A recent study found that 87% of patients who experienced an adverse symptom from a prescribed drug spoke to their doctor. However less than half of the doctors went through with filing the adverse event paperwork to notify the drug manufacturer. Why is this?

The research was published in the latest issue of Drug Safety. Doctors dismissed patients' complaints, and told them their symptoms were not connected to use of the drug. One doctor commented that the time it takes to complete the adverse event drug paperwork is time-consuming, and often not worth it unless it is life threatening. Would Hippocrates have accepted that answer? Please review your Hippocratic Oath, doc.

Your doctor is too busy to file the necessary paperwork to notify the FDA a drug is potentially harmful. What is a patient to do? Good question and here's an answer! If you experienced any adverse side effects from the use of a prescription drug, please let the FDA know. Click BEGIN and bring this monkey business to an end!

The chairman of the FDA advisory panel that reviewed the safety of rosiglitazone (Avandia) last week believes the time has come to abandon "surrogate endpoints" for approval of type 2 diabetes drugs, according to a report at www.medpagetoday.com.

There is a man living in Springfield, MIssouri who developed diabetes because he took a commonly prescribed antibiotic, according to a lawsuit filed Tuesday. The complaint against Bristol-Myers Squibb and Schering Corporation claims its antibiotic drug Tequin and its generic equivalent gatifloxacin may have significantly increased a patient's risk of developing diabetes or another blood-sugar disorder.

The lawsuit seeks compensatory and punitive damages for Patrick Bills, who developed severe hyperglycemia and new onset diabetes while taking Tequin for a skin infection. The drug was also commonly prescribed for sinus, lung, and urinary tract infections, as well as other illnesses.

According to the complaint, filed in the U.S. Southern District Court in New York, the pharmaceutical company ignored mounting reports of diabetes-related problems until February 2006 when -- in conjunction with the FDA -- it added a warning to the label that diabetics should not take Tequin. However, the newly added warning label did not include any danger to non-diabetic patients, which the plaintiff was.

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.

In the past, I've blogged about an Australian experiment using implants that could, theoretically, eliminate the need for type 1 diabetics to use insulin shots. Researchers said it's possible to implant seaweed-coated capsules containing insulin-producing cells in the abdomen. The cells produce insulin, but the tiny pores in the seaweed do not allow immune system cells to pass through and destroy the cells. Allie has also looked at a related issue: experiments that surgically attach kelp-coated islets to the liver for the same purpose.

Sounds pretty brilliant. But could it really work? The verdict looks like "Yes." According to the results of a new Johns Hopkins University study, such implants could be helpful for type 1 diabetics whose bodies otherwise reject insulin transplants. The capsules utilized in the study were coated with a substance made from alginate, which is derived from seaweed. The technology could eventually be offered to diabetics whose bodies reject insulin cell transplants, something which could became standard treatment in the future. It would likely be a safer choice than the only other option known so far: anti-rejection drugs. Talk about the power of nature!

The results of the study have been published in Nature Medicine. Next step is a larger trial that will lead to seeking FDA approval for the technique.

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.

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?

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!

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.