Ever heard of MedCo Health Solutions? It's not a household name like the big pharmaceutical companies Novo, Glaxo etc. However, MedCo, which happens to be in the prescription benefit management business, is a large and powerful company. Now it's about to become even larger: the company is poised to pay $1.5 billion for PolyMedica Corporation, the nation's biggest supplier of diabetes-related products.

According to a Forbes report on the deal, PolyMedica has nearly one million patients using its products. Its product line includes Liberty Healthcare brand, blood glucose test kits and meters, lancet kits, insulin and the like. The Forbes article says the move is basically a smart one on the part of MedCo: it can cash in on the growing demand(14.5 % growth, annually!) for diabetes supplies. MedCo's chief exec, David Snow, told Forbes he anticipates the purchase could make his company (indirectly) the supplier of diabetes treatment products to half of all insured Americans with diabetes.

Factoid: ads for PolyMedica star "Cocoon" and "Seinfeld" actor Wilford Brimley.

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.

The votes of yesterday's advisory panel on Glaxo's Avandia demonstrate how dysfunctional this government can be. I was just reading up on the details. There were two key votes. On the question: does Avandia increase risk for heart attack, the vote was 20 to 3 in agreement. Yet, incredibly, the same panel also voted overwhelming - 22 to 1 - to keep Avandia on the market.

Coverage on the subject in today's New York Times described the meeting as "extraordinary" in that US Food and Drug Administration officials were openly in disagreement with each other as to what steps to take. As I mentioned yesterday, one of those officials, Dr. David Graham, said the drug should be withdrawn. However, Dr. Robert Meyer, another FDA high-up-official, disagreed.

Let's recap: Glaxo knew Avandia might cause heart trouble and informed the FDA of this. The FDA did nothing. An article in the New England Journal of Medicine (May 2007) stated the drug increased the risk of heart attack. The FDA twiddled its thumbs. Now this? The drug may stay on the market at the behest of the same FDA officials who voted in agreement that it poses a heart risk. Has the world gone mad? The sooner we get some reform at the FDA, the better off we will all be.

Also worth noting: the Times reports that Dr. Steven Nissen, whose NEJM article sparked the controversy, says he would have voted to remove Avandia from the shelves. Also quoted was Dr. Sidney Wolfe of Public Citizen, a drug safety advocacy group. Observed Dr. Wolfe: "If Avandia were up for approval today based on what we know now, it would be rejected."

Earlier today I blogged about the Avandia advisory panel which met today. As of earlier today, the word was an FDA official, David Graham, had issued a written preview of the comments he intended to make. In it, Graham stated his view that GlaxoSmithKline's diabetes drug Avandia is dangerous and should therefore be removed from sale.

Now comes breaking news from the Associated Press that the panel will recommend, against the wishes of many - Dr. Graham included, that Avandia stick around. According to the AP, government health advisers have argued that, hey, sure Avandia may cause increased risk of heart attack, but let's just keep it out there. What?! As of writing, the AP was still waiting for a tally of how the panel voted on the issue, but word is a majority voted against recommending a ban.

The FDA's patient representative for the panel was quoted as saying studies indicating Avandia causes heart trouble "have very significant weaknesses and are inadequate for us to make that kind of decision." In short, the FDA seems to be saying Avandia causes heart damage, but the study-based proof is not strong enough for a ban. Talk about your contradictory messages! Baffled? Disgusted? Join the club.

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.

Oh, this is awesome news for anyone touched by the Avandia mess: manufacturer GlaxoSmithKline (GSK) has announced that its shares are up despite its troubles over the diabetes drug Avandia. The scandal arose over revelations that Avandia could cause heart problems. Things only escalated as details came to light, particularly the role of the US Food and Drug Administration and its completely inadequate response to the problem.

Given all this bad publicity, wouldn't you expect GSK's stocks would take a dive? Well, they did during the quarter that Avandia hit the news. However, the company's overall outlook for the year 2007 still looks pretty darn good, apparently. As a result, projections for earnings-per-share remain stable and the company is expanding its share buyback program.

So much for suffering the consequences of your actions... On the other hand, GSK has vigorously defended Avandia against claims of heart damage. They would say: "Why should we suffer? We haven't done anything wrong."

The way that the US Food and Drug Administration (FDA) dropped the ball on Type 2 diabetes drug Avandia has fueled calls from both in and outside of government for FDA reform. We should all be afraid, very afraid, that a government body charged with protecting the public good on such a basic level is toothless. And that's putting it kindly.

The public radio show Marketplace just ran a two part feature on this issue. Its reporter asks the question: when did the FDA first learn about the health risks posed by Avandia (namely, increased risk for heart attack)? Also, what did the FDA know before the story broke in the media? Shockingly, Avandia manufacturer GlaxoSmithKline (GSK) informed the FDA back in 2005 that the drug raised the risk of heart attack. GSK even supplied the FDA with a copy of its internal analysis on the subject in 2006, which the FDA then confirmed with its own analysis. The FDA's explanation for its silence was that it was trying to assemble a comprehensive picture of the situation before acting. Sure. But how much longer would the FDA have sat on the Avandia issue if the story hadn't broken following the criticisms of cardiologist Steven Nissen?

Because the FDA is supposed to be our public health watchdog, these questions will ultimately prove far more significant than questions about what GSK knew and when. Big Pharma - like all business enterprises, large and small - is focused on the bottom line. It's up to the FDA to look out for the rest of us. Yet many in our government believe in letting market forces prevail; that in a healthy economy, little government oversight is necessary. Fact is, this just doesn't work. Are you scared yet?

Happy July 4th!

House Calls, a popular newsletter written by the prestigious Dr. Inglis, highlights a very important question in light of the Avandia mishap: how many other potential whistle-blowers are out there who have been silenced into submission before the Big Pharma vultures?

A medical expert testified that he agreed to sign a statement that was meant to appease the company's investors. This is not the type of behavior anyone should expect or dismiss of a doctor, entrusted with a patient's life. In his defense, he did forward a letter with his concerns to the FDA, which means they also were aware of the same threat. This same doctor is the President-elect for none other than the American Diabetes Association. Isn't that special? The ADA -- my friend, my confidant, my utter supporter of the C-peptide crusade ... sense the sarcasm? So much for advocacy, when the president-elect of this organization so willingly swept those safety concerns under the table, when he should have been throwing a tantrum on top of it! And all over the threat of litigation from a drug company more concerned about its investors than patients.

The closing comments in Dr. Inglis' newsletter say it all: There are so many vultures out there waiting to pick the bones of the American public, it disgusts me. This example goes to show why I always recommend to you -- and to all of my patients -- that you always question everything when it comes to your health. I don't care if it's your doctor you've had for 50 years or one of these nonprofit organizations -- give them all hell.

Congressional investigators have been looking into very serious claims that Avandia's maker silenced medical professionals who attempted to speak out about the potential for cardiovascular problems by using the drug.

Dr. Buse, who is about to become the president of the American Diabetes Association, was an early and frequent critic of Avandia after it reached the market in 1999. In a March 2000 letter to the F.D.A., he said Avandia might raise patients' risk of heart attacks, and he criticized the company's marketing, saying it employed "blatant selective manipulation of data" to overstate the drug's benefits and understate its risks.

More recent questions about Avandia's potential risks, as outlined in a New England Journal of Medicine article last week, have prompted the Congressional hearing. The author of that article, Dr. Steven E. Nissen, a heart specialist at the Cleveland Clinic, has also been called to testify. See the full story on the upcoming congressional hearing.

You will soon have role playing cards available for your doctor's visits. The conversation is scripted with four questions and the answers as to whether or not you should be on a statin. Two can play, but millions will have a chance of their very own!

The pocket cards are intended to empower patients to determine whether they should or should not take a statin. Statins are cholesterol lowering drugs that supposedly reduce the risk of heart attack. Diabetics are typically at a higher risk for heart attack. The card includes answers to four questions: (1) What is your risk of having a heart attack in 10 years? (2) What are the benefits of taking statins as compared to not taking statins? (3) What side effects can you expect from statins? (4) What do you want to do now?

If the risk of having a heart attack is very small, a pill that reduces that risk may not be worth it, but if the risk is really high, lifestyle changes (or a pill) might sound compelling. Once a patient has a sense of the potential dangers and benefits they can make an informed choice. I hope the cards come equipped with the source of the funding for this study: Mayo Clinic and the American Diabetes Association. I wonder if that's the underhanded way to say this study was funded by Merck, Pfizer, and GSK?

For more the more than 300,000 users that once relied on animal-derived insulin, the final chapter of animal insulin is finally ending for the US market. In December 2007, Novo Nordisk has officially decided to discontinue making animal-insulin. Their explanation doesn't go into great detail why they chose to discontinue it. But the supporting evidence they use to warrant the decision is a little weak.

Novo says, animal insulin is derived from the pancreas of slaughtered animals. This statement is as true as the statement "human insulin is derived from the pancreas of slaughtered humans". Novo continues, since that time there has been significant improvement of insulin quality and formulation. Absolutely true! In fact, a Novo pork product was shown to be greater than 99% pure, while an Eli Lilly human insulin only exceeded the 97 percentile. As a consequence, demand for these old animal insulins has declined by as much 20% in the last year to a point where approximately 2% of all insulin users are currently using these products. Largely due to the fact doctor's were advising their patients they must prepare to switch to GM insulin because animal-derived insulin would be nearly impossible to obtain. True. The research that introduced GM insulin (back in the 80s) was preemptive, at best. The claims supporting it was better than the existing insulin choices was clearly debatable .A telling similarity to the discovery about Avandia.

The long-term results of GM insulin and its analogs would prove to be a nightmare if the right questions were asked, and the data properly collected. Is it fair for any of the companies to ask us to change from an insulin product we have grown to love? No, but much like the off-Broadway play suggests: We love you (as a customer). Your diabetes is perfect (for our bottom line). Now change your insulin (we don't feel like making that kind anymore). Too bad type 1 diabetics forced to change to GM insulin didn't have the outspoken advocates like those taking Avandia.

When blood sugar is falling, the stopper built into the body is the release of glucagon from the alpha cells of the pancreas which stimulates the release of glucose from the liver (but only if your adrenaline is flowing). However, when hypoglycemia is due to injected insulin - the stopper isn't entirely in place. Scientists explain how epinephrine (adrenaline) plays a major role in regulating glucose in times of low blood sugar and how this response could be adversely affected by the use of beta-blockers.

During insulin-induced hypoglycemia in dogs, the roles of adrenaline and glucagon were evaluated. The dogs fasted overnight to remove excess glucose from the blood. The dogs also had their adrenal glands removed. The adrenal glands are the source of adrenaline. Adrenaline is released into the bloodstream in response to physical or mental stress,to initiate the stimulation of glucose, among many other functions. Adrenaline and insulin were released at two different rates: a basal rate or a variable rate to simulate an adrenaline response. When the blood sugar fell to 42 mg/dL, the dogs in the basal rate group failed to release glucagon, but the simulated adrenaline response group increased normally. The liver response to releasing glucose fell in the basal group but increased in the simulated adrenaline response group. The researchers conclude that adrenaline must be responsible for this critical response to insulin-induced hypoglycemia.

Beta blockers are a common class of prescription drugs that counteract the stimulatory effects of adrenaline. Diabetics who inject insulin and take beta-blockers should be extra cautious of hypoglycemia. Hypoglycemic unawareness is already established for diabetics injecting GM insulin (genetically modified human insulin). Given the side effects of beta blockers, there is greater reason to be more aware of hypoglycemis unawareness -- yes, oxymoron. Those individuals who are on the brink of diabetes should avoid beta-blockers at all costs, according to a study in The Lancet (January 2007) beta-blockers used for hypertension increase a patient's risk of developing diabetes.

Last time I checked -drugs weren't cool, but according to a recent study, within the last 3 years, the number of teens using type 2 diabetes drugs has soared.

Medco, the largest US drug benefits manager, found the number of children taking medicine for type 2 diabetes more than doubled between 2001 and 2005. An analysis of prescription data found a 146% increase over four years in young people aged 10-19 taking type 2 diabetes drugs, and 115 % increase in all children in the survey. Children on diabetes medicines also faced other serious problems. About 17% of the boys and 13% of the girls were on drugs for high blood pressure; 5% of both were taking cholesterol-reducing drugs; and nearly 20% were taking narcotic pain relievers, drugs for respiratory conditions and antidepressants. Medco reviewed over 500,000 children each year. Of those aged 10-19, about 1.47 per 1,000 were taking type 2 diabetes drugs with a clear rising trend.

I'm so glad I'm not a teenager any more. These days it's not about abstaining from drugs. It's about the type of drugs you use. Just because your doctor is the one prescribing it doesn't mean you have to succumb to the peer pressure of drug use. I found an appropriate Chinese proverb for this blog: it is easy to get a thousand prescriptions but hard to get one single remedy. Put that in your pipe and smoke it.

Researchers defined a link between high insulin levels and defective lipid metabolism but the cause may not be exactly what you think. According to a study published in June, 2005 -- this could be due to their choice in blood sugar lowering medication.

The conclusion of the study identified obese insulin-resistant subjects taking metformin (brand names Glucophage, Diabex, Diaformin, Fortamet, Riomet, Glumetza) and rosiglitazone both improve insulin sensitivity (increase insulin production) but DO NOT improve lipid metabolism. Rosiglitazone (brand name Avandia) may have a detrimental effect on chylomicron metabolism

Blood vessels of insulin-resistant rats build up a substance called chylomicron cholesterol following a high fat meal. Because the rats are insulin-resistant, more insulin (in the form of an anti-diabetes pill) is required to clear sugars and fats from their bloodstream. Higher insulin levels reduced the rate of chylomicron removal from the blood stream following a meal. This slower clearing rate increased the chylomicron particles sticking around the blood vessels, leading to arterial plaque build up and heart disease.

Knowing that high levels of insulin are associated with elevated levels of chylomicron cholesterol, researchers will use this information to try to figure out how this happens.

Why would they do that? The answer was already explained in June, 2005. Oh it must be because arterial plaque builds differently in Australian's on anti-diabetic pills than it does in American's on anti-diabetic pills. We should all thank the good folks at GlaxoSmithKline, Bristol-Myers Squibb, Pfizer and Merck. Without their medicine -- how would anybody ever know about this stuff? First you're on an anti-diabetic pill, then you're on cholesterol lowing pill, what's next? Of course -- the blood pressure!!

How many people are Gold Star type 2 diabetic patients?

A study published in 1991, comparing the efficacy of human synthetic insulin to porcine insulin states "there is no reason to treat all insulin-requiring diabetic subjects with human insulin except those who have developed insulin allergy".

In light of this study - how was rDNA synthetic human insulin able to monopolize the US market?

The absence of highly purified porcine insulin in the US is probably (my guess) because it's cheaper to manufacture. The saturation of the US market with rDNA synthetic human insulin seems to be treating the masses with a specialized need existing in only a few individuals. But the top line of this marketing campaign must have had a good effect on the bottom-line, too. Sales reps convinced doctors to switch their patients because it was going to become nearly impossible to continue getting animal derived insulin. The insurance companies (the guys picking up the tab) must've loved this option, too. Why wouldn't they? It's better - right?

I'm going to do a self-analysis of the stuff, based on my IAA, IA and C-peptide levels. I've been on human synthetic insulin since 1985. I've never been on highly purified porcine insulin. The IAA is my insulin autoantibodies -- the antibody attacking my islets. My IA is the insulin antibody attacking the injected insulin and my c-peptide will tell me how much insulin my body is making. After 12 weeks on the highly purified porcine insulin - I'm going to do my labs again. I'm curious to see if these levels move, at all. If my c-peptide levels rise, that's a GOOD indicator what's best for Allie Beatty.

So is the best choice for me the best choice for all? Probably not. But at least I can see for myself - even if it costs me a pretty penny to get my hands on highly purified porcine insulin. Nobody said being an experimentalist was cheap. However, never exploring my options would deeply discount the value of experience.