A quick scan of Dr. Frank Cerra’s 14-year tenure as head of the University of Minnesota’s health science programs causes one word to come to mind: “Big.”
Big, as in the $1.2 billion academic health center, where Cerra oversees the medical, nursing, pharmacy and dentistry schools. Big, as in the $292 million Biomedical Discovery District and the adjoining Minnesota Science Park. Big, as in the high-profile research partnership between the university and Mayo Clinic.
Yet big doesn’t always mean better. In fact, big can be downright ugly.
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.
“The entrepreneurial spirit has always been in me,” Dr. Cerra said in an interview with MedCity News. “But when I moved into this position, it really reshaped my views. The future of the state depends on the future of the university. It’s the engine that drives the economy, and the biggest part of that is health.”
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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Dr. Cerra certainly has left us with a lot to chew on. The Biomedical Discovery District is arguably the most significant economic development project in Minnesota’ recent history.
By grouping together state-of-the-art research facilities on cancer, imaging, Alzheimer’s and stem cell technology, the university hopes to create an innovation cluster that spurs technologies and startups in the same manner as Research Triangle Park in North Carolina.
“This is a huge deal,” Dr. Cerra said. “The Biomedical Discovery District is about getting the assurance that Minnesota will not be a flyover state. It’s kind of apolitical. Everyone is supporting it.”
The district has attracted strong support from technology transfer experts, including the Association of University Research Parks, (AURP) which recently held its annual conference at the university. A nonprofit group is trying to create the adjacent Minnesota Science Park, where private investors can commercialize technologies originating from the district.
“His efforts to guide the establishment the Biomedical Discovery District will for years serve a a prime example of how his leadership has contributed to the long-term academic and economic health of the university and the state,” said Peter Bianco, an AURP board member who’s leading efforts to create the science park. “Whoever his ultimate successor turns out to be has has some seriously big shoes to fill.”
But the state’s financial woes could hamper the 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. Part of the problem is that many of the partnership’s research projects focus on cutting-edge technologies that require several years to develop.
But Cerra said the partnership will benefit Minnesota beyond economic development. For instance, the partnership is working on a major public health initiative to fight diabetes, he said.
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.
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.
Cerra’s supporters say his record speaks for itself.
Cerra is “not flashy and keeps a low profile, but when he weighs in on an issue, you feel it,” Bianco said.” He’s obviously made a few enemies and detractors along the way, but that’s to be expected when true leadership is applied in such a complex organization and culture like the university’s.”
“You can’t argue with his success or the long term impact he’s had on the academic health center,” he said.
