Jennifer Washburn: All Publications, Events and Press

Academia and the Company Coin | Nature Biotechnology

Cecille Isidro — Fri, 01 May 2009 12:35:00 -0400

In some cases, the problem may be that industry is taking over more study designs and doing so with marketing in mind. “It’s about ‘How can we broaden out the uses of this drug, how can we promote it among more populations’… studies are marketing designs rather than public health designs. It doesn’t advance the body of evidence-based medicine in this country,” says Jennifer Washburn, author of University, Inc.: The Corporate Corruption of Higher Education and a fellow at the New

Jennifer Washburn in The New York Times | 'When Academia Puts Profit Ahead of Wonder'

Communications — Sat, 06 Sep 2008 08:06:00 -0400

The Bayh-Dole Act of 1980 started out with the best of intentions. By clearing away the thicket of conflicting rules and regulations at various federal agencies, it set out to encourage universities to patent and license results of federally financed research. For the first time, academicians were able to profit personally from the market transfer of their work. For the first time, academia could be powered as much by a profit motive as by the psychic reward of new discovery...

...“Bayh-Dole tore down the taboos that existed against universities engaging in overtly commercial activity. Universities really thought that they were going to make it rich,” said Jennifer Washburn, author of “University Inc.: The Corporate Corruption of Higher Education” (Basic Books, 2005). “Each school was convinced that if they came up with that one blockbuster invention, they could solve all their financial problems.”

Ms. Washburn says that was “extremely wrong-headed.” Initially reacting to the law by slapping patents on every possible innovation, universities quickly discovered that patents were an expensive proposition. The fees and legal costs involved in obtaining a single patent can run upward of $15,000, and that doesn’t count the salaries of administrative staff members. Instead of bringing home the bacon, university tech transfer offices were throwing money into the void with little hope of returns. LINK

Jennifer Washburn in Journal of Life Sciences on Academia & Industry

Communications — Tue, 13 Nov 2007 14:35:00 -0500

Merck and Harvard enter a collaboration that reflects the closer ties being forged between industry and academia, but it's a trend that is alarming to some. ...

At a time when federal research dollars have grown scarcer, universities are embracing industry partners interested in getting a first crack at their cutting-edge technologies.

The latest evidence of this comes from a recently announced agreement between Harvard Medical School and the pharmaceutical giant Merck. Merck and Harvard Medical School will collaborate to advance research programs in oncology and central nervous system disorders. Merck's decision to open a research facility just down the road from Harvard in 2004 put researchers at both institutions in walking distance of each other.

For Merck, the deal gives the company an early look at new discoveries and the right to negotiate licensing deals for technology that emerges from the collaboration before anyone else. For Harvard, the agreement provides not only funding, but a chance for researchers concerned about seeing their work commercialized an opportunity to interact with a major drug company. It also provides an avenue to advance their projects at a time when capital for early-stage development to carry potential products to a point they can… more

Science's Worst Enemy: Corporate Funding

Cecille Isidro — Mon, 01 Oct 2007 14:14:00 -0400

In recent years there have been a number of highly visible attacks on American science, everything from the fundamentalist assault on evolution to the Bush administration’s strong-arming of government scientists. But for many people who pay close attention to research and development (R&D), the biggest threat to science has been quietly occurring under the radar, even though it may be changing the very foundation of American innovation. The threat is money -- specifically, the decline of government support for science and the growing dominance of private spending over American research.

The trend is undeniable. In 1965, the federal government financed more than 60 percent of all R&D in the United States. By 2006, the balance had flipped, with 65 percent of R&D in this country being funded by private interests. According to the American Association for the Advancement of Science, several of the nation’s science-driven agencies -- the Environmental Protection Agency (EPA), the Department of Agriculture, the Department of the Interior, and NASA -- have been losing funding, leading to more "outsourcing" of what were once governmental science functions. The EPA, for example, recently began conducting the first nationwide study on the air quality effects of large-scale animal production. Livestock producers, not taxpayers, are slated to pay for the study. "The government is clearly increasing its reliance on industry and forming ‘joint ventures’ to accomplish research that it is unable to afford on its own anymore," says Merrill Goozner, a program director at the Center for Science in the Public Interest, a consumer advocacy group.

The full text of this article can be found at: http://discovermagazine.com/2007/oct/sciences-worst-enemy-private-funding

An Unholy Alliance

Cecille Isidro — Mon, 09 Apr 2007 00:20:00 -0400

Five hundred million dollars is a lot of money -- especially for a public university. When the giant oil company BP announced Feb. 1 that it had chosen the University of California, Berkeley, to lead the largest academic-industry research consortium in U.S. history, University of California officials appeared giddy.

If the deal is approved, BP, formerly known as British Petroleum, will give $500 million over 10 years to create a multidisciplinary Energy Biosciences Institute at UC Berkeley. Berkeley would partner with the Lawrence Berkeley National Laboratory and the University of Illinois at Urbana-Champaign to establish the institute devoted to researching biofuels -- fuels derived from plants and other organisms.

Many university and state officials pronounced the BP alliance a victory for the environment. "A tremendous day for Mother Earth," UC President Robert Dynes declared when the partnership was announced. From a public relations standpoint, BP’s willingness to invest in alternative energy research vastly improved the company’s image, which had been sullied by a refinery explosion in Texas and a 267,000-gallon oil spill from corroding pipelines in Alaska.

But the terms of the research alliance -- and the implications for the UC system -- haven’t received sufficient scrutiny. Shortly after the BP deal was announced, Dynes said, "We are reinventing the research university in this public-private partnership."

He’s right. And that is what’s so troubling.

The BP alliance is not simply an environmental initiative; it is a plan to substantially reinvent -- and privatize -- America’s research universities. Such a radical proposal warrants careful public scrutiny, given that these same universities have given birth to many of America’s most remarkable scientific and technological achievements.

Unfortunately, UC officials haven’t encouraged public debate. After the deal was announced, UC withheld the agreement containing specific terms of the plan for a month. In late March, administrators agreed to let faculty participate in the final contract talks with BP, but only after more than 130 faculty members signed a protest petition calling for the chancellor to investigate whether there was adequate faculty senate review and consultation.

Traditionally, universities have strived to maintain a clear, arms-length relationship with their corporate benefactors over academic research. The BP alliance would break this relationship, effectively turning the university into a contract research organization for industry. As such, the alliance would undermine the university’s academic freedom, its ability to perform independent research and broadly disseminate results. And, possibly, it might undermine the public’s trust.

The plan’s fine print suggests Berkeley’s administrators might have been more concerned with beating out four competing universities to win the BP deal than they were in protecting UC’s public research mission.

The plan would allow BP to station 50 of its employees on the Berkeley and the University of Illinois campuses, where they would "be embedded within the campus research environment" and work with professors and students on research. It would further allow BP to operate its own private, commercial labs on the campuses, where research would be confidential and proprietary.

The plan also dispenses with numerous traditional safeguards designed to protect the university’s independence. It grants BP unusual control over the institute’s research agenda, makes no mention of peer review, downplays commercial conflicts of interest and contains provisions on publication that would violate UC’s written policies, which state: "There can be no fundamental limitation on the freedom to publish as the result of accepting extramural research support." Finally, the plan gives BP exceptionally broad commercial rights to co-own and license the institute’s academic inventions.

In short, for $500 million, the plan would allow BP, a company valued at $250 billion, to turn an academic research institute into its own profit-making subsidiary.

The proponents of the BP alliance are motivated by noble goals. Many are world-renowned scientists, who feel an urgent need to tackle the problem of global warming and are eager to secure research funding. In a Berkeley online interview, Steven Chu, a Noble Prize winner who directs the Lawrence Berkeley National Laboratory, explains: "Partnering with BP we will have the resources to actually carry out some of the things we want to do in order to help save the world."

Gov. Arnold Schwarzenegger also sees an alignment of interests. Under California’s new global warming law -- Assembly Bill 32 -- the state is required to reduce greenhouse gas emissions, such as from vehicles, industries and power plants, by 25 percent in 13 years. The governor believes that energy companies need to help develop alternatives to fossil fuels and has pledged $40 million on top of $30 million in state bonds toward the construction of a Berkeley science facility dedicated to the Energy Biosciences Institute.

Schwarzenegger and Chu are right that energy companies need to be part of the solution. But their participation should not come at the price of Berkeley’s academic integrity and the open scientific process, which the university has long embraced. Otherwise, the state could wind up adopting expensive, new energy alternatives that appear environmentally friendly and boost corporate profits, but fail to significantly reduce carbon emissions or slow climate change.

Berkeley has been down this road before. In 1998, Berkeley signed a five-year, $25-million agreement with Novartis, a Swiss-based pharmaceutical company and a producer of genetically modified crops. The deal allowed Novartis to pay for one-third of the research budget of an academic department; it also granted the company licensing rights to nearly all the department’s most valuable inventions.

This controversial alliance led Berkeley to pay for an external academic team from Michigan State University to study the Novartis arrangement at the request of Berkeley’s faculty senate. The study did not uncover any overt manipulation of the academic research, but it concluded that the Novartis alliance was "outside the mainstream" of academic-industry relationships and badly tarnished the university’s perceived independence on issues ranging from genetically modified agriculture to the environment.

The Michigan State team made several recommendations: Avoid industry agreements that involve complete academic units or large groups of researchers; carefully assess the potential for institutional conflicts of interest; and encourage broad debate early in the process when developing new research agreements. The current UC administration has ignored these in the alliance with BP.

Even when research is funded by industry, the university normally holds the reins of control. The alliance with BP is different. It asserts that the Energy Biosciences Institute’s director will be "proposed" by BP; its associate director will be "employed by BP" and other high-level positions will be filled by BP appointees, giving the company power to set the research agenda, control the purse strings and oversee daily operations. The plan acknowledges this shift: "(BP’s) business-industry leadership will strongly differentiate the EBI from other primarily academic research enterprises."

This is worrisome. Historically, universities have recognized they can’t serve two masters: objective science and the bottom line. That’s why most universities try to keep the academic and commercial spheres distinct.

The BP deal ignores this tradition. By allowing BP scientists to set up labs inside of academic facilities, the plan states it will foster the "flow" of information between the "open" academic and "proprietary" corporate sides of the institute and encourage extensive research collaborations between BP scientists, professors and students.

This information flow appears to benefit BP more than the university. Up to 30 percent of BP’s $500-million grant may be spent inside BP’s proprietary labs. Any faculty or student who wishes to enter BP’s labs would have to obtain "controlled card-key access." In contrast, BP employees would have open access to more than a dozen world-class, publicly funded laboratories at Berkeley, Lawrence Berkeley National Laboratory and the University of Illinois. BP employees would also have privileges, usually reserved for faculty, including the ability to participate in designing and delivering courses and mentoring students. At one faculty senate forum, a graduate student remarked: "I didn’t come to this university to be lectured on climate change or energy by British Petroleum, which is in this to make a profit."

The alliance cavalierly suggests that the academic and corporate-proprietary sides of the institute will "comfortably accommodate" one another. But this contradicts years of university-industry experience. Industry scientists place a premium on secrecy and commercial profitability; academic scientists are more interested in the open exchange of scientific knowledge and fundamental research.

It’s worth remembering why this open culture is important to preserve: The biotechnology and the computer revolutions were born out of research performed in academia, not in industry. It’s possible that the next great breakthrough in environmental technology will also spring from this open academic environment.

The BP plan violates a bedrock academic principle: That all campus-based research be published, or openly shared. The University of California’s official policies on publication emphasize that the open exchange of information is fundamental to the advancement of science and education. That’s why Berkeley bans all classified military research from campus. Yet the plan specifies that BP’s 50 scientists on campus would "have no obligation to publish."

Intellectual property is another area where the alliance could distort UC’s public mission. Universities, as a rule, hold the intellectual property rights in their research, no matter how it is funded. To foster innovation and competition, universities generally try to permit more than one company to license their discoveries for commercial purposes. The alliance with BP, by contrast, would give the energy company privileged access to many of the institute’s inventions. It allows BP to co-own intellectual property in some instances and to receive exclusive, albeit time-limited, commercial licenses, as well. These two options, whenever exercised, would grant BP a monopoly, blocking commercial competition.

Beth Burnside,the vice chancellor of research, reassured Berkeley’s faculty senate that these intellectual property arrangements with BP follow "standard research procedures." But the plan notes that some of these terms "deviate from standard policy" and would "require exceptions to policy in order to be implemented."

Another area of concern involves the research. The plan states the Energy Biosciences Institute is dedicated to finding "long-term technological solutions to global energy challenges." However, when BP invited Berkeley and the other universities to apply for its research grant, it specified a targeted research area: The development of genetically modified crops and other organisms, which could be converted to lower polluting transportation fuels or be used to enhance the extraction and utilization of fossil fuels.

At campus forums and in the media, many Berkeley professors have challenged the narrowness of the institute’s research agenda, noting that it fails to consider solar, wind and other promising areas of energy research. Whenever you have one corporation issuing a research grant of this size, it can skew the university’s research agenda. In an effort to bring money into their labs, faculty will tailor their research to suit the sponsor’s interests. In this case, BP’s commercial interest is biofuels.

The plan promises to study the "productivity, cost effectiveness, land use, and environmental impacts" of biofuels. But given BP’s influence, many professors have questioned how balanced this research will be. Currently, biofuels require so much energy to produce that they are not energy efficient. And they pose other serious drawbacks, as well: Industrialized farms for biofuel production may further exacerbate topsoil erosion, water contamination, deforestation and other problems.

Jay Keasling, a chemical engineering professor affiliated with the BP project, told the faculty senate that "risk assessment" will be built into everything the institute does. But given BP’s commercial interest, will the public be able to trust this research?

Given that there’s nothing in the plan that calls for independent selection of specific academic research projects -- a process often governed by scientific peer review -- can the Energy Biosciences Institute be trusted to pursue research that might prove that biofuels are the wrong alternative energy choice?

BP executives and university leaders from the partner institutions are working out a final contract. An agreement could be ready for the UC president and the regents to sign in July. It’s possible that the current plan could be re-written to better protect the university’s autonomy.

However, this would necessitate major reform of the plan: The university would have to remove BP’s private labs and employees from campus; rescind BP’s leadership role in the institute; and adopt a truly independent system for selecting research projects and allocating funds, one driven by scientific merit not commercial criteria.

BP has already accepted the current plan as the basis for awarding its contract to Berkeley, so major reform is unlikely. The best option now is to throw out this deal and start fresh.

Tadeusz Patzek, an engineering professor at Berkeley who worked as an industry scientist at Shell, recently commented in an op-ed article for the Daily Californian that the BP alliance would turn Berkeley into a better corporation. "But if UC Berkeley becomes yet another corporation," he asked, "will there be another great public university to take its place?" That’s what UC officials and regents need to ask themselves before they sign this deal.

Stanford's Deal with Exxon Mobil Raised Concerns

Cecille Isidro — Sun, 08 Apr 2007 17:22:00 -0400

The alliance between the oil giant BP and the University of California, Berkeley, stands out because of its $500 million price tag, its commercial scope and the potential for BP to exert excessive influence over the academic research. But it isn’t an isolated case.

The second largest such partnership is a 10-year, $225-million deal Stanford University signed with Exxon Mobil and other energy firms in 2002 to fund a Global Climate and Energy Project.

The Stanford deal was controversial from the start, but one aspect recently captured headlines. The San Jose Mercury News reported March 11 that Steve Bing -- a movie producer and environmentalist -- was withdrawing a $2.5 million donation to Stanford and all future donations. (Bing had already donated $22.5 million to the school.) Why? Because Exxon Mobil has exploited its close relationship with Stanford in ads -- on TV and in print -- that seek to portray the company as a "green" company.

The most egregious of these was an ad in The New York Times, part of a series appearing on the commentary page, which celebrated the company’s new research partnership with the "best minds" at Stanford.

The ad suggested the global warming debate is ongoing: "Although climate has varied throughout Earth’s history from natural causes, today there is a lively debate about ... the climate’s response to the presence of more greenhouse gases in the atmosphere." The ad was signed by Lynn Orr, who directs the Global Warming and Energy Project.

About this time, Exxon Mobil was pushing the U.S. government to reject any mandatory curbs on greenhouse gases; it was also continuing to call for more research on whether human use of fossil fuels actually caused global warming, despite the overwhelming scientific consensus that it does. Many observers found the university’s blatant endorsement of Exxon’s PR campaign shameful.

The Stanford deal has many unusual features. A management corporation, with representatives appointed by each of the corporate sponsors and one university representative, Orr, approves the budget and the areas of research that will receive funding. This gives the sponsors considerable power to shape the institute’s research priorities.

The sponsors also enjoy an automatic, exclusive license to any of the project’s discoveries. The sponsors can block outside companies from gaining access to the university’s discoveries for up to five years. What’s more, they don’t have to pay any royalties to the university.

Criticism of the Stanford deal has been more muted, but from time to time the deal continues to raise eyebrows. During the campaign for Proposition 87, which called for a tax on oil extraction to raise public money for alternative energy research, some observers detected something strange. James Sweeney, a Stanford professor, began giving quotes to the media opposing Proposition 87. Sweeney’s ties to Exxon were never mentioned. But his research with the Global Climate and Energy Project was funded by Exxon, and he also served as a consultant.

Big Oil Buys Berkeley

Cecille Isidro — Sun, 25 Mar 2007 01:59:00 -0400

On Feb. 1, the oil giant BP announced that it had chosen UC Berkeley, in partnership with the Lawrence Berkeley National Laboratory and the University of Illinois at Urbana-Champaign, to lead the largest academic-industrial research alliance in U.S. history. If the deal is approved, BP will give $500 million over 10 years to fund a new multidisciplinary Energy Biosciences Institute devoted principally to biofuels research.

Gov. Arnold Schwarzenegger, UC administrators and BP executives immediately proclaimed the alliance -- which is not yet a done deal -- a victory for higher education and for the environment. But here’s another way to see it. For a mere $50 million a year, an oil company worth $250 billion would buy a chunk of America’s premier public research institutions, all but turning them into its own profit-making subsidiary.

This is shameful. The core mission of Berkeley is education, open knowledge exchange and objective research, not making money or furthering the interests of a private firm. In the last two decades, however, Cal and other universities -- increasingly desperate for research dollars -- have signed agreements that fail to protect their essential independence, allowing corporations excessive control over their research.

The BP deal magnifies this trend. Most corporations sponsor university research one study and one lab at a time. With the Energy Biosciences Institute, BP would exert influence over an entire academic research center (spanning 25 labs at its three public partners), bankrolling and setting the agenda for projects that cut across many departments.

What’s more, BP would set up shop on campus: 50 scientists employed by the company would work on joint projects with academic scientists at Berkeley and the University of Illinois. BP also would set up private labs on these campuses, where all the research would be proprietary and confidential.

Robert Reich, former secretary of labor and now a professor of public policy at Berkeley, has warned that -- because of its size and commercial scope -- the BP alliance could be either "a huge feather in Berkeley’s cap or a huge noose around Berkeley’s neck." The question is, do rules and practices set up to safeguard academic integrity and independence stand up to a corporate deal of this magnitude?

The fine print of the plan, which UC made public only after it was leaked, doesn’t create much confidence. Californians need to know that their public university is dedicated to pursuing the best science, not just science that generates profits for BP. Unfortunately, the plan indicates that narrow commercial criteria could guide much of the Energy Biosciences Institute’s research.

Normally, even when university research is corporate sponsored, professors alone direct and shape it. Often, funds are assigned and research proposals are accepted through an independent, peer-review process. In the BP deal, however, the institute -- with a director to be "proposed" by BP and other high-level positions to be filled by BP employees or appointees -- would play a major role in setting research agendas and controlling purse strings. The plan touts the company’s role: BP’s "business industry leadership will strongly differentiate the EBI from other primarily academic research enterprises."

The plan also would hand unusual control to BP in other areas. A bedrock principle of academia is that campus-based research should be published. That’s why Berkeley bans classified military research from campus; the open exchange of information is fundamental to the advancement of science and education. But those 50 BP scientists on campus would, according to the plan, have "no obligation to publish."

Universities also, as a rule, hold the intellectual property rights in their research, no matter how it’s funded. In order to foster competition and innovation, they generally allow more than one company to use their discoveries for commercial purposes. This plan allows BP to co-own intellectual property in some instances and to receive exclusive (albeit time-limited) commercial licenses as well. The plan itself notes that such terms "deviate from standard policy" and "require exceptions to policy in order to be implemented."

Ultimately, there is an even more basic question to consider. Would the institutionalization of BP at Berkeley call into question the essential objectivity of the research generated by the collaboration? BP is clearly investing its $500 million not just in public-good research; it’s hoping to advance an energy source it’s already committed to commercially. Given that there is nothing in the plan that calls for truly independent selection of research proposals, can the Energy Biosciences Institute be trusted to pursue research that might prove that biofuels are the wrong alternative-energy choice? Would its social sciences arm freely investigate potential ecological and economic downsides?

UC President Robert Dynes has characterized the BP deal in telling words. "It is my belief," he said, "that we are reinventing the research university in this public-private partnership."

Five hundred million dollars is a nice chunk of change, but does any amount of money justify "reinventing" UC Berkeley’s academic integrity? That’s what UC officials should ask themselves before they sign this deal.

Jennifer Washburn Condemns Corporate Sponsored Education on WABC-TV

Communications — Thu, 26 Oct 2006 20:23:00 -0400

Westchester - WABC, October 26, 2006) -- A new trend in being seen in higher education: Big business spending big bucks to influence what's taught in college classes. Eyewitness News education reporter Art McFarland has the story.

Matt Ganis is teaching computer programming at Pace University in Pleasantville. But he's not paid by the university. He's an IBM employee, brought in to give this lecture as part of a worldwide, $100 million IBM program to shape college curricula in information technology...

IBM has invested more than a quarter of a million dollars at Pace, for hardware, software, faculty training and student field trips to IBM research labs. But critics say businesses should not have such influence.

New America Foundation's Jennifer Washburn writes on the subject.

"We really depend on our institutions of higher education to be independent institutions that train students to be very versatile and creative in their thinking," Washburn said. "We don't turn our institutions into corporate training grounds..."For the complete article, please visit the WABC-TV website.

Textbook Foolishness

Cecille Isidro — Wed, 13 Sep 2006 18:03:00 -0400

An important education bill -- sponsored by state Sen. Martha Escutia (D-Whittier) and supported by prominent education groups -- is sitting on Gov. Arnold Schwarzenegger’s desk awaiting his signature. The bill would allow publishers to develop textbooks for the state that would be designed to foster the language skills of non-native English speakers.

Virtually everyone agrees that these English language learners, who make up about 25% of the state’s student population, need more help mastering English. According to a 2006 state-commissioned report, fewer than 40% of English learners in California schools are likely to meet the linguistic and academic criteria needed to reclassify them as "fluent" in English after 10 years.

In 2005, only 3% of English learners in the 10th grade scored "proficient" in English on the California Standards Tests. Meanwhile, on the California high school exit exam -- a graduation requirement -- only 50% of English learners in the 11th grade passed the portion testing English skills.

Sadly, the chances that Schwarzenegger will sign the bill are slim -- despite the fact that it has the support of the California School Boards Assn., representing 95% of the state’s school boards, as well as the Assn. of California School Administrators, representing 16,000 school superintendents, principals and other administrators. Both groups say educational materials available to help English learners are woefully inadequate. The new textbooks would integrate basic English-language instruction into every lesson and would be fully aligned with curriculum and testing standards.

Shelly Griffith of the administrators association says her members see an urgent need for new textbooks that would enable early-stage English learners to "keep up with grade-level subject matter, even as they are improving their command of English." She emphasizes that individual school districts could choose whether they want to use the textbooks.

But the bill may well be vetoed because of an old political debate about bilingual education that has nothing to do with this measure. Ron Unz, who led the 1998 initiative campaign that eliminated most bilingual instruction from California’s public schools, recently told the Los Angeles Times that he suspected the Escutia bill was a "backdoor" effort to bring back bilingual education. Some newspaper editorial boards have made similar claims.

It’s true that Escutia is a well-known supporter of bilingual education, and her strong-arm political tactics have alienated many. But this bill has nothing to do with bilingual education. It calls for textbooks written in English for use in English-only classrooms.

If a school has a large number of English learners who are below grade-level in reading and writing, such textbooks may be advantageous. If a school has only a small number of limited-English students, it may choose to use this alternative curriculum in tandem with standard textbooks, giving the teachers more instructional tools to work with.

The other main criticism of the bill is that it might lead to English learners being segregated in classrooms where "they tend to get a dumbed-down, second-rate education," as The Times recently editorialized. This is not an unreasonable fear because many school districts serve disproportionately high numbers of English learners.

But it’s pretty clear that the current situation is no better. When limited-English speakers are placed in classrooms where they cannot comprehend most of the instruction, it is de facto segregation. As Holly Jacobson of the California School Boards Assn. told me: "Many English learners have to sit through a big chunk of their day not understanding most of what is being taught."

The proposed books and materials are designed to give English learners the second-language instruction they are supposed to receive but often do not. Some kids do learn English through the sink-or-swim total-immersion approach, but too many struggle and fall behind.

Just ask Jane Schrenzel, an elementary school teacher in Laguna Hills. Last year, she taught a fifth-grade class that had close to 95% English learners. Many of her students were born in the U.S., but most were reading one to two levels below grade level. Five were recent immigrants who spoke no English. Just getting through one seven-page story in the state-approved textbook was challenging. "There are so many basic vocabulary words the kids just don’t know," she said. "And the supplemental materials we have are extremely limited. It’s very time consuming to modify all the time and scrape together the materials ourselves."

These textbooks may not be the magic bullet. But we would be giving teachers and school districts more and, we hope, better choices.

Jennifer Washburn on Company-Designed University Curricula in the Wall Street Journal

Communications — Tue, 12 Sep 2006 07:56:00 -0400

RALEIGH, N.C. -- When graduate students at North Carolina State University took their seats on the first day of a class called Services Management, the kickoff lecture wasn't delivered by a professor. Instead, it was given by a manager from International Business Machines Corp.

The company, in fact, helped develop the curriculum and awarded grants to the school with the expectation that the course would be taught -- all with the aim of producing graduates better prepared to work for IBM. The guest speaker, a regional manager, began his lecture by saying, "My name is Craig Nygard, and I am a services professional," later adding, "You have started thinking about tackling big problems and turning them into revenue opportunities."

A fast-moving, competitive economy -- and the perception that students are unprepared for its demands -- is creating a new phenomenon at colleges and universities: courses supported by, and tailored for, potential employers. In addition to IBM, other major corporations seeking to increase their presence and influence on campus include Credit Suisse Group and German auto maker BMW AG...

To read the rest of the article, please visit The Wall Street Journal website.

The Best Minds Money Can Buy

adminn — Fri, 21 Jul 2006 19:09:00 -0400

Most of us place enormous faith in our universities. We trust that they are autonomous, independent institutions committed to education, scholarship, academic freedom and the production of knowledge free from the influence of special interest groups. Right?

Wrong. In the last 25 years, the United States has given birth to a market-model university, one where professors increasingly work "for hire." Just last week, The Wall Street Journal reported that a major academic study -- which found that antidepressants were safe and effective for pregnant women -- was tainted by undisclosed conflicts of interest.

Apparently, although the study itself was financed by the federal government, most of its 13 authors -- including many prominent academics -- also served as paid consultants to manufacturers of antidepressants. None of these financial ties were made public.

Reports like this have proliferated in the last decade. Today, it is common for professors to moonlight as consultants for drug firms. They receive generous stipends to join company advisory boards. For a nominal fee -- anywhere from $2,000 to $5,000 -- some professors will even agree to be named as authors on journal articles ghostwritten by the drug industry and published without disclosure of company involvement.

Editors at top medical journals have warned that such commercialism threatens to undermine the integrity of academic science, but the blurring of academia and commerce continues.

It's not just medical professors who have such conflicts. The new commercialism also involves law and business professors and academics in many scientific disciplines. It even affects administrators, such as Chancellor Marye Anne Fox of UC San Diego, who is a director at three corporations (two medical firms and a chemical company). In the last year alone they paid her cash and stock worth at least $339,260, according to the San Diego Union Tribune.

And the universities themselves, eager to share in the profits from research being done on campus, are getting in on the act. In recent years, changes in federal patent law have allowed universities to behave more like commercial enterprises. They now run their own patent offices and venture capital funds and industrial parks, and sometimes have equity interests in the companies that do the research, causing new institutional conflicts of interest.

Industry money represents a small percentage of overall university research funding (the bulk of which comes from the federal government), but the number of professors who receive supplemental income from industry is continuing to grow. Last week, the San Jose Mercury News reported that more than a third of Stanford University's top administrators, department heads and other leaders have outside financial interests related to their research. These include stock options, royalties, consulting fees, etc.

Even more worrisome, seven of the 10 faculty members who sit on Stanford's conflict-of-interest committee -- charged with oversight -- have financial connections to medical companies.

The pharmaceutical industry has certainly made the deepest inroads into academia, but commercial conflicts are hardly confined to medicine.

Consider Exxon Mobil's unusual relationships with Stanford. In 2002, Stanford signed a 10-year, $225-million deal with Exxon and other energy companies to fund a Global Climate and Energy Project, or GCEP. At the time, Exxon Mobil was pushing the U.S. government to reject any mandatory curbs on greenhouse gases; it also continued to question whether human use of fossil fuels causes global warming, despite an overwhelming scientific consensus to the contrary. Instead, it called for more research.

Shortly after the deal was signed, Exxon ran advertisements on the Op-Ed page of The New York Times celebrating its research alliance with the "best minds" at Stanford. One ad suggested that the scientific debate about global warming is ongoing: "Although climate has varied throughout Earth's history from natural causes, today there is a lively debate abou...the climate's response to the presence of more greenhouse gases in the atmosphere."

Remarkably, this ad was signed by Lynn Orr, the professor heading up GCEP, and it carried the official Stanford University seal. Many observers found the university's blatant endorsement of Exxon's PR campaign shameful.

Current academic conflict-of-interest policies are weak and vary enormously from one institution to the next. Each university is afraid to tighten its rules for fear that this might drive talented faculty (and industry dollars) to other schools with more lax policies. But until the top U.S. research universities collectively adopt one rigorous, uniform policy, their autonomy will continue to erode.

Want an Exit Exam? Spend the Money

Cecille Isidro — Sun, 21 May 2006 16:20:01 -0400

The recent court ruling clearing the way for students who flunked California's high school exit exam to receive their diplomas anyway was frustrating to anyone who wants the state to reclaim its former glory as home to the nation's greatest public education system. The fact that 47,000 students lack a rudimentary proficiency in either eighth-grade math or 10th-grade English is appalling. More appalling is that the exam doesn't test 12th-grade proficiency.

The unpleasant truth is that decades of severe financial neglect have undercut the ability of the state's public education system to administer the exam equitably. About 61% of the students who haven't passed the test come from low-income households, and 44% are English-learners. According to a UCLA study, schools where more than 70% of the students in the class of 2006 flunked were six times more likely to be critically overcrowded, 11 times more likely to be seriously short of fully credentialed teachers and three times more likely to have half of their math classes taught by teachers not certified to teach mathematics.

Instead of appealing Alameda County Superior Court Judge Robert B. Freedman's decision with June graduation so near, state Superintendent of Public Instruction Jack O'Connell and the Legislature should lay the foundation for a more equitable relaunch of the exam in 2010.

A four-year delay is regrettable, but three decades of insufficient funding and a huge influx of non-English-speaking immigrants into classrooms have diminished the quality of the state's public schools. California continues to spend well below the national per-pupil average on public education, and on national standardized tests, it ranks close to the bottom in student achievement.

In 1999, the Legislature sought to boost performance by requiring all students to pass the exit exam, with the class of 2004 the first to take it. By spring 2001, however, more than half the students hadn't passed a trial run. The California Board of Education voted in 2003 to postpone the exit exam, pushing it back to the class of 2006. O'Connell admitted that "not all of our students have had the tools to succeed," particularly in low-income districts.

In August 2004, Gov. Arnold Schwarzenegger suddenly announced that the state was settling a long-running lawsuit, Williams vs. California, alleging that it had violated the state Constitution by failing to provide students in low-income school districts with the same basic educational tools that wealthier districts received. As part of the settlement, the Legislature passed five bills setting higher standards for certified teachers, school facilities and textbooks, along with an improved tracking system to ensure greater equality. But these reforms came too late to benefit the class of 2006.

States that have successfully used exit exams to boost student achievement without increasing dropout rates have emphasized the need to employ multiple types of learning and personalized remedial courses and training. In late 2005, the Legislature did vote to spend $20 million on test-prep courses, but the money was too little, too late.

Unfortunately, California's post-exam planning was worse. When the exit exam ruling came down, the Legislature was still considering various bills, initiated by O'Connell, to boost spending on adult education and other post-high-school remedial programs. This last-minute push indicates that California was woefully unprepared for the tens of thousands of students due to "drop out" of the system in June without a diploma.

Freedman's decision could be a blessing in disguise. It gives the state time to address two urgent needs: fully credentialed teachers in all schools, and enhanced remedial programs, especially for nonnative English speakers, before and after the exit exam to prevent dropout rates from skyrocketing. If the exam is to be successful, California will have to ensure that teachers have the resources to close learning gaps among students rather than simply have its educators teach to the test.

The Legal Lock on Stem Cells

Cecille Isidro — Wed, 12 Apr 2006 00:00:00 -0400

California's $3-billion stem cell program has encountered repeated setbacks since it was approved by voters 17 months ago. Now it faces an entirely new and potentially even more worrisome challenge arising from two powerful patents -- patents No. 5,843,780 and No. 6,200,806, to be exact -- which cover all human embryonic stem cells and the method by which they're made.

Patents are supposed to stimulate innovation. That's why they exist. But it appears that these two patents, held by a foundation affiliated with the University of Wisconsin, may exert a dangerous monopoly over all future research in the field -- one that may pose an even greater long-term threat to stem cell science than the Bush administration's federal funding ban.

Here's the background. In mid-March, the Wisconsin Alumni Research Foundation, or WARF, announced that the state of California must sign a legal contract and pay user fees to the foundation if any state-funded scientists want to work with human embryonic stem cells of any kind. Yes, of any kind.

The foundation's patents are based on the work of James Thompson, a University of Wisconsin professor who was the first scientist to isolate embryonic stem cells, in 1998. But the patents are so broad -- unreasonably broad -- that they cover all human embryonic stem cell lines in the U.S., not just the specific lines developed by Thompson.

Jeanne Loring, an embryologist at the Burnham Institute in La Jolla, is one of many scientists who worry about the effect of this monopoly. In 1999, Loring tried to launch a company to work with stem cells, but the firm quickly collapsed when it couldn't raise the $100,000 in upfront fees the Wisconsin foundation charged. The foundation's commercial contracts also typically include an annual maintenance fee of $40,000 -- a steep hurdle for any young company.

Andrew Cohn, a spokesperson for the foundation, says the group has gone a long way toward meeting the concerns of its critics. In response to pressure from the National Institutes of Health, it dropped the fees it charges academics from $5,000 to $500 and adopted a more flexible licensing agreement. In its standard university contract, the foundation is careful not to claim any commercial rights to inventions made by academic licensees, even though its patents would permit that.

But Kenneth Taymor, a Stanford University attorney with the Program on Stem Cells in Society, says this discrete contract language is meaningless. "If a scientist develops a research tool, a therapy or some other useful invention stemming from embryonic stem cells," he says, "WARF can step in whenever it wants to and claim a share of the commercial rights." This, of course, inhibits research and commercial investment -- a problem only made worse by the foundation's close ties to Geron Corp. of Menlo Park.

In 1996, the foundation granted Geron Corp. exclusive commercial rights to many of the most valuable therapeutic uses of its human embryonic stem cells. In Taymor's words, the license encompasses "the crown jewels of regenerative medicine," including all the neurodegenerative diseases (Alzheimer's, Parkinson's, Lou Gehrig's), as well as diabetes and heart diseases. In 2001, Douglas Melton, a Harvard scientist, publicly complained that, because of this license, anything he develops in his academic lab is owned by Geron.

This monopoly doesn't just threaten the future of stem cell research. It also raises a fundamental question: Should the U.S. Patent Office allow the basic building blocks of science to be patented? This question goes to the heart of a recent U.S. Supreme Court case. The court is considering whether a patent should have been issued on the basic biological relationship between homocysteine (an amino acid found in human blood) and vitamin B deficiencies. After the patent was issued, its owner sued a competitor simply for stating the biological facts of the relationship in a publication.

Controversial patents like these have proliferated over the last two decades. They range from the absurd -- a patent on crust-less peanut butter and jelly sandwiches -- to the deeply troubling: a patent on the human gene responsible for hereditary breast cancer, which the owner has used to block other scientists engaged in breast cancer research and diagnostic testing.

California doesn't have a lot of room to maneuver. The Foundation for Taxpayer and Consumer Rights, based in Santa Monica, has urged California's stem cell agency to challenge the Wisconsin patents. But patents are not easy to reverse, even when they are clearly contrary to the public interest. That's why Congress needs to act now to reform the U.S. patent system.

The problem is twofold. First, Congress and the courts have continually expanded the range of inventions that are eligible for intellectual property protection, as well as the duration of that protection. Second, the patent office encourages examiners to approve patents, not reject them, so many that don't really meet the eligibility criteria slip through. If one examiner rejects an application, the applicant can file a "continuation" with another until it gets approved. This is precisely what happened with the Wisconsin stem cell patents.

It's time to bring rigor back to the U.S. patent system and stop this rubberstamping.

Bush Makes His Pitch to be a Pro-Science President

Cecille Isidro — Sun, 09 Apr 2006 00:00:00 -0400

When President Bush announced his support for an American Competitiveness Initiative in his State of the Union address in January -- including $136 billion over 10 years to boost research funding in the physical sciences and train 70,000 math and science teachers to improve the skills of American students -- many of California's scientists and teachers were stunned. Bush hasn't exactly shown much respect for science during his two terms as president.

Many Americans still deeply resent the president's decision to restrict funding for embryonic stem cell research because of opposition from a small religious minority. (Fifty-nine percent of California voters were so outraged they approved a $3 billion bond measure to finance the research. ) We also painfully recall how this administration misrepresented the scientific consensus on global climate change and suppressed information about mercury's effects on public health, along with numerous other scientific findings not compatible with the administration's political agenda.

More than 700,000 scientists were so appalled by this politicization of science that they signed their names to a report in 2004, charging the administration with "suppressing, distorting or manipulating the work done by scientists at the federal agencies."

Still, Bush's competitiveness initiative could not be more important to this state's economy and it deserves strong support from all Californians, even if you must hold your nose while you dial the White House hot line.

It's true that Bush seized on this issue rather late: He announced his plan only after a package of bills had already gathered strong bipartisan support from 60 senators. But Washington rarely devotes attention to long-term competitive needs, and bipartisan consensus is unusual, so now is the time to make sure that Washington follows through with the actual funding.

The United States' competitive advantage in science and technology is fast eroding. Consider these facts:

Foreign students earn more than half of the master's degrees and two-thirds of the doctorates in electrical engineering awarded by U.S. universities.
U.S. 12th-graders now rank below the average of 21 countries on a test of general knowledge in mathematics and science.
In 1999, only 41 percent of eight-graders in the United States had a math teacher who had majored in math or studied the subject for teacher certification. (The international average was 71 percent.)

Foreign advances in basic science now often rival or exceed those of the United States. This is evident in the decline in the number of patents on high-impact inventions held by the United States compared with Asia, and in the number of U.S. papers (in physics, engineering and materials science) that appear in prestigious publications, which has also declined.

For years, the United States has been in a state of denial about its weakened research strength. As Craig R. Barrett, chairman of the board at Intel Corp., observed last year: "It's a creeping crisis, and it's not something the American psyche responds well to -- it's not a Sputnik shot, it's not a tsunami. It is rather a slow and steady erosion of our competitive advantage."

For roughly 30 years after the Cold War, the United States invested heavily in research and education. It built up one of the greatest university systems the world has ever known. Both the computer and biotechnology revolutions were born out of basic research performed in U.S. universities.

But starting in the late 1970s, the United States became complacent. Congress continued to lavish money on the health sciences, but federal funding across other fields -- including the physical sciences -- grew scarce. And the overall quality of our K-12 education system steadily plummeted.

Our competitors in Europe, Asia and India have been consciously emulating our Cold War strategy. Last year alone, China and India graduated 600,000 and 350,000 engineers respectively, compared to roughly 70,000 in the United States.

Bush's "Competitiveness Initiative" certainly isn't perfect. In his 2007 budget, the president proposes drastic cuts to many important educational programs. These are counterproductive and should be stopped. Bush's budget proposal also fails to increase overall basic research spending, and calls for overly drastic cuts at the National Institutes of Health.

But the president has acknowledged that America's economic security depends on sustaining high levels of support for basic research and education. This is critically important, and gives Congress a green light to expand on the president's recommendations.

In California, as George Scalise, president of the Semiconductor Industry Association, says, nothing could be more critical to the state's future: "For the past 50 years, a major segment of the California economy has been driven by federal investments in basic research and student training at our universities. Without this support, the state's high-tech industrial sector would be at risk."

Colleges' New Economics

Cecille Isidro — Mon, 23 Jan 2006 00:00:00 -0500

A trend toward privatization and a shift in spending priorities is putting California's public colleges and universities at risk of forsaking their mandate to deliver a quality public education to the state's growing ranks of would-be college students.

The eye-popping compensation packages paid by the University of California to its top administrators--even as Sacramento raised fees, cut services and increased class sizes--are the latest sign that the state's higher-education system is in trouble. Last year, according to recent reports, UC quietly doled out more than $871 million in bonuses and other benefits to its top employees and administrators. Former Chancellor Robert M. Berdahl of UC Berkeley, for instance, got a 13 1/2-month paid leave, at $315,600 a year.

These extraordinary expenditures can't just be explained away as waste, mismanagement or greed; the problem is more fundamental than that. It's all part of a changing business model, a new economics that is driving public colleges nationwide into uncharted, potentially troublesome, waters.

Over the last two decades, public financing for higher education has waned at the same time that education costs (labor, laboratories, health coverage, etc.) have continued to rise. This has forced public colleges nationwide into a competitive marketplace that is threatening public education.

Many college presidents no longer see their state schools as public; they are "state assisted." Over the last four years, UC absorbed a 16% reduction in state funding while student enrollments rose by 16%. Nationwide, even flagship state universities are struggling to compete against private colleges that have endowments and can charge whatever tuition the market will bear.

To make up for state budget shortfalls, public colleges have turned to private donors, the federal government and corporations for a larger share of their operating funds--and boosted tuition and fees.

From 1993 to 2003, industry-sponsored research in the UC system grew from $65 million to $155 million--meaning that public higher education more and more is driven by what private interests and business will pay for, and less and less by the public interest or the needs of students.

"If private donors and corporations are providing much of a university's budget," said a former president of the University of Wisconsin, "then they will set the agenda."

Here's another, unhealthy change brought on by this heightened competition: Public colleges used to provide an important ladder of opportunity to every student in the state who was academically qualified, regardless of family income. Today, this democratic vision is rapidly being shunted aside in favor of recruiting high-performing students, prestigious research professors and highly paid administrators who can raise an institution's ranking and, ultimately, its overall wealth.

These national rankings, published by U.S. News & World Report among others, have a huge bearing on a school's reputation and its ability to attract federal and private money. Because the ranking system places the greatest value on research, income and prestige (and little value on teaching or learning outcomes), it has encouraged many colleges to neglect their primary teaching mission.

In the hopes of luring the best and brightest students (who often also are the most affluent ones), colleges are also splurging on luxury dormitories, lavish new gymnasiums and other country-club-like amenities. (Duke University gave iPods to all its first-year students.)

Similarly, both public and private colleges now use financial aid as a competitive tool to attract the highest-performing students, at the expense of those with the greatest financial needs. According to a recent study, the amount of student financial aid that states awarded not on the basis of need grew from 10% to more than 25% from 1998 to 2002, the latest year for which figures are available.

Administrators of public institutions, who are responsible for private fundraising, are demanding salaries commensurate with those in the private sector. A Chronicle of Higher Education survey found that 23 public university presidents now earn more than $500,000, six more than the previous year.

Meanwhile, the gap between administrative and faculty salaries continues to worsen. (Of course, star professors--who can bring in research revenue and prestige--are offered six-figure salaries and promises that they will rarely, if ever, have to see an undergraduate.) The undergraduates are taught largely, if not exclusively, by part-time adjuncts and graduate students. Studies suggest that an increase in the use of low-paid, part-time faculty is associated with a drop in student graduation rates.

What is needed is a new compact between the state of California and all of its public colleges. In exchange for providing a larger, more dependable revenue stream to all of its public colleges and universities, the state should insist on measurable improvements in undergraduate education. This might include expanding low-income access, giving undergraduates more time with full professors and improving graduation rates, which remain unacceptably low, both in California and nationally.

If the state wants to meet the challenges of a post-industrial economy, it will need to reaffirm its commitment to public--not market-driven--higher education.

Rent-a-Researcher

Cecille Isidro — Thu, 22 Dec 2005 00:00:00 -0500

Earlier this month, Sheffield University in Britain offered $252,000 to one of its senior medical professors, Aubrey Blumsohn. According to a copy of a proposed settlement released by Blumsohn, the university promised to pay him if he would agree to leave his post and not make any detrimental or derogatory statements about Sheffield or its employees. For several years, Blumsohn had been complaining of scientific misconduct. His concerns primarily revolved around a $250,000 research contract between Sheffield and the Ohio-based Procter & Gamble Pharmaceuticals. Blumsohn claimed that the company had denied him access to key data and then tried to ghostwrite his analysis of it. He further alleged that P&G had engaged in such practices before.

Why did Sheffield, a top-flight research university, try to silence and get rid of Blumsohn? The answer appears to lie in the complex and increasingly compromised relationships that have grown up between some research universities and the pharmaceutical industry. In 2001, the editors of nearly a dozen prominent medical journals warned that growing industry interference with academic research (from study design to data analysis and publication) was threatening the objectivity and trustworthiness of medical research. The editors issued new guidelines requiring all authors publishing in the journals to verify that they had full access to all of the data related to their studies and that they took complete responsibility for the accuracy of the data analysis.

But in the years since, universities with medical schools have become dependent on drug companies for an ever-larger share of their research budgets "roughly 80 percent of clinical research is now privately funded. And drug companies, in turn, have pressed for greater control over the research process, making it easier for them to obscure or delete negative results from published academic papers. Earlier this month, the New England Journal of Medicine accused Merck of failing to report three patient deaths in the trial that led to FDA approval of the painkiller Vioxx, which was pulled from the market last year because of its association with heart attacks and strokes. The careful record Blumsohn kept of his dealings with Procter & Gamble and Sheffield suggests that P&G didn't control academic research on its own. It needed Sheffield University to permit incursions on scholarly independence.

In the summer of 2002, Blumsohn, a senior lecturer and bone metabolism specialist, and Dr. Richard Eastell, Sheffield's research dean, signed a $250,000 research contract with Procter & Gamble. Blumsohn and Eastell were to evaluate the effectiveness of P&G's osteoporosis drug, Actonel. The goal was not to win FDA approval; Actonel was already being widely prescribed. Instead, the Sheffield study would shed further light on how Actonel affects women's bones and their susceptibility to fractures. According to Blumsohn, Eastell had already reviewed blood and urine samples from two previous P&G clinical trials of Actonel. Now Blumsohn was supposed to evaluate a third trial, with the aim of providing a final analysis of all three.

But in the past, it seemed, P&G had not allowed Eastell to perform his own data analysis. In an e-mail that Eastell wrote to P&G and copied Blumsohn on, he confessed that while presenting a paper at the International Osteoporosis Foundation, he had been unable to respond to questions about his own research posed by a fellow academic. I think that to avoid criticism in the future it would be good if we could say that we had done the analyses independently, Eastell wrote in the e-mail. He suggested that Blumsohn be entrusted with the independent analysis, so he could vouch for results that would be published under both their names.

Blumsohn and his staff reviewed thousands of blood and urine samples from women with osteoporosis. At this stage, they were blinded from knowing which patients had taken Actonel and which had taken a placebo. This helped to ensure objectivity. But when he finished examining the samples in December 2002, Blumsohn says he asked P&G to release the codes for the raw data so he could independently interpret the results.

Blumsohn requested the data access codes for 18 months, as numerous e-mails and other records document (here's one). P&G officials wrote back refusing to permit independent access to the data. However, in a written statement, the company denied that it withheld necessary data. "We have appropriately shared our clinical data with both investigators and regulatory authorities, and have conducted our business with the highest of standards."

Meanwhile, Blumsohn says P&G began to analyze his Actonel data and write up the final results for him to present at the American Society of Bone and Mineral Research in Minneapolis in fall 2003. The previous April, P&G statistician Ian Barton informed Blumsohn and Eastell by e-mail that Mary Royer, the company's medical ghostwriter, would help write up the Actonel manuscripts for publication. Blumsohn and Eastell would both be listed as authors. Barton emphasized that the ghostwriter was familiar with our key messages.

By now, Blumsohn thought he knew what those key messages were. In 2004, P&G's main rival, Merck, was due to publish a head-to-head study comparing its osteoporosis drug, Fosamax, with Actonel. Many doctors considered Fosamax more effective at increasing bone density and decreasing the rate at which bones degenerate "and thus probably also more effective in preventing fractures," the biggest concern for women with osteoporosis. Fosamax's global sales were $3 billion a year, compared to about $1 billion for Actonel. In the summer of 2003, Blumsohn received a copy of P&G's proposed statistical plan for analyzing his data. It stated that the purpose of his research was to bring about an Osteoporosis Paradigm Shift.

Eastell's earlier research asserting P&G's claims about the effectiveness of Actonel appeared in June in the prestigious Journal of Bone and Mineral Research. Eastell and his co-investigators stated that all authors had full access to the data and analyses. Based on Eastell's earlier e-mail, Blumsohn knew that wasn't true and that Eastell had most likely violated the new safeguards that medical journal editors had put in place in 2001. Blumsohn says he warned Eastell they could both be accused of scientific fraud if they kept authoring papers without seeing the underlying data. A few days later, P&G's Barton sent an e-mail reiterating that Blumsohn could not perform his own independent analysis of his data but could come to P&G's offices to look at it.

When Blumsohn sat down with Barton at the company's Surrey headquarters in late July, he says he spotted something peculiar. In one critical graph showing how Actonel affects fracture rates, Blumsohn noticed that 40 percent of the patient data was missing. Inclusion of the data, he thought, would have disproved P&G's key message about Actonel's effectiveness in reducing bone fractures. Several months later, Blumsohn recorded a meeting in which Barton expressed concern that if P&G included the missing 40 percent of the data, Merck would exploit the results. Because that is contradicting our original manuscript, he said. I just know what Merck are like. I think they are going to use it.

P&G denies that it skewed data to achieve desired results, saying that Blumsohn was given access to all of the data related to his research. But the company's previous written statements seem to contradict this assertion. When Blumsohn's lawyer filed a formal data request on his behalf, P&G responded: It is not the standard practice of P&G to allow unlimited access to raw data from clinical trials to individual investigators, as these data are proprietary.

In November, Blumsohn won a few concessions. He says P&G agreed to remove the graph he'd objected to from an oral presentation and to delete some text from a paper appearing in his name. But P&G's educational materials and other writings continued to make assertions about Actonel's effectiveness, which Blumsohn believed the data he'd seen did not support.

Increasingly, Blumsohn felt he was doing battle not only with P&G but with his university. Shortly after Blumsohn complained about the apparent manipulation of his Actonel data, he recorded a conversation in which Eastell warned, the only thing we have to watch all the time is our relationship with P&G. The P&G money is a good source of income, we have got to really watch it.

Over the next 22 months, Blumsohn wrote formal complaint letters to various Sheffield officials. The university didn't investigate his claims, according to an article in the British Times Higher Education Supplement. In July, Blumsohn announced that he would go public with his concerns. Sheffield suspended him in September, citing, among other things, his refusal to comply with a reasonable management instruction by briefing journalists. Sheffield then offered him the $300,000. Sheffield states that it repeatedly asked Blumsohn to provide evidence supporting his allegations and urged him to bring that evidence through the proper channels. The university says legal negotiations were initiated at Blumsohn's request and undertaken in good faith by the University.

Universities have long accepted funding from pharmaceutical companies to conduct clinical drug trials. But in the past, their professors insisted on running those trials independently of the sponsor. As the Blumsohn case makes clear, this arm's-length relationship appears to be breaking down. Earlier this month, the Wall Street Journal reported on the growing willingness of some academics to sign their names "and lend their prestige "to articles and editorials penned by drug-company ghostwriters. In addition to the Vioxx episode, recent reports indicate that published academic studies related to the drugs Celebrex, Paxil, and Zoloft appear to have been skewed when their authors permitted the suppression of negative results.

The British Parliament has promised to investigate Blumsohn's allegations. And in January, medical journal editors will be gathering once again to discuss what can be done to restore the integrity of the research they publish. One idea that's been floated in the United States is a new arm of the National Institutes of Health that could serve as a repository for complete clinical trial data while also monitoring trials and verifying the accuracy of published results. Whatever the solution, something needs to be done soon. Scholarly independence has already taken too many hits.

Sidebar

Actonel (P&G's drug) and Fosamax (Merck's drug) both reduce bone turnover, the rate at which bone material degenerates or breaks down. Fosamax tends to reduce bone turnover by a larger amount (60 percent or more) compared to roughly 50 percent for Actonel. P&G sought to demonstrate, however, that once a drug reduces bone turnover by a certain threshold amount "roughly 30 to 40 percent "any further reduction in bone turnover is not really significant because it does not actually result in fewer bone fractures.

Sidebar

The 40 percent of data missing from this graph represented the subset of patients in the study who had the largest decreases in bone turnover (60 to 80 percent). If P&G was right that Actonel and Fosamax were equally effective, then this group of patients should have had roughly the same number of bone fractures as patients with far lower reductions in bone turnover (the 30-to-40-percent levels P&G cited). But, according to Blumsohn, the data revealed just the opposite. The patients with the highest reductions in bone turnover "who were excluded from the graph "experienced fewer fractures than the average patient taking Actonel. Most had no fractures at all.

Sidebar

Blumsohn wrote to Eastell, Sheffield's medical school dean, vice chancellor, and head of human resources.

Tainted to the Core

Cecille Isidro — Mon, 20 Jun 2005 00:00:00 -0400

In the fall of 2001, the editors of 12 prominent medical journals collectively announced that they would refuse to publish research on new prescription drugs unless the authors provided assurances that they had had unimpeded access to the data and were fully responsible for the paper's conclusions. The announcement was an extraordinary admission of just how extensive industry control over medical research had become. The editors noted that more and more, the authors of scientific papers -- even authors based at prestigious universities -- did not have access to the complete trial data. In some cases, the editors observed, authors were unable to publish without prior authorization from the corporate sponsor.

The journal editors pointed out that publication of clinical studies in respected peer-reviewed journals is the "ultimate basis for most treatment decisions," so it is essential that the data be gathered and presented in "an objective and dispassionate manner." Medicine is only as good as the science on which it is based, and if that science is not objective and honest, then patients can be seriously harmed. The editors noted "that the current intellectual environment . . . may threaten this precious objectivity." Until recently, university medical centers contributed to the "quality, intellectual rigor and impact of such clinical trials," they explained, "but as economic pressures mount, this may be a thing of the past."

With the possible exception of business schools, industry's penetration into the nation's medical schools has been more sweeping than in any other sector of the university. Pharmaceutical companies sponsor daily lunches for medical students, during which they market their latest drugs; they ply professors with fancy dinners, gifts, luxurious trips and free prescriptions designed to influence their medical decisions and prescribing habits. These academic "opinion leaders" consult for, or hold equity in, the same firms that manufacture the drugs they are studying, while also often accepting generous fees to join their corporate advisory boards and speakers' bureaus. Sometimes they even hold the patent to the drug or device being tested. In a study of 800 scientific papers published in leading journals of medicine and molecular biology, Sheldon Krimsky, a professor of public policy at Tufts University, found that slightly more than a third of the lead authors based at research institutions in Massachusetts had a significant financial interest in their own reports. These included owning related patents, or holding an executive, advisory or major equity position in a company with a stake in the research.

So pervasive are such ties that journal editors now frequently complain they can no longer find academic experts who do not have a financial interest in a drug or therapy they would like to review. This may be good news for corporations, but it is anything but good news for ordinary citizens. Indeed, the growing nexus between universities and the pharmaceutical industry could not come at a worse time. The cost of pharmaceutical drugs -- and health care in general -- in America continues to skyrocket. Expensive new drugs are aggressively marketed on TV and in doctors' offices the moment they hit the market. Yet physicians warn that many of these hyped prescriptions are simply "me-too drugs" that vary only slightly from medications already on the market, despite being far more expensive. Research suggests that publicly funded science, most of it performed at universities, was a "critical contributor" to the discovery of nearly all of the 25 most important breakthrough drugs introduced between 1970 and 1995. If university scientists lose their independence, who will perform this pathbreaking research and objectively evaluate the safety and effectiveness of drugs already on the market?

Independence in jeopardy

Unfortunately, it is this scholarly independence that is now in jeopardy. "The boundaries between the academic medical colleges and the drug companies are becoming ever more porous," says Marcia Angell, a senior lecturer at Harvard's School of Public Health and former editor in chief of the New England Journal of Medicine (NEJM). "It used to be that academic medical colleges said, 'OK, we will take this industry grant and do the study, but our researchers are going to retain the data; they are going to analyze the data.' Now this arm's-length relationship has broken down."

Indeed, there are strong indications that university-based medicine is losing its hallowed objectivity. After conducting an extensive review of the medical literature for an article in the NEJM, Thomas Bodenheimer, an internist at University of California, San Francisco, found that academic investigators were rapidly ceding to industry the control over nearly every stage of the clinical research process.

In the past, for example, it was common for university scientists to initiate the research protocol. Now, however, studies are frequently conceived and designed in the company's own pharmacological and marketing departments, thus removing this formative stage of the research from academic hands almost entirely. The company then shops the study around to various academic institutions (and a growing number of competing for-profit entities as well), in search of investigators to conduct the research. Should a professor choose to reject the study or insist on changes not agreeable to the sponsor, another university scientist will very likely be more solicitous.

In this way, industry is slowly changing the direction of academic research, causing it to be far more market-driven and less directed toward truly important science. Not surprisingly, wrote Bodenheimer, exercising control over trial design makes it far easier for companies to build biases into their research -- some easier and some harder to detect. One analysis by Paula Rochon, published in the Archives of Internal Medicine, found that in 54 percent of corporate-sponsored arthritis drug trials, the dose of the funding company's drug was higher than that of the comparison drug, so that the results were clearly skewed in the sponsor's favor.

Another disturbing trend in university medicine today is the growing use of ghostwriters and "guest writers." Readers may see a prominent academic's name at the top of a research article or review, but that scholar may or may not be the person who actually wrote the paper. Frequently, a big-name professor or department chair is invited to appear as a "guest author," even though she or he had no involvement in the research. Or in the case of company-initiated studies and reviews, the manuscript may have been ghostwritten by a medical communications company working for the drug maker, and its author may have been paid an honorarium to attach his or her name to it. The average reader thus thinks the study bears the stamp of approval of an independent academic scholar, when in fact this is nothing more than an illusion. The Lancet commented on this alarming phenomenon in an editorial, noting with some bitterness that "the pinnacle of success, presumably, is to sign up a prominent academic" to lend an aura of objectivity and prestige to the company's research.

The practice of ghostwriting has become extremely prevalent, raising troubling questions about the trustworthiness of the science appearing in even the most prestigious medical journals. As Richard Horton, editor of The Lancet, caustically observed in 2004, "Journals have devolved into information-laundering operations for the pharmaceutical industry."

Buried data

Regulating access to the raw data from a large, multisite trial is yet another tactic the drug industry commonly deploys to skew medical research in its favor. Sometimes the principal investigators are given unimpeded access, but increasingly companies prefer to control the data themselves. Frequently, explained Bodenheimer, studies are designed with multiple end points (or measurable outcomes), so that it is relatively easy for the company to "publish those end points favorable to their product and bury data on less favorable end points."

Recently, M. Michael Wolfe, a gastroenterologist at Boston University, publicly disclosed that Pharmacia Corporation, the manufacturer of the blockbuster arthritis drug Celebrex, had duped him in precisely this manner. In the summer of 2000, the Journal of the American Medical Association (JAMA) asked Wolfe to write a review of a Celebrex study showing that the drug was associated with lower rates of stomach and intestinal ulcers and other complications than two older arthritis medications (diclofenac and ibuprofen). Wolfe found the study, tracking eight thousand patients over a six-month period, persuasive and penned a favorable review, which helped to drive up Celebrex sales. But early the next year, when he had occasion to review the same study again -- this time while serving on the Food and Drug Administration's arthritis advisory committee -- Wolfe was flabbergasted by what he saw. Pharmacia's study had run for one year, not six months, as both Wolfe and JAMA had been led to believe. When the complete data set was considered, most of Celebrex's advantages disappeared because the ulcer complications that occurred during the second half of the study were disproportionately found in patients taking Celebrex. "I am furious . . . I wrote the editorial," Wolfe told the Washington Post. "I looked like a fool. But . . . all I had available to me was the data presented in the article." None of the original study's sixteen authors, including eight university professors, had spoken out publicly about the suppression of data. All the authors were either employees of Pharmacia or paid consultants of the company.

The sordid story of SSRIs

Industry also manipulates academic research by suppressing negative studies altogether. Consider the recent medical scandal surrounding the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which have been linked to an increased risk of suicidal thinking and behavior in young people. Throughout the latter half of the '90s, the number of young Americans being given Prozac, Paxil, Zoloft and other antidepressants skyrocketed. By 2002, roughly 11 million prescriptions had been handed out. Boys under the age of 12 diagnosed with "conduct disorders" were the fastest-growing group. The bulk of the published academic literature strongly supported treating depressed children and adolescents with SSRIs. As it turns out, however, this recommendation was at odds with what the complete research record showed. In early 2004, an FDA scientist reviewed all 15 pediatric SSRI studies in the agency's files, including many that had never been published. In all but three of those studies, young patients suffering from depression experienced no greater improvement taking an SSRI than they did with a placebo, or sugar pill. Given that scientists were very likely involved in a large portion of this research and duty-bound to publish, how did so much of this negative evidence drop from public view?

In June 2004, this question made its way into the headlines when New York attorney general Eliot Spitzer filed suit against GlaxoSmithKline (GSK), the manufacturer of Paxil, charging that the company had "engaged in repeated and persistent fraud by misrepresenting, concealing and otherwise failing to disclose" information showing that its drug was not only ineffective in treating child and adolescent depression but also linked to an increased risk of suicidal thoughts and self-injurious behavior. GSK had funded five studies on Paxil and childhood depression, only one of which ever got published. Taken together, however, the data clearly showed that those children who took Paxil were approximately two times more at risk of becoming suicidal than those taking a placebo. Parents of children who had committed suicide, along with a small minority of psychiatrists, had been suggesting for some time that there appeared to be a link between SSRIs and suicide, but until these revelations, their concerns had been largely discredited.

Unfortunately, GSK wasn't the only company burying research in this way. When Andrew Mosholder, a senior FDA epidemiologist, examined 22 pediatric studies, he found that children taking a wide range of antidepressants were also nearly twice as likely as those given a placebo to show signs of becoming suicidal -- a finding that his FDA supervisors initially sought to suppress but was later corroborated by an independent research team at Columbia University. What was perplexing was that nearly all of the published literature, authored by many of the leading lights of academic psychiatry, had arrived at the opposite conclusion: SSRIs were safe and effective in treating depression in youngsters.

Was this really what their academic studies showed?

When the FDA and other independent scientists took a closer look, they found a striking discrepancy between what these esteemed academic psychiatrists had written in their papers -- and what the data actually revealed. In a surprising number of cases, the benefits of these drugs were overstated, and the problems were downplayed or buried. The only GSK study of Paxil that ever got published, for example, concluded that the data "provides evidence of the safety and efficacy of [Paxil] in the treatment of adolescent depression." (On the basis of this one study, GSK launched a massive promotional campaign telling its sales representatives going out to doctors' offices that Paxil had "REMARKABLE Efficacy and Safety in the treatment of adolescent depression.") But when an FDA examiner studied the data more closely, he found the authors' claims highly exaggerated, as the drug actually failed on the protocol's two primary measured outcomes. The study also concluded that "most adverse events were not serious," when, in fact, seven of the children who took Paxil had to be hospitalized after suffering severe adverse effects from the drug.

Eighteen of the Paxil study's 22 authors were university scholars. Its lead author, Martin B. Keller, is a highly acclaimed psychiatrist and chair of the psychiatry department at Brown University who has extensive ties to the drug industry. In 1998, when the Rhode Island attorney-general's office forced Keller to forfeit hundreds of thousands of dollars in state grant money to settle a financial fraud inquiry, it came to light that Keller had received more than half a million dollars from drug companies that year, most of it from the same firms whose drugs he had touted in journals and at medical conferences. According to the Boston Globe, Keller's financial ties were so numerous that they prompted the National Institute of Mental Health to review its conflict-of-interest rules. The most recent publicly available data shows that as of June 2003, Keller had been consulting for at least 17 major drug firms, including Merck, Bristol-Myers, Eli Lilly and Pfizer, while also working under a $ 25 million research grant from Wyeth-Ayerst.

It is impossible to prove a direct causal relationship between Keller's funding sources and the distortions found in his research. But at least three other studies authored by prominent academic psychiatrists on the pediatric use of SSRIs evidenced similar distortions -- and all the authors had financial ties to the manufacturers. One of these was a 2003 study published in JAMA led by Karen Wagner, a renowned psychiatrist and director of the Division of Child and Adolescent Psychiatry at the University of Texas Medical Branch. The study claimed that the anti-depressant Zoloft was "effective and well tolerated for children and adolescents." But when the FDA and other outside experts examined the data from the two pooled studies more closely, they again found that the drug had failed to demonstrate positive outcomes. In fact, according to one analysis, when data left out of the published study were included, Zoloft had "an unfavorable risk-benefit balance." In other words, the risks associated with taking the drug were greater than the anticipated benefits. At the time of this study, Wagner reported receiving research money from numerous pharmaceutical companies, consulting for 10 drug firms, and participating in speakers' bureaus for Abbott Laboratories, Eli Lilly, GlaxoSmithKline, Forest Laboratories, Pfizer and Novartis. The study itself had been funded by Pfizer, the maker of Zoloft, and the "study supervisor" held stock options in the company. Finally, the FDA criticized two Prozac studies (1997, 2002) for overstating the drug's efficacy in treating childhood depression. Both studies had been led by Graham Emslie, a professor at the University of Texas Southwestern Medical Center, and financed by Eli Lilly, the maker of Prozac. Emslie receives research support from industry; he also consults and serves on speakers' bureaus of numerous drug companies, including Bristol-Myers, Eli Lilly and Wyeth-Ayerst.

In December 2003, when the faulty nature of this research finally came to light, it prompted a quick response from the British Drug Authority, which recommended that doctors not prescribe SSRI antidepressant drugs to children under 18, citing a two- to threefold increase in the risk of suicidal behavior and insufficient evidence of benefit. Nearly one year later, in October 2004, the FDA announced that all such antidepressants must carry a "black box" warning label linking the drugs to an increased risk of suicidal thoughts and behavior in children and teenagers.

Where's the media?

Sadly these government warnings and restrictions have done little to address the underlying problem: The growing influence of pharmaceutical companies on academic medicine and research. When the American media tried to sort out the implications of the FDA's new warning label on the SSRI drugs, the first experts they turned to were often the same academics who had been implicated in overlooking the SSRI drugs' problems. In one story, the Chicago Tribune asserted that "a number of mental health experts cautioned that the strict warning label could discourage the use of antidepressants by adolescents who need them." It went on to quote Graham Emslie, one of the doctors who had overstated the drugs' benefits relative to his research data. None of Emslie's financial ties to the drugs' manufacturers were ever mentioned in the story. Emslie was simply identified as "the chief of child and adolescent psychiatry at the University of Texas Southwestern Medical Center." Could anything sound more credible than that?

Thus far, neither the federal government nor the universities themselves have been willing to adopt strict conflict-of-interest guidelines. Unless the media and medical journals vigorously investigate these commercial ties -- and bring them to the public's attention -- the drug industry will continue to exploit the aura of objectivity and independence that our universities command, eroding the academic mission and causing great harm to the medical enterprise and public health.

University, Inc.

Communications — Mon, 21 Mar 2005 11:00:00 -0500

A New America Event
03/21/2005 - 12:00pm

During the past two decades, commercial forces have quietly transformed virtually every aspect of academic life. Corporate funding of university research is growing -- and the money increasingly comes with strings attached. Universities themselves are starting to behave like commercial entitities, while professors are behaving more like businessmen. The speakers will discuss the origins of this remarkable commercial transformation, and explore its impact on education, medicine, and U.S. innovation over the long term.

University Inc.

adminn — Tue, 15 Feb 2005 18:02:00 -0500

Selected reviews of University Inc. are featured below:

Publishers Weekly

American universities are the envy of the world, but they may be on the brink of discarding the very values and practices that have made them so successful, argues journalist Washburn, as secretive connections between private industry and the academy have begun to "undermine the foundation of public trust on which… more

Selling Out

Cecille Isidro — Sat, 12 Feb 2005 00:00:00 -0500

Elias Zerhouni, director of the US National Institutes of Health, last week took one small step along the road to repairing the tainted ethical reputation of government science. New conflict-of-interest rules that he announced will at last bar NIH scientists from moonlighting as consultants for private industry. The move follows a series of investigations by The Los Angeles Times and the US Congress that uncovered extensive financial ties -- many previously undisclosed -- between agency scientists and the drug and biotech firms that have a financial stake in the outcome of their research.

This is reassuring news, but it is only a start. The government must now turn its attention to the $20 billion or so in research money it disburses each year to American universities. This public money provides 60 per cent of their research funding. Yet commercial entanglements have grown commonplace in academia, and what was once a culture of autonomous research has morphed in recent decades into something more closely resembling "University Inc".

The US government has threatened several times to apply tougher conflict- of-interest rules to academics who receive grants, but it has always succumbed to pressure from university leaders to allow universities to regulate themselves. Despite promises to put their own house in order, the rules now in place are lax and public disclosure of financial conflicts is still not mandatory.

You don't have to look far to see just how corporate-minded American universities have become. It is now standard practice, for example, to encourage staff to spin off profit-making companies from their research. Many schools run their own venture-capital funds and industrial parks, and patent their professors' inventions to maximise royalties. Star professors consult for the very firms that make the products they are studying.

It was not always like this. While American universities have traditionally had a more utilitarian bent than their European counterparts, they also vigorously defended academic autonomy and nurtured a research culture distinct from private industry. The two spheres were considered to have different roles to play in advancing science: one dedicated to long-term research and the open dissemination of knowledge, the other to proprietary research and the extraction of profits.

This changed abruptly in 1980, when Congress passed laws granting universities automatic patent rights to inventions that came out of publicly funded research. The aim was to speed the transfer of academic knowledge to industry, but it also unleashed a dangerous profit motive into the heart of academia. Universities were further propelled into forging alliances with industry by declining public spending on higher education. In 2001, the most recent year for which figures are available, industry spent $2 billion on academic research, making it the fastest-growing segment of university budgets. This trend is not confined to the US: industry-led research is fast becoming commonplace in universities everywhere, in particular the UK.

The consequences of blurring the boundary between the academic and business spheres are serious. Curiosity-driven "blue sky" enquiry is being pushed out to make way for commercial research. Disciplines that make money, study money or attract money are showered with institutional resources and lab space. Meanwhile, physics, philosophy and other fields that have trouble supporting themselves like this are left to scrape by.

The openness that used to characterise university life has given way to a culture akin to that of the business world. In a 1997 survey of 2167 members of life sciences departments, 34 per cent of professors reported being denied access to research results or products generated by their academic peers. Universities are so focused on generating profits that they frequently impose onerous licensing restrictions on basic knowledge.

When researchers at the University of Utah discovered a gene responsible for hereditary breast cancer in 1994, they did not make it freely available despite the fact that taxpayers had invested $4.6 million in the research. The university raced to patent the gene and granted monopoly rights to Myriad Genetics, a start-up company founded by a University of Utah professor.

If the government needs further convincing, stricter conflict of interest rules are also needed to prevent a dangerous imbalance between universities and federal science institutions. Many NIH scientists warn that Zerhouni's new measures could prompt scientists to leave for greener pastures in academia.

There's an obvious solution: apply conflict-of-interest rules to all publicly funded scientists. If we want to rein in the commercialism that is destroying our public research institutions, they must all be held to the same high standards.