The issue of orphan drugs is one that is not easily resolved. The public generally has a need for these drugs; however, when compared to the need for other drugs being researched and developed, both the need and the profit margin are small. In terms of purely profit-driven motives, the obligation of the drug companies is clear. Because their shareholders and their investors expect the greatest amount of profit, the drug companies should focus on researching, developing, and producing variations of drugs for which there is both need and demand.
In human terms, however, it is possible to argue that the companies are obligated to provide an equal amount of support for people with rare diseases and conditions as they do for those with ailments that are more common. Although it might seem clear, taken at face value, that human lives are more important than profit margins, this dilemma truly has no clear solution.
As tempting as it might be to claim otherwise, the purpose of a business is to make money. Even when a business has other, apparently philanthropic, aims stated, these aims take a back seat to the profit-making nature of the business. Without the profit, there is no business; without the business, whatever philanthropic efforts it makes are lost.
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The same argument can be made for the pharmaceutical companies, as well. If a drug company focuses its efforts on unprofitable orphan drugs, then the company will not make money. Indeed, it is possible that the company will actually lose enough money to cause 1) the need for restructuring, 2) the loss of various programs or drugs currently being produced, or 3) closure of the company. Any of these eventualities argue against support of the orphan drugs that the company could produce.
The standards for drug companies and drug researchers are not always viewed as being one and the same. According to Drews (2005) “drug researchers, too, are under a fundamental obligation to set their thematic priorities according to the criteria of existing therapeutic needs and medical and technical feasibility, leaving nonmedical and nonscientific considerations aside” (p. 22). Using this standard, the answer to the question is again clear: researchers are obligated to focus as much attention on the “orphan” drugs as they are on the more commonly used drugs, in the hopes of creating more effective drugs that will aid those individuals with ailments that have few available treatments.
However, these drugs require extensive clinical trials that might be difficult to run. Drews explains that in these trials, “medical ethics in this case would require that all patients be treated with a drug of proven tolerability that could be reasonably be expected to have a curative effect” (2005, p. 24). However, in the case that such a drug does not exist, scientific controls are needed with which it might be difficult for the researchers comply. Due to the expense and the difficulty involved with compliance, drug companies once again fall into the dilemma of resolving their obligations to their shareholders and resolving their obligations to the people who require these orphan drugs.
For these reasons, the pharmaceutical industry has a tendency to focus on drugs that meet more common needs and less on “rare” diseases. These rare diseases are those, according to United States law, which are defined as those that affect fewer than 200,000 people. This figure, assuming a populace of approximately 300 million people, represents only one individual per one thousand in the population (Drews, 2005, pp. 30-31). Because medical ethics require that the profitability of a situation be ignored, Drews argues that it is this kind of ethical argument that needs to be made (Drews, 2005, pp. 30-31).
Is it possible to make ethical demands like these situational? Kantian ethics, most often used in the business world, would say no. Kantian ethics demand the use of the “categorical imperative; that is, that all actions must be able to be universalized and that they reflect the manner in which the actor would choose to be treated. It is a concept that is not found in this extensive text used as a reference for this paper. However, is the pharmaceutical industry absolved from the need to apply this form of ethical code? As compelling as the profit margin argument might be, the answer to this question would best be answered as “no.”
Actions capable of being universalized are not those that take profit into account, since profit is a personal and private concern. That is, people are rarely concerned about other people’s profit. Not only do most people resent being used as a commodity for other people to make a profit, they are equally unconcerned when they, in turn, use others to make their own profit. Therefore, a decision made for profit-making motives is not capable of being ethical; however, it may arguably be the “right” decision for the business to make in terms of remaining in business.
Dessing (2002) states that today’s definition of “moral” values, or that of ethics, appears to be independent of what he terms “metaphysical” principles, holding an objective position outside of culture and tradition (p. 28). He essentially rejects moral behavior as defined by Aristotle or by Kant. He argues that:
Moral excellence means that we have knowledge and choices, and any action must proceed from a firm and unchangeable state. The best state is the intermediate between excess and deficit. [. . .] Moral excellence is the consequence of a choice, determined by reason: the reason of a man of practical wisdom. Virtue was a mean between two vices. (p. 28)
The author points out, however, that moral choices made in terms of this definition are dependent on cultural explanations of “virtue,” based on what was important in that particular culture. He points out that every culture differs from other cultures in terms of defining important values. Even when accepting Aristotle’s definition of moral behavior, Dessing indicates that it is impossible to know how virtues were ultimately defined during Aristotle’s life.
Dessing also essentially rejects Kant, who attempted, in Dessing’s words, to formulate “eternal values” using a “construction of ethical principles [that] is elegant and merely metaphysical in nature (p. 28). Dessing appears to disdain Kant’s stance of rejecting the categorical imperative as being “disputable” (p. 29), stating that the “strong metaphysical aspects of this theory undermines its acceptance by today’s society” (p. 29).
Dessing favors what he terms “analytical philosophy,” which, he explains, “implies that ethics should be observed through the windows of time and place” and that new moral codes and principles can be introduced by analytical reasoning (p. 29). By rejecting the categorical imperative and by focusing on individuality, ethics then become situational, using a different definition of “happiness” in each culture examined and based on the autonomy of individuals in that culture.
Is the categorical imperative necessary to moral behavior? Not necessarily. Other forms of ethical reasoning exist. However, by acknowledging autonomy over universality in the pharmaceutical industry, the door is then opened to refusing to sponsor orphan drugs, or to select the production of drugs solely on how their manufacture will benefit the company over how it will benefit the public good. However easy it is to dismiss “metaphysical” leanings in moral philosophy, some code that takes into account the larger group over the autonomy or needs of the one is probably necessary for that code to have value.
Without universality, it becomes possible to argue that, while an action may not benefit many people overall, it is socially acceptable because it is culturally acceptable. In the breakdown of the universal “melting pot” American culture, this perspective can become particularly problematic. The concept of autonomy in moral philosophy appears to have some commonality with the idea of diversity in culture.
Rather than acknowledging that the whole is greater than the sum of its parts, both autonomy in moral philosophy and diversity in culture tend to leave the nation floating in a sea of integers that are never added to reach a single conclusion. While diversity in culture is an admirable thing, autonomy in moral reasoning leads to a diluted moral philosophy with different standards for different people. It is possible to conclude, then, that with individualized moral and ethical reasoning, that the needs of the few can supercede the needs of the many.
The question then becomes, if such reasoning is possible, then what is the purpose of such a moral code? Clearly, this code of moral philosophy fits well into the needs of the business community. Without the need to address the “metaphysical” focus of a moral code, then a purely practical focus can then used to address various issues.
Orphan drugs, which are unprofitable and therefore detrimental to a corporation’s bottom line, no longer need to be considered an issue, because in the American culture, strong businesses and a strong profit-driven economy is what makes people happy. Using that moral reasoning, those with wealth and power all but have permission to make decisions based on profit margin alone and taking the moral high ground when they state that their motives are purely for the good of the economy.
Utilitarianism provides another perspective on this issue. This moral philosophy posits that an ethical decision is the one that brings the greatest amount of happiness to the largest amount of people. Jeremy Bentham, the “father” of utilitarianism, attempted to design a moral science, which, like the moral philosophy described by Dessing, takes the metaphysical out of the equation. His “hedonistic calculus” included seven factors to determine the effects of pain or pleasure in taking an action. An action that produces intense pleasure of long lasting duration that affects a large number of people would be considered a moral one. An action that produces intense pleasure of short duration and affecting only one person at the expense of other people would not be considered moral.
This system is objective, as Dessing appears to desire; however, it still takes universality into consideration. Using this argument, it is possible to conclude that a pharmaceutical company’s decision not to support research, development, or production of an orphan drug is indeed an ethical one. If a drug that treats only .1000 of the population is produced over a drug that the vast majority of the population may use and benefit from, then clearly it is not bringing the greatest amount of happiness to the largest number of people.
Mill, who went on to expand on and to refine Bentham’s utilitarianism, also made a distinction between the different kinds of pleasure, however, which changes the value of this equation somewhat. He determined that high quality pleasure was superior to low quality pleasure. Actions that created small amounts of high quality pleasure could be deemed superior to actions that created large amounts of low quality pleasure.
In judging the quality and quantity of happiness that a drug that treats a rare and debilitating illness can create, as opposed to that created by a new over-the-counter pain reliever, it might appear that the rarer drug brings the greatest amount of happiness, using Mill’s form of utilitarian reasoning. Few people are made happy by an aspirin, after all; in truth, they simply want it to work in order to get on with their day. This form of utilitarianism, far from absolving the pharmaceutical industry of the need to create orphan drugs, appears to create an obligation to research, develop, and produce them if their actions are to be deemed moral.
In truth, there is no good answer to the ethical dilemma caused by orphan drugs. Using situational ethics creates situational answers, none of which are grossly objectionable. Moral reasoning based on culture and cultural differences may be appealingly politically correct, yet those in need still are left without the medication that they need. Only moral philosophies that take universality into account appear to change this outcome. Ultimately, the argument that favors providing equal and adequate health care to all people seems to be the best--and most moral--form of moral philosophy in this situation.
Dessing, R. P. (2002). Ethical rationalism applied to pharmaceuticals. In Pharmaceutical Ethics, Sam Salek and Andrew Edgar (eds.). Hoboken, NJ: John Wiley & Sons.
Drews, J. (2005). Drug research: Between ethical demands and economic constraints. Ethics and the Pharmaceutical Industry, Michael A. Santoro and Thomas M. Gorrie (eds.). New York: Cambridge University Press.
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