Ethics And The Pharmaceutical Industry

1. Introduction

Over the past couple of decades, a sudden change has started to take over the way business is done. The time when no rules applied, and anyone could do what they pleased at the cost of others or the environment is rapidly ending. Instead, companies today have become aware that it is essential for them to employ ethics and morality in their actions, if not they will be heavily scrutinized and rejected by the public. This way of thinking also applies to the pharmaceutical industry, which over the past century has been rapidly expanding. Do to the fact that this industry can determine the health and lives of millions of people, it is imperative that this industry follow an ethical and moral path.

When talking about applied ethics, medical ethics has always been extremely important. This however, is not the same with Pharmaceutical ethics, which has been somewhat neglected. Over the past years there have been several cases and debates with important pharmaceutical companies like Merck and Pfizer, Inc. about their research methods, and the development, pricing, and distribution of medicine all over the world. These issues have caused a great deal of damage to the pharmaceutical industry in the eyes of the consumers, and now must find a way to regain the trust of the people. This is where applied ethics comes in, by helping the industry change its methods so that it can be more beneficial to society, while still keeping its business orientation.

The purpose of this paper is to analyze the ethical side of the pharmaceutical industry. The first section will be a brief description of Ethics and how it has been incorporated over the years into medicine and pharmaceutical industry. Following will be a section that deals with the ethics of the drug discovery and development process. Some examples of how these two processes are done will be given and discussed in this section. The next segment of the paper will be about the distribution of drugs. This segment will discuss how the pharmaceutical companies place a price on their medicines, and how they decide who needs them, and when to help out others (third world countries, people with insufficient income, etc. The last section will talk about the company of Pfizer, Inc. and see what ethical approach they have taken over the past years in order to adjust to the needs and expectations of the global market today.

2. Ethics and the Pharmaceutical Industry

2.1 Incorporating Ethics into the Pharmaceutical Industry

The medical profession has an old history involving the code of Ethics. But before discussing this matter, I will explain Ethics and morality. As defined by the Encarta World English Dictionary, Ethics is the study of moral standards and how they affect conduct. This leads to morality, which is a system of moral principles governing the appropriate conduct of a person or group. In this case, the persons or group are Doctors and physicians that since the 4th Century B.C. have been making the Hippocratic Oath. This Oath outlines the basic principles and moral values that a physician should have and live by. The Hippocratic Oath has lasted until today, with some revision and changes along the way. Out of all the revisions, the most important is the 1948 Declaration of Geneva, which was adopted by the World Assembly of the World Medical Association. This is a declaration of physicians' dedication to the humanitarian goals of medicine. Some of the key points of the current declaration are the following:

* I solemnly pledge to consecrate my life to the service of humanity

* I will practice my profession with conscience and dignity

* The health of my patient will be my first consideration

* I will respect the secrets that are confided in me, even after the patient has died

* I will not permit considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, social standing or any other factor to intervene between my duty and my patient

* I will maintain the utmost respect for human life

While ethics has always been a big part of medicine, it is not the same case with the pharmaceutical business. Even though the pharmaceutical industry has made great improvements to human health and quality of life, like creating drugs for the treatment of AIDS, cancer, and other diseases, an increasing tension is growing between the public and the industry. These thoughts are fueled by issues such as drug pricing, affordable health care, and the battle against epidemic diseases in third world countries; social critics wonder whether this multi-billion dollar industry is giving enough back to the community and fulfilling its social responsibility.

But the question still remains, how has ethics become involved in the pharmaceutical Industry? To understand this better, I will briefly talk about the history of the industry. In the late 19th and early 20th century key discoveries, such as insulin and penicillin, were made. These medicines were needed in large quantities, and thus allowed major companies that we know today to begin the mass-manufacture and distribution of these. In order to test and approve drugs and to require appropriate labeling legislation was enacted. As the pharmaceutical industry grew, prescription and nonprescription drugs became legally distinguished from one another.

From the 1950's on, numerous new drugs were developed and mass-produced, including the first oral contraceptive, Cortisone, blood pressure drugs, etc. In 1960 Valium was discovered, and then marketed in 1963. This became the most prescribed drug in history, but along with it came great controversy and criticism over the dependency. During these years we see the beginning of ethical behavior in the industry. Several attempts were made to increase regulation and limit financial links between the pharmaceutical industry and prescribing physicians. In 1964, the World Medical Association issues its Declaration of Helsinki, which set standards for clinical research and made it a requirement for subjects to give their informed consent before enrolling in an experiment. The Pharmaceutical companies were forced to prove the clinical trials had worked before being able to market the drugs.

The 1970's and 1980's saw an expansion at a greater rate of the pharmaceutical companies. As legislation allowing for strong patents came into force in most countries, small biotechnology firms started to struggled, and eventually were bought buy larger ones, concentrating