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Viagra is on every man's lips, but not as much as we'd like. Managed care organizations have started to limit access. According to the Associated Press, Aetna offers no coverage. Kaiser Permanente is studying it. Prudential and United HealthCare cover some patients, depending on the plan. Cigna will pay for six pills monthly--two fewer than were used in clinical studies.
Should managed care ration a reasonably effective, emerging therapy for a wildly prevalent but underdiagnosed medical problem? Should all enrollees pay for the sexual potential of 30 million newly hot men? And what about the women?
When hot and bothered, sometimes I cool off with Jonsen, Siegler and Winslade's four-point framework on clinical ethics. It's not the same as 40 minutes on the NordicTrack, but it gets the job done.
The disease? Erectile dysfunction (ED) or impotence: failure to attain an erection of sufficient strength to attain normal ejaculation. But is this a disease or just a deficiency?
How is the diagnosis made? No blood test, no widely used objective standard, few quantifiable criteria except nocturnal penile tumescence testing. Drugs, endocrine disorders and neurogenic diseases may be proximate and reversible causes.
Prevalence? Big. Very big. Etiology? Mostly organic, though psychogenic impotence is also prevalent--especially in younger men. In "Is Sex Necessary?", James Thurber and E.B. White write, "Sex is less than 50 years old, yet it has upset the whole western world. The sex urge involves, for its true expression, another individual. It is this 'other individual' that causes all the trouble."
Usual treatment? Ah, here's the rub: nothing. Before Viagra, physicians seldom diagnosed erectile dysfunction, except to note it in a review of systems. Until March, the only therapy was distressing.
Caverject, for example, is injectable into the base of the penis. It is often effective, but it is cold, painful and inconvenient. There is also Muse--an intraurethral penile suppository. Again, sometimes effective, but not without side effects.
What about Viagra (sildenafil citrate)? There is little widely available clinical data. The package insert, however, is 35 inches long. Oral absorption is rapid, peaking between 30 and 120 minutes. Metabolism and excretion are hepatic. Unpublished clinical studies show 70 to 80 percent effectiveness in diabetic, spinal cord-injured, postprostatectomy and psychogenic ED patients. Effectiveness means increased frequency of successful penetration and maintenance of erections after penetration. Headache, flushing and dyspepsia are the most common adverse effects; administration with nitrates is contraindicated.
How about 40,000 prescriptions daily?
But hold on there, fella. How about women? There are no clinical studies. But women have vaginal engorgement through the same nitric oxide enhancement/phosphodiesterase inhibition mechanism. Sure enough, there are anecdotal reports of first orgasms in years.
The ability to have sex is pure quality of life: in vitro fertilization eliminated necessary erectile function for procreation. Pfizer is considering dissolvable wafers impregnated with the right stuff to get Viagra in faster.
Are there precedents for managed care paying for quality-of-life treatments? Yes, within a medical context. Many managed care organizations send out self-treatment books, promoting self-confidence and independence. Some cover fertility drugs for women, considering infertility a disease, but up to a point--in vitro fertilization is usually not a covered benefit.
Many quality-of-life treatments are not covered--liposuction, cosmetic surgery and massage therapy come to mind. Finasteride for baldness (but not for benign prostatic hyperplasia) and Retin-A for acne (but not for wrinkles) are cosmetic. Contraception and elective abortion are often not covered.
Unlike other quality-of-life treatments, fraud and abuse are unlikely to be a problem with Viagra. But that's just what managed care organizations are worried about. Too many men without erectile dysfunction, taking it just for fun, pushing their doctors to prescribe it, making payers raise premiums yet again. Too much quality of life could be bad for managed care companies' profits.
Here's where the action is. Caverject isn't cheap--about $18 per 10 microgram dose, syringe and wipe included. Muse is also expensive--about $21 for a 250 microgram intraurethral pellet. Viagra's $10 price seems a bargain to men who have been only able to fantasize, with little to show for it.
But the real cost is not what managed care has been paying, but what it could pay-- inappropriately. Should you spend your time and capitation dollars on the woes of men who want to recapture youth--perhaps unwisely--or on your patients who experience the daily physical agony of Crohn's or osteoarthritis?
Deploying resources wisely is a trust. Managed care organizations that are one big capitated family can vote with their dollars, moving money from one pot to another. Few allocation decisions have been put to members systematically--with a few exceptions, such as Group Health Cooperative of Puget Sound. The fairest way to decide about Viagra would be to ask enrollees to prioritize their tradeoffs.
Like phen/fen before it, Viagra should be used for medical reasons--not cosmetic ones. There are women who were not obese but wanted to lose a few pounds who have heart valve problems now. Many necessary valve replacements and many more unnecessary echocardiograms have been performed because too many physicians yielded to the pressure to prescribe.
Men should have a legitimate ED diagnosis to receive Viagra. They should not have to try Caverject or Muse first. Studies should be conducted in women to learn whether they encounter adverse effects and experience improved quality of life.
The main ethical issues raised by Viagra use are the definition of medical necessity (disease vs. deficiency), truth-telling by physicians to insurers, gaming the system, potential discrimination against the indigent and appropriate resource allocation within a limited budget.
Analysis of these and other issues will have to wait. As is often the case, ethics was caught with its pants down while technology seized the stage.
If there is an ethical issue involving managed care that you'd like Dr. La Puma to discuss, write to:
John La Puma, M.D., Ethics Columnist
301 Oxford Valley Rd.
Suite 1105-A, Yardley, PA 19067
Fax: (215) 321-6670