I don't mind high sugars as much as I loathe lows. Personally I'm not so ruffled by shots either (but my liver begs to differ). However, in a message posted on The Islet Foundation, Pfizer reported that insulin-dependent diabetics declared they most hate taking shots. Was this the warm-up for the Exubera campaign? Here's a fact I support! A close second to this hatred is the hypos. Any diabetic will confess -- hypos are unforgiving. So what if you could catch two birds with one capsule?

I must reiterate the scientific genius behind the Oramed gel caps. The encapsulated insulin bypasses destruction in the stomach cavity. It reaches an entry point in the intestines where it reports for duty to the liver. This allows the liver to resume command of the glucose metabolism, just like Mother Nature intended. Whey you inject insulin - you are overriding the livers ability to monitor blood sugar and putting yourself in the line of fire for the dangerous lows. We all know this state of derangement too well. You won't find my lows picture on a milk carton if I happen to lose it, either.

Frequent episodes of hypoglycemia (even mild ones) force the brain to become accustomed to the low glucose. Unfortunately this also causes suppressed signaling of adrenaline, the livers last resort before dangerous lows. More specifically, the glucose transporters located in the brain cells are damaged from frequent episodes of hypoglycemia. So what was once the hypo threshold for the brain to signal adrenalin release becomes lower. Clinically, the result is hypoglycemic unawareness. Down with the shots, down with the lows and big ups with the future of diabetes control! Now we're getting somewhere.

The results are looking good for the first-round of human testing for Oral-lyn, Generex's flagship product. The oral insulin, delivered into the body through the oral cavity (with no deposit in the lungs), is as effective as injected insulin.

The efficacy of Oral-lyn for controlling blood sugar was decidedly as good as multiple insulin injections. The research found that regular insulin and Generex Oral-lyn had similar effects on lowering blood sugar in subjects with type 1 diabetes. The subjects received twice-daily insulin analogue for basal coverage. So this might rewind some of us old timers to the days long-gone where we could get by with two shots. Period. If Oral-lyn makes it to the local pharmacies - maybe mealtime corrections could be easy to swallow. Praise patient compliance!

On an even more impressive note - it looks like the mucosal membrane in the lungs is giving Exubera negative challenges to overcome. Perhaps Oral-lyn will come out looking a little more pristine in this capacity, since it doesn't go anywhere near the lung membranes. I'm not in favor of diabusiness - but for crying out loud - I'd like to see some companies start working for their money. Generex is one of those companies with the Big Idea!

Pfizer's bandwagon might be busted! Turns-out a study says inhaled human insulin, whether formulated as a powder or liquid, is more immunogenic than injected insulin.

Adverse effects of antibody formation have not been thoroughly investigated. But it was shown, comparatively, that inhaled insulin provokes more of an immune response than injections. Spitting is a dirty habit - but it's not good for nothing. The mucosal defense system is the body's primary line of defense against inhaled foreign matter - kind of like the MARINES of the human body. It is uniquely able to discern self from non-self bodies. So far - it looks like Pfizer's toker is a no go.

As I said before - the adverse events have not been thoroughly investigated. Until we know exactly what kind of mucosal revenge or pulmonary punishment lies ahead - I'd stick to the tried and true...subQ, for now. However the Generex Oral-lyn human trials are looking pretty promising. Stay tuned.

A year ago, competitors were out to produce their own versions of Pfizer's Exubera, the inhalable insulin. However, now it's clear that Exubera is a bomb. Yes, a slick new ad campaign might revive its fortunes, so don't count Exubera out of the race quite yet. But it's not likely to be the blockbuster product many thought it could be.

Now the fallout is hurting those companies that were scrambling to compete/cash in by producing their own inhalable insulins. According to a report in Forbes, those same companies are ready to beat a smart retreat. Meanwhile, they're trying to reassure nervous investors. Case in point: MannKind Corp. shares fell nearly ten percent on Monday after it was announced the company could take longer to line up a partner for its inhalable insulin, the Technosphere Insulin System.

Not only that, MannKind postponed the release of its second quarter financial report. Wall Street analysts downgraded the stock, saying its short-term outlook is "challenged" and cited disappointing sales of Exubera as a factor. The outlook could be even worse if it looks like insulin caps will make it to market. As I said in a previous blog on that topic, who wants to tote a bulky inhaler around if you can pop some capsules instead?

There's a story running on CNN Money about the progress of Oramed Pharmaceuticals' insulin capsule, which is currently under development. The capsule, taken orally, could provide a more convenient way for diabetics to get insulin than through shots. And popping a gel cap would, needless to say, also be more convenient than toting and blowing on one of those big old clunky Exubera inhalers.

In the quest to get its product to market, Oramed needs cash, and lots of it. Answering the call, a combination of private investors are putting up more than two million dollars in financing for the Israel-based company.

It's hoped the money will help to propel the insulin capsule through completion of Phase 1 (drug safety) trials by the middle of next year. Said Oramed CEO Nadav Kidron, "This investment marks a milestone for Oramed's stability, allowing the company to fully focus on its research and development efforts and complete its phase 1 product trials."

Stay tuned.

Remember back in 2006 all the buzz surrounding Exubera, Pfizer's inhalable insulin product? It was much-hyped by Pfizer and, let's face, the media happily joined in too, spreading the word that (as Pfizer would have it) Exubera would be wildly successful and make squillions of dollars for investors.

It didn't work out that way at all. Sales so far have topped out at around four million dollars per quarter, far short of the two billion projected before the product was released. Now, in a bid to lift lackluster sales, Pfizer is launching a major ad campaign for Exubera. Yes, the inhaler device is extremely indiscreet. Yes, long-term use of the drug itself could cause lung damage. Oh, and health insurers may not cover prescriptions for Exubera for those diabetics who want to try it. But I guess where there's a slick selling strategy there's a way...into the pockets of consumers, that is.

Which is not to say I blame Pfizer. The company has poured so much money into this product, does it really have a choice at this point? No. Also, it's entirely possible Pfizer could turn things around. This article by Arlene Weintraub for Business Week reminds readers that the drug giant had enormous success with its clever ad campaigns for Viagra and for the incontinence drug Detrol. Writes Weintraub, this new campaign will probably cost Pfizer big-time: we're talking tens of millions of dollars, but it will be worth it for Pfizer if it can reproduce that kind of success.

If at first you don't succeed - go straight to the patient's home. After a lackluster attempt to sell doctor's on prescribing Phizer's inhalable insulin, Exubera, the company has decided to begin running television and print campaigns to advertise directly to patients.

The ads will start appearing the second half of 2007. However the main contention from Congress and medical groups is that mass marketing to patients encourages excessive use of costly therapies. Exubera gained a reputation for being an over priced and not-so-discreet way to administer insulin. Doctors say the inhaler is unwieldy. Depending on a patient's health care plan, they can pay about $600 a year more for Exubera than injectable forms of insulin. Clinical trials have found the product can reduce lung function for some patients. Pfizer says the condition is reversible and is conducting a five-year study among users to monitor it.

Why the push, Pfizer? You seem hell-bent on making this one stick. The president of Pfizer's worldwide pharmaceutical operations says the television ads will target newly diagnosed diabetics who may not want to inject themselves daily. Patients who develop diabetes later in life may put off using insulin because of needle phobia. Fair tradeoff: I see your fear of needles and raise you $600 a year, a license to toke (in public), and maybe a little bruising on your alveoli. Puff, puff...give it a shot.

So the price of drugs just seems to keep on climbing. And sometimes I wonder if the sky really is the limit in terms of the prices we are expected to pay. I, for example, just filled a prescription and received a tiny bottle the size of a purse-pack-sized bottle of eye drops. And how much did I pay? $25. Yes, and that's with insurance. It's insane. But it's not happening everywhere. In western Europe, where publicly-owned, government-run health care systems are the norm, people are putting the squeeze on the big pharmaceutical companies.

Let's look at insulin. A while ago there was a kerfuffle in the UK when government advisers overseeing the National Health Service basically said "no, thanks" to Pfizer's inhalable insulin, Exubera. Too expensive, they said. Now, Germany. This week, the biggies - Eli Lilly, Novo Nordisk and Sanofi-Aventis - decided to slash the cost of their insulin products in Germany. Why? Officials from Germany's health ministry say the new fast-acting versions of insulin just aren't worth the money. That left Big Pharma with little option but to play ball anyway, by cutting prices by up to thirty percent. For Novo Nordisk, this means a projected loss of $14.5 million in sales this year, reports Bloomberg.com. According to this article, the German government is, in this regard, following in the footsteps of the UK and the US. In effect, this means trying to cut spending by carefully weighing the costs of specific drugs against their benefits, rather than just picking up the tab willy-nilly.

Bottom line? Market expert Mark Belsey says the big drug producers will have to adapt as the tide turns, spending a lot more time and money justifying the worth of their products. This new strategy, he says, will come at the expense of what used to be their main focus: creating and marketing fancy new mega-drugs.

Think that big old Exubera inhaler (pictured) is sorta comical? You're definitely not alone. I was surfing around trying to get a clearer sense of how Pfizer's much-hyped inhalable insulin device is doing. Are users liking it? Is it really easy to use? Etcetera. But I got sidetracked into reading about that inhaler. It's big, it's plastic, it's bulky. The insulin bong. Come on, admit it. You were thinking the same thing! Here are some of the choicest comments I came across:

Spotted on one message board: "As a pharmacist, my biggest problem with Exubera is that the delivery system looks not entirely dissimilar to a bong. I just don't see the conversation starter 'excuse me, I need to take a hit off of my insulin bong' to be a great opener."

On another board, one wag lists off what he/she considers Exubera's shortcomings. In addition to the fact that, yes, it looks like a bong, this reader also observes that diabetics "have to carry around enough bulky s**t as it is." Plus there's the fact that "Type II's can't afford it...unless they cut back on their food budget...but then they will lose weight...and they wouldn't need insulin."

On Diabetes Mine: the device "really is as bad as it looks in pictures. Worse, because the bulky 'white' plastic portions are not white at all, but that hospital-grade beige that reminds you of walkers and bedpans. An aesthetic nightmare, in the age of cool gadgetry...The funny thing was that the happy Exubera user in Pfizer's video must live in a city as tolerant or as jaded as San Francisco or New York, because not one patron even glanced over as he cocked and sucked on his medicinal bong."

Medical humor site QFever pokes fun at the device's arguably limited appeal with a satirical article describing how Exubera will be a practical alternative for "several diabetics." They missed a golden opportunity here by not zooming in on the inhaler for comedic mileage. What were they thinking?!

The final word goes to Drug Nazi (who I believe has now changed his moniker to Drug Monkey), who finds the Exubera inhaler reminds him of, er, something else entirely: "Oh Yeah...gimmie some of that sweet insulin lovin' baby..." (Oh, PS, if you visit this site, you have to read "Why does my prescription take so damn long to fill?) Happy inhaling.

What is all the diabetic buzz about these days? Byetta and Exubera are certainly two biggies. My intention is to tantalize your interest in these juicy topics and leave a little to the imagination. Don't fret, I have a direct route to the quickest answers to any burning questions about these monster topics.

Byetta is getting a lot of attention nowadays. It comes from a poisonous lizard, the Gila monster. So quite literally, it really is monstrous. But don't let that discourage you from looking into it as a potential enhancement to your diabetes management. Many people have been pleased with its appetite suppressing, weight reducing attributes. Call it a shot of heroism -- since you must take it by injection. Traditional drugs to treat type 2 diabetes tend to cause a surge in appetite and weight gain. Could Byetta be the brute force to reckon with these dispiriting effects?

Exubera, what do you have to say for yourself? You can start by bragging that over 90% of the patients who tested you in clinical trials have chosen to continue using you. So the question is does this stuff work? It sounds like the answer is a resounding YES. Exubera is the newest form of insulin to hit the market since the debut of insulin, around 1890 (but please, don't quote me). You inhale it! The common concerns for this delivery of insulin include: how accurate is the dosing? What will be the long-term effects on your lungs? How long does the inhaled dose last? Will it need to accompany injections of longer-acting insulin? View the dLife TV interview with Dr. David Nathan, of Massachusetts General Hospital, and Ed a type 2 diabetic who has used Exubera for 9 years.

dLifeTV clears the air with answers to some of the common questions about Byetta and Exubera. Watch dLifeTV, airing every Sunday evening on CNBC, 7:00 PM on the East coast, 6:00 PM Central time and every Sunday morning on DIRECTV channel 251 at 7.30 AM Eastern time zone.

Pfizer Inc. has pushed back the release date for its much-anticipated new diabetes drug, Exubera, an inhalable form of insulin. Exubera was to be released mid-summer - i.e. around about now. However, Pfizer now says it will not be out until September. The reason, says Pfizer, is the complexity of the manufacturing process for Exubera, which I guess has slowed production a little bit.

This is all to the disappointment, I'm sure, of those diabetics eager to try the product and see how it stacks up against regular old-fashioned insulin injections. Not to mention health professionals curious to see how well it works on their patients and how well their patients like it. Finally, it must be a huge disappointment for medical industry analysts whose bread and butter it is to guess and out-guess each other predicting how Exubera will do and who, I'm sure, are dying to see how it actually performs after all these months of speculation!

Six months after Exubera, the new inhalable insulin product by Pfizer Inc., received approval for release in the US, Canadian diabetics and doctors are still waiting. The Canadian government has not yet given the drug the green light for use in that country, and no one seems to know when that permission might come. According to the article I read on the topic, neither the company that markets Exubera nor the government will say when it might be available. When word does come, it will be through Health Canada, the country's healthy care organization.

The article also quotes Dr. Edmond Ryan, an Edmonton diabetes specialist who says of inhalable insulin: "I would say the majority like it. Others just shrug their shoulders and actually find it doesn't give as tight control as with injectable insulin."

Exubera, Exubera. What will become of you? That is the big question. Pfizer's eagerly awaited inhalable insulin device is nearing the market. For anyone following this saga, there is a must-read market analysis piece on Business Week's website. With the great title to boot: "From Pfizer, Irrational Exubera?"

The article looks at the big question everyone is asking about Exubera: will it be the blockbuster drug it's been hyped as? While Pfizer says it expects billions of dollars in sales (and the company is pouring millions into promoting the product), critics say it is an overhyped, overpriced product that could put some diabetics in danger of lung damage. Not to mention the device is the size of a county fair prize-winning squash! Who wants to suck on that in public?! Let alone tote it around. On the other hand, let's not forget it's big selling point: no needles. Yet critics maintain so-called needle phobia is not as widespread as Pfizer would have you believe.

If you check out this article, also take a look at the readers' comments at the end. There seems to be a fairly even split in opinion on this thing.

There's a report in The New York Times today about the growing market for diabetes drugs--and how that market grows as the so-called diabetes epidemic escalates. The article also touches on the positive spin-off in terms of money-making possibilities for the drug companies and their investors. (The market for diabetes drugs is now worth an estimated $15 billion, and that is expected to grow to at least $25 billion worldwide by 2001!)

The article is worth a look because it profiles the four diabetes-fighting drugs that are generating the most excitement these days. They are: 1. Byetta, 2. Exubera, 3. Galvus, and 4. Januvia. Byetta (pictured) is already available and comes in the form of an injection. Exubera is an inhalable insulin delivery device that will be released for sale in the US in July. Galvus and Januvia come in the form of pills and are expected to arrive on the market next year.

The reason there is so much excitement surrounding these drugs is that they are relatively hassle- and pain-free to use and, best of all, they help treat the underlying causes of diabetes. Anyway, this article gives a handy overview of what all the fuss is about - check it out!

The controversy continues in the UK over the introduction of the inhalable insulin product Exubera from Pfizer Inc. Well, really the source of the controversy is not the drug itself, but the fact that those who oversee treatments dished out by the nation's public health system (the National Institute for Health and Clinical Excellence) think Exubera is a big old waste of precious cash. The public health service people (although not all of them, by any means) say why waste money on a new-fangled insulin delivery method when the old-fashioned insulin shots are perfectly effective if they are used correctly. And anyway, they say, why should our taxpayers help line the pockets of Pfizer, which plans to charge a pretty penny for Exubera? Finally, they argue that there is no evidence to back up Pfizer's claim that Exubera will be more effective than using shots simply because it will be easier to use and pain-free.

The latest development is that the National Institute for Health and Clinical Excellence has backed off a little and has said the system will pay for Exubera to be given to diabetes patients who have a proven phobia of needles. While I hate to see the pharmaceuticals industry make mega-bucks, I don't see why you should have to have a proven phobia to get this drug. I actually suspect Pfizer may be correct in its claims that access to inhalable insulin will increase treatment compliance amongst diabetics. Bottom line: tons of people out there hate using needles. No, they may not have a diagnosed phobia about it, but aren't they entitled to the least painful treatments out there?