In many industries, a consumer will simply not participate in the market if their demand is below the market price. However, for essential medicines, demand is so inelastic that the supplier could charge an exorbitant price and demand would remain stable. Essentially, pharmaceutical suppliers can put a price on human life – and that price can be high. Given the risk of compromising patient relationships and the integrity of the research process, physicians should exercise caution when dealing with industry. Both Trump and Clinton believe the industry needs to become more competitive to drive down drug prices. Trump agrees with Clinton that “consumer access to imported, safe and reliable drugs from abroad will provide consumers with more options.” He also believes that the lobbying power of Big Pharma prevented reform: “Congress will need the courage to step away from vested interests and do what`s right for America.” Because pharmaceutical companies spend more money lobbying than any other industry, about $229 million in 2014, Trump says the pharmaceutical industry has significant influence over lawmakers. In cases where research projects are funded by the pharmaceutical industry, the fundamental principle is that the values of science and clinical medicine must take precedence over commercial constraints and monetary values. However, eliminating bias in research and publication is a big issue and is not discussed here. We believe that this is an issue of great public importance that must be actively addressed by the medical profession in consultation with consumer organizations, government and the pharmaceutical industry. Research and publication should be guided by scientific and ethical rather than commercial values. Regulation of the pharmaceutical industry by the FDA and similar organizations in other countries provides a framework to protect the health and safety of patients worldwide. However, as with all rules or guidelines, there is the possibility of violations or misinterpretations – erroneous or intentional – that can lead to serious consequences. In the case of medical devices, they can be life-threatening.
The FDA`s responsibilities are fulfilled by laws “that require that drugs and devices be safe and effective for their intended uses, and that food, drugs, and equipment be accurately labeled and handled so that they are not contaminated.” The first regulation that gave the FDA the authority to oversee the safety of food, drugs, and cosmetics was the aptly named Federal Food, Drug and Cosmetic Act (FFDCA) of 1938. In the decades since, many changes have expanded the FDA`s jurisdiction and the controls it imposes on researchers, manufacturers, distributors, and users of drugs and medical devices. Deontologists would consider extraordinary price increases for necessary drugs unethical. Kant`s categorical imperative states that we must “act in such a way that you treat humanity, whether in your own person or in the person of others, always simultaneously as an end and never only as a means” (Institute of the Seven Pillars). By raising drug prices to high levels, companies treat patients as a means to an end. These companies know that patients or their insurers will continue to pay for treatment regardless of the price, as demand is inelastic. Taking advantage of another human being, however, violates the moral duty to “seek a goal that is the same for all peoples” (Seven Pillars Institute). With an ethical framework, pharmaceutical companies have a moral duty to maintain fair drug prices. Predatory pricing is immoral because it exploits the underprivileged for the benefit of the company.
When a doctor enters into a relationship with a pharmaceutical company, there is a duality of interests. It cannot be assumed that such duality is a “conflict” in all cases – it depends on the circumstances, and often not everyone will agree anyway. Dualities of interest are common; Relatively rare conflicts. While the distinction between the two is sometimes clear, at other times it can be subtle and depend on the nature of the relationship in question and the values of the community in which it occurs. Dualities of interests constitute “conflicts” only if they are associated with competing obligations that may lead directly to a compromise of primary responsibilities. In order to determine whether there is a conflict of interest, it is necessary that the actual details are explained and that the community has the opportunity to examine the issues publicly. When former CEO Michael Pearson joined Valeant in 2008, he developed a new type of pharmaceutical industry (Vanity Fair). Pearson has decided that instead of investing billions of dollars in the development of new drugs that may never be approved by the Federal Drug Administration (FDA), it should acquire companies that currently hold drug patents. He theorized that by buying these companies and dramatically increasing the prices of their products, he could significantly increase profits. Since the company held a patent, there would be no competition in the market to keep the price low. Pearson significantly reduced Valeant`s research and development spending, focusing instead on acquisitions to generate profits.
While opinions differ as to whether voluntary guidelines or binding rules are the best way to monitor potential conflicts of interest, no professional association or institution has proposed banning interactions between physicians and the pharmaceutical industry. Indeed, it is accepted that such a policy would not serve the interests of any party. We believe that the most desirable approach is to develop a friendly relationship that allows for healthy criticism and is based on clear but unconvincing guidelines.