Academic Freedom and the Corporate University
Commercial threats on campus have mounted—from industry control of research and corporate ghostwriting to restrictive sponsored-research agreements and intellectual property deals that place profits ahead of public health.
By Jennifer Washburn
Posted May 12, 2009
The funding for academic research has been taken over by business
By George Monbiot. Published in the Guardian, 12th May 2009
Why is the Medical Research Council run by an arms manufacturer? Why is the Natural Environment Research Council run by the head of a construction company? Why is the chairman of a real estate firm in charge of higher education funding for England?
Because our universities are being turned by the government into corporate research departments. No longer may they pursue knowledge for its own sake: now the highest ambition to which they must aspire is finding better ways to make money.
At the end of last month, unremarked by the media, a quiet intellectual revolution took place. The research councils, which provide 90% of the funding for academic
research in Britain(1), introduced a new requirement for people seeking grants: now they must describe the economic impact of the work they want to conduct. The councils define impact as the “demonstrable contribution” that research can make to society and the economy(2). But how do you demonstrate the impact of blue skies research before it has been conducted?
The idea, the government says, is to transfer knowledge from the universities to industry, boosting the UK’s economy and helping to lift us out of recession. There’s nothing wrong, in principle, with commercialising scientific discoveries. But imposing this condition on the pursuit of all knowledge does not enrich us; it impoverishes us, reducing the wonders of the universe to figures in an accountant’s ledger.
Picture Charles Darwin trying to fill out his application form before embarking on the Beagle. “Explain how the research has the potential to impact on the
nation’s health, wealth or culture. For example: fostering global economic performance, and specifically the economic competitiveness of the United Kingdom … What are the realistic timescales for the benefits to be realised?”(3) If Darwin had been dependent on a grant from a British research council, he would never have set sail.
The government insists that nothing fundamental has changed; that the Haldane Principle, which states that the government should not interfere in research decisions, still holds. Only the research councils, ministers say, should decide what gets funded.
This is humbug of the same species as newspaper proprietors use. Some of them insist that they never interfere in the decisions their newspapers make. But they appoint editors who share their views and know exactly what is expected of them. All the chairmen of the five research councils funding science(4), and the chairs of the three higher education funding
councils(5) (which provide core funding for universities) are or were senior corporate executives.
These men are overseen by the minister for science and innovation, Lord Drayson. Before he became a minister, Paul Drayson was the chief executive of a pharmaceutical company called PowderJect. He was involved in a controversy that to many feel symbolises the absence of effective barriers between government and commerce.
On 30th November 2001, the British government decided to buy large quantities of a variant of the smallpox vaccine called the Lister strain. The only company which possessed enough of it was a firm called Bavarian Nordic. On December 6th 2001, Paul Drayson was among a small group of businessmen who took breakfast with the then prime minister, Tony Blair. At around the same time, Drayson gave a donation of £50,000 to the Labour party. Soon afterwards, government officials sought to buy the vaccine from Bavarian Nordic. They
were told that they were too late: PowderJect had just bought the exclusive distribution rights for the UK(6). So the government had to buy it from Drayson’s company. It paid PowderJect £32m: £20m more than PowderJect had paid Bavarian Nordic(7). The prime minister’s office and Paul Drayson both refused to answer questions about whether the Lister strain was discussed at the breakfast in Downing Street. It is not clear whether Lord Drayson was aware at that time of the government’s decision to choose the Lister strain.
Drayson doubtless rubs along well with the chairman of the Medical Research Council, Sir John Chisholm. Chisholm founded a military software company before becoming head of the government’s Defence Research Agency. He was in charge of turning it into the commercial company QinetiQ, through a privatisation process which was completed while Lord Drayson was minister for defence procurement. During this process, Sir John
paid £129,000 for a stake in the company. Its value rose to £26m when QinetiQ was floated(8). The former managing director of the Defence Research Agency described this as “greed of the highest order”(9). Lord Gilbert, a former minister of defence procurement, remarked that “frankly the money made by the leading civil servants was obscene. … They did not contribute anything to the turnaround of the company, it was the work of the research staff that made the difference.”(10) Sir John Chisholm remains chairman of QinetiQ. Is there anyone outside government who believes that these people should be overseeing scientific research in this country?
In March Lord Drayson told the Royal Society that “the science budget is safe … there will be no retreat from pure science.”(11) A month later, this promise was broken, when the budget transferred £106m from the research councils “to support key areas of economic potential”(12): which
means exchanges of staff and research with industry(13).
Science policy in the United Kingdom is now governed by the Sainsbury Review, which the government says it will implement in full. It was written by the Labour donor, former science minister and former supermarket chief executive Lord Sainsbury. The research councils, the review says, should “be measured against firm knowledge transfer targets” to show that they are turning enough science into business(14). They have been told to fund £120m of research in collaboration with industry. This has been topped up with £180m from the regional development agencies(15,16). The government is also spending £150m a year “to change the culture in universities: boosting the work they do with a whole range of businesses and increasing commercial activity.”(17) All this is another covert bail-out, relieving companies of the need to fund their own research.
The economic impact summaries
they now have to write ensure that all researchers will be aware that the business of the universities is business. As the government’s white paper points out, universities are already “providing incentives (for example promotion assessment)” to persuade researchers to engage with business(18). If your research doesn’t make someone money, you’re not likely to get very far.
Even judged by its own objectives, this policy makes no sense. The long-term health of the knowledge economy depends on blue skies research that answers only to itself: when scientists are free to pursue their passions they are more likely to make those serendipitous discoveries whose impacts on society and the economy are both vast and impossible to predict. Forced to collaborate with industry, they are more likely to pursue applications of existing knowledge than to seek to extend the frontiers of the known world.
But knowledge is not just about impacts. It
is about wonder and insight and beauty. Much of it might never have an application, but it makes the world a richer place, in ways which the likes of Lord Drayson would struggle to perceive.
UNIVERSITY, INC: THE CORPORATE CORRUPTION OF HIGHER EDUCATION
By Jennifer Washburn. Basic Books, 2005
This stunning account of how the commercial ethos in universities has subverted the values of humanism and the public good is a heads-up for anyone involved in higher education. Jennifer Washburn has accumulated an alarming amount of information about the intrusion of market forces into research universities. Not only are academic activities skewed in the interests of profit, but the public at large is also cheated and sometimes harmed.
Here are some of here examples:
In the 1990s, the tobacco industry paid academic scientists up to $20,000 each to publicly downplay the risks of smoking.
The Enron Corporation financed the Harvard Electricity Policy Group, which wrote thirty-one reports promoting deregulation of California's energy markets.
At Brown University, Micro fibres, Inc. tried to prevent Dr. David Kern from publishing his findings on potentially fatal new lung disease that affected workers at its factory. Microfibres was being asked to donate to a new project at Brown Medical School, and the Brown administration told Kern not to publish or present his work. After protest, Brown backed off and Kern presented his results at a conference--but a few days later, his teaching and research positions were eliminated.
The Best Minds Money Can Buy
By Jennifer Washburn
Los Angeles Times
July 21, 2006
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.
Shouldn't we be pleased that universities are increasingly business minded?
By Jennifer Washburn
February 12, 2005
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.
Hired Education A hidden culprit in the Drug scandals: the increasingly corporatized university.
By Jennifer Washburn
The American Prospect
February 4, 2005
M. Michael Wolfe, a gastroenterologist at Boston University, admits he was duped by the Pharmacia Corporation, the manufacturer of the blockbuster arthritis drug Celebrex. (In 2003, the company was purchased by Pﬁzer.) In the summer of 2000, The Journal of the American Medical Association asked Wolfe to write a review of a study showing that Celebrex 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 8,000 patients over a six-month period, persuasive, and penned a favorable review, which helped to drive up Celebrex sales.
But early the next year, while serving on the Food and Drug Administration’s (FDA) arthritis advisory committee, Wolfe had occasion to review the same drug trial again, and was ﬂabbergasted by what he saw. Pharmacia’s study had run for one year, not six months, as the company had originally led both Wolfe and the Journal to believe. When the complete data 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,” Wolfe told The Washington Post in 2001. “I looked like a fool. But ... all I had available to me was the data presented in the article.” Remarkably, none of the Journal study’s 16 authors, including eight university professors, had spoken out publicly about this egregious suppression of negative data. All the authors were either employees of Pharmacia or paid consultants of the company.
Celebrex, an anti-inﬂammatory drug similar to Vioxx, is once again in the news due to concerns that it may be associated with the same cardiovascular risks that caused Vioxx to get yanked from the market. In recent months, we’ve heard a great deal about conﬂicts of interest at both the FDA, the agency that approves drugs for public safety, and the National Institutes of Health, where publicly funded scientists moonlight as consultants for the very companies that manufactured the drugs they are testing. Still largely ignored, however, is the role played by the once-autonomous ivory tower and the university scientists who, either knowingly or unknowingly, facilitate the pharmaceutical industry’s manipulation of drug testing by lending it an aura of objectivity.
Today, market forces are dictating what is happening in the world of higher education as never before, causing universities to look and behave more and more like business enterprises. Instead of honoring their traditional commitment to teaching, disinterested research, and the broad dissemination of knowledge, universities are aggressively striving to become research arms of private industry. Faced with declining government funding, they are avidly seeking to enhance their role as “engines” of economic growth, promising state legislators and governors that they will help drive regional economic development by pumping out commercially valuable inventions.
This radical redeﬁnition of the university’s mission can be traced back to the economic stagnation of the 1970s. Propelled by heightened competition from Germany and Japan, Congress passed landmark legislation in 1980 that allowed universities to automatically retain the rights to intellectual property stemming from taxpayer-ﬁnanced research. The intent of the legislation, popularly known as the Bayh-Dole Act (its sponsors were Senators Birch Bayh and Bob Dole), was to stimulate innovation and speed the transfer of federally ﬁnanced research to industry. What it accomplished in the process was the introduction of a dangerous new proﬁt motive into the heart of the university.
As a result, schools now routinely operate expensive patenting and licensing operations to market their faculty’s inventions, extracting royalty income and other fees in return. They invest their endowment money in risky startup ﬁrms founded by their professors. They run their own industrial parks and venture capital funds. They publish newsletters encouraging faculty members to commercialize new research by launching independent, faculty-owned companies. Star professors consult for, or hold equity in, the same ﬁrms that manufacture the drugs they are studying, while also often accepting generous fees to join corporate advisory boards and speakers’ bureaus. Sometimes these professors 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. So pervasive are such ties that journal editors now frequently complain that they can no longer ﬁnd academic experts who do not have a ﬁnancial interest in a drug or therapy the journal would like to review.
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? Conﬂicts of interest are more than an academic concern. When it comes to health policy, they pose a serious threat to public health.
With the possible exception of business schools, the nation’s medical schools have been more inﬁltrated by industry than any other sector of the university. Pharmaceutical companies sponsor daily lunches for medical students at which they market their latest drugs; they ply professors with fancy dinners, gifts, luxurious trips, and free prescriptions designed to inﬂuence medical decisions and prescribing habits. The drug industry also spends millions of dollars ﬁnancing clinical drug research at the academy, but increasingly this money comes with many more strings attached. After conducting a thorough review of the medical literature for The New England Journal of Medicine in 2000, Thomas Bodenheimer, an internist at the University of California, San Francisco, concluded that academic investigators were rapidly ceding to industry 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, 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 subcontractors that run clinical trials) in search of investigators to conduct the research. As university medical schools have grown more dependent on industry grants to sustain their operations, their professors have become increasingly willing to accept an industry-initiated protocol without modiﬁcation, even though the study may be largely designed to secure a company’s market position. Should a professor reject the study or insist on changes, another university scientist will very likely be more
Industry also encourages the use of ghostwriters on scientiﬁc papers. This means an article or review bylined by a prominent academic might in fact have been written by a medical-communications company working for the drugmaker, with the “author” paid an honorarium to attach his or her name to it.
When Wyeth-Ayerst sought to boost market demand for Redux, one part of the once highly popular “fen-phen” diet-drug combination, the company hired a company called Excerpta Medica to help draft the manuscripts and pay doctors to review and sign the articles. One of the many doctors who signed Excerpta’s papers was Richard Atkinson, a renowned obesity expert at the University of Wisconsin-Madison. Atkinson denied having any knowledge of Excerpta’s connection to Wyeth, but as an independent academic, he nonetheless agreed to lend his name to a company he apparently knew little about. (Excerpta maintains that all its authors were told of the company’s association with the manufacturer.) In a deposition on January 15, 1999, Wyeth-Ayerst executive Jo Alene Dolan admitted that her company had written the article for Atkinson, stressing that all drug companies ghostwrite articles. Shortly before the article could be published,
Redux was pulled from the market because of its association with serious heart and lung problems.
Scientists who perform industry-sponsored research are also asked routinely to sign legal contracts requiring them to keep both the methods and the results of their work secret for a period of time. Research conducted by David Blumenthal and Eric Campbell, health-policy researchers at Harvard University, suggests that data withholding and publication delays have become far more common over the last 25 years, particularly in molecular biology, medicine, and other life-science disciplines, where commercial relationships have grown dramatically in recent years. In a survey of 2,167 life-science faculty, Blumenthal found that nearly one in ﬁve of them had delayed publication for more than six months to protect proprietary information.
Industry also manipulates academic research by suppressing negative studies altogether. Recently, it came to light that a whole class of popular antidepressants -- including such heavily prescribed drugs as Paxil, Zoloft, and Prozac -- are largely ineffectual in treating childhood depression and actually increase the risk of suicide. One of the main reasons this information was not available to doctors and the broader public, it turns out, is that the academic investigators who led these studies either allowed industry to bury their research or were complicit in downplaying negative ﬁndings in their own published papers. How prevalent is such corporate meddling? The question has received surprisingly little scholarly attention, but what research does exist is not encouraging. One survey of major university-industry research centers in the ﬁeld of engineering, for example, found that 35 percent would allow corporate sponsors
to delete information from papers prior to publication.
But all the blame for the eroding objectivity of university researchers does not rest with industry. Universities themselves are complicit: They are so ﬁnancially invested in their professors’ research through patents, equity, and other ﬁnancial holdings that their disinterested pursuit of knowledge has been gravely compromised. For instance, when the Harvard Center for Risk Analysis’ longtime director, Professor John D. Graham, was nominated by President George W. Bush to become the government’s “regulatory czar” at the Ofﬁce of Information and Regulatory Affairs (part of the Ofﬁce of Management and Budget), it helped to expose just how extensive Harvard’s ﬁnancial conﬂicts really were. Congressional hearings revealed that Graham’s center solicited tobacco money and worked with the tobacco industry to disparage the risks of secondhand smoke. (Harvey Fineberg, a dean at the Harvard School of Public
Health, demanded that one check from Philip Morris be returned. In response, Graham wrote to the company asking if it might send the $25,000 back to the Harvard center via the Philip Morris subsidiary Kraft Foods instead.) Graham’s center also argued that cell-phone use by drivers should not be restricted, even though its own research, which was funded by AT&T Wireless Communications, showed that such use could lead to a thousand additional highway deaths a year. As a member of the Environmental Protection Agency’s scientiﬁc advisory board subcommittee on dioxin, a known human carcinogen, Graham argued that reducing dioxin levels might “do more harm … than good.” His Harvard center, meanwhile, was heavily funded by dioxin producers.
Worse yet, the universities’ loyalties are now so conﬂicted that schools are increasingly willing to cave in to narrow commercial demands rather than defend their own professors’ academic freedom or the public interest. When researchers at the University of Utah discovered an important human gene responsible for hereditary breast cancer, for example, they didn’t make it freely available to other scientists, even though we -- the U.S. taxpayers -- paid $4.6 million to ﬁnance the research. The university raced to patent it, then granted the monopoly rights to Myriad Genetics Inc., a startup company founded by a University of Utah professor, which proceeded to hoard the gene and prevent other academic scientists from using it.
Professors, too, are increasingly driven by the bottom line. More and more, they not only accept industry grants to support their research but also hold stock in or have other ﬁnancial ties to the companies funding them. Many experts fear this skewing of professors’ research toward short-term commercial goals will impede long-term scientiﬁc and technological innovation. Financial entanglements between researchers and corporations have grown so common that the Securities and Exchange Commission (SEC) has investigated numerous academic researchers suspected of engaging in insider trading. In a case ﬁled in Pennsylvania, the SEC charged Dale J. Lange, a Columbia University neurologist, with pocketing $26,000 in proﬁts after Lange bought stock in a company that was about to release promising new ﬁndings concerning a drug to treat Lou Gehrig’s disease. Lange had good reason to expect the stock to soar because he had
conducted the conﬁdential clinical trials himself. In 2000, an investigation by USA Today found that more than half the experts hired to advise the U.S. government on the safety and effectiveness of drugs -- a large number of whom are academics -- now have ﬁnancial links to companies that will be affected by their conclusions. When Wyeth-Ayerst was trying to get its diet drug, Redux, approved for sale in the United States, for example, it faced a serious hurdle: Patients in Europe who had taken a drug virtually identical to Redux had an increased chance of getting a rare, life-threatening lung ailment known as pulmonary hypertension. To combat this negative health proﬁle, the company packed an FDA hearing room with a who’s who list of the nation’s top academic obesity experts, all of whom were also paid consultants to Wyeth-Ayerst or other companies involved in the sale of Redux. In addition, the company recruited expert
“opinion leaders,” such as George Blackburn, a renowned obesity expert at Harvard, to testify before the Medical Society of Massachusetts for approval of the drug. Blackburn and other academic luminaries further participated in the company’s “Visiting Important Professors Program” and were paid thousands of dollars in honoraria to ﬂy to fancy resorts and promote Redux at medical conferences. Not surprisingly, the drug handily won market approval, and prescriptions in the United States began to soar.
Soon, however, evidence of the drug’s association with lung damage surfaced once again, and the company turned to leading university scientists to do damage control. In the summer of 1996, an internal company memo revealed that the company was planning to spend $5.8 million to pay for more university-based studies, noting that that money was needed to “establish and maintain relationships with opinion leaders at the local and national level to communicate to their colleagues the beneﬁts of Redux and to encourage its use.” Among the many doctors willing to heed the company’s call was Atkinson, the obesity expert at the University of Wisconsin, whose name appeared on a company-authored article. “Let me congratulate you and your writer,” wrote Atkinson in a thank-you letter to the ghostwriting ﬁrm that was one of numerous company documents that became public during subsequent legal proceedings. “Perhaps I can get
you to write all my papers for me!”
So how does this growing web of academic-industry ties affect research outcomes? A vast body of work suggests that industry-funded research is far from impartial. In 1996, Stanford researcher Mildred Cho co-authored a study in the Annals of Internal Medicine that found that 98 percent of papers based on industry-sponsored research reﬂected favorably on the drugs being examined, compared with 79 percent of papers based on research not funded by industry. An analysis published in The Journal of the American Medical Association in 1999 found that studies of cancer drugs funded by the pharmaceutical industry were nearly eight times less likely to reach unfavorable conclusions than similar studies funded by nonproﬁt organizations. More recently, a systematic review of 1,140 clinical trial studies, published by researchers at Yale in 2003, concluded that, from cancer to arthritis to cholesterol, the evidence is
overwhelming that when research is industry-sponsored, it is “signiﬁcantly more likely to reach conclusions that [are] favorable to the sponsor” than non-industry-funded research.
In the area of health and drug research, of course, the results of such manipulation can be deadly. Running down the list of drugs recently pulled from the market or subject to increased health warnings -- Rezulin, the diabetes drug; Redux (or fen-phen), the diet drug; Retin-A, the anti-wrinkle cream; Neurontin, the epilepsy drug; Paxil, Zoloft, and the many other antidepressants now deemed ineffective for children -- one ﬁnds that a remarkable number of prominent university professors with close ﬁnancial ties to the manufacturers played a central role in lobbying for these drugs to be approved, recommending them to other doctors, and, in many cases, urging that they remain on the market long after the problems or lack of effectiveness became known. Not infrequently, the university scientists who shill for the drug companies most aggressively are also the biggest-name professors in their ﬁelds.
Universities have gone out of their way to assure the public that their clinical trials meet the highest standards of “scientiﬁc excellence” and “academic rigor.” But over the last 20 years, public dismay over the growing ﬁnancial entanglements in clinical research has prompted the federal government to impose tougher conﬂict-of-interest regulations, only to encounter ﬁerce university opposition. In 1995, the federal government ﬁnally succeeded in pushing through rules that would apply to all academic researchers funded by the Department of Health and Human Services (HHS) or the National Science Foundation (NSF). But the rules, which remain in place today, were not tough enough to be effective. Although they mandate that serious conﬂicts of interest must be managed and/or eliminated, they leave the determination of what action is to be taken, if any, entirely up to the university. The policy also doesn’t
provide any guidance on which conﬂicts warrant serious attention, nor does it impose any prohibitions, such as banning ﬁnancial conﬂicts outright in the area of human-subject research. Signiﬁcantly, the policy also says nothing about institutional conﬂicts of interest.
The result, not surprisingly, is that university conﬂict-of-interest rules vary widely. One comprehensive 2000 survey of the written policies at 100 academic institutions found that only 55 percent of schools required disclosure of conﬂicts of interest from all faculty, and only 19 percent speciﬁed any limits on researchers’ ﬁnancial ties to corporate sponsors. Worse yet, under this fragmented system, there is enormous pressure on universities to keep their policies lax. Schools with tighter restrictions run the risk of losing talented faculty to competing schools with more permissive policies, where the ﬁnancial rewards and commercial prospects are likely to be greater.
Another conspicuous problem with the HHS/NSF policy is that it does not require universities to make any of the information they compile on faculty ﬁnancial conﬂicts available to the public. Many academic journals do require their authors to disclose corporate ﬁnancial ties. But in practice, reporting is astonishingly poor. In a 2001 study, Tufts’ Krimsky found that a mere 0.5 percent of the 61,134 papers appearing in 181 peer-reviewed journals contained statements about the authors’ ﬁnancial ties. More recent studies have found similarly low levels of reporting.
In some respects, the whole debate reﬂects how far the academic world remains from dealing seriously with the issue; disclosure of potential conﬂicts of interest is, after all, a far cry from eliminating them outright, as many professions not only recommend but also require. In the legal profession, for example, attorneys are prohibited from taking on cases in which they have a ﬁnancial interest or other explicit conﬂicts that might be seen to compromise their professional integrity. The same is true of judges. But when it comes to academia, neither the medical community nor the government (whether through Congress or the regulatory agencies) has taken up the task, instead proceeding under the assumption that universities can be trusted to manage these commercial interactions themselves. It’s a nice idea. But are academic institutions really capable of performing this function? There is good reason to be skeptical: Far
from being independent watchdogs capable of dispassionate inquiry, universities are increasingly joined at the hip to the very market forces the public has entrusted them to check, creating problems that extend far beyond the research lab.http://newamerica.net/index.cfm?pg=article&DocID=2189
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