Thursday, September 30, 2010

MedCity News Reviews

AHC VP and Medical School Dean

Frank Cerra's Tenure at

the University of Minnesota

Ouch!

Thomas Lee

Cerra leaves University of Minnesota with a mixed legacy

Under Cerra’s watch, the medical school suffered what critics call embarrassing ethical lapses between its physicians and industry. The school’s proposed conflict-of-interest policy has been slammed by people who say it doesn’t go far enough, as well as those who claim it will stifle innovation and business ties.

Here lies the conflict of his career: Dr. Cerra, who retires at the end of the year, has worked hard to position the university as both a research powerhouse and a major catalyst for economic development.
But whether a university still haunted by major government sanctions more than a decade ago can pursue its agenda — and preserve its integrity — is very much an open question.

...the state’s financial woes could hamper the [biomedical discovery] district. The university already has scaled back the project: instead of constructing separate buildings for cardiovascular and cancer research, the school plans to build a facility that houses both departments. The district’s success also depends on recruiting world-class scientists and researchers. That requires money. Lots of it.

Cerra also was instrumental in creating The Minnesota Partnership for Biotechnology and Medical Genomics, a joint venture between the university and Mayo Clinic.

State officials had hoped the partnership, founded in 2003, would create companies and jobs, but the partnership’s progress has been modest at best

Cerra’s tenure also has been marked by serious legal and ethical woes at the medical school.

When the university appointed Cerra senior vice president of health sciences in 1996, the medical school already was reeling from high-profile scandals. [Cerra's own appointment came under fire because of his ties to Caremark Inc., a company under federal investigation at the time for paying kickbacks to doctors.]

In 1994, a federal court sentenced Dr. Barry Garfinkel, a former director of the school’s Department of Child and Adolescent Psychiatry, to prison for falsifying documents related to clinical trials of the drug Anafranil.

In 1995, a federal grand jury indicted Dr. John Najarian, a renowned transplant surgeon, on charges of fraud, theft and tax evasion relating to the illegal sale of ALG, an experimental anti-rejection drug. Although the Food and Drug Administration never approved ALG, the school’s surgery department, which Najarian chaired, sold $80 million-worth of ALG throughout the 1970s and 1980s, with much of that money benefiting the university.

A jury acquitted Najarian the following year, but the damage was done. The school paid $32 million in fines, and the National Institutes of Health placed severe restrictions on the university’s freedom to use research money.
The Najarian scandal, observers say, severely curtailed the school’s appetite for pursuing commercialization deals with outside companies.

“Yeah, that was something that took us several years to get over,” Dr. Cerra said. “The whole turmoil took several years of working with everyone so they were ready to move in a common direction. We’re coming out in much better shape.”

Has it though? As the university rebuilds its ties to the business community and aggressively pursues commercialization, the medical school has once again suffered from perceived ethical breaches.

Last year, the Star Tribune in Minneapolis reported that recently released court documents showed AstraZeneca, the maker of psychiatric drug Seroquel, claimed the drug was superior to standard treatments for schizophrenia even though it knew the research did not back the claim.

Dr. Charles Schultz, chief of psychiatry at the university, had presented research to a medical conference that backed AztraZeneca’s claims. Schultz claims the company never shared its concerns with him.

In 2003, a St. Paul woman sued the university, accusing the school of forcibly enrolling her son in an AstraZenca-funded clinical trial involving Seroquel. The man later killed himself. An FDA investigation ultimately found no evidence of wrongdoing, and a federal judge dismissed the lawsuit.

The list goes on. Dr. David Polly, an orthopedic surgeon, drew fire for his consulting deals with Medtronic Inc.

The Star Tribune reported that Dr. Leo Furcht had funneled university grant money into a company he ultimately sold for nearly $10 million. Furcht had been serving as co-chair of a task force drafting new rules on conflict-of-interest problems.

Deborah Powell, who had appointed Furcht to the task force, ultimately stepped down as dean of the medical school. She was replaced by Cerra — the first person to head both the medical school and the academic health center.
Cerra has steadfastly defended the school’s need to collaborate with outside companies. Nevertheless in August, the academic health center released new rules governing potential conflicts of interest between personnel in its medical school and business interests, including drug and medical device companies.
All of the people covered by the health center’s new policy must report their financial interests, as well as executive positions and board memberships, to the university annually. The dollar threshold for triggering a conflict-of-interest review by an internal committee is $5,000 at the academic health center, compared with $10,000 for others at the university.

Cerra praises the new policy, but others aren’t so happy. Gary Schwitzer, a former university health journalism professor recruited by Dr. Furcht to serve on the task force, said the school rushed the process.

The result was a watered-down policy that omits key recommendations, such as banning industry efforts to fund education events for faculty, Schwitzer said.

Cerra has largely escaped the turmoil unscathed. Even faculty members who have been openly critical of Cerra declined to comment for this story because of his impending retirement.
[Disclosure: I declined comment.]
 
Schwitzer, who now runs the HealthNewsReview blog, said he does not know Cerra personally. However, holding top university officials like Cerra and president Robert Bruininks (a Cerra ally who’s also retiring) accountable for the medical school’s problems is perfectly legitimate, he said.

“Somebody has to be responsible,” Schwitzer said.

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1 comment:

mike howard said...

Thank you Professor Gleason for being in the minority willing to expose the egregious behavior that is now the University of Minnesota. As a consumer, I am appalled every time I read/re-read Dr. Schulz's excuses for his now infamous Seroquel/Haldol presentation. Are we truly suppose to believe that a renowned psychiatrist/investigator doesn't check and re-check his data before presentation? Give me a break. Why has he not for scientific and academic responsibilities published a redacted article stating he screwed up? and the University wonders about it's credibility and standing in the community. It has no credibility. Again, thank you Professor Gleason for caring. Albert Einstein says it best: "the world is a dangerous place to live, not because of evil people, but because ordinary people do nothing about it"