Abstract and Introduction

Abstract

Background: The association between methamphetamine use and HIV seroconversion for men who have sex with men (MSM) was examined using longitudinal data from the Multicenter AIDS Cohort Study.
Methods: Seronegative (n = 4003) men enrolled in 1984 to 1985, 1987 to 1991, and 2001 to 2003 were identified. Recent methamphetamine and popper use was determined at the current or previous visit. Time to HIV seroconversion was the outcome of interest. Covariates included race/ethnicity, cohort, study site, educational level, number of sexual partners, number of unprotected insertive anal sexual partners, number of unprotected receptive anal sexual partners, insertive rimming, cocaine use at the current or last visit, ecstasy use at the current or last visit, any needle use since the last visit, Center for Epidemiologic Study of Depression symptom checklist score > 16 since the last visit, and alcohol consumption.
Results: After adjusting for covariates, there was a 1.46 (95% confidence interval [CI]: 1.12 to 1.92) increased relative hazard of HIV seroconversion associated with methamphetamine use. The relative hazard associated with popper use was 2.10 (95% CI: 1.63 to 2.70). The relative hazard of HIV seroconversion increased with the number of unprotected receptive anal sexual partners, ranging from 1.87 (95% CI: 1.40 to 2.51) for 1 partner to 9.32 (95% CI: 6.21 to 13.98) for 5+ partners. The joint relative hazard for methamphetamine and popper use was 3.05 (95% CI: 2.12 to 4.37). There was a significant joint relative hazard for methamphetamine use and number of unprotected receptive anal sexual partners of 2.71 (95% CI: 1.81 to 4.04) for men with 1 unprotected receptive anal sexual partner, which increased in a dose-dependent manner for > 1 partners.
Conclusions: Further examination of the mechanisms underlying the synergism of drug use and sexual risk behaviors on rates of HIV seroconversion is necessary for the development of new targeted HIV prevention strategies for nonmonogamous drug-using MSM.Introduction

The use of methamphetamine, a powerful central nervous system stimulant associated with sexual enhancement, has been popular among men who have sex with men (MSM) for many years.[1-3] Behavioral research has demonstrated that gay male methamphetamine users are more likely to engage in high-risk sexual practices for the transmission of HIV and other sexually transmitted infections and to be HIV-seropositive.[4-18]

Even though a substantial literature exists to demonstrate the cross-sectional relationship between methamphetamine use and risk for HIV transmission among MSM, only a few studies have examined the relation between methamphetamine use and HIV seroincidence. Chesney et al[19] demonstrated 1.02 and 2.89 relative risks of HIV seroconversion for current methamphetamine users versus nonusers and chronic methamphetamine users versus nonusers, respectively, after adjusting for unprotected anal intercourse in 337 seronegative gay men followed for 3 years from the San Francisco Men's Health Study. Most recently, Buchacz et al[20] examined the association of methamphetamine use and HIV seroincidence in 2991 MSM who were tested anonymously for HIV in San Francisco. Thirty-four of 290 methamphetamine users (within the past year) had recently seroconverted, yielding a relative risk of HIV seroconversion associated with methamphetamine use of 2.5 (95% confidence interval [CI]: 0.9 to 6.9), adjusted for age, race, ethnicity, use of other noninjected drugs in the past year (including poppers), marijuana use, and alcohol use. Although important in documenting a possible link between methamphetamine use and increased risk of HIV sexual transmission, these studies have been limited by the small number of seroconversions and self-reported data collected over a short follow-up period, inadequate adjustment for confounding factors, or limited geographic diversity, and thus only provide a limited measure of the methamphetamine-HIV seroconversion relation.

A better understanding of the drug use-HIV seroincidence relationships in general and the methamphetamine-HIV seroincidence relation in particular among vulnerable populations is needed for effective preventive interventions. An examination of this relationship across multiple sites and over longer periods of time, taking into account important risk factors, might provide an important replication of the finding that methamphetamine use is associated with new HIV infections among MSM as well as potential clues to the mechanism(s) of this relationship. Because methamphetamine use can highly disengage sexual pleasure from cognition[21] (the well-known behavioral disinhibition mechanism), its recent spread among MSM across geographically diverse areas has led to its association with the intentional practice of unprotected anal sex (barebacking).[22-25] This recent trend only intensifies the potential impact of methamphetamine use among MSM and others in maintaining the current unacceptably high rate of new HIV infections.[7]

Our examination of popper use, in addition to methamphetamine use, in this study was the result of previous findings demonstrating popper use as one of the most consistently and strongly associated drug use behaviors in HIV seroconversion among Multicenter AIDS Cohort Study (MACS) participants[26] and in the study by Chesney et al[19] as well. Additionally, popper use has been shown to be frequently used, along with methamphetamine, to enhance sexual pleasure, get a better high, or take the edge off of methamphetamine.[27] More significantly, however, may be the fact that popper use can enable an individual to experience multiple orgasms during a methamphetamine-fueled extended sexual session.

In this study, we examined the association of methamphetamine and other drug use, along with risky sexual behavior, on HIV seroconversion using data from MSM who were initially HIV-seronegative and were followed over time in the MACS.  Printer- Friendly Email This

J Acquir Immune Defic Syndr.  2007;45(1):85-92.  ©2007 Lippincott Williams & Wilkins
This is a part of article The Relationship Between Methamphetamine and Popper Use Taken from "Cheapest Sildenafil Citrate" Information Blog

Abstract and Introduction

Abstract

Prostate cancer has many treatment options. In addition to open retropubic and perineal approaches to radical prostatectomy, laparoscopic robotic prostatectomy is available as a newer surgical option. Potential advantages of robotic surgery include reduced pain and trauma, less blood loss, reduced infection risk, shorter hospital stay, faster recovery, and less scarring (Intuitive Surgical, 2005). A variety of nursing care considerations involving pre-operative education and preparation, intra-operative and immediate postoperative care issues, and long-term followup must be understood to meet the needs of a robotic surgical patient. Patient selection is very important to optimize a positive surgical outcome. Just as certain criteria make a good surgical candidate, there are factors that could complicate the surgery or adversely affect recovery.Introduction

Prostate cancer is the second most common malignancy diagnosed in American men (National Cancer Institute [NCI], 2003). An estimated 232,090 new cases occurred in the United States in 2005 (American Cancer Society [ACS], 2005). Incidence rates are significantly higher in African-American men. More than 30,000 men died of prostate cancer last year, second only to lung cancer. Survival has improved dramatically over the past 20 years due to earlier diagnosis and improved treatment options. The 5-year survival rate for all stages of the disease has increased from 67% to 99% (ACS, 2005).

When prostate cancer is diagnosed following prostate biopsy, possible treatment options must be considered. Many factors should be considered when choosing the best treatment: patient age, overall health and life expectancy, co-morbidities, the grade and stage of the cancer, and an evaluation of the risks and benefits of each option (NCI, 2003). A comprehensive list of available treatment options can be found in Table 1 . Laparo scopic robotic-assisted prostatectomy will be discussed in this article. Since there are often two or three reasonable alternatives for each patient, the decision can be difficult.   Printer- Friendly Email This

Urol Nurs.  2006;26(2):129-136.  ©2006 Society of Urologic Nurses and Associates
This is a part of article Care of the Patient Undergoing Robotic-Assisted Prostatectomy Taken from "Male Erectile Disfunction" Information Blog

Early Penile Rehabilitation

Introduction

The introduction of prostate screening programs, which include annual digital rectal examinations and PSAs, has led to earlier detection of most prostate malignancies. Earlier detection has significantly improved cancer cure, allowing us to redirect our focus towards quality of life issues. It has become apparent that erectile function is a significant problem following RP. Currently, potency rates range between 30 and 60% in the reported literature. Potency rates from the experienced surgeons would indicate that, even after a considerable volume of experience, ED following nerve injury is a major problem.

Urologists have been the pioneers in recognizing the impact of radical pelvic surgery on sexual dysfunction. Multiple authors have reported their techniques on nerve-sparing RP from the retropubic, perineal or laparoscopic approach. These reports have provided the stimulus for the other surgical fields to perform the nerve-sparing technique. In the world of colorectal surgeries, exciting new techniques for the treatment of rectal cancer has evolved like autonomic nerve preservation with TME. The concept of sexual dysfunction is evolving in the field of radical and as well as simple hysterectomies also. More urologists performing transvaginal sling procedures are recognizing female sexual dysfunction as an important issue. The concept of nerve-sparing surgery will soon be followed in radical and simple hysterectomy as well. These other disciplines will soon discover what urologists have learned, that despite anatomical nerve sparing there is still dysfunction due to the period of neuropraxia.

When analyzing potency rates following RP, it would appear that our focus should be into the rehabilitation and nerve recovery rather than looking for the further advances in the surgical technique. Urologists have led the way into early rehabilitation programs to promote the nerve recovery and nerve regeneration. These programs will soon evolve into other disciplines that are performing pelvic surgeries. Performing anatomical nerve-sparing procedures rarely guarantees immediate postoperative recovery of potency. So the other disciplines will soon develop early rehabilitation programs. We will discuss our experience with various early programs intended to shorten the period of neuropraxia after RP.Role of Oral Medications in Early Penile Rehabilitation

There is a growing interest among urologists regarding the early use of daily oral sildenafil. This was first reported by Padma-Nathan et al.,[95] who conducted a randomized controlled study in 76 men (oral sildenafil daily (50 mg, n=23; 100 mg, n=28), placebo=25) who underwent nerve-sparing RP with normal preoperative erectile function. Sildenafil was given for 36 weeks in the study group. After 48 weeks (~11 months) follow-up, 14 of 51 (27%) patients receiving sildenafil demonstrated return of spontaneous erections compared to one of 25 (4%) in the placebo group. This study revealed that oral daily sildenafil increased the return of erections to seven-folds compared with placebo group and was well tolerated. However, this study has been criticized because the return of spontaneous erections in the placebo group was only 4%, which is very low compared to the other reported series in the literature. Further multicenter randomized studies are ongoing to investigate the potential benefit of daily sildenafil following radical RP.Early MUSE

We recently completed a prospective nonrandomized study on the use of early MUSE after RP at the Cleveland Clinic Foundation. To our knowledge, this is the only report in literature. We included a total of 91 patients. Of the 91 patients, 56 received early MUSE and 35 (Control group) did not receive any early treatment. Patients in the early MUSE group received 125 µg 3 times/week for the first 6 weeks. At 6 weeks, the MUSE dose was titrated to 250 µg, 3 times/week for 4 months. Patients who could not tolerate the 250 µg doses remained at 125 µg for 4 months. Treatment efficacy was analyzed by the patient's response to the Sexual Health Inventory of Men (SHIM) questionnaire. In the MUSE Group, 38/56 (68%) continued MUSE treatment. At 6 months, 28/38 (74%) of the patients resumed sexual activity, 15/28 (53%) had natural erections sufficient for vaginal penetration without MUSE and 13/28 (47%) continue to use MUSE as an adjuvant treatment for successful intercourse. Overall, including those who discontinued MUSE, at 6 months 27% (15/56) achieved natural erections sufficient for sexual intercourse. The MUSE discontinuation rate was 32% (18/56). Nine of the 18 (50%) discontinued because of inadequate erections, five (28%) due to loss of sexual interest and four (22%) due to local pain/burning. In the Control Group, 13/35 (37%) resumed sexual activity, 4/13 (30.7%) had natural erections sufficient for vaginal penetration, 9/13 (69.3%) were dissatisfied with the erections and used oral therapy/erectaids as adjuvant treatments. Overall, in the control group 11% (4/35) at 6 months achieved natural erections sufficient for satisfactory sexual intercourse.

In our experience, early MUSE therapy following RP increased the frequency of sexual activity, increased the incidence of spontaneous erections sufficient for intercourse and appeared to shorten the neuropraxia period.Early VCD

We recently completed a prospective nonrandomized study on the use of early VCD after RP at the Cleveland Clinic, which included 109 patients who underwent RP between August 1999 and October 2001.[96] Of the 109 patients, 74 (Group 1) patients used early VCD daily for 9 months and 35 observed without any erectogenic treatment (Group 2). Treatment efficacy was analyzed by responses to the SHIM. Patient outcome regarding the compliance changes in the penile length and circumference, return of natural erection and ability for vaginal intercourse was also assessed. After a minimum follow-up of 9 months, 80% (60/74) in Group 1 successfully used their VCD with a constriction ring for vaginal intercourse at a frequency of twice per week, with an overall spousal satisfaction rate of 55% (33/60). Of these 60 patients, 19 (32%) reported return of natural erections at 9 months, with 10/19 (52%) having erections sufficient for sexual intercourse. The abridged IIEF-5 score significantly increased after VCD use in both the NS and NNS groups. After a mean use of 3 months, 14/74 (18%) discontinued treatment. Overall, in the early VCD group, 14% (10/74) had natural erections sufficient for sexual intercourse.

In Group 2, 37% (13/35) of patients regained spontaneous erections at a minimum follow-up of 9 months after surgery. However, only four of these patients (29%) had erections sufficient for successful vaginal intercourse and the rest of the patients (71%) sought adjuvant treatment. Overall, in the control group at 9 months, 11% (4/35) achieved natural erections sufficient for satisfactory sexual intercourse. Note that 11% vaginal intercourse rates were identical in both the Group 1 and 2.

Interestingly, when assessing the penile length and girth after surgery, of the 60 compliant patients, only 14 (23%) reported a decrease in penile length and girth at 9 months (range, 4-11 months), with 12/14 (85%) noncompliant patients complaining of decrease in penile length and girth. In the control group, 22/35 (63%) reported decrease in penile length and circumference, demonstrating that routine early use of the VCD helps in preventing the decrease in penile length and circumference.

We concluded that early use of VCD following RP facilitates early sexual intercourse, early patient/spousal sexual satisfaction, potentially an earlier return of natural erections sufficient for vaginal penetration and preservation of penile length and girth.Early Injections

Montorsi et al.[97] from Milan, Italy, first reported their experience using intracavernous injections in 1997. Of the total 30 patients who underwent nerve-sparing RP, 15 were randomized into Group 1 (alprostadil injections 3 times/week for 12 weeks) and another 15 patients were randomized into Group 2 (observation without erectaids). The dose of PGE1 varies from 4 to 14 µg, with a mean dose of 8 µg. At 6 months, 67% of the patients in the injection group reported to have return of spontaneous erections sufficient for satisfactory intercourse compared to 20% in the observation group. We initiated a similar study in 2001 with a dose of 10 µg PGE1 at the Cleveland Clinic Foundation. Of the eight patients, six discontinued because of pain, which prompted us to discontinue our early PGE1 program 3 years ago.

Recently, we wanted to re-examine the role of early intracorporeal injections, with lower dose of PGE1 (4 µg/2-3 times/week) starting at 2 weeks after RP, combined with oral sildenafil (50 mg/day). We reduced the injection dose to 4 µg, to get partial erections with minimal, if any, pain. Our goal was to have a compliance of more than 90%. Further modifications have been made according to the tolerance of patient and response; the dose of PGE1 was reduced to 2 µg in some patients with the same response to minimize the adverse effects and maximize the compliance. We included a total of 18 patients in this study. Of the total 18 patients, 16 were using injections with Viagra and two were using daily sildenafil alone. Of the total 16 patients, two increased the dose up to 8 µg without any pain (one having mild discomfort), six patients continuing the same dose of 4 µg and the rest of the patients decreased the dose. Of the eight patients who decreased the dose, six are using 2 µg dose and two patients further reduced the dose to 1 µg. Patients who were not willing for the injections given daily 50 mg oral sildenafil alone. Two patients were started only on Viagra. We are currently investigating the role of injections and oral sildenafil in patients who underwent nerve-sparing RC also. We included two patients in the study. Until now, the compliance with this program is 100%. After a mean follow-up of 10 weeks (4-18 weeks), 15/16 patients were sexually active. One patient sexually inactive due to incontinence. Our early data revealed that lower doses of IC PGE1 (4, 2 and 1 µg) with sildenafil was as effective as high doses of PGE1 alone (8 µg), without any penile discomfort ( Table 4 ). The reasons for these high compliance rates are good counseling and follow-up by the physician and proper dose modification according to the patient's desire and side effects. Early injection facilitated early sexual intercourse, patient and spousal satisfaction.   Printer- Friendly Email This

Int J Impot Res.  2006;18(1):1-18.  ©2006 Nature Publishing Group
This is a part of article Sexual Dysfunction after Pelvic Surgery Taken from "Male Erectile Disfunction" Information Blog

Sci/Tech

Pill can 'boost or kill' sex drive

Viagra has been prescribed to 200,000 men in the first four weeks it has been on sale in the US

Doctors in the United States are warning that the new pill used to treat sexual impotence in men could break up marriages rather than giving them a boost.

In their fourth week on the American market, the little blue pills called Viagra have led to the sale of more than 200,000 new prescriptions.

Doctors report that patients grabbing the chance to boost their wilting libidos have rejoiced in second honeymoons.

Spectre of the Viagra widows

But some warn older women may not be able to keep up with the sexual demands of their newly-reinvigorated husbands.

Miami doctor Carlos Nazir said: "I guess we will be using a new term in the future, you know - the Viagra widows.

"This is going to happen to the woman - her husband is on Viagra and she's not keeping up with him with the sexual interest or the sexual frequency."

Reliving youth

Sex experts say Viagra, made by New York drug giant Pfizer Pharmaceuticals, could make a 70-year-old man feel 40 years younger.

The drug works as an enhancer of arousal, getting blood to the penis when a man is sexually stimulated and allowing it to stay there.

The result is an erection in men who have been unable to have one, usually for medical reasons.

Insurers paying for 'lifestyle' drug

Pharmaceutical analysts say Viagra could become one of the top-selling drugs marketed.

However, a number of negative claims are now being made against the Viagra revolution.

Some critics claim American health insurance companies are paying for what they regard as a "lifestyle" drug but not covering other medical conditions.

The American College of Obstetricians and Gynaecologists says that some insurers are providing Viagra for men yet are refusing to pay for contraception for women.

Experts estimate that 30 million American men suffer from erectile dysfunction.

Viagra has not yet been approved for use by women, but clinical trials are taking place. The drug is expected to go on sale in Europe later this year.
This is a part of article BBC News | Sci/Tech | Pill can ‘boost or kill’ sex drive Taken from "Cheapest Sildenafil Citrate" Information Blog

Viagra: A Success Story for Rationing?

from Health Affairs

Typology of National Rationing Strategies

In this section we set out the various strategies for rationing Viagra adopted in the countries we studied. However, before doing so, we need to put the specific case of Viagra into the wider context of health care rationing more generally, to see whether it conforms to a standard pattern or has any special features.[7]Forms of Rationing

Rationing — decisions to deliver less than the optimum amount of effective health care as a result of setting priorities among competing demands on the system — pervades across all health care systems, regardless of spending levels. It takes many forms, of which the explicit denial of a service is the most dramatic but not necessarily the most important. Other forms of rationing are exclusion (sections of the population not covered), dilution (fewer tests ordered, fewer nurses on the ward), deterrence (making access to care difficult), and delay (waiting lists). But not only do the forms of rationing differ. So, too, does the decision-making mode involved.

Thus, decisions can be either made centrally or diffused among the professional service deliverers. Similarly, they can be made either explicitly (setting out the criteria for allocating resources to individual patients) or implicitly (fixing global budgets that force choice between competing demands on resources at the point of delivery). Generally speaking, diffused and implicit rationing by professionals has been the dominant mode cross-nationally, a strategy that diffuses not only responsibility but also blame. Presenting decisions about whom to treat and in what way as reflecting professional judgments and scientific evidence, rather than budgetary limitations, is clearly in the interests of politicians and insurance managers. It also may be a rational approach, given uncertainty about which medical intervention works for whom.[8]

Various attempts have been made to devise limited menus of entitlements with explicit exclusions; Oregon's Medicaid waiver is the best-known example. But these have invariably run into trouble.[9] Not only has there been menu creep (a combination of consumer pressure and professional ingenuity in reclassifying conditions has meant that the menu of services tends to be elastic), but also attempts to exclude specific interventions immediately raise the objection that almost every procedure or drug can be medically necessary for someone. Even cosmetic surgery, a standard item in most exclusion lists, may be crucial for someone contemplating a future career as a ballet dancer, for example. So explicit exclusion policies quickly develop holes as exceptions are allowed, as the case of Viagra illustrates.

In many respects, the case of Viagra follows the standard rationing pattern. When the drug was first launched worldwide, the over-whelming, although not entirely unanimous, response of decisionmakers was to exclude it from the reimbursable health care menu. Subsequently, however, policies have been modified to accommodate arguments of medical necessity. Total bans in practice turned out to be leaking colanders. However, it was mainly at this stage that differences in rationing modes emerged between countries. For the sake of simplicity, we present these differences as four models derived from the experience of specific countries. These, we must stress, are very much "ideal-type models"; that is, in practice there are overlaps between countries and modes, if only at the edges. However, they provide a useful analytic framework for analyzing policy responses across nations.Diffusion by Inaction

As so often in comparative health policy studies, the United States emerges as an outlier, unique unto itself. A nonsystem made a nondecision about Viagra. Absent a national decision, even U.S. federal programs adopted divergent positions. The Department of Veterans Affairs (VA) refused to add Viagra to its formulary on the grounds that the costs of providing the drug would add 20 percent to its pharmaceutical budget (although the ban was not complete; an escape clause allowed doctors to argue for its prescription as exceptions).[10] In contrast, the Medicaid program automatically included Viagra for the treatment of ED following its approval by the Food and Drug Administration (FDA), as required by legislation, although the agency feared clinical and financial abuse.[11] Of course, the financial implications of this were relatively modest compared with those faced by the VA health system, given that only about 10 percent of Medicaid beneficiaries are adult males. In any case, the decision was variously implemented by the states. Some resisted out-right (among them, NewYork, Wisconsin, and Nevada).[12] Others followed the recommendations of the Centers for Medicare and Medicaid Services (CMS) designed to minimize misuse and rationed the amount prescribed: from four pills per month (for example, in Alabama and Florida) to ten (in Utah).[13]

Health insurers and plans showed a similarly mixed picture. A very few plans included Viagra in their formulary from the start; one such was Tufts, which put it in its highest copayment category.[14] The great majority resisted. "Simply put, having sexual relations is not a medical necessity," one Aetna official argued to the New York Department of Insurance. However, under the challenge of both court rulings and state regulators, many of the insurers were forced to abandon or modify the blanket exclusion of Viagra.[15] Overall, then, the consequence is that access to reimbursable Viagra prescriptions for American men—the conditions under which it is prescribed, the number of pills deemed appropriate, and the level of copayments—depends on where they live and with whom they are insured. In this respect, of course, Viagra does not represent so much a deviant case as an illustration of the U.S. health care condition.Juridification

Although Germany's health care system could not be more different from that of the United States, there is one shared characteristic: The courts have played a major role in shaping decisions. Germany's system is based on social insurance—that is, a network of sickness funds—and it has a corporatist style of governance. Within the broad framework set by the federal government, policy decisions are negotiated by the representatives of the medical profession and the sickness funds—the Bundesausschuss der Ärzte und Krankenkassen. It was this body that decided that Viagra should not be included in the standard package of reimbursable drugs. However, the decision was appealed. The Federal Social Court decided that the Bundesausschuss did not have the constitutional right to issue an unconditional ban on any drug.[16] This left matters in limbo, and the court has yet to give a more detailed ruling about the specific issues raised by the case of Viagra and other "lifestyle" drugs. At first eager to secure such a ruling, the insurers have stopped pressing for a decision, fearing that the Federal Social Court would take its cue from the lower courts, which have consistently ruled in favor of patients appealing against refusals to reimburse Viagra.[17]

In a series of cases, the lower courts have decided in favor of reimbursing the cost of Viagra prescriptions wholly or partially. Among successful arguments have been that patients should be reimbursed when ED is the consequence of medical intervention or condition (for example, a bladder cancer operation, dialysis and kidney transplantation, diabetes, or multiple sclerosis) and when ED causes depression and psychosocial problems. In one case, the court sought to draw a distinction—central to the debate about lifestyle drugs—between using Viagra to enhance potency and prescribing it for the restitution of normal bodily function. Only in the latter case, the court determined, should Viagra be reimbursable (although normal may not be simple to define). "Intact erectile function is part of the image of a healthy man, including the elderly," the Hanover Social Court ruled.[18]

These individual, case-by-case decisions have not been generalized into any kind of applicable guidelines. Rationing in Germany continues to take the form of scattergun juridical decisions. Indeed, muddling through is in the interests of the insurers; if the Federal Social Court were to generalize the generosity of the lower courts, the result would be much more expenditure. For the time being, the original ruling of the Bundesausschuss therefore determines the policy of insurers—that is, no reimbursement, absent a specific court decision. For the longer term, it is worth noting that sickness funds and physicians share a common interest in limiting demands on their collective drug budgets: If individual physicians are overly generous in prescribing Viagra or any other lifestyle drugs, they not only limit the resources available to their colleagues but can be held personally responsible for the cost. Whether this shared interest in self-restraint will survive if the government implements its decision to remove the cap on the drug budget is another matter.Centralization-Politicization

In contrast to both the United States and Germany, policy in Britain for rationing Viagra in the National Health Service (NHS) was centrally determined by government ministers. Given the highly centralized nature of the NHS, this might at first appear to be a highly predictable outcome—an illustration of path dependency. In fact, this would be a misleading conclusion. The paradox of the NHS is that rationing has always been implicit. Traditionally, ministers have set budgets but have allowed the medical profession to translate financial constraints into clinical decisions—a highly effective blame-diffusion strategy.[19] The oddity of the decision about Viagra was thus that it represented not so much the logic of the NHS as a new departure.

It was a reluctant departure. The first instinct of ministers was to depoliticize the issue by asking for expert advice.[20] But the Government's Standing Medical Advisory Committee refused to oblige. It concluded that there was no medical reason for refusing to make Viagra available by prescription in the NHS—"in common with many treatments available under the NHS this improves quality of life, but does not save or prolong it"—but that it was for ministers to make the final decision in light of the "availability of resources." The decision of the secretary of state for health was that since "impotence is in itself neither life threatening, nor does it cause physical pain," and since Viagra threatened to increase the cost of treating impotence tenfold, general practitioners (GPs) would be restricted in their ability to issue NHS prescriptions for Viagra. Availability would be limited to groups of men whose disabilities were linked to specific medical conditions: for example, those treated for prostate cancer or kidney failure and those suffering from Parkinson's disease and multiple sclerosis (MS). The official ration, furthermore, was to be one tablet a week. Exceptional cases not falling into the official categories would be referred to hospital specialists.

The logic of this decision was far from self-evident, as the leader of Britain's GPs was quick to point out: Its only justification appeared to be that it promised to constrain demand and spending.[21] Also, in apparently limiting the NHS's treatment responsibilities to dealing with conditions that either threatened life or caused physical pain, the secretary of state appeared to be expounding a new restrictive, unsustainable doctrine. However, subsequent correspondence in the British Medical Journal suggested general support among doctors for rationing Viagra: "Nobody needs an erection at public expense" was the heading of one letter.[22] Furthermore, British GPs have a shared interest with government in controlling demands. The creation of Primary Care Trusts, with responsibility for purchasing health care for given populations, has given them responsibility for controlling their own (capped) drug budgets.Bureaucratization

Sweden is an interesting, because exceptional, case of a policy reversal. Although in many respects a first cousin to Britain's NHS—inasmuch as it is funded through taxes—Sweden's health care system is a far more decentralized one. County councils are responsible for running health care services and, since January 1998, for pharmaceutical budgets. However, decisions about drugs remain firmly national. As in Britain, policy is driven by the assumption that the same package of health care services should be available regardless of where people live. The result has been tension between the budget holders (the county councils) and the central decisionmakers. At the time of Viagra's launch on the market, the rule was that any pharmaceutical product accepted as a prescription drug in Sweden automatically had to be included in the drug benefit package. Accordingly, Viagra was included.

However, conscious of the financial implications of automatically endorsing all new products and under pressure from the county councils, the Swedish government subsequently appointed a commission of inquiry. Its report, published in 2000, recommended that drugs be divided into two categories.[23] The first, involving treatment for disease and injury, would continue to be part of the standard package. The second, which included not only Viagra but also drugs for the treatment of obesity, smoking cessation, and hair loss, would be available only in exceptional circumstances. Detailed criteria were to be defined by a governmental committee, whose report was over-due at the time of this writing, to replace present procedures.

At present, decisions are made case by case by the Ministry of Health, in consultation with the Medical Products Agency (MPA), the Läkemedelsverket, which is the regulatory agency for medical products. In effect, there is bureaucratic rationing. Applications have to be made by the individual patients concerned, with support from their doctors. In making the determinations, the criterion appears to be different from that used in Britain (and other countries). The emphasis is on the consequences of ED, not the cause or associated morbidities. Treatment is sanctioned in those exceptional cases where ED aggravates an existing condition. In practice, this means psychiatric conditions. The system appears to have been effective in containing demand and expenditure. By the end of 2001 there had been roughly 3,000 applications, of which fewer than 10 percent had been approved.[24] Given the low success rate, it is perhaps not surprising that the number of applications has been diminishing over time. A further deterrent may well be the lack of privacy: Under the Swedish system of open government, applications are in the public domain.Rationing by Expertise

There is an emergent fifth model of rationing, relevant to the introduction of lifestyle drugs more generally, that overlaps with those already discussed but is worth noting. This is rationing by expertise. Since 1999 Britain has had the National Institute for Clinical Evidence (NICE), an agency charged with reviewing the evidence about new health technologies and producing guidelines about their use in the NHS. Had NICE been in existence in 1998, ministers would no doubt have referred the case of Viagra to it with a profound sense of relief. And, as noted above in the case of Sweden, bureaucratic rationing is seen as a temporary expedient until effective guidelines can be devised. In both instances, the hope is that rationing decisions can be depoliticized by invoking the expertise of a neutral, authoritative agency or committee. The experience of NICE so far suggests that this may be an overly optimistic view.[25] Many of NICE's decisions have proved controversial, and some have been modified following lobbying by the pharmaceutical industry or consumer groups representing patients with specific diseases. Although it is relatively easy to determine which interventions are effective, deciding on priorities within constrained budgets is a different matter. It is far from clear that the expertise of agencies such as NICE carries legitimacy in determining this much larger question.

This is a part of article Viagra: A Success Story for Rationing? Taken from "Male Erectile Disfunction" Information Blog