1. Objectives

Teachers' Objectives
After completing this module, you should be able to simply yet effectively teach:

1.) The basics of the pharmaceutical and biotechnological development process
2.) Recent trends regarding emerging diseases and their treatment
3.) The ethical and sociological questions raised by the process of medicalization

Curriculum Integration Ideas
This brief may be used in life science, health, and social studies classes during units for topics including:

1.) Human physiology and psychology
2.) Health economics
3.) Public and health policy discussions
4.) The social construction of health, disease, and illness

2. Pharmaceutical and Biotechnological Medical Development

The many drugs and technologies that are used today in doctors' offices have to undergo rigorous testing to ensure safety and efficacy. The Food and Drug Administration (FDA) oversee 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. Phase 1 is normally done on healthy volunteers, that is people without the disease 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 on 100-500 people with the disease to see if the drug or device is effective. Phase 3 is a large-scale (thousands of patients) trial in which the drug is tested for effectiveness compared to existing treatments or placebos and side effects. After this, the drug or device is ready for marketing. Phase 4 is an optional segment of the clinical trial in which the drug is monitored for side-effects while it is being actively marketed and sold.

Clinical trials are a lengthy and expensive process for pharmaceutical and biotechnological companies to undergo but are required by the government in order to market their products. A company can spend up to 15-20 years developing a new drug or device by the time it hits the market. This all adds up to a cost, on average, of over 800 million dollars per drug or device. Because of the time and financial investment as well as the competition between different drug and device companies, companies have a vested interest in selling their product well to make a profit.

3. Medicalization

Medicalization refers to the process in which health conditions and behaviors are labeled and treated as medical issues. Some of this has been a product of the rapid advancement of science in the last thirty years. For example, while infertility has been a common component of every culture throughout history, the rise of drugs and technological procedures to treat infertility has lead to an explosion in infertility diagnoses. Thus, while infertility used to be just a common part of life for some couples, it is not a medical problem that can be treated. That is medicalization. Another example is obesity. What used to be seen as someone simply being overweight, has spawned an entire industry of health products, weight loss medications and surgeries, and referral services and centers. Critics have labeled this over-medicalization or disease-mongering, since by labeling normal health variants as pathological states, medical industries have made enormous profits.

Of course, the opposite is also true. Demedicalization is when conditions or behaviors previously thought to be diseases are recognized to be normal parts of life. Examples of this include masturbation and homosexuality. While people were unsuccessfully "treated" or punished for these behaviors in the past, medicine now recognizes them as dimensions of a normal and healthy life.

Years ago, diseases like cancer and HIV first emerged and were recognized by patients and doctors. This would prompt pharmaceutical and biotechnological companies to search frantically for a treatment that would be available years after the first people were diagnosed with these conditions. Now, more and more often, diseases and treatments are appearing simultaneously. For example, ten years ago, patients either did not complain of restless leg syndrome or it was misdiagnosed or ignored by their physicians. But now that medications are available to treat it, almost 12 million Americans have been diagnosed with it and prescribed drugs to treat their symptoms.

4. What Are Some Of The Ethical Issues Raised?

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

Patient Safety
Because of the enormous amount of time and money pharmaceutical and biotechnological companies have invested into their products, they are determined to sell them to as many customers as possible. An example of this is medications for Attention Deficit Hyperactivity Disorder (ADHD). Critics say that while ADHD is a real disease, 2-4 times the number of children in America have been prescribed medication for it than in other countries. This may be due to companies heavily marketing their drug in order to make a profit. 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?

Racism and Gender Discrimination
Another problem with medicalization is it has medicalized the normal social variants of gender and race. Pregnancy and childbirth used to be a process that happened at home with a midwife and older females in one's family overseeing the delivery and recovery. Now, childbirth occurs in sanitized hospital rooms with medications, electronic fetal monitoring systems, and the ever-waiting operating room for Caesarean sections. Critics argue that medicalization has affected women unfairly since more of their bodily processes and functions are visible to society. Is this discrimination or is this acceptable in the name of science? Race has also been affected by medicalization as we uncover the secrets of the genome as well as prescribe different blood pressure medications depending on race. Proponents argue that these medications 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 with medicalization is the expanding use of these approved drugs and devices for recreational or off-label uses. For example, Viagra was initially approved for male impotence. But nowadays you see commercials advertising the blue pill to men to improve their sexual functioning, regardless of whether they suffer from clinically-diagnosed impotence or not. Since we have the scientific capabilities to improve human functioning in this manner, should we use this knowledge? Or should medications and devices only be used for the strict purposes they were tested and licensed?

5. Review Questions

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

References

1. Food and Drug Administration
2. President's Council on Bioethics, Working Paper on Medicalization
3. Peter Conrad, The Medicalization of Society
4. WHYY News and Information, Inventing a Disease