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Posts with tag BigPharma

Lobbying the feds don't come cheap

The American Association of Diabetes Educators has spent big bucks this year ensuring its point of view gets across to our representatives in the federal government. The AADE spent $375,000 on lobbying in just the first half of 2007, according to a Senate disclosure form that has been picked up by the media. The law requires that such disclosures be made public. Members of the organization include big Pharma names like Eli Lilly, Novartis and Merck.

The AADE is, obviously, a member organization for diabetes educators, with advocacy in Washington - for professionals and patients - coming as an additional service. The government-run site Healthfinder lists more about the AADE if you're interested. Given the amount of money involved, I'm surprised how little attention this has attracted on the Web. Many news services have featured the disclosure, but only in brief. What I'd like to know is: what issues were the AADE lobbying for and against?

Glaxo touts diabetes wellness plan for employees

Pharmaceutical giant GlaxoSmithKline has announced an initiative designed to improve the health of employees with diabetes. Yes, the company's head honchos decided they would take the bull by the horns: if employees have difficulty taking care of their health, they determined to find out why and correct the problem. Result: an internal analysis of healthcare spending within GSK.

Turns out diabetes was one of the biggest problems for Glaxo employees. Glaxo's number-crunchers found the company spends more on diabetes medications, but less on medical care, than the national average. GSK's report states the company spent a total of $26.2 million on diabetes treatment for employees in 2005. Glaxo has now launched what it describes as a multilateral plan to address the needs of employees with diabetes. Leading the charge: a patient education campaign ("Know Your Numbers") and a physician intervention program.

Says Glaxo's US benefits chief, Michael Killian, "As a nation, we are seeing our healthcare costs soar and patients' health decline due to chronic diseases such as diabetes. GSK faces these same challenges and is prepared to meet them." Translation: prevention, prevention, prevention.

Glaxo figures there is nothing to lose, but lots to gain. Healthcare plans for employees already cost a bundle. By targeting the health issues that are hurting employees the most, the company can give those employees a better life and save a lotta money. In addition to making the results of its internal analysis available to the general public, Glaxo has invited other employers to utilize this same approach.

CNN coverage of diabulemia is bananas!

I'm outraged at the coverage CNN provided on diabulemia. They accuse diabetics who suffer with the condition of doing the wrong thing. CNN neglected to address the cause of diabulemia. The drug all insulin dependent diabetics must use is a synthetic hormone that has been genetically modified. It is nothing like human insulin or any natural vertebrate insulin, for that matter.

The fact that 1 in 3 diabetics choose to take less insulin is not because they wish to eat more food. It is a reaction provoked by an inadequate and dangerous genetically modified drug. The reason a diabetic would take less insulin is to avoid experiencing the unnatural side effects the insulin is causing. CNN sensationalized diabulemia and put a damaging veneer on the victims without fully researching the facts. Genetically modified insulin does not penetrate the blood-brain barrier like natural human insulin. Genetically modified insulin distorts hormone responses to hunger. Genetically modified insulin does not protect diabetics from entering ketoacidosis when their blood sugar becomes too high. An inadequate drug causes diabulemia. Accuse the drug manufacturers of making the wrong choice. Or is that biting the hand that feeds you?

Make it right, CNN. Mass media should be the defenders of righteousness, not the accomplices to Big Pharma. Do a study comparing human insulin (natural vertebrate insulin) and genetically modified insulin. The comparison should include: penetration zones of the body, hormonal reactions stimulating and suppressing hunger, amino acids, c-peptide, lipophilic and hydrophilic nature, and pH values. The difference in natural human insulin and Lantus pH is remarkable: 7.5 to 4.0. How similar is that? CNN you've slipped on the peel and missed the facts. Now perform your due diligence to help make it right. I ask every insulin dependent diabetic to email CNN and ask them to put the facts on the line. Link to this blog so they have an idea of where to start. Thank you!

Why is hindsight 20/25 in diabetes?

Bev did a great job covering the study of obese mice having protection from elevated blood sugar due to a plethora of adiponectin. Adiponectin was shown to enhance insulin signaling which transported the excess glucose to less harmful areas of the body, rather than the cells which would endure diabetes complications. The results of this study created a condition called ratones mórbidamente obesos - which sounds better in Spanish because in English this means morbidly obese mice.

You know what they say about hindsight, right? A study from a year ago revealed some good news and some bad news. Good news first - turns out Type 2 diabetes drugs using troglitazone increased adiponectin. Rezulin was one of these drugs, but it was removed from the US market March 21, 2000. Now the bad news, the Type 2 diabetes drugs made with metformin were shown to reduce adiponectin. A few of the drugs that use metformin are Fortamet, Glucophage, Glucophage XR, and Riomet.

So why must diabetics be led with imperfect vision? Because the bottom line is researchers and doctors believe they are saving lives every day. Yes, they do. But there is a lot to behold when you tinker with His design. Remember the movie Malice? These lines don't make it into movies for nothing. Producers know human nature and they stretch it to the extreme. Whether or not you want to admit it - you know a few people with a complex like Alec Baldwins. Alec Baldwin says, "You ask me if I have a God complex. Let me tell you something: I am God". Click for the entire 1:30 scene, courtesy of YouTube.

Insulin pens cheaper, better than shots

Drug War '07: drug giants Novo Nordisk and Sanofi-Aventis have been sparring recently over their insulin pen designs. Novo alleges Sanofi has stolen its design ideas, basically. Check out Bev's post on this to learn more.

The reason it's such a big deal to them is money. The insulin pen could be super-lucrative for investors. Meanwhile, here's some news that's bound to get big pharma even more excited: a new study reports that insulin pens are cheaper and more effective than insulin shots.

Why so good? Fewer trips to the emergency room and fewer visits to the doctor. Insulin pens boast a pre-measured dosing system, with each dose of insulin contained in a single, disposable cartridge. This eliminates the risk of over- or under-dosing, says senior author of the study, Dr. Rajesh Balkrishnan of Ohio State University in Columbus. The researchers say that study participants who used an insulin pen instead of a regular syringe ended up reducing their annual healthcare costs by nearly $17,000. Wow.

What I'm not clear on here is whether or not they factored in the added expense of upgrading from syringes to insulin pens.

Want to know more? The study has been published in the latest issue of Clinical Therapeutics, but you can click here to read a summary.

Novo rides high as new type 2 drug results roll in

Shhh. Big Pharma scientists hard at work. On what, you ask? Why, on Novo's new "baby" - a drug designed to treat type 2 diabetes. Liraglutide, a hormone analogue, is supposed to improve blood sugar control. It's also supposed to get you that coveted magic bullet (a la Byetta): weight loss. Ooh, baby. Now that's medication!

Novo Nordisk has been working on Liraglutide for a while now. Here's the latest: Novo announced Monday that two Phase III studies were successful in demonstrating the aforementioned blood sugar control and weight reduction. Novo is riding high on the news: its shares rose six percent on the announcement. According to a pharmaceutical industry analyst quoted by Reuters, the shares surged so healthily because the positive news was expected.

The powers-that-be at the drug giant say they hope Liraglutide can be submitted for regulatory approval by mid-2008. They hope it will become another blockbuster, with estimated annual sales topping one billion. Stay tuned.

Oral-lyn has the big idea

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!

Exubera woes hurt outlook for other inhalables

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?

Funding boost for insulin gel caps

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.

My first hate mail

A little over 2 weeks ago I posted something about diabulemia on site where diabetics exchange their feelings, frustrations, and experiences with the disease. Two Type 1 diabetic women took the time to write me a very thoughtful hate mail. Hate is a strong word but these are some strong accusations. For starters, they said, "There ain't no such word as diabulemia. It's called diabetic stupidity." That is cut directly from the email, and as you can see - it was written with an arrogant disregard for the 450,000 people suffering from this serious condition.

I understand strong words come from passion. An email with the subject title "There's type 1, and then there are fools with type 1" could only have been composed with hateful passion. Within the passionate lines of this email were statements like "Insulin shock therapy was used in mental institutions (where you belong)." Not exactly nice words to come from a teacher - but again, the words were incensed with passion. Good, bad or ugly - feedback is terribly important to me because it conveys what matters to you. Knowing is half the battle.

By logging my experiences with diabetes on the web, these hate mailers refer to me as "You fool" for exercising my Freedom of Speech (First Amendment). To this I add -- thank goodness for the Freedom of Information Act. If I'm a Fool for sharing my experience with overcoming diabulemia and trying to lend consoling advice to others struggling with it - I'm a damn proud Fool! Hate on, haters!

Is this prediabetes in action?

Ever wonder what would happen to a non-diabetic's blood sugar if they loaded up on a pile of concentrated sugar, preservatives and weird science fats? Doctors and the ADA call it prediabetes. This clip takes it to the extreme by sandwiching the center of 16 double stuff Oreos! Sometimes you have to be insanely blunt to make your point.

This is a brilliant example of the diabetes epidemic in action. In today's world -- many people are eating for convenience without realizing the consequences. More convenient equates to less nutritious - more preservatives, more sugar and even more fattening (the wrong fats, too!) The combination increases the amount of time our digestive enzymes need to work on these lab-derived ingredients. This sustains an elevated blood sugar following the time of consumption. Add the ADA definition of pre-diabetes (a blood sugar between 140 to 199 mg/dl 2 hours after a meal) and there you have it -- a potential player on Team Diabetes!

Think what would happen if this guy was in his doctor's office 2 hours after this stunt. I'd like to thank his employer for keeping him busy (whatever he's paid to do) well after the lunch hour - and protecting him from becoming another statistic. Big ups to HR for hiring this guy!! If he's not in marketing already -- you might consider a transfer and give this guy a raise. He's my Oreo hero.

Let freedom ring

For those diabetics injecting insulin and getting frustrating results - this blog's you. I include in this group of frustrating results: hypo unawareness, diabulemia, lethargy, weight gain, erratic blood sugars, and missed periods (for the ladies) - these are all side effects people have experienced once beginning genetically modified human insulin. It so happens it is the only kind available in the United States.

Bev did a terrific blog on the Insulin Dependent Diabetes Trust and the difference a choice has offered me: more controlled blood sugars, lower blood pressure, less hunger and even a little weight loss - high five! But herein lies the problem - the choice is not easy to come by. Most doctors believe Big Pharma pushed genetically modified human synthetic insulins because it was better. However this, like the insulin analogues - was nothing but stellar marketing with lackluster scientific proof.

If any of those symptoms listed in my first paragraph kept you reading to this point - please ask your doctor to give natural animal insulins a second chance. Do yourself and other diabetics a favor and request information to bring to your doctor by emailing enquiries@iddtinternational.org. The IDDT will send information on natural animal insulins. You may not be interested, but another diabetic may love the fact it will soon be a choice for them. Freedom of choice - isn't the Liberty Bell appropriate here?

Damning FDA report confirms Avandia risks

The beleaguered US Food and Drug Administration (FDA) today released its review of the Avandia debacle. It contains a fairly damning assessment of what went wrong, one that implicates not only Avandia's manufacturer GlaxoSmithKline, but also the FDA itself.

The 436-page review confirms that Avandia does indeed increase the risk of heart problems, a claim that Glaxo has vigorously denied. (Can't wait to see how they respond to this.) The FDA reviewers concluded that the risk is also far greater than that posed by a similar drug, Actos, which is manufactured by Takeda. In addition, the FDA reviewers were dismissive of the studies conducted by Glaxo - studies that the drugmaker claimed provided proof of Avandia's safety. The report also restates the allegation that Glaxo tried to coerce a doctor into remaining silent about the risks posed to diabetics from taking Avandia.

The report goes on to find fault with the FDA's inaction and, by implication, its completely pathetic pandering to Glaxo. Now, even insiders are publicly saying FDA officials repeatedly put the interests of Glaxo above the interests, health and safety of consumers.

All-in-all, this represents a big victory for Glaxo/BigPharma's critics. It almost goes without saying that this report likely marks the end of the line for Avandia. Perhaps more significant could be the impact of the whole mess on the FDA. The review effectively highlights the shortcomings of the agency for all to see, greatly strengthening the hand of its critics - both in and outside government - who are calling for major reforms there.

Click here to read more.

Stay tuned for news of the advisory committee hearing on Avandia, which is scheduled to be held Monday.

SFDA Official executed for accepting bribes

Former head of the State Food and Drug Administration (SFDA), was executed for taking bribes in return for approving the use of certain medicines. No, you didn't miss anything. The SFDA to which the news story refers is in China. At ease, boys- you're all safe (for now).

Mike Adams of NewsTarget explains in his cartoon that the FDA is a clear and present danger to the health and safety of the American people. The agency is so deeply entangled in protecting drug company profits and corporate interests that it has utterly abandoned its mission of protecting the people. In fact, bribery is routine in the United States drug approval process. A policy exists that allows FDA decision panel experts -- the people who decide which drugs to approve or reject -- to accept up to $50,000 in bribes from drug companies and still serve on such decision panels.

What's really interesting about the press coverage of China's execution is that virtually no one has bothered to call for arresting and prosecuting corrupt FDA officials in the United States. We inherently trust everything we are told by our doctors and our elected officials - we chose them in the first place. It is not until we are awakened to someone else's problem, and realize that it is ours. The U.S. FDA is trustworthy, right? Our people would never stoop to accepting bribes - especially not the president elect for the American Diabetes Association, right?

Lilly for Life Awards

Eli Lilly has an award they give to people who have been diabetic for 25, 50 and 75 years. They call it the Lilly for Life Award. The award recognizes people who have been enslaved to the exorbitant expenses of diabetes management, in addition to the other schedules of daily life. Endearing isn't it? The award is a significant token of Lilly's appreciation for all you have endured and sacrificed.

Lilly awards people who have used insulin for 25 years with the monetary equivalent of what your diabetes management has cost. All your copays for each bottle of insulin, each box of syringes, each blood sugar testing strip, and your ability to adapt to the ever-changing technology of diabetes care (I swear, it says that in block letters) - Lilly awards you $42,500!! I told you I lived in the land of milk and honey. ACTUALLY - it's a medal and a consent form to have your face exploited in Big Pharma marketing. You should've bought the stock! The shareholders of LLY paid approximately $1.75 per share 25 years ago, when you were diagnosed. Today that share is worth approximately $56. Anybody know the math on that return? It's probably around 3,000%.

Let's go back to that statement ever-changing technology of diabetes care. Why must it be ever-changing? Doesn't that sound a lot like never-ending? We need not spend too much time on identifying how to treat this disease when we've got that down. What we need to do is spend more time and energy on preventing the disease from happening in the first place. That is what I consider achievement. Achieve that, Lilly! And by the way - I'll take 3,000% of my $42,500 while you're at it. Thanks.

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