Matching Items (7)
Description
With the number of internationally-run clinical drug trials increasing, the double standards between those in developed nations and those in developing nations are being scrutinized under the ethical microscope. Many argue that several pharmaceutical companies and researchers are exploiting developing nation participants. Two issues of concern are the use of a placebo control when an effective alternative treatment exists and the lack of drug availability to the country that hosted the clinical trial should the experimental drug prove effective. Though intuitively this seems like an instance of exploitation, philosophically, exploitation theories cannot adequately account for the wrongdoing in these cases. My project has two parts. First, after explaining why the theories of Alan Wertheimer, John Lawrence Hill, and Ruth Sample fail to explain the exploitation in clinical drug research, I provide an alternative account of exploitation that can explain why the double standard in clinical research is harmful. Rather than craft a single theory encompassing all instances of exploitation, I offer an account of a type, or subset, of exploitation that I refer to as comparative exploitation. The double standards in clinical research fall under the category of comparative exploitation. Furthermore, while many critics maintain that cases of comparative exploitation, including clinical research, are mutually beneficial, they are actually harmful to its victims. I explain the harm of comparative exploitation using Ben Bradley's counterfactual account of harm and Larry May's theory of sharing responsibility. The second part of my project focuses on the "standard of care" argument, which most defenders use to justify the double standard in clinical research. I elaborate on Ruth Macklin's position that advocates of the "standard of care" position make three faulty assumptions: placebo-controlled trials are the gold standard, the only relevant question responsive to the host country's health needs is "Is the experimental product being studied better than the 'nothing' now available to the population?", and the only way of obtaining affordable products is to test cheap alternatives to replace the expensive ones. In the end, I advocate moving towards a universalizing of standards in order to avoid exploitation.
ContributorsFundora, Danielle (Author) / McGregor, Joan (Thesis advisor) / Brake, Elizabeth (Committee member) / Portmore, Douglas (Committee member) / Arizona State University (Publisher)
Created2013
Description
In this paper, I analyze the pharmaceutical supply chain to identify the main causes of drug surplus. The main example I use throughout the paper is the current opioid epidemic, which has resulted in thousands of fatalities, caused by overdoses. After researching the industry players and their relationships in the supply chain, I have identified four main causes of drug surplus: the consolidation of pharmaceutical corporations with third-party manufacturers, along with consolidation within the wholesaler industry; the inappropriate pricing of opioid-based prescriptions negotiated by pharmacy benefit managers (PBMs); the significant influence of pharmaceutical corporations on physicians, leading to potentially unethical practices; and lastly patients openly distributing leftover prescriptions to the market, and looking for prescriptions elsewhere. To alleviate the drug surplus issue, I provide three solutions: implement both blockchain and reverse logistics into the pharmaceutical supply chain, improving transparency, and allowing patients to return incomplete prescriptions; and research the consolidation of PBMs with providers (hospital systems, clinics, etc.) to increase buyer power and appropriately price opioid-based prescriptions.
ContributorsRutkowski, Sarah (Author) / Helm, Jonathan (Thesis director) / Wiedmer, Robert (Committee member) / Department of Information Systems (Contributor) / W.P. Carey School of Business (Contributor) / Department of Supply Chain Management (Contributor) / Barrett, The Honors College (Contributor)
Created2018-05
Description
This project will explain the positive impact and effectiveness of Sarbanes-Oxley on corporate responsibility, and through that lens, examine how to make certain subchapters of Title 42, "the Sunshine Act", concerning healthcare fund tracking more transparent and without conflicts of interest. There will be an analysis of the implementation of the Sarbanes-Oxley Act in corporate America and the impact it had on corporate responsibility. There will be a comprehensive review of the history of both the Sarbanes-Oxley Act and the Sunshine Act, along with their origins, stakeholders, and impact on their respective industries. Suggestions to improve certain current United States Code subchapters and subsequent regulations will be announced considering the success that has come from Section 404 of Sarbanes-Oxley.
ContributorsRogers, Anne Marie (Author) / Brian, Jennifer (Thesis director) / Agne, Sara (Committee member) / School of Accountancy (Contributor) / Hugh Downs School of Human Communication (Contributor) / Barrett, The Honors College (Contributor)
Created2017-05
Description
This thesis elucidates the responsibility of the pharmaceutical industry for the current opioid epidemic, an epidemic which caused over 40,000 American deaths in 2016 alone. Twenty years prior, Purdue Pharma unleashed an extended-release formulation of the opioid oxycodone: OxyContin. With this, Purdue began a highly aggressive advertising campaign with the primary intention of guaranteeing the success of this drug; however, in doing so, they often neglected to ensure that the information they were propagating was wholly accurate. Previous reform attempts aimed at mollifying this crisis have ultimately fallen short, as they have failed to recognize the true extent of Purdue Pharma's involvement, especially with regard to the underlying issues that led to the initiation and progression of the epidemic. Future improvements should be targeted at the reform of regulatory agencies and insurance companies, as well as the cultural attitudes regarding pain and pain treatment that have been cultivated over the last several years. Ultimately, however, these reforms will likely prove to be insufficient unless the failings of the current healthcare system, including the pharmaceutical industry, are also taken into account.
ContributorsOzeran, Rachel Hoku Lii (Author) / Fong, Benjamin (Thesis director) / Brian, Jennifer (Committee member) / School of Life Sciences (Contributor) / Barrett, The Honors College (Contributor)
Created2018-05
Description
Biosimilar pharmaceuticals are new lower-cost drugs awaiting large-scale approval within the United States (U.S). Biosimilar pharmaceuticals or simply biosimilars, are complex, large-molecule, and biologically-derived drugs that are deemed molecularly similar to currently approved reference biologics. Biologics and biosimilars both treat a wide range of conditions with no clinically meaningful difference between them. However, numerous states, with help from large pharmaceutical companies lobbying, are passing legislation complicating the prescribing and dispensing process for biosimilars by mandating a "notification" or "communication" requirement. The notification requirement requires pharmacists to contact prescribers when dispensing an interchangeable biosimilar in place of its reference biologic. This type of mandate is not only unprecedented in current U.S. pharmaceutical law, but it also incentivizes pharmacists to dispense more expensive biologics in place of biosimilars. The notification or communication requirement also falsely gives consumers the appearance that biosimilars are more dangerous in comparison to other types of biological medicines. These two factors, pharmacist hesitation and consumer distrust, serve as barriers to successful biosimilar market entry. High research and development costs and forecasted poor sales inhibit biosimilar companies from making the investment in innovating new drugs. The lack of investment in research and development prevents new biosimilars from entering the market to compete with currently approved biologics. In turn, current biosimilar legislation is reducing pharmaceutical competition and increasing drug prices. Information Measurement Theory supports the notion that in climates without competition (caused by a lack of transparency) sparks low quality and high costs. Transparency and improved biosimilar market conditions can be achieved through repealing the large pharmaceutical company backed notification requirement.
ContributorsFelthouse, Karis Renee (Author) / Kashiwagi, Dean (Thesis director) / Kashiwagi, Jacob (Committee member) / School of Politics and Global Studies (Contributor) / School of Film, Dance and Theatre (Contributor) / School of Sustainability (Contributor) / Barrett, The Honors College (Contributor)
Created2016-05
Description
The pharmaceutical industry is closely related to the national economy and people's livelihood, with high drug prices and pressure on health insurance. The implementation of the band purchasing policy has made an important contribution to lowering drug prices, improving the balance rate of health insurance, reshaping the pattern of the pharmaceutical industry, and improving the efficiency of pharmaceutical production and circulation, but how the band purchasing policy affects the performance of the majority of pharmaceutical enterprises, and how the pharmaceutical enterprises can effectively deal with the challenges of environmental mutation and other related problems have not yet been effectively explored.To this end, this paper collects data from A-share listed pharmaceutical companies in China from 2014 to 2022, takes 2018 as the base year for the implementation of the "4+7" "band purchasing" policy, and utilizes a multi-period DID double-difference model for hypothesis verification. It is found that the implementation of the band purchasing policy significantly reduces the profitability performance and growth performance of pharmaceutical enterprises. Secondly, the implementation of enhanced innovation can moderate the negative impact of band purchasing on the growth performance of enterprises, and the expansion of exports and the enhancement of digitalization can significantly
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improve the negative impact of band purchasing on the profitability performance of enterprises, but has no effect on the growth performance of enterprises. In addition, this paper analyzes the process of pharmaceutical enterprises' implementation of enhancing innovation, expanding exports, and improving digitalization through case studies, and refines the strategic change process model of "coping strategy formation - coping strategy implementation - adaptation to the new state" under the sudden change environment. This paper explores the differentiated effects of coping strategies of different types of pharmaceutical enterprises in the face of the band purchasing policy, and provides some insights into the practice of related enterprises.
ContributorsBao, Sheng (Author) / Zhu, David (Thesis advisor) / Chen, Xin (Thesis advisor) / Dong, Xiaodan (Committee member) / Arizona State University (Publisher)
Created2023
Description
Purdue Pharma was started by Arthur, Mortimer, and Raymond Sackler in the 1950s. Its most successful product was OxyContin. Purdue failed to perform the required trials and used misleading marketing practices to promote the drug. The Sackler family encouraged these false advertising campaigns in an attempt to drive up sales. These deceitful tactics caught up with the company and Purdue Pharma’s affiliate pled guilty to deliberately misbranding the drug in 2006. Purdue Pharma currently faces thousands of lawsuits, with Sackler family members personally named, for misleading marketing practices. States uncovering evidence of the Sackers attempting to hide their fortune via wire transfers and offshore accounts and institutions removing the family name from their doors threaten both the Purdue Pharma and the Sackler family’s money and influence.
The opioid crisis was inflamed by multiple sources, from which Purdue Pharma and other pharmaceutical companies benefited. The first is the Revolving Door, where government workers go to work for the companies they were once in charge of regulating. Existing loopholes allow former officials to immediately become lobbyists and perform consulting work. The Food and Drug Administration has close ties with lobbyists and pharmaceutical companies, which casts doubt and suspicion on its policies. Tightening and expanding current Revolving Door regulations would begin to stem this problem. Extending the cooling-off period to a minimum of five years would prevent former government workers from immediately influencing government policies. Furthermore, the laws need to be modified to include more specific language to eliminate loopholes. Banning former government employees from any counseling services or lobbying any government branch, agency, or office will make it much more difficult to circumvent the rules.
The second are “pill mills,” whereby physicians, clinics, or pharmacies prescribe prescription drugs inappropriately. There exists a web of regulation and reporting laws from federal and state governments, but pill mills still established themselves. Florida enacted laws that created stricter requirements for dispensing drugs, medical examinations, and follow-ups before and after prescribing opioids for chronic pain. These laws had positive results in stopping pill mills. Similar laws should be enacted nationally. Existing laws focusing on the pharmaceutical manufacturers, distributors, and pharmacies should be expanded to improve reporting between those agencies and the DEA and the DEA and other government agencies.
The last one is the American drug addiction rehab system. It is fraught with stigma, lax insurance information, inconsistent treatments, and poorly utilized information. The system often fails to provide care for those who need it. Increasing the scope of treatments would boost its effectiveness. States need to require insurance companies to cover mental health treatment to the same extent and degree as physical health issues and use a uniform, standardized tool to decide the necessary level of care addiction patients need. Public report cards for treatment centers would improve their long-term level of care and ease patients in finding a treatment center that fits them.
Addressing these problems has already begun at the both federal and state level. As these causes are identified and attacked, it will become easier to pass the laws needed to repair the system that allowed the opioid crisis to occur.
The opioid crisis was inflamed by multiple sources, from which Purdue Pharma and other pharmaceutical companies benefited. The first is the Revolving Door, where government workers go to work for the companies they were once in charge of regulating. Existing loopholes allow former officials to immediately become lobbyists and perform consulting work. The Food and Drug Administration has close ties with lobbyists and pharmaceutical companies, which casts doubt and suspicion on its policies. Tightening and expanding current Revolving Door regulations would begin to stem this problem. Extending the cooling-off period to a minimum of five years would prevent former government workers from immediately influencing government policies. Furthermore, the laws need to be modified to include more specific language to eliminate loopholes. Banning former government employees from any counseling services or lobbying any government branch, agency, or office will make it much more difficult to circumvent the rules.
The second are “pill mills,” whereby physicians, clinics, or pharmacies prescribe prescription drugs inappropriately. There exists a web of regulation and reporting laws from federal and state governments, but pill mills still established themselves. Florida enacted laws that created stricter requirements for dispensing drugs, medical examinations, and follow-ups before and after prescribing opioids for chronic pain. These laws had positive results in stopping pill mills. Similar laws should be enacted nationally. Existing laws focusing on the pharmaceutical manufacturers, distributors, and pharmacies should be expanded to improve reporting between those agencies and the DEA and the DEA and other government agencies.
The last one is the American drug addiction rehab system. It is fraught with stigma, lax insurance information, inconsistent treatments, and poorly utilized information. The system often fails to provide care for those who need it. Increasing the scope of treatments would boost its effectiveness. States need to require insurance companies to cover mental health treatment to the same extent and degree as physical health issues and use a uniform, standardized tool to decide the necessary level of care addiction patients need. Public report cards for treatment centers would improve their long-term level of care and ease patients in finding a treatment center that fits them.
Addressing these problems has already begun at the both federal and state level. As these causes are identified and attacked, it will become easier to pass the laws needed to repair the system that allowed the opioid crisis to occur.
ContributorsNowicki, Elizabeth Anne (Author) / Koretz, Lora (Thesis director) / Moore, James (Committee member) / Department of Management and Entrepreneurship (Contributor) / School of Politics and Global Studies (Contributor) / Barrett, The Honors College (Contributor)
Created2020-05