Weight-loss pills fly off the shelves in New York

hrongs of New Yorkers looking to shed pounds—be it five or 50—scooped up bottles of a new, nonprescription diet pill called Alli over the weekend.

Although drugstore aisles are well stocked with self-proclaimed weight-loss pills, such as TrimSpa and Xenadrine, Alli is the only one to have won approval of the US Food and Drug Administration. The product hit shelves on Friday and while sales numbers for the weekend are not yet available, New Yorkers seem to be rushing out to buy it.

A pharmacist at Windsor Pharmacy in Midtown Manhattan, Maha Omar, said the store initially bought 10 boxes of Alli, but reordered about two dozen more on Saturday after initial demand was strong. The store has sold about 20 boxes, each of which includes a month’s supply.

“We are getting a lot of calls,” Omar told The New York Sun. “There’s definitely a huge buzz about it.”

Omar says most of those looking to buy Alli are women who are not obese, but looking to lose between 20 and 25 pounds.

Alli is a lower-dose formula of Roche Pharmaceuticals’ prescription diet drug Xenical, which has been on the market since 1999.

The feeding frenzy for Alli has some dieticians warning that the drug is no silver bullet. A dietician who practices in Midtown, Jennifer Andrus, says her patients who have tried Xenical “haven’t found it to be incredibly effective.”

“A lot of people are asking for it,” a pharmacist at King’s Pharmacy in TriBeCa, Harry Loo, said, gesturing toward a display case where 90-pill Alli “Starter Kits” were on sale for $59.95.

According to GlaxoSmithKline, the pharmaceutical company that’s selling it, the new-to-the-market supplement blocks the digestion of some dietary fat, which can lead to weight loss. The company also stresses that the product works in conjunction with a low-fat diet and exercise.

In New York, the pharmaceutical giant prefaced the June 15 debut of Alli with an ambitious marketing campaign that included advertisements on television and on taxicabs. It also held a promotional exhibit at Union Square.

A spokesman for GlaxoSmith-Kline, Lori Lukas, said yesterday that the company’s exhibit in Union Square attracted more than 10,000 visitors during the three weeks it was open. She also said the company’s Web site had received more than 1.7 million visitors since its debut in early April.

At a Duane Reade on Columbus Avenue at 79th Street, customers had been coming in all of last week looking for the drug, though it only hit shelves on Friday. At Thomas Drugs, several blocks south, a sales manager, Bleranda Spahiu, said the pharmacist had placed an order for Alli based on dozens of customer requests.

The dietician Andrus says the drug’s impact is often minimal when consumed with a low-fat diet because the product is designed only to block a portion of the fat being consumed. She says when taken with a high-fat diet, side effects—which can include abdominal pain, loose stools, and gas with oily discharge—can be agonizing.

For Vivus, there may be life after Viagra

Vivus, Inc., a company specializing in drugs for sexual dysfunction and obesity, is proving that there is life after Viagra.

Vivus (up $0.02 to $5.25, Charts), a Mountain View, Calif.-based company with a market cap of $300 million, took a big hit in 1998 when Pfizer introduced the blockbuster Viagra. Pfizer’s sexual dysfunction pill for men became one of the world’s most recognizable names in pharma. Viagra’s sales are still growing, albeit slightly, with $816 million sales for the first half of this year.

But not so many people have heard of Muse, Vivus’ once-promising flagship drug for sexual dysfunction. Muse was off to a good start, with sales totaling $129 million during its first year on the market, shortly before Viagra’s appearance.

But Muse’s mode of delivery is uncomfortable for many men, and Vivus’ sales evaporated with the introduction of Pfizer’s little blue pill, which is considered more convenient. In the first quarter of 2007, Muse sales were a paltry $1.6 million.

“Muse was the first revolutionary product for erectile dysfunction, but Viagra basically trumped it,” said Ken Trbovich, analyst for RBC Capital Markets. “Viagra almost destroyed this company.”

But now, investors are saying “Vive Vivus!” The stock has shot up more than 40 percent this year, and some analysts believe it will go up another third in the next 12 months. This is largely in anticipation of a $140 million milestone cash injection from KV Pharmaceuticals (up $0.20 to $28.61, Charts). KV agreed to buy Vivus’ Evamist, an experimental drug that women spray onto their skin to reduce post-menopause symptoms like hot flashes.

“Here’s a company with a $300 million market cap, and they could get a $140 million cash payment within a month,” said Trbovich.

Kicking sand in Pfizer’s face

Vivus chief financial officer Timothy Morris said the milestone payment could come in as early as July 29, the Food and Drug Administration’s target date to complete its review of Evamist. KV has already paid Vivus $10 million, but isn’t handing over $140 million unless the FDA approves the drug. Following a positive FDA decision, Vivus would eligible for an additional $30 million, if Evamist achieves certain sales targets for KV. But Morris emphasized that the FDA does not always complete its decisions on its target dates.

“Our plan initially was to take [Evamist] to the market ourselves,” said Morris, who believes that Vivus will garner more sales from another experimental drug: Qnexa. “This came down to economics.”

Morris said his company will use the money to fund late-stage trials for its anti-obesity drug Qnexa. Earlier-stage tests showed that patients lost an average of 20 pounds over six months, said Morris.

“Right now, investors are focusing primarily on their obesity program, and that’s what this cash is going to fund,” said Ian Sanderson, analyst for Cowen & Co. “I think they’re feeling that they could get a better return investing that money into their obesity program.”

But potential sales for Qnexa are years away. Sanderson projects that Qnexa will enter the market in 2010, reaching $125 million in sales by 2011 and peaking between $300 million and $400 million by 2013.

Sanderson said that Qnexa’s success depends on whether the drug has any serious side effects. So far, patients in early-stage tests have experienced a tingling sensation in the extremities. The analyst said that more advanced trials are needed to gauge the seriousness of this side effect.

The 237 reasons to have sex

If you think people have sex for pleasure and for procreation, you’re right. They also have sex to get rid of a headache, to celebrate a special occasion, to get a promotion and to feel closer to God.

New research published in the August issue of Archives of Sexual Behavior has come up with a list of 237 reasons that motivate people to have sex.

Who knew?

Cindy Meston, a professor of psychology at the University of Texas at Austin and the lead author of the paper, said most people assume there are a few simple reasons for having sex: “It feels good, you’re in love, or you want to have a child. We found that people are having sex for lots of other reasons.”

Knowing that, she said, could boost sex education, help devise more effective strategies for preventing the spread of sexually transmitted diseases and lead to improved treatments for people with sexual problems.

“You need to know why people are having sex if you’re trying to put into place a safe-sex program,” Meston said. “If you assume people have sex because they’re in the heat of the moment, then [you tell them to] carry condoms. But if they’re doing it for revenge or because they want to enhance their social status, that will require a different strategy.”

Meston and co-author David Buss conducted their research in two stages. First, they asked a group of more than 400 students and volunteers to simply list “all the reasons you can think of why you, or someone you have known, has engaged in sexual intercourse in the past.” That produced 715 reasons. After deleting identical or very similar entries, the researchers were left with 237.

Some were “pretty shocking,” Meston said, such as “I wanted to give someone else a sexually transmitted disease.” She said she also was surprised that some people said they had sex because “I wanted to get closer to God.”

“Most of the literature shows that religious people have more sexual problems,” she said. “But several people endorsed the idea that religion and sexuality were actually closely linked.”

In the second stage of the research, they asked 1,500 other students to rate how important each of the 237 reasons was in their own sexual behavior.

The students were asked to indicate how frequently each reason had led them to engage in sexual intercourse in the past, on a scale from 1 for never to 5 for all the time. Those who had not had intercourse (27 percent of the women and 32 percent of the men) were asked to indicate the likelihood that each of the reasons would lead them to have sex in the future.

Men, women share reasons

Most of the students gave the usual reasons for having sex: “I was attracted to the person,” “It feels good” and, “I wanted to show my affection” were high on the lists of both men and women. Lesser priorities on both lists were reasons such as, “Someone offered me money to do it,” “I felt sorry for the person,” “I wanted to punish myself” and, “Because of a bet.”

Meston said she was somewhat surprised by the similarities between the genders. Men were more likely to endorse having sex for physical reasons (such as, “The person was too hot to resist”) and to boost their social status (“I wanted to brag to my friends about my conquests.”) But there was no difference in the emotional reasons, such as, “I wanted to express my love for the person.”

“The stereotype that men have sex for physical reasons and women have sex for love — our data didn’t really support that,” Meston said. “These young men and women were having sex for physical pleasure and also for emotional attachment, feeling connected to another person.”

Meston and Buss said their findings contradict the stereotype that women, more than men, use sex to obtain special favors. In their study, men were more likely to endorse reasons for having sex that involved utilitarian goals (“To get a favor from someone”).

Leonore Tiefer, a sex therapist and psychologist at New York University School of Medicine, said the findings did not really answer the question, “Why Humans Have Sex,” as the title of the paper asserts.

“It’s why Texas students say they have sex,” Tiefer said.

Nevertheless, she said, it’s “useful to discuss motives, as opposed to just counting.”

Meston acknowledged the limitation of her research and said she planned to look at other populations.

“This is just the start,” she said. “The next step is to see how these motivators change across time, how they differ between genders across the age range, how they differ by ethnicity.”

Another limitation of the study, Meston acknowledged, was that people might have been reluctant to cite socially unacceptable motivations, such as the desire to make money or punish a partner. Conversely, they might have exaggerated their response rates to socially desirable reasons, such as expressing love.

Survey may aid therapists

But she said the survey, dubbed “YSEX?,” already could be used to start developing new treatments for people with sexual problems. “Just giving the list to people to check off would give a therapist more to work with,” she said.

In addition, Meston noted, people in therapy often are hesitant to talk about sexual experiences they’re not proud of. “Learning you’re not the only one who has had sex for a stupid reason might bring a bit of relief,” she said.

Another benefit could be for people with very low sex drive. A recent landmark survey found that nearly one-third of women aren’t interested in sex.

“A lot of people have low desire,” Meston explained. “It’s not a problem if their partner also has low desire. But if their partner wants to have sex much more often than they do, it could become a problem in the marriage. Some women really resent having sex, because they’re not getting physical pleasure.

“If they learn that they’re not so unusual — that not everyone is having sex because it feels good — they might find another reason that makes them feel less resentful, like ‘Oh, yeah, having sex does make me sleep better.’”

- – -

The reasons people give are clustered in four groups:

Physical – My hormones were out of control – I was attracted to the person – It seemed like good exercise Goal-directed – I wanted to get a raise – Because of a bet – I wanted to change the topic of conversation

Emotional – I realized I was in love – I wanted to say ‘thank you’ Insecurity – I didn’t know how to say ‘no’ – I felt obligated ———-

Sanofi Hoping Acomplia Will Be Approved in Europe for Treating Diabetes

While diet drug Acomlia / Zimulti (rimonabant) seems unlikely to make it to the U.S. market for at least a couple of years, Sanofi-Aventis appears hopeful the pill — which already is on sale in Europe — may soon be approved there for treatment of type 2 diabetes.

Executive Vice President Hanspeter Spek, talking to financial analysts on Aug. 1st, said the European Medicines Agency (EMEA) “is reviewing the data” from the SERENADE study in which diabetics not treated with other diabetic medications experienced significant improvements in blood sugar control.

In the study, blood sugar levels of half of the patients on Acomplia fell to below 7 percent — the target set by the American Diabetes Association for good glucose control — and the patients taking Acomplia lost almost 15 pounds of weight compared to 6 pounds for those on a placebo.

The trial showed that HbA1c levels (a measure of blood glucose) in patients with a baseline average of 7.9 who took a 20 mg Acomplia pill once daily fell 0.8 percentage points compared to a drop of 0.3 points in those taking a placebo.

Patients with an HbA1c level of at least 8.5 when they started taking Acomplia saw their their blood sugar level decrease 1.9 points compared to 0.7 points in patients on a placebo.

Results of the study were submitted to both the FDA and the EMEA earlier this year in hopes that both might approve use of the drug for treating diabetes as well as for weight control.

The EMEA approved Acomplia more than a year ago as an aid to weight loss in obese patients and overweight patients with type 2 diabetes or other risk factors. Despite safety concerns that led to withdrawal of Sanofi’s application to market Zimulti in the U.S., the EMEA decided to permit its continued sale.

“The overall [EMEA] review of SERENADE in respect to the usage of the product in diabetes patients is still ongoing, and we cannot report anything else,” Spek said.

“We do not know what comes out of it, and we don’t know when the EMEA will express how they see SERENADE in respect to a potential enlargement of the indication here in Europe,” Spek added.

Nutritionists weigh in on new weight loss aid, Alli

Christina Cesario works out five times a week. She says she’d try the new FDA approved diet pill, Alli. “I would definitely be interested in trying it and see if it helps me loose a few more pounds and how it makes me feel,” said Cesario

The makers of Alli claim it can help its users lose 50-percent more weight than dieting alone. An example they use is, if you loose 10 lbs on your own, you’ll loose 15 with Alli.

Nutritionist Kelly Waters says, “I’m afraid that they’re gonna say well this pill is great. I’m just going to take this pill and be okay, when really that’s not how it is.”

Alli creators say the pill works on the digestive system. Officials say the Alli prevents enzymes in the intestines from digesting about a quarter of the fat a person eats. But if you don’t stick to the recommended diet plan Alli officials say there could be “treatment effects.” “If people take this pill and they continue to eat fried foods, trans fats, that’s when they’re definitely going to have the gastrointestinal distress. It will not agree with their body,” said Waters.

For some that’s enough to stay away from the pill.

Eric Patrick says he’ll never use diet pills. “I probably wouldn’t use it. No I think that I would just go ahead with the vegetables and fiber,” said Patrick.

Nutritionists say just because the pill is FDA approved, doesn’t mean it will perform miracles.

Nutritionists say some of the fat Alli passes out of the body is fat the body needs. Like Vitamin A, D, E and K.

Alli is only for people age 18 and over.

The makers of Alli say most weight loss occurs in the first six months of use.

A starting package costs $60 for 90 capsules at most stores. The refill packages are $70 for 120 capsules.

Novartis Could Thrive On New OTC Stop-Smoking Gum

THE U.S. FOOD AND DRUG Administration (FDA) has granted approval of Thrive, a smoking cessation drug from Parsippany, NJ-based Novartis Consumer Health.

The mint-flavored nicotine-replacement gum comes in 2-mg and 4-mg doses, and is designed to help smokers quit smoking in 12 weeks. The company said it doubles a smoker’s chances of quitting.

A company spokesperson said that when Thrive goes on sale late in 2007, packaging will include a Thrive user’s guide and audio CD. The company will also have a toll-free counseling line to aid smokers in their attempt to quit smoking, at 866.384.3011.

Novartis says Thrive delivers low levels of nicotine to the bloodstream to help reduce cravings and other withdrawal symptoms associated with the cessation of smoking. The lower dose is for people who smoke fewer than 25 cigarettes each day; the 4-mg dose for 25-or-more per day smokers.

Competitor Pfizer got a jump on the category a year ago when its Chantix pill became the first smoking-cessation drug to get FDA approval in 10 years.

Pfizer launched Chantix late last year with the theme line: “My time to quit,” and will begin a new marketing program for the drug this summer with advertising touting it as cheaper than a pack of cigs. Pfizer reportedly earned $162 million in the first quarter this year on the drug, driven by the U.S. market.

Cost of the new Novartis drug was not divulged, but Chantix runs about $3 per day, as opposed to a minimum $7 per pack of cigarettes in most cities. The Chantix Web site at www.mytimetoquit.com lets consumers tally the money they spend on cigarettes.

The first nicotine-replacement product to help smokers stop was developed by Pharmacia and marketed by Smithkline Beecham as Nicorette.

Others include the Pharmacia-developed patch, which became Johnson & Johnson’s Nicotrol patch, and SKB’s Nicoderm.

Before Chantix, the most recent approval was in 1997 for Glaxo Wellcome’s Zyban a non-nicotine cessation drug known in the world of psychopharmacology as the anti-depressant Wellbutrin. Two years later, the FDA approved the combined use of Zyban and a nicotine patch.

Sales in 2000 of nicotine-based cessation drugs were reportedly $700 million. (tk)

AUA: ED Drugs May Have Role in Treatment of BPH

Treatments for erectile dysfunction may prove effective against benign prostatic hyperplasia and lower urinary tract symptoms, possibly because they share a common etiologic pathway.

Studies involving all three of the currently available type 5 phosphodiesterase (PDE5) inhibitors showed improvement in BPH and urinary symptoms, regardless of whether the patients had concomitant erectile dysfunction. The three studies, two from the U.S. and one from Germany, were reported at the American Urological Association meeting.
The data reinforce an emerging theoretical and scientific framework that posits a common pathway for development of erectile dysfunction, benign prostatic hyperplasia, and lower urinary tract symptoms, and, the research suggests, possibly overactive bladder, researchers said.
The larger of the two prospective, randomized trials was conducted by Kevin McVary, M.D., of Northwestern University, and colleagues. It involved 369 men who had erectile dysfunction and concomitant lower urinary tract symptoms.
The patients, whose mean age was 60, had about a six-year history of erectile dysfunction and a five-year history of BPH and lower urinary tract symptoms. They were randomized to placebo or to 50 mg of sildenafil (Viagra) taken nightly before bedtime or 1 hour before sexual activity.
Treatment continued for 12 weeks. The primary endpoints were change in the erectile function (EF) domain score of the International Index of Erectile Function, change in the International Prostate Symptom Score (IPSS), and change in maximum urinary flow (Qmax).
Overall, patients treated with sildenafil had a 6.32-point improvement in the IPSS compared to 1.93 for the placebo group (P<0.001). EF domain scores improved by an average of 9.17 in the sildenafil group and 1.86 in the placebo group (P<0.001). Qmax did not differ between groups at baseline or at the end of the study.
Stratification of the data by baseline severity showed that patients with severe (IPSS =20) lower urinary tract symptoms improved substantially more compared with placebo than did those with moderate (IPSS 8-19) symptoms (P=0.0619). Among men with severe symptoms at baseline (54% of the cohort), substantially more had mild (16% vs. 4%) or moderate (57% vs. 36%) symptoms compared with placebo at the end of the study, the researchers found.
“The improvement in IPSS correlated with the IIEF changes,” said Dr. McVary said. “Patients with more severe symptoms had more improvement, in a sense because they have more room for change.”
He noted, however, that the researchers were surprised to find that the improvement did not correspond with the flow rate. “Although we didn’t have an active comparator, the improvement looks to be comparable to what we might expect when giving alpha-blockers or a five-alpha reductase inhibitor,” he said.
Asked to speculate about the lack of correlation between symptom improvement and flow rate, Dr. McVary said he and his colleagues initially suspected a predominance of urgency symptoms as opposed to obstruction. However, the data showed that both types of symptoms improved to a similar degree.
With respect to potential mechanisms involved in the co-existence of lower urinary tract symptoms and erectile dysfunction and the lack of flow improvement, Dr. McVary said that a pelvic deficiency in nitric oxide remains a viable explanation.
Other possibilities, he said, include an effect on bladder compliance, modulation of potential PDE5 effects on sensory innervation, and perhaps a change in pelvic flow affecting ischemia.
German investigators prospectively evaluated vardenafil (Levitra) as treatment for BPH in a randomized placebo-controlled study involving 222 men with moderate or severe symptoms.
The patients were randomized to placebo or vardenafil 10 mg BID for eight weeks, and the primary endpoints were change in IPSS, UROLIFE (a BPH quality-of-life questionnaire), and the EF domain of the IIEF.
The mean baseline IPSS was 16.8 in both groups. At the end of the study, vardenafil patients had a mean improvement of 5.9 compared with 3.6 for the placebo group (P=0.0013), reported Christian Stief, M.D., of Ludwig-Maximilians University in Munich.
Vardenafil also led to significantly greater improvement in the IPSS subscales for obstructive symptoms (3.2 vs. 1.9, P=0.0081) and irritative symptoms (2.6 vs. 1.7, P=0.0017).
The vardenafil group had significantly greater improvement on the UROLIFE questionnaire (P<0.0001 compared to placebo) and in the subscales for activity and perceived sexual life. IIEF scores improved by an average of 7.5 with vardenafil and 1.5 with placebo (P=0.0001).
The third study, a post hoc analysis of 156 men with erectile dysfunction and concomitant lower urinary tract symptoms showed that tadalafil (Cialis) significantly improved erectile function compared to placebo after 12 weeks of randomized therapy, reported Marc C. Gittelman, M.D., of South Florida Medical Research in Aventura, and colleagues.
Patients randomized to tadalafil started treatment at 5 mg/day for six weeks, followed by dose escalation to 20 mg/day over an additional six weeks.
Baseline IIEF scores averaged 13 to 14 in the placebo and tadalafil groups. The data were stratified by baseline urinary symptom severity.
Among patients with moderate symptoms, the erectile function score had improved by 6.8 points with tadalafil at six weeks versus 0.8 with placebo. At 12 weeks the tadalafil patients had a mean improvement of 8.3 compared with 1.7 in the placebo group.

Pill to boost women’s sex drive and help them lose weight

A DRUG that boosts female sex drive while helping women lose weight is being developed by one of Scotland’s leading experts on human reproduction.

Professor Robert Millar has been working on a hormone that can be used to treat loss of libido, a problem that affects millions of women each year.

But Millar, director of the Human Reproductive Sciences Unit at the Medical Research Council, said the hormone has the added benefit of suppressing appetite.

Tests of the “wonder pill” on animals have proved successful, but Millar admits a version for humans could be as much as a decade away.

The scientist has spent 30 years researching

Type 2 gonadotropin-releasing hormone, which drives the reproductive system in animals and humans.

Millar said that when female musk shrews and marmoset monkeys were directly injected with doses of Type 2 GnRH, they displayed classic mating behaviour towards their male counterparts.

In musk shrews this was shown by “rump presentation and tail wagging”, and in monkeys it included “tongue flicking and eyebrow raising”.

However, in an unexpected short-term side-effect, the laboratory animals also ate significantly less food than usual. In some cases this was one-third less than their usual daily diet.

Millar expects that a similar rise in libido and lessening of appetite would be seen in women given the hormone. He will now work on reproducing it in the form of a pill.

Although rare in men, lack of sex drive is very common among women, with up to 40% thought to be affected at some point in their lives. Common causes are stress, relationship difficulties and having a baby.

British women spend up to 31 years of their adult lives, or six months of each year, on a diet – more time than they spend sleeping or raising children. Nearly two-thirds are unhappy with their bodies and think being thinner would make them happier.

Although a number of drug treatments are already on the market aimed at treating obesity and sexual dysfunction, Millar believes his discovery could lead to the first ‘lifestyle drug’ that works on the sex drive and the appetite.

He said: “This hormone is distributed in the brain in areas that we suspect affect reproductive behaviour. The musk shrew is a very primitive ancestor of primates and when given to the females they displayed reproductive behaviour and the males would mate with them.

“In marmoset monkeys the females given the hormone also solicited sex with tongue flicking and eyebrow raising. It also significantly inhibited appetite and food intake, which is the bonus,” he added.

“It is considered a major pharmaceutical endeavour to address the area of libido. So the next stage is to produce a drug that simulates the actions of this hormone. It is most likely that we will do it in partnership with a pharmaceutical firm. It could be available to women within the next 10 years.”

Millar suspects that a pill that simulates the hormone could also work for men, but as yet he has not carried out any tests on male animals.

The pill could become even more effective for women than the male impotence drug Viagra has for men because it works on the sex drive itself rather than just sexual function. Viagra is thought to have been taken by around 900,000 men in the UK.

Hormones are often suggested as a remedy for lack of libido in women, but so far with little real success. Doctors have been trying out the male sex hormone testosterone on women for a number of years, but it has a number of unwanted side-effects, including hairiness, spots and a deep voice.

A testosterone patch, Intrinsa, is soon to become available on the NHS for postmenopausal women with diagnosed sexual problems. The patch will release the chemical slowly to avoid the side-effects.

About 8,000 people in Scotland are taking anti-obesity drugs at an annual cost of more than £4m.

Dr Lesley Perman-Kerr, a chartered psychologist, said women would be more likely to take the pill to suppress their appetite than to increase their sex drive.

She added: “Some women have problems specific to libido, but often if they go off sex, it’s more to do with their relationship than with their level of libido. In my experience, when couples come to me and they are not having sex, the last thing they want to do is examine their relationship. They want to believe that it’s nothing to do with their relationship.

“So it may be that women would take the pill when they have a good sex life and they want to enhance it.”

Erectile Dysfunction Internet Pitches Called Risky by FDA

eware the smooth-tongued Internet pitchmen touting so-called “dietary supplements” that allegedly treat erectile dysfunction and enhance sexual prowess, the FDA has warned consumers.

Specifically, the agency cited seven alleged supplements that “are in fact illegal drugs that contain potentially harmful undeclared ingredients.” The FDA warned against buying or consuming the dangerous seven, all unapproved. They are Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, and 4EVERON. “There is no guarantee of their safety and effectiveness, or of the purity of their ingredients,” said the FDA.

The FDA said its chemists analyzed the drugs and found that one, Zimaxx, contains sildenafil, the active ingredient in Viagra, and that the others contain chemical analogs to sildenafil or to vardenafil, the active ingredient in Levitra. None of the product labels mentions the presence of these ingredients, the FDA noted.

“These products threaten the public health because they contain undeclared chemicals that are similar or identical to the active ingredients used in several FDA-approved prescription drug products,” said Steven Galson, M.D., director of FDA’s Center for Drug Evaluation and Research. “This risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure.”

Sildenafil and vardenafil are selective inhibitors of 5-phosphodiesterase (PDE5), an enzyme that degrades the second-messenger molecule cyclic guanosine monophosphate (cGMP), which is chiefly responsible for the smooth muscle relaxation of blood vessels in the corpus cavernosum of the penis.

PDE5 inhibitors also affect the nitric oxide/cGMP pathway in blood vessels in the cardiovascular circulation and may potentiate the blood-pressure lowering effects of nitrates used to treated angina.

In fact, Viagra was originally developed as an anti-angina agent. Its effect on erectile function was discovered serendipitously, when investigators noticed that men involved in the original clinical trials were reluctant to return their unused medication.

The FDA warned that men with diabetes, hypertension, high cholesterol or heart disease often have erectile dysfunction and may be also be taking nitrates, unaware that there could be seriously or potentially fatal drug interactions with the hidden ingredients in the mail-order drugs.

The FDA said it sent official warning letters to the firms marketing the illegal products. The letters stated that the products are illegal drugs based on claims made for the products or their ingredients, and that the product labels are false and misleading because they fail to list all of the ingredients.

The FDA has instructed agency staffers to stop the importation of Libidus from Malaysia, and the agency recently stopped a shipment of 4 EVERON from entering the United States.

The Web site for, Libidus, based in Kuala Lampur, states that “it has come to our attention that a recent laboratory test of Libidus indicated that there was unlisted ingredients found in the product and therefore have made the decision to immediately stop marketing the product until such time as it can be determined how these unlisted ingredients found their way into the product and assurance that the product is once again ‘all natural’.

The FDA, which in recent years has been criticized for being lax in its oversight of over-the-counter drugs, herbal products, and dietary supplements, recently undertook a survey and analysis of 17 dietary supplements hawked on the Internet for the treatment of erectile dysfunction and enhancement of sexual performance in men.

Ulster’s Sexual Health Crisis

Sexually transmitted infections are rapidly increasing in Ulster, where it can take six weeks to get an appointment because of a lack of doctors and nurses.

Consultant at the Royal Victoria Hospital Wallace Dinsmore, who has held a Genito-Urinary-Medicine (GUM) clinic there for almost 20 years, told the Telegraph that the service is reaching crisis point province-wide.

The latest figures from the Communicable Diseases Surveillance Centre show that the number of diagnoses for STI’s – chlamydia, gonorrhea, syphilis, herpes and genital warts – reached record levels in 2005.

In 2004 the total diagnoses was recorded as 11,481. Last year figures peaked at 12,847.

The four hospitals that operate GUM clinics (with varying frequency) and their current waiting lists for a new appointment are; Royal Victoria, two weeks, Daisy Hill in Newry, four weeks for men and six weeks for women, Altnagelvin in Londonderry, four weeks, and the Causeway in Coleraine, two weeks.

A statement from Altnagelvin Hospital said: “We operate a triage system. When a caller contacts the GUM clinic and if they do not have symptoms, they need a check up, or they have a non-urgent condition such as genital warts, they will be added to the appointment list which is 4 weeks at present.

• Should the caller feel that their condition is more urgent, a nurse at the clinic will establish if an urgent appointment is necessary and the caller will then be seen within 48 hours.

Dr Dinsmore said that although hospitals like Altnegelvin are doing their best, the situation is simply unacceptable.

• There is a percentage of people with more than one infection, but that figure remains similar year on year, numbers attending GUM clinics are also going up all the time, quite often people going for a check up who have nothing wrong with them.
• This is because a lot of money has been put into health promotion in Northern Ireland, including raising awareness about STI’s and advising people to go to GUM clinics.
• But they have not completed the picture, because there is very, very little money to pay for the doctors and nurses needed to staff these clinics.
• The existing service providers are under enormous pressure, there is a major deficit here in Northern Ireland and this is why we have such long waiting lists for appointments at GUM clinics. “Three week waiting lists are common place. If you have syphilis or Gonorrhea, over a period of several weeks you can become quite seriously ill. You could also easily have an infection you don’t know about and be spreading it.
• We do try to see priority cases straight away but we can’t make an exception for everyone. For example the Altnagelvin clinic does not operate on a Thursday because there is neither a nurse nor a doctor to open it. So if you’re suicidal with worry on Wednesday night where does that leave you?
• There is a real need for a review of services, the provision needs to be addressed urgently.
• There is a continuous rise of new infections and new patients.
• Five years ago every clinic in Northern Ireland was walk in – that’s a distant memory now.
• In order to try to cope with the new numbers, we’ve tried to up the number being seen, but we just can’t see all of them.