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.

On sale: slave-raised Louisiana crawfish

From "The New American Slavery," by BuzzFeed reporters Jessica Garrison, Ken Bensinger and Jeremy Singer-Vine:

“We live where we work, and we can’t leave,” said Olivia Guzman Garfias, who has been coming to Louisiana as a guest worker from her small town in Mexico since 1997. “We are tied to the company. Our visas are in the company’s name. If the pay and working conditions aren’t as we wish, who can we complain to? We are like modern-day slaves.”

The phrase "modern-day slave" is not hyperbole. This investigative report documents a terrifying array of abuses to the H-2 visa system, which brings over 100,000 immigrant workers to America every year to perform menial jobs: picking fruit, setting up carnival rides, peeling crawfish in Louisiana.

A BuzzFeed News investigation — based on government databases and investigative files obtained through the Freedom of Information Act, thousands of court documents, as well as more than 80 interviews with workers and employers — shows that the program condemns thousands of employees each year to exploitation and mistreatment, often in plain view of government officials charged with protecting them. All across America, H-2 guest workers complain that they have been cheated out of their wages, threatened with guns, beaten, raped, starved, and imprisoned. Some have even died on the job. Yet employers rarely face any significant consequences.

Here is an example, detailing the arrest of two Mexican women in Louisiana who dared leave the farm where they were being held:

The police brought the women, who were both in their twenties, to the station house. McGee told them they couldn’t leave West’s farm without permission, warning that they could wind up dead. To drive home the point, an officer later testified, McGee stood over Valdez and Gonzalez and pantomimed cutting his throat. He also brandished a Taser at them and said they could be deported if they ever left West’s property without his permission.

A little after 2 in the morning, they released the women to West for the 15-minute drive through the steamy night to his compound — a place where, the women and the Mexican government say, workers were stripped of their passports and assigned to sleep in a filthy, foul-smelling trailer infested with insects and mice. Valdez and Gonzalez also claimed that they and other women were imprisoned, forced to work for little pay, and frequently harassed by West, who demanded to see their breasts and insisted that having sex with him was their only way out of poverty.

It gets much worse. You can read the rest of this harrowing report on BuzzFeed,

Thursday, July 30, 2015

Pharmalot is shuttered -- again

But have no fear. According to Ed Silverman, Pharmalot will resume publication at "Stat, a forthcoming website that will devote itself to tracking the fascinating ins and outs of life sciences."  Watch this space for more details.

Wednesday, July 29, 2015

Podcast of "The Best-Selling, Billion-Dollar Pills Tested on Homeless People"

The podcast Shaken and Stirred has just released an audio version of my Matter article, "The Best-Selling, Billion-Dollar Pills Tested on Homeless People."

It is also in the iTunes podcast store:

You can sign the petition asking the FDA to take action here. 

Thursday, July 23, 2015

Universities cultivate tribal solidarity among students and alumni in order to paper over the emptiness at their core

So says Kevin Carey in the New York Times, quoting Clark Kerr: "Professors are a series of individual faculty entrepreneurs held together by a common grievance over parking.”

Wednesday, July 22, 2015

City Pages on the U's forgery scandal

From Susan Du at City Pages:

A University of Minnesota student reporter was caught fabricating quotes for news articles last week. About the same time, a U researcher was caught forging a federal document. The key difference between the two cases: the Minnesota Daily fired its writer, but the faculty member will not be disciplined.

The rest of the story is here.