Big Pharma in the bedroom: Are drugs that enhance sex a good thing?

Does anyone remember life before Viagra? In 1997, no one had heard of or used the term erectile dysfunction or ED--nor would most men have admitted to having the condition. Before the sanitized term debuted, ED was known by doctors as "impotence" and by the rest of us as "not getting it up." It was usually blamed on circumstances like too much to drink and men and their partners rarely talked about it.

In fact, erection-challenged sex lives were a lot like what Betty Friedan called "the problem that has no name" 30 years earlier, referring to women's malaise of unfulfillment: A problem millions had but no one talked about because they thought it was "just them."

Pfizer's Viagra, launched in 1998 just as direct-to-consumer drug advertising began, changed all that. Just as valuable as giving an ED sufferer hope of a treatment, it brought ED out of the closet, shedding sunlight on the problem and removing the taboo. Suddenly, couples were able to talk about "it."

It did not hurt that former presidential candidate Sen. Bob Dole and soccer star Pele further destigmatized ED when they served as Viagra pitchmen.

Of course most people know the social and financial phenomenon ED drugs turned out to be. Thirty-five million men have used Viagra alone which still claims almost half the market, shared with Cialis, Levitra and other drugs. When news of an ED drug first hit the airwaves, Dr. Jed Kaminetsky, a New York University urologist, said he had to add weekend hours to accommodate all the men requesting prescriptions. In 2012, Viagra sales were still $2 billion a year.

ED drugs do not work for everyone and, of course, have side effects. But they have transformed the very way people think about their sex lives by establishing the right to a good sex life, even as people age.

"More than any pill ever to be dispensed, Viagra has played to the yearnings of American culture: eternal youth, sexual prowess, not to mention the longing for an easy fix," wrote the New York Times a few years ago.

ED drugs were not just used by those with ED. They became recreational and dating drugs paired with meth, MDMA, ecstasy and opioids, probably not what Bob Dole intended.

Professional athletes were reported to use Viagra because they believed its "swelling" effects would open their blood vessels and enrich their muscles. Viagra even made flowers "erect" reported Israeli and Australian researchers. When they put Viagra in a vase of water, old flowers stood up past their natural life span.

Yet, ED drug have not been a sexual panacea. Nine years after Viagra's launch, vision loss in some users and dangerous counterfeit and clone versions of the drug cut worldwide sales in half. A baby boom from newly-enabled sires never materialized. And some couples found, when their sex life was restored, that sex was not the real problem with their relationship--that impaired sex was not the cause but probably the result of relationship problems.

What About Women?

Another problem with the ED revolution was women's place. Why shouldn't we have a sex-enhancing drug paid for by insurers, women began to ask, charging gender discrimination. Why should men have all the fun?

Of course, part of the discrimination related to sheer mechanics. Male ED drugs increase blood flow to the penis, are taken as needed and do not create desire. Women's sexuality, on the other hand, is less blood flow-linked and more desire-dependent. Moreover, early sex drug candidates for women had to be taken all the time, not just as needed like the men's drugs.

Last year, hopes of a "pink Viagra," with a provocative photo, were splashed across the cover of the New York Times magazine, hooked in to a heavily promoted book called What Do Women Want? Get ready, said the article: a women's Viagra is on the way.

Actually, there are two female Viagras in the works, made by the Dutch drug company Emotional Mind-- Lybrido containing testosterone and sildenafil (Viagra) and Lybridos contains testosterone with the antidepressant buspirone. Since all the ingredients in the drugs are already approved and have been on the market in other preparations, the drugs are expected to win FDA approval soon.

There have been other attempts to enhance women's sexual desire with testosterone before Lybridos. A testosterone patch from Procter & Gamble called Intrinsa was submitted to the FDA but rejected in 2004. Intrinsa produced only "small improvements in sexual parameters and large placebo responses," said a review that proved a nail in the drug's coffin. "Unwanted side effects are common and not always reversible," said another review.

Still, some women do report increased sexual desire when taking on testosterone. "This stuff is great if your libido has gone AWOL," wrote a 39-year-old woman on the drug rating site Askapatient.com.

Lybrido and Lybridos have another perk, according to their manufacturer, if and when they are approved: they will help the large number of women with antidepressant-linked sexual dysfunction. Nearly one in four women between the ages of 50 and 64 is on antidepressants and both older and new antidepressants can cause anorgasmia, the inability to achieve orgasm, even with adequate stimulation.

Some women are less concerned about the lack of a Pink Viagra than the medicalizing of female sexuality and/or labeling of it as dysfunctional. For example, for insurance companies to pay for female sex enhancement drugs if they are approved, women would have to be diagnosed with "hypoactive sexual desire disorder," a condition found in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders. HSDD is defined as "the persistent or recurrent lack (or absence) of sexual fantasies or desire for any form of sexual activity." Who makes that decision, ask some women? For too long women's sexuality--whether considered too intense or too weak--has been defined by men.

"I have long had a problem with the tendency of the healthcare system, aided and abetted by the pharmaceutical industry, to diagnose as a problem a symptom or sign experienced by the majority of people," wrote Ingrid Nygaard, M.D. Obstetrics & Gynecology.

Women also voice concerns about drug safety. “There is nothing sexist about ensuring that a drug is adequately effective and safe before approving it for marketing,” says Barbara Mintzes, PhD, associate professor in the School of Population and Public Health at the University of British Columbia. She is co-author of Sex, Lies, and Pharmaceuticals: How Drug Companies Plan to Profit from Female Sexual Dysfunction.

If the lack of a female Viagra "were gender bias, we would be yelling and screaming,” said Cindy Pearson, executive director of the National Women’s Health Network." The problem is the drugs. Our biology is so much more complicated than men’s.”

What is Next in The Post-Viagra World?

ED drugs were amazingly successful. But they are no longer new and the wheel that drives the consumer health market is "new." Enter Low-T, the next big thing in which men with signs of aging such as weight gain, lack of vigor and lack of sexual desire are now told they might be suffering from low testosterone.

Marketing hormones as an anti-aging remedy is not new. From the 1950s until ten years ago, women were told by the medical profession to replace their lost hormones with hormone replacement therapy (HRT). People don't lose hormones because they grow old, they grow old because they lose hormones was the intelligence-insulting spin. Right. Unfortunately, HRT caused cancer and heart attacks in women and is no longer recommended. Sorry about that. Testosterone may have a similarly concerning safety profile: it can activate hormone-fed tumors like HRT, say some reports.

Men can be truly deficient in testosterone but it is a rare condition and most treatment of "Low T" is meant to promise a fountain of youth to the aging. Low T centers have become big business in the post-Viagra era.

Another post-Viagra development is new interest in the male sexual problem of premature ejaculation. Like ED, few men or their partners are eager to talk about "PE" or realize how many others may also suffer. Like ED, they may blame PE on individual circumstances and not consider it a constant condition.

Over-the-counter preparations that promise to make men "last longer," often sold at health food stores, are not new. But recently a PE preparation was launched that is acknowledged by the FDA and listed on DailyMed, the official provider of FDA label information. While not FDA approved since it is not a prescription drug, PROLONGZ is said to comply with applicable regulations and policies. The preparation contains three, herbs fenugreek, ginseng and damiana, anecdotally linked to enhanced sexuality. The latter two have merited government clinical trials.

Certainly from the perspective of many women, a man who cannot get an erection or one who can't keep an erection for any length of time are similar frustrations. One YouTube video to sell the preparation in Australia depicts a woman cajoling and shaming a man for lasting only "a minute." Premature ejaculation is sometimes defined as reaching a climax too early during sex without fulfilling a partner but it is also defined as performing for under three minutes.

Whether ED, HSSD (hypoactive sexual desire disorder) or PE, there is clearly money to made in sex enhancement drugs. Less clear is whether the drugs work, are safe or will save a troubled relationship.