October 2011 Archives

Bullying. Drug use. Increasing STD rates. Sound like high school? Guess again. Those are all problems on the rise in retirement communities. And not surprisingly, Viagra is largely responsible for the last one.

Thanks to Viagra and other treatments like hormone therapy, more seniors than ever can now enjoy active (and we mean active) sex lives well into old age. In retirement homes and senior-centric communities, many residents may have lost a spouse, or are divorced, and seek out companionship from their neighbors. And more and more are making use of online dating sites.
 
Nothing wrong with that, and more power to them. Staying sexually active is a great way to keep your zest for life. But while those little blue pills have been a boon to silver-haired Casanovas, they've had some unanticipated health consequences for the senior population. Unfortunately, many seniors have had less basic sex education than the average teenager, and are less likely to take the sexual precautions considered standard these days.

Unlike those of us brought up post-HIV, they never got indoctrinated with Safe Sex 101, and may not be comfortable talking with a partner about STDs. They're past child-bearing age, so they don't need condoms for birth control. Plus, really, no one expects seniors to be passing around sexually transmitted diseases, right? Well, it happens - HIV rates in those over 50 have skyrocketed in the last decade, and the fact that diseases like chlamydia, herpes and HPV are spreading like wildfire in senior homes is a tip-off that there's some serious swinging going on. After all, the folks hitting retirement nowadays came of age in the Age of Aquarius - they're the free-love generation.

You probably don't even want to think about Grandma getting it on with one of her nursing home suitors. But if you have a loved one who's single and dating in their golden years - a parent, a favorite uncle, your godmother - you might do them a favor and delicately broach the topic.

Another suggestion: the next time you drop by the old folks' home to visit Aunt Marge, drop a a few condoms into the dish of hard candies on the coffee table, or sneak some in with the Sweet & Low packets in the cafeteria.

Pfizer has chosen Avon ad agency Adams & Knight to market Viagra in Africa and the Middle East. This conjures the image of ladies going door to door with boutique decanters of Viagra tablets, or Tupperware parties for ED drugs. Oh, wait. It's not the ad agency for Avon Products - it's an ad agency headquartered in Avon, Connecticut. Nevermind.

Viagra is hardly new to the Middle East, though. There's been a huge market for erectile dysfunction drugs in Arab states since the drug came on the market, and Saudi Arabia is one of the world's biggest consumers of Viagra. In fact, some figures say that Arab men have one of the highest percentages of impotence in the world - about 10%, and half of the men over 40 in the United Arab Emirates have some degree of erectile dysfunction. The reasons: a lot if it is stress and bad lifestyle choices.

An article in the International Journal of Impotence Research noted that Viagra is "highly effective in individuals from developing countries with cultural, racial, and religious characteristics differing markedly from those of the United States and European countries" where Viagra was developed and initially marketed. Not sure why it wouldn't, since sildenafil works on a physiological level, no matter what your religious beliefs.

Marketing Viagra, on the other hand, does have to take regional and religious culture into account. Muslim societies are conservative, and any suggestion of sexual content is unacceptable. Advertising has to be a lot more coy, and even tame US prime time ads, with smiling middle-aged couples cutting a rug, would be out.

Reem Nouh, the new head of Pfizer's Viagra campaign in the Middle East and Africa, has her work cut out for her, but apparently she's well qualified - fluent in Arabic, lived and worked in the Middle East, and has lead many successful pharma accounts in the same countries. Apparently A&K has already started rolling out the campaign, but press releases are vague on the details. We'd be interested to see what approach they're taking to raise Viagra's already high profile.

Teva Pharmaceutical, who challenged Pfizer over their Viagra patent, got spanked yet again, and is now on the hook for nearly $400,000 in legal fees to be paid out to Pfizer.

In Teva's original claim against the larger drug maker, partway through the case they tried to introduce the accusation that Pfizer engaged in "inequitable conduct" - pulling the wool over the US Patent Office's eyes - in order to get the Viagra patent approved. It was a hail mary pass that didn't go over well with the judge.

After the US District Court ruled against Teva, Pfizer went after them with a bid to collect legal fees on the basis that Teva's claims were baseless. Teva, having come so far in taking on a pharmaceutical giant, didn't back down, and instead upped the ante. They countered that, not only were their claims not baseless, but Pfizer's actions constituted "egregious misconduct".

The Court, however, did not buy it, and instead ruled that Teva was trying to take advantage of a loophole in another recent drug patent decision (Therasense v. Becton Dickinson), a ruling that was, ironically, intended to prevent frivolous claims.

You would think at this point Teva would cry uncle. But no, they're going back for more, and have not only filed an appeal of the decision squashing their original case, but also plan to appeal the award of legal fees to Pfizer.  Maybe they feel they have nothing to lose, but it kind of reminds me of that definition of insanity: doing the same thing over and over and expecting a different result.

As we've noted here before, Viagra doesn't work for everyone who suffers from erectile dysfunction. In fact, some ED has proven downright drug resistant - some men who have take Viagra don't get the desired results.

A team of doctors has devised a treatment method that may help with these tough cases. The procedure involves inserting stents - small mesh tubes - into pelvic arteries to keep them open and increase blood flow. Although Viagra's action dilates blood vessels, if the vessels themselves are blocked enough, circulation will still be compromised and the blood won't get to where it needs to go. Implanting stents had a positive effect for 20 out of 30 patients who had the procedure, which is an impressive success rate.

If you're heard of stents being used before, it's most likely been in relation to heart surgery, since stenting is most commonly used to open blocked blood vessels around the heart. The medical company, Medtronic, that is sponsoring the studies, won't comment on the design of the pelvic stents as compared to the heart stents they make.

Doctors involved in the study are quick to point out that this is very preliminary and experimental research, and the stenting procedure is not intended to be a substitute for Viagra or other ED drugs. "We see this as an adjunct to current therapy," said research head Dr. Jason Rogers. "We can't recommend that doctors start doing this."

It doesn't sound like this is an operation that will make Viagra obsolete, especially since there are various causes of ED. But for some people, it might get things moving down there enough for the drugs to do their job. 

Anybody who has an email account has encountered Viagra spam at one time or another. But now it's becoming an increasingly common, and annoying, problem on Twitter.

Given that Twitter has been around for over five years, it's surprising that spamming isn't more prevalent. Twitter has been pretty diligent about deactivating bad accounts, but spam is like a hydra: you chop off one head and two more grow back. And spammers have started stepping up their game - co-opting popular hash tags like #iranrevolution, "tweet-jacking" @usernames, hacking accounts. They also take advantage of the Twitter convention of shortening URLs through services like bitly, effectively disguising the true nature of a link until it's too late.

Some whiz kids over at the University of Akron's Department of Computer Science did some fancy research using data mining techniques to develop a method of identifying and filtering tweeted pharma spam. A high proportion of the spam they found was related to (surprise) Viagra. They reported a new Viagra related tweet every 30 seconds, which very informal observations will confirm as a reasonable, even conservative average. Of the V tweets I saw, about 80% were spam.

One repercussion of this flurry of spam, as a blogger at PharmTech points out, is that it poisons the well for pharma companies who want to employ social media to legitimately engage with users. What? You're not following @pfizer_news?

Yahoo Mail has launched a slick new data visualization feature that shows what keywords are trending in email across the whole Yahoo network. I haven't quite figured out how to use it, but it's still fun to look at.

The folks over at Fast Company's Co. Design were pretty quick to apply their interpretation to the ever-changing river of data: "Note the presence of 'vaga'--presumably, that's a wave of spam about viagra that's striking out across the network". They then go on to extrapolate that the variations on the spellings of Viagra must number in the sextillions, fittingly enough.

Another fun figure: every second, hundreds of thousands of new Yahoo mail accounts are created. For what ends? Probably to put out more spelling permutations of Viagra. And so the cycle begins anew.

Protesters have been gathering in cities across the U.S. and around the globe to voice their displeasure at economic injustice, targeting Big Money: Wall Street, Big Banks, the Super Rich and now...Big Pharma?  Last week a group of about a dozen protesters picketed outside a Pfizer plant in Groton, Connecticut. Are all those jokes about "economic Viagra" for the flaccid job market more literal than we thought?

The protesters say that Pfizer moved into Groton, took advantage of local and state tax breaks, and now that the tax advantage has expired, they're moving thousands of jobs out of state or overseas. Pfizer's also been laying off thousands elsewhere, while the company last year claimed $8 billion in profits, and it's CEO claimed a sweet raise.

So far protesters have mostly focused on big financial institutions, but the general anti-corporate sentiment is growing, and with issues in healthcare inequity in this country, it seems inevitable that the movement will take aim at Big Pharma for taking big profits. Pfizer might want to get their PR people thinking about proactive ways to deflect some of the criticism. Maybe the 99% would appreciate some free samples of Viagra, to keep up their...spirits...during those long days and nights of fighting for the cause.

It's well established that Viagra can affect some people's eyesight - blurred or bluish tinged vision is a known side effect of the drug. Not a common one, but it happens. But anecdotal evidence and some preliminary medical studies indicates that Viagra may affect hearing as well.

An article published earlier this year in The Laryngoscope cited 47 cases of sudden hearing loss associated with Viagra or other PDE-5 inhibitors such as Cialis or Levitra (with the change in hearing occurring within 24 hours of the patient having taken the drug). Over 200 other cases were reported but not included in the study due to lack of detail. Average age of those experience hearing loss was 57. The majority lost hearing in one ear only. (It was also reported that the ratio of male to female patients reporting hearing loss was 7 to 1, but it's hard to know the significance of that given the fact that not many women take Viagra).

Doctors don't know how these drugs might cause hearing loss, but one theory is that increased blood flow to the inner ear damages tissues. This seems plausible. The same increased circulation and dilation of blood vessels that causes headaches and a sense of pressure in the head is blasting blood into the delicate tissues of the inner ear. Or it could be some other physiological process. And although the reported cases involved sudden and dramatic loss of hearing, it seems it could also be possible that a regular Viagra user might experience less noticeable and cumulative hearing damage over time.

There's no conclusive evidence that Viagra or similar ED meds directly cause hearing loss. The connection between the meds and hearing loss in these cases was temporal - meaning it happened soon after the drug was taken. All doctors can say is that "further research is warranted," and that patients should be warned about this potential side effect. But if you're a regular user of an ED drug and you're over 40, it might be a good idea to get your hearing checked periodically.

The U.S. Central Intelligence Agency has been known for its, er, ingenuity, from using heavy metal music for psychological warfare, to creating spy kitties wired with listening devices to infiltrate Soviet embassies. The agency has also never shied away from using drugs to achieve its ends, and in the '60s supposedly dosed unsuspecting subjects with LSD for 77 days straight in some kind of mind control experiment.

Given this history, it's not surprising that the CIA would also put Viagra to use to reach military intelligence objectives. The U.S. needed some leverage to gain the trust and loyalty of tribal leaders in war-torn Afghanistan, but cash and showy gifts were too conspicuous. Sex always has universal buying power, but when you're dealing with fundamentalist Muslims, offering prostitutes is out of the question. Then someone came up with the bright idea of passing out Viagra. In a tribal system where procreative abilities are key to power and influence, the magic blue pill could be gold.

Of course, it didn't hold the same appeal for everyone, but it had its specific applications:

"You didn't hand it out to younger guys, but it could be a silver bullet to make connections to the older ones," said one retired operative familiar with the drug's use in Afghanistan. Afghan tribal leaders often had four wives -- the maximum number allowed by the Koran -- and aging village patriarchs were easily sold on the utility of a pill that could "put them back in an authoritative position," the official said. 

Wonder if Pfizer has a contract as a supplier to the Dept. of Defense.

So what name do you think the agency assigned to this scheme? We went over to the Random Military Operation Name Generator and came up with a few that might have been suitable:

Operation Eternal Missile

Operation Congested Omar

Operation High-pressure Fatwa

Operation Piercing Beaver

Operation Sore Lover

Operation Engorged Python

Operation Ejaculating Turban

Can you OD on Viagra? What happens? Has anyone ever died from a Viagra overdose?

You can get too much of a good thing, and that includes Viagra. For most people, the recommended dosage of 50mg or 100mg suffices, and they have no reason to take more than that. It's not advisable to take more than 100mg in a 24-hour period. And if the recommended dosage is working for you, why waste the pills?

But there have been cases reported of men taking excessive doses, and suffering the consequences. Viagra is sometimes abused recreationally by younger guys who don't have ED, and used in combination with other drugs, like ecstasy. In those situations, folks may be altered or drunk, and aren't aware of (or don't care) how much they're ingesting. Like Tom Kaulitz, the 20-year-old guitarist of German rock group Tokio Hotel, who overindulged during a tour of Asia after getting the tablets (and probably a few other things) from a drug dealer. Not exercising the best judgment, he popped several pills and woke up with a killer headache and blurry vision that lasted two days.

All things considered, he got off easy, unlike the Russian dude who supposedly downed a whole bottle to fuel a 12-hour sex marathon with two women, with a $4300 wager riding on it. He made it through the 12 hours, then promptly had a heart attack and died. He was 28. Medics said it was likely the excessive Viagra killed him. A bottle of Viagra has about 30 100mg tablets, so that would be 3000mg. I'm surprised his head (or another body part) didn't just explode first.

In laboratory settings, researchers have given people up to 800mg of Viagra, and they survived, but that was in a monitored clinical setting. And I'll bet those guys weren't having much fun. Too much of the drug can cause your blood pressure to drop dangerously. Symptoms of a Viagra overdose can include headache, blurred vision, nausea, dizziness and fainting, and irregular heartbeat. And there can be worse effects, like heart attacks and strokes.

So don't go overboard trying to fuel any record-breaking sex sessions, or the only thing that's going to be pounding is your head. Taken in normal quantities under a doctor's supervision, Viagra is a safe drug. But if you do suspect you've ingested too much Viagra, or are having a drug interaction, get medical help immediately.

Medicare - the U.S. government's health plan for people over 65 - does not cover Viagra or other erectile dysfunction drugs, such as Cialis.  At least, not anymore. In 2006, something called Medicare Part D went into effect, stating that a medication would not be covered "when used for the treatment of sexual or erectile dysfunction, unless such drug were used to treat a condition, other than sexual or erectile dysfunction, for which the drug has been approved by the Food and Drug Administration." 

Medicare does cover Revatio, which is the same drug (sildenafil) as Viagra, but comes in different doses and is used to treat pulmonary arterial hypertension. To prevent abuse of this allowance, there are supposed to be auditors verifying that the patients actually have a diagnosis of PAH.

Interestingly, Hurricane Katrina was ultimately responsible for the loss of the Viagra coverage. Congress voted in 2005 to discontinue covering Viagra, and use that money to fund medical care and unemployment benefits for hurricane victims. However, despite the restrictions put in place, it came to light earlier this year that there had been a little slip up between 2007 and 2008, when Medicare accidentally paid out $3.1 million for Viagra and other ED drugs. Medicare administrators blamed it on a software error.

In the news recently, a second defendant was charged in a case involving trafficking in counterfeit Viagra - on Craigslist. Now, Craigslist is a great place to find a used lawnmower, to apartment hunt, job hunt, or try to find that special someone who shares your passion for dressing up like an Oompaloompa. But for buying Viagra? Not so much. So who do you think is dumber - the folks who try to sell Viagra (real or fake) through Craigslist, or the people who buy it?

As for this guy who was just put away, when his partner placed an ad on Craiglist to sell the bogus pills, he commended her on "taking the initiative to ... generate sales" - and with nearly 50,000 tablets, they had some product to move. But he also recognized the risk of getting caught, and sure enough, Pfizer spotted the ad and called in some undercover agents.

A quick search of the SF Bay Area CL yielded dozens of ads selling some version of V. Most of them make no attempt to be subtle. It's obvious there's prostitution happening on Craigslist, but the escorts and Johns have the sense to use some kind of code, even if we all know what "100 roses" means.

As for buying Viagra on CL, that's taking a huge risk with your health (not to mention illegal). Pfizer recently issued warnings about the dangers of counterfeit drugs, and not for no reason. "People who buy pills from strangers over the internet have no idea what they may be ingesting," said U.S. Attorney Rod J. Rosenstein. We would hope that would be obvious, but apparently it's not obvious enough.

I'm confused about the relationship between Viagra and strokes. Can Viagra cause strokes? I heard that it could be used to treat them.

While it's documented that use of Viagra is associated with an increased risk of heart attack, stroke, or transient ischemic attack (a mini-stroke), the causal relationship isn't clear. The correlation doesn't necessarily mean that the drug per se caused the heart attacks or strokes. It may be that men who are more at risk for those events are also more likely to use Viagra. Their erectile dysfunction may be a symptom of a more serious underlying condition. Or, if they were already at risk, it may be that the physical exertion and elevation of blood pressure during sex precipitated the heart attack or stroke. This is why it's so important to consult with a physician and review your medical history before taking Viagra, or any drug.

On the flip side, it's true that for several years, doctors have been researching the use of sildenafil to facilitate stroke recovery. Note that the drug is used to treat damage to the brain after a stroke - it's not used for stroke prevention. In laboratory settings, Viagra has been shown to aid mice in recovering from stroke damage, by helping regrow brain cells. And there have been reports of the drug being used successfully to treat human stroke victims. In a particularly dramatic case, a woman with "locked in syndrome" - paralysis so complete she could only move her eyes up and down - was able to move all four limbs and make facial expressions following treatment with sildenafil. Her doctors seemed a bit reluctant to definitively credit Viagra for her remarkable recovery, but it's been established that the drug can assist in neurological regeneration. The mechanism involved in sildenafil's effect on brain tissue is unrelated to those that make the drug effective for treating erectile dysfunction and hypertension.

There are a variety of risk factors - genetics, lifestyle, diet, as well as medications - that are associated with strokes. As always, talk to your doctor about these risks before using Viagra, follow up on any concerns, and continue to get regular checkups while using the drug. 

Last Thursday Pfizer and the National Association of Boards of Pharmacy teamed up to issue a warning to the public about the dangers of counterfeit drugs, and launched a website and a series of YouTube videos to educate consumers. Since Pfizer stands to lose millions in sales due to counterfeiting, this might seem like a self-interested campaign, but there are absolutely real and serious health concerns associated with fake prescription medications, and Viagra is a common target for counterfeiters.

Counterfeit drugs aren't just sugar pills made to look like the real deal. Some would be a lot less dangerous if they were. Counterfeits may contain the actual drug they purport to be - but it could be too much, too little, or another drug altogether, so it's impossible to know if you're getting a correct dose of medication. This is illustrated by the recent bust of a counterfeit Viagra ring.  You might expect the real drug content to run low, but in this case, analysis showed that the tablets contained 8 percent more sildenafil than genuine pills. For a 50mg tablet, that would work out to 4mg, which might not seem like a lot, but it's hard to say what effect that could have. 

Then there's everything else that makes its way into these imposter meds. As you can imagine, quality control is not a high priority for these folks: "Counterfeit medicines are often produced in unsanitary conditions by people without any medical or scientific background," said Patrick Ford, Pfizer's head of global security in the Americas. The medications are cut with unidentified fillers and may be contaminated with heavy metals and toxins, including rat poison. 

Pfizer's message is an important one: When it comes to prescription medications, the only way to be sure that you're getting a safe product is to acquire it from a reputable source - i.e. a licensed pharmacy, whether it be brick-and-mortar or online.

After being challenged by another drug company, Teva Pharmaceuticals, Pfizer's successfully defended their patent on sildenafil as a treatment for erectile dysfunction. The patent is set to expire in 2019.

Pfizer's original patent on the compound sildenafil will expire next year. Because Pfizer held two different patents for the drug, Teva tried to make the case that the company "double patented". However, the judge ruled in favor of Pfizer's argument, which hinged on the serendipitous circumstances that lead to the discovery that sildenafil could be used treat ED. Pfizer argued that it would not have been apparent to "anyone skilled in the art of drug development" that sildenafil could be used as a treatment for ED.

Its effectiveness as an ED treatment was discovered accidentally during trials of the drug for heart conditions, when men taking the drug experienced spontaneous erections. It seems fair to say that no one would have seen that coming. However, realizing the potential there, Pfizer jumped on it and developed the drug as a treatment for ED. For that bit of foresight, they get to hang onto their patent of the drug - as a treatment for ED - for a few more years.

However, Pfizer's patent Revatio, sildenafil used to treat pulmonary hypertension, is expiring next year. Since this is close to the purpose for which sildenafil was originally developed, we can assume that anyone skilled in the art of drug development could have conceivably figured that out on their own. So Pfizer's probably going to have to let that one go. And when Revatio does become available in a generic form, we can expect that some doctors will prescribe it "off-label" for the treatment of ED.

It will be interesting to see what happens when Revatio goes generic. How will that impact Pfizer's sales of Viagra?

Meanwhile, Pfizer has just filed a suit against Teva Pharmaceuticals to halt sales of their version of generic Viagra in Russia.

Teva has challenged a number of other Pfizer patents, including one for the heartburn drug Protonix. The Viagra victory was a major one for the larger company, and doesn't bode well for Teva in the ongoing legal battle. Teva may be sorry they ever tried to take the pharmaceutical giant down.

You may have recently seen a news story about a Massachusetts teenager who ordered a barrel for his paintball gun and received a box of Viagra and porn instead. The story raised a lot of eyebrows, and a lot of questions. Obviously this was a mix-up, but what is a paintball company doing selling Viagra? And are online Viagra sales so unregulated that the drug could accidentally get into the hands of a 14 year old?

While it sure made for some sensational headlines, most of the reports were completely misleading. To set the record straight, the teen did not in fact receive actual, pharmaceutical Viagra. It wasn't even generic Viagra. A photo of the contents of the parcel shows three boxes of a male enhancement formula - so-called herbal Viagra - as well as some erection-enhancing oil marketed under the same brand, some pheromone spray, and a DVD of some sort.

Apparently the paintball company wasn't directly responsible for the goof, either. As this story reports, the paintball business, like many online stores, uses a product fulfillment service - with a warehouse full of thousands of other products - to ship out their orders. The company that sells the male enhancement pills happens to use the same service, and a mailing label got put on the wrong box.

So why does this matter? Well, for one thing, the inaccurate reporting blurs the distinction between Viagra - a prescription drug with medical applications - and questionable "male enhancement" products. They're hardly interchangeable. Also, a story like this give an impression that online pharmacies, especially those that sell medications like Viagra, are sketchy and unregulated - to the point where they could dispense the drug to a teenager - and that a small sporting goods company or any other Joe Schmoe with an online business could have a sideline selling Viagra, packing and shipping it along with their other products. In reality, reputable online pharmacies selling genuine Viagra are well regulated, and when you order Viagra from one, you're ordering from a business that specializes dispensing pharmaceuticals. They may sell other drugs as well, but that's all they sell. Well, maybe pill splitters, too.