Lifestyle Drugs Straddle Medical and Social Domains

Feeling ugly, feeling unhappy, and feeling different are not diseases. A century ago, researchers and health care providers looked to drugs solely for the potential to prevent, cure, or ameliorate infection or disease.¹ During the past few decades, several drugs that have nothing to do with disease have entered the marketplace with tremendous fanfare.² Others, once used for disease, now have additional, seemingly frivolous indications. Some have become wildly popular. The term lifestyle drugs has come on the scene. This term encompasses drugs that do the following:

• Treat conditions resulting from personal responsibility or behavior choices
• Enhance life or performance
• Treat problems falling outside the medical or social definitions of health
• Straddle medical, social, and environmental domains^1-4

Extreme definitions of the term include drugs that treat target symptoms that most members of society do not consider part of a "real" disease or disorder.⁵

Clearly, there is some ambiguity. Consider Richard Russo's book Empire Falls. He describes people who populate a fictional town in Maine (they have all the usual warts and blemishes) and their perception of some people in California (who have used medical means to "eradicate ugliness").⁶ The story line demonstrates that, geographically, opinions differ about what is medically necessary and what constitutes a lifestyle drug. Other factors that may influence the definition are the definer's religion, socioeconomic status, country of national origin, profession, and gender. An actor who is a Scientologist, for example, may classify antidepressants as "lifestyle drugs."

Each individual adapts and integrates into the social milieu (eg, creates a lifestyle) uniquely. Individuals may use alcohol and tobacco (or not), develop specific dietary habits, and engage in exercise (or not). Lifestyle has important health implications. With a growing understanding of genetics and its role in phenotype expression (eg, appearance), people may be more likely to perceive certain problems as beyond control and consider them as legitimate targets for drug therapy.⁷

The term lifestyle drug first appeared when insurers were faced with prescription drug coverage issues: with limited health care dollars, should they pay to enhance happiness or "eradicate ugliness"? The debate began in the early 1990s but escalated seriously in 1998 with the launch of Viagra. Insurers, estimating budget-busting numbers of prescriptions from men seeking performance enhancement, took measures to define the circumstances under which erectile dysfunction (ED) drugs would be covered.⁸ Drugs frequently included for some (but not necessarily all) other indications are listed in the Table.

Fueled by ample and frequent direct-to-consumer advertising, the market for lifestyle drugs is projected to exceed $29 billion by 2007.^1,2,5,9 With its "Who pays?" origin,⁷ the term lifestyle drug has generated plenty of controversy.

Medicalization

Health conditions occur along a continuum. A treatment might be deemed a "medical necessity" if it provides tangible benefit while incurring acceptable risk. It might be deemed "enhancement" if it promotes or augments good health, or "elective" if the individual can live well without it.¹ Some critics of lifestyle drugs worry about medicalization of conditions, meaning that conditions that might be treated with behavioral modification or personal changes move along the continuum toward "medical necessity," removing individual responsibility.^1,2

Although pharmacoeconomic studies of lifestyle drugs are rare,¹ sometimes few or no data indicate that these drugs are better than other interventions. Studies indicate, however, that, if drug treatment is available, physicians are less likely to use nondrug treatments, even if the evidence shows the nondrug treatment to be superior.^2,10

Consider the individual who shuns social situations. To some, he or she is shy. To others, he or she has social phobia and may be a candidate for fluoxetine. Yet, studies show that cognitive-behavioral therapy is as effective as drug treatment in the short run and better than drug treatment over the long run.² Also, recently some researchers have attempted to increase acceptance of compulsive shopping disorder (binge shopping with subsequent financial hardship), and others have promoted the use of "smart drugs" to improve children's academic performance.^5,11

Thought Evolution

Other stakeholders will support lifestyle drugs in the name of progress, indicating that science redefines optimal health constantly.¹ For example, when braces and fluoridation were first discovered, many people considered both of them cosmetic and resisted their use. Today, the relationship between poor oral health and poor general health, especially heart disease, has been elucidated.¹²

Such evolution of thought is occurring with such conditions as obesity and smoking. It may occur with such interventions as using oral contraceptives to reduce a woman's menstrual cycles to 4 or fewer per year,¹³ beta-blockers to erase traumatic memories,^14,15 or some yet undiscovered drug to maintain muscular strength. It is unlikely, however, that any of the "diseases" that physicians in a British Medical Journal survey voted as the Top 10 Non-Diseases (aging, work, boredom, under-eye bags, ignorance, baldness,?), will ever work their way to medical conditions.⁵

Striving for Sameness

Another concern is societal homogenization.^1,2 This concern becomes a philosophical argument, based in part on the arguments cited above?that progress produces new standards. "Menu creep" raises the bar on what is "normal." Previously untreated/untreatable conditions tend to migrate to treatable under consumer pressure.⁸ Similarly, drugs move from nonformulary to formulary status over time, and vice versa. These changes occur as better background information becomes available to clinicians and payers.⁸

One last concern is that of drug substitution strategies. Many stakeholders worry that patients will use one drug to replace another with little or dubious clinical benefit. Such is the debate when benzodiazepines are used to replace alcohol or methadone is used to replace heroin. If, however, people with addictions can find drugs that are equally satisfying to their addictions but safer, many clinicians argue that the safer drugs are preferable.¹⁶ Until many of the myths and stigma that accompany addiction are attacked, this debate will continue.

The Pharmacist's Role

When patients present at the pharmacy with lifestyle-drug prescriptions, they usually are unconcerned about controversy or philosophical debates. They want results. Pharmacists should not trivialize lifestyle drugs, keeping in mind that all drugs have side effects, and that the acceptability of the side effects is proportional to the patient's (not the physician's or the insurer's or the pharmacist's) assessment of the condition's severity.² Pharmacists should be prepared to counsel patients about what to reasonably expect (eg, that an ED drug will cause an erection only under appropriate conditions, or that an agent indicated for alopecia will restore only recently lost hair).

If the lifestyle drug comes in different delivery methods, pharmacists should be prepared to counsel on what is available and the advantages and disadvantages of each. Sometimes, prescribers either do not know about various options or do not have the time to discuss them. Look also for potential drug interactions in a patient.

Warn patients that lifestyle drugs often are counterfeited,¹⁷ and tell them that most counterfeit drugs are obtained over the Internet. Counsel them to use reputable sources for their prescriptions and to monitor what their drugs should look like as well as their response to the drugs.

Remember that drugs of abuse often represent uninformed attempts to increase happiness,⁵ and watch that legitimate lifestyle drugs do not become recreational as used by patients. Watch for what drug manufacturers call "unauthorized use" of drugs: modafinil to create more productive hours in a day,¹⁸ stimulants or steroids used to enhance normal intelligence or sports ability,⁴ or ED drugs to boost run-of-the-mill sexual performance.¹⁷

Be aware when lifestyle drugs make headlines, and monitor trends in your area. Keep in mind that Medicaid suspended coverage of ED drugs when officials realized that 800 convicted sex offenders in 14 states had received these drugs.^19,20

Coming Soon

The exploration of lifestyle drugs will continue as long as humankind evolves. In the pipeline, look for drugs that are pleiotropic (producing many effects in different systems). Rimonabant, an investigational agent for the management of cardiovascular risk factors, for example, is in phase 3 clinical trials. In combination with reduced calorie diets, it promotes weight loss and smoking cessation.²¹ Under what circumstances will it be considered a lifestyle drug?

Ms. Wick is senior clinical research pharmacist at the National Cancer Institute, National Institutes of Health, Bethesda, Md. Views expressed in this article are those of the author and not those of any government agency.

For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. A. Stahl, Pharmacy Times, 241 Forsgate Drive, Jamesburg, NJ 08831; or send an e-mail request to: astahl@ascendmedia.com.