Question: In early spring 2 0 0 8 , Anders Dejgaard, chief medical officer of Novo Nordisk, a leading developer and manufacturer of insulin and related

In early spring 2008, Anders Dejgaard, chief medical officer of Novo Nordisk, a leading developer and manufacturer of insulin and related products, is contacted by a business journalist from the Danish national newspaper Berlingske Tidende. The journalist is investigating the offshoring of clinical trials by Danish companies, which have been accused of conducting trials in developing countries under allegedly unethical conditions. The Danish National Committee on Biomedical Research Ethics has expressed concerns about the lack of ethical reviews for such trials in Denmark. Dejgaard is considering whether to meet with the journalist or focus on his business trip to new production facilities. Novo Nordisk, created in 1989 through a merger between two Danish companies, has a broad and innovative diabetes product portfolio, including advanced insulin delivery systems. The company holds market shares for insulin of about 56% in Europe, 41% in North America, and 73% in Japan. In 2008, about 18% of employees are working within research and development.
Novo Nordisk is a leading pharmaceutical company that prioritizes corporate social responsibility, focusing on environmental, social, and economic viability. The company has been recognized for its commitment to sustainability through its Environmental Report, Social Report, and World Diabetes Foundation. Novo Nordisk has also been included in the Dow Jones Global Sustainability Indices, ranking as "best in class" in the healthcare category in 2007.
The company heavily invests in the development of new medications, which must be approved by regulatory authorities like the FDA and EMEA. Clinical trials are conducted in four stages: Phase 1, which assesses the drug's kinetic properties and tolerability; Phase 2, which assesses the drug's effectiveness and safety; and Phase 3, which involves thousands of patients to provide a definitive assessment of the drug's effectiveness and safety.
These trials are often conducted as multinational studies involving up to 15 countries, with increasing patient exposure requirements and drug testing numbers. These trials are often conducted at multiple hospitals, ensuring consistency and compliance with existing guidelines. Multi-site trials also facilitate the recruitment of patients with diverse backgrounds and demonstrate their universal properties.
In the early 2000s, major pharmaceutical industries moved parts of their trials to countries outside their traditional areas, such as Eastern Europe, South America, India, and China. These trials provide access to qualified medical staff and larger numbers of patients with specific conditions, potentially at lower costs. However, conducting clinical trials in these areas raises ethical issues.
The pharmaceutical industry has faced significant ethical issues, particularly in clinical trials, which have been criticized for failing to meet the expectations of interest groups. Medical professionals and NGOs focus on the Hippocratic oath, which commits doctors to treat each patient to the best of their abilities, never cause intentional harm, and maintain patient confidentiality. Scientists and approval authorities are concerned about the scientific rigor of tests to provide solid evidence of the effects of a new drug and protect potential future users. Pharmaceutical companies have been accused of performing trials in developing countries with lower attention to ethical principles, leading to accusations of "ethical bribing" and generating documentation for compounds sold only in developed countries.
Medical ethics concern primarily the individual patients participating in any experiment, with the relationship between the doctor and the subject governed by the doctor's responsibility to care for their patient. To prevent such scandals, professional medical organizations have developed guidelines and principles of ethics, such as voluntary informed consent, respect of patients, and independent review. Scientific ethics are concerned about the validity of the results of the scientific inquiry and the methodological rigor of the study.
Ethical businesses must balance their interests with their pursuit of profits, with some arguing that firms should prioritize shareholders over other interest groups. Others believe that firms should engage in corporate social responsibility to benefit their bottom line in the long run, while others believe that firms have an intrinsic, normative responsibility to do good for society and aspire to the highest moral standards. However, their financial resources will be limited, and businesses must make critical decisions about how best to use their scarce resources.
Placebo trials, where a control group of patients receives a new method, have raised concerns about their ethical implications. The World Health Organization (WHO) reaffirms its position that extreme care must be taken in using placebo-controlled trials, and that in general, this methodology

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