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.

Details are emerging from today's advisory committee meeting on Glaxo's Avandia. First up was a presentation by Dr. Robert Ratner of Washington's MedStar Research Institute outlining the unprecedented spread of type 2 diabetes. Ratner emphasized the inadequacy of current drug therapies for diabetes and the strain on the health system caused by the disease. The possible implication: Avandia does more good than harm right now, so let's keep it as an option.

Next, in written preview comments, an official from the US Food and Drug Administration stated his belief that the diabetes drug should be taken off the market. The official, Dr. David Graham, says the heart risks posed by Avandia mean it's just not worth the risk to patients. Especially, he said, not when there are safer alternatives like Actos (by Takeda), which also stabilizes blood sugar levels.

It's a significant step that someone from the FDA publicly made this statement. But will anything come of it? Maybe not. The decision about whether or not Avandia stays on the market is not up to Dr. Graham, who The New York Times reports has a history of coming down harder on drug risks than many colleagues. (Give the guy a medal!) Thing is: there appear to be plenty of other officials within the FDA who don't agree with Graham's interpretation.

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.

Avandia, a drug used to treat Type 2 diabetes, has been in the news of late following the release of controversial study results which concluded the drug leaves patients at an increased risk for heart trouble. My fellow blogger Bev has touched on the conundrum now facing diabetics on Avandia regimens. You can quit taking Avandia, but then what? Thousands of Americans are now facing this predicament and many have opted to switch their prescriptions to something else. The Philadelphia Inquirer is running a feature about this and talks to some diabetics who have opted for the "try something else" route.

The Inquirer profiles, among others, pharmacist Ben Briggs, 59, who switched to Merck's Januvia in the wake of the Avandia scandal, but was sorely disappointed in the results. Instead of seeing an improvement in his blood sugar levels, his health actually declined rather rapidly: he gained eight pounds and said he was "feeling awful." He promptly ditched that drug too and is now on yet another medication. According to diabetes experts interviewed by The Inquirer, patients should "tread carefully" and avoid rushing to switch to drugs such as Januvia, which do not have the proven track records of the old standbys insulin and metformin.

Bottom line: this whole dust-up over Avandia is a nightmare for its producer, GlaxoSmithKline. However, its competitors Merck and Takeda Pharmaceutical could stand to make a bundle as diabetics switch in droves from Avandia to Januvia or Takeda's Actos. According to Deutsche Bank analyst Barbara Ryan, sales of Januvia alone could be up as much as $300 million annually as a result of Avandia's troubles, while Actos profits could rise even higher than that. You have to imagine Merck and Takeda must be nervously making hay while the sun shines, hoping they don't end up testifying to Congress some day in the future.

Call the art director and the printer. It's time for a label redesign.

Glaxo just finished revving up the printing press for their aggressive PR campaign assuring us all Avandia is safe. Yesterday, the FDA ordered Glaxo to add their strictest warning to bottles of Avandia -- the dreaded black box label. They also ordered the black box label be placed on Avandia's closest competitor, Actos, manufactured by Takeda Pharmaceuticals and Eli Lilly & Company.

This bomb was dropped by FDA commissioner, Dr. Andrew C. von Eschenbach, in the midst of a packed House hearing investigating the FDA's questionable handling of Avandia. In a written statement, he said the agency asked Avandia and Actos makers to add the more prominent black box warning of heart failure because the drugs were being prescribed to patients with significant heart failure, despite existing warnings on the bottle. Dr. Nissen's May 21 study, which sparked the controversy, revealed a 43 percent higher risk of a different side effect, heart attack.

Revealed to the public only yesterday, turns out the FDA had requested drug makers for the black box label on May 23, a mere two days following publication of Dr. Nissen's study in the New England Medical Journal.

In the wake of the disastrous media coverage now being given to GlaxoSmithKline over its diabetes drug, Avandia, Louise Story of The New York Times has taken a closer look at Glaxo's strategy for selling the drug. It appears that a central pillar of that strategy was pitching the drug extra hard to the African American community. Seems Glaxo was faster and savvier than its competitors to recognize what seems sort of obvious in retrospect: African Americans suffer from Type 2 diabetes at a rate disproportionately high compared with that of the general population, so reaching out to that community could be lucrative for drug manufacturers. Glaxo has been targeting diabetic African Americans in a glossy and carefully crafted ad campaign for some years now.

Della Reese (pictured) was Glaxo's big star for the campaign. Remember Reese? The Touched by an Angel actress and jazz singer was too perfect. Black diabetic? Check! Celebrity status? Check! Grandmotherly yet sassy? Check! Click here to see a sample of the ad literature and images featuring Reese.

The question that industry analysts are now asking is this: will Glaxo's strategy now backfire in the wake of the Avandia scandal? That is, will black diabetics lose trust in the company name over this controversy? Times journalist Story speculates that this could indeed happen; that African Americans have been ill-used before by drug companies and scientists, most famously in the notorious Tuskegee syphilis experiments. Regardless, this is a sector of the market Glaxo can't afford to lose.

Glaxo is turning up the volume. Thanks to this post yesterday, we are all aware Glaxo's media department has been busy spinning the news on Avandia. Now they are spinning the RECORD study -- quite differently from critics. Preliminary results of the study were released today via an editorial in the New England Medical Journal, one day before today's Congressional investigation of the FDA. Opponents contend the FDA ignored heart risks associated with Avandia.

Interim analysis of RECORD reports an 2.15 increase in heart failure for Avandia-takers, but no increased risk in the death rate for heart attack or stroke. Glaxo's Chief Medical Officer, Ron Krall, claims the results are reassuring and compares Avandia's safety profile to other type 2 medications on the market.

Critics have an entirely different opinion on the RECORD analysis (thank goodness someone else is weighing in). In the editorial, Dr. David Nathan, director of the diabetes center at Boston's Massachusetts General Hospital, states there is not enough evidence to implicate or clear Avandia and too many people have dropped out of the study. Nathan recommends doctors STOP prescribing Avandia as it might increase severe cardiovascular events and death by 8 percent. Did you hear that? Stop prescribing Avandia altogether.

New Avandia prescriptions from May 25-June 1 have dropped 16 percent, while total prescriptions have dropped 6 percent. No wonder Glaxo has jumped into the deejay booth, can you imagine the money at stake? Here is the full story in Bloomberg.

For those of you following the Avandia story in the news, you're probably wondering how the patients currently taking Avandia are feeling. Are they flushing the pills down the toilet? What about the patients enrolled in GlaxoSmithKline's current Avandia clinical trial -- are they dropping out like flies? If you are unfamiliar with the Avandia debate, news broke last week that Avandia, a popular diabetes drug, may increase the risk of heart attack. A 43% higher risk.

It may depend on the specialty of your doctor. BusinessWeek has reported endocrinologists tend to be more skeptical of the study, noting its weaknesses compared to original, more rigorous clinical trials. Many cardiologists and drug safety experts give the study more weight, and remain worried about Avandia's potential cardiac danger. Doctors on the frontline are concerned patients may stop taking the drug without medical consultation as many are confused and frightened.

Dr. Nissen, the whistle-blower on Avandia and leader of the fight to withdraw Merck's arthritis drug Vioxx due to safety issues, acknowledges there are real limitations in his analysis, but he points out Glaxo's own data found a 30% increase in the risk of heart attack from Avandia. Nissen was alarmed enough to release his meta-analysis showing a 43% increased risk versus waiting for the results of Glaxo's 4,400-patient, eight-year clinical trial named RECORD, which is specifically measuring cardiovascular outcomes of Avandia.

Critics say Nissen went too far out on a limb this time as a meta-analysis examining 42 Avandia trials with varying research methodologies is not terribly reliable.