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This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical products in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs.
Most new drugs are protected by pharmaceutical patents, which give the patent holder exclusive control over that drug’s supply for 20 years. When the patent term expires, the drug becomes available for generic production by any company. The resulting competition typically leads to dramatic reductions in price. In Brazil, generic drugs are on average 40% cheaper than reference or brand-name drugs. In the United States, the Federal Drug Administration reports up to 85% price differences. Consumers in India have witnessed more than 100-fold price reduction for antiretroviral (ARV) drugs due to generic production. Generics thus play a key role in broadening access to health care, mostly by driving costs down, both in the developing and developed world.
In early 2011, news emerged that United States authorities had begun to apply injections of pentobarbital, a substance provided by Danish pharmaceutical company Lundbeck, when executing capital punishments. Lundbeck reported to be appalled by such unintended usage of pentobarbital, which is licensed for treatment of refractory forms of epilepsy and for usage as an anaesthetic.
The human rights NGOs Reprieve and Amnesty International urged Lundbeck to ensure that pentobarbital was not made available to U.S. authorities for use in capital punishments. Lundbeck argued that complete halting of provision of pentobarbital would be detrimental to patients suffering from conditions of severe epilepsy for whom the substance was developed and intended for treatment for life-threatening epileptic seizures. Lundbeck’s Danish headquarters also argued that controlling the provision of pentobarbital was out of Danish Lundbeck’s hands because the substance is produced at Lundbeck’s plant in the United States. Eventually, after talks with Amnesty International and Reprieve, Lundbeck in July 2011 announced that it would seek to put a stop to using pentobarbital in capital punishment through the introduction of a “drop-ship” program (ensuring that the drug is distributed through one specific channel and buyers are required to sign a statement that the product will not be applied towards capital punishment).
The Constitution of the World Health Organization (WHO) affirms that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.” The Universal Declaration of Human Rights lays the foundations for the international framework for the right to health. This human right is now codified in numerous national constitutions, as well as legally binding international human rights treaties, such as the International Covenant on Economic, Social and Cultural Rights.
Although medical care and access to medicines are vital features of the right to health, almost two billion people lack access to essential medicines, leading to immense avoidable suffering. Improving access to essential medicines could save 10 million lives each year, four million of them in Africa and South-East Asia alone. Gross inequity is a shocking feature of the world pharmaceutical situation.
Approximately two billion people lack access to medicines globally. People living with HIV, cancer patients, those suffering from tuberculosis or malaria, and other populations in desperate need of life-saving medicines are increasingly unable to access existing preventative, curative, and life-prolonging treatments. In many cases, treatment may be unavailable or inaccessible for even some of the most common and readily treatable health concerns, such as hypertension. In the developing world, many of the factors that contribute to making the world’s most vulnerable and marginalized populations particularly susceptible to illness also operate to restrict their access to medicines. As a result of dramatic economic inequities and widespread poverty, it is not profitable for most originator pharmaceutical companies to develop new medicines for sale in developing markets or to lower the cost of existing drugs so that they are affordable for the majority of these populations.
Our society is obsessed with health. At every second, everywhere, we are surrounded and overwhelmed by distressing calls on how vital it is to adopt a healthy lifestyle. While incorporating a healthy diet and physical exercise into our routines are the foremost commandments, everything from tobacco to refined sugars, trans fat, excessive alcohol, caffeine, and even eggs are declared public evils. Yet there is hope: medicines will save us! And indeed medicines exist available for all kinds of human afflictions. There are pills to help you relax and forget about stress, while some others, on the contrary, can keep you miraculously alert. There are pills that heal your most unbearable pains, physical or emotional, wherever their location — the head, back, quadriceps, heart, or soul. Though they may cause your stomach to burn, that is easily remedied by taking a complementary pill that will neutralize your stomach acidity with only some minor and negligible side effects elsewhere. There are also magic pills that promise you happiness, by giving you the power to thrive and the endurance to conquer the world. They ignite your hunger for achievement, but also for extra sugar and saturated fat.
Do we have a legal and moral right to health care against others? There are international conventions and institutions that say emphatically yes, and they summarize this in the expression of “the right to health,” which is an established part of the international human rights canon. The International Covenant on Social and Economic Rights outlines this as “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” but declarations such as this remain tragically unfulfilled. According to recent figures, roughly two billion people lack access to essential drugs or to primary health care. Millions are afflicted by infections and illnesses that are easily avoidable or treatable. In the developing world many children die or grow stunted and damaged for lack of available treatments. Tropical diseases receive little or no attention by the major pharmaceutical companies’ research departments. Is this a massive violation of the right to health? And if so, why does it attract so little attention? Is it because our supposed commitment to human rights and the rule of law is hypocritical and hollow? Or is it because the right to health is a special case of a right, so that these tragedies are no violation at all? Jennifer Prah Ruger summarized this puzzle when she wrote: “one would be hard pressed to find a more controversial or nebulous human right than the right to health.” In this essay I discuss three different theories of a right to health care. I conclude by offering my own reconstruction of one such theory.
The idea that physicians should accept recommendations from learned colleagues on how to practice medicine is probably as old as medicine itself, but beginning around 1990, it took on new urgency in the face of rising health care costs, widespread, unjustifiable variation in practice patterns, concerns about medical errors and quality of care, and what some perceived to be perverse effects of the malpractice system. One solution put forward was practice guidelines, which the Institute of Medicine (IOM) defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.
[T]each the law to empower physicians individually and collectively to use the law and law colleagues to serve patients and promote public welfare; in short to better foster the goals of the medical profession.
[A]ntipathy appears to be deeper and more pervasive than ever before, making it hard to imagine that relations between attorneys and physicians can get much worse.
It has long been recognized that an understanding of at least some core legal rules and concepts is an important piece of medical training. To address this, law is now typically part of the core medical school curriculum, often incorporated into bioethics and/or practice of medicine coursework — whether as part of a distinct course or series of courses or threaded through the curriculum (or both). While often this education focuses on rules, some have recommended that it also include fundamentals of legal reasoning, and go beyond knowledge to include skills, attitudes, and behaviors vis-à-vis the law.
Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver educational talks to groups of physicians in the community to help market the company's brand-name drugs. These speakers receive substantial compensation to lecture at events sponsored by pharmaceutical companies, a practice that has garnered attention, controversy, and scrutiny in recent years from legislators, professional associations, researchers, and ethicists on the issue of whether it is appropriate for academic physicians to serve in a promotional role. These relationships have become so contentious that three years ago the pharmaceutical industry trade association, the Pharmaceutical Research and Manufacturers of America (PhRMA), adopted voluntary guidelines stating that drug companies should stop giving doctors free pens, calendars, sports bags, or tickets to entertainment events. Further, numerous medical associations, such as the Association of American Medical Colleges (AAMC), the American Board of Internal Medicine (ABIM) and the Institute on Medicine as a Profession (IMAP), and government bodies such as the Institute of Medicine (IOM) have recommended that medical schools and teaching hospitals prohibit or strongly discourage faculty from participating in so-called industry Speakers Bureaus — promotional events designed solely to market pharmaceutical products.
In her opening address to the 2011 session of the World Health Organization's (WHO) governing body, the World Health Assembly, WHO's Director-General, Dr. Margaret Chan, noted that WHO's job was much more straightforward when it was dealing mainly with germs, hygiene, medicines, vaccines and sister sectors, like water supply and sanitation. Today, international public health governance is much more complex. It is not only about forging agreement around shared health problems, but also being concerned with health as an outcome of global policies in areas such as trade, intellectual property, and human rights and, nationally, as an outcome of work in other sectors such as education, agriculture and the environment. Global health governance is increasingly fragmented, and WHO is not the only health game in town.
Individual research protections provided by bioethical principles can be extended to group protections, particularly for place-based (geographic) communities and cultural groups who may share a common harm or burden. In this article, an argument is made for the need to consider the group conditions of individual research subjects in the ethics of individual report-backs of human biomonitoring results. Human biomonitoring, the measuring of concentration of chemicals or their metabolites in blood, urine, breast milk, hair, and other biological samples, can provide an assessment of an individual's exposure to a chemical(s) and can integrate exposures from multiple pathways and sources. Biomonitoring studies have been increasing in the past decade for such purposes as measuring the levels of chemicals that are ingested by members of the general population and at what concentrations, to determine if exposure levels are higher in some groups vs. others, to track temporal trends to establish reference ranges for chemical exposures, and to investigate an association with health.
In an explicit attempt to reduce physician paternalism and encourage patient participation in making health care decisions, the informed consent doctrine has become a foundational precept in medical ethics and health law. The underlying ethical principle on which informed consent rests — autonomy — embodies the idea that as rational moral agents, patients should be in command of decisions that relate to their bodies and lives. The corollary obligation of physicians to respect and facilitate patient autonomy is reflected in the rules that have been created to implement consent procedures, especially those requiring disclosure of relevant information.
However, there are many practical impediments to patient self-determination in health care decisionmaking. Well-meaning physicians often lack the time to live up to the ideal of facilitating genuine, informed deliberation with and by their patients, and many lack the motivation or skill to do so successfully.
A wide range of medical institutions have developed and implemented policies to mitigate the adverse consequences of conflicts of interest. These newly implemented policies, which include regulation of industry contact with physicians and hospitals, controls on gifts from industry, and greater transparency in industry sponsored activities, have generated considerable controversy.
Formulating and evaluating policies in a neutral, unbiased fashion can be difficult for those personally affected. When people have a stake in an issue, they tend to process information in a selective fashion that supports their personal interests, a phenomenon known as “motivated reasoning.” When decision makers with preexisting opinions are exposed to information, they are inclined to selectively use the information to arrive at conclusions that justify their prior beliefs. When confronted with information that contradicts existing views, people evaluate it with greater skepticism. Additionally, once decision makers have reached a decision, they are likely to evaluate subsequent evidence in a biased manner that supports their decision.
A major issue facing the health of both minors and young adults in the United States is the often unintentional lack of confidentiality maintained in the provision of sensitive health services. Studies have shown that access to confidential care is crucial for minors seeking preventive care and treatment for sensitive services. Evidence demonstrates that many minors will not seek health care if confidentiality cannot be ensured, which can have significant negative health implications; this finding can be extended to young adults covered under their parents health plans. Young adults, not just minors, also often forgo important sensitive services when they face a breach of confidentiality, which most likely occurs when their parents have access to the adult child's health information.
Currently, private insurance companies generally send the policyholder an explanation of benefits (EOB) whenever a service is provided under a plan. EOBs generally include information identifying the patient, provider, type of care received, total charge for services, amount paid by the insurance company, and any financial obligation of the policyholder.
There is a concern that physicians/researchers are inappropriately profiting (by buying or selling stock) from information derived from advance copies of high-impact clinical trial data distributed by medical conferences or journals. Despite these concerns, it has never been systematically evaluated, and little is known about the degree to which it exists. This is largely due to difficulties associated with directly verifying whether or not such activities have taken place and, furthermore, many medical conferences/journals today have taken the necessary actions to guard against this. One medical association in particular, the American Society of Clinical Oncology (ASCO responsible for conducting the largest annual oncology-related medical conference), only began responding to such concerns several years ago. Their actions during that time serve as a compelling case study, with wide-ranging ramifications, and provide the unique opportunity to delve into this phenomenon.
Up until 2008, ASCO selectively and discreetly distributed abstracts from all forthcoming presentations (at the ASCO Conference) to ASCO members two weeks prior to it becoming publicly accessible during the conference.