The scientific method defined and described


Conflicts of interest are an enormous problem



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Conflicts of interest are an enormous problem


Scientists have human prejudices

Reuben Abel (prof. of philosophy, New School for Social Research, New York City), Man Is The Measure, 1976, p. 82

“Let us also note that scientists are human beings. That means that their judgment may be biased, their selection of problems may be whimsical, their assessment of the evidence may be faulty, their determination of the facts may be subjective, their motivations may be suspect, and their observations may be distorted by their values.”
There are increased ties between science and industry

Deborah Runkle (staff writer), “Conflicts of Interest in Science,” Science, December 1, 1989, p. 1117

“Increasing ties between academic and government research and industry have come about largely because of mounting concern over the loss of American preeminence in the high-technology international marketplace. The impetus for cooperative research has come not only from scientists and their institutions, but also from the executive branch and Congress.”
The industrialization of science has changed the social framework

David Baltimore (prof. of biology, Rockefeller Univ.; Nobel Prize in Medicine, 1975), “On Doing Science in the Modern World,” from The Tanner Lectures on Human Values, Delivered at Cambridge University, March 9 and 10, 1992, p. 263; Online: www.tannerlectures.utah.edu/lectures/documents/Baltimore93.pdf, accessed April 30, 2008

“I have the feeling that the societal framework in which science is being done today is different from even that of the recent past. Science is a victim of its own success. It has gone from being the province of gentlemen to being a central force of society; from a financially marginal part of governmental outlays to a significant one; from a minimal part of the academic enterprise to a dominant one. The pivotal role of science has brought it into the political spotlight, which is fundamentally changing the internal workings of the enterprise.
Granting scientists rights to exploit their research triggered the potential for conflict of interest

Sheldon Krimsky (prof. of urban and environmental policy, Tufts University), “The Hope, Hype, & Reality of Genetic Engineering,” The Quarterly Review of Biology, Volume 79, No. 3: September 2004, p. 306

“Also in 1980, the commercialization of molecular biology had ostensibly begun. Scientists, who retained their academic positions, incubated hundreds of new venture capital firms. The Bayh-Dole Act (1980) transferred to researchers and their commercial partners all intellectual property rights derived from federally funded research discoveries.”
Funding taints the research process, so the ethical researcher must focus elsewhere

Michael E. Frisina (Lieutenant Colonel [Retired], Medical Service Corps, United States Army; formerly, Director, Bioethics Program, Medical Research and Development Command, Fort Detrick, Maryland), “Medical Ethics in Military Biomedical Research” in Military Medical Ethics, Volume 2; Col. Dave E. Lounsbury, MD, FACP, editor-in-chief, p. 540

“Considering the history of the development of the atomic bomb, many scientists have come to believe that they have no control over the results of their work when conducted under the auspices of military funding and oversight. Their argument is simple: The only way to control the results of one’s work is to control what one works on in the first place. The ambiguity related to biological defensive versus offensive research is such that many scientists claim the only way to control proliferation of biological weapons, for example, is to not participate in any military-sponsored biological research. Some contend there is no distinction at all between offensive and defensive biological research and contend the military simply mislabels offensive research as defensive to attract researchers.”
Traditionally, a career in science was not intended to be a ‘get rich quick’ scheme

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “The Profit of Scientific Discovery and its Normative Implications,” The Chicago-Kent Law Review, Vol. 75 (1999), p. 15

“Until the late nineteenth century, the profession of scientist in Western societies was comprised almost exclusively of men from the propertied classes or bourgeoisie who were educated at the elite European universities. It was a calling of sorts, not unlike the ministry, for those with means and pedigree who could afford the luxury of investigating the workings of the universe by expanding and challenging their intellect. There was no vast wealth to be made — maybe a comfortable living at the peak of one’s career. With the rise of federal land grant colleges in the United States and the expansion of free national universities throughout the world, new scientific career options were created for people of diverse socioeconomic status. Through much of the early twentieth century a career in academic science was much like a monastic order. The pursuit of knowledge, the sharing of its fruits, the gratification of self-enlightenment and mentoring students were all the reward one required to sustain and nurture a career.”
Laws which commercialized science in the late 1900s also created conflicts of interest

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “The Profit of Scientific Discovery and its Normative Implications,” The Chicago-Kent Law Review, Vol. 75 (1999), p. 21

“The Stevenson-Wydler Technology Transfer Act of 1980 encouraged interaction and cooperation among government laboratories, universities, big industries and small businesses. In the same year, Congress passed the Bayh-Dole Patent and Trademark Laws Amendment, which gave intellectual property rights to research findings to institutions that had received federal grants. Discoveries and inventions from public funds could be patented and licensed, initially to small businesses, with exclusive rights of royalties given to the grantee. The Economic Recovery Tax Act of 1981 gave companies a twenty-five percent tax credit for sixty-five percent of their direct funding to universities for basic research. In 1983, by executive order, President Reagan extended the Bayh-Dole Act to all industry. To close the circle of research partnerships among industry, universities and government, Congress passed the Federal Technology Transfer Act of 1986, which expanded science-industry collaboration to laboratories run by the federal government. Governmental standards for keeping an arm’s length from industry were being turned on their head. Through this act, a government scientist could form a ‘Cooperative Research and Development Agreement’ (‘CRADA’) with a company as a route to commercializing discoveries made in a federal laboratory. Government scientists could accept royalty income up to a given amount, fifteen percent of the National Institutes of Health (the ‘NIH’) share, to supplement their salaries. At the time this policy was enacted, there was virtually no public discussion about the blatant conflicts of interest that this would introduce.”
Commercialization of science is hurting the spread of knowledge

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “The Profit of Scientific Discovery and its Normative Implications,” The Chicago-Kent Law Review, Vol. 75 (1999), p. 35-36

“Medical knowledge must serve the common good. This fundamental value which survived through millennia of medical practice, is superseded by the normative changes taking place in biomedical sciences. Because every biomedical discovery has potential monetary value, the new culture of science will seek to protect that discovery from becoming part of the ‘knowledge commons.’ Filing patent applications prior to publication establishes a proprietary interest in the discovery. Even after the patent application is filed, it is not in the interest of the applicant to disseminate too much information about the discovery in the event that a competitor will find a way to use the knowledge that avoids patent infringement. Scientists, instead of sharing their discoveries in a timely fashion, are protecting them as trade secrets. This has resulted in wasteful duplication of research, not for the sake of verifying results, but rather for establishing the unpublished data needed to secure intellectual property rights over the discovery. Writing in Science, Eliot Marshall noted, ‘[w]hile some duplication is normal in research, experts say it is getting out of hand in microbe sequencing. Tuberculosis, like Staph aureus and H. Pylori will be sequenced many times over in part because sequencers aren’t sharing data, whether for business reasons or because of interlab rivalries.”
Scientists have absorbed a new, profit-motive respecting value system

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “The Profit of Scientific Discovery and its Normative Implications,” The Chicago-Kent Law Review, Vol. 75 (1999), p. 27-28

“The implications of the new financial opportunities in molecular genetics were profound because they contributed to a new set of relations between scientists and their work. First, the time lapse between scientific discovery and commercial use, which had traditionally buffered scientists from the lure of pecuniary affairs, was now very short. This meant that almost any discovery of a new gene had potential commercial value. Second, scientists internalized a new set of values. Added to the traditional value in academia of the ‘pursuit and dissemination of knowledge’ was the responsibility to use that knowledge for the development of marketable products. A new ethos emerged in the biological sciences that meant balancing interests between two independent and potentially conflicting premises. The first states that knowledge is part of the common human heritage, while the second treats knowledge as possessing economic value that should be realized.”
Business ties reinforce biases

Deborah Runkle (staff writer), “Conflicts of Interest in Science,” Science, December 1, 1989, p. 1117

“But conflicts of interest potentially affect most members of the research community. By encouraging cooperation, the government has, ironically, also been encouraging scientists and their institutions to form relationships that can lead to personal or institutional conflicts, can bias research, and can lead to loss of the public’s confidence in research conducted with public funds.”
Bias distorts the scientists’ results

Reuben Abel (prof. of philosophy, New School for Social Research, New York City), Man Is The Measure, 1976, p. 121

“On an elementary level, of course, such considerations of bias are obvious: an anthropologist who is a fascist is more likely to ‘prove’ the inferiority of the colored races than one who is nonpolitical; experimenters working for tobacco farmers are less likely to find a correlation between cigarette smoking and lung cancer than scientists employed by a consumers’ organization.”
Industrial ties destroy the disinterested expertise needed for wise policy decisions

Deborah Runkle (staff writer), “Conflicts of Interest in Science,” Science, December 1, 1989, p. 1117

“There is also concern that America is losing the cadre of disinterested scientists who can advise on a wide range of technical dilemmas and decisions facing American policy-makers and the electorate. Advisory committees to the federal government have a hard time finding knowledgable technical advisers who are not also employed by relevant industries, or who do not receive income through consulting arrangements.”
Ties between science and commerce will erode public confidence

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “Science on Trial: Conflicts of interest jeopardize scientific integrity and public health,” Gene Watch, Vol. 16, Number 5: September-October 2003, p. 5

“Two other changes are likely as the partnership between corporations and universities expands. First, the public’s trust in the integrity of academic science will decline. Universities and their faculty will be viewed as just another set of special interest groups. This was the reaction of the citizenry toward some members of the University of Pennsylvania faculty after the death of Jesse Gelsinger, who volunteered as a subject in a human gene therapy experiment. When it became known that the chief clinical investigator of the trial and the University of Pennsylvania had equity in a biotechnology company seeking to profit from the experiment, the Gelsinger family sued the university. One of the grounds for the suit was the financial conflict of interest held by the university and the clinical investigator.”
Conflicts of interest appear to affect the conclusions presented in scientific research

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “When Conflict-of-Interest is a Factor in Scientific Misconduct,” Medicine and Law, Vol. 26 (2007), p. 460-461

“Research into the relationship between the funding of science and the outcome of research findings were not undertaken prior to the mid-1980s. By the 1990s, because of a growing interest in conflict of interest, a number of published studies revealed the existence of the funding effect in biomedical research. Let’s take a few examples. The best predictor of whether a review article came out positively or negatively on the hypothesis that there are health effects from passive smoking was whether the author had a conflict of interest. That factor weighed more heavily on the conclusion than the quality of the review. In the field of nutrition, authors who studied the relationship between author association with food companies and their position on the fat substitute olestra found that 96 percent of the nutritionists who supported olestra, compared with 50 percent of neutral authors and 44 percent of critical authors, had financial relationships with at least one company in the food and beverage industry. In a study of studies in the biomedical sciences, Bekelman et al. found that the outcome of scientific studies can be influenced by COI relationships. The authors concluded, ‘Evidence suggests that financial ties that intertwine industry, investigators, and academic institutions can influence the research process. Strong and consistent evidence shows that industry-sponsored research tends to draw pro-industry conclusions.’ In another study illustrating the funding effect Stelfox et al. found ‘a strong association between authors’ published positions on the safety of calcium-channel antagonists and their financial relationship with pharmaceutical manufacturers.’ Similar illustrations of the funding effect have been found in other drug efficacy and safety studies including randomized drug trials, as well as studies of addictive behavior, secondhand smoke, new-versus old therapies, meta-analyses, nutrition and climate change.”
Corporate interests breed secretiveness, destroying scientific openness

Claire Nader (science policy consultant), “Technology and democratic control: The case of recombinant DNA,” in The Gene Splicing Wars: Reflections on the Recombinant DNA Controversy ed. by Raymond Zilinkas and Burke Zimmerman, 1986, p. 147

“Corporations thrive on secrecy, assertedly in the name of competition. As commercialization of RDNA technology accelerates, corporate trade secrecy will dominate even further the tradition of open communication in science. ‘Scientists who once share prepublication information freely and exchange cell lines without hesitation are now much more reluctant to do so,’ noted Stanford University president Donald Kennedy several years ago.”
Industrial ties negate basic research

Deborah Runkle (staff writer), “Conflicts of Interest in Science,” Science, December 1, 1989, p. 1117

“Some also argue that American academic and government science is no longer conducted in a spirit of wide-ranging intellectual curiosity. Instead, they say, large industry investment can force laboratories to become job shops, solving practical commercial problems rather than pursuing the basic research for which American universities have been noted.”
Money corrupts open research

Deborah Runkle (staff writer), “Conflicts of Interest in Science,” Science, December 1, 1989, p. 1117

“Some critics, for example, fear that the large financial stake that industry now has in American universities is irretrievably compromising the laudable goal of open research that has been a hallmark of academic science.”
Existing rules against conflicts of interest are insufficient

Eliot Marshall (staff writer, subsequently deputy news editor), “When Commerce and Academe Collide,” Science, April 13, 1990, p. 156

“Representative Weiss says that while he ‘applauds’ the AAMC and AAHC for developing conflict-of-interest guidelines, they do not go far enough. He favors ‘strong minimum standards for all research institutions.’ Unless everyone plays by the same rules, Weiss says, ‘universities that make serious efforts to minimize conflicts of interest could be at a disadvantage in recruiting scientists who enjoy lucrative financial relationships with the private sector.’”
Conflict of interest (COI) policies are widely ignored in science publications

Sheldon Krimsky (Dept. of Urban and Environmental Policy at Tufts University) and L.S. Rotherberg (Dept. of medicine, Univ. of California at Los Angeles), “Conflict of Interest Policies in Science and Medical Journals,” Science and Engineering Ethics, Vol. 7, #2 (2001), p. 210

“Our survey of journal editors reveals that the vast majority usually publish author disclosure statements suggesting that low rates of personal financial disclosures are either a result of low rates of financial interest (nothing to disclose) or poor compliance among authors to the journals’ COI policies. Based on the previously mentioned pilot study, higher disclosure rates in the template journals, and the growth of commercialization in the biomedical sciences, we believe that poor compliance is the more likely explanation for low disclosure rates in most journals with COI policies.”
Pharmaceutical companies have incentives to arrange for ghost written articles

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “When Conflict-of-Interest is a Factor in Scientific Misconduct,” Medicine and Law, Vol. 26 (2007), p. 450

“For a company, let us say a drug company, the incentive to find a ghostwriter is to have a prominent scientist support the company’s product in a professional publication (medical journal), including a commentary or editorial. When a drug is being considered for off-label use, the manufacturer is prohibited from promoting such use before the drug has been approved by the Food and Drug Administration (FDA). But a scientist or physician can support its use without the same restriction. By orchestrating ghost-written papers, companies can get publicity for off-label uses of drugs without violating the law. They simply craft an article, hire a company to find a willing scientist, and find a journal that will publish it.
Ghost authorship is commonplace

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “When Conflict-of-Interest is a Factor in Scientific Misconduct,” Medicine and Law, Vol. 26 (2007), p. 451-452

“After an investigation into the practice of ghostwriting, the British newspaper The Observer reported ‘hundreds of articles in medical journals claiming to be written by academic doctors have been penned by ghostwriters in the pay of drug companies.’ Ghost writers, once used in journal supplement articles paid for by companies, have now become commonplace in mainstream journals. The signatories of the articles frequently do not even see the raw data about which they are writing. Cullen explained how the process of soliciting ghost writers works in his field of anesthesiology where potential phantom writers are screened and sent letters asking them to sign a pre-written paper. Flanagan et al. surveyed authors from randomly chosen list of 1,179 articles. Questionnaires were returned by 809 corresponding authors, of which 93 responses (11%) indicated that ghost authorship had occurred. Another study published in PLOS Medicine reported a high prevalence of ghost authorship in industry-initiated clinical trials in Denmark.”
The recombinant DNA business demonstrates industry domination

Claire Nader (chairperson, Council for Responsible Genetics), “Technology and democratic control: The case of recombinant DNA,” in The Gene Splicing Wars: Reflections on the Recombinant DNA Controversy ed. by Raymond Zilinkas and Burke Zimmerman, 1986, p. 149-150

“Over 150 firms are now in the business of designing microorganisms for industrial uses. Past experience tells us that in the absence of strong, full-time public involvement and adequate government health and safety standards, corporate interests will prevail over the general interests of the citizenry.”
The 1988 TPA ethics issue is a case study in conflicting interests

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “The Profit of Scientific Discovery and its Normative Implications,” The Chicago-Kent Law Review, Vol. 75 (1999), p. 31

“As an example, in 1988, a federally-sponsored study published in the Journal of the American Medical Association reported that an anticlotting medication to prevent heart attacks-called tissue plasminogen activator (‘TPA’), which is manufactured by Genentech, was significantly more effective than the drug currently in use called streptokinase. Subsequently, it was reported widely in the print media that some of the study’s investigators were long-term Genentech stockholders. A journal that prided itself in its ethical standards for its contributors was criticized harshly for not disclosing the authors’ conflicts of interests.”
The tobacco industry demonstrates the risks and failures of current conflict-of-interest policies

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “Science on Trial: Conflicts of interest jeopardize scientific integrity and public health,” Gene Watch, Vol. 16, Number 5: September-October 2003, p. 3-4

“The poster child for scientific conflict of interest is the tobacco industry. Reports from the World Health Organization (WHO) and documents released during discovery from the multi-state tobacco litigation showed an industry that bought its research from academic centers and well-financed scientists to further its interests in obfuscating studies linking cigarettes to lung cancer and other diseases and in subverting the WHO’s efforts to control tobacco use. Among the activities used to create its own science, the tobacco industry secretly funded speakers at WHO conferences, created quasi-scientific front organizations, established an ostensibly independent coalition of scientists, rewarded scientists at prestigious universities for critiquing epidemiological and toxicological studies on tobacco smoke, and held scientific symposia to support pro-industry positions. A similar strategy of industry-corrupted science continued after public health scientists began linking second-hand smoke and lung cancer.”
Scientific advisory committees have conflict-of-interest problems

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “Science on Trial: Conflicts of interest jeopardize scientific integrity and public health,” Gene Watch, Vol. 16, Number 5: September-October 2003, p. 5

“The U.S. Federal Advisory Committee Act (18 U.S.C. Sec. 203) prohibits a person from serving on an advisory committee if that individual has a financial interest in the subject matter under discussion and if the particular matter will have a ‘direct and predictable effect on that interest.’ That is the first of two rules. The second rule is that Rule #1 can be waived. And waivers for advisory committee members are given quite liberally. In 2000 an investigative report published in USA Today revealed that ‘more than half of the experts hired to advise the government on the safety and effectiveness of medicine had financial relationships with the pharmaceutical companies that will be helped or hurt by those decisions.’”
Rules to disclose conflicts of interest only serves to make them acceptable

Sheldon Krimsky (Professor, Department of Urban and Environmental Policy, Tufts University), “Science on Trial: Conflicts of interest jeopardize scientific integrity and public health,” Gene Watch, Vol. 16, Number 5: September-October 2003, p. 5

“In response to the rising tide of such conflicts of interest, scientific journals, government, universities and professional societies are looking toward transparency as the universal antidote. However, the trend toward disclosure rather than prevention unfortunately will legitimate the multi-vested roles of scientists and their institutions.”



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