Tuesday, May 26, 2015

"It will sicken you"

Have a look at this comment posted on my editorial about psychiatric research scandals in today's :
New York Times

I monitor clinical trials for a living, I can tell you that none of the suggestions here will work unless there are additional changes. These changes need to be 1) fully fund the FDA, including inspections with the power to immediately halt research at sites AND impose criminal sanctions. 2) tie the validity of the medical license of the physician to their behavior as a PI or Co-PI on a clinical trial. If they are debarred by the FDA, they should lose their medical license.

When physicians sign the FDA Form 1572, that is a contract with the federal government to run the trial on an ethical basis. When they fail to do that, time after time, nothing happens except "retraining". Guess what counts as "retraining"? Reminding them not to do it again. What is repulsive and shameful to me, is to take a name from the FDA's list of debarred investigators and then do a Google search on them. Without fail, they are still practicing medicine even if they were debarred for placing experimental devices into patients without their consent. The debarment often has no effect on whether or not they can continue to practice medicine, and often the public knows nothing about this. And these practitioners are making tons of money. 

Here is the FDA Debarment List:

http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/ucm2005408.htm

Read through some of the Debarment letters describing the findings by the FDA. It will sicken you. Then tell me if we give a damn about ethics in this country.

How research at the U has become dependent on corporate funding

“'The university is not for sale,' said Brian Herman, vice president for research."

No, of course not. The word "sale" sounds so final, and who knows when the market will change?

Leasing, renting and licensing are much more flexible.

Dan Browning at The Star Tribune has the story.

Saturday, May 23, 2015

Star Tribune editorial board is snowed by U propaganda campaign

Don't read this Strib editorial until you have taken an antiemetic.

Afterwards, be sure to read these computer-generated tributes to the U medical school by Richard Beeson and Brooks Jackson.  

Sunday, May 17, 2015

Dishonesty and bad management have destroyed U medical school, writes former cardiology chief

"Over the last two decades, the Medical School has been rocked by successive ethical scandals. Poor financial management led the Board of Regents in 1996 to sell the university hospital to Fairview, a community hospital chain with an average reputation in health care. Since then, review after review has found a lackluster record of achievement; a loss of important faculty members, and inept, bloated administrative functions."

"All of this prompted the dean of the University of Michigan Medical School (who is a University of Minnesota graduate) to tell the Michigan Daily about his once-great alma mater: 'They have disassembled the whole enterprise … and they’ll never recover from it.'"

In the editorial pages of the Star Tribune, Robert Wilson, the former chief of clinical cardiology at the University of Minnesota, asks, "What did they to do my U?"

Saturday, May 16, 2015

FTI review finds serious violations of federal guidelines in U of M bifeprunox study

From Minnesota Public Radio:

"An outside review commissioned by the University of Minnesota has found a university psychiatry researcher made three safety procedure violations during a 2007 study — two of them serious."

"The report by FTI Consulting, released Friday, says Dr. Stephen Olson failed to give a research subject important information about a drug he was taking. Olson and his team also inappropriately prepped the patient for the study before he agreed to participate."

You can read the MPR report here, and my (unanswered) May 11 letter to Debra Dykhuis about the bifeprunox study here.

Friday, May 15, 2015

Schulz fired

From Minnesota Public Radio:

"A month after stepping down as chief of the University of Minnesota's psychiatry department, Dr. Charles Schulz says he has resigned as executive medical director of behavioral health services."

"Schulz said he was asked to step aside by Dr. Levi Downs, chief medical officer of University of Minnesota Physicians, after complaints by staff members who thought Schulz should not remain in that position."

The story is here.

When you are dealing with a major medical scandal...

... it is best to run out the clock until the legislature has approved your handsome budget appropriation.


"The higher education agreement leaves room for $30 million to the University of Minnesota Medical School, designed to elevate its national reputation."