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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 sildenafil 100mg next day delivery 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 will examine the strategies used by Pfizer, the maker of Viagra, to ensure that the drug was seen as legitimate therapy for almost any man.

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. There is no doubt that Viagra is an effective and quite safe drug in treating ED secondary to these causes, although a systematic review of the evidence found that the drug probably only results in successful intercourse 50%–60% of the time [ 1]. Had Viagra been confined to use only in cases of ED secondary to organic causes, the drug would probably have been a modest success for Pfizer.

In order to grow the

market

The perceived prevalence of ED needed to be expanded. The impression had to be created that ED was of significant concern to many, perhaps even most, men or at least those over 40 years of age. The criterion of success for treating ED had to be redefined. And 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. Redefining the Prevalence of ED and Its Psychological Effects.

On its Web site, Pfizer states that “in fact, more than half of all men over 40 have difficulties getting or maintaining an erection” ( http://www.viagra.com/ed/index.asp). The Web site does not give a reference to support this statement.

One possible source of support for this statement is the Massachusetts Male Aging Study (MMAS), a community-based, random sample observational survey of men aged 40 to 70 years old conducted from 1987 to 1989 in cities and towns near Boston, Massachusetts [ 2].

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” [ 2]. 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

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. Moreover, 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 [ 4].

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 [ 5].

Out of 13 studies on the prevalence of ED that were published until June 1998, the MMAS results were among the highest [ 1]. 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”) [ 2].

While not to deny that there is 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 [ 5]. Only 20% of Japanese men 40 to 79 years of age reported more than little 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 [ 6]. On its Web site, 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” ( http://www.viagra.com/whyViagra/highlyEffective.asp).

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 Web site as the number who experience improved erections ( http://www.viagra.com/consumer/aboutViagra/index.asp). It is open to speculation whether the goal of most men is improved erections, or successful intercourse and the achievement of an

orgasm

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” ( http://www.viagra.com/faqs/faqs2.asp).

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 have identified lifestyle drugs as a “growth market.” The initial television ads in the US for Viagra used an aging Bob Dole (born 1923) as a spokesman, a 1996 Republican presidential candidate.

Since then, Pfizer has refocused its advertising campaign to match the lifestyle message on its Web site.

There is now advertising of Viagra at NASCAR races, and Pfizer hired 39-year-old Rafael Palmeiro, a former Texas Ranger baseball player as a spokesman ( Figure 1 ) [ 7]. Pfizer teamed up with Sports Illustrated magazine to create the Sportsman of the Year Trivia Game ( http://www.viagra.com/sports/index.asp).

Between 1999 and 2001, Pfizer spent over US$303 million in direct-to-consumer advertising to get its message about Viagra to men [ 8–10]. Besides the large promotion budget, Pfizer has also paid a number of doctors to act as “consultants,” delivering public lectures and appearing in the mass media to expound on ED and Viagra [ 11] Pfizer denies that it is targeting younger men or that it is positioning Viagra as a lifestyle drug.

Mariann Caprino, a spokeswoman for the company, is quoted in the New York Times as saying, “Have we gone out and given our advertising agency instructions to speak to this young population? But the

message

Increasingly, the age profile of men using Viagra reflects the younger audience that Pfizer denies it is targeting.

Between 1998 and 2002 the group showing the largest increase in Viagra use was men between the ages of 18 and 45, and only one-third of these men had a possible etiologic reason for needing Viagra [ 12]. Economic and Social Implications of the Expanding Market for Lifestyle Drugs.

Drug companies have identified lifestyle drugs as a “growth market.” The problems that they are designed to treat are easily self-diagnosed—we can all see if we are bald or fat—and as the baby boomers age, the population looking to these drugs will continue to grow.

Drug companies, driven by profit, go where the money is. Because of the potential

size

Do we accept order sildenafil tablets our limitations with grace, or is it legitimate to seek technological solutions for them?

In one corner is the view of health as freedom from disease, where “the central purpose of health care is to maintain, restore, or compensate for the restricted opportunity and loss of function caused by disease and disability” [ 13]. In this model, a just medical system would not cover treatments and interventions that aim to enhance abilities not affected by disease and disability. Opposing this is an expansionist definition, such as the one offered by the World Health Organization, where health is “a state of complete physical, mental and social well-being” ( http://www.who.int/about/definition/en/print.html). If we accept this view, then are we not obliged to provide for people who want to enhance themselves so that they can achieve mental and social well-being? This debate is further complicated because there is not an equal balance in how we look at the options of accepting limitations and seeking enhancement. In a market-driven world, the money is in promoting enhancements, not in accepting limitations. The ad featuring the man who chooses not to accept even occasional erection problems is one example of how commercial pressures bias the debate [ 14].

Because of the possibility that large numbers of men would request Viagra from their doctors, getting insurance companies to pay for Viagra presented Pfizer with special problems. Early on, Kaiser Permanente refused to cover Viagra for its 9 million members because of costs expected to be in the range of US$100 million per year [ 11]. According to one interpretation, reactions from insurers such as Kaiser Permanente were the reason that Pfizer put in place a US$35 million campaign to change insurers' decisions [ 11]. Another goal of Pfizer's campaign was to make ED an acceptable topic for public discourse, in order to remove the stigma attached to it and increase the possibility that third parties would provide coverage. Viagra presents a microcosm of the debate surrounding drugs that enhance lifestyle choices.

The drug is effective and safe for people with medical problems warranting treatment, but it also can be used by a much wider population.

The company that manufactures the drug, recognizing that the potential market is huge, has aggressively targeted that much larger community. Pfizer's well-financed campaign was aimed at raising awareness of the problem of ED, while at the same time narrowing the treatment possibilities to just a single option: medication.

Having succeeded in turning Viagra into a consumer product, Pfizer then turned its attention to payers in order to reap the benefits of the expanded market. Ultimately, there must be a debate about how limited resources for health care should be spent and who should make those decisions.

Are men who seek to enhance their normal sexual function “worthy” enough to have their treatment paid for?

If we pay for drugs and other procedures that enhance lifestyles, then other treatments either may not get funded at all or may become inadequately funded. As the number of enhancement treatments grows, the scenario surrounding Viagra will become all too familiar with other drugs.

Now is the time to start sildenafil 100mg next day delivery preparing for how we will deal with the inevitable explosion of drugs and other interventions that can make us “better than well” [ 16]. Erectile dysfunction (ED) is one of the most common conditions affecting middle-aged and older men.

Nearly every primary care physician, internist and geriatrician will be called upon to manage this condition or to make referrals to urologists, endocrinologists and cardiologists who will assist in the treatment of ED. This article will briefly discuss the diagnosis and management of ED. In addition, emerging concepts in ED management will be discussed, such as the use of testosterone to treat ED, the role of the endothelium in men with ED and treating the partner of the man with ED. Finally, future potential therapies for ED will be discussed.

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Nearly every primary care physician, internist and geriatrician now understand that many older men retain an interest in sexual activity as they age. Some primary care physicians think that sexual potency in older men is the norm, and that if it is lacking, it is ‘all in the head.’ This viewpoint has not been supported by current literature. The Massachusetts Male Aging Study (MMAS) found that 52% of men between 40 and 70 years old reported having some form of erectile dysfunction (ED).1 The reality is that ED is a natural part of ageing and that the prevalence

increases

The myths that surround the problems of impotence or ED confound the attempts of patients to receive treatment and the attempts of physicians to help them.1. Many factors can contribute to sexual dysfunction in older men, including physical and psychological conditions, comorbidities and the medications used to treat them. Aspects of an ageing man’s lifestyle and behaviour and androgen deficiency, most often decreasing testosterone levels, may affect sexual function as well. A study of men between the ages of 30 and 79 years showed that 24% had testosterone levels below 300 ng/dL and 5.6% had symptomatic androgen deficiency.2.

The percentage of men who engage in some form of sexual activity decreases from 73% for men aged 57–64 years to 26% for men aged 75–85 years.3 For some men, this constitutes a problem, but for others it does not.

The aetiology for this decline in sexual activity is multifactorial and is in part due to the fact that most of the female partners undergo menopause at 52 years of age with a significant decline in their libido and desire to engage in sexual activity. A study by Lindau and colleagues3 that examined sexuality in older Americans showed that 50% of the men in a probability sample of more than 3000 US adults reported at least one bothersome sexual problem and 33% had at least two such problems.3 This article will review the normal changes that occur with ageing, factors that influence these changes, individual variations and perspectives, and the available treatment options for ED and androgen deficiency.

Impotence treatments were discussed in the oldest Chinese text, The Yellow Emperor’s Classic of Internal Medicine, which describes traditional Chinese medicine during the time of the Yellow Emperor’s rule which ended around 2600 BC. One of the treatments for impotence discussed is a potion with 22 ingredients.4.

Nearly 1000 years later, the Egyptian Papyrus Ebers, a medical Egyptian document dated 1600 BC, describes a cure for impotence in which baby crocodile hearts were mixed with wood oil and applied topically to the penis.4. In 1973, Dr Brantley Scott from Baylor College of Medicine reported on the implantable inflatable prosthesis that urologists still use today.5. The major breakthrough occurred in 1998 when sildenafil became the first oral drug to be approved to treat ED.4 This was followed by the use of tadalafil and vardenafil as similar phosphodiesterase-5 inhibitor oral medications for treating ED in 2003.4. Overview of physiological changes and other risk factors.

As with most other organ system in the human body, changes and loss of function is normal consequence of the ageing process. This is also true of the endocrine system, specifically the levels of testosterone production from the Leydig cells of the testicle. Accompanying the decrease in testosterone is a decrease in erections which also has a component in decrease in the blood supply to the penis making erection not as frequent and not as rigid compared with a young man’s erectile function.

Although these changes are in itself not life threatening, they

can

hypercholesterolaemia

ED is defined as the inability to achieve a full erection or the inability to maintain an erection adequate for sexual intimacy.

Other types of sexual dysfunction such as premature ejaculation and low libido may occur; however, the most common and disruptive problem in men is ED. Although most men will experience periodic episodes of ED, these episodes tend to become more frequent with advancing age. Medical conditions, such as hypertension, diabetes mellitus, and cardiovascular disease (CVD), and psychological conditions, such as depression and anxiety, also contribute to sexual dysfunction in middle-aged or elderly men.

CVD and hypertension cause a narrowing and hardening of the arteries, leading to reduced blood flow to the corporal bodies, which is essential for achieving an erection. Diabetes is a common aetiology of sexual dysfunction, because it can affect both the blood vessels and the nerves that supply the penis.

Men with diabetes are four times more likely to experience ED, and on average, experience ED 15 years earlier than men without diabetes.7 Obesity is also correlated to the development of several types of dysfunction, including a decrease in sex drive and an increase in episodes of ED.8.