Western Pharmaceutical Companies Research Articles

What COVID-19 Vaccine Distribution Disparity Reveals About Solidarity

What COVID-19 Vaccine Distribution Disparity Reveals About Solidarity

In Shortage: Understanding Global Antibiotic Supply Chains Through Pharmaceutical Trade Fairs

Many countries have reported supply shortages of antibiotics in recent years. The COVID-19 pandemic has sparked interesting discussions among government officials, public health practitioners, and scholars on how to maintain the security of the global pharmaceutical supply chain and how to decrease dependency on countries such as China. This article discusses the experiences and initial findings of tracing global pharmaceutical supply chains through pharmaceutical trade fairs and events at multiple locations. I argue that the reasons behind antibiotic supply shortages are multifold. Although the geographical concentration of the production of key raw materials and Active Pharmaceutical Ingredients (APIs) in China is considered the main reason for the unstable and disrupted supply chain, it is also important to recognize that the same forces that have driven Western pharmaceutical companies to shift some of their less profitable manufacturing lines to China are also challenging Chinese pharmaceutical companies to adjust and reorient their strategies. As such, antibiotics are facing a conundrum in which the governance of excessive use is complicated by a shortage problem that hampers access to essential drugs.

The Economic Implications of the Relationship between Pharmacy and Psychiatry in Lithuanian 2001-2020: The Problem of Biomedical Access

Although previous research in Lithuania has indicated the construction of the diagnosis and treatment of mental illness through historical and cultural chapters, a considerable amount of research has been published in foreign literature that has emphasized the role of the pharmaceutical industry in diagnosing and treating mental illness. In this paper we examine the relationship between the pharmaceutical industry (pharmaceutical and medical device manufacturing companies), healthcare professionals and healthcare organizations in the mental health field. The relationship between the pharmaceutical industry (pharmaceutical and medical devices manufacturing companies) and healthcare professionals can be analyzed in two ways: research-oriented interactions and promotion practices. This relationship is inevitable and can be beneficial, however, conflicts of interest arise, which create a risk of potential harm to users and patients (e.g. as receiving suboptimal or unsuitable treatment, or waste of private and public money). This research analyzes both the relationship between the diagnosis and treatment of mental illness and the pharmaceutical industry market in Lithuania in 2010-2020, as well as the efforts of Lithuanian health care institutions in restructuring the mental health care system. Based on the analysis of the literature and statistical data, we state that after the restoration of independence, the main method of mental health treatment in Lithuania is still medical treatment, i.e., patients with mental illnesses and behavioral disorders are treated with medication. The main factors determining the still dominant method of medical treatment of mental illness are the following: first of all, the Soviet legacy (the paradigm of medical treatment - the Soviet paradigm); secondly, the restoration of independence in our country has created excellent conditions for Western pharmaceutical companies to develop their activities and increase sales of medicines, including psychotropic drugs; and third, medical treatment is cheaper for the state than complex treatment. This study draws on an analysis of the social origins of mental illness, while reviewing the previously unappreciated role of the interests of pharmaceutical companies in expanding their markets for the treatment of mental illness with drugs.

The Use of Avian Yolk Antibodies in the Inactivation of Highly Toxic Components of Biological Weapons and Especially Dangerous Infections

Currently, Western pharmaceutical companies have mastered the production of licensed drugs based on transovarial chicken specific antibodies (IgY antibodies) intended for the treatment and prevention of infections caused by Helicobacter pylori, influenza virus and other pathogens. Of particular interest is the possibility of using IgY antibodies as an inexpensive specific antidote for emergency specific prevention of infections caused by pathogens of dangerous and especially dangerous infections. The purpose of this work is to summarize the results of studies that have shown a high therapeutic potential of transovarial specific immunoglobulins in the treatment and prevention of dangerous viral, bacterial infections and injuries by biological toxins – potential agents of biological weapons (BW). The advantage of using IgY technologies for passive immunization is a non-invasive method for obtaining antibodies, as well as a large amount of them – 20–30 g of immunoglobulins, which can be obtained from one laying hen per year. An important advantage of IgY over immunoglobulins derived from mammalian serum is that they do not interact with complement components, nor with rheumatoid factor, nor with Fc receptors of mammalian immunocompetent cells, which significantly reduces the manifestation of adverse reactions, in particular, antibody-dependent enhancement of infection (ADE). Experiments carried out in vivo and in vitro showed a high activity of IgY antibodies in suppressing the damaging effect of pathogens of especially dangerous infections and biological toxins. It is shown in the article, that the replacement of mammalian IgG with avian transovarial IgY allows obtaining commercially significant amounts of thermostable specific antibodies that do not cause ADE, and expands the possibilities of methods for specific prevention and treatment of lesions caused by viruses, bacteria, and toxins – potential agents of biological weapons

First World Medical Practices as Tools for Dominance:

This paper examines how the introduction of novel medical practices in third-world countries is complicit with the pharmaceutical politics of the First World, as projects of medical welfare have been used by the First World to generate capital by establishing pharmaceutical companies in the Third World. This study draws on Deepika Bahri’s concept of ‘postcolonial biology’ and Frantz Fanon’s critique of the nexus of capitalism, colonialism and the ruthless medical practices carried out by the First World in the Third World. This paper presents an analysis of John le Carre’s The Constant Gardener and Sonia Shah’s The Body Hunters: Testing New Drugs on the Poorest Patients to uncover the patterns through which Western pharmaceutical companies dehumanise native Africans by testing lethal vaccines on them without their consent. Through the analysis of these texts, we propose that the First World is guilty of ‘biological neo-colonialism’ as these countries experiment lethal drugs on the people of the Third World, which cause permanent deformities in these individuals. At the same time, the bureaucrats and governments of these third-world countries do not hesitate to assist such ventures, and they lure the needy by offering them medication at low cost that have direct horrible health consequences. Such medical practices create suspicion among the natives regarding Western medicine, and when they reject using it, they are labelled as backward people.Keywords: Biological colonisation, biological neo-colonialism, exploitative capitalism, pharmaceutical politics, Third World exploitation.

Indigenous knowledge codification of African traditional medicine: Inhibited by status quo based on secrecy?

This paper is located within global debates about the codification of indigenous knowledge (IK) practices vis-à-vis traditional medicine in Africa. Following a theoretical research based on an extensive literature review, the paper questions whether it is possible to codify all elements embedded in Africa’s indigenous knowledge practices in traditional medicine following that the medicine encompasses esoteric and non-esoteric elements. There is a persistent plea for the elements of Africa’s indigenous knowledge practices in traditional medicine to be codified and to desist from its status-quo phenomena of secrecy for posterity. Within Africa’s indigenous knowledge (IK) practices in traditional medicine are certain aspects that it may not be possible to codify. The non-esoteric aspect of African traditional medicine can be codified as it encompasses no secret, while the esoteric aspect may not be codified as it is considered to be secret for a select few traditional healers who exploit it for livelihood. The raison d’être for the examination stems from the notion that Africa’s indigenous knowledge practices in traditional medicine has a high livelihood potential, hence needs to be protected. Traditional healers have over generations fostered relationships with other groups, creating a complex web of high levels of cooperation, exchange and support that are essential for livelihood. Their fast erosion due to internal and external factors poses a serious threat to livelihood development in the subregion. The lack of codification of Africa’s indigenous knowledge practices in traditional medicine gives an urge to western pharmaceutical companies, who make huge profits from indigenous knowledge of medicinal plants. With further theoretical research, the paper exposes the esoteric and non-esoteric elements that encompass African traditional medicinal plants and the possible reasons why the status-quo based on secrecy persists within the esoteric aspects of the medicinal plant practices and how the status-quo may be uplifted within intellectual property rights (IPR) in the form of patent and other approaches for posterity.

The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961-1990).

BackgroundAfter the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the archives of the GDR State Security Service (Stasi, MfS) has not been systematically analysed. Until now, the role of the Stasi with respect to the surveillance of the trials has been unclear.MethodsA keyword search within the database of the Stasi files was conducted. All available files were screened in order to identify institutions, companies and personnel involved in the clinical trials. On this basis, further files were requested. A total of 259 files were available for analysis. Relevant data was derived from 160 of these files. A contextualised approach was applied, which critically explored the origin, content, and impact of the data. In addition, an approach guided by the central steps of document analysis was applied.ResultsAt least 400 clinical trials were conducted during the GDR period. The exact number remains speculative. According to references found in the Stasi files, it might have been considerably higher. Initially, the main goal of the trials was for the GDR authorities to decide whether to import certain Western drugs. By 1983, this intention had changed. Now, the primary aim of the trials was the procurement of foreign currency. The Stasi feared that the pharmaceutical companies could have a significant influence on GDR Health System. Stasi spies were holding positions in the responsible medical committees, universities, and hospitals. Constant surveillance by the Stasi served the purpose of monitoring any contact between people from the West and the East. Unknowingly, representatives of Western companies were surveilled by the Stasi. The studied documents also point to the fact that a number of clinical trials conducted during the GDR period did not comply with GDR regulations, and were therefore deemed illegal by the Stasi. The Stasi was not particularly interested in medico-ethical questions.ConclusionsClinical trials conducted during the GDR period were surveilled by the Stasi. It was their aim to monitor all people involved in the trials, including their Western contacts. Relevant medico-ethical questions like patient consent and safety with respect to the clinical trials were not the focus. Considering the significant number of conducted trials, only limited evidence exists of doctors having discussed them critically. The public was not officially informed about the trials.

Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain

Western pharmaceutical companies conducted clinical trials in the Eastern Bloc during the Cold War. Recently, media reports about alleged human experimentation provoked a wave of indignation. However, a scientific and...

PSY1-1 - Drug Screening Using Chemical Arrays in NPDepo

ABSTRACT Cancer drug development for Japanese patients by Western Pharmaceutical Companies carries two main challenges. First, many new agents still offer incremental benefits over existing therapies or are hampered by acquired drug resistance and, secondly, they reach Japanese patients with an ∼2–3 year delay after their regulatory approvals in the European Union and the United States. This is based on the mechanisms of traditional cancer drug development where new agents are either tested as monotherapies or are placed in the context of moderately effective standards-of-care often based on regulatory considerations rather than science. Furthermore, Western cancer medicines are not formally investigated in Japanese patients until late in their development causing a delay for the additional investigations needed to address potential biologic differences in Japanese patients. Greater benefits and faster access for Japanese patients may be achieved through combined progress in cancer genetics, drug development and regulation. The introduction of precision medicine utilizing biomarker-driven patient selection for molecularly targeted agents has been a first step toward greater patient benefit in defined populations. In addition, new treatment modalities such as immunotherapy have become available to induce greater long-term effects. The next wave of innovation to overcome drug resistance and substantially improve patient outcomes may now require co-development of science-driven drug combinations within and across defined pathways within the cancer and the host. Furthermore, integrated drug development strategies are needed to achieve simultaneous availability of new medicines for Western and Japanese patients. This will require investigation of drug dosing, pharmacokinetics and pharmacodynamics in Western and Japanese patients as part of a global development program, which enables us to understand and address differences in cancer genetics, host genetics as well as disease prevalence. Such programs should be accompanied by earlier and more frequent regulatory interactions as well as Japanese regulations supporting effective execution of global programs and co-development of novel drugs. Overall, close collaboration between all stakeholders on the pharmaceutical, academic and regulatory side is needed to accomplish the goal of bringing greater benefit and faster access of Western-developed anti-cancer drugs to Japanese patients.

Towards an Animal Welfare policy for 21st Century Science: An Opportunity for Asia

Animal based scientific research has increasingly been outsourced by big western pharmaceutical companies to Asia on the basis of government policies and indigenous programs in Asia which emphasise economic development priorities. As a result of this the quality of laboratory animal care in Asian contexts of science has also come under increasing scrutiny from the major stakeholders in the international bio-medical research community. Of particular concern to stakeholders with a specific interest in sustainable laboratory animal welfare is the absence of effective legislation and a culture that recog- nizes the value of animals or the importance of their welfare. This paper will explore the idea that the growing challenge of coming up with an appropriate animal welfare policy in Asian contexts of science also represents an opportunity to consider the requirements of a globally applicable animal welfare policy for the 21st century. It will do so in terms of also reviewing how concepts of dominion and stewardship have given way to that of duty of care in modern Western contexts. On this basis it will propose that the concept of duty of care linked together with Singer’s contemporary adaptation of utilitarian philosophy might form the basis of a more sustainable 21st century animal welfare policy that could put Asia’s new bio-medical research players in the vanguard of animal welfare policy.

Toxicologic Pathology in a Multicultural World—India

The global practice of drug development is expanding into many different continents and countries. India, in particular, is rapidly emerging as an economic force in this arena by offering ever-expanding opportunities for pharmaceutical market expansion as well as productive drug development partnerships. The key to the country's current socioeconomic success appears to be education, particularly the development of higher and professional education. Also, recent modifications to India's patent laws offer greater protections and incentives for international investment. Increasing numbers of competent contract research organizations create attractive opportunities for large Western pharmaceutical companies with a desire to gain access to burgeoning markets as well as mitigate the rising cost of drug development with less costly services. Well-trained veterinary pathologists are available, appropriate facilities are being constructed, and laboratory capabilities are expanding. Developing a productive partnership with a credible laboratory service in India, as with any new provider, requires due diligence and knowledgeable scrutiny of key elements of the work stream, such as facilities, education and training of laboratory personnel, Good Laboratory Practices, animal care, timelines, and data management. Ultimately and with appropriate management, mutually beneficial drug development partnerships are available in India.

Paradoxes of Understanding the Other: Mankell Explores the "African Darkness"

SWEDISH AUTHOR HENNING MANKELL (b. 194-8), well known for his crime novels about police inspector Kurt Wallander, has a deep devotion to Mozambique. Mankell first visited Africa in 1972, and since 1985, he has lived in Maputo for part of the year. One of the results of this dedication has been his long standing work in trying to raise international awareness of the severity of the African AIDS epidemic. When Jag dor, men minnet lever (2003; I Die, But My Memory Lives On, 2004) was published in a second English edition in 2005, it was provided with a foreword by South African archbishop and Nobel Peace Prize Laureate Desmond Turn as well as an afterword by Samuel Worthington, head of Plan USA, one of the world's leading organizations dealing with AIDS issues. There, thus, is no doubt about the sincerity of commitment to the AIDS problem or about the way his commitment is perceived by the educated world community. Desmond Turn writes: Thanks to [... Mankell's] efforts, memory books and Project AIDS have done an enormous amount to raise awareness of the epidemic. By encouraging parents to recall their life stories, not just for their children, but also for humanity, Helming Mankell has given a great gift to the world. (viii) Strong words, not least considering from whom they have come. Against this background, this article will explore in what sense the African characters in fiction are still portrayed as being Other (in the sense often stressed in postcolonial theory, cf. Dearie 356). For this purpose, novel, Kennedys hjarna (2005; Kennedy's Brain, 2007), will be analyzed. Like many of novels, Kennedys hjarna is a crime novel, although it is not part of the celebrated Wallander series (1991-2002), and the mystery is not the main objective of the novel. However, Kennedys hjarna is also characterized by a strong, righteous anger over the injustices in the world and in that sense still resembles the Wallander novels. In Kennedys hjarna, Mankell portrays how powerful Western pharmaceutical companies exploit poor, black Africans by using them as guinea pigs in order to develop a cure for AIDS. The readers of the novel are undoubtedly expected to take a stance against the corporations and their scientific and economic approaches. In a seminal article on Mankell in Crime and Fantasy in Scandinavia (2008), Andrew Nestingen observes that Mankell's novels are a discourse on solidarity and they attempt to force readers to think through solidarity's ethical and political (232). Solidarity is also a fundamental issue in Kennedys hjarna (a novel not included in Nestingen's study), and both dimensions mentioned in this quotation are therefore relevant here. But does focus on solidarity automatically imply identification with AIDS victims? Is his critique unproblematic, or is his novel perhaps--despite its good intentions--still suffering from the Western perspective, thereby unintentionally furthering the alienation of Africans as Other? It is an ethical impossibility to overcome the distance to the Other completely, but to what extent might this gap be bridged? These are some of the questions that will be addressed in this article. In Kennedys hjarna, Louise Cantor, a Swedish archeologist, finds her son, Henrik, dead in his Stockholm apartment. She refuses to believe he has committed suicide and suspects he was murdered. Like Dan Brown in The Da Vinci Code (2003), Mankell uses the humanities scholar as detective by enabling Louise Cantor to employ her skills and research methods as an archeologist to gather, put together, and interpret the pieces of the puzzle. Following in the footsteps of Henrik, she travels around the world: to Australia, Spain, and finally to Mozambique. During her journey, she learns that Henrik had another, completely different life that she knew nothing about. She also discovers that he had been infected with HIV, and finally, in Mozambique she encounters a foreign and frightening world filled with unfamiliar things she cannot understand. …

Intellectual Property and Public Health: An Overview of the Debate with a Focus on U.S. Policy

Over the past fifteen years, the United States and other developed countries have employed trade agreements to substantially strengthen the protection of intellectual property rights for pharmaceutical products in the developing world. The associated rules changes have already had an effect on pharmaceutical prices in developing countries, prompting conflicts between developing country governments seeking to promote drug access and Western pharmaceutical companies wishing to protect their exclusive rights. If anything, such conflicts are bound to intensify as more patent protected drugs enter pharmaceutical markets outside rich countries. This paper describes the global shift in intellectual property policies and employs economic analysis to evaluate its consequences for developing countries. It also puts forward several recommendations for policymakers in developing countries and in the United States, seeking to better reconcile innovation incentives and access needs.

TRIPS post-2005 and access to new antiretroviral treatments in southern countries: issues and challenges

Until 2005 some developing countries with pharmaceutical manufacturing capacities especially India used the transitional period allowing local manufacturers to produce and sell generic versions of first-generation ART drugs patented in industrialized countries and originally produced and sold at high prices by Western pharmaceutical companies. Thanks to international competition between generic manufacturers and these companies significant price reductions were achieved for the large majority of these drugs. This was a key factor in the implementation and strengthening of access to AIDS treatment in developing countries and a strategic element in the World Health Organization (WHO) 3by5 plan. However with the end of the extended deadline for TRIPS compliance the scenario is likely to change radically. Considering the end of the transitional period which effectively will prohibit the free manufacture of newer and innovative antiretroviral generations to mark a key episode in the history of the fight against AIDS in developing countries this review will provide an overview of the meaning and consequences of this turning point and to present some of the new challenges of the post-2005 period. (excerpt)

Public Sector Corruption: Lessons to be learned from the Ukrainian Experience

This paper introduces certain problems of the Ukrainian health-care system, and provides an overview of the local health-care system and pharmaceutical market, and identifies regulatory and legal issues. The authors present the preliminary results of an interview programme with medical practitioners in Ukraine that address the issues of development of relationships between Western pharmaceutical companies and medical practitioners in Ukraine. It also identifies some unique features of these relationships, and discusses the implications for the culture of bribery in this important developing market.

SOCIAL AND INTELLECTUAL CAPITAL FORMATION IN LEADING INDIAN PHARMACEUTICAL COMPANIES

A number of Indian pharmaceutical firms have achieved high levels of success globally in product and process development. They are competing effectively in the generic pharmaceutical markets of the USA and Europe. They have progressively accumulated process development and manufacturing capabilities which meet the stringent criteria of the US and European Union regulators, and have also acquired drug "discovery" skills to a level which has gained some recognition from major Western pharmaceutical companies. This paper analyses evidence from a range of documentary sources in order to elucidate how two of the leading Indian companies have accumulated the intellectual and social capital which has enabled this degree of innovative success. It finds evidence that environmental factors have opened up opportunities which drew on the firms' early capabilities, while requiring additional skills. In response, these firms have invested in expanding their initial internal competences through a number of routes, including hiring Indian-born, Western-trained scientists and industry executives, membership of an internationally oriented industry association, etc. As their profits and reputations have grown, they have also been able to access external knowledge through Western alliances and acquisitions. It concludes that they have built a broad business and technical knowledge-base and very wide networks, which have been effectively integrated thus far in pursuit of business objectives, but raises the question of whether they should now adopt a more focused approach.

Basmati Rice: Geographical Indication or Mis‐Indication

Indian farmers may not understand the Lockean or the Hegelian justification for intellectual property. Neither do they understand the politics (realpolitik) of the negotiations of the Agreement on Trade‐Related Aspects of Intellectual Property Rights (TRIPS). Many of them had no idea that in September 2003 their fate might have been decided in the Cancun Ministerial meeting of World Trade Organization (WTO) member countries. But they do understand simple economics, i.e. if the American company which has registered a patent for basmati rice continues to sell rice as American‐style basmati rice, it may hurt their exports. If the Indian Government had a key to the past, they would have definitely renegotiated‐TRIPS to protect $350 million export market of basmati rice. Even if we opprobrium TRIPS and characterize it as an instrument of exploitation used by developed countries to protect their own interest, the fact of the matter is, there is no escape from it. Withdrawing from TRIPS entails too many implications for the Indian economy, and it would be cynical to suggest such an idea. Developing and least developed countries have fallen to the economic and political pressure of the Developed countries, and the former group of countries will never be able to convince the latter to renegotiate TRIPS to bring a balance to it, even if their call is eloquent, justified and reflects reality. It would be like knocking on the lid of a coffin: knock, as much as you like, you will not wake him. Post‐Cancun (WTO Ministerial Meeting), it is vital for the Indian Government to formulate strategies to protect its interest in TRIPS. The strategy should focus on the options available within the TRIPS framework. We might have lost advantage in the field of patents to western pharmaceutical companies, but if a proper strategy is formulated we will be able to protect our basmati exports.

The Political and Legal Dilemmas of Globalisation

Over and above the reasons or the wrongs of the apologists and the critics of globalisation, it seems impossible to deny the development, during these last few decades, of a global network of social connections and functional interdependences that link individuals and nations no one is excluded. As Tony Spybey and Roland Robertson remind us, even the deepest meanings of existence, the most intimate of personal experiences and daily behaviour are involved in this radical change of cognitive and symbolic reference points: the world as a whole.1 The globalised world is the result of a series of compressions and integrations that have reduced the so-called 'empty gaps' in the material of human relations. As Joseph Stiglitz emphasized, the thing that has favoured the process of global compression-integration is the impressive reduction of the time and cost of transport and communication, and the demolition of artificial barriers to the international circulation of goods, services, capital, knowledge, and even if still strongly obstructed of people and labour.2 It is true that this process almost exclusively interconnects the industrial nations, and that it is guided by the international economic institutions ruled by these nations. However, this process has relevant effects also maybe in particular in those areas of the world which are excluded from this integration; as is the case for those countries that are lagging further behind on a technological and industrial level, particularly in Africa and large sections of Asia and Latin America. And these effects are not positive ones. On the African continent, for example, the rapid spread of serious epidemics such as AIDS is mostly a result of the decisions taken at the Uruguay Round, which in 1994 strengthened intellectual property rights with the result that the large Western pharmaceutical companies were able to charge prohibitive prices on their patented drugs, even in the extremely poor countries of sub-Saharan Africa.3 Likewise, the shelving in 1997 of the Kyoto protocol, as a result of the pressure exerted by the petroleum

The history of acute promyelocytic leukaemia.

The history of acute promyelocytic leukaemia.

Anti-HIV drug price cuts

The Indian generic drug manufacturer Cipla Ltd announced at the beginning of February 2001 that it will supply triple-drug therapy for HIV to the world's poor at a cost of <$1 a day, significantly undercutting multinational companies. The company, which makes cheap copies of drugs that are patent-protected in other countries, is offering stavudine, lamivudine and nevirapine to the international charity Medecins Sans Frontieres (MSF) for $350 per patient per year, and to governments for $600; their normal price is $1200 per patient per year. MSF said the offer showed that its target of $200 per year was almost within reach, and it called on western pharmaceutical companies to match the Cipla price. The same combination therapy would cost $10 400 per year in the USA. CK