Dubious research statistics lead to BigPharma claims of 'Viagra for Women' Print E-mail

Refer Feminist Research : Dumble, Lynette J. VIAGRA: A CAN OF WORMS FOR WOMEN. Health Sharing Women, Volume 10 No. 2 November 1999, pages 14 -16. Scroll down to read full article

And now in 2009, on the basis of 4.5 satsifying sexual events per month in women taking daily flibanserin, compared with 3.7 such events in women taking the placebo, BigPharma claims to have found its Holy Grail "Viagra for Women", with a spokeswoman for Boehringer Ingelheim saying that the drug could be approved for treating women with a low libido within 18 months!!!!!!! Do read on ....
 London ~ Tuesday November 17 2009, page 11


'Female Viagra' boosts sexual desire in women with flagging libido

Women who took the drug during a trial reported more satisfying sexual encounters and a higher libido
By Ian Sample, science correspondent

Low libido or reduced sexual desire affects between 9% and 26% of women, depending on age and whether they have been through the menopause. Photograph: Novastock/Rex Features

Ever since Viagra arrived a decade ago and became a global blockbuster worth billions, an equivalent that works wonders for women has been the Holy Grail for drug companies.

Yesterday, doctors announced that the search might finally be over. A major clinical trial of a drug some already describe as the "female Viagra" showed it can boost sexual desire in women whose libidos are flagging.

The drug, which was originally developed as an antidepressant but was later found to have libido-boosting side effects, could be approved for use in Britain within 18 months.

Women who took the drug during the six-month trial reported more satisfying sexual encounters and higher libidos than those who were given a placebo.

Doctors involved in the study said the drug may prove to be an effective treatment for low libido, a problem they estimate affects between 9% and 26% of women, depending on their age and whether they have been through the menopause.

The drug has proved controversial among sex researchers. Some argue pharmaceutical companies are exaggerating the number of women affected by low libido to expand their market, and are pushing a pill that will not deal with psychological issues that might put someone off sex, such as poor body image or stress.

Nearly 2,000 pre-menopausal women aged 18 and above took part in the study after being diagnosed with a condition called "hypoactive sexual desire disorder", characterised by a very low libido for long periods of time.

Women who took a daily 100mg dose of the drug, called flibanserin, reported having satisfying sex more often than those who took a placebo. Before the trial, subjects reported an average of 2.8 satsifying sexual events per month. Those who took daily flibanserin saw this rise to 4.5 times a month, compared with a rise to 3.7 times a month for those taking placebo. None of the women knew whether they were taking the drug or the sham pills.

"It's essentially a Viagra-like drug for women in that diminished desire or libido is the most common feminine sexual problem, like erectile dysfunction in men," said John Thorp, professor of obstetrics and gynaecology at the University of North Carolina Medical School. The results were announced today at a meeting of the European Society for Sexual Medicine in Lyon.

Flibanserin was originally developed as an antidepressant by the German pharmaceutical company Boehringer Ingelheim. The drug performed badly in clinical trials and was never approved, but questionnaires given to the patients revealed that an unexpected side effect for women was a boost to their libido. According to some reports, some women were unwilling to give the pills back once the trial was over.

"Flibanserin was a poor antidepressant," said Thorp, who was involved in running the latest trial. "However, astute observers noted that it increased libido in laboratory animals and human subjects. So we conducted multiple clinical trials and the women in our studies who took it for hypoactive sexual desire disorder reported significant improvements in sexual desire and satisfactory sexual experiences."

Viagra was originally developed as a treatment for high blood pressure and the heart condition angina, but men who took part in early trials realised the drug had an interesting side effect. The drug arrived in 1998 and has since been prescribed to 25 million men creating a multibillion pound global market.

In the latest trial, doctors asked women to keep a record of how often they had satisfying sex and to rank their day-to-day sexual desire in an electronic diary. A variety of other tests were used to assess their libidos and levels of stress experienced during sex. These were compared with information taken before and after the trial.

Thorp said the results point to a possible treatment for "the sexual problem that plagues reproductive age women the most".

Petra Boynton, a healthcare researcher at University College London, said the pill was not a "magic bullet" and feared it could stop couples talking through underlying issues. "There are all kinds of physical, psychological and emotional reasons that could put someone off sex and a pill is not going to help resolve those. It's not going to make you feel better about your body image and it won't make your partner better in bed," she said.

A spokeswoman for Boehringer Ingelheim said the drug could be approved for treating women with a low libido within 18 months. The data from the latest trials will be sent to American and European drug regulators to review.

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Health Sharing Women, Volume 10 No. 2 November 1999, pages 14 -16.

VIAGRA: A CAN OF WORMS FOR WOMEN

By Lynette J. Dumble

BIRTH OF VIAGRA:
Sildenafil citrate (Viagra) was originally developed by the Brooklyn-based Pfizer Inc to treat angina. The drug’s erection-enhancing effect was serendipitously discovered when initial trials revealed a side-effect of increased penile blood flow in response to sexual stimulation. By April of 1999, Pfizer chairman and Chief Executive Officer, William C. Steere, Jr., told shareholders that the company was destined to become “the number one pharmaceutical company in the world". Executive vice-president Dr. McKinnell, echoed the sentiment, noting that Pfizer had skyrocketed from eleventh in the world in pharmaceuticals sales in 1990 to second place in 1998, the year that the company had raked in a massive $US788 million from Viagra, outstripping sales of both Prozac (fluoxetine) and the anti-balding drug Rogaine (minoxidil). Even in Australia, with about 70,000 men on the drug, retail sales are estimated to top $60 million annually (1).

McKinnell saw the speed of Viagra’s rollout, launched in March, 1998 in the US, and 39 other countries before the year had closed, to be as remarkable as the global demand which saw the blue diamond-shaped tablets become the fastest selling new drug in history. Though the prevalence of male impotence is poorly documented because of men’s reluctance to talk about “erectile dysfunction”, Viagra prescriptions, priced at $7.50 per 50mg pill, soared past the magic million in the first month of FDA approval in the United States. Media hype, news stories, updates, features, television and radio programs, and medical and scientific journals lauded the arrival of what was quickly dubbed the "Pfizer riser". Word spread rapidly that Viagra was more than a useful addition to the dispensing repertoire for men who have erectile dysfunction as a result of diabetes and some vascular disorders.

Within the space of three months it was also common knowledge that Viagra enhanced the sexual performance of those with no obvious impairment. In Britain, Viagra became the vital component of a new recreational drug craze which hit the club scene some months before Viagra was officially licensed in the UK in September of 1998 (2). One survey of recreational Viagra, referred to as “Coke and poke”, showed that users were mainly men, all of whom reported positive effects, but with half complaining of headaches, genital soreness, and intoxication. Similarly, a study of 4000 men with erectile dysfunction indicated that 60-80% were satisfied by Viagra, but that headache, indigestion and flushing were common.

Recreational use of Viagra ignores the warnings issued by both Pfizer and drug authorities. Enhancing the muscle-relaxant effects of nitric oxide, and thereby increasing the blood flow into the penis, Viagra risks life-threatening consequences when taken with organic nitrates. In addition to advising users to undertake a thorough medical examination pre-Viagra, Pfizer alerted physicians to consider the cardiac status of patients for whom they were planning to prescribe Viagra, and recommended that the drug not be prescribed to patients taking organic nitrates in any form.

Overall, while the utopia of Viagra erections began to falter amidst reports of 139 Viagra-related deaths [a New South Wales car dealer is believed to have been the drug's first Australian victim in 1998], and the drug’s more common side-effects of migraine and indigestion, Pfizer has also made enemies amongst animal liberation groups. Notably in the UK, anti-vivesectionists were outraged to learn of experiments which removed the foreskins of anaesthetised beagles before administering electrical shocks to the centre of the dog’s penis to measure the firmness of the erection promoted by varying doses of Viagra. Company spokesman Andy Burrows defended the experiments, claiming that some effects of any new drug could only be tested by using animals, but failed to address the offensiveness of mutilating dogs for a drug which was mainly about sexual gratification, and could make no claim to being “life-saving”.

By December of 1998, revised labeling of Viagra in the US addressed postmarketing reports of heart attacks, sudden cardiac deaths, and hypertension in Viagra users, noting the cardiac risk of sexual activity in men with preexisting cardiovascular disease (3). In fact, Viagra’s impact on men who had suffered a heart attack, stroke, recent life-threatening arrhythmia, high or low blood pressure, or cardiac failure or coronary artery disease causing unstable angina, had never been studied in pre-marketing trials. One 33 year-old Australian prescribed Viagra to cope with his insulin-dependent diabetes-related erectile dysfunction admitted that Viagra was not the wonder drug it was hyped to be. In his opinion. it was not “like where you pop a pill and you get an instant erection". Pfizer too admits that Viagra does not give instant erections. The blue diamonds take about an hour to work, but the company is working on that, opening the possibility of taking wham, bam, thank you mam to unprecedented levels!.

VIAGRA’S GENDER SHIFT:
Despite this background of hasty and inadequate premarket testing of Viagra in men, a worrying incidence of fatalities, and what can only be seen as plastic sex, the worldwide success of Viagra encouraged ideas that the market size could be at least doubled if there was a Viagra for women. Although diminished libido is deemed more complex in women than in men, women are supposed to be four times more frequently affected than men. By August 1998, a global race had commenced to develop a Viagra-equivalent which would appeal to women. Clinical trials were underway with six different drugs, most already licensed for other conditions, which fell into two categories; those like Viagra which enhance sexual arousal by increasing the blood flow to the genitals; and analogues of the hormone testosterone which, in combination with oestrogen, is believed by some to restore libido in post-menopausal women.

Women-based trials of Pfizer’s plastic sex has produced a mix of success and failure (4). One study reported that although Viagra improved the blood flow to the clitoris, lack of arousal, difficulties attaining orgasm and insufficient lubrication persisted. At Columbia University College of Physicians and Surgeons in New York City, Viagra was given to 33 postmenopausal women who had suffered “medically-perceived” sexual dysfunction for at least six months. The women took 50 milligrams of Viagra about three times per week for 12 weeks and filled in a questionnaire every four weeks, but only one in four women reported any improvement, and only one in five wanted to continue taking the drug at the end of the trial.

According to the trail co-ordinator, urologist, Steven Kaplan, "Clitoral blood flow improvement, manifested in our group by increased clitoral sensitivity, may not have translated into improved sexual function”.

A subsequent study at the University of Boston, claimed to be the first double-blind, placebo-controlled trial of Viagra in women, concluded from observations in just seventeen women that Pfizer’s plastic sex for men also worked for women. Researcher, Dr. Jennifer Berman told the media that this meant “that the same physical mechanisms that can make men impotent can cause sexual problems in women as well”. Berman’s trial candidates, all postmenopausal, were given either Viagra or a dummy pill, and three months later the women who got Viagra were switched to a placebo and the women who had been given sugar pills got Viagra. According to Berman, “Subjectively, with regard to lubrication, sensitivity, the ability to have orgasm, and satisfaction, the women noted a significant differences .... It does appear to be Viagra because these are physiological changes that can't be faked”.

Nonetheless, Berman’s conclusion is contradicted by her own earlier non-placebo-controlled Viagra trial, where in 48 women [aged 22 to 71, with psychological sex problems attributed to “poor body image, a history of sexual abuse, or marital trouble”] she found no response “to Viagra or any drug, whereas eighty-five to 90 percent of men with psychological problems respond to Viagra.”. Urologist Steven Kaplan agreed, explaining that his emotionally or psychologically disturbed patients may not have been optimal Viagra candidates. In effect, this means that like many others in their field, Bergman and Kaplan will continue the search for a group of women they can claim are Viagra beneficiaries. This approach mistakenly assumes that women’s orgasms parallel the penis-dependent orgasms of men, when in fact women are have a profound capacity for both clitoris-dependent and nonclitoris-dependent orgasms.

VIAGRA’S CAN OF WORMS: To date, Pfizer’s sex pill has created new dilemmas for women. First and foremost, Viagra’s most lucrative market lies not with men or women suffering from [medically-perceived] sexual dysfunction secondary to other complaints, or with those who flirt with death in recreational drug escapades. Rather, Viagra’s appeal is chiefly to the men of the baby boomer generation, those currently in their fifties and sixties and yearning for their lost sexuality, which according to Jennifer Berman is defined in terms of rigidity. Viagra’s plastic sex therefore confronts the partners of the male baby boomers, overwhelmingly women of the baby boomer generation who most often define their sexual satisfaction in terms of emotional fulfillment Multiple nightly organisms are clearly the stuff of vacations and/or new relationships, not the everyday moderation which forms the basis of long-standing loving partnerships for baby boomer generation women. Suddenly, because of Viagra, these now menopausal women are faced with men urging them to change the accepted life style of occasional quality sexual intercourse.

Undoubtedly, men infatuated with Viagra’s plastic sex impose novel pressures on their sexual partners, the negatives of which have barely been considered from a woman’s perspective. If women submit to the demands of Viagra users, they risk either faking or surrendering their personal values of sexual satisfaction, and perhaps accusations of complicity in the Viagra-related death of their partner. If they resist, they may join the queue of abused women who have sex forced upon them, or they may join the queue of deserted women whose partners have gone elsewhere to satisfy their physical desires, or they may be ridiculed for their “frigidity” and sent off for a prescription of some other risky drug which numbs their objections to plastic sex.

London Independent columnist Joan Smith seems to think that the Viagra economy has established orgasm as an inalienable human right (5), and argues that women are entitled to a share of the action: “we can hardly expect disappointed women just to lie back and think of England”. Others, notably those active in campaigns for social and environmental justice, see Viagra from a totally different perspective, one that reflects patriarchal values which seek to conquer women and nature. As a result, Viagra has already acquired an uncomplimentary translation, as evidenced by Canadian Janet Eaton’s reference to NATO’s Viagra in describing the ecological and human catastrophe of the 1999 Kosova war (6), and by India’s Arundhati Roy, when describing the malignant patriotism which spawned the subcontinent following India and Pakistan’s nuclear test explosions in 1998 (7):
“Reading the papers, it was often hard to tell when people were referring to Viagra (which was competing for second place on the front pages) and when they were talking about the bomb - "We have superior strength and potency”.

At the end of the day, that’s what Viagra amounts to; a diamond-shaped tablet filled with the strength and potency which underpin male sexual/political power. There is little need to reiterate that, for more than half of the world’s women, this kind of male power translates to subordination, exploitation and abuse.
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REFERENCES:
1. Taylor, Tania. The high cost of renewed sex life, Herald-Sun, September 18, 1999, page 10.
2. Aldridge, Judith and Measham, Fiona. Sildenafil (Viagra) is used as a recreational drug in England. BMJ 1999; 318: 669.
3. Bradbury, Jane. Is the honeymoon over for Viagra? The Lancet, 1999; 351: 1635.
4. Boyce, Nell. Viagra doesn't do it for women. New Scientist, 13 March, 1999.
5. Smith, Joan. Women will be wanting orgasms next. The Independent [London], January 24, 1999.
6. Eaton, Janet M. NATO's Viagra: Yugoslavia Solves the West’s Mid-Life Crisis. [In Press, 1999].
7. Roy, Arundhati. Frontline, Vol. 15, no. 16, August 1 - 14, 1998 [also included in Roy, Arundhati. The Cost of Living. London, Sydney: Random House, 1999, pages 115-162].
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Dr. Lynette Dumble, Associate Senior Research Fellow, History and Philosophy of Science, University of Melbourne, Parkville, Vic., 3052. International co-ordinator of the Global Sisterhood Network