For well over 20 years I have been arguing that someday we will have to ration health care for the elderly. I got started in the mid-1980s when I served on an Office of Technology Assessment panel to assess the likely impact on elderly health care costs of emergent, increasingly expensive medical technologies. They would, the panel concluded, raise some serious problems for the future of Medicare. The panel did not take up what might be done about those costs, but I decided to think about that question and wrote a book called, Setting Limits: Medical Goals in an Aging Society.

Financial relationships between physicians and industry are widespread. Highly publicized financial relationships between physicians and industry raised disturbing questions about the trustworthiness of clinical research, practice guidelines, and clinical care decisions. Recent incidents spurred calls for stricter conflict of interest policies and led to new federal laws and NIH regulations. These stricter policies have evoked praise, concerns, and objections. Because these new federal requirements need to be interpreted and implemented, spirited discussions of conflicts of interest in medicine will continue.

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions (often defined as 1-100 nm, but sometimes defined to include dimensions up to 1000 nm, as discussed further below) where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products (biologics), implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. Nanotherapeutics and in vivo nanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes (including the bloodbrain barrier) and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents.

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.

Nanotechnology not only offers the promise of new enhancements to existing materials but also allows for the development of new materials and devices. The potential applications of nanotechnology range from medicine to agriculture to health and environmental science and beyond. Nanotechnology is growing at such a rate that Lux Research in 2007 estimated that nanotechnology will be incorporated into 15% of global manufactured goods by 2014. The U.S. National Nanotechnology Initiative defines nanotechnology as the following: “(1) Research and technology development involving structures with at least one dimension in the range of 1-100 nanometers (nm), frequently with atomic/molecular precision; (2) Creating and using structures, devices, and systems that have unique properties and functions because of their nanoscale dimensions; (3) The ability to control or manipulate on the atomic scale.” Nanomedicine and its subcategories of nanotherapeutics and in vivo nanodiagnostics incorporate nanoscale materials with unique properties that can enable new or improved treatments and diagnostics for many diseases and disorders.

Mr. M. was a 77-year-old decisionally incapacitated long-term nursing home resident with chronic schizophrenia who was admitted to the hospital with a bacterial pneumonia. His past medical history was notable for deteriorating functional status over the past 2-3 years, urinary retention requiring chronic indwelling bladder catheterization, and two recent hospitalizations for urinary tract infections leading to sepsis. He developed respiratory failure soon after admission and was intubated and placed on mechanical ventilation. Follow-up studies suggested worsening pneumonia and acute respiratory distress syndrome (ARDS), as well as worsening kidney function.

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.

Physicians, scholars, and policymakers continue to be concerned about conflicts of interests among health care providers. At least two main types of objections to conflicts of interest exist. Conflicts of interests may be intrinsically troublesome if they violate providers’ fiduciary duties to their patients or they contribute to loss of trust in health care professionals and the health care system. Conflicts of interest may also be problematic in practice if they bias the decisions made by providers, adversely impacting patient outcomes or wastefully increasing health care costs. This latter objection may be observed in differences in the prescriptions written, procedures performed, or costs billed by health care professionals who have conflicting interests, when compared to those that do not have such financial relationships.

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).

Conflicts of interest have been reduced to financial conflicts. The National Institutes of Health’s (NIH) new rules for managing conflicts of interest in medical research, the first major change to the regulations in over 15 years, address only financial ties. Although several commentators urged that the regulations also cover non-financial interests, the Department of Health and Human Services declined to do so. Similarly, the Institute of Medicine’s (IOM) influential 2009 Conflict of Interest Report focuses almost exclusively on financial conflicts. Institutional policies at academic medical centers and guidance from professional bodies and medical journals also primarily emphasize financial ties. Even broadly worded rules are applied more readily to financial ties than non-financial interests, such as the regulations that restrict institutional review board (IRB) members with conflicting interests from participating in protocol reviews.

This paper addresses two interconnected concepts — health disparities and social justice — as they pertain to screening, diagnosis of disease, and health care access among minority elders in the American society. Health disparities are defined as differences in treatment provided to members of different racial or ethnic groups that are not justified by the underlying health conditions or treatment preferences of patients. Disparities currently exist in many aspects of American health care. For example, when compared to whites, the infant mortality rate is higher for African Americans; health insurance coverage is lower for Latinos and African Americans; and ethnic minorities experience poorer care and survival rates for HIV, even after controlling for other confounding factors including income, insurance, health status, and severity of disease. Among older Americans, health status varies by race, income, and gender. Older minority Americans have consistently been shown to have worse health than whites of the same age group across measures of disease, disability, and self-assessed health. When compared to whites, elderly Latinos have higher rates of diabetes and disabilities, and older African Americans have more chronic conditions.

While the definitions employed by different governmental agencies and scientific societies differ somewhat, the term “nanotechnology” is generally understood to refer to the manufacturing, characterization, and use of man-made devices with dimensions on the order of 1-100 nanometers (1 nanometer [nm] = 1 billionth of a meter). Devices that comprise a fundamental functional element that is nanotechnological are also frequently comprised within nanotechnology, as are manufactured objects with dimensions less than one micrometer. The differences in definition lead to occasional paradoxes, such as the fact that the most widely used nanodrug (albumin nanoparticles of dimensions up to 300 nm, comprising the anticancer drug paclitaxel) is labeled a “nanopharmaceutical” by governments of European countries, Canada, and Australia, but it is not a nanotechnology for the U.S. Food and Drug Administration (FDA). It is also common in scientific domains to restrict the term “nanotechnology” to objects that possess special, “emerging” properties that only arise because of their nanoscale dimension.

The medical profession is under a state of increasing scrutiny. Recent high profile scandals regarding substantial industry payments to physicians, surgeons, and medical researchers have raised serious concerns over conflicts of interest. Amidst this background, the public, physicians, and policymakers alike appear to make the same assumption regarding conflicts of interest; that doctors who succumb to influences from industry are making a deliberate choice of self-interest over professionalism and that these doctors are corrupt. In reality, a myriad of evidence from social science indicates that influence from conflicts of interest often occurs on a subconscious and unintentional level. This poses an important issue, since such conflicts can steer wellintentioned physicians away from their primary professional goal to provide the best medical advice and treatment possible.

I was initially assigned the working title, “Pursuing Equality in Health Care for the Elderly Is Futile.” I prefer to think of that particular dead end of health policy as one of listening to the wrong music for too long. Hence, this article reprises and revises the title song of the early 1980s movie, Urban Cowboy, but with Johnny Lee’s original lyrics adapted as “Looking for better health [rather than either ‘love’ or ‘love of equality’] in all the wrong places.” The better goal is to achieve more progress in improving health for more people, including (but not limited to) the elderly. It need not be as futile as the pursuit of the elusive abstraction of “equality” for all — but only if we first move away from a path-dependent approach of recent times that remains too narrowly focused on statistical disparities in health care services received by particular groups.

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.

In prominent funding and policy statements, a particle with at least one dimension in the 1-300 nm size range must have novel physicochemical properties to count as a “nanoparticle.” Size is thus only one factor. Novelty of a particle's properties is also essential to its “nano” classification. When particles in this size range are introduced into living systems, they often interact with their host in novel ways that require some modification of existing methods and models used by pharmaceutical scientists and toxicologists for assessing their efficacy and safety. It is not clear, however, whether the novelty of the intended physicochemical properties is in any way related to the novel behavior of those particles when their toxicity is evaluated. In fact, when considering toxicity, much of the concern about nanoparticles relates to the unanticipated or poorly understood interactions.