Free A Justification For The Profits Of Drug Companies Argumentative Essay Sample

Today, pharmaceutical sales exceed $850 billion a year, a vast amount of money. Regardless, people spend money on drugs because of the positive role they play in saving lives, preventing epidemics and controlling chronic illnesses. In this important capacity, drugs are heavily regulated with respect to their development, sales and distribution. The following paper discusses the controversy regarding the high cost of drugs and the profits of pharmaceutical companies. The paper takes the argument that the high costs of pharmaceuticals are necessary to ensure that commercial drugs are safe and efficacious, and to provide incentives to drug companies to continue to bring forward research and development for new, life saving products.
Drug discovery today is a financially demanding business [1]. It takes approximately one billion dollars for a pharmaceutical company to move through the stages of screening for potential new drugs either from natural sources or through the use of combinatorial libraries, to determining the drug’s potential efficacy, toxicity and appropriate dosage. New drugs have to be tested in cell culture, in animal models, and finally in a series of human clinical trials before they can be considered for commercialization. This process itself can take as long as ten years and does not guarantee that a drug will make it to the marketplace. In fact, only a small percentage of new drugs that undergo these tests and trials actually find their way to be sold to the general public. Clearly, the process is lengthy and expensive, and a great deal of incentive must come from the pharmaceutical company to ensure that the process is followed to its final stages. This means that drug companies must be willing to financial invest enormous amounts of money to see that much needed drugs are brought out for the general public.
While clearly regulation by government is a pressing financial point for drug companies, it is an essential process. The basic drug regulation structure has evolved over time, and the range of legislative and regulatory powers has grown in response to the expanding sophistication and complexity of the drug industry itself. Drug regulation can to an extent be defined as a public policy response to perceived societal challenges and requirements [1. 2]. This means that the laws set out for pharmaceuticals must be constantly updated in order to keep up with new changes in the public environment that a drug is released into. The laws must reflect that the public is protected from all areas of pharmaceutical activity in a given country, and include licensing, inspection of manufacturing facilities, control of clinical trials and quality control of the product. The fees for following regulatory standards and guidelines for all of these functions are costly, and are borne in large part by the drug company as well as by the general public out of tax dollars. Information must also be made available to the public to ensure transparency in the drug regulation process [3].
Some controversy is evident regarding the degree of the relationship between drug companies and governmental regulatory bodies, particularly when it comes to profit. Let us now look at the end result of the under regulation of another class of bioactive molecules known a nutritional supplements and herbal medicines. For example, Peter Cohen writes in the New England Journal of Medicine of a recent cluster of cases of severe hepatitis and liver failure that was tracked to the dietary supplement known as OxyElite Pro [4]. By the time the FDA was able to learn of the cases and remove this popular over-the-counter supplement from store shelves, 97 cases, including 47 hospitalizations, three liver transplants and one death had been linked to this supplement. The weak response of the FDA is the result of the current regulatory system’s inadequacy in monitoring potentially dangerous nutritional supplements for safety. The current Dietary Supplement Health and Education Act states that anything labeled as a supplement is assumed safe unless proven otherwise. As a result, many sports drinks, herbal medicines and similar products remain for sale at retail stores as commonplace as Walmart without any safety tests, clinical trials, or other regulatory hallmarks. The danger of these ‘natural’ drugs is a stark reminder of what would be our current pharmaceutical industry would look like in the absence of a strict regulatory template.
While clearly a robust regulatory framework is necessary to protect public health, is this alone responsible for the high price of many of today’s drugs? Some would argue that the current high price of drugs are also influenced by patent protection rights; in order to compete and keep biosimilars and generic drugs off the market, major pharmaceutical companies have to pay dearly for expensive intellectual property protection for their inventions [5]. Keeping in mind the additive effect of clearing regulatory hurdles and maintaining the competition at bay, it is not surprising that a surplus in cost must be included in the drug’s cost, in order to give the drug companies incentive and motivation to invest in the research and development necessary to bring a new drug along the pipeline and into the marketplace. That said, fewer consumers will purchase the drug if it is considered to be too expensive. The predicted number of sales and revenues of the pharmaceutical company therefore will ultimately determine the pricing of the drug (Levy and Rizansky, 2014).
Recently, however, this trend is changing. The new drugs available for Hepatitis C virus (HCV) are a great example of how drug pricing has gotten out of control .When first launched by Gilead Sciences, Sovaldi, which cures 95% of HCV patients, cost $1,000 a pill [6]. Although this price seems over the top, treating patients with Solvadi is actually less expensive and more efficacious in the long run than previous medication regiments. Furthermore, the fact that treatment takes only one or a few pills means that doctors could potentially reduce the impact of HCV dramatically. While lower prices set by competitors should somewhat reduce the high price of this anti-HCV drug, it is clear that expensive medications such as these are not sustainable. The National Coalition on Health Care and The Campaign for Sustainable Rx Pricing have both indicated that a better pricing structure will be required that addresses the needs of drug companies and balances them with the interests of society [7].
It is important to remember that much of this debate concerns drug companies who are marketing to the Western, industrialized world. This next section describes the role of major pharmaceutical companies in providing much needed drugs to the developing world, including Southeast Asia and sub-Saharan Africa. In these instances, drug companies must interact closely with regulatory agencies, academia, the patient community and non-Government organizations such as the Gates Foundation or Rockefeller Foundation to provide a rapid response to address some of the worst diseases that prevail in the poorest of countries [8]. For example, antiretroviral medicines against HIV/AIDS have been developed and prescribed to millions of HIV-1 positive people in sub-Saharan Africa, where the disease can be found at its worst [9]. Success in prevention of the spread of HIV-1/AIDS has resulted in a turnaround for people of these countries, but it could not have taken place without the compliance and commitment of multinational pharmaceutical companies such as Glaxo Welcome and Roche, along with not-for profit organizations such as the World Health Organization. In this case, pricing had to be set so that the drugs will not be out of reach of people in developing countries, but not too low so that the pharmaceutical companies would cease to provide them [9] . The fact that these drugs can themselves be set at higher prices in middle and high income countries is another source for controversy [10].
In conclusion, the high profits of drug companies are generally in accordance with their role in public health [11, 12]. Pharmaceutical companies work not only to ensure that their products are efficacious and safe, but also that products can be made available for people in developing countries who need access to modern drugs, such as the example of HIV positive patients in sub-Saharan Africa. Patent rights must be protected to assure the motivation of these companies to continue along the path of research and development for new drugs. Governmental regulation must remain in place to assure that tragedies such as that found for the unregulated dietary supplement OxyElite Pro do not take place. The high costs of some drugs such as the new medication for HCV can be partially explained by the improved prognosis for those suffering with the disease, but efforts must be made by regulatory bodies to ensure that they are sustainable with our current healthcare system. These factors must be imposed in order to maintain high levels of health and wellbeing for all.

References

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