Profit versus public health in pharmaceutical industry ethics

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.

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 employees to nations where no such laws or regulations exist. Consumer goods are manufactured abroad at a very small fraction of the cost of producing the same product domestically and then sold domestically at a tremendously increased profit margin. Within the pharmaceutical industry, the 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 & Gorrie, 2005).

In essence, it was one of many examples whereby the powerful corporate lobbyists and their hired technical experts managed to successfully persuade legislators on matters where their respective comprehension of the issues differed greatly and where the former achieved their goals by a combination of "incentives" and obfuscation of relevant issues that lawmakers are ill-equipped to decide based on their lack of fundamental understanding of the merits of the scientific arguments (Tong, 2007).

Finally, the influence of the pharmaceutical industry lobbyists on Washington lawmakers having to do with the lucrative practice of prescribing drugs for so-called "off label" uses either not approved or not yet approved by the Food and Drug Administration (FDA) is yet another example of this dynamic (Santoro & Gorrie, 2005). Currently, it is regulated only by a voluntary code of ethics established by the American Medical Association, no doubt, with the help and influence of pharmaceutical representatives (Santoro & Gorrie, 2005). Naturally, pharmaceutical companies are even les constricted in this regard in the global market than they are domestically in the U.S.

Conclusion

In many respects, the modern pharmaceutical industry has served an extremely valuable purpose furthering human health throughout the 20th century. There is no doubt that the development of many drugs have enabled the medical community in the First World to eradicate some of the worst diseases that had previously caused so much misery in human societies since antiquity. Initially, globalization enabled the populations inhabiting the less developed parts of the world to benefit from some of those important advances in healthcare attributable to pharmaceutical products. However, in the contemporary age of globalization, the pharmaceutical industry is insufficiently regulated to prevent the widespread exploitation of large patient populations, especially in the Third World. Even in the most advanced societies, pharmaceutical lobbyists have succeeded in corrupting the process of government legislation to further their financial interests, substantially at the expense of human health.