Healthy Skepticism Library item: 19806
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Belsky L, Emanuel EJ
Conflicts of Interest and Presrving the Objectivity of Scientific Research
Health Affairs 2004 Jan; 23:(1):268-270
http://content.healthaffairs.org/content/23/1/268.full
Full text:
Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?
by Sheldon Krimsky
(Lanham, Md.: Rowman and Littlefield, 2003), 247 pp., $27.95
In 1980 Congress passed the Bayh-Dole Act, giving universities title to inventions made with federal funding and not only encouraging but also obligating them to commercialize these inventions. In the same year, on a 5 to 4 vote, the Supreme Court ruled in Diamond v. Chakrabarty that living organisms could be patented. These two events, followed by tax credits and other initiatives, triggered the further commercialization of scientific discoveries and the formation of extensive university-business connections. One indicator is that the number of patents held by universities increased from 1,500 in 1992 to more than 3,200 in 2000, primarily in the biomedical sciences. In this forceful and persuasive study, Sheldon Krimky of Tufts University deplores the ethical and professional compromises engendered by increased university-business connections. Although largely one-sided, his dire warning merits serious attention.
Krimsky has long been a critic of business links to universities. Science in the Private Interest integrates his work and that of others, arguing that the link between universities and business actually presents a serious threat to both universities and society:
Public policies and legal decision have created new incentives for universities, their faculty and publicly supported nonprofit research institutes to commercialize scientific and medical research…The consequences are that secrecy has replaced openness; privatization of knowledge has replaced communitarian values; commodification of discovery has replaced the idea that university generated knowledge is a free good, a part of the social commons…[and] an unprecedented rise in conflicts of interest…As universities turn their scientific laboratories into commercial enterprise zones and as they select their faculty to realize these goals, fewer opportunities will exist in academia for public-interest science—an inestimable loss to society (page 7).There are certainly cases and data that bolster Krimsky’s argument. One is the case of Nancy Oliveri, a hematologist at the University of Toronto, who found that a new iron-binding drug made by Apotex was losing efficacy and provoking serious adverse reactions. In the midst of negotiating a multimillion-dollar donation to the university, Apotex tried to suppress the data. In response, the university, swayed by the prospect of the donation, removed Oliveri as director of the hemoglobinopathies program rather than standing behind her work. Luckily, Oliveri was ultimately exonerated after considerable adverse publicity and intervention by colleagues at other universities.
Another case involved a randomized trial of a brand-name thyroid replacement drug against its generic competitors. The study was conducted by the University of California, San Francisco, and sponsored by the manufacturer, a subsidiary of Boots Pharmaceuticals. When the study demonstrated that Boots’s drug was equivalent to the generics, the company tried to suppress the study, questioning its legitimacy and threatening to sue the researchers.
These are only two cases. There are many other stories about businesses trying to suppress studies or pay off investigators. In essence, Krimsky argues that such private influence corrupts dispassionate scientific inquiry. Krimsky further suggests that rising corporate investment in the academic research community will skew researchers’ aims and motivations, influencing the topics that researchers decide to study in the first place. How can a person remain an educator, a knowledge creator, and a public servant when the prospect of making millions is fanned before his or her eyes? Indeed, some black humor has it that the “value” of a medical school professor is determined not by the number of students he educates or patients he aids but by the number of start-up biotechnology companies he founds or consults for.
By way of contrast, Krimsky portrays Barry Commoner, an influential environmental scientist, as the model academic researcher—one who crusades on behalf of the poor, powerless, and dispossessed. His solution is thus to eliminate any of the commercial or financial conflicts of interest that might lead the motivations of a man like Commoner astray. Disclosure and management of conflicts of interest will not suffice to protect the integrity and role of the academic research community. Krimsky writes, “By accepting the premise that conflicts of interest in the university must be subtly managed, rather than prohibited or prevented, nothing less than the public interest function of the American academic enterprise is at stake.”
If the majority of business-university collaborations were corrupting, Krimsky’s dire tone would be understandable. But it is not all bad. There are many cases in which university-business links are beneficial, producing drugs or medical interventions that are tremendously important and probably could not have been achieved without the links. For example, Gleevec, the first drug derived from proteomics, has been very successful in treating patients with chronic myeloid leukemia and has provided a paradigm for a whole new approach to drugs. Without the collaboration between Novartis (Gleevec’s maker) and Brian Druker at Oregon Health Sciences, it is doubtful that Gleevec would ever have been developed and marketed.
Krimsky’s claim that the expanded patent system gives researchers an irresistible incentive to research only what is commercially valuable also seems overstated. As Fred Abbott, an intellectual property law professor not known for his Big Pharma sympathies, contends, a strong intellectual property system certainly encourages people to invest capital and build plants needed to manufacture and produce new drugs. However, the empirical data from detailed studies of the history of innovations do not substantiate the claim that patents spur individual researchers to focus on commercially viable inventions. They seem more driven by puzzles, serendipity, and hopes to make a difference. Patents come after the discovery, not as the spur to discovery. It is unlikely that they then play a major role in influencing what a researcher chooses to pursue.
Krimsky’s alternative is that universities need to maintain more independence by shunning corporate investors in favor of governmentally supported research. But this is a problematic solution. First, despite a doubling of the National Institutes of Health (NIH) budget in the past five years, federal support of research, especially biomedical research, is becoming a smaller proportion of research funds. While the numbers are rough, pharmaceutical and biotechnology companies probably spend three times as much on clinical trials of drugs and devices as the NIH does. With growing federal budget deficits, the ratio is likely to shift even more in favor of industry.
More importantly, the disinterested nature of federal support for research seems to be becoming a historical relic. Increasingly, the government itself is acting much like industry, interested in having more influence over what is being researched and the precise nature of the outcomes. And this is also true of special-interest groups. For instance, the Traditional Values Coalition’s recent criticism of more than 200 researchers and grants on sex, homosexuality, and related topics supported by federal funding highlights the potential for ideology, rather than merit, to influence research priorities and funding. As of yet, the actual impact of these charges on federal funding decisions is uncertain, but their mere existence indicates that commercialization, while important, is not the only threat to free inquiry.
The growing attempts by businesses, special-interest groups, and individual governmental agencies to control scientific research priorities and actual research results are an indication of the growing importance of science and technology to society. They also validate Krimsky’s worry about the dangers of commercialization and conflicts of interest. The multiplicity of threats to the objectivity of the scientific enterprise, however, underscores the fact that trying to isolate the university from the marketplace as much as possible will not ensure free, objective scientific inquiry.
We ask a great deal of the academic science community. We want our academic researchers to uncover the mysteries of the world and the dangers of our existing practices. We also want them to alleviate the suffering of those who lack the money to provide funding, while being attentive to the needs of those who do generate funds. We want them to educate the public and inspire students to become future scientists. What would the individual researcher, locked in her ivory tower, be most inclined to pursue? No one knows; but it is reasonable to presume that neither she nor her isolated community would naturally fulfill all of these goals.
The maintenance of university-business connections, if properly managed and controlled, plays an important role in ensuring that our investments in science will be actualized in the form of real medical interventions. The market alone will not enable the fulfillment of all that we want from researchers—but neither will sequestering them inside the university.
