Buy Cialis

Title: viagra GROUNDED ,  By: GERACI, RON, Men’s Health, 10544836, Apr99, Vol. 14, Issue 3

Section: malegrams: sex & health

diversions

WHEN WE heard that the Federal Aviation Administration had warned pilots not to take viagra for at least 6 hours before taking off, we couldn’t dial the phone fast enough. What the hell, we wondered, could have inspired that? Did they catch one too many guys pointing due north in the cockpit? Had flight attendants been complaining about a rash of “happy to see you” jokes?

The actual reason, according to Fraser Jones, a spokesman for the FAA, is that viagra ’s most significant side effectmight cause pilots to have trouble distinguishing between blue and green lights on their flight-control panels.

PHOTO (COLOR): CLEARED FOR TAKE-OFF: But leave the viagra on the tarmac.

~~~~~~~~

EDITED BY RON GERACI

Title: Love Potions ,  By: Song, Sora, Time Canada, 03158446, 2/9/2004, Vol. 163, Issue 6

Section: Love, Sex & Health

Sex may be a natural act, but for the millions who suffer from sexual dysfunction, it ran be vexingly unattainable. Below, a guide to some of the medical treatments available for what ails our libidos:

• Viagra, Levitra and Cialis: All these drugs work the same way, by relaxing smooth-muscle cells and widening blood vessels, primarily in the penis. Cialis stands out as particularly long-acting–up to 36 hours, compared with four or five hours for the others
• Testosterone: For men who don’t produce enough, patches (Androderm, Testoderm) and gels (Androgel) deliver extra hormone through the skin
• Alprostadil: This vasodilating drug can be self-administered as an injection (Caverject) in the penis or inserted into the urethra as a suppository (MUSE

• Ginkgo biloba: Better known as a memory enhancer, this herb is believed by some to improve blood flow to the body, including the penis. Conclusive scientific proof is lacking
• Ginseng: In the lab, ginseng has been shown to release nitric oxide, but there’s no evidence to suggest that it improves erectile function
• L-arginine: This naturally occurring amino acid is precursor to nitric oxide and is believed to improve the flow of blood to the genitals

• Penile prostheses: These surgically implanted devices are still used by men who, for medical or physical reasons, don’t respond to drugs

• Testosterone: Doctors prescribe the hormone in lower doses than typically used for men, though in the U.S. it’s not government-approved for this use. Women can also take under-the-tongue drops specially formulated by pharmacies or use patches and gels
• Estrogen: Tablets (Vagifem), creams (Estrace, Premarin) and a silicone ring (FemRing) inserted into the vagina release estrogen to alleviate such symptoms of menopause as vaginal dryness
• Viagra and Levitra : Initial trials are disappointing, but the drugs appear to work for some women

• Avlimil: The pill contains various plant leaves and roots and is touted as the female Viagra, but experts question its effectiveness
• Zestra: A botanical-oil lotion applied to the genitals can create a tingling sensation and enhance orgasm (breath mints or a few drops of Binaca on your partner’s tongue during oral sex do the same)
• XZITE: A daily capsule, manufactured in Marina del Rey, Calif., containing Chinese plant bark, flowers and roots, which doctors at UCLA’s Female Sexual Medicine Center say works for many of their patients

• Slightest Touch: UCLA doctors express high hopes for this device, which uses a set of electrodes to stimulate nerve pathways

~~~~~~~~

By Sora Song

Title: WHAT GOES UP MUST COME DOWN ,  By: Gallagher, John, Advocate, 00018996, 06/23/98, Issue 762

viagra ’s glory story may be tainted–the potency pill doesn’t mix well with protease inhibitors or recreational drugs

Before it even was introduced on the market, viagra had achieved the kind of fame usually reserved for Hollywood superstars. As an easily used drug that can successfully treat male impotence, viagra became the hottest topic in the media and provided an enormous boost to the stock of its manufacturer, Pfizer Inc., as doctors wrote tens of thousands of prescriptions in its first two weeks of availability alone. But now that the little blue pill is the Titanic of medications, doctors and mental health experts are warning gay men about the drug’s potential downsides.

“I have never seen in my career a greater demand for prescriptions before a drug was released,” says Gary R. Cohan, a physician at Pacific Oaks Medical Group in Los Angeles. “There’s a great demand, but there are a couple of interactions gay men need to know about.”

However, dangerous side effects or not, doctors believe some men may rush to the drug without fully exploring whether they need it. “I would really caution people not to see it as a panacea but as something useful after they and their doctor work out what else is going on,” says Kenneth Mayer, professor of medicine and community health at Brown University.

viagra treats impotence by acting on an enzyme that causes erections to subside. In men with erectile dysfunction, the enzyme is stronger than GMP, the body chemical that initiates erections. viagra keeps the enzyme from breaking down GMP, letting it produce an erection without interference. Doctors recommend that patients take viagra a half hour to an hour before sexual activity.

Within weeks of viagra ’s introduction, AIDS Treatment News and the Gay and Lesbian Medical Association both issued alerts about potentially serious interactions between viagra and other drugs. Their concern centered on two different circumstances during which the drag may be used: in combination with protease inhibitors and in combination with poppers, a class of recreational drugs used by some men to enhance sexual feeling.

Benjamin Schatz, executive director of the medical association, says Pfizer approached his group to discuss potential problems. “It speaks well for them,” Schatz says. “Imagine a pharmaceutical company approaching a gay and lesbian medical group about something not HIV-related. On that level what they did is really important and should be applauded.”

In the case of protease inhibitors, the drugs work on the same enzyme as viagra . “ viagra is metabolized by the same enzyme that metabolizes protease inhibitors,” Mayer says. “It’s not thought that viagra itself will influence the levels of protease inhibitors in the blood, but protease inhibitors, particularly ritonavir, can raise viagra levels.” viagra also interacts with certain antibiotics, such as erythromycin.

Mayer says the potential side effects of the interaction are still unknown, although even at high doses viagra does not seem to cause any long-term, serious medical problems. “Whether it translates into longer-lasting erections or more headaches is not clear,” he says. “In the scheme of things, a protease inhibitor study is medically necessary, particularly when you’re dealing with people who are otherwise doing well.” Medical experts advise men taking protease inhibitors to limit their dosage of viagra to 25 milligrams, half the normal suggested dose.

The issue is of particular concern because impotence is a common problem among men with HIV. Often the difficulty is caused by lowered levels of testosterone in the blood. “ viagra would probably work best in people with HIV-related erectile dysfunction if they are getting testosterone,” Cohan says. “You first have to get the libido back, and then viagra helps the blood flow to happen properly.”

However, the causes of impotence are many. viagra could make it easy to overlook some of the thornier issues, such as depression, that result in impotence. “It would be a shame if people don’t see if something else is going on,” Mayer says.

The other potential drug interaction of concern to gay men is with poppers, liquid nitrates that when inhaled cause blood pressure to drop and, for some, heighten sexual pleasure. Although the version of the drug widely used during the 1970s and ’80s, amyl nitrate, can no longer be obtained legally, other versions have been enjoying increased popularity.

“ viagra is absolutely contraindicated with poppers,” Cohan says. “It can cause the blood pressure to drop suddenly. Those are warnings I’m putting up in my exam rooms today.” A dramatic drop in blood pressure could lead to fainting, shock, or even death. Mayer warns that other results would be less horrible but still painful: “You’d be well advised not to be standing up where your head might hit something sharp.”

Often lost in the hoopla over viagra is the fact that it is not an aphrodisiac. It cannot produce erections in the absence of desire, which is what releases GMP into the blood in the first place. Nor is there any evidence that it can promote greater staying power or more intense orgasms in men who have no problem getting an erection.

Nonetheless, the buzz about the drug has already made it a hot item on the black market, where pills go for about $16 each, roughly 60% more than the typical retail price of the drug. As a result, some health experts are concerned that gay men will turn to viagra as a new recreational drug.

“I’m reluctant to stereotype gay men as a group, but there is a certain segment of the community where other drugs are abused in the context of sex,” Schatz says. “So a drug that has a cultural reputation of enhancing sexual prowess could be abused in situations in which people are desirous of having multiple partners or greater staying power.”

So far, the drug is too new to have had much of an impact on potential abusers. “It’s kind of early,” says David Schwing, director of Project Connect, the drug and alcohol program at the Lesbian and Gay Community Services Center in New York City. “It has not come to our attention at this stage of the game. People really don’t come in and start talking about these things immediately.”

“There’s always the opportunity for abuse, but at this point it hasn’t come up,” says Marc Malvin, a mental health clinician specializing in addictions at the Los Angeles Gay and Lesbian Center. “A little further down the line, we may see it come up more. It’s something we have to be diligent about.”

The primary concern is that some gay men will see viagra as an antidote to the side effects of crystal meth, which arouses desire but can also cause impotence. The possibility that viagra would restore potency could have a potentially disastrous impact on AIDS prevention.

“You will suddenly have a group of people who mercifully have not been able to be hypersexual and now would become quite potent,” Cohan says. “That could be a problem. If it emboldens people to use more drugs, that’s the last thing the community needs.”

But Cohan says his bigger concern is the issue of dependence. “Men may be turning themselves into a sub-culture of pill poppers: to grow hair, to get erections, to keep HIV in check,” he says. “The gay community has almost become the Valley of the Dolls/If they don’t need the pill, they shouldn’t be using it. I’ve had a number of patients with normal erectile function ask about viagra because they think it may enhance it. Psychologically, people think they need to have the drug to have sex, and that’s kind of sad.”

~~~~~~~~

By JOHN GALLAGHER

Title: Sildenafil in the Treatment of Erectile Dysfunction ,  By: Rose, Verna L., American Family Physician, 0002838X, 07/01/98, Vol. 58, Issue 1

Section: Clinical Briefs

The U.S. Food and Drug Administration has approved the oral therapy sildenafil (Viagra) in the treatment of erectile dysfunction. Sildenafil is the first in a new class of medications known as phosphodiesterase type 5 ‘inhibitors that improve blood flow to the penis. Sildenafil is taken about one hour before anticipated sexual activity.

In clinical trials of men with mild, moderate or complete erectile dysfunction (mean age: 55 years), the drug was shown to be effective in approximately seven out of 10 men overall and was effective across patients with erect fie dysfunction attributed to diabetes, spinal cord injury or psychologic causes, among others Most of the study subjects had experienced erectile dysfunction for an average of five years before entering the clinical trials.

Sildenafil was well tolerated. The most common side effects seen in the men in the clinical trials were headache, facial flushing and indigestion. The drug is contraindicated in patients receiving nitrates in any form, including nitroglycerin.

The American Foundation for Urologic Disease (AFUD) has issued a statement regarding the approval of sildenafil for the treatment of erectile dysfunction. AFUD notes that only 5 to 10 percent of men with impotence currently seek treatment, and AFUD hopes that approval of the drug will encourage more men to visit their physicians for consultation. They suggest that men “take this opportunity to openly discuss all symptoms, causes and treatment options with their physicians and have an overall health examination to select the most appropriate course of treatment.”

~~~~~~~~

By VERNA L. ROSE

Title: New drug keeps impotence sufferers up all night ,  By: Goldie, Stephen, Student BMJ, 09666494, Mar2003, Vol. 11

Section: news

In the United Kingdom, men with erectile dysfunction now have a choice of drug treatment after the launch of Cialis (tadalafil). Erectile dysfunction is thought to be a very common condition, affecting an estimated 2.3 million men in Britain.

Cialis is in competition with Viagra (sildenafil), which comes as a blue diamond shaped tablet. The new drug emulates the distinctive shape but is yellow in colour. Manufacturers Eli Lilly have priced the drug to be comparable to Viagra. The main benefit of the new drug is that it can be taken 30 minutes to 12 hours before anticipated sexual activity and its effect may last for up to 24 hours, allowing a more natural intimacy. Viagra is taken immediately before intercourse and has been criticised for its lack of “spontaneity.”

Cialis works by relaxing smooth muscle in the corpus cavernosum, thereby allowing blood to engorge the penis and produce an erection. In order to achieve the desired effect the patient must also have sexual stimulation.

In 80% of cases erectile dysfunction has a physiological cause, commonly diabetes mellitus, nerve damage, or hypertension. Some cases are due to a varying degree of psychological issues.

~~~~~~~~

By Stephen Goldie, Glasgow

Title: THE LONG GOODBYE ,  By: Lowry, Richard, National Review, 00280038, 09/01/98, Vol. 50, Issue 16

THE last week in July, President Clinton treated an audience at an education conference in Washington, D.C., to a full-throated denunciation of the Republicans who are blocking his education and training agenda. “Some would deny Head Start opportunities to as many as 25,000 of our disadvantaged children,'’ the President intoned as part of a long litany of charges. A few days later, he was back at it in an even harsher speech at a hospital in Maryland where kids work in a summer-jobs program. According to the President, if the GOP Congress has its way, kids working this summer “would not have a job next year.'’

Both speeches were broadsides against the GOP, rehearsing Democratic campaign themes on an issue on which Republicans have traditionally been vulnerable. Both were also totally ignored. They came, respectively, the day after Monica Lewinsky cut her immunity deal with Ken Starr and the day the White House tried to revive the claim of attorney - client privilege in connection with Bruce Lindsey. On CNN, footage from the hospital event was used as a backdrop for reports about the latest developments in the Lewinsky scandal.

Clinton’s critics have always said that his is the Administration of the “Big Lie.'’ Actually, it has been a running accumulation of little lies, about scandals, policy, and his personal life. Until now — when, by happenstance, one particular lie has become all-consuming, the Big Lie that eclipses all the other prevarications and exaggerated pronouncements. Now when Clinton accuses Republicans of taking jobs from young people, it’s irrelevant, drowned out by the steady deconstruction of his denial in the Lewinsky case.

It is a fitting end. And it is an end. Ever since the Lewinsky affair broke in January, the scandal has drained the meaning and vigor from Clinton’s Presidency, leaving the facade of his office undisturbed but steadily rotting out the inside. Clinton still smiles and gives speeches and travels abroad. His advisors grind away formulating policy in the White House and the Old Executive Office Building. But his Presidency is over. If Nixon gave us “the imperial Presidency,'’ Clinton is creating “the exiguous Presidency,'’ diminished, without serious purpose, reedy of voice.

Interngate has debilitated the Clinton Presidency in myriad ways. At the most basic level, it has distracted the President and his advisors, many of whom are left guessing what Clinton’s select coterie of personal lawyers will decide on a given day. More fundamentally, it has frayed the cords that attach moral authority to power, leaving the President’s high approval ratings dangling unconnected to the wellsprings of real authority. These are the effects a tawdry, high-profile sex scandal would predictably have on any politician. But, for Clinton, the Lewinsky scandal is even more damaging.

It has served to make his fundamental political project impossible. Clinton had planned to spend his second term making a renewed call for mutual obligation and responsibility, and doing it with the tool he brandished to such effect in 1996: the sheer communication power of the Presidency. Now, perhaps the most popular word in American politics, “responsibility,'’ has become an embarrassment to him. And his power to “move a message'’ has been compromised both by the media’s obsession with Monica Lewinsky and by his own need to lie low.

The price of the scandal was evident almost immediately in February’s disastrous “town hall'’ meeting in Columbus, Ohio, to discuss Iraqi policy. President Clinton, the master of the form, didn’t dare subject himself to live-fire questions from an audience. It was left to his lieutenants Madeleine Albright, William Cohen, and Sandy Berger to field questions, sounding as flat and unconvincing as they had when they left the President’s first post-Monica Cabinet meeting to profess their faith in his denials. Meanwhile, the tone of questions from the audience was rude and distrustful.

Democratic consent is a fragile thing, dependent on a sense that public officials are accountable, not just to elections, but to laws and propriety. The Clinton Administration has attenuated that sense by skating over “snafus'’ from Waco to Filegate to Monica. In Columbus, it was seeing its cynicism reflected back at it — and it wasn’t pretty. In less stark ways, the Columbus experience has been repeated again and again over the last seven months, with Clinton missing from public debates and the Administration abandoning one moral crusade after another against a backdrop of public indifference.

“It took him out of the box for a lot of the year,'’ one GOP aide says. “In 1995, early 1996, he was everywhere. He was on TV, having press conferences. This year he was either hiding from the press or he was out of town.'’ His child-care initiatives disappeared without a trace, as did the great anti-tobacco crusade and his education agenda. All these happened to be initiatives for “the children'’; this ready justification for any policy inevitably lost resonance when it was revealed the President’s alleged paramour was a 21-year old intern who still has baby fat.

Meanwhile, Clinton has had to tone down talk of “responsibility.'’ His post-Monica State of the Union address was still soaked through with themes of accountability and responsibility, but they have been fading since. “I think that hurts him and it hurts Democrats,'’ says one Democratic strategist. Responsibility was a key part of Clinton’s pivot in 1996, when he consciously set out to win back middle-class families for the Democrats by talking about values. This freed the rest of his traditional Democratic agenda from the taint of discredited social liberalism, giving it a new life.

The scandal puts this Clinton-initiated revival at risk for two reasons. One is that it needs continual rhetorical spade work that the President can no longer do. The other is more fundamental. The re-positioning of the Democrats in 1996 was mostly symbolic. The party of acid, amnesty, and abortion became the party of curfews, school uniforms, and V-chips. The Lewinsky affair trumps them all, and the risk for the Democrats is that by standing by the President too long they become by association the party of sexual dysfunction and lies.

Clinton’s Presidency is already irrevocably tainted by both. His approval ratings are high, but clearly are being carried by the economy (his personal rating is now below 40 points in some polls). The approval numbers don’t translate into clout on Capitol Hill and the President is in no position to appeal over the head of Congress directly to the public. Meanwhile, the point of his second term on a fling with an intern. Let’s hope he at least had fun.

PHOTO (BLACK & WHITE): President Clinton boarding a helicopter.

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By RICHARD LOWRY

Title: A PROMISING ORAL TREATMENT FOR ERECTILE DYSFUNCTION ,  Modern Medicine, 00268070, Aug97, Vol. 65, Issue 8

Section: clinical NEWS

An investigational oral drug, Sildenafil (Viagra), may bring some hope to men suffering from erectile dysfunction who are reluctant to undergo prosthetic-implant surgery or administer penile injections or suppositories. This is according to two studieson Sildenafil that were presented during the American Urological Association’s annual meeting in New Orleans.

Researchers say that the drug is effective and well tolerated, and it appears to benefit men with either organic or psychogenic impotence.

Sildenafil produces its pro-erectile effect by inhibiting type-5 phosphodiesterase, an isozyme that inactivates cyclic guanosine monophosphate (cGMP). cGMP, which is produced in response to sexual arousal, promotes smooth muscle relaxation in the corpus cavernosum. This is the action that is responsible for the vascular changes that produce an erectile response.

A look at the two studies:

EUROPEAN STUDY. Jacques Buvat, MD, conducted a multicenter, open-label trial of 311 men (mean age: 53) whose dysfunction was non-organic in nature.

For 1 year, the men took Sildenafil 1 hour before each anticipated intercourse. The starting dose was 25 mg; the men had the option of reducing the dose to 10 mg or increasing it incrementally to 50 mg and then to 100 mg, depending on tolerance and efficacy. The men were instructed to take the drug no more than once a day.

Forty men dropped out for various reasons, which left 271 (87%) who completed the trial. Of the 40 who did not finish, 13 stopped because of a lack of efficacy and 12 because of an adverse effect (only 3 of which were ascribed to Sildenafil ). Six men were lost to follow-up, 5 withdrew for unknown reasons, and 4 claimed that they were cured.

The remaining men reported that the quality of their erections was significantly better (more rigid, longer duration) than it was prior to treatment. More than 85% of the men said they were satisfied with the results.

The drug’s side effects, which were mild, consisted mainly of headache (11%) and facial flushing (4%).

Buvat points out that unlike the vasodilator drugs that are used to treat erectile dysfunction, Sildenafil requires that the patient have some degree of sexual desire in order for it to be effective.

U.S. STUDY. Tom F. Lue, MD, and colleagues conducted a double-blind, placebo-controlled, multicenter study of 416 men who had erectile dysfunction. Their impotence was the result of either an organic (73%) or a psychogenic (9%) cause, or a combination of the two (18%).

The men were randomized to take either placebo or Sildenafil at 5, 25, 50, or 100 mg about 1 hour prior to each anticipated sexual encounter. The trial lasted 8 weeks, and the drug’s efficacy was assessed with follow-up questionnaires.

The men who took Sildenafil rated the quality of their erections and sexual satisfaction much higher than those who took placebo (see chart, page 25).

Most of the side effects that were reported by the Sildenafil patients were mild. They included headache, vasodilation, dyspepsia, and diarrhea.

Lue told MODERN MEDICINE that he expects Sildenafil to be approved for use in the U.S. by the end of next year.

Dr. Buvat is an internist in Lille, France. He is the secretary-general of the International Society for Impotence Research.

Dr. Lue is a professor of urology at the University of California, San Francisco.

Legend for chart: 
	
A - Placebo
B - 5 mg
C - 25 mg
D - 50 mg
E - 100 mg 
	
                       A        B       C       D        E 
	
Improved
 erection[*]         27.7     47.7    60.9    72.9     77.8 
	
Ability to achieve
 an erection
 satisfactory for
 intercourse[a]      2.00     2.69    2.93    3.28     3.69 
	
Ability to maintain
 an erection
 satisfactory for
 intercourse[a]      2.05     2.40    2.95    3.32     3.60

All dosages of Sildenafil were more effective than placebo, although the higher the dosage, the better the results,

* Percentages of men who had improved erections,

[a] Mean response score on a scale of 1 to 5, with 1 indicating “never” or “almost never” and 5 meaning “always” or “almost always.”

Source: Tom F. Lue, MD.

Title: THREE TREATMENT CALLED EQUALLY EFFECTIVE FOR ERECTILE DYSFUNCTION ,  Geriatrics, 0016867X, Jan97, Vol. 52, Issue 1

Section: WHAT’S NEW

Source: American Urological Association

Three treatment options for erectile dysfunctionappear to be equally effective and safe, according to new American Urological Association (AUA) treatment guidelines.

“The therapeutic armamentar-ium for treating erectile dysfunction has greatly increased over the past two decades. Primary care physicians can help their patients with impotence problems by explaining the causes and various treatments available,” Jack McAninch, MD, president of the AUA, told GERIATICS.

The guidelines (see table) apply to the “standard patient.” He is a man who develops erectile dysfunction after a well-established period of normal function and whose dysfunction is primarily organic rather than psychological. He has no evidence of hypogonadism or hyperprolactinemia. According to the guidelines:

• Vacuum constriction devices use a plastic cylinder that fits over the penis and a pump to create a vacuum, which causes an erection. They have no serious side effects when used properly. For safety and efficacy, men using such a device should receive individual instruction on its use. Only devices available by prescription should be used.
• Penile injection therapy involves injection of vasoactive drugs into the corpora cavernosa to expand the arteries, relax penile tissue, and permit increased blood flow into the erection chambers. A firm erection is produced within 5 to 15 minutes of injection. If an erection lasts more than 4 hours, patients should be told to contact their physician.
• Penile implants consist of a prosthetic device implanted inside the penis to make it rigid. Once the prosthesis is implanted, the patient can create an erection at will. The guidelines advise physicians to obtain the concurrence of a psychiatrist or psychologist before providing implants to men with psychogenic erectile dysfunction.

According to the panel, the benefits of the oral medication yohimbine have been modest, with a pronounced placebo effect. Men who would benefit from yohimbine cannot be accurately identified before treatment. The panel also cites venous and arterial surgery as having unpredictable results and low reported success rates.

Physicians can order the guidelines and a patient guide from the AUA’s Health Policy Department at (410)223-4310 or its Fax Information Line at (410)223-4367. Ask for document #4504.

The following chart reads as follows: 
	
Row 1: TREATMENT 
	
Row 2: ADVANTAGES 
	
Row 3: DISADVANTAGES 
	
Vacuum constriction devices 
	
        Reliable and safe with no serious side effects when
          reputable prescription devices are used properly
        Patients can discontinue and try another treatment 
	
        Lovemaking must be interrupted
        Numbness or coldness of the penis and/or discomfort when
          ejaculating may occur 
	
Penile injection therapy 
	
        Tends to produce firm erection
        Easy to do with practice and usually painless
        Patients can discontinue and try another treatment 
	
        1 to 8% chance of prolonged erection, which can cause
          injury to the penis
        May cause scar tissue to form in the penis 
	
Penile prostheses 
	
        High rates of patient satisfaction
        Allows patient to create an erection whenever he wishes
        No change in skin sensation or ability to have an orgasm 
	
        Once a device is implanted, it is difficult to choose a
          different option; removal requires another operation
        Mechanical failure is possible, as are complications
from
          surgery

* Options are for the standard patient with organic erectile dysfunction

Title: CIALIS POSTPONED UNTIL 2003 ,  Drug Store News, 01917587, 5/20/2002, Vol. 24, Issue 7

Section: Pharmacy News

PHARMACY NEWS

Although Eli Lilly received an approvable letter from the Food and Drug Administration for impotence drug Cialis (tadalafil), it will still be talking with the agency about additional clinical data.

The drug’s new potential launch date is now 2003 or later.

Viagra, a Pfizer drug, is the best-selling medication in this category with U.S. sales of $1.5 billion in 2001, according to Pfizer.

Title: NO SPECIAL TRADE MARK TREATMENT FOR PFIZER’S WONDER DRUG ,  Managing Intellectual Property, 09605002, Oct98, Issue 83

Section: NEWS

INTERNATIONAL

Frank Dobson is not a happy man. The UK Minister of Health’s reaction to approval of the anti-impotence drug Viagra by the European Medical Evaluation Agency (EMEA) in mid-September was something less than ecstatic. Estimates that Viagra could cost the country’s National Health Service between £ million and £150 million per year ($80 million to $215 million) have led Dobson to restrict the ability of doctors to prescribe the drug: “Media coverage to date has created expectations that could prove a serious drain on the funds of the NHS. I cannot allow this to happen.”

No doubt, one thousand miles to the south the pharmacists of Andorra are equally disappointed by the EMEA’s decision. Before the Agency cleared Viagra for sale in the European Union, the tiny Principality was the only place in western Europe where people could buy the drug. And they did, in huge numbers. Says David Betbese of patent and trade mark agents SPI: “The queues of cars driven by prospective purchasers of Viagra coming from both France and Spain have been incredibly long.”

Andorra is no stranger to consumer tourists. Although its permanent population is a mere 65,000, 10 million people visit every year, mainly to take advantage of the ski resorts and a duty free tax regime. Top of the incomers’ wish lists at any normal time would be electronic equipment, perfume and cosmetics, all available at much lower prices than in the north east of Spain and the south of France, the Principality’s main catchment areas. But the thousands who have been crowding the kilometre long main street of capital city Andorra La Vella in search of Viagra are not so concerned with getting a good price. They have been willing to pay whatever is necessary to get the product of their dreams. “Customers are being charged $490 for a container holding 30 Viagra pills,” states Betbese.

Given the demand for the drug in the United States, the rush of middle aged European men to Andorra comes as no surprise. Pharmaceutical industry analysts are predicting that Viagra’s manufacturers Pfizer can expect to make $1 billion worth of annual sales of the drug after 2000. Already Viagra accounts for eight out of 10 impotence prescriptions in the US, according to statistics released by research company IMS America. Yet, says Pfizer’s senior corporate trade mark counsel, Arthur Silverstein, the company did not treat the trade mark registration process for Viagra any differently than normal: “It was the same as with any other drug. We began registering in December 1995 in a number of European countries, in Latin America and in the Far East” The company now has well over 50 registrations for the Viagra trade mark and many other applications are pending.

The unprecendented global coverage given to Viagra means that Pfizer is having to deal with what Silverstein estimates as “many hundreds of infringments all over the world”. He says that these typically fall into three main areas: primarily in the US, there have been a number of cases where similar marks are being used on herbal remedies which claim to have the same effects as Viagra. Names used include Vaegra and Viagro; many companies have also used the Viagra mark and images of the trade dress in promotional material designed to imply a connection between the advertiser’s products and the perceived properties of the Pfizer drug; and finally many organizations are using the Viagra brand name, or a similar one, on products totally unrelated to pharmaceuticals.

Silverstein confirms that it is his company’s policy to clamp down aggressively on anyone who infringes the Viagra name: “Viagra is an extremely valuable trade mark. We have invested a lot of time and money in its research and development, and the Viagra brand has a great deal of goodwill. It is a serious medicine for a serious medical condition.” Often, he says, problems occur because people are ignorant of trade mark law. In such cases, the activity stops very quickly once Pfizer gets in touch. But, Silverstein confirms, a few legal actions are pending against others who he sees as deliberate infringers.

Paul Walsh, head of the brands group at London firm Bristows, believes that the Pfizer strategy is exactly right: “It is vital to have a vigorous trade mark enforcement policy. It keeps the competition off your back and it also prevents your product becoming genericized.” To do this the company must be seen to crack down on infringement in all its forms. And it is genericization, Walsh stresses, which Pfizer will fear most: “The company is first on to the market with an impotence treatment of this type and they have a major opportunity to establish brand loyalty before the patent expires.” But if the name Viagra becomes associated with impotence treatments in general, that would not be possible and the company’s market share in the area would be considerably reduced. “Pfizer’s over-riding objective,” says Walsh, “will be to use its intellectual property rights to stay in pole position.”