Objectives of this primer from NYU Langone’s High School Bioethics Project are to understand the basics of the pharmaceutical and biotechnological development process, review recent trends regarding emerging diseases and their treatment, and discuss ethical and sociological questions raised by the medicalization process, or the process by which conditions and behaviors are labeled and treated as medical issues.

Curriculum Integration Ideas

This brief may be used in life sciences, health, and social studies classes during units that cover topics including the following:

• human physiology and psychology
• health economics
• public and health policy discussions
• the social construction of health, disease, and illness

Pharmaceutical and Biotechnological Medical Development

The many drugs and technologies that are used today in doctors’ offices undergo rigorous testing to ensure safety and efficacy. The U.S. Food and Drug Administration (FDA) oversees this testing.

After a new medication or device has been studied successfully in laboratories and in animal models, it is ready for study in humans in a phased approach:

• Phase 1 is normally performed with healthy volunteers, meaning people without the disease that the medication or device is intended to treat, and is used to test safety. Only a small number of volunteers are used (less than 100 usually).
• Phase 2 is performed with 100 to 500 people with the disease to see whether the drug or device is effective.
• Phase 3 is a large-scale trial (usually involving thousands of patients) in which the drug is tested for effectiveness compared with existing treatments or placebos, and for side effects. After successful completion of this phase, the drug or device is ready for marketing.
• Phase 4 is an optional segment of the clinical trial during which the drug is monitored for side effects while being actively marketed and sold.

Clinical trials are a lengthy and expensive process for pharmaceutical and biotechnological companies. A company may have spent up to 15 to 20 years developing a new drug or device by the time it hits the market. This all adds up to a cost, on average, of more than $800 million per drug or device. Because of the time and financial investment as well as competition among different drug and device companies, companies have a vested interest in selling their product well to make a profit.

Medicalization of Normal Health Variants

Medicalization refers to the process in which conditions and behaviors are labeled and treated as medical issues. Critics have labeled this over-medicalization or disease mongering, since by labeling normal health variants as pathological states, medical industries have made enormous profits.

Some of this has been a product of the rapid advancement of science in the last 30 years. For example, while infertility has been common throughout history, the rise of drugs and technological procedures to treat infertility has led to an explosion in infertility diagnoses. It is now a medical condition that can be treated, an example of medicalization.

Of course, the opposite is also true. De-medicalization is when conditions or behaviors previously thought to be diseases are recognized to be normal parts of life. While people were unsuccessfully “treated” or punished for these behaviors in the past, medicine now recognizes them as parts of a normal and healthy life.

HIV was identified in the early 1980s, and AIDS, the disease it causes, was subsequently recognized as such, prompting pharmaceutical and biotechnological companies to search frantically for treatments that would be available years after the first people were diagnosed. More frequently now, diseases or conditions and their treatments are appearing simultaneously. For example, people did not complain of restless leg syndrome (RLS) or it was misdiagnosed or ignored by their physicians. But now that medications are available to treat RLS, almost 12 million Americans have received an RLS diagnosis and prescription drugs to treat their symptoms.

What Are Some of the Ethical Issues Raised?

There are a wide variety of ethical issues that have been raised by the trend of medicalization.

Patient Safety

Because of the enormous amount of time and money pharmaceutical and biotechnological companies invest in their products, they are determined to sell them to as many customers as possible. While the FDA has cleared these drugs, no drug or device is without its side effects. Is it safe for us to be using drugs or devices we don’t really need?

An example of this is medications for attention deficit hyperactivity disorder (ADHD). Critics say that while ADHD is a real disease, two to four times the number of children in America have been prescribed medication for it than in other countries. This may be the result of companies heavily marketing their drug to make a profit.

Racism

Race is also part of the medicalization debate. Proponents of prescribing according to race argue that certain products, such as blood pressure medicines, have been proven to act differently depending on race in clinical trials, but critics say this is just another way to racially profile and discriminate. What do you think?

Recreational Drug Use

Another potential ethical problem to consider with medicalization is the expanding use of approved drugs and devices for recreational or off-label uses. For example, Viagra^® (sildenafil citrate) was initially approved for male impotence, but before long, manufacturers started advertising the blue pill to men to improve their sexual functioning, regardless of whether they had clinically diagnosed impotence or not. Since we have the scientific capabilities to improve human functioning in this way, should we use this knowledge? Or should medications and devices only be used for the strict purposes for which they were tested and licensed?

Review Questions

Consider some sample questions to discuss during this lesson:

• Explain briefly the process by which drugs and devices come to the market.
• Define medicalization and de-medicalization. Can you name an example of each that was not discussed in this module?
• Identify three ethical issues that arise from medicalization and discuss your stance on each one.
• What other medications are used recreationally or outside their intended purpose? Is this medicalization or simply drug abuse?

References

U.S. Food and Drug Administration: Learn About Drug and Device Approvals

Conrad P. The Medicalization of Society: On the transformation of Human Conditions into Treatable Disorders. Baltimore: The Johns Hopkins University Press; 2009. DOI.

President’s Council on Bioethics: Exchange of Letters on Medicalization Between Leon R. Kass, M.D., and Paul McHugh, M.D.