Pharmaceutical Ethics Issues
Generally, business ethics is a concept that has not been upheld or exemplified to any high standard by the modern pharmaceutical industry. It is an industry frequently plagued by unethical marketing decisions and practices, the pursuit of business strategies and policies that violate public trust in spirit if not necessarily in the written word, and that has embraced research practices that are sometimes highly questionable. In the modern age of business globalization, those concerns are only magnified by virtue of the larger number of human lives potentially affected by unethical decisions and practices and by the additional availability of legal and arguable ethical loopholes in the pursuit of higher profits for pharmaceutical companies.
A Fundamental Problem: Profit vs. Public Health Concerns
The most fundamental ethical problem in the modern pharmaceutical industry is simply that the objective of maximizing profit by private business organizations is inconsistent with and often directly at odds with the interests of public health, safety, and welfare. That fundamental problem does manifest itself through the decisions and actions of isolated individuals; rather, it is a problem that permeates the entire mindset and approach to business throughout the pharmaceutical industry (Beauchamp & Childress, 2009; Santoro & Gorrie, 2005). On the other hand, the problem is much more complex than one whose solution is limited to reforms within a single industry. In fact, a comprehensive solution will require the combined efforts of pharmaceutical companies, government legislators, industry regulators, private review boards, public welfare advocacy groups, representatives from both medical and scientific communities, and of national and international research-funding agencies.
The Pharmaceutical Product Development Process since the 1960s
When it comes to the business of pharmaceutical development, testing, and use, ethical issues are framed by no less than three independent industries, each with different sets of concerns and criteria: namely, those of the medical community, the scientific research community, and those of business organizations (Santoro & Gorrie, 2005; Tong, 2007). The problems in that regard first began becoming globally significant issues during the 1960s when scientific research, modern production methods and processes, and transnational marketing all became sufficiently developed and interconnected to represent potentially serious problems for large patient and other consumer populations for the first time (Beauchamp & Childress, 2009; Santoro & Gorrie, 2005; Tong, 2007).
By that time, the growing financial expense of pharmaceutical research and drug development were increasing so much that principles of business profitability became priorities, often at the direct expense of the therapeutic needs of patients (Beauchamp & Childress, 2009). The natural evolution for-profit business practices began to be the primary drive for scientific research in pharmaceutical development instead of human need. That dynamic is directly responsible for the modern trend of focusing on the development of drug therapies intended to cure male pattern baldness, erectile dysfunction, and other quality-of-lifestyle (as opposed to quality-of-life) issues. Quite simply, the business of pharmaceutical research and development has been driven more by the needs (whether real or perceived) of the populations of the wealthiest patient populations rather than by the medical predicaments of less wealthy populations. In that regard, the increased globalization of potential revenue streams has only exacerbate that problem, particularly in nations and global regions where small populations of the very wealthy (or the comparatively wealthy) live side-by-side their impoverished neighbors (Beauchamp & Childress, 2009; Santoro & Gorrie, 2005; Tong, 2007).
Comparative Pharmaceutical Regulation
As has, unfortunately, proven to be the case in business more generally, the availability of the global marketplace to product manufacturers in the wealthiest nations has provided the opportunity to conduct business in various ways that are strictly impermissible domestically but unregulated abroad (Beauchamp & Childress, 2009; Santoro & Gorrie, 2005). In other (i.e. non-pharmaceutical) industries, this feature of globalization typically manifests itself in the exportation of manufacturing operations from nations where labor laws prohibit the exploitation or endangerment of process is reversed: pharmaceutical products developed in the wealthiest nations are marketed to the populations of the poorest nations largely free from the many restrictions and safety requirements imposed domestically to govern their sale and consumption for the express purpose of ensuring patient health, safety, and welfare (Halbert & Ingulli, 2009; Santoro & Gorrie, 2005).
Patient Welfare, Rights, and Autonomy in the Third World
The modern era of business globalization has led directly to a situation in which some of the largest and wealthiest nations routinely exploit foreign populations of vulnerable individuals in ways designed specifically to circumvent ethical principles that limit those practices domestically. Typically, the largest pharmaceutical companies are chartered and their principal offices are located in First-World nations where domestic law strictly protects patient rights, autonomy, and informed consent throughout the lengthy pharmaceutical research process necessary to develop new products for the market (Beauchamp & Childress, 2009; Santoro & Gorrie, 2005).
By contrast, in many of the poorest nations where some of those pharmaceutical companies have deliberately chosen to establish research facilities, there are scant (if any) legal protections in that respect, even in connection with the use and exploitation of some of the most vulnerable populations of human research subjects, including children. Particularly within Third-World nations, clinical trials can operate free from the strict ethical limitations and legal protections that would prohibit research in the more developed nations (Beauchamp & Childress, 2009; Santoro & Gorrie, 2005). As a result, pharmaceutical research intended to further the development of drugs intended for consumption in the developed world can still be conducted in areas where they may directly threaten public health, safety, and human welfare. Even worse, in some of those regions, there are absolutely no prohibitions about using specific racial and ethnic minorities in clinical trials in a manner reminiscent of the infamous Tuskegee incident in the first half of the 20th century in the United States.
The Regulatory Influence of the Pharmaceutical Industry in First-World Politics
Various recent issues that have dominated the public discourse in American politics have well-documented the extent of the problem of special interest group and industry lobbyists in Washington, DC. The debates over healthcare reform in particular highlighted the extent to which private for-profit industries have the ability to influence congressional voting and support for decisions that are solely in the financial interest of private industries, and largely (sometimes very directly) at the expense of the population.
In that regard, one of the most significant changes that Washington lobbyists have succeeding in promoting pertains to eliminating previous prohibitions on direct-to-consumer advertising (DTCA) practices (Santoro & Gorrie, 2005). Critics of these practices have argued (rightfully) that DTCA establishes a climate that erodes the unique relationship of trust that is essential between patients and their physicians. Specifically, the heavy promotion of "lifestyle" drugs directly to consumers also changes the nature of patient-physician communications in ways that (ultimately) reflect the financial interests of pharmaceutical companies rather than patient health (Santoro & Gorrie, 2005).
Furthermore, the long-standing practice of intense promotion of pharmaceutical products directly to physicians through thinly veiled compensation schemes designed as educational "retreats" and "junkets" is a form of for-profit manipulation that also conflicts directly with the best interests of patients by altering the decisions of their physicians purely for the benefit of the pharmaceutical companies (
Beauchamp & Childress, 2009; Tong, 2007). In fact, even the U.S. federal prohibition of funding for crucial human stem cell therapy-based research during the Clinton administration was a result of the direct influence of pharmaceutical industry lobbyists responding to the potential threat from non-pharmaceutical treatments for diseases that generate billions of dollars in revenue annually for that industry (Santoro &…
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