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Abstract

Commercialism has become almost synonymous with an overemphasis on maximizing proﬁt. In a highly competitive world, bioscientiﬁc companies invariably seek patent protection to safeguard their intellectual property, recoup investment, and achieve a proﬁtable return. Such businesses are keen to exploit the discoveries of scientiﬁc research for commercial advantage and proﬁt and progressively look more and more toward academic science to enhance or extend in-house capability.

The relationship between industry and academia can be mutually advantageous, but there may also be conﬂicts of interest and ethical concerns. While academic science is conducted in an atmosphere of openness, both to advance knowledge and career and to permit scrutiny and independent validation, the business world is traditionally highly secretive, particularly regarding research programs and company “know-how.” Big Pharma and associated companies have a vested interest in the positive outcome of clinical and toxicological studies that support product registration and sales, and their research programs are also inclined to neglect “rare” diseases or those predominantly affecting poorer countries. Scientists in the universities should be scrupulously aware of the ethical challenges endemic in the business world and not solely the opportunities that relationships with commerce may introduce. While vigilance to prevent deleterious inﬂuences is essential and ongoing, there are opportunities for the universities not only to contribute more directly and more urgently to the development of new medicines but also to inﬂuence the selection of therapeutic disease topics for research (speciﬁc demographic population, disease, or health issue). Closer links between universities and commerce to improve equitable access to medicines globally, perhaps through a system of open licenses, would contribute markedly to the global common good.

Introduction

Science almost continuously reveals new possibilities and extends our knowledge of the material world including potential for therapeutic and prophylactic intervention. After discussing the nature of commercialism and proﬁt-based motivation, the need for continuous innovation in bioscientiﬁc companies, and the patent system, the key factors relating to the association between academic science and business are reviewed. Conﬂicts of interest may arise because of the competing goals of science and those of industry and the differential power relationships. Nevertheless, there may be opportunities for academia to ensure that the fruits of academic science are more beneﬁcially and universally employed to assist commerce for the common good.

The Nature Of Commercialism

No market system in the world operates entirely freely. All countries without exception are constrained by market controls, through legislation or by other governmental means. Nevertheless, despite these limitations, markets operate by and large efﬁciently, on the basis of relatively free active competition and competitive supply and demand. Innovation to provide new products can make an important and sometimes vital difference to company prosperity and may also provide novel pharmaceuticals, bioactive compounds, or other welfare beneﬁts for mankind. The assumption that corporate capitalism has become a prime mover and dominant force in bioscientiﬁc research and especially in drug development is beyond question.

And if we are to employ a term that describes the attitude and conscious awareness of the importance of innovation and proﬁtability in a commercial enterprise, it is commercialism. Although some will disagree, it is probably fair to argue that commercialism, the entrepreneurial drive to seek out advantageous trading opportunities has been the primary motivational force that has inﬂuenced progressive economic prosperity throughout history, and particularly, though not solely since the time of the European industrial revolution. There is undoubtedly widespread poverty and global economic disparity in the market place. These factors have a signiﬁcant inﬂuence on the availability of all commodities including those associated with health care. Both governments and relevant pharmaceutical and other bioscientiﬁc companies have a responsibility and role to play in ameliorating these issues wherever possible.

Although some English language dictionaries indicate that commercialism can mean the basic spirit, principles, or procedure of commerce, there is perhaps a common perception that commercialism relates to the activities or attitudes of people who think that making a proﬁt is more important than anything else and may lead to unethical or highly questionable behavior. And commercialism has progressively become synonymous with an (over)emphasis on maximizing proﬁt; and activities to which the term is applied are frequently perceived disapprovingly. This is often associated with widespread concerns about the commodiﬁcation of knowledge for corporate proﬁt and especially the patent system, and the failure to pursue morally worthy but ﬁnancially low return undertakings. Milton Friedman’s 1962 assertion that the social responsibility of business is to increase its proﬁts no longer reﬂects, if it ever did, the majority of businesses which increasingly take corporate social responsibilities very seriously. However, such social responsibilities are understandably constrained and tied to company proﬁtability or its limitations.

The Need For Innovation And Contribution Of Science

Many commercial businesses not only thrive but are highly dependent on continuous innovation. In the twenty-ﬁrst century, a business that stands still without new markets or an innovative product portfolio is effectively moribund and ripe for takeover or decline. New or improved products or other means of market expansion attract customers and are necessary in an age of intense competition, rapid communication, and consumer awareness of obsolescence and change. Innovation is also indicated where there is an apparent unfulﬁlled need, where nothing meets a perceived requirement or at best, does so inadequately, representing a market opportunity. Industries such as aerospace, communication, agrochemical, engineering, pharmaceutical, and other biosciences employ large numbers of in-house scientists and technologists in the search for and validation of products which can sustain or extend the company’s business portfolio. And it is important for businesses to be perceived as cutting edge. According to Baumol (2004, pp. 1–2), “Under capitalism, innovative activity – which in other types of economy is fortuitous and optional – becomes mandatory, a life-and-death matter for the ﬁrm. .. .Whatever the deﬁciencies of the free market, it is certainly very good at one thing: the manufacture of economic growth. .. .The free market, once the institutional impediments to its development had been reduced sufﬁciently, just grew by itself and by itself became the machine that generates innovation and dramatic growth in profusion.”

Since the early part of the twentieth century, there has been a progressive shift in the application of scientiﬁc research toward commercial ends. And the business world is also acutely aware of the need to seek out potential beyond intramural activities, looking more and more toward universities to supplement or enhance in-house searches for scientiﬁc innovation. Academic institutions have become acutely aware of both the potential and even the necessity of achieving a ﬁnancial return to remain solvent or to expand activities but are also increasingly conscious of pitfalls. The practice of undertaking scientiﬁc research on behalf of commercial companies under contract is now widespread among universities and links with commercial partners are actively pursued. Many “entrepreneurial” universities have internal units that keenly seek to generate potential products or processes that can be licensed out or to harness the ﬁnancial beneﬁts of serendipitous discovery through spin-off enterprises. There is no longer clear water between academic science and commercial science.

The Nature And Goals Of Science

The goals of science are generally taken to be the expansion of knowledge and to aid understanding of the world. Merton (1973) proposed four scientiﬁc norms which he argued generally guide and stimulate scientiﬁc practice: communism (more properly understood as communalism), universalism, disinterestedness, and skepticism. Implicit in these Mertonian norms is an expectation (as formulated by J. D. Bernal) that science should be open and secrecy ﬁrmly rejected. This is reﬂected in the practice of universities and scientiﬁc establishments encouraging publication of detailed scientiﬁc methodology and results, that are transparent and open to peer review and, importantly, to validation or falsiﬁcation. Such openness also contributes to a scientiﬁc commons, a massive, continuously expanding, and accessible broad database that fosters potential for extension and further innovation. At the same time, the authors of research are able to establish and contribute to personal scientiﬁc reputation and career progression. For Merton (1957, pp. 639–640), “scientists are motivated by a priority recognition reward system, which encourages scientists to share their ﬁndings and thereby contribute them to the common stock of scientiﬁc knowledge, in exchange for recognition by the scientiﬁc community for this contribution, through citations, prizes and other markers of esteem.”

But not all research is open as Bernal envisaged. The twenty-ﬁrst century and second half of the twentieth century are characterized by a tremendous growth in knowledge, particularly with the possibilities of manipulating genetic materials, and in the creation of novel pharmacotherapeutic substances (the biosciences), but also and especially in electronics and computer software which have themselves facilitated an ability to transmit and access knowledge. Rights to property have been recognized in most societies for hundreds of years. The patent system is an integral and vital part of free-market capitalism and patents now operate on a virtually global though somewhat differential basis. A patent is an institutional device issued and administered by a government agency that confers the right to exclude others from making, using, selling, importing, or offering to sell an invention claimed in the patent without express permission. That right, essentially protecting a company’s intellectual property, is enforceable by national and, sometimes, by international courts. Thus, possession of a patent entitles the holder to a period of temporary exclusivity, a transient monopoly effectively blocking would-be copyists in exchange for full disclosure. Jaffe (2007, quoted in Lehman 2009, p. 87) importantly emphasizes that “Whilst creativity is inherent in human nature .. .it does not help society unless it is taken further and converted into a commercially useful new product or process, and this stage of converting inventive ideas into real products is very costly and uncertain. The economic function of the patent system is to provide a measure of predictability and protection to this expensive process of product and process development. As such, it lies at the heart of technological progress, which is in turn the primary engine of economic growth.”

There are three indispensable and ostensibly uncontentious requirements for patentability: (1) novelty, (2) inventiveness or nonobviousness, and (3) industrial potential or utility. Patents, patent C procedures, and rules are generally similar throughout the world, but there are sometimes important national differences, and patents are often a source of controversy regarding novelty and inventiveness or indeed whether some fundamental “life-related” knowledge should be excluded from the patent system. In recent years, patent applications relating to genomics and human genetics have come to the fore. These proliferated greatly during a period of intensive activity following Crick and Watson’s seminal discoveries on the structure of DNA in 1953. Considerable funding was employed from governmental, nonproﬁt, or commercial sources. Cook-Deegan and Heaney (2010, p. 6) indicate that “Human genetics and genomics differ from many other ﬁelds of research and development (R%26D) in the nature of the downstream products and in a strong general interest in and concern about how the science is done, how it is applied, and how fairly its beneﬁts are distributed. .. .Ownership of data, materials, and control spill over into Who owns this? questions that are more pointed with reference to genes than for computers or cell phones.” Such biotechnological patents, procedures, their application, and interpretation are incredibly complex and often require specialist knowledge. Some have queried just whether all genetic components, natural or derived, should be deemed non-patentable. Indeed patents in the biotechnological domain raise questions not simply about ownership rights as such, but about the implications for the variety of cultural and communal values around the world.

Yet, a key ethical question in this highly sensitive arena of the fundaments of life remains. How are the extremely high levels of funding for potentially transformative genetic research both in academia and industry to be recouped without resort to substantial commercialization and patent protection?

Have Concerns About Commercialization And Academic Scientific Research Been Set Aside?

Disquiet about commercial application of scientiﬁc research is not new; neither is the concept of the special open nature of innovation and discovery in universities. According to Feldman and Desrochers (2001), Johns Hopkins University was established as the ﬁrst American research university in 1876, dedicated to the norms of open science. Commercial interests were not permitted to inﬂuence research agendas, and potential patentability or licensing considered anathema. These proscriptions did not inhibit the chemist Constantin Fahlberg, a visiting postdoctoral fellow at Johns Hopkins who inadvertently discovered saccharin, the ﬁrst artiﬁcial sweetener in research undertaken during his tenure. Fahlberg obtained both US and European patents and, returning to his native Germany, undertook highly lucrative large-scale manufacture with commercial and ﬁnancial success. Neither the role of Johns Hopkins University nor his colleague Remsen was ever acknowledged. Throughout the twentieth century, transformation of the discoveries of academic science into commercial products became increasingly commonplace, subsequently leading to the establishment of university-funded science parks and preparedness to pursue spin-offs and patenting or licensing directly. Proﬁts achieved by these academic extension activities have become an important, though sometimes controversial, source of income for universities.

It is undoubtedly the case that links between academia and commercial organizations have become progressively more widespread and commonplace, particularly in the biosciences. So what’s the harm? There have been increasing concerns about conﬂicts of interest and related ethical issues, and that “cozy” relationships with industry might impair or “color” academic decisions concerning selection of research topics and direction. More seriously still, there is evidence that academic scientists have been cited as authors in clinical publications substantially or signiﬁcantly authored by industrial concerns (ghostwriting) and which are favorably disposed to a company’s own product and that publications which demonstrate adverse effects or insigniﬁcant therapeutic beneﬁts suppressed. Smith (2012, p. 499) indicates that “The pharmaceutical industry has gained unprecedented inﬂuence over the conduct of clinical evaluation and an “overriding interest (in) accountability to shareholders .. .The only way of effectively eliminating the problem (of undue inﬂuence) is by separating or putting at arm’s length clinical research from pharmaceutical industry funding.” Krimsky (2003, pp. 215–231) strongly advocates reinvestment in public interest science, restoration of the universities’ unique role and status, greater emphasis on the social value of academic freedom, and reestablishment of traditional roles and boundaries. The question that remains largely unanswered is who is to fund the huge costs of early-/ middle-stage development and clinical evaluation to meet increasingly demanding regulatory standards, if not Big Pharma?

It is undoubtedly the case that there is a risk that commercial interests have sometimes used their considerable inﬂuence and clout to manipulate people and results. There can be no excuse for falsiﬁcation or manipulation of results to advantage, particularly where the results of the study are used to support a drug regulatory application or clinical regime. Scientiﬁc integrity, honesty, and transparency are essential elements of all research, but above all in health care. This applies equally within companies themselves and to academic associates. And it is probably in the contrasting spheres of secrecy (companies desire to protect and optimize their interests) and openness (transparency a fundamental scientiﬁc criterion) that conﬂicts of interest are most acute. Bok (1982, p. 40) laments the fact that scientists have failed to confront the question of “how can secrecy be contained or eliminated when unwarranted, and yet strengthened in the narrow regions where it is needed?” And commercialism requires that not just in-house scientists but also academic scientists are bound by secrecy.

Science And The Commercial Wind Of Change

A central question that can be posed is whether it is time to challenge or to review the familiar perception that scientiﬁc research in universities is necessarily and should remain exclusively disinterested and curiosity driven alone. There is an assumption that these widely acknowledged essential characteristics of open science which have an aura of being virtuous should be strictly preserved from outside inﬂuences at risk of compromising a vital and indispensable ethos. Doubtless, there is a case to be made that the fundamental aim of academic scientiﬁc research should be solely to contribute to an evolving corpus of scientiﬁc knowledge, broadly complying with Mertonian norms of communalism, universalism, detachment, and skepticism. Research results should be freely accessible, be open to scrutiny and falsiﬁcation, and remain entirely indifferent to potential application and utility beyond the scientiﬁc domain. Academic pursuits should be inherently curiosity driven and not sullied and contaminated or possibly corrupted by commercial considerations, nor should serious scientists be deﬂected from selﬂess focused pursuits.

And indeed, as indicated, close links with the business world can be problematic for academic scientists. Brownlee (2015) argues that there is a fundamental antagonism between industry and academia. He claims that multinational corporations such as Big Pharma have increasingly and adversely affected university research and tarnished its image. Indeed, provision of research funding with strings may compromise academic research. On the other hand, no strings funding from the public purse, or independent donations, may not provide the best value or outcome in contributing to a common good. It remains curious that so much university research is not inclined toward potential application, perhaps perceived as standing somewhat arrogantly aloof from such mundane matters, almost sine qua non.

Certainly, an overly slavish adherence to the traditional norms of academic science may be disadvantageous and outmoded. Sonnert (2002) suggests that the ivory towers of academia are already becoming replaced by “ivory bridges,” linking academia with the commercial world. And it is increasingly apparent that the nineteenth-century view of academic scientiﬁc research operating within a metaphorical ivory tower is no longer seriously maintained in the round, if indeed such views were ever held other than by the minority. It can be argued that areas of research, both academic and commercial, exist or should exist to serve the general public, albeit in markedly different ways. Academia also provides an established thorough training ground and exploratory in methodology and research techniques for young scientists. Where academic research does have a decided advantage is that it’s very freedom and being relatively untrammeled, albeit often with severely constrained ﬁnancial resources, may lead to wholly unexpected, serendipitous, and valuable discoveries. The pursuit of intellectually challenging problems may lead to discoveries that can trigger paradigmatic shifts in both fundamental scientiﬁc understanding and, ultimately, commercial innovation.

The general expectation for scientiﬁc research, both academic and industrial, is that the work should be undertaken responsibly and in an intellectually rigorous manner. All work must be performed with honesty and integrity and recorded in a method that permits independent assessment of methodology, results, and experimental replication. Science sets exacting standards and most branches publish ethical guidelines for practitioners. There is justiﬁable concern that free association between pharmaceutical and other bioscience companies with academia risks conﬂict of interests and there are numerous examples of willful misbehavior or misconduct such as falsiﬁcation, suppression or selective release of data, misrepresentation, or fabrication of claimed facts. But this calls for vigilance not embargo. The European Medicines Agency has consulted on policy concerning publication of and access to clinical trial data (summary report May 2014) which may resolve or at least alleviate the problem of industry suppressing unsupportive study results.

Special Considerations Regarding Commercialism And Scientific Research In Emerging And Economically Less Developed Countries

It has been argued that the underlying ethical duties and responsibilities of all scientists are universal, encompassing justice, fairness, honesty, integrity, and the need for authentic informed consent where relevant. What differ to a smaller or greater extent are the particular local or national contexts in which research is conducted and a need for nonindigenous researchers and marketeers to be aware of and sensitive to local legal, cultural values and religious distinctiveness. For instance, Benatar (2002, p. 1132)) advises that “When those in privileged positions and in wealthier countries consider undertaking collaborative research in developing countries it is necessary to understand both their own framework of thinking, and the implications of very different mind-sets and environments in which research projects may be carried out in developing countries. Their own, Western mind-sets and ethical research framework are most probably characterised by a biomedical approach to disease, and a neoliberal approach to economics and trade. There is a need to be sensitive to the fact that not all, especially those who are disadvantaged or who have been exploited, will see the world through the same lenses .. ..” Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries identiﬁed three components of a “fair beneﬁts framework”: fair and tangible beneﬁts for research participants and the population, a truly free and uncoerced collaborative partnership, and complete transparency with publically accessible repository for all agreements (El Setouhy et al. 2004). Of particular concern is “… the increasing participation of poor and low-income countries in transnational clinical trials .. .targeting diseases that affect mainly patients in the sponsoring (Western) countries” (Lorenzo et al. 2010, p. 111). Clearly, employing trial participants in countries with a low incidence of a particular disease is unlikely to reﬂect “a fair and tangible beneﬁt” for those involved. Undertaking clinical evaluation automatically incurs profound responsibilities and obligations. All participants in clinical evaluations are stakeholders by virtue of their participation and have a vested interest and expectation of tangible beneﬁt for themselves and/or their community.

There is a related serious concern. Even if trials are successful and clinically relevant, early commercial availability of any resultant marketed product in poor and low-income countries is most unlikely given very high prices set in the dominant domestic Western markets. Western companies are reluctant to allow differential pricing and supply to beneﬁt poor and low-income countries because of the risk of reexport as lower-cost competitors in Western markets (parallel imports). Furthermore, although there are notable exceptions, multinational pharmaceutical or other bioscientiﬁc companies are generally disinclined to devote resources and to undertake research on diseases which are mainly or almost exclusively those of poor and low-income countries because of the improbability of recovering investment. This is at variance with UNESCO-declared objectives in the Universal Declaration on Bioethics and Human Rights and the Declaration of Helsinki.

The patent system and the proﬁt-driven capitalistic economy are often seen with some justiﬁcation as major obstacles in a failure to redress global health inequalities. The mainly Western research-based multinational pharmaceutical companies have made major contributions in the ability to treat a wide range of common and sometimes life-threatening diseases. Yet, as Kapczynski et al. (2005, p. 1032) stress: “Each year, millions of people in low and middle-income (LMI) countries die from preventable and treatable diseases. AIDS provides one of the starkest examples: it killed more than three million people in 2004 and has become the world’s leading cause of death for adults aged 15–59. These deaths continue despite the fact that we have known for years that antiretroviral combination therapy (ARVs) can substantially improve the lives of those living with HIV/AIDS and even reverse the tide of death associated with the disease.”

There are undoubtedly massive differences in health care both qualitative and quantitative between the afﬂuent countries of the West and major emerging economies and heath care available in poor and low-income countries. Only a small proportion of global scientiﬁc research and development for new drugs and associated matters is devoted to the health-related problems of the vast majority of the world’s population. Nevertheless, it is probably unreasonable to expect that Big Pharma companies acting individually and independently would deviate markedly from their traditional approach focusing on research likely to lead to proﬁtable medicines. Some companies, however, have successfully targeted a number of tropical diseases as a relatively small though valuable part of their overall research portfolio, and charitable foundations are important donors in funding such work.

In their comprehensive review of global health inequalities, and barriers to progress, Kapczynski et al. (2005) indicate approaches and innovations that universities might employ such that their increasingly key role in the research process for new medicines is no longer routinely consolidated into and subverted by the Big Pharma proﬁt-based model. The authors advocate that universities pursue “commons-based initiatives” and a system of “Equitable Access Licenses” for their research as part of a model to change practices and to challenge the exclusivity-based pricing that impedes access to the developing world. “By collectively adopting such an agenda, as well as clear and binding policies governing the use of these approaches, universities can maximize their joint potential to close the R%26D and access gaps and improve the lives of people living in LMI countries. .. .The opportunity to prevent these deaths is a worthy goal for the community of scientists and universities to pursue, and to pursue together” (Kapczynski et al. 2005, p. 113).

The principal challenge for commercialism and scientiﬁc research is to maximize mutual beneﬁts and to chart a path ensuring safer and more effective medicines globally, in a continuously evolving and far from equitable world.

Conclusion

Both academic scientiﬁc research and industrial scientiﬁc research bring new possibilities to light, but only commerce can harness those possibilities and successfully bring them to the market. The relationship between academia and business is becoming ever closer and promises to enhance progress in the bioscientiﬁc world. The familiar incompatibility between openness and secrecy is not an insurmountable barrier, though conﬂicts of interest may arise because of the competing goals of science and those of industry and signiﬁcant power disparities. Nevertheless, there may be opportunities for academia to ensure that the fruits of academic science are more beneﬁcially and universally employed to assist commerce for the common good.

While vigilance to prevent harmful inﬂuences is essential and ongoing, there are opportunities for the universities not only to contribute more directly and more urgently to the development of new medicines but also to inﬂuence the selection and targeting of therapeutic domains both medical and in respect of geographical region. There is a growing recognition and expectation that companies have a far greater responsibility toward society and to all stakeholders than simply harnessing research and the opportunities of supply and demand and pursuing maximum proﬁtability. Closer links with universities to improve equitable access, perhaps through a system of open-licensed university discoveries, would contribute markedly to the global common good.

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