Interdisciplinary Aspects of Research

UNIT 4 - INTERDISCIPLINARITY OF RESEARCH

Unit 4 - Interdisciplinarity of Research

Christopher Gress

LSTD 3953 – SID Prospectus

Dr. Miller

University of Oklahoma – College of Professional and Continuing Studies

I certify that I have read a student’s Guide to Academic Integrity at the University of Oklahoma, and this paper is an original paper composed by me for this course. Except where properly cited and attributed, it has not been copied or closely reworded from any other source and has not been submitted as a whole, or in part, for credit in any other course at OU or any other educational institution. It has not been created or submitted for any other purpose such as a job assignment at my workplace or any other agency.

Running head: UNIT 4 - INTERDISCIPLINARITY OF RESEARCH

Interdisciplinarity of Research

Importance

Interdisciplinarity is defined as the combination or combining of two or more academic disciplines to achieve a common task. Using interdisciplinarity, a person can produce connections between concepts and ideas across different disciplinary boundaries. By drawing knowledge from several fields, one can address a problem effectively and thoroughly. Using interdisciplinarity, the researchers are better suited to confront the imminent challenge. Combining the perspectives of two or more disciplines, a researcher can understand a complex subject. As is the case with the attempt to understand the multitude of ways the Food and Drug Administration (FDA) and its subsidiaries approve foods and medications regarding big business, money priorities, and political interests. This matrix is a complex subject that can only be understood by combining aspects from different disciplines like sociology, psychology, biology, and business. By combining elements within these disciplines, we will understand the complexity involved in the regulatory process and understand how the FDA approval process produces.

Sociology

The structure of the FDA comes to question when one thinks about the sociology of its drug approval. It has been shown that most of the regulatory employees began their careers in the pharmaceutical industry (Mulinari, 2015). Having a previous repour with the industry and personnel influences their drug approvals. Due to career development, regulators will maintain personal and professional courtesies with the trade as they may have plans to return to an industry or vice versa. Regarding the familiarity, the regulatory agency is prioritizing the interests of the industry over the interests of the consumer. FDA’s has prioritized the interests of the industry since it depends on industry funding, which comes with “strings attached” (Hilzenrath, 2016). The bias has resulted in the drug approval process being expedited and long-term drug effects being overlooked (Jarvis & Williams, 2016). While the FDA was formed to serve the interests of the public, it has, over time, started to serve the interests of pharmaceutical companies. This is evidenced on the increasing influence of big pharmaceutical companies on the agency’s drug advisory committees (Block, 2018).

Psychology

Employees of the FDA have links to pharmaceutical companies. According to Sifferlin (2016), there is a revolving door between the pharmaceutical companies and the FDA, which has attracted criticisms. These links were formed when the employees started their careers in the pharmaceutical companies and then progressed to regulatory work. Most of these regulators continue personal and or professional relationships with pharmaceutical companies and representatives that may influence to approve drugs. Pharmaceutical companies tend to hire agency employees who successfully managed reviews of their drugs or gave them some favors when working for the federal agency (Piller, 2018). It is human nature to favor a colleague over a guest. This psychological behavior becomes evident as FDA regulators are inclined to believe the data submitted by pharmaceutical companies regarding the effects of a drug (Mukherji, Janakiraman, Dutta, & Rajiv, 2017). Considering that the FDA cannot review each drug submitted for approval, it will be inclined to favor the data presented and approve drugs based on provided research (Barber & Diestre, 2019). There are subconscious signals that a regulator will have towards a company they have been employed with in the past. The inherent ability may result in the controller trusting the company and pushing for their drug approval.

Biology

Drug interactions in the body are different for each person. Pharmaceutical companies understand science, which is why they utilize healthy individuals during the testing phases of new drugs (Sun et al., 2017). Biasing data outputs reduce the impact of negative results and ensure that the data produced regarding the medicines are mostly positive. Without proper research being conducted to determine the efficacy of a drug on poor, unhealthy, or older people who are most likely to use the medication, the pharmaceutical company may be awarded approval for the drug while the side effects may not be exhibited entirely. The trials conducted are performed long enough to reveal the desired reactions, not the side effects.

Consequently, when patients begin using the drug, they may have side effects such as mortality risks that have not been indicated. It is the research and hope that drugs with harmful effects will not be approved (Fisher, Cottingham, & Kalbaugh, 2015). Understanding the physiological interaction of a particular drug is vital as it demonstrates how the medication may affect populations.

Business

Opposed to commercialized notions, pharmaceutical companies are in the business of making drugs for profit. Despite receiving significant assistance from the federal government in the form of publicly funded basic research and tax breaks, pharmaceutical companies continue to charge excessive prices for drugs (Meller & Ahmed, 2019). Subsequently, the institution\\\'s focus is targeting individuals to use the drugs they manufacture provided it may help them. The more people dependent on the drug, the more successful the business. Having successful business models in mind, corporations may employ devious strategies to promote their medications regardless of the outcome. Pharmaceutical companies practice only submitting results that demonstrate a drug is effective and can be used to treat a specific condition (Barber & Diestre, 2019). They do not exclude that the drug has acceptable side effects. However, sufficient side effects are considered regular while the extremely adverse are not listed. The FDA acts accordingly based on data as the Federal entity does not possess the analyzing resources for quantification on human subjects before it approves them. Described by Fisher et al. (2015), two in seven new drugs have side effects severe enough to warrant action by the FDA. Regrettably, this rarely happens as the FDA is limited in terms of approval and drug testing, forcing the company to rely on the results presented by drug companies to approve medications.

Annotated Bibliography

Barber, B., & Diestre, L. (2019). Pushing for speed or scope? Pharmaceutical lobbying and Food and Drug Administration drug review. Strategic Management Journal, 40(8), 1194-1218.

This paper demonstrates how pharmaceutical companies make use of political activities to progress the approval of drugs. Pharmaceutical companies have used their political clout to push for the review and approval of drugs manufactured by the company. The leverage results in the FDA receiving undue pressure to have certain drug approvals expedited. The result of this is that drugs do not undergo the full review before they get the final approval. Pharmaceutical companies use social behavior to push legislators to have their drugs approved faster than those of their competitors. Faster drug approval means some drugs will be approved and result in harmful effects to the patients. This resource will be used in the professional and applied and behavioral sciences disciplines within business and psychology. The research will be located within the interdisciplinarity of research section of the prospectus. The information used is relevant to the psychological phenomenon that coincides with business transactions.

Block, J. (2018, July 10). The Increasing Influence of Big Pharma on FDA Drug Advisory Committees. Retrieved from https://medshadow.org/conflicts-interest-fda/

The article explores the growing influence of big pharmaceutical companies on the FDA. Recent surveys have suggested that members of the agency’s drug advisory committees later obtain kickbacks from big pharmaceutical companies whose drug they approve. This implies that a conflict of interest arises as these individuals do not make decisions independently as required of them. The undue influence from these companies threaten the public health and safety as drug advisory committee members prioritize their interests rather than the interests of the public. The information provided in this publication is imperative in the social sciences in the context of sociology. Information in this article will be used in the research to demonstrate the sociological context in which the agency ends up prioritizing the interests of the industry over the interests of the consumer.

Jarvis, M., & Williams, M. (2016). Irreproducibility in preclinical biomedical research: Perceptions, uncertainties, and knowledge gaps. Trends in Pharmacological Sciences, 37(4), 290-302.

The researcher focuses on the scientific fact making involved in the clinical trials of drugs. The clinical trials are the basis for securing approval from the FDA before the drug can be released. By understanding what goes on in the clinical trials, it becomes clear that the pharmaceutical companies will, at times, prefer only to demonstrate the positive effects of a drug over the adverse side effects. Naturally, with positive side effects, the drug can get faster approval. The outcome of such actions has skewed researchable data. Data research regarding oncology, women’s health, and cardiovascular disease reported that only 65% of testing could be reproduced. This research will emphasize the sociological impact within the academic discipline of the social sciences. The resource will be located within the interdisciplinarity of research section of the prospectus. Jarvis’ research will help to elaborate on the societal implications of significant pharmaceutical and FDA streamlining processes.

Fisher, J., Cottingham, M., & Kalbaugh, C. (2015). Peering into the pharmaceutical “pipeline”: Investigational drugs, clinical trials, and industry priorities. Social Science & Medicine, 131(3), 322-330.

The researchers have focused on the harmful side effects of some of the drugs that have received approval by the FDA. The paper shows how pharmaceutical companies have corrupted medicine as they influence the drugs being developed, their testing, and their medical knowledge. Since drug companies pay authorization of user fees, and they are FDA\\\'s prime clients, they can control expedited drug approval. Self-interest reduces the time taken to review a drug that the FDA does not have enough time to examine thoroughly. The FDA has focused on meeting the needs of the pharmaceutical companies over the needs of the public, noted with Merck’s voluntary withdraw of VIOXX. The discipline of this research will lie in the Natural Sciences and professional and applied sciences within the contexts of biology, physiology, and business. The resource will be located within the interdisciplinarity of research section of the prospectus. Side effects of medications are a regrettable but necessary evil to prove a drug. This research will allow emphasis of less than corrupt business dealings overshadow the physiological impacts of insubstantial reporting.

Hilzenrath, D.S. (2016, December 1). FDA Depends on Industry Funding; Money Comes With “Strings Attached.” Retrieved from https://www.pogo.org/investigation/2016/12/fda-depends-on-industry-funding-money-comes-with-strings-attached/

The article explores how FDA’s dependence on industry funding has provided an avenue for undue influence from pharmaceutical companies. The undue influence has been evident over the past decade as “user fees” have increased to 71%. As the FDA continues to rely on industry funding, pharmaceutical companies explore this reliance to exert their extraordinary influence over the regulator. Consequently, the pharmaceutical industry inadvertently set the agenda for the FDA on critical areas like drug approval. This implies that the FDA seemingly serves the interest of the industry over consumer interests. Information from this article is relevant to the business and sociological aspect of the present research. The article will be used to draw the reader’s attention to how commercial interests dominate the interests of the industry and eventually shape the agenda of the FDA.

Meller, A. & Ahmed, H. (2019, August 30). How Big Pharma Reaps Profits While Hurting Everyday Americans. Retrieved from https://www.americanprogress.org/issues/democracy/reports/2019/08/30/473911/big-pharma-reaps-profits-hurting-everyday-americans/

Big pharmaceutical companies have prioritized commercial interests, which is the premise for their drug development efforts. Despite receiving federal government assistance, these companies continue to charge excessive prices for drugs. In addition to the high prices for their drugs, big pharmaceutical companies benefit from research and development tax breaks. The article suggests that the major motivation of big pharmaceutical companies is to make money rather than help promote health and save lives. The insights from the article highlight the business or commercial aspect of the collaboration between the industry and the FDA. This research will allow emphasis of how commercial interests overshadow consumer interests in the link between the FDA and the industry.

Mukherji, P., Janakiraman, R., Dutta, S., & Rajiv, S. (2017). How direct-to-consumer advertising for prescription drugs affects consumers\\\' welfare: A natural experiment tests the impact of FDA legislation. Journal of Advertising Research, 57(1), 94-108.

The FDA allowed drug companies to market to consumers directly, resulting in increased prescription drug sales, which creates an overdependence on drugs by the population. Pharmaceutical companies have contested they use the advertisements to improve consumer knowledge. However, the effect of advertising is to increase sales of what is being advertised. Researchers have analyzed the impact of direct to consumer advertising and have shown it has increased consumer dependence on pharmaceutical drugs. The promotion has, in turn, affected the body\\\'s immune system. This resource is imperative to the behavioral sciences in the context of psychology. The resource will be located within the interdisciplinarity of research section of the prospectus. Creating an atmosphere of vulnerability by corporations to the public is little less than propaganda. The research is relevant to understand the psychological impact the advertisement makes.

Mulinari, S. (2015). Divergence and convergence of commercial and scientific priorities in drug development: The case of Zelmid, the first SSRI antidepressant. Social Science & Medicine, 138(2), 217-224.

The researcher focuses on the sociological impact of the relationship between pharmaceutical companies and regulatory agencies. A bias is formed at the macro and meso levels, which manifests itself at the micro-social level. Using a relist sociology analysis, the researcher has managed to show how regulatory agencies and commercial priorities are influenced by pharmaceutical companies to approve drugs. Commercial interests have overshadowed and taken the science away from the interests of the consumers resulting in drug injuries. This text is found in the social sciences within the context of sociology. The resource will be located within the interdisciplinarity of research section of the prospectus. The influence of any corporation over one as crucial as a pharmaceutical agent is a significant gradient. This research is relevant to the multitude of societal injustices commercial and regulatory entities create while only observing an equitable outcome.