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Phase III testing for ED drug delayed

August 30, 2007

PTN0.65, -1.08, -62.5%) said that after a review of Phase I and Phase II clinical data, the Food and Drug Administration has expressed concerns that the drug candidate, known as bremelanotide, might raise blood pressure in certain patients.
Accordingly, the agency has questioned its benefit as a first-line therapy, suggesting it may be better suited as a therapy for men who have not responded well to other erectile-dysfunction medications, such as Viagra, Cialis or Levitra.
King and Palatin said they plan to review the FDA’s suggestions in order to determine how best to proceed with the program. End of Story

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Woman disgusted with men who use Viagra stops dating

August 23, 2007

We’ve heard from The Pharmaceutical Widow and Sore and Exhausted, both women whose experiences with Viagra, “that little blue pill” that makes men “feel like they’re 20 again” have been miserable. The Pharmaceutical Widow said her husband had “the erection of a 20-year-old in a fiftysomething-year-old body” and he didn’t want her anymore.

Sore and Exhausted said “when a man pops his Viagra, he can go like he’s 20, but if his partner is going through menopause, her body probably cannot keep up. This causes resentment on both sides. Women withdraw, and men look around.”"I want to add my voice to the women who are speaking out about Viagra. First, I have to say that I’m a woman in my 50s. I’ve been on the dating scene, if that’s what you can call it, for the past 10 years, and I’m thoroughly disgusted. Most men my age are not interested in dating anyone unless they’re at least 10 years younger than them. Quite a few men of this age seem to think that going to a younger woman and ditching the woman who bore him his children and raised them for him (while at the same time worked full time and did 99 percent of the housework) is the thing to do.

“And certainly Viagra helps him attract the sweet young things, along with his now healthy bank book, which his wife also helped him achieve. There are certain snags in this Sweet-Young-Thing Theory (which I will go into in a moment), but first I want to reflect back on the women who are left behind, the women of their same age whom they could be dating.

“We’re a hearty bunch. We watched our parents, mom at home, dad going off to work every day. When it came to be our turn, we found that we needed to do both of those jobs. While our husbands were willing to go off to work like their fathers, they also expected us to go to work, too, to earn money for the household. Yet they were not willing to help with the housework, grocery shopping or child rearing. So we did it all.

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“Then, just when we got the kids off on their own, along came Viagra and the man of the house now had the ability and the desire to woo a younger woman who can keep up with him. So, here we are, left alone. But as I said, we’re a hearty bunch, and we can usually feed, clothe and house ourselves. Maybe not in the same manner as when we were married, but at the same time, we’re very happy not to have to clean up after our husbands. And also not be expected to keep up with their Viagra. This is just not the natural thing for women of a menopausal age. Even with artificial help, it simply isn’t comfortable, certainly not for hours.

“Now back to the Sweet-Young-Thing Theory. In the area I live in, I see it all the time. There she is, shopping with her spouse, who looks to be very much her senior, in tow. He’s pushing the stroller and tending to the small children while she does the shopping. He never looks very happy. I find it particularly amusing at the grocery store. Not only did my ex never enter the grocery store with me, he never took care of the kids so I could do it without having them along. And he never pushed a stroller! So you see, Viagra is great for the men, up to a certain point.

“I recently backed off the dating scene. The men who’re interested in dating me are 10 to 20 years my senior, and I’m not interested in dating them. Men my age are either self-absorbed bores or totally unable to take care of themselves and are looking for a housekeeper who cooks, cleans and does laundry, while not minding the ill effects of Viagra. I tried that, but I find that I’m happy to be on my own.”

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Men, do you take Viagra or another erectile dysfunction drugs? What effect has it had on your relationship? Send your tale, along with your relationship questions and problems, to cheryllavin@aol.com or Cheryl Lavin, 435 N. Michigan Ave., Chicago, IL 60611. Please include day and evening phone numbers. Letters may be used in whole or in part and become the property of the column. Read “Tales From the Front” every Monday, Wednesday and Thursday in Tempo.

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Viagra and Golf – Is Sex Worth the Sacrifice?

August 18, 2007

I was driving to a client’s office this morning and I heard a radio ad for Viagra and its claim that an estimated 17 million men have ED. Yes, erectile dysfunction. I was shocked to hear that so many men can’t bring themselves to attention. I also didn’t know that we have an epidemic on our hands. According to Webster’s New World Medical Dictionary, an epidemic is defined as “The occurrence of more cases of a disease than would be expected in a community or region during a given time period.” How did our society reproduce with so many men that couldn’t get it up? Is there something in our water? I digress.

What struck me as quite interesting was that the ad closed with “…and see our ad in Golf Magazine.” That made me rise up in my seat. Why did the advertiser mention Golf Magazine as the only place where the print ad was running? Is there some sort of connection between ED and golf? Why didn’t they mention Forbes, Fortune or Maxim? What about Rolling Stone, Sports Illustrated or Science? Don’t any of these publications’ readers have ED? Is it only those who read Golf Magazine that have this dreaded disease?

Perhaps we should thrust ourselves into a deeper understanding of the connection between golf and ED? Yes, I think we should.

A quick check of Golf Magazine’s 2006 media kit is very telling:

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95% of the readership is male – VERY MALE
They have an average net worth of over $1 million — RICH
They have an average household income of $148,000 — RICH
They have played golf an average of 25 years — OLD
They play an average of 58 rounds per year – PLAY LOTS OF GOLF
83% are professional or managerial – IN MANAGEMENT

What do we have: rich old male managers that play too much golf and according to Viagra, they have an ED problem. Clearly a target rich market.

So, I think the conclusion we can draw from this is that playing too much golf (58 rounds/year mind you) leads to ED and so your choices are:

A) Stop playing golf. — NOT
B) Stop playing golf, take Viagra and still have sex. - NOT
C) Keep playing golf, take Viagra and still have sex. — POSSIBLE
D) Keep playing golf and stop having sex. - ???

Hmmmm…. don’t rush me, I’m still thinking about it.

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Maker of Asian ‘viagra’ launches complete lines in Bacolod

August 15, 2007

ACTOR and health counselor Ricardo Cepeda was here last Saturday as part of the team that launched the complete product lines of Dynapharm, a Malaysian-based multi-products company.

In Bacolod, Dynapharm is owned and managed by multi-awarded businessman Roberto Montelibano. Dynapharm is selling almost all kinds of coffee and other beverages made of herbs used by Asians since ancient times and a long product lines of generic and vitamins extracts.

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According to Cepeda, “Its ‘Dano’ coffee and ‘Tongkat Ali’ products that had made an initial dent in the Philippine market especially Tongkat Ali because it is popularly known as the Asian viagra.”

“But now, we are here to explain why Tongkat Ali had become popular. It is simply because it worked. A lot of Tongkat drinkers, male and female, found it to be effective, improved their sexual lives and very safe because it’s only coffee extract but with only about three percent caffeine,” Cepeda said.

“Here in Bacolod, under the leadership of Mr. Montelibano, you will see that Tongkat Ali is manufactured by Dynapharm and there’s a hundred other product lines from coffee to cosmetics, household items, vitamins, generic drug for all diseases and many more to come,” Cepeda Added.

Cepeda stressed that while Dynapharm will be using the networking marketing schemes, Bacolod people need not be afraid, saying, “This is not ‘pyramiding.’

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For your P1,200 initial investment, you will immediately get a promo kit worth P1,500. Either you keep it or use it, it is our policy not to engage in hard selling.”

“Since majority of our products are household items, your P1,200 will entitle you to automatic 20 percent discount. Or, you sell them or organize a network and we don’t need to explain that you get a rebate everytime you recruit,” Cepeda said.

“We will not deal so much with telling you who became millionaires here or that the more you recruit, the more your earn things. We believed in the effectiveness of our products and making everyone earn or buy household items at a discounted price is our focus,” he added.

Cepeda talked to around 30 initial recruits gathered during the launching last Saturday.

Meanwhile, Montelibano stressed that for his part while people whom he recruited will earn, his investment under Dynapharm is his ‘tuition fee’ in learning network marketing.

“I’d like to emphasized that all Dynapharm products had passed the Bureau of Food and Drugs (BFAD) examinations. Bacolod is assured of safety and health for all these products,” Montelibano said.

“Also, Dynapharm, while imported, the prices are reasonable and some are even lower than the more popular brands,” Montelibano added.

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Viagra, Cialis imitations seized in London raid

August 7, 2007

In the latest episode of illegal drug trading, a hoard of unlicensed medicines was seized by the UK Medicines and Healthcare products Regulatory Agency (MHRA) last week, taken from a London lock-up containing a stash of various male impotence drugs.

The drugs were unlicensed, generic versions of Pfizer’s Viagra (sildenafil citrate) and Eli Lilly’s Cialis (tadalafil), going by the names Kamagra (in tablet and sachet form), Lovegra and Apcalis.

The confiscated goods were worth around £350,000 (€519,000), and most likely manufactured in the Far East before being imported into the UK, according to an MHRA spokesperson.

Viagra and Cialis were two of the most widely faked drugs in Europe over 2006, with a rich black market trade in imitation and purportedly genuine tablets gnawing away at authentic drug sales and posing a significant risk to the health of those who purchase them.

“It is essential the medicines are licensed correctly,” said MHRA head of criminal operations Danny Lee-Frost.

“The type of medicines we seized cannot be guaranteed to be acceptably safe because they have not gone through the correct licensing regulatory process. At best these medicines could be a waste of money, at worst they could be severely detrimental to your health.”

Although the MHRA was unable to comment on how the seized meds were likely to reach the market, a spokesperson from the agency did agree that the unlicensed medicines are widely available through a host of online pharmacies claiming to offer cheaper, easily accessible alternatives to the authentic branded drugs.

“There are people out there illegally selling these medicines online,” the MHRA spokesperson told in-PharmaTechnologist

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“These male impotence drugs, lifestyle drugs, are certainly the kind of things widely peddled online.”

Many of these internet pharmacies will be located in countries outside the regions regulated by the MHRA, with a similar situation for equivalent authorities representing other countries. As such, the agency warns that the risk of substandard or fake medicines is vastly increased through buying online.

In a bid to try and establish some kind of standard or policing method of these internet pharmacies, in 2006 the Royal Pharmaceutical Society of Great Britain (RPSGB) initiated a pilot logo scheme to help the public identify whether a specific website is linked to a bona fide, registered pharmacy.

Through the scheme, online pharmacies carry a logo which, although not an accreditation by the RPSGB in any way, legitimises the pharmacy’s online activity and links it to a real bricks-and-mortar pharmacy on the street.

The initial pilot involved 20 online pharmacies, and once the scheme is launched fully, it will be compulsory for all pharmacies registered with the RPSGB and trading online to carry the logo.

The project is still in development, and although original plans were for the scheme to launch next month, technical delays have meant that it is more likely that the fully-fledged logo programme will kick off in the new year.

Last week’s West London seizure was the latest success in the MHRA Enforcement Team’s continuous clamp-down on the sale and distribution of unlicensed and illegal drug products. Although no arrests have been made as yet, any individual convicted of offences under the UK Medicines Act can be sentenced to a maximum of two years imprisonment and/or an unlimited fine.

If found to have financially benefited from the proceeds of the crime, the MHRA can also cite the Proceeds of Crime Act in order to recoup illicit earnings from guilty parties.

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Viva Viagra?

August 2, 2007

The setting is a folksy bar off a dusty highway. The scene: a group of guys who have gotten together for a jam session, to sing about … the wonders of erectile dysfunction medication.

The new commercial for Pfizer Inc.’s Viagra is striking for a few reasons.

For one thing, there are no women in it — this is a commercial all about guys bonding with other guys over the good times this medication has brought them, not sharing an intimate moment with their female partner. And secondly, some of the guys here strike the viewer as pretty young for erectile dysfunction.

Is Viagra taking things too far? The AIDS Healthcare Foundation thinks so. It alleges that the ad’s take on the celebratory ditty “Viva Las Vegas” — in their version, it’s “Viva Viagra” — helps encourage the use of Viagra as a party drug rather than a more serious medication.

Pfizer disagrees. Spokesman Francisco Gebauer said the ad is intended to help men get over the embarrassment of talking about erectile dysfunction with their physicians, and that the company is committed to safe and appropriate use of the drug.

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He said all the men in the commercial are over age 40, and that the company’s research shows that 50 percent of men over age 40 struggle with erectile dysfunction to some degree.

We’ve certainly come a long way from the days of then 70something Bob Dole earnestly hawking Viagra. But then again, over the past few years plenty of pharmaceutical companies have started taking more humorous and daring approaches to promote their medications. Also, Viagra now faces much fiercer competition in the market, so it needs to do more to stand out.

Still, is it appropriate for prime-time television? When Ads of the Weird wrote about a commercial for Trojan condoms earlier this summer, plenty of readers wondered why major networks refused to show that commercial during peak television viewing hours, while they seem to have no problem with commercials for “E.D.” drugs.

“Viva Viagra” debuted during the “NBC Nightly News.” It will air on network and cable programming with more than 90 percent adult viewers, Gebauer said.

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