Edited Article and Commentary by Dr. Don Rose, Writer, Life Alert

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How did Viagra evolve from a treatment for erectile dysfunction (ED) in older Americans into a drug that younger men with no (or mild) ED also took in droves to enhance sexual performance? What is the boundary between medical treatment and lifestyle enhancement? Should health insurance ever cover the latter? What degree of ED “treatment” should be paid for by health care providers? What are the implications of the expanding market for “lifestyle drugs”, of which Viagra is a part? The article below addresses some of these intriguing issues. --Dr. Don Rose

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In the pursuit of profits, pharmaceutical companies are continuously looking to expand the market for their products. This article examines how Pfizer transformed its drug Viagra from an effective product for ED due to medical problems, such as diabetes and spinal cord damage, into a drug that “normal” men can use to enhance their ability to achieve an erection (and maintain it in a “stronger” state for a longer period of time).

The path to Viagra’s mass appeal and household-name status was not a straight and obvious one. Its rise to the top seems to have been helped by at least two examples of Pfizer applying creative marketing genius.

Initially, Sildenafil (the compound in Viagra) was studied for use in high blood pressure and angina, but Phase I clinical trials suggested the drug had little effect on angina. However, it proved capable of improving erectile function. Hence, Pfizer decided to market it for ED, rather than for angina. The drug was patented in 1996 and approved for use in ED by the FDA in March 1998, becoming the first pill approved to treat ED in the United States. The “ED Med” was offered for sale in the U.S. later that year.

Then came another example of Pfizer’s marketing savvy. Viagra was initially a treatment for ED meant for older Americans, such as elder Boomers and senior citizens. However, this market was not wide enough for blockbuster success. Hence, Pfizer took on the task of making ED more “mainstream” in terms of male awareness and acceptance as a mainstream topic of discussion, for a wider age range (for example, men over 40). Studies were undertaken showing that, apparently, a large percentage of men over 40 suffered from at least some degree of ED. The plan worked. With the ED market expanded greatly and growing fast, Viagra soon became a colossal “hit”; annual sales of the drug from 1999 to 2001 exceeded $1 billion.

Yet Viagra’s success has raised many questions. What can we learn from the way this little blue pill evolved from an ED treatment for older folks (of the Bob Dole generation) into a drug that younger men with mild-to-no ED wanted too (for enhancing sexual performance)? What is the boundary between medical treatment and lifestyle enhancement? What degree of ED “treatment” should be covered by health care providers? What are the implications of the expanding market for “lifestyle drugs”? Let us examine some of these issues.

An important emerging issue in health care is the availability of medications to treat what until recently have been regarded as the natural results of aging, or part of the normal range of human emotions. For example, we see treatments advertised for male pattern baldness and shyness. Deviating even further, drug therapy is moving beyond treating diseases to providing enhancements to what was once seen as normal functioning.

This evolution in the use of medications has introduced dilemmas and controversies about what are legitimate conditions and treatments for those concerned with prescription medications. Is any deviation from normality fair game for treatment? What about people who have nothing medically wrong with them, but just want to feel better? Who will pay for these therapies, and what are the implications for the way we use health care resources? Medications that embody these controversies are generally referred to as lifestyle drugs and perhaps the best known of these is sildenafil citrate (Viagra). This article examines the strategies used by Pfizer to ensure that its Viagra pill was seen as legitimate therapy for almost any man. The more a drug is considered useful for “near normal” members of a group, the more it can be viewed as a lifestyle drug for that group.

Pfizer took steps to make sure that Viagra was not relegated to a niche role of just treating men who had ED due to organic causes, such as diabetes or prostate surgery. The drug is generally considered by many to be safe and effective in treating ED secondary to these causes. However, had Viagra been used only in cases of ED secondary to organic causes, the drug may have been only a modest success. In order to grow the market, Pfizer had to make Viagra the treatment of choice for a much wider population of men. The perceived prevalence of ED needed to be expanded. The impression had to be created that ED was of significant concern to many, or even most, men (at least those over 40). The success criterion for treating ED had to be redefined. Finally, Viagra had to be seen as an important treatment option for men with any degree of ED, including rare or transitory failures to achieve or maintain erections. Creating a kind of “Club ED”, where any man with mild-to-heavy ED felt that they were one of millions turning to Viagra for relief, and that it was perfectly normal to do so, was a shrewd move indeed.

On its website, Pfizer states that “more than half of all men over 40 have difficulties getting or maintaining an erection”. One possible source of support for this statement is the Massachusetts Male Aging Study (MMAS), a community-based, random sample observational survey of men 40 to 70 years old conducted from 1987 to 1989 in cities and towns near Boston, Massachusetts. The authors of the study extrapolated the results to argue that 52% of the entire male population in the United States between the ages of 40 and 70 suffer from ED. The authors stated: “In the MMAS sample the prevalence of impotence of all degrees was estimated at 52%. Projection of these results to 1990 population data would suggest that impotence affects 18 million American men 40 to 70 years old”.

However, the MMAS figures must be viewed with a number of caveats.

First, there were actually two different groups of men in this study. The first, and larger, group answered a series of nine questions about sexual activity. The second, and much smaller, group answered the same nine questions, plus an additional question to self-rate themselves as not impotent, minimally impotent, moderately impotent, or completely impotent. The answers to this final question by the men in the second group were then applied to the first group to derive the percent in the various classes of potency. The authors do not provide any information about whether the two groups were similar, and there are reasons to think that differences may exist between the groups. The first group was randomly selected from towns and cities in the Boston Standard Metropolitan Statistical Area, while the second group was made up of men presenting to a university center urology clinic. Even if the scores from one group can be transferred to the other, the 52% figure is still deceptive because it doesn't differentiate ED by age. In the MMAS, 40% of 40-year-old men had ED, including 17% who were only minimally impotent, whereas 67% of 70 year olds were impotent.

In addition, not all studies are in agreement with these figures. Analysis of data from the US National Health and Social Life Survey indicates that among men 50–59 years old, 18% complained of trouble achieving or maintaining an erection during the past year. A survey in the Netherlands found that only 1% of men 50–65 years of age had a complete inability to achieve an erection, and it was only in men aged 70–78 years that the rate of ED was similar to that in the MMAS. Out of 13 studies on the prevalence of ED that were published until June 1998, the MMAS results were among the highest. Thus, Pfizer's statement that “more than half of all men over 40 have difficulties getting or maintaining an erection” does not reflect the large variation in the prevalence of ED found in different studies.

The MMAS found a strong association between ED and psychological factors, including “depression, low levels of dominance, and anger either expressed outward or directed inward.” The authors suggested that psychological symptoms might be a cause of ED, but these symptoms could also be an effect of ED (they wrote that “a man who has experienced a recent pattern of ED may be expected to be anxious, depressed and lacking self-esteem and self-confidence”). While there may well be an association between ED and psychological symptoms, once again the MMAS may be an outlier. In the Dutch study previously mentioned, only one-third of all men and only 20% of men over the age of 70 with significant ED had major psychological concerns. Furthermore, in sexually active men, 17%–28% had no normal erections, indicating that full erectile function is not essential for sexual functioning. Only 20% of Japanese men 40 to 79 years of age reported more than minimal worry and concern about sexual functioning, suggesting that perceptions of elderly male sexual function and its impact on health-related quality of life may differ among cultures and ethnic groups with differing values.

On its website, Pfizer states: “VIAGRA can work for you. In fact, studies show that VIAGRA works for more than 80% of men with ED taking VIAGRA 100 mg versus 24% of men taking a sugar pill”. The 80% success rate that Pfizer quotes for Viagra is important, though not critical, to being able to promote its use to a wide variety of men. But that number is qualified on the Pfizer website as the number who experience improved erections. It is open to speculation whether the goal of most men is improved erections, or successful intercourse and the achievement of an orgasm. In most studies on Viagra, a 50%–60% rate of successful intercourse is recorded (in studies comparing Viagra to placebo, up to 25% of patients’ attempts at intercourse were successful on placebo compared with 50%–60% for folks taking Viagra 25–100 mg). This 50%–60% rate, while an improvement, is short of the “more than 80% of men” that Pfizer trumpets.

To make Viagra into a lifestyle drug, Pfizer needs to convince men that it is the first choice of therapy for any degree of ED, whatever the genesis of the problem. However, drug therapy may not always be the most appropriate treatment option. The National Health and Social Life Survey data indicate that emotional and stress-related problems such as a deteriorating social and economic position generate elevated risk of experiencing sexual difficulties. In these cases, Viagra may be less important than counseling or help in finding a new job. These possibilities are never mentioned on the Viagra website.

Here is a sample of the questions and answers on the “About ED” portion of the website:

• Question: “I don't have ED because the problem doesn't happen often. Does this mean that VIAGRA is not for me?”
• Answer: “Even if erection problems happen only once in a while, VIAGRA can help. You should know that most men with ED only experience problems some of the time. In one study, VIAGRA helped 87% of men with mild-to-moderate ED have better erections versus 36% of men taking a sugar pill”.

In case the message is missed, there is a couple on the Web page where the man looks to be in his mid-to-late 30s. Pfizer reinforces its message with direct-to-consumer magazine ads, such as one featuring a virile looking man around 40 saying, “A lot of guys have occasional erection problems. I chose not to accept mine and asked about Viagra.”

Drug Companies Identify Lifestyle Drugs as a “Growth Market”

Economic and Social Implications of the Expanding Lifestyle Drug Market

Conclusion

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