Ethical Lapses That Affected GSK Product Quality - Report Example

Workplace Violence Name: Lecturer: Course: Date: Executive Summary Ethics can be defined as the issues relating to the nature of morals in addition to certain moral choices that should be made by an individual. Several ethical lapses affected GSK’s product quality. The company was involved in a range of unethical practices concerning its quality control, marketing and product liability. The company had two of its research trials for its drugs, Avandia and Paxil, fixed to falsify the results and to “gloss over” results. It was also involved in irresponsible marketing of these drugs. Further, a number of drugs initially labelled for being “bacteria free” had in actual fact had some discrepancies regarding their quality because of unhygienic practices. GSK's leadership failed to prevent ethical issues related to integrity. The leaders were expected to institute ethical culture in the organisation. Failure in ethics showed the organisation’s failure in leadership. The company had two different cooperate cultures that brought confusion. Leaders also appeared to be more concerned about the bottom line than the company’s reputation and that of the employees and customer satisfaction. In light of the recent bribery and misconduct allegations, there were several omissions and weaknesses in GSK’s code of conduct. GSK’s code of conduct posed as mere clichés rather than set of codes that demanded reasonable behaviour from employees. GSK’s codes of conduct also failed to provide detailed and specific prohibitions on certain prevalence behaviours within the industry. To prevent future ethical dilemmas and to restore its damaged reputation, GSK needs to build an ethical organisation. Six steps of integrative model of organisational trust are proposed in this respect. It will include leadership and management, culture, systems, product development and service delivery, stakeholders and strategy. Table of Contents Executive Summary 2 Table of Contents 3 Introduction 4 Part 1 4 Ethical lapses that affected product quality at GSK 4 Causes of GSK's leadership failure to prevent ethical issues related to integrity 8 PART 2 11 Weaknesses and omissions in GSK’s code of conduct 11 Actions GSK can undertake to prevent future ethical dilemmas and disrepute 14 Conclusion 18 References 18 Introduction Ethics refers to a systematic process of reflection where issues that one is morally obligated to perform are decided, analysed and evaluated, using moral reasoning that covers ethical theories and principles. Ethics can be defined as the issues relating to the nature of morals in addition to certain moral choices that should be made by an individual, institution or a company. Put differently, ethics derives from an individual or an institution’s moral philosophy. This essay analyses ethics at GSK. Examined include ethical lapses that affected product quality at GSK, causes of GSK's leadership failure to prevent ethical issues related to integrity, weaknesses and omissions in GSK’s code of conduct and the actions GSK can undertake to prevent future ethical dilemmas and disrepute. Part 1 Ethical lapses that affected product quality at GSK Ethics can be defined as the issues relating to the nature of morals in addition to certain moral choices that should be made by an individual, institution or a company. Put differently, ethics derives from an individual or an institution’s moral philosophy. GSK’s roles as pharmaceutical company entailed research, production and development of drugs. All these roles implied the company was entrusted with the role of promoting and sustaining human health. However, the company seemed to have failed on its moral obligation in fulfilling the duty as it was involved in a range of unethical practices. In this regards, several ethical lapses affected GSK’s product quality. GlaxoSmithKline was involved in a range of unethical practices concerning its quality control, marketing and product liability. It faced great criticism from the public for selling drugs whose quality it had not verified, especially those it suspected or knew could be harmful to the patients’ health. This signifies that the company had failed on its quality assurance, a term that refers to a system of practices aimed at ensuring that the quality of a product is able to satisfy an intended purpose with reasonable confidence. Several researchers have argued that in the manufacturing industry, ethics are tied to quality assurance (Bazerma & Tenbrunsel 2011). In this case, an assumption could be made that at GSK, quality assurance should have covered all issues that collectively or individually influenced the product quality. The keynotes for quality assurance are that the quality system are the cornerstone of effective management of the organisation, based on the philosophy of prevention and that are able to meet the entire business processes (Halis, Akova & Tagraf 2007). Based on this background, it is clear that quality assurance calls for compliance with ethical standards. For a pharmaceutical company such as GSK, quality assurance is categorised into quality control, distribution, production and inspection. Based on the facts provided by the case, GSK flouted all the four areas (Ferrell & Ferrell 2012). The company had two of its research trials for its drugs, Avandia and Paxil, fixed to falsify the results and to “gloss over” results. Paxil, which was an antidepressant, was found to be able to alleviate depression symptoms while at the same time worsening its key side effects such as suicidal tendencies and birth defects (Ferrell & Ferrell 2012). Essentially, manufacturers are morally obligated to test and ensure quality, efficacy and safety of their products. Generally, all these activities are covered under good manufacturing practice (GMP) in quality assurance. Good manufacturing practice is a component of quality assurance that covers manufacturing and testing drugs to ensure that the critical procedures in manufacturing process are validated. With regard to safety and efficacy, GMP essentially ensures ethical conduct (Noordin 2012). Additionally, despite the fact that GSK targeted children with its marketing of Paxil, it was found that the children were the most vulnerable group to the side effects. Ultimately, the company had a class action filed against it for misconduct on claims that it was marketing Paxil for the children while hiding facts about the safety of children who used the drug. On the other hand, Avandia, which was a diabetes medication, had questionable quality given the severity of its potential to increase heart attack (Ferrell & Ferrell 2012). Subsequent studies had revealed that patients who used the drug could suffer from heart attacks. It was alleged that the company had been aware about the risks but failed to inform the public about it. The two examples show evidence that the intended purposes of the drugs, such as alleviation of systems and enhancing life, had been compromised to an extent where their qualities became dubious. Maria Carmen, a psychiatrist specialist employed by the company, confessed to having been involved in research fraud at the trial phase of Paxil and falsified the inferences regarding the psychiatric diagnoses (Ferrell & Ferrell 2012). She was found guilty of falsifying records, fraud and diagnosing underage children and concealing crime. All the charges evidence that the company had yet to institute ethics as an organisational culture. Another lapse was more direct, as it involved a physical compromise at the company’s product site. A number of drugs initially labelled for being “bacteria free” had in actual fact had some discrepancies regarding its quality because of unhygienic practices. Workers at the company’s production plant used bacteria-contaminated water and raw materials whose cleanliness quality had been unverified. The company had allowed its employees to use bare hands inside sterile control tanks, exposing the tanks to contamination (Ferrell & Ferrell 2012). Additionally, since employees did not clean the machines, scenarios where medications could get mixed up became likely. As a global leader in the pharmaceutical industry, its focus should have been on corporate social responsibility, which also entailed responsible marketing. However, the conduct of the company and the litigations brought against it symbolised that it had failed on using ethical conduct as its driving force (Noordin 2012). Following the merger of SmithKline and Glaxo Wellcome to form GlaxoSmithKline, the company seemed to be more profit-driven than service- or quality-driven. Pharmaceutical companies have the moral obligation and a duty to maintain an ethical relationship with the consumers. They are required by the code of conduct to uphold the safety and care of human beings. Pharmaceutical companies are therefore morally obligated to inform the public of the true efficacy and the side effects of the drugs during marketing. Pharmaceutical companies need to market the drugs as well as give information on how to use the new drugs, drug interaction with food or other drugs and the side effects (Ferrell & Ferrell 2012). From the analysis, it means that the pharmaceutical industry should be greatly dependent on code of ethics (Ferrell & Ferrell 2012). However, GSK’s ethics was more profit-driven that quality-driven. Generally, for a pharmaceutical company such as GSK, the driving force should be ethical conduct. Causes of GSK's leadership failure to prevent ethical issues related to integrity Ethics refers to a systematic process of reflection where issues that one is morally obligated to perform are decided, analysed, evaluated using moral reasoning that covers ethical theories and principles. Based on this definition, leadership and decision making are essential elements in an organisational environment where “profit focus” is replaced by a “service focus.” Indeed, the orientation towards profit-oriented business has threatening impacts on ethical conduct. It is based on this background that the factors that caused GSK to fail in preventing ethical issues relating to integrity can be analysed (Ferrell & Ferrell 2012). The leaders were expected to institute ethical culture in the organisation. Failure in ethics showed the organisation’s failure in leadership. Indeed, in the case study, this was preventable tragedy because of the limited effort in which the leaders in the organisation could have created, defined, implemented and sustained a logical, intelligent, morally and ethically defensible code of conduct. For the employees to adopt ethical behaviour, some theorists have postulated that conditions of role flexibility, power, inquiry, inclusion, trust and power must exist. For instance, workers need to have the capacity to receive the right information (inclusion), to feel the freedom to suggest something (power), to feel they have the freedom to complain or disagree with an issue and to increase their knowledge on an issue (trust). The company had two different cooperate cultures that brought confusion. As a result of this, employees received two different perspectives whenever confronted with ethical dilemmas. The company was hence unable to integrate ethics as culture due to conflicting approaches to management after the merger. The conflicting management styles from the start can be argued to have caused the disgruntled leadership. Glaxo Wellcome CEO Richard Sykes had a different approach to management compared with that of SmithKline’s director Leschly. Leschly had a stern management approach and performance-based culture conflicted with that of Syke’s belief in traditional management approach. In general, while no code of conduct is wide enough to cover all possible scenarios, it can be helpful in instituting an ethical culture, which could give organisation ethical leadership credibility. Employees who reported issues of concern were either dismissed or downsized. This is demonstrated by the fact that when quality control manager at GSK’s Cidra plant informed the company of bacteria-tainted water in addition to the contaminated raw material. No action had been taken. Additionally, Eckard had claimed that some medications were either too strong or weak. She told her superiors about the problem. However, no action had been taken. She later sent a summary to the company’s seven executives that informed of the high risk of the plant. However, she was instead demoted. Eckard became a whistleblower. In general, leadership as the principle fact capable of determining whether a company is able to integrate ethics effectively into a company strategy. This brought fear and lack of transparency that is essential for an ethical corporation. Indeed, only a dynamic and an effective leadership are able to set a corporate culture that averts damage to a company’s reputation, which causes unethical behaviour. Leaders failed to make ethics a priority. Indeed, the leaders appeared to be more concerned about the bottom line than the company’s reputation and that of the employees and customer satisfaction. When Jean-Paul Garnier became the CEO of the company in 2000, his priorities seemed misplaced due to the confusions in leadership styles resulting from the merger. He had to patch up two diverse corporate cultures, as well as confront criticisms from the shareholders and consumers as well as control a number of worst drugs in the pipeline. Rather than prioritising on establishing ethics is a corporate culture, the company instead centralised marketing and clinical trials. GSK also deemed it necessary to remain competitive. This shows that little significance was given to building ethics as a culture to build integrity across the organisation. The failures in leadership could also be attributed to the inability of the leadership to hold the company true to its values of corporate social responsibility. For instance, given the number of allegations and class action lawsuits brought against the company, the leadership seems to have continued to act unethically. The company had used some 3.49 billion to deal with a litigation case that concerned the company Avandia lawsuits and marketing malpractices. Indeed, in the previous year, the company paid $2.59 billion in lawsuit settlements regarding Paxil and Avandia in addition to charges that stemmed from investigations into its plant in Puerto Rico. The company continued to be criticised with claims of “off-label” drug promotion that had the potential to harm consumers. For instance, the drug intended for use as an antidepressant had been prescribed for weight loss to a patient. Leaders can also allow the company to pursue outmoded business models even when there is evidence that the assumptions in which such models were based have changed. In the case, it is clear that the leaders needed to recognise the threats to the company’s reputation posed by unethical marketing practices. A failure to recognise such factors was however evident. It was arguably the key reason behind the continual ethical misconducts even after expensive law suits that affected the company’s finances. PART 2 Weaknesses and omissions in GSK’s code of conduct In light of the recent bribery and misconduct allegations, there were several omissions and weaknesses in GSK’s code of conduct. GSK was accused in July 2013 by the Chinese police for massive bribery scandal over sale of drugs that involved some 700 middle men and millions of dollars in bribes in a span of six years (Pratley 2013). Following the allegations, the police detained GSK executives after claims that they had been involved in bribing Chinese officials, hospitals and doctors to raise the sale of medicine and to boost sale of GSK drugs. Some allegations were also made that the company’s employees received bribes that were sexual in nature in addition to the cash bribe from the company’s middle men. It was found that bribery is a key activity of the company to boost sales and increase sale of drugs (Pratley 2013). GSK’s code of conduct posed as mere clichés rather than set of codes that demanded reasonable behaviour from employees. In which case, GSK’s code of conduct was supposed to be the ultimate terms of reference for employees’ conduct. This shows weaknesses and omissions in the company’s code of conduct. Codes of conduct are written with the purpose of guiding behaviour. Indeed, the key implication of code of conduct is that it should guide and affect employee behaviour. Some researchers have debated on whether codes of conducts should generally revolve around general codes as mere clichés or whether there should exist a more detailed codes of conduct that require behaviour on how reasonable people should conduct themselves (Gilman 2005). Scholars have reached a consensus that codes of conduct should be more detailed to required behaviour rather than pose as mere expressions (Gilman 2005). In the case of GSK’s code of conduct, it is clear that it merely posed as a set of clichés rather than a code that required reasonable conduct of behaviour (Pratley 2013). GSK’s codes of conduct failed to provide detailed and specific prohibitions on certain prevalence behaviours within the industry. Instead, they were merely broad set of principles intended to inform of specific laws governing employees within the organisation. Indeed, it is based on this background that it can be argued that they failed to specifically prohibit bribery in details, such as through cash bribes or sextortion. The codes of conduct should have been able to provide a framework that guided how the managers should carry out their responsibility, such as promoting sale of drugs in other ways other than through bribery. The codes had certain omissions and weaknesses that prevented it from ensuring professionalism in emerging markets. For instance, they failed to unambiguously articulate unacceptable behaviour as well as provide a vision for which the company should operate in emerging multinational markets, such as China. Indeed, when GSK’s CEO Sir Andrew Witty was asked to comment about the scandal, he responded that it seemed individuals has acted outside the company’s system, which indicated that the controls and audits were not strong enough for high risks markets such as China (Pratley 2013). Some observers have also argued that compliance programs that are not enforced in good faith such as in ensuring corporate management implicitly and explicitly can encourage employees to engage in misconduct. This is what happened at GSK. The codes should have been more detailed to ensure that the managers and the employees are all subject to safeguards that promoted transparency, efficiency and recruitment of sale staff based on merit. After recruitment, it should have further ensured that the recruits are subject to codes of conducts with an added emphasis through training as well as set out the relevant disciplinary measures. The code of conduct failed to elaborate on accountability and transparency within the company and between the company and outsiders or stakeholders. It should have established specific requirements that could prevent corruption, specifically with regard to sale and promotion of drugs. This could have ensured that the stakeholders expect high standard of conduct from the company’s sales representative and middle men. Further, it would have been able to articulate a special sense of responsibility on the part of the company’ sales workforce and middlemen. In the case of GSK, the company was accused of massive bribery scandal over sale of drugs that involved some 700 middle men and millions of dollars in bribes in a span of six years by the Chinese police. Such allegations are proof that the code of conduct failed to guide the company and its stakeholders such as the middlemen. GSK’s code of conduct must have also been weak enough to appeal to emotions of the workforce. Gilman (2005) argued that the value of code of ethics should originate from cognitive (reasoning) demands that enable the workforce to understand such codes in addition to giving them the capacity to appeal to human emotions. Gilman’s (2005) assumption is based on the argument that emotions such as shame, guilt, pride and conscience in profession can be essential in motivating ethical behaviour. The researcher pointed out that emotive elements are a critical consideration in determining how to create codes of conducts that have impact. Basing on this analysis, it can be argued that GSK’s code of conducts lacked enough capacity to appeal to emotive elements such as guilt and shame as well as pride in profession. The scandal covered a span of six years and involved more than half of the staff in China, which evidences that there was no guilt and shame of misdoing on the part of the errant staff. The company should have used the codes as a management tool. Since managers in high risk markets such as China faced difficulty in directing behaviour in relation to influencing high sales, the codes could have been used to clearly articulate new professional standards (Shobert 2013). In this way, GSK could have been able to minimise the impact of bad actors in addition to eliminating. The principles should have made the individuals managers responsible as well as assessed them to be effective in eliminating errant behaviours. In all, good ethics should have emphasised rules and principles. Actions GSK can undertake to prevent future ethical dilemmas and disrepute To prevent future ethical dilemmas and to restore damaged reputation, GSK needs to build an ethical organisation. The company needs to institute ethics and compliance in the organisation (Kramer 2006). This will in particular involve setting up informal and formal constraints, expectations, incentives, norms and values capable of influencing employee behaviour as well as that of its stakeholders (Fox 2013). In this respect, a six-step approach called “Integrated Model of Organisational Trust” can be suggested for the company to establish a culture of ethics and compliance. In addition to embedding a culture of ethics and compliance into the company, the model will establish the six signals employees in the organisation can rely on when they make decisions of trust into their core functions. Schoorman, Mayer and Davis (2007) argue that this has the capacity to earn the company trust from stakeholders. The six steps of integrative model of organisational trust include leadership and management, culture, systems, product development and service delivery, stakeholders and strategy. Leadership and management: in reconstructing leadership and management, the management should be able to integrate all levels of company value, serve all stakeholder interests as well as check that all stakeholder interests are served competently and with integrity. The management should also be able to communicate with the employees openly as well as listen and show concern to their interests. The management should also be able to hold the teams accountable to execution of the corporate strategy with competence (Dietz & Gillespie 2012). Culture: GSK should instil culture requiring shared beliefs and norms to encourage all stakeholders to maintain companywide value as well as prevent deviation from set values. The company should check that the cultural values are strong enough to bond employs as well as ensure respect of stakeholders and ensure that they act with integrity (Dietz & Gillespie 2012). This will ensure that business is done with integrity while delivering all stakeholder expectations. Systems: GSK should put up a system in place that ensures reinforced planning and reporting as well as budgeting to strengthen behaviour that are ethical and compliant, and which are linked to corporate strategy and culture (Fox 2013). In this respect, GSK should have an effective communication system that ensures employees and managers can effectively communicate and that the company can ably communicate meaningfully as well as ensure mutual dialogue with various stakeholders. Most importantly, the company should have a robust mechanism that promotes effective reporting of ethical violations (Schoorman, Mayer and Davis 2007). Product development and service delivery: GSK should develop a process that ensures that all needs and expectations of the stakeholders are met. The process should also ensure that the corporate values are upheld and that the anticorruption and anti-bribery laws are complied with (Schoorman, Mayer and Davis 2007). In this respect, GSK should see to it that all production and development processes focus on serving the company as well as its stakeholder interests, including the suppliers and customers. GSK should have a supply chain and marketing process that is monitored to meet the goals of fairness, respect and competence to reach company as well as stakeholder expectations (LRN 2007). Structure: GSK should have formal organisation and governance that is able to set clear roles as well as accountability. It should also be able to provide discretion. To ensure this, the company should ensure that its structure offers clear roles, accountabilities, responsibilities as well as aligns to the interests of stakeholder groups (Schoorman, Mayer and Davis 2007). The corporate structure should also be able to provide sufficient governance and monitoring across all levels to ensure execution of competence in a way that upholds the corporate values. The company’s structure should also promote open communication with the stakeholders (Fox 2013). Strategy: GSK should also have a clear mission that ensures it does business ethically as well as in compliance with its code of ethics. They should also be able to accommodate stakeholder values. GSK should therefore check that the company is clear about its strategy and mission to accommodate the needs of its stakeholders, particularly its customers. The implementation of the strategy should also be evaluated from the perspective of all stakeholders. The company’s strategy should also align with promoting values and integrity. The company should also ensure that any strategic trade-offs are more in a fair and transparent manner (Dietz & Gillespie 2012). Fox (2013) and Schoorman, Mayer and Davis (2007) further suggested that all the six concepts have to be integrate fully into the organisation to effectively wade off future ethical dilemmas and repair any reputational damage without which compliance and ethics may fail. This is since significant elements may be allowed to become misaligned. In which case, further actions can also be done to rebuild reputational damage. Fox (2013) suggests investigation, evaluation and organisation reform. Investigation: conducting investigations are essential for an effective process in repairing a corrupt corporation. The company should conduct investigations into its Chinese subsidiary with rigor, independence, accuracy and credibility to discover all corrupt individuals (Brodhead & Higbeem 2012). Such attempts are necessary in situations where a company is concerned about building its reputation that it is unwilling to engage in the extent of examination needed to eliminate entrenched corruption tendencies. After an investigation report is made, the company should make recommendations for systematic reforms (Fox 2013). Organisational reform: GSK should institute systematic reforms that ensure universal change across all departments in its Chinese subsidiary. To ensure this, the reforms need to be congruent and reinforcing to allow trustworthiness to be embedded in organisational culture. This implies that in addition to the leaders changing the ways in which they operate, employees should also change the ways in which they do their marketing, or general work. The focus should be on stemming out bribery and corrupt tendencies among the leaders and the employees (Brodhead & Higbeem 2012). Evaluation: After the systematic reforms are made, they still need to be evaluated to see to it that they are functioning as intended and that drawbacks are addressed. This is since a truly systematic change can be increasingly difficult when it falls short of ensuring that business is done ethically (Fox 2013). Conclusion Leadership and decision making are essential elements in an organisational environment where “profit focus” is replaced by a “service focus.” Dwelling too much on profit-making and have in imbalanced priority with regard to meeting stakeholder needs can cause ethical misconducts. Indeed, the orientation towards profit-oriented business has threatening impacts on ethical conduct. It is based on this background that the factors that caused GSK to fail in preventing ethical issues relating to integrity are analysed. For the employees to adopt ethical behaviour, conditions of role flexibility, power, inquiry, inclusion, trust and power must exist. For instance, workers have to have the capacity to receive the right information (inclusion), to feel the freedom to suggest something (power), to feel they have the freedom to complain or disagree with an issue and to increase their knowledge on an issue (trust). To prevent future ethical dilemmas and to restore is damaged reputation, GSK needs to build an ethical organisation. The company needs to institute ethics and compliance in the organisation. This will in particular involve setting up informal and formal constraints, expectations, incentives, norms and values capable of influencing employee behaviour as well as that of its stakeholders. The six steps of integrative model of organisational trust that GSK can use include improving leadership and management, culture, systems, product development and service delivery, stakeholders and strategy. References Dietz, G & Gillespie, N 2012, The Recovery of Trust: Case studies of organisational failures and trust repair, Institute of Business Ethics, London Bazerman, M & Tenbrunsel, A 2011, Ethical Breakdowns, Harvard Business Review, viewed 26 Jan 2014, http://hbr.org/2011/04/ethical-breakdowns/ar/1 Brodhead, M & Higbeem T 2012, "Teaching and Maintaining Ethical Behavior in a Professional Organization," Behav Anal Pract. Vol. 5 No. 2, 82–88. Ferrell, C & Ferrell, J 2012, Business Ethics: Ethical Decision Making & Cases, Cengage Learning, New York Fox, T 2013, How to Build a Culture of Ethics and Compliance, Compliance Alert, viewed 27 Jan 2014, http://compliancealert.org/how-to-build-a-culture-of-ethics-and-compliance/ Gilman, S 2005, Ethics Codes And Codes of Conduct as Tools For Promoting an Ethical and Professional Public Service: Comparative Successes and Lessons, viewed 26 Jan 2014, http://www.oecd.org/mena/governance/35521418.pdf Halis, M, Akova, O & Tagraf, H 2007, "The Relationship Between Ethics And Quality: Conflicts And Common Grounds," Serbian Journal of Management, Vol. 2 No. 2, pp127 - 145 Kramer, R 2006, Organizational Trust: A Reader, Oxford University Press, Oxford Noordin, M 2012, Ethics in Pharmaceutical Issues, viewed 27 Jan 2014, http://www.intechopen.com/download/get/type/pdfs/id/31746 LRN 2007, Ethics and compliance risk management, viewed 26 Jan 2014, http://www.ethics.org/files/u5/LRNRiskManagement.pdf Pratley, N 2013, GlaxoSmithKline should have seen the warning signs in China, The Guardian, viewed 27 Jan 2014, http://www.theguardian.com/business/blog/2013/jul/24/glaxosmithkline-china-andrew-witty-corruption Rolland, 2008, “Whistle Blowing in Healthcare: An Organizational Failure in Ethics and Leadership,” The Internet Journal of Law, Healthcare and Ethics, Vol. 6 No. 1, viewed 26 Jan 2014, http://ispub.com/IJLHE/6/1/9204 Schoorman, D, Mayer, R & Davis, J 2007, "An Integrative Model of Organizational Trust: Past, Present, and Future," Academy of Management Review, Vol. 32, No. 2, 344–354 Shobert, B 2013, Why Glaxo’s China scandal needed to happen, CNBC News, 27 Jan 2014, http://www.cnbc.com/id/100923253 Smart, V & Barman, T 2010, Incorporating ethics into strategy: developing sustainable business models, viewed 26 Jan 2014, http://www.cimaglobal.com/Documents/Professional%20ethics%20docs/Incorporatingethicsintostrategyweb1.pdf Read More

Based on the facts provided by the case, GSK flouted all the four areas (Ferrell & Ferrell 2012). The company had two of its research trials for its drugs, Avandia and Paxil, fixed to falsify the results and to “gloss over” results. Paxil, which was an antidepressant, was found to be able to alleviate depression symptoms while at the same time worsening its key side effects such as suicidal tendencies and birth defects (Ferrell & Ferrell 2012). Essentially, manufacturers are morally obligated to test and ensure quality, efficacy and safety of their products.

Generally, all these activities are covered under good manufacturing practice (GMP) in quality assurance. Good manufacturing practice is a component of quality assurance that covers manufacturing and testing drugs to ensure that the critical procedures in manufacturing process are validated. With regard to safety and efficacy, GMP essentially ensures ethical conduct (Noordin 2012). Additionally, despite the fact that GSK targeted children with its marketing of Paxil, it was found that the children were the most vulnerable group to the side effects.

Ultimately, the company had a class action filed against it for misconduct on claims that it was marketing Paxil for the children while hiding facts about the safety of children who used the drug. On the other hand, Avandia, which was a diabetes medication, had questionable quality given the severity of its potential to increase heart attack (Ferrell & Ferrell 2012). Subsequent studies had revealed that patients who used the drug could suffer from heart attacks. It was alleged that the company had been aware about the risks but failed to inform the public about it.

The two examples show evidence that the intended purposes of the drugs, such as alleviation of systems and enhancing life, had been compromised to an extent where their qualities became dubious. Maria Carmen, a psychiatrist specialist employed by the company, confessed to having been involved in research fraud at the trial phase of Paxil and falsified the inferences regarding the psychiatric diagnoses (Ferrell & Ferrell 2012). She was found guilty of falsifying records, fraud and diagnosing underage children and concealing crime.

All the charges evidence that the company had yet to institute ethics as an organisational culture. Another lapse was more direct, as it involved a physical compromise at the company’s product site. A number of drugs initially labelled for being “bacteria free” had in actual fact had some discrepancies regarding its quality because of unhygienic practices. Workers at the company’s production plant used bacteria-contaminated water and raw materials whose cleanliness quality had been unverified.

The company had allowed its employees to use bare hands inside sterile control tanks, exposing the tanks to contamination (Ferrell & Ferrell 2012). Additionally, since employees did not clean the machines, scenarios where medications could get mixed up became likely. As a global leader in the pharmaceutical industry, its focus should have been on corporate social responsibility, which also entailed responsible marketing. However, the conduct of the company and the litigations brought against it symbolised that it had failed on using ethical conduct as its driving force (Noordin 2012).

Following the merger of SmithKline and Glaxo Wellcome to form GlaxoSmithKline, the company seemed to be more profit-driven than service- or quality-driven. Pharmaceutical companies have the moral obligation and a duty to maintain an ethical relationship with the consumers. They are required by the code of conduct to uphold the safety and care of human beings. Pharmaceutical companies are therefore morally obligated to inform the public of the true efficacy and the side effects of the drugs during marketing.

Pharmaceutical companies need to market the drugs as well as give information on how to use the new drugs, drug interaction with food or other drugs and the side effects (Ferrell & Ferrell 2012).

Read More