Biotech & Other Corporations Buy Out US Universities

TUESDAY, JUNE 19, 2001

Corporate cash & campus labs

The credibility of university research is on the line as industry steps up
its funding

By Mark Clayton (claytonm@csps.com)
Staff writer of The Christian Science Monitor

It was to be a landmark university-corporate research partnership:
Novartis, a Swiss-based pharmaceutical conglomerate, would pay $25
million over five years to the University of California at Berkeley.

But what the company was to get in return shocked faculty, students, and
outsiders alike.

In exchange for funding, Novartis would be allowed to sift through the
research of the department of plant and microbial biology at Berkeley's
College of Natural Resources - licensing up to about one-third of the
researchers' output.

Students declared it a sellout. Legislators scheduled hearings. Professors
protested the secrecy of the negotiations. One professor decried the deal
for creating an "apartheid" of have and have-not faculty. Outside observers
were no less impassioned.

"What if the [Novartis-Berkeley] experiment were to succeed?" wrote Robert
Rosenzweig, former president of the Association of American Universities,
in response to the deal. "What would be the next part of the university to
be sold to a corporation?"

Portending the turmoil to come, company and university officials announcing
the November 1998 deal at a press conference had to duck to avoid being
hit by a pie. Despite protests, the deal went through, and administrators
report that it is working.

Yet misgivings persist. "This is a public university that is supposed to
work for all sectors of society," says Miguel Altieri, associate professor
at Berkeley. "Obviously the sectors we're going to be working for in the
future are the ones that bring in the money."

Such comments only hint at the vortexes created by university-corporate
partnerships. Critics cite fears over limits on academic freedom, conflicts
of interest among researchers, and bias creeping into scientific research.

Over the long run, observers also worry that research priorities might
shift away from breaking scientific ground to more short-term,
product-related efforts. And there is the possibility, too, that the public
will lose confidence in higher-education research.

Nelson Kiang, professor emeritus at the Massachusetts Institute of
Technology, has watched the changes during his long career. What's
different today is that "the sheer number of corporations involved in
sponsoring research has exploded," he says. "The ethos of the university
is the free exchange of ideas. Now we're running into two sets of ideas
from two cultures. When they start to interact intimately, accommodations
have to be made. At the moment, there's no agreed upon way to do that."

Acknowledging a deep divide between corporate America and American
universities, a two-year study issued last week by the Business-Higher
Education Forum - a partnership between the American Council on Education
and the National Alliance of Business - outlined problems and
recommendations for smoothing the rocky road between the two worlds.

"Some research collaborations have experienced serious, high-profile
difficulties," stated Hank McKinell, chairman of the board of the New
York-based pharmaceutical company Pfizer and co-chair of the report
task force. "The report is intended to help clarify the issues."

Bullies in the lab?

One such issue is academic freedom. Corporate and academic priorities
clash when scientists want to share research discoveries, but contracts often
require secrecy for 30 to 90 days or longer while patents are weighed.

Betty Dong at the University of California, San Francisco, discovered data
that led her to question the effectiveness of a medication being used daily
by millions of people. But when she went to report it, she was blocked for
seven years by the company that paid for the study.

David Kahn, another researcher at the same school, was sued last November
for $10 million by the company that sponsored his study, after he published
a report that the AIDS drug he was testing was ineffective.

"They're like bullies in a sandbox who take away their toys when you don't
agree with them," Dr. Kahn told The Chronicle of Higher Education.

Few foresaw these clashes two decades ago. Such research partnerships had
long been a staple of American higher education, going all the way back to
the 1862 federal legislation that created the land-grant university.

But university research started melding with the business world at a much
faster pace with the 1980 passage of the Bayh-Dole Act. Bayh-Dole sped
up the patenting process for university research, supercharging
university-corporate partnerships with profits and competition.

In the 1970s, just a few hundred patents resulted from university research
each year. But in fiscal 1999, more than 120 US research universities filed
a total of 7,612 patent applications, according to the Association of
University Technology Managers. Licenses to industry generated $641 million
in gross income for the universities - and about $40 billion in economic
activity overall.

"You used to have big corporations with labs that would do their own basic
research," Mr. Kiang says. "But ... it's much more effective to turn the
universities into R&D labs for them. By sprinkling money around ... they
don't have to compete for the best brains in the academic world, they
simply buy them at low cost."

The federal government is still by far the dominant funding source for
university research. In 1998, corporations were responsible for less than 8
percent of the funding.

That may not sound like much, but it represents a seven-fold growth since
1970. According to the new report, the flood of patents has been a big
boost to America's increasingly knowledge-based economy.

Federal Reserve Chairman Alan Greenspan told governors last year: "The
payoffs, in terms of the flow of expertise, new products, and startup
companies ... have been impressive."

Indeed, for every challenged program like the Novartis-Berkeley union, the
Business-Higher Education Forum report documents other collaborations that
are working well. At Washington University in St. Louis, for instance, a
funding deal with Monsanto (now Pharmacia) has been harmoniously in place
for two decades.

Smaller companies have prospered, too. Ribozyme Pharmaceuticals gave the
University of Colorado a five-year, $500,000 unrestricted research grant.
In return, the university shared research that helped the company grow.

Despite this robust productivity, some fear that a key product of
universities - unbiased research - is at risk.

In some fields, especially medical research, scientists complain that
corporate cash appears to be undermining the credibility of research
results.

In 1996, Tufts researcher Sheldon Krimsky studied nearly 800 scientific
papers published in prominent biology and medical journals. In 1 out of 3
cases, he found that a chief author of the paper had a financial interest
in the company for which research was being done. In most cases, the
connections were not disclosed to readers.

Mildred Cho, a senior research scholar at the Center for Biomedical Ethics
at Stanford University, took a different tack. Her 1996 study found that 98
percent of university studies of new drug therapies funded by the
pharmaceutical industry reported that those new therapies were more
effective than standard drugs. By comparison, just 79 percent of studies
without industry financing found the new drugs to be more effective.

Other researchers are disquieted, too.

"There has been in some fields a substantial, industrial-commercial
influence," says David Blumenthal, director of Massachusetts General
Hospital's Institute for Health Policy and a professor at Harvard Medical
School. In a 1998 study, he and colleagues found that 43 percent of
scientists - many of them at university medical centers or schools - had
received at least one research-related gift. About two-thirds said the gift
had been important to their research.

Such conflicts are hardly confined to the medical field. In his 1997 book,
"The Heat Is On," Ross Gelbspan cites professors for not disclosing that
coal and oil companies had funded their studies, which were used to
undercut arguments in favor of reducing greenhouse gases.

Meanwhile, back at Berkeley, the Novartis funding is winning converts.
Despite what one university official described as "lingering resentment,"
only two of 31 faculty members in the Berkeley department have declined
to seek grants ranging from $60,000 to $200,000 to fund their research,
according to the just-issued report.

A need for more disclosure

Will the scientists who do accept corporate funding disclose that
information when they publish their research?

Pressure has been building at the federal level for tough new disclosure
requirements since the 1999 death of Jesse Gelsinger, a teenage volunteer
in the clinical trial of a gene-therapy drug at the University of
Pennsylvania. In that case, a researcher had a financial interest in the
drug's success. (The death this month of a volunteer in a Johns Hopkins
University asthma study is being investigated, but no information has
surfaced suggesting any conflict of interest in that federally funded
study).

At a meeting last fall, scientists debated whether and how much to disclose
about such interests to potential patient volunteers, but could not agree.
Researchers receiving federal grants must disclose any income greater than
$10,000 from a corporation. But that rule does not apply when companies
do all the funding. And even when scientists do report, it is usually only to
the university itself, which often does not disclose such financial ties.
One ray of hope: The New England Journal of Medicine recently admitted
that it had failed to disclose 19 authors' conflicts of interest - and toughened
its disclosure policy.

More disclosure at all levels is needed, Dr. Blumenthal argues. The
long-term risk, he says, is nothing less than a loss of public confidence
that could permanently undermine support for universities.

"There is a need for guidelines and protections to assure the public that
commercial motives are not excessive," he says. "It won't be hard to do
that if we could get the universities to take the long view.... But in the
heat of battle, it's hard to do."