9-Misc: Peer Reviewers Give Thumbs Down to Berkeley-Novartis Deal

[coordination@genet-info.org]

                                  PART I
------------------------------- GENET-news -------------------------------

TITLE:  Peer Reviewers Give Thumbs Down to Berkeley-Novartis Deal
SOURCE: Chronicles of Higher Education, USA, by Goldie Blumenstyk
DATE:   30 Jul 2004 

--------------------- archive: www.genet-info.org/ --------------------


Peer Reviewers Give Thumbs Down to Berkeley-Novartis Deal

A team of scholars says universities should avoid unusual and 
controversial research agreements such as the one the University of 
California at Berkeley had with the company formerly known as Novartis. 
The university had invited the team of outside scholars to evaluate its 
relationship with the company.

The arrangement at Berkeley, in which nearly an entire department of 
biology participated in a five-year, $25-million corporate-sponsorship 
agreement, was "outside the mainstream for research contracts with 
industry," the team of evaluators concludes.

"While an intriguing experiment, there appears little rationale for 
repeating the approach," they say in their report, which is scheduled to 
be released this weekend.

The report also suggests that Berkeley's relationship with Novartis 
created a potential conflict of interest among administrators that 
affected the tenure review of a faculty member, Ignacio Chapela, who was 
an outspoken critic of the agreement. He was denied tenure in late 2003. 
The report does not offer an opinion on whether Mr. Chapela should have 
received tenure, but it does state that "there is little doubt" that the 
Berkeley-Novartis relationship was a factor in the tenure decision.

The agreement "played a very clear role and an unsatisfactory role in the 
tenure process" of Mr. Chapela, said Lawrence Busch, a professor of 
sociology at Michigan State University, who headed the evaluation.

More than 200 academics and others have called for an investigation of the 
tenure denial for Mr. Chapela, an assistant professor of microbial 
ecology. He has said that the Academic Senate's Committee on Privilege and 
Tenure will investigate whether he received due process, and that his term 
of employment has been extended to December 31, 2004.


A Divided College

The 188-page report is the product of more than two years of work by a 
team of 10 Michigan State researchers, who were selected to conduct the 
evaluation. Berkeley's Academic Senate requested it when the Novartis deal 
was announced, in 1998.

At the time, officials of Berkeley's department of plant and microbial 
biology and the dean of the College of Natural Resources, where the 
department is housed, heralded the deal as a pathbreaking venture that 
would pump up the department's financial base, provide members access to 
sophisticated equipment, and help it to win additional research support.

But the deal also had its critics, including two within the department, 
several in other parts of the college and campus, and many in academe as a 
whole. They said it could compromise faculty members' independence and 
skew research priorities.

As it turned out, said Mr. Busch, neither the hype nor the condemnation 
proved justified.

"None of the worst fears came to pass," said Mr. Busch, who is director of 
the Institute for Food and Agricultural Standards at Michigan State. 
But "none of the greatest hopes came to pass," either.

The report notes, for example, that the department did see an overall 
increase in its research support during the period that its arrangement 
with Novartis was in place. But at the same time, the report says, another 
biology department at Berkeley also saw its research support increase. For 
purposes of comparison the researchers looked at a plant-biology 
department at Michigan State and noted that its financing, too, rose 
during the same period.

The deal concluded at the end of 2003. By then Novartis had split off its 
agribusiness arm and merged it with that of another company to create a 
new corporation, Syngenta.


No Smoking Gun

While the team found no egregious examples of wrongdoing in regard to the 
research itself, it did fault Berkeley on several fronts.

"The perception that the agreement was negotiated behind the scenes 
without following normal procedures," the report says, "signaled an 
erosion of shared governance to a number of faculty."

The evaluation also raises questions about the broad rights that Berkeley 
granted to Syngenta to commercialize inventions. Under the agreement, the 
company had the first rights to negotiate licenses on inventions by 
faculty members who participated in the agreement, even if the work had 
been financed with federal funds.

"Such an occurrence," the report says, "strains conventional thinking on 
the proper stewardship of public funds."

Berkeley officials had maintained that the intellectual-property deal 
followed principles set out years earlier by the National Institutes of 
Health, because Syngenta was entitled to choose no more than one-third of 
all inventions from the department to commercialize.

But the report says that the deal "fell short of at least the spirit of 
the NIH's guidelines" because Syngenta could see everything and choose 
what it wanted. "They could cherry-pick," said Michigan State's Mr. Busch.

Berkeley sought patents on 20 of the department's inventions during the 
period of the sponsorship, 10 of which derived at least in part from 
Syngenta-supported research. The company expressed interest in six of 
them, including two that involved ways to improve grains, but never 
licensed any.

The agreement also became a lightning rod for divisions within the College 
of Natural Resources, where the biology department became identified as a 
bastion of support for agricultural-biotechnology research, while other 
departments in the college were critical of such work.

Relations among faculty members within the college "continue to be a 
serious problem," the report says. "Such a poor state of collegiality 
hinders the productive capacity of the college as a whole and the quality 
of education that it is able to provide."


Bad Impressions

Paul W. Ludden, dean of the college since mid-2002, did not respond to 
requests for his comments on that assessment.

Berkeley's executive vice chancellor and provost, Paul R. Gray, oversaw 
the agreement for the administration. He declined to be interviewed by 
telephone, saying through a spokeswoman that he was too busy.

But in a written response to questions, Mr. Gray noted that the 
Novartis/Syngenta funds had accounted for only 27 percent of the biology 
department's overall sponsored-research budget during the period of the 
agreement, and that participants considered it a success.

"The department is substantially healthier" than it was at the outset of 
the agreement, he wrote.

He declined to comment on the Chapela matter because it is an "ongoing 
academic personnel case."

Robert Spear, a professor in the School of Public Health who was a leader 
of the Berkeley Academic Senate when the deal began, said he was 
disappointed that the report did not focus more directly on whether the 
deal had led to a skewing of professors' research priorities.

He also noted, however, that the issue became less of a concern for 
faculty members when it became clear, in 2002, that Syngenta would not 
renew the agreement.

Syngenta never gave a reason, but the presumption was that the strong 
antipathy to biotech crops outside the United States had prompted it to 
scale back that kind of research.

Mr. Spear said he agreed with a recommendation in the report that Berkeley 
review its arrangements with industry to ensure that those ties did not 
compromise researchers' ability to be seen as honest brokers of 
information and analysis on important issues. The biology department's 
deal with Novartis/Syngenta "certainly did compromise the department," 
said Mr. Spear.

Mr. Busch, in a follow-up e-mail exchange, said that recommendation, like 
others in the report, applies to all public universities as well.

The deal created the impression that the department was "on the dole" 
and "biased toward the funding source," he said. "Universities as 
institutions can only be objective observers on the scientific and 
regulatory scene to the extent that some distance remains between them and 
industry funding sources."


                                 PART II
------------------------------- GENET-news -------------------------------

TITLE:  Five-year deal with Novartis hurt UC Berkeley
SOURCE: The Sacramento Bee, USA, by Edie Lau
        http://www.sacbee.com/content/business/v-print/story/10214098p-
11134579c.html
DATE:   1 Aug 2004 

--------------------- archive: www.genet-info.org/ --------------------


Report: Five-year deal with Novartis hurt UC Berkeley

A USD 25 million, five-year research deal between plant biologists at UC 
Berkeley and the biotechnology company Novartis was a costly experiment 
that should not be repeated, outside reviewers conclude in a report being 
released today.

The reviewers, from Michigan State University's Institute for Food and 
Agricultural Standards, found that damage done to the University of 
California's premier research campus, from campus infighting to a 
tarnished reputation, simply wasn't worth the money.

The findings could reverberate far beyond Berkeley. Campuses around the 
country, including UC Davis, considered the Novartis agreement a possible 
model for their own arrangements with industry.

"When one looks at the negative publicity that occurred, the enormous 
amount of time that was spent after the fact trying to justify the 
agreement, as well as the serious problems it poses for the perceived 
objectivity of the scientists, this is probably not a good idea to do," 
said Lawrence Busch, who led the 10-member review team.

The contract, which expired in November, gave a select group of Berkeley 
biologists USD 25 million for research along with access to trade secrets, 
principally in genetics. In return, Novartis got first dibs on potentially 
lucrative discoveries.

The deal provoked vigorous and often angry debate on campus and inspired 
numerous articles in the popular press, including one in Atlantic Monthly 
magazine titled "The Kept University."

In the end, the collaboration didn't turn out as anyone expected. The 
company didn't try to strong-arm the scientists to pursue only 
commercially valuable research, as some had predicted.

And participants - 23 faculty members in the department of plant and 
microbial biology, plus their research staffs and students - did not make 
any dramatic discoveries. In fact, the company did not license a single 
invention produced during the five-year period.

Yet to this day, talking about the contract elicits strong emotions on 
campus. Busch, a social scientist by training, said that's because the 
controversy is a symptom of a bigger issue for universities nationwide: 
confusion and disagreement over their mission and role.

Is the primary purpose of a university to create knowledge? To stimulate 
economic growth? Train high-tech specialists needed in a modern economy? 
Educate the masses? Be of service to its customers?

"The vision of the university as an engine of growth is now the dominant 
view," the reviewers wrote in the conclusion to the 188-page 
report. "Lamentably, this has occurred with little or no real debate among 
faculty, students or external constituencies."

The issue of conflicts of interest among public university researchers 
working with the biotechnology industry was the subject of a Bee article 
in "Seeds of Doubt," a five-part series about genetically engineered food 
published in June.

At UC Davis, the administration and some faculty have high interest in 
strengthening ties with the commercial world.

"Take a high-tech university like UC Davis, the majority of our students 
will wind up working in industry," said Barry Klein, vice chancellor for 
research. "We don't want to view industry as the enemy - that's where our 
students are going. We want to build a bridge to them."

After reading the executive summary of the UC Berkeley-Novartis review, 
Klein said the report offers food for thought. But he said the UC Davis 
administration has been careful to air its goals on attracting industry 
and to invite faculty feedback, and, he said, that feedback usually is 
positive.

"To the extent that the Busch report is right ... and the failing was 
largely one of perceptions and what have you," Klein said, "we're doing 
the right thing by at least talking about these issues."

At Berkeley, Chancellor Robert Berdahl was on vacation and not available 
to discuss the review. In his absence, Vice Chancellor Paul Gray provided 
brief written answers to questions submitted by e-mail.

While he did not say so explicitly, Gray appeared to disagree with the 
reviewers' fundamental conclusion that the Novartis contract - because it 
involved virtually an entire department - was a mistake.

"Among the ways the report is helpful is that it provides data to show 
that the (plant and microbial biology) department is healthier today than 
it was before the agreement was put into place," Gray wrote.

That's because, he said, the department was able to leverage the money it 
received from the company into grants from other outside sources, 
including the federal government, boosting its overall research funding.

Damon Lisch got a job at UC Berkeley because of the Novartis money, and 
has kept that job thanks to subsequent government grants.

"It changed my life," said Lisch, a researcher in the laboratory of 
Michael Freeling, who was one of the top beneficiaries of the agreement, 
receiving USD 950,000 over five years.

"It was very hard for me to rationalize not accepting the money when there 
were so few strings," Lisch said. "They never told us what to do."

However, Lisch still lives with the larger controversy over agricultural 
biotechnology, which he believes has been damaged by negative public 
perception.

"I told a little kid the other day that I'm a corn geneticist, and she 
said, 'Ewwww!' " Lisch said, chuckling.

David Quist, a UC Berkeley doctoral student in ecology who helped start a 
student group that opposed the Novartis contract, said he was pleasantly 
surprised by the "brave" assessment of the review team.

"I didn't really anticipate that they were going to hit on a lot of the 
biggies," Quist said. "To me, the report brought to the surface a lot of 
the invasive, yet unacknowledged, concerns about financial conflicts of 
interest and also the philosophical or world view conflict of interest.

"For genetic engineers, making the genetically engineered product often is 
the endpoint of their research," he said. "Whereas for me as an ecologist, 
it's the beginning point. Those are very different points of view and 
world views."

The USD 225,000 review was paid for by the UC Berkeley administration.

The report will be posted online at www.msu.edu/user/ifas/ beginning 
Monday, Busch said.


                                  PART III
------------------------------- GENET-news -------------------------------

TITLE:  Study of the University of California at Berkeley Novartis 
Agreement
SOURCE: Michigan State University, Institute for Food and Agricultural 
Standards, USA
        http://www.msu.edu/user/ifas/current.html
DATE:   Aug 2004 

--------------------- archive: www.genet-info.org/ --------------------


Study of the University of California at Berkeley Novartis Agreement

The agreement between the University of California at Berkeley (UCB) and 
the Novartis Agricultural Discovery Institute (NADI, now part of Syngenta) 
has been the subject of considerable debate on campus, in the Bay Area, 
and nationally. Given its large size and scope, it poses issues of 
changing university-industry relations, already the subject of 
considerable discussion, in a contested and highly publicized manner. Yet, 
despite widespread media coverage and much debate, no comprehensive study 
of the impact of that relationship on UCB, the Department of Plant and 
Microbial Biology, or major research universities has been undertaken. 
This study will attempt to eliminate that gap in our understanding of this 
type of universityindustry relationship. It will employ an 
interdisciplinary team of six persons, each with an interest in the 
subject matter, to (1) analyze the impact of the agreement on the 
Department of Plant and Microbial Biology, (2) evaluate the agreement's 
significance for UCB as a whole, (3) assess the significance for research 
universities with special attention to Land-Grant institutions, and (4) 
formulate conclusions and guidelines for future agreements of this kind. 
The PIs will attempt to understand the issues from the perspectives of UCB 
faculty members, administrators, students, industry executives, California 
officials, members of the agricultural community in California, as well 
other key stakeholders. They will employ focused, semistructured, in-depth 
interviews as well as a review of printed documents and media accounts to 
obtain a thorough knowledge of the situation. They will set the project 
within the framework of academic literature on university-industry 
relations, and science and technology studies. Moreover, they will 
cooperate with another project with similar objectives, funded by the 
United States Department of Agriculture, to provide comparative data 
across institutions. The PIs will produce a draft report by the end of 
year one and a final report six months later. They will also pursue 
publication of results in both higher education news and scholarly 
publications in their respective fields. To see the Final Report, please 
click here. (PDF file size: 378 KB)




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