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 David Graham, said the drug should be withdrawn.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."

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.

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."

Certain models of the Medtronic Paradigm insulin pump can be irrevocably damaged by exposure to MRI radiation. As a result - and based on information supplied voluntarily by Medtronic - the US Food and Drug Administration has declared a Class II recall for the affected pump models. MRIs (magnetic resonance imaging) can cause the pump to malfunction and deliver a dangerously high dosage of insulin to the user.

Bottom line is that there's nothing defective about these pumps in terms of normal usage. You need only be concerned if you own one of the affected models and if your pump was exposed to MRI magnetic waves. Medtronic says the pumps that are affected should sound an alarm to warn users, but it is feared that people might override such alarms and continue using the devices, unaware that permanent damage has been done.

Owners of the affected models should have received a letter in the mail from Medtronic explaining the recall. If you use a Medtronic pump and have had an MRI, swing over to the FDA's website. There you can read the feds' statement (complete with typo misspelling "paradigm"!) on the problem and confirm whether or not yours is one of the problem pumps. This article in Diabetes Health is also useful. Strangely, I found the Medtronic website devoid of helpful info on the subject, but eventually tracked down a pdf of the letter sent to customers on the company's Canadian website.

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!

Eureka! I have just stumbled across the best explanation of Type 2 diabetes that I have ever read. The author is fitness enthusiast Mark Sisson and the entire text can be accessed at his website, Mark's Daily Apple. This is where Mark posts his blogs on health and fitness-related topics, and it also links into his online store, which sells nutritional supplements.

Mark does a great job of explaining what he calls the "Completely Unnecessary Disease Epidemic" - how Type 2 diabetes works and why the US Food and Drug Administration could be doing much more to help people avoid or minimize the disease's impact. We are overloading ourselves with carbohydrates and those carbs are poisoning us. Why? Because they are converted into sugars that our bodies just can't handle. In a detailed, yet easy-to-read and light-hearted way, Mark explains exactly how this occurs and his advice is simple: ignore the government's stodgy old food pyramid and cut those carbs. (Yes, I know, they've updated the food pyramid, but not enough to really address the problem, as far as I'm concerned.)

Mark, in fact, personally favors the "Stone Age" diet that did good things in a recent study involving overweight Type 2 diabetics. Click here to read more about that. He has even designed his own "Carb Pyramid," which you can view by clicking here. Mark happily describes his own food routine, and this is where he and I part ways because he says "I'm not really a pasta or pizza guy" and "I'm not much of a snacker." Must be nice...

After you've read his blog, Mark says, "Print this explanation out, stick it on your fridge, email it to your aunt. And put down the pasta." Oh, Mark, now you're just breaking my heart!

GlaxoSmithKline has its hands full right now big-time, defending its conduct over the ever-deepening Avandia scandal. But the big-name pharma company isn't giving up the fight. (No surprise there...) Today Glaxo ran full-page advertisements in a number of prominent US newspapers. The move is described by Britain's Guardian as the launching of a major PR war. The ads are featured in fifteen major newspapers, says the Guardian, including The New York Times, The Washington Post, The Wall Street Journal, and the LA Times. The ad is a direct appeal to patients, taking the form of an open letter from Glaxo's chief medical officer, Dr. Ronald Krall. (Guess he's working some late nights at the moment, huh?)

The ads were timed to appear one day before the congressional hearing on the US Food and Drug Administration's work on Avandia and consumer safety, which is scheduled for tomorrow. Another Glaxo-penned letter defending Avandia was also published in the medical journal the Lancet. Said a company spokesman of today's ads: "We are determined to make sure the science we feel backs us up is heard."

This article also notes that weekly prescriptions for Avandia have fallen by sixteen percent since the recent publication of a damaging article by Dr. Steven Nissen in the New England Journal of Medicine. Nissen asserted that Avandia could increase the risk of heart attack by forty-three percent and the risk of cardiac-related death by sixty-four percent.

By the way, it is worth checking out the Wikipedia entry on Glaxo for a brief rundown of the company's history, including previous wrangles with the media and the law over its products. Note, though, the entry has not yet been updated in the wake of the Avandia scandal.

I just read that the US Food and Drug Administration (FDA) has announced that it is re-classifying the drug NovoLog to allow its use by women with Type 1 diabetes who are pregnant. NovoLog is manufactured by drug-producing giant Novo Nordisk. The change came after a trial which found that pregnant women with T1 diabetes who took NovoLog had HbA1c levels and rates of maternal hypoglycemia comparable to women on regular insulin. The study did not, however, evaluate whether babies whose moms take the drug while pregnant have a greater risk of congenital malformations. On the other hand, women taking NovoLog benefited from a lower risk of diabetes-related pregnancy dangers such as preterm delivery.

Pregnancy and drugs. It's a complicated issue. What's safe? What's not? If only it were so simple as dividing all drugs into one category or the other - the Good or the Bad. Unfortunately, many common medications are in a third category - the Ugly? These drugs, known as category B drugs, constitute a sort of pharmaceutical no-man's land. You see, these meds have not been proven to cause harm to unborn children, like category C drugs. Yet they have not been proven safe, either, like category A drugs. This means, as I discovered when I was pregnant in 2006, if you're sick and could benefit from some specific No-Man's-Land drug, odds are your doc will offer to write you a prescription for it. He or she will warn you that it's possible the drug causes harm and leave the decision of whether or not to take it up to you. Now, I don't want to go back to the Bad Old Days when doctors told patients "do this" or "do that," "take this" or "take that," and, by golly, you did it and didn't ask questions. But wouldn't it be nice to just know what to do? Or to know that your doc knows all the answers? What's a gal to do??

A new once-daily diabetes pill is about to enter the US market. The US Food and Drug Administration has approved the release of Duetact, a drug that combines Actos and Amaryl into one pill. Duetact should be available for purchase later in the year, according to manufacturer Takeda Pharmaceuticals North America.

The pills will be available in varying dosages, but all offer the benefits of taking both drugs at one time. The two drugs both help to lower blood sugar levels, but they work in different ways. (Actos improves insulin resistance, while Amaryl increases insulin production.) According to Takeda, there are possible adverse side-effects to consider when taking Duetact, including low blood sugar, weight gain and heart problems.

The Federal Trade Commission has banned a company from selling its product Dia-Cope, which the commission says has been falsely marketed as a diabetes cure. Dia-Cope has been advertised on several web sites in seven different languages: English, Chinese, Japanese, Korean, Indonesian, Spanish and Russian. The advertisements contained the false claim that thousands of clinical trials proved Dia-Cope could prevent, treat and cure diabetes. The website set up to market the product, www.diacope.com, also stated that the US Food and Drug Administration had approved the product - again, not true.

The company in question, Sagee U.S.A. Group, Inc., has already been prosecuted for selling a fake herbal supplement, Sagee, that it claimed would treat Alzheimer's disease. This time the FTC will make the company surrender the assets earned from the sale of Dia-Cope as punishment for violating the court order against misrepresentation of a product, issued for its marketing tactics used with Sagee.

The US Food and Drug Administration (FDA) is behind the recall of Disetronic D-TRONplus Power Packs, manufactured by Disetronic Medical Systems Inc. of Indiana. These devices are the power packs that go with the D-TRONplus Insulin Pump. Disetronic is issuing a voluntary nationwide recall at the urging of the FDA.

Disetronic says "there is a real potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning. If a shut down occurs, insulin delivery is interrupted." This is serious. Anyone with one of these pumps should be aware of the possible dangers. You can contact Disetronic by calling 1-800-688-4578.

Pharmaceutical giant GlaxoSmithKline has announced it's newest diabetes drug has been approved by the US Food and Drug Administration (FDA). This means the company can go ahead with plans to launch the drug as a treatment for Type 2 diabetes.

The medication in question is named Avandamet and is designed to improve blood sugar control. Avandamet contains two active agents: rosiglitazone maleate, an insulin sensitizer, and metformin HCl, a drug that reduces the blood sugar produced by the liver. Basically, the idea is that by combining these two commonly used drugs into one treatment, it will make it easier for Type 2 diabetes patients to achieve blood sugar stability. GlaxoSmithKline says that studies have shown that, in fact, the two medications are significantly more effective when taken together than taken separately.

Check out GlaxoSmithKline's website for more information.