Robert Langer is an unlikely pioneer in the burgeoning
field of bioengineering. For one thing, he's not a biologist.
Yet, Langer, 54, a much-honored professor of chemical and biomedical
engineering at the Massachusetts Institute of Technology, is pre-eminent
in the field, and his work has led to highly effective and novel cancer
therapies and drug-delivery systems. His name graces more than 400
patents, licensed to scores of companies. Around 35 products have been
sparked from his research. Indeed, Langer has found 12 biotech companies.
By almost any measure, he is a success, an archetypal 21st-Century
Renaissance man who adroitly blends cutting-edge academic science with
When he began his work, just ahead of the biotech boom
that commenced in the early 1980s, academic research in the life sciences
and business were strangers to one another. Langer was initially a
pariah for having the audacity to link them. And today on the nation's
campuses there remain pockets of disquiet about this ongoing mating
dance between academia and private enterprise, and where it may lead.
Voices of warning and cautionsome quite alarmist, some more measuredpipe
up with regular frequency. Two recent booksUniversities
in the Marketplace, by former Harvard President Derek Bok, and Science
in the Private Interest by Sheldon Krimsky, a professor of public
policy at Tufts, turn a critical eye on these collaborations.
To Langer, however, collaborating with industry just
made sense. His team was developing ideas with potentially life-saving
applications, and without the help of corporate partners, he reckoned, they
weren't going to get out to the public. Only industry has
the hundreds of millions of dollars to research, test, and bring new
products to market. Of course, in the past two decades, these kinds
of academic-industrial ties have become commonplace, and Langer's
business acumen now commands respect. Federal and many state laws encourage
collaboration and make it easier for research universities to work
with the private sector. The result: a wellspring of new lifesaving
drugs and other life-enriching products, as well as the birth of the
biotech sector and the enhancement of the information technology industry.
Billions of dollars of wealth and countless jobs have been created.
And for many schools, the commercializing of academic research and
the funding of research by industry have unearthed new revenue streams
and helped keep their labs humming.
Critics fret that American academia's long and fine
history of basic research could be crippled if too many scientists
focus too much on the kinds of applied research that industry needs.
Cozy relations between industry and universities have at times led
to dangerous conflicts of interest, untoward secrecy that's anathema
to good science, and to the suppression of information. The consequences
are that secrecy has replaced openness; privatization of knowledge
has replaced communitarian values; and commoditization of discovery
has replaced the idea that university-generated knowledge is a free
good, Krimsky writes in his book. The consequences, he tells
Prism, could be an irrevocable erosion of public trust in research
schools. What is happening is that integrity is being compromised
left and right.
To be sure, there have been high-profile episodes of
egregious lapses in judgment as well as unsettling studies that underscore
these concerns. For example, a gene-therapy trial at the University
of Pennsylvania Medical School resulted in the 1999 death of 18-year-old
patient, Jesse Gelsinger. What wasn't disclosed until later was
that both the school and the director of the institute conducting the
trial had huge financial stakes in the company that financed the research.
Then there's the study that found that 35 percent of major engineering
research centers say it's O.K. for industrial partners to edit
out information from papers ahead of publication. While few critics
want to re-erect the old barriers between academic science and business,
or even think that that's possible, they argue that steps need
to be taken to minimize conflicts of interest and protect the reputation
of American research schools.
Certainly the past 20 years have seen a rapid rise in
partnerships between academia and industry that shows no sign of peaking.
The Association of University Technology Managers (AUTM), in its FY
2001 survey of members, found that royalties from product sales totaled
$845 million, a 12.5 percent increase over 2000. And while gross license
income fell from $1.26 billion to $1.1 billion, other figures indicated
that the commercialization trend remains healthy. Invention disclosures
jumped 4 percent to 13,569, while new patent applications were up nearly
7 percent to 6,812. A total of 22,937 licenses and options were active
that year, a 9 percent increase over 2000. Moreover, AUTM reports its
membership has more than doubled in the last five years to 3,200, an
indication that universities continue to open or expand technology-transfer
Additionally, industry spending for academic research
dollars continues to climb, going from $1.4 billion in 1994 to $2.2
billion in 2001, a jump of 57 percent. But then, federal spending has
been accelerating at only a slightly slower pace: It rose 51 percent
to $19.2 billion in the same period. But when one takes a longer view
of industry support for academic research, the increase in support
is more apparent. In the 1960s, industry money accounted for just 3
percent of academic research funds; today it's nearly 8 percent,
on average. But there are schools where corporate dollars comprise
30 to 40 percent of their research budget. Meanwhile, some schools
are on a private-sector bender. Duke, for instance, received $109 million
in research money from industry in 1999, more than triple the $31 million
it got in 1992.
The growth in campus-corporate ties is easy to explain
from the schools' point of view. It's a new and potentially
huge source of revenue. As the U.S. economy continues to muddle through
a slow-slog recovery, research universities and the lawmakers who help
fund them see commercialization as a means of not only bringing in
money to the schools but as a tool for regional and statewide economic
development. Across the nation, governors are asking legislatures to
inject funds into technology-transfer offices and to enact laws making
it easier for schools and faculty members to commercialize research. Legislators
realize that the knowledge industry creates the jobs of the future.
And that's what legislators get elected to docreate jobs, says
Patricia Harsche-Weeks, AUTM president. What's more, says Bok,
the former Harvard president, there is no such thing as a universitypublic
or privatethat is ever satisfied with its financial resources.
Competition between schools has always been fierce as they fight for
the best faculty, the best facilities, the best students. And that's
an expensive rivalry that imposes a chronic condition of
financial neediness, he notes.
Collaboration shifted into overdrive after 1980 when
Congress passed the Bayh-Dole Act, which gave universities the right
to patent intellectual property that resulted from taxpayer funding.
And Bayh-Dole's effect was further enhanced by subsequent laws,
including tax breaks to companies that fund research. Before the act,
universities were applying for about 250 patents a year, compared with
nearly 7,000 a year now. And while Bok wants both sides to exercise
caution, he tells Prism that Bayh-Dole was a positive. It's
a plus if universities try to make the process of technology transfer
Perhaps the biggest fear is that academics, seduced by
the lure of filthy lucre, will concentrate so heavily on applied science
that basic, blue-sky research will be squeezed. We're concerned
that universities will become just another outpost of industry, says
Virginia Sharpe, director of the Center for Science in the Public Interest's
Integrity in Science Project. But studies show that that fear is unrealized.
At least so far. Since the late 70s, the percentage of basic
research conducted on U.S. campuses has remained unchanged, despite
the increase in corporate dollars. We haven't seen that, responds
Lita Nelsen, director of MIT's Technology Licensing Office, when
asked if scientists are abandoning basic research. Bok writes that
if some areas of basic research are underfunded, that's
likely to reflect the shortsightedness of government authorities (or
perhaps foundation officials) rather than the malign influence of business. Many
academics dispute that there is a divide between public and commercial
interests because using industry to bring good ideas out of the lab
to meet human needs is in the public interest. Notes Langer: Certainly
the things we do are in both interests. What we do certainly is in
the public interestimproving people's health. And
it's to be expected that companies need to earn a profit from
investing in that process, he adds.
If basic research isn't on the wane, some schools
have figured out ways to do additional, profitable work simultaneously.
Duke, for instance, leads a consortium of schools that conduct for-profit
drug testing for the pharmaceutical industry. But even proponents of
collaboration say some corporate work should be eschewed. Universities
need to be wary of trivial research, like tests to determine
if brand name drugs are more effective than generic rivals, Bok writes.
Christopher Edwards, a professor of mechanical engineering at Stanford
University, is also deputy director of the school's new $225 million
Global Climate and Energy Project. The 10-year program, called G-CEP,
is funded by four companiesExxonMobil, General Electric, Slumberger,
and Toyotawith the goal of seeking options to stop or sharply
cut global emissions of greenhouse gases that come from
burning fossil fuels. Many scientists say greenhouse gases contribute
to global warming. Given his remit, Edwards clearly sees value in working
with private enterprise. But, he warns, universities must not become the
applied-science arm of industry. Edwards recently toured the
labs of another big school, and it seemed to him as if all of its projects
were designed as problem-solving tasks for various companies. That's
not research, that's contract work, Edwards says, which
is a waste of time and talent. Why would a university want to
do that? It's not expanding knowledge. But many schools
justify taking on such chores, claiming the money can be used to support
other, loftier research and build needed infrastructure in their labs.
There's a widespread perception that only the government,
and not corporations, support basic research. On a whole, that may
be true, but there are times when research seems so speculative, so
risky that it's the government that balks at paying for it. For
instance, Jim Swartz, a chemical engineer at Stanford, is working on
research to see if microorganisms can be used to capture and convert
solar energy to hydrogen. The Department of Energy would not get involved,
so he's forging ahead using G-CEP funding. James L. Sweeney, a
professor of management science and engineering, who helped bring G-CEP
to fruition, says that regardless of where a researcher gets fundingthe
government, the private sector, a foundationit's never totally
free of strings. After 30 years of research, he adds, very often I've
found industry funding sources less constraining than government sources.
MIT's Langer says government agencies often opt not to fund promising
research. Edwards says that the idea that academics can work on any
research that is totally detached from having an application at some
point in the future, even if there is no corporate money involved, is
pretty much a fallacy.
One of the darker offshoots of collaboration is stories
of efforts to quash findings that run counter to a company's commercial
agenda. In recent years there have been several high-level examples
of drug researchers who have endured heavy-handed pressure to sit on
findings and had their careers jeopardized when they balked and published
anyway. What's not known is how widespread of a problem this is.
The worry is that other academics have also faced such pressures and
quietly given in. Sharpe says that past scandals involving tobacco,
lead, and pesticides prove that companies have been willing to manipulate
science for noxious goals. Regardless of how rampant such cases are,
the fact that they can and have occurred has led to some rule tightening.
Two years ago, the top 10 medical journals, for example, agreed to
accept articles only after guarantees from researchers and sponsoring
companies that unfavorable findings haven't been suppressed, or
that results haven't been doctored. If part of the problem stems
from academics signing contracts without properly digesting the fine
print, some schools are becoming more proactive in vetting contracts
between individual academics and companies before they're signed.
AUTM's Harsch-Weeks says university lawyers can close loopholes
that would let companies suppress information.
Secrecy is another issue. Schools and academics have
been pressured by companies to delay findings. And that's a slap
at the ingrained practice of free exchange of scientific research.
While it's understandable that a sponsoring company may want some
time to file a patent, there have been many instances where companies
have sought postponements that go far beyond the need to protect proprietary
information. The National Institutes of Health (NIH) suggests that
a delay of a month or two is reasonable, but some schools, like Texas
A&M, set the deadline at six months. And too often it's the
universities themselves placing too many restrictions on the free exchange
of information. Some schools have sought exclusive patents when
a nonexclusive patent might be better, Bok says. The NIH says
it gets complaints from industry that undue restrictions placed on
research tools by universities are hampering scientific discovery.
What's ironic about the paper-money chase is that
very few schools earn substantial sums from commercialization, at least
not from technology transfer. The latest AUTM figures, from 2001, show
Columbia University as the tech-transfer powerhouse, grossing nearly
$130 million from transfer fees, a whopping amount. MIT was a distant
second at just under $74 million, while the University of California
System ranked third at nearly $67 million. But the grosses for many
top-flight schools are hardly eye popping. Consider: Duke, $5.6 million;
Georgia Tech, $4.6 million; the University of Southern California,
$1.9 million; Princeton, $1.7 million. Only half of all patents are
licensed, and the average income per license is a mere $20,000. And
the legal costs of handling intellectual property, including the protection
of patents, aren't cheap. Some schools surveyed by AUTM spend
more in legal fees than they collect from patents and licensing. The
sluggish economy also takes its toll. Tech-transfer officials now spend
time chasing companies that are late in paying licensing fees.
Checks and Balances
Even champions of entrepreneurial academic research say
that strong ground rules are needed to keep abuses in check. In fact,
MIT's set of rules overseeing commercialization is considered
a great model. The Center for Science in the Public Interest says that
at a minimum, academics and schools should publicly and fully disclose
all sources of funding and links to companies. Bok is among those who
say that when research places human lives at risk, scientists should
be prohibited from involvement if they have a financial stake in any
of the companies taking part. He also says that schools should not
invest in start-up companies formed by faculty members. Langer agrees,
noting that he neither sought nor wanted MIT money when he started
his many companies. Historical checks and balances can still be useful
in combating dangerous behavior. Peer review remainsmore often
than nota good means for ensuring that researchers don't
fiddle with their findings. And good, old-fashioned competition among
schools also helps keeps them in line. If a school is collecting huge
amounts of industrial cash, but it becomes apparent that much of its
research has become mediocre, the revenue stream would likely dry up
as the school's reputation plummets. Notes Stanford's Edwards, It's
not that much money. It's not worth a school's reputation.
Commercialization of academic research despite some serious
and disturbing bumps in the road has by and large proved a successful
route: for schools, for industry, and for the public. Henry Etzkowitz,
head of the Science Policy Institute at the State University of New
York, believes it's foolhardy to think that science can progress
if barriers exist between private-sector and academic researchers,
because many great scientists work in industry, and campus-corporate
collaboration energizes basic research. Economist Gordon Rausser, in
an article he wrote for Berkeley's alumni magazine a few years
ago, noted that access to commercially developed proprietary
databases is essential to providing top-notch graduate education
and conducting fundamental research. And then there's Langer's
argument that great inventions will languish in labs without industrial
support. MIT's Nelsen says preserving basic research while working
with industry is something that can and should be done. But it's
an art. You're walking a tightrope. However, if more schools
insist upon and adhere to strict rules of engagement with industry,
then perhaps the resulting safety nets will make it a high-wire act
with less risk.
Thomas K. Grose is a freelance writer based in Washington,
He can be reached at firstname.lastname@example.org.