Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?
One of the most striking aspects of John Paul II’s papal leadership has been his frequent and outspoken forays into science, especially the life sciences. His positions on abortion, sexuality, and contraception have alienated vast numbers of Catholics and non-Catholics. Many people had seen his tenure in the Vatican as an opportunity for progressive leadership on issues ranging from AIDS in Africa to the reproductive rights of women. They have been disappointed. But his staunch orthodoxy has had one unexpected, and some would say beneficial, consequence—a decisive opposition to the commercial exploitation of science.
In a letter to the apostolic nuncio in Poland on March 25, 2002, John Paul II condemned the “overriding financial interests” that operate in biomedical and pharmaceutical research. These forces, he wrote, prompted “decisions and products which are contrary to truly human values and to the demands of justice.” His particular target was “the medicine of desires,” by which he meant those drugs and procedures that are “contrary to the moral good,” serving as they do the pursuit of pleasure rather than the eradication of poverty. In an especially thoughtful passage, he wrote that
the pre-eminence of the profit motive in conducting scientific research ultimately means that science is deprived of its epistemological character, according to which its primary goal is discovery of the truth. The risk is that when research takes a utilitarian turn, its speculative dimension, which is the inner dynamic of man’s intellectual journey, will be diminished or stifled.
Sheldon Krimsky, a physicist, philosopher, and policy analyst now at the Tufts University School of Medicine, puts it more bluntly. In Science in the Private Interest, a strongly argued polemic against the commercial conditions in which scientific research currently operates, he shows how universities have become little more than instruments of wealth. This shift in the mission of academia, Krimsky claims, works against the public interest. Universities have sacrificed their larger social responsibilities to accommodate a new purpose—the privatization of know- ledge—by engaging in multimillion-dollar contracts with industries that demand the rights to negotiate licenses from any subsequent discovery (as Novartis did, Krimsky reports, in a $25 million deal with the University of California at Berkeley). Science has long been ripe for industrial colonization. The traditional norms of disinterested inquiry and free expression of opinion have been given up in order to harvest new and much-needed revenues. When the well-known physician David Healy raised concerns about the risks of suicide among those taking one type of antidepressant, his new appointment as clinical director of the University of Toronto’s Centre for Addiction and Mental Health was immediately revoked. Universities have reinvented themselves as corporations. Scientists are coming to accept, and in many cases enjoy, their enhanced status as entrepreneurs. But these subtle yet insidious changes to the rules of engagement between science and commerce are causing, in Krimsky’s view, incalculable injury to society, as well as to science.
This escalating corrosion of values derives from a sharp change in the political climate during the 1970s. University administrators came to see their faculties as an undervalued resource. To counter what was seen as a culture of financial passivity, the Patent and Trademark Amendments (Bayh-Dole) Act of 1980 enabled universities to claim entitlement to inventions made with the support of federal funds. Suddenly university deans found themselves sitting on a mountain of unrealized income. Scientists took to their new commercial calling with relish. Surveys reveal that a high proportion of researchers have ties to the industries whose products they are investigating.1 Many have argued and some no doubt believe that money could never influence their scientific independence. But Krimsky makes a telling comparison of journalists and public officials, two groups for whom monetary conflicts of interest, now endemic in science, are anathema to their professional ethics. Instead, and this is surely a remarkable double standard, scientists absolve themselves from the dangers of often deep financial conflicts (such as company directorships, equity ownership, research grants, honoraria, and travel costs) by the simple means of disclosure. Reporting a payment, a gift, or other interest has become a panacea, especially in medical journals, allowing scientists to wash their hands of criticism.
This situation cannot be justified. Krimsky writes that “the relationship between conflicts of interest and bias has been downplayed within the scientific community to protect the entrepreneurial ethos in academia.” But the damage inflicted by the influence of profit on the purpose of science has spread far beyond the university. The federal advisory committees that dispense funds now give private interests priority over public ones. If committee members receive substantial payments from industries, this should in principle disqualify them from decisions affecting those industries. In the case of vaccine policy, for example, Krimsky quotes a 1999 US House of Representatives Committee on Government Reform, which concluded that conflict of interest rules on FDA and CDC advisory committees had “been weak, enforcement has been lax, and committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee proceedings.”2
Even scientific journals, supposedly the neutral arbiters of quality by virtue of their much-vaunted process of critical peer review, are owned by publishers and scientific societies that derive and demand huge earnings from advertising by drug companies and from the sale of commercially valuable content. The pressure on editors to adopt positions that favor these industries is yet another example of the bias that has infiltrated academic exchange. As editor of The Lancet I have attended medical conferences at which I have been urged to publish more favorable views of the pharmaceutical industry. For Krimsky, “the idea that public risk (that is, publicly supported research) should be turned into private wealth is a perversion of the capitalist ethic.” The Pope would probably agree.
The idealism of Krimsky and the Pope—some would call it naiveté—could be a misleading guide in matters of scientific value. The notion that there was once some golden age of universal, communal, disinterested, and perfectly skeptical science, to use Robert Merton’s famous tacit presuppositions about scientific cultures, is nonsense. Bertrand Russell was right when he argued that for as long as human beings have embarked on the activity we call science, their inquiries have had the twin functions of helping us to do as well as to know.3 As Merton himself admitted, “Readiness to accept the authority of science rests, to a considerable extent, upon its daily demonstration of power.”4
Yet this allegedly inescapable connection between science and technology has been challenged by a strain of historical study, one omitted by Krimsky, that finds a clear division between scientific inquiry and its more practical applications. For example, the American historian Steven Shapin, in his forceful exploration of the basis for scientific knowledge in the seventeenth century,5 links the origins of English experimental philosophy with the cultural importance of truthfulness—“the gentlemanly constitution of scientific truth,” as Shapin puts it. He argues that our personal knowledge of the world depends to a large degree on what others tell us. Our understanding therefore has a moral character, based as it must be on trust. In constructing a body of reliable individual knowledge, trustworthy people are crucial. In the seventeenth century, the concept of the gentleman embodied these notions of trust. “Honor” was the key to believing someone’s testimony. Lying was seen as incompatible with a civilized society. A series of social conventions followed from this claim—the importance of face-to-face conversation, the centrality of “epistemological decorum.”
In view of these conditions for truth, an opposition was bound to emerge between gentlemen and the trading classes. The merchant sought private advantages that created strong motives for lying. Deceit was pervasive in mercantile activities. Shapin quotes Erasmus: “their lies, perjury, thefts, frauds, and deceptions are everywhere to be found.” And Robert Boyle, who discovered fundamental laws on the behavior of gases, “found by long and unwelcome experience, that very few tradesmen will, and can give a man a clear and full account of their own practices; partly out of envy, partly out of want of skill to deliver a relation intelligibly.” Secret scientific knowledge and commercial exploitation of discoveries thus have a long and much-abhorred history within science, whatever scientists might claim in order to justify themselves today.
Still, most scientists and academic leaders will reject this negative attitude toward collaborations between science and industry. The argument for partnership seems entirely reasonable. Science aims to acquire knowledge but needs money to invest in research. Industry wants to develop products for a profit, but needs a sound base of knowledge on which to do so. In other words, both activities need each other. Their interests are complementary. As the costs of basic science and clinical research have soared, thanks largely to the technological and organizational complexity of modern research, so universities have become more dependent than ever on the deep pockets of industry. The standard line advanced by corporate leaders is that these partnerships have been crucial to recent major advances in diagnosis and treatment of disease.6
But something changed dramatically in the early 1980s to push academia and industry closer together. These forces were not accidental, and whatever today’s rhetoric of complementarity and synergism might suggest, their consequences are not benign. The emerging biotechnology industry, based as it was on new techniques developed from molecular and gene biology, became the driving force behind this marriage of opportunities. The federal government enacted a list of statutes that mandated the National Institutes of Health (NIH) to cooperate with the private sector. Concerns were raised long ago by some academics about this changing landscape of science. Writing in 1991, William Raub, then acting director of the NIH, commented that
the American body politic traditionally has erupted in anger when publicly financed activities yield undue private gain, when information intended for the many becomes the exclusive possession of the few, when personal goals are advanced at the expense of national ones, or when the prospect of profit breeds dishonest dealing.7
A decade later, many of these predictions have come true. When scientists ask colleagues to share their data, genetic discoveries, for example, are frequently withheld.8 This proprietorial approach to new research findings is an increasing trend, especially in commercially sensitive disciplines. Lack of collaboration with other scientists prevents investigators from confirming and extending new discoveries. Contractual agreements between medical schools and industry sponsors of new research are also vulnerable in this culture of covert inquiry. The agreements fail to ensure that clinical trials follow widely agreed-on ethical practices, such as full protection of the patients enrolled in the study.9 Contracts frequently contain no requirements for independent committees to monitor research and its safety. The access of an investigator to the trial’s data is often not guaranteed. And usually there is no agreement that a trial’s results will be published. These poor standards impugn the integrity of the entire field of biomedical research. And they put the well-being of patients at risk.
One now well-known case documented by Krimsky shows these difficulties all too clearly.10 In the 1990s, Nancy Olivieri worked at the University of Toronto and at the city’s Hospital for Sick Children on a drug to treat a rare blood disorder called thalas-semia. Her work was sponsored by the Canadian Medical Research Council and a pharmaceutical company called Apotex. She discovered that the drug was not as effective as the company had originally hoped. Worse, the drug appeared to have very serious adverse effects. When Olivieri indicated her wish to publish her findings and inform the patients in her care of the drug’s potential dangers, the company threatened her with legal action.
Krimsky describes how the hospital and university, which should have been the first to offer her protection from this outrageous intimidation, were the last to defend both her freedom to report her findings and her duty to act in the best interests of the patients under her care. Indeed, the hospital began an inquiry that failed to give Olivieri a fair hearing and other protections of due process. Astonishingly, she was fired. All this went on while the university was itself engaged in discussions with Apotex about a $12.7 million donation by the company to the University of Toronto. The president of the university was lobbying the Canadian government on behalf of Apotex. As Krimsky points out, a gift of this size “would make any university exquisitely attentive to the interests of the donor.”
After a further long and acrimonious investigation, Dr. Olivieri was cleared of any alleged wrongdoing. Her reputation was restored and her position reestablished. But the case ignited a furious debate within medicine about the moral responsibilities of investigators, their academic freedom, and the vital importance of strong institutional mechanisms to resist commercial forces that put stock value before professional ethics.
These institutional mechanisms are currently fragile. The purpose of the universities that support extensive research programs is changing—inevitably and inexorably, say some of its leading analysts11—to meet an ever-greater need for money. More funds are necessary to secure top faculty, build new facilities, and finance scholarships. University administrators feel they have no choice: they have to move away from a mission based on the education of students to be informed and capable democratic citizens; instead, they have to concentrate more on producing people who can contribute to a “knowledge economy.”
The problem is not only institutional. An extraordinary culture of gift giving now exists within scientific research, a culture that has altered the way in which new discoveries are shared and debated. Take virtually any major medical conference—for example, the three annual gatherings of cardiologists hosted separately by the American College of Cardiology, the European Society of Cardiology, and the American Heart Association. It is now entirely usual, among the many thousands of participants, for air fares, hotel costs, registration fees, and evening entertainment (dinner, theater, music) to be paid for by corporate sponsors, usually the pharmaceutical industry.12 In return for this largesse, the conference organizers will hire space for an enormous trade exhibition at which the sponsors are allowed to display their products, services, and promotional material, while offering even more gifts, such as golf balls, pens, bags, computer equipment, games, toys, and clothes to its captive audience.
These meetings are usually billed as scientific conferences. It is true that keynote lectures, together with symposiums at plenary sessions and parallel meetings, make up a substantial proportion of the program.13 But the visitor cannot help being struck by the scandalous bargain that has been made between professional societies and industry—namely that, in order for science to be reported and discussed among a professional society’s membership, sponsors will be given free rein to market their products to attending physicians. The venality of those taking part in this corrupt covenant is difficult to square with a profession that is quick to squeal at the mere suggestion of government intrusion into the delivery of health care. Any claim that the science and practice of medicine are disinterested is utterly groundless.
About a quarter of scientists working in medical research have some sort of financial relationship with industry. And, not surprisingly, there is a strong association between commercial sponsorship and the conclusions scientists draw from their findings. Scientists who argue in favor of a particular product are more likely than their neutral or critical colleagues to possess a financial stake in the company that is funding their research or the product they are studying.14 And, for the most part, these conflicts of interest are not reported when research is either presented at scientific meetings or published in medical journals.
Indeed, medical journals have become an important but underrecognized obstacle to scientific truth-telling. Journals have devolved into information-laundering operations for the pharmaceutical industry. Here is how it works. A pharmaceutical company will sponsor a scientific meeting. Speakers will be invited to talk about a product, and they will be paid a hefty fee (several thousand dollars) for doing so. They are chosen for their known views about a particular drug or because they have a reputation for being adaptable in attitude toward the needs of the company paying their fee. The meeting takes place and the speaker delivers a talk. A pharmaceutical communications company will record this lecture and convert it into an article for publication, usually as part of a collection of papers emanating from the symposium. This collection will be offered to a medical publisher for an amount that can run into hundreds of thousands of dollars.
The publisher will then seek a reputable journal to publish the papers based on the symposium, commonly as a supplement to the main journal. The peer-review process will be minimal or nonexistent, and is sometimes not even the responsibility of the editor-in-chief of the parent journal. Publication of the supplement appears to benefit all parties. The sponsor obtains a publication whose content it has largely if not wholly influenced, but which now appears under the imprint of a journal that confers on the work a valuable credibility that the company has bought, not earned. The publisher receives a tidy high-margin revenue from the deal.
Why is this practice wrong and dangerous? The scientific quality of research in the thousands of industry-sponsored supplements published each year is notoriously inferior to the research published in properly peer-reviewed scientific journals.15 The process of publication has been reduced to marketing dressed up as legitimate science. Pharmaceutical companies have found a way to circumvent the protective norms of peer review. In all too many cases, they are able to seed the research literature with weak science that they can then use to promote their products to physicians.
Derek Bok, a former president of Harvard University, describes the damaging effects of this pervasive commercialization of science in his important report on academia, Universities in the Marketplace. The concerns of research, he argues, have become skewed toward answering questions that are concerns of industry, not of the public. Secrecy disrupts a productive collegiality among scientists, leading to waste and inefficiency as investigators are forced to duplicate the hidden work of others. Opinions are rented out to the highest bidder. A nefarious web of incentives is introduced into research. And, most worrying of all, public confidence in medicine, science, and the academy is undermined. Knowledge is just one more commodity to be traded.
The short-term effects of introducing a business culture into the academy may be so subtle that they will go unnoticed until it is too late to reverse their long-term consequences. As Bok writes, bit by bit
commercialization threatens to change the character of the university in ways that limit its freedom, sap its effectiveness, and lower its standing in the society…. The problems come so gradually and silently that their link to commercialization may not even be perceived. Like individuals who experiment with drugs, therefore, campus officials may believe that they can proceed without serious risk.
Is science, and especially biomedical science, now hopelessly compromised by its apparent dependence on industry? The optimists who deny that it is tend to fall into one of two camps. First, there is the growing view that science must be reclaimed for the public interest. Krimsky argues this case vigorously. For him, public interest science is “research carried out primarily to advance the public good.” The values of public service in science need to be strengthened. Independent voices of dissent must be protected. The constraints on a scientist’s freedom to think, write, and investigate must be kept to a minimum. The business values of efficiency, assembly line production, and the quest for utility need to be tamed.
How is this to be done? Krimsky and some other reformers believe that whether in the academy or in the clinic, there should be a sharp separation between knowledge producers and wealth creators. All personal interests must be declared. If investigators have a direct financial stake—such as substantial stock ownership—in the outcome of research, they should not take part in it. And academic institutions with investments in particular corporations should not accept grants from those same companies. To this set of prescriptions, one might add that the gift culture of science should be substantially if not totally curbed. A gift of any kind may introduce unrecognized bias that cannot be ameliorated by either disclosure or limiting the size of the gift.16
An alternative view is that a dissolution of the partnership between science and commerce is neither possible nor desirable. Science is not merely about generating knowledge. It is about innovation. Businesses are increasingly “outsourcing” their research and development costs, i.e., allocating them to academic and other research institutions with which they make contracts. Universities have long had a valuable and justifiable part to play in fostering research into new medical remedies. Those scientists who wish to be entrepreneurs should be encouraged to develop an interest in their invention, not prevented from doing so. The crucial point is that rules should be put in place to ensure that these more commercially minded investigators are not permitted to conduct human research without tough independent oversight. In this way, the powerful incentives that drive scientific advance would be protected, while their more undesirable risks would be managed.
For such oversight to occur, however, universities, professional organizations, and scientific publications will have to improve many of their current practices and take a more demanding position toward private companies. It is far from clear either that this is what the universities and professional organizations want to do or that there will be any effective sources of public pressure to make them change their ways.
Instead of possibly choking off innovation by legislating against the judicious commercial development of scientific research, a better way to proceed, according to John Ziman, a respected philosopher of science, is to let this work proceed unhindered while at the same time protecting the “non-instrumental” functions of science that are currently under threat.17 Ziman argues that the erosion of traditional scientific values—such as the principles that research should be driven by curiosity and by the desire to advance scientific knowledge—has created a new “post-academic science,” a science that seeks an immediate economic payoff. Sustaining some form of non-instrumental science—which practically means not routinely applying the litmus test of wealth creation to every new idea or hypothesis—is important not only for inquiry into fundamental theoretical questions but also because society needs a model of independent critical rationality for the proper conduct of democratic debate, judicial inquiry, and consumer protection. But non-instrumental science can only be protected by organizations whose funding decisions are determined by disinterested scientists themselves, whether in university departments, charitable foundations, or government agencies such as the National Institutes of Health.
While Ziman’s partial solution to the threat posed by private-interest science certainly sounds more practical than Krimsky’s desire to turn back the entire tide of commerce, it also poses its own dangers. In a brief and tantalizing epilogue to his social history of truth, Steven Shapin speculates about the way trust and credibility are manipulated in the modern era. He notes that
we are told things about the world [today] by people whom we do not know, working in places we have not been. Trust is no longer bestowed on familiar individuals; it is accorded to institutions and abstract capacities thought to reside in certain institutions…. We trust the truth of specialized and esoteric scientific knowledge without knowing the scientists who are the authors of its claims…. The gentleman has been replaced by the scientific expert, personal virtue by the possession of specialized knowledge, a calling by a job, a nexus of face-to-face intervention by faceless institutions, individual free action by institutional surveillance.
If personal virtue has indeed given way to impersonal expertise, and if moral character has become secondary to institutional prestige, it would be wrong to conclude that the connection between public trust and the integrity of the individual scientist has been wholly erased. But it has often become subject to a new set of institutional authorities. And this is a source of contemporary anxiety.
For if expertise is found to be shaped by motives of personal gain (as it increasingly is) and if the reputations of institutions are stained by private advantage (as they increasingly are) then trust will be as vulnerable to commercial corrosion now as it was to ungentlemanly behavior in the salons of seventeenth-century English experimentalists.18 If these influences go unchecked, Thomas Hobbes’s injunction “against the lucrative vices of men of trade” could well become the dismal epitaph for modern science.
See Justin E. Bekelman et al., “Scope and Impact of Financial Conflicts of Interest in Biomedical Research,” JAMA, January 22, 2003, pp. 454–465. ↩
The NIH is currently embroiled in controversy following allegations, first reported in the Los Angeles Times on December 7, 2003, that money received by some of the agency’s top scientists has biased research decisions. NIH director Elias Zerhouni has responded quickly by setting up committees to investigate these “important” claims. ↩
See Bertrand Russell, “General Effects of Scientific Technique,” The Impact of Science on Society (Routledge, 1985), pp. 29–54. ↩
See Robert K. Merton, “Science and the Social Order,” Philosophy of Science, Vol. 5 (1938), pp. 321–337. ↩
See Steven Shapin, A Social History of Truth (University of Chicago Press, 1995). ↩
See Sidney Taurel, “Hands Off My Industry,” The Wall Street Journal, November 3, 2003, p. A14. ↩
See William F. Raub, “The Emerging Partnerships Among the National Institutes of Health, Academic Health Centers, and Industry,” Preparing for Science in the 21st Century (Association of Academic Health Centers, 1991). ↩
See Eric G. Campbell et al., “Data Withholding in Academic Genetics,” JAMA, January 23, 2002, pp. 473–480. ↩
See Kevin A. Schulman et al., “A National Survey of Provisions in Clinical-Trial Agreements Between Medical Schools and Industry Sponsors,” New England Journal of Medicine, October 24, 2002, pp. 1335–1341. ↩
See Jon Thompson, Patricia Baird, and Jocelyn Downie, The Olivieri Report (James Lorimer, 2001). ↩
See Derek Bok, Universities in the Marketplace (Princeton University Press, 2003), and Daniel Callahan, What Price Better Health (University of California Press, 2003). ↩
Few physicians are prepared to discuss openly their links with industry. A rare exception was recently provided by a UK professor of medicine, Edwin Gale. See his “Between Two Cultures: The Expert-Clinician and the Pharmaceutical Industry,” Clinical Medicine, November/December 2003, pp. 538– 541. ↩
Although a variable but often considerable proportion of the “scientific” content is promotional too—typically in the guise of sponsored satellite symposiums at which speakers, in exchange for substantial fees, will lecture to a specially invited audience with a particular product in mind. ↩
See H.T. Stelfox et al., “Conflict of Interest in the Debate Over Calcium-Channel Antagonists,” New England Journal of Medicine, January 8, 1998, pp. 101–106. ↩
See Lisa A. Bero et al., “The Publication of Sponsored Symposiums in Medical Journals,” New England Journal of Medicine, October 15, 1992, pp. 1135–1140; and Paula A. Rochon et al., “Evaluating the Quality of Articles Published in Journal Supplements Compared with the Quality of Those Published in the Parent Journal,” JAMA, July 13, 1994, pp. 108–113. ↩
See Jason Dana and George Loewenstein, “A Social Science Perspective on Gifts to Physicians from Industry,” JAMA, July 9, 2003, pp. 252–255. ↩
See John Ziman, “Non-instrumental Roles of Science,” Science and Engineering Ethics, Vol. 9 (2003), pp. 17–27. ↩
The signs are not encouraging. In the UK, for example, a recent report urges government to strengthen the encroachment of commerce into science. See “Lambert Review of Business– University Collaboration” (HM Treasury, 2003). ↩