Commercialization of Scientific Research and its Social Ramifications

Jane Kwon
University of Washington

Commercialization of Scientific Research and its Social Ramification

Over the years, scientific research has led to advances in technology and medicine, from
the development of flu vaccines to information transfer through internet. Many researchers are
publically funded through the National Institutes of Health (NIH), which invests about 30.1
billion dollars annually (NIH Budget, 2014). In 1980, the Bayh-Dole act was passed to enable
patent and commercialization of federally funded research, in hopes of providing economic
incentives, encouraging further research and development, and returning the outcomes of
research back to the society (Schacht, 2006). While the objectives of the Bayh-Dole Act were
met, Congress did not anticipate the impact of the Act on the culture of scientific research. The
Act increased competitiveness, led to more conflicts of interest between academia and industry,
shifted the focus of scientific research on financial incentives, and put more emphasis on
applicable research than basic science research. This can detract the field of science from
pursuing knowledge and advancing our society to focus more on profit and less emphasis on
creating positive social impact.
The objective of the Bayh-Dole Act is to encourage productive research and development
by enabling the commercialization of research innovations. Currently, most of the research
funding relies on federal budget. With limited resources and the recent economic downturn,
encouraging private industries to invest in scientific research will help expand the capacity of
scientific research. Since the Act, there had been a significant increase in business and corporate
funding of university research by 74 percent (Schacht, 2006). Not only did the Bayh-Dole Act
allow increaseding funding of scientific research, it also led to increased collaboration between
the University and business, which allowed technology transfer between two sectors. Also,
commercialization of federally funded research can lead to greater outreach to the public,
maximizing the return of investment to society (Loise & Stevens, 2010). The initial goal of the

Commercialization of Scientific Research and its Social Ramification

Act has been met, as there are increasing collaborations between academia and industry, and
more technology [ such as1-2 brief examples of products developed through univ/industry
partnerships] are affordable and available for consumers.
Despite the success of the Bayh-Dole Act in incentivizing and increasing cooperation
between academia and industry, one must consider the unintended consequences of the BayhDole Act. Such joint research endeavors have led to increased opportunities forof conflicts of
interests (Schacht, 2006). Conflicts of interests arise when financial incentives or personal
relations or commitments play a role in research design and analysis, and usually occur due to
differences in values between the stakeholders. Traditionally, academic research focuses on
education and public service, while industries main goals are to generate profit through
commercialization. Since the passing of the Bayh-Dole Act, the line between academia and
business has been blurred. The social implication driven by the focus on the commercialization
of scientific researcher includes: increased competition, publication bias, and a shift toward
applied research, rather than basic science research (Schacht, 2006).
The difference in goals of scientific research in academia and industry leads to conflicts
of interest. One study suggests that 35% of biotechnology researchers experienced delay in
research, due to difficulties when using patented technology for research (Bayhing for blood or
Doling out cash?, 2005). The Supreme Court case, Association of Molecular Pathology v.
Myriad Genetics, is a perfect example. Myriad Genetics patented the BRCA1 gene and
BRCAnlysis, for breast cancer diagnostics in 1994, and were granted exclusive use of the
BRCA2 gene in 2003 (Norrgard, 2008). By patenting and commercializing these genes, Myriad
Genetics halted further scientific research by charging 3,120 dollars for genetic screening used
for research and diagnosis (Norrgard, 2008). In contrast to the objectives of the Bayh-Dole Act,

Commercialization of Scientific Research and its Social Ramification

which was to create greater dissemination of scientific research, gene patenting led to limited
access of resources created by scientific research. The focus on economic incentives
overshadowed the goal of scienceto advance the society through dissemination of knowledge.
Patenting provides an avenue for researchers to take ownership of their innovations, and
to make profit. By giving patent licenses, scientists are protected under patent law to exclude
others from using and making profits of their findings. Also patents are also useful in creating
transparency in research. Along with publications, research results are being publicly available,
which leads to further research development, while regenerating revenues. However, despite the
intent of patents, many scientists disagree that patents have positive impact in their research
fields (Lei, Juneja, & Wright, 2009). Commercialization of research tools has forced scientists to
shift their focus toward financial gains and contracts with the private sector. This may forbid
academic scientists to pursue innovative research, if it deems to be too risky and its financial
outcome is not guaranteed. Many scientists view licensing of patents as a burden in academic
freedom, which can delay research progress or narrow the scope of research. While the
commercialization of research can encourage further innovations, it also has potentials to limit
the types of innovations being produced.
The focus on economic incentives also led to increased competition between researchers.
The commercialization of research encourages scientists to become more innovative and be the
first in their field to make new discovery. By making a novel discovery, a scientist gains
prestige and reputation in the field that he works in, which brings in funding for further research.
In order to keep research funded, scientists must keep publishing and compete with each other to
further discovery in their fields. While this may sound like a healthy competitive nature, the
focus on success and publication can obscure research integrity. The 1990 Hood Lab scandal in

Commercialization of Scientific Research and its Social Ramification

Caltech illustrates how competitive nature in scientific research can lead to research misconduct
(Roberts, 1991). Two research fellows, Vipin Kumar and James Urban, in Dr. Leroy Hoods lab
were investigated and found guilty of data fabrication, because they were just trying, because of
pressure, to speed the review process (Roberts, 1991). Aside from Hood Lab scandal, there have
been many other research misconduct cases, either through fabrication or omission of data as
scientists are trying to secure funding, or market the newly developed therapies. The focus on
economic incentives and commercialization of scientific research has intensified the competitive
nature within the scientific community. While competition can lead to more productive research
environment, it can also have adverse effect on research integrity.
Research misconduct not only slows the research and development, but it can also put
peoples lives in danger. In 2004, Vioxx (Rofecoxib), an arthritis pain medication, was taken off
market due to increased cardiovascular risks. Since the development of Vioxx, many scientists
raised concerns about the adverse effects on cardiovascular system; however, Vioxx was put on
the market in 1999 by Merck, a pharmaceutical company (Tanne, 2008). When the study for
publication and Food and Drug Administration (FDA) application was conducted, Merck
purposefully designed the study to not have a standardized procedure to collect and adjudicate
cardiovascular outcomes (Krumholz, Ross, Presler, & Egilman, 2007). Furthermore, Merck
hads asked multiple scientists to analyze data on cardiovascular outcomes until the analysis
showed no increased risk of cardiovascular diseases. Irregularity in procedure and data collection
was mentioned nowhere in the publications. Also three data on cardiovascular failure were
omitted because those events occurred a month after data collection was completed (Krumholz et
al., 2007). The act of Merck falls under federal definition of research misconduct with
falsification. Falsification is defined as manipulating research materials, equipment, or

Commercialization of Scientific Research and its Social Ramification

processes. . . [and] not accurately represented in the research record (Office of Science and
Technology Policy, 2002). During the time which Vioxx was on market from 1999 until 2004,
nearly 30,000 people had cardiovascular event due to drug use (Krumholz et al., 2007). The
Vioxx case highlights how research misconduct can affect not just scientific community, but also
the general population who are the consumers of research outcomes.
FThe further investigation of then Vioxx case also illustrateds conflicts of interest issues
that aroise from academia and industry collaboration. Merck, as a company, had a high stake in
Vioxx as it brought in billions of dollars of revenue. In order to combat the concerns of a couple
of research scientists and doctors that[Vioxx caused adverse cardiovascular events?], Merck
targeted their advertising to doctors and health professionals to promote the use of Vioxx.
Moreover, when academic researchers raised questions on the validity of data and claims in
publications, Merck responded by pressuring them to keep quiet, sometimes even through
department chairs of the institution (Krumholz et al., 2007). Also, the use of ghostwriters was a
common practice in subsequent publications regarding the benefits of the use of Vioxx. While
most of the publication was written by Merck employees, Merck invited academic researchers to
review the manuscript and offered them first or second authorship (Ross, Hill, Egilman, &
Krumholz, 2008). Thus, the Vioxx papers were published without having to disclose financial
support from Merck and any conflicts of interests, and the academic researchers gained prestige
and funding by having more publications. The authors of these publications did not know
whether the data was falsified, and were not familiar with the details of the study. This allowed
Merck to craft a publication to their benefit and make Vioxx more profitable. Academic and
industry collaboration created more room for research misconduct, rather than increase in
research and development as the Bayh-Dole Act has anticipated.

Commercialization of Scientific Research and its Social Ramification

Joint effort between pharmaceuticals and academic researchers are very common in
clinical trials, consequently initiating hence increase in opportunities for conflicts of interest and
potential harm for patients and consumers. Conflicts of interest between academic researchers
and pharmaceutical companies arise primarily due to differences in their goals of research. While
academic scientists main motivation for research is to make further discoveries and to produce
technology useful to the society, the goal of industry usually lies within generating revenues
from the discovery made. Often academic researchers are swayed by the financial incentives
from industry, which results in unfortunate events during clinical trial, such as Jesse Gelsinger
case (Sibbald, 2001).
Jesse Gelsinger had ornithine transcarbamoylase (OTC) deficiency and entered a genetherapy trial lead by Dr. James Wilson in 1999. Before entering the trial, Gelsinger was relatively
healthy; however, after receiving the injection of OTC gene through attenuated cold virus,
Gelsinger died 4 days later by severe reaction to the injection. While Gelsinger was informed
that the study would not directly benefit him, he was not informed of severe side effects that
eventually led to his death. The negative findings from animal testing prior to the trial were not
fully disclosed to the FDA for approval. Moreover, Gelsinger was not an ideal candidate of the
study due to the condition of his liver (Liang & Mackey, 2010). The fact that these were
overlooked can be explained by conflicts of interest. Wilson, the principal investigator, and
University of Pennsylvania, where the trial was conducted, owned patents to this gene therapy
and could have had an enormous financial gain if the trial was successful (Liang & Mackey,
2010). The Bayh-Dole Act allowed the ownership and commercialization of academic research
findings through patents. Consequently, the focus of research has been shifted toward financial
gain, away from developing safe and innovative therapies for life-threatening diseases.

Commercialization of Scientific Research and its Social Ramification

Furthermore, the intent of the Act to promote further research backfired in the case of Gelsinger,
as it was widely publicized, preventing the progress of gene therapy research (Liang & Mackey,
2010).
In the cases of both Vioxx and Gelsinger, the financial support from the private industry
was not properly disclosed. Perhaps the unfortunate events and deaths could have been avoided
if potential conflicts of interest were discussed in advance, which would have allowed for
appropriate measures to be taken to protect research subjects and patients. Instead, these
unresolved conflicts of interests and increased competitions within the scientific community led
scientists to commit research misconduct or put innocent lives in danger. Negative findings were
either falsified or neglected in both publications and applications for grants and FDA approvals.
The Bayh-Dole Act has exacerbated the issue of publication bias, where only positive data and
new exciting discoveries are being published disproportionally compared to the amount of
publication on negative, and yet important findings.
Recently, there have been efforts to promote transparency in research. All clinical trials
are registered within clinicaltrials.gov, which allows scientists to track and obtain information on
clinical trials, whether or not it is published in papers. Though the findings of clinical trials are
explicitly uploaded, the database provides some transparency in research. (National Library of
Medicine, 2014). Also a blog called Retraction Watch was launched in 2010 to promote
transparency in retracted publications (Marcus & Oransky, 2014). With these continued efforts
and conversations around research intergrity, one could hope that the objectives of the BayhDole Act gets back on the right trackto spur research innovations and enable the society to
benefit from them.

Commercialization of Scientific Research and its Social Ramification

Unfortunately, the efforts to promote transparency in research do not properly address the
root of the probleminsufficient research funding. The Bayh-Dole Act puts a bigger emphasis
on research innovations that have direct outcomes and benefits to society. However, the findings
that arise from basic science research will affect the society is unpredictable. Unpredictability in
outcomes does not translate into useless research. Basic science research often have huge
benefits to the society, as illustrated by the Nobel Prize in medicine awarded in 2013 to Randy
Schekman, Thomas Sudhof and James Rothman for their discovery of vesicle transport (Altman,
2013). The research findings on the properties of vesicles, small packages to transport molecules
within the cell, enabled the development of therapies targeting diabetes and hepatitis B Vaccines
(Altman, 2013). The discovery of vesicles was done using yeast cells as a model system and the
three scientists were not directly involved with the clinical outcomes of their research. While
their success and contribution in their field are monumental, these scientists are struggling to
secure funding for their on-going research, as many funding agencies do not see direct
implications of their research projects. While basic science research does not necessarily have
clear outcomes and is often far removeddistant from clinical applications, it provides a basis for
most clinical research and drug development as represented by award-winning research on
vesicles. Although the Bayh-Dole Act led to increase in research funding through private sector,
this increase is attributed mostly to non-basic science research.
Overall, the federal funding for basic science research has declined by 16 percent (Kaiser,
2014). Funding for scientific research are under more pressure than ever before and scientists are
forced to make their research more appealing by stating a direct and immediate outcomes of their
research projects (Caplan, 2012). Consequently, many researchers in basic science are
encouraged to transform their findings into clinical applications. In order to secure funding, more

Commercialization of Scientific Research and its Social Ramification

scientists are encouraged to pursue translational research, an area of scientific research that
bridges between basic sciences and medicine (Caplan, 2012). The focus on translational research
produces a greater return of investment to the society. However, what the emphasis on
translational research is missing that there are still so much unknown about cellular mechanisms
and our systems. Developing new drugs or therapies cannot be done unless there is a significant
progress within basic science research.
The goal of the Bayh-Dole Act was to alleviate the problem of lack of research funding,
by enabling private sectors to invest in research. However, industry is more interested in
generating revenue, which neglects basic science research in the pursuit of more profitable
clinical research. Passing the Act may have increased funding for more applicable research, but
decreased funding opportunities basic science. The culture of scientific community has steered
away from pursuing knowledge into securing research funding and making financial gains.
Decreased investment and value in basic science research will eventually hinder the progress of
research innovation, as translational and clinical research cannot go forth without knowledge
produced from basic science. And it is questionable as to whether this culture actually
contributed to advancement in research and development or hindered the research progress by
shying away from basic sciences.
Another area of research that has been negatively impacted by the greater emphasis on
research with direct outcomes is research on third-world diseases, such as malaria and Ebola.
There is a huge discrepancy between the number of incidences of these diseases and the amount
of research funding distributed. In 2012, about 207 million people were affected by malaria and
14 million were affected by cancer worldwide (World Health Organization, 2013). In the same
year, NIH has funded about 192 million dollars on malaria research compared to 5.6 billion

Commercialization of Scientific Research and its Social Ramification

10

dollars on cancer research (National Institutes of Health, 2014). The US and most first world
countries do not value global health research compared to cancer or diabetes researcher, because
the direct implications and return of investment is not clear. However, global health diseases can
have a huge impact on the US, as seen in recent case of the Ebola epidemic.
The Ebola outbreak was notified to the World Health Organization (WHO) in March
2014, and WHO declared the epidemic in August (WHO Ebola Response Team, 2014). As of
November 28th there have been total of 16933 confirmed cases with 6000 deaths (Centers of
Disease Control and Prevention, 2014). The Ebola epidemic has become a worldwide problem as
death tolls in West Africa are rising and many healthcare workers are being infected. Though
Ebola epidemic is very recentPrior to the most recent epidemic, there had been many several
outbreaks have occurred throughout West Africa since 1976 (World Health Organization, 2014a).
Up until the outbreaks, the funding for Ebola vaccine research was minimal. The cure of Ebola
does not exist at this point, and this poses a great public health risk for the global populations.
The focus on profitable research, fueled by the Bayh-Dole Act led to dire consequences as
illustrated by the current Ebola epidemic. The death tolls are currently rising and there is no
adequate healthcare infrastructure to properly respond to the epidemic. WHO, Center for Disease
Control and Prevention (CDC), and the countries worldwide are working together to come up
with solutions and respond effectively to combat the epidemic.
While the Bayh-Dole Act exacerbated the Ebola epidemic by implicitly encouraging
profitable research, the Act also enabled the scientific community to respond to the epidemic
promptly. There are two vaccines in safety trials and four clinical trials regarding therapies, and
WHO predicts that potential therapies will be available by the end of 2014 and mid-2015 (World
Health Organization, 2014b). A typical drug development, clinical trials and FDA approval

Commercialization of Scientific Research and its Social Ramification

11

process can take decades, not months. The efforts to combat the Ebola epidemic were accelerated
by collaboration between the government, academic researchers and biotechnology companies.
Such collaboration in a short period of time would not have been possible without the Bayh-Dole
Act. The response to Ebola outbreak demonstrates how the Act play a role in promoting research
and development, and how federal and private sector collaboration can lead to greater return of
investment on the society. This adds complexity to the outcomes of the Actthe outbreak could
have been prevented if the scientific community did not primarily focus on direct outcomes
research, and yet the quick responses to the epidemic are attributed to cooperation between the
academia and industry.
The Bayh-Dole Act has been successful in increasing athe number of technology transfer
offices, issuing patents and licenses for academic research innovations, and providing financial
incentives for research and development (Loise & Stevens, 2010). However, the Act had
influenced the culture of scientific research in ways that no one has anticipated. And the change
in the science community affects everyone, as policymakers, students, and consumers of research
innovations and technology. The ethical implications of the Bayh-Dole Act brought new
challenges and old fundamental questions to researchers: what is the purpose of scientific
research? Should science be for profit? Should research and development be incentivized by
financial gain? While incentivizing scientific innovation through a new policy, one should
consider all possible social implications and never lose sight of the aim of science research: to
create knowledge and advance our society.

Commercialization of Scientific Research and its Social Ramification

12

References
Altman, L. K. (2013, October 7). For 3 Nobel Winners, a Molecular Mystery Solved. The New
York Times. Retrieved from http://www.nytimes.com/2013/10/08/health/3-win-joint-nobelprize-in-medicine.html
Bayhing for blood or Doling out cash? (2005, December 20). The Economist, p. 109. Retrieved
from http://www.economist.com/node/5327661
Caplan, S. (2012, December 11). Coming out of the scientific closet: unapologetic about basic
research. The Guardian. Retrieved from http://www.theguardian.com/science/occamscorner/2012/dec/11/scientific-closet-basic-research
Centers of Disease Control and Prevention. (2014). 2014 Ebola Outbreak in West Africa.
Retrieved December 02, 2014, from http://www.cdc.gov/vhf/ebola/outbreaks/2014-westafrica/index.html
Kaiser, J. (2014, April 1). Neurological Institute Finds Worrisome Drop in Basic Research.
Science Magazine. Retrieved from http://news.sciencemag.org/brainbehavior/2014/04/neurological-institute-finds-worrisome-drop-basicresearch#disqus_thread
Krumholz, H. M., Ross, J. S., Presler, A. H., & Egilman, D. S. (2007). What have we learnt from
Vioxx? BMJ (Clinical Research Ed.), 334(7585), 1203. doi:10.1136/bmj.39024.487720.68
Lei, Z., Juneja, R., & Wright, B. D. (2009). Patents versus patenting: implications of intellectual
property protection for biological research. Nature Biotechnology, 27(1), 3640.
doi:10.1038/nbt0109-36
Liang, B. A., & Mackey, T. (2010). Confronting conflict: addressing institutional conflicts of
interest in academic medical centers. American Journal of Law & Medicine, 36(1), 13687.
Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/20481404
Loise, V., & Stevens, A. J. (2010). The Bayh-Dole Act turns 30. Science Translational Medicine,
2(52), 52cm27. doi:10.1126/scitranslmed.3001481
Marcus, A., & Oransky, I. (2014). Retraction Watch. Retrieved November 28, 2014, from
http://retractionwatch.com/

Commercialization of Scientific Research and its Social Ramification

13

National Institutes of Health. (2014). Estimates of Funding for Various Research, Condition, and
Disease Categories (RCDC). Retrieved December 02, 2014, from
http://report.nih.gov/categorical_spending.aspx
National Library of Medicine. (2014). ClinicalTrials.gov. Retrieved November 28, 2014, from
http://clinicaltrials.gov/ct2/about-site/background
NIH Budget. (n.d.). Retrieved from http://www.nih.gov/about/budget.htm
Norrgard, K. (2008). Diagnostic Testing and the Ethics of Patenting DNA. Nature Education,
1(1), 84. Retrieved from http://www.nature.com/scitable/topicpage/diagnostic-testing-andthe-ethics-of-patenting-709
Office of Science and Technology Policy. (2002). Federal Policy on Research Misconduct.
Retrieved November 30, 2014, from http://www.whitehouse.gov/administration/eop/ostp
Roberts, L. (1991). Misconduct: Caltechs Trial by Fire. Science, 253, 13441347.
Ross, J. S., Hill, K. P., Egilman, D. S., & Krumholz, H. M. (2008). Guest authorship and
ghostwriting in publications related to rofecoxib: a case study of industry documents from
rofecoxib litigation. Jama, 299(15), 180012. doi:10.1001/jama.299.15.1800
Schacht, W. H. (2006). The Bayh-Dole Act: Selected Issues in Patent Policy and the
Commercialization of Technology. Congressional Information Service, Library of Congress.
Sibbald, B. (2001). Death but one unintended consequence of gene-therapy trial. CMAJ:
Canadian Medical Association Journal = Journal de lAssociation Medicale Canadienne,
164(11), 1612. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/81135
Tanne, J. H. (2008). Merck used ghostwriters and selective data in Vioxx publications, JAMA
says. BMJ, 336(7649), 849849. doi:10.1136/bmj.39553.344965.DB
WHO Ebola Response Team. (2014). Ebola Virus Disease in West Africa - The First 9 Months of
the Epidemic and Forward Projections. The New England Journal of Medicine, 115.
doi:10.1056/NEJMoa1411100
World Health Organization. (2013). Malaria Factsheet on the World Malaria Report 2013.
Retrieved December 02, 2014, from
http://www.who.int/malaria/media/world_malaria_report_2013/en/
World Health Organization. (2014a). Ebola virus disease Fact sheets. Retrieved from
http://www.who.int/mediacentre/factsheets/fs103/en/

Commercialization of Scientific Research and its Social Ramification

14

World Health Organization. (2014b, November 5). Potential Ebola Therapies and Vaccines (pp.
136).