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 first in-depth comparison of type 2 oral medications arriving on the scene over the last decade was published earlier this week in the Annals of Internal Medicine. The review determined older, cheaper diabetes drugs are as safe and effective as new alternatives. Oh boy, Big Pharma's newer drug sales teams won't like this conclusion.

Metformin, also known as Glucophage, was cited as the safest and best option, as it works as well as other oral medications, but does not cause weight gain or hypoglycemia. Bad cholesterol is also lowered on metformin, and the drug only costs about $100 a year. Newer drugs cost as much as $262 a month, stated lead researcher Dr. Shari Bolen, and there was no benefit to the newer drugs unless tolerance to an older one was at issue. They also noted taking two oral meds can improve blood sugar, but the cost and risk of side effects are both higher.

The researchers reviewed more than 200 published studies and some unpublished information from the Food and Drug Administration. Avandia's manufacturer, GlaxoSmithKline, stated this analysis was completed prior to the completion of one Avandia study that showed Avandia improved blood sugar control compared to two rival meds.

But the dinosaur Metformin does have a roar -- it can cause a rare, dangerous side effect called lactic acidosis. Read more in Globe and Mail.

.

According to a new Associated Press (AP) feature, federal regulators have experienced a dramatic surge in reports of Avandia-related side effects. In fact, they say they are receiving triple the number of reports just in the last month. This trend began when news broke that the drug, which has been a big money maker for GlaxoSmithKline, may increase the risk of heart trouble.

The data supporting the claim was gathered by the AP from the US Food and Drug Administration. Whoever wrote this article makes a point of noting that the figures were obtained with the backing of the Freedom of Information Act, although the report does not say the FDA resisted handing the information out. The key finding: in the thirty-five days before the Avandia story broke in the media, only five heart attacks were reported as side effects involving rosiglitazone. Rosiglitazone is the active ingredient in Avandia and its little cousin Avandamet, which combines that drug with metformin. Yet in the thirty-five days following the revelation, that number soared to ninety. The AP also says reports of heart-related hospitalizations increased dramatically.

The AP says that several experts consulted for the article agree that doctors are probably attributing patients' heart problems to the drug, whereas before they likely would not have made the connection. The report also touches on the problem that's at the heart of the Avandia story: the dire need for reform of the FDA. Right now, there is no organized governmental oversight of drug safety once a drug is on the market and all reporting of side effects is voluntary. No one is driving the bus, basically. Click here to read more.

Don't know about the Avandia scandal? Want to read more on the background to this story? Click here for just one of a gazillion news stories published recently on Avandia and the FDA.

Celebrate the 4th of July! Be informed - it's patriotic. Check out an awesomely funny video from Prescription for Change. The colorful cartoon comes complete with singing and dancing prescription drug capsules, accompanied by the seriously screwed-up patients who popped pills with abandon and are now suffering the horrible consequences. (Male lactation, anyone?)

Prescription for Change is a public awareness-raising project funded by the powerful nonprofit Consumers Union. The vid's purpose: to raise awareness about inadequate prescription drug regulation in the US and to recruit public support in pushing for change. Specifically, it's about rallying support for the drug safety bill (HR2900) now before the US House of Representatives. It's not too much to ask, surely, that prescription medications be safe and affordable, and that information about drug side effects be fully explained to patients.

Diabetics be aware: a major case in point, illustrating Prescription for Change's critique of the status quo, is the Avandia scandal. The US Food and Drug Administration (FDA) failed to alert the public that Avandia, the Type 2 diabetes drug, manufactured by GlaxoSmithKline, increases the risk of heart attack. Oops.

View the cartoon by visiting YouTube. Or click here to visit the Prescription for Change website, which also features additional information about why reform is needed. You can also send an email to your Representative in support of the changes. Can Prescription for Change make a difference? Stay tuned.

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!

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.

Go Speed Racer, Go -- pole position has been taken in the litigation race against GlaxoSmithKline for their alleged Avandia misdealings. Winner of the pole is none other than a Glaxo shareholder.

The law firm Kaplan Fox & Kilsheimer filed the lawsuit in the U.S. District Court for the Southern State of New York on behalf of shareholder Leon D. Borchoff. Mr. Borochoff purchased an undisclosed stake in Glaxo stock on May 16, 2007 at $56.92 per share. The firm is seeking damages for all investors purchasing shares between October 27 and May 21.

The firm accuses Glaxo of failure to disclose to investors their own meta-analysis which revealed Avandia increased the risk of heart attacks. Glaxo did reveal results to the Food and Drug Administration back in September 2005, but a public disclosure in late May only occured after Dr. Nissen published his own damaging meta-analysis showing an increased heart attack risk of 43 percent.

Prescriptions have how fallen 15 to 20 percent since Dr. Nissen's study was released on May 21 in the New England Journal of Medicine. With $3.2 billion in Avandia sales last year, Glaxo's future profits are taking a huge hit. A Deutsche Bank analyst has estimated Avandia litigation could cost Glaxo up to $5 billion.

I coach a girls' softball team. Whenever they take the field, I often bark out, "Ready positions!" Dust gently rises and settles as they spread their feet, bend their knees and open their gloves in anticipation. But dust from the recent Avandia scare is not settling, and within this cloud of confusion stand injury lawyers in ready position to snag the first clients.

As I researched the news on Avandia the past few weeks, my peripheral vision couldn't miss the on-screen Internet banners soliciting clients. When Glaxo's PR machine ran full-page newspaper ads assuring us Avandia is as safe as other type 2 diabetes medications, Houston lawyer Bill Bass ran an ad in the Houston Chronicle targeting Avandia-prescribed type 2 diabetics with heart problems interested in litigation.

As in softball, the Avandia plaintiffs bar team of lawyers play different positions. Houston lawyer Mark Lanier, known for winning the first case against the painkiller Vioxx, explained "chicken catcher" lawyers are adept at advertising and attracting good clients, while "chicken plucker" lawyers do not often advertise, but do take cases to trial. There is a switch-hitter position for the lawyers able to attract good clients, broker most off to the trial lawyers, then keep a few cases for themselves to try and settle after the first wave of litigation establishes a settlement value.

A typical "chicken catcher" takes 25 to 40 percent reaped by the trial lawyer. Recent television ads by Houston lawyer Adam Pulaski generated nearly 10 percent of their firm's 10,000 forecasted calls in the first few days, but many inquiries will not end up candidates for court. Lawyer buzz frames Avandia may be a hard case to win.

For Avandia takers possibly hurt by the drug, I hope you are okay. If you do decide to fly the coop and get caught, may you be sold at market to a seasoned "plucker". Read more in this Houston Chronicle story.

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.