 issue of the American Journal of Psychiatry.

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