How did we allow insulin to evolve into a genetically modified hormone?

It all boils down to propaganda. If you're confident your current insulin surpasses former natural insulin in: purity, availability, allergy response, similarity and safety - I encourage you to review the following facts that were conveniently neglected or not available, due to restraints of time travel.

Purity: In the 1970s, a Genentech scientist stated that natural insulin was incredibly pure. In the 1980s, rDNA humulin insulins were less pure than the natural insulins of the 70s. The advertising campaign for rDNA insulin suggested otherwise. Here's a quote, as printed in the book, Invisible Frontiers: "They impressed upon us very, very clearly that this (human insulin) was going to be no advantage at all."

Supply and demand: A USDA scientist told the world the diabetic population's insulin needs would outstrip the supply of natural pancreatic glands. This was sensational propaganda. Have you visited McDonald's or Wendy's lately? There doesn't seem to be a shortage of Big Mac's, does there?

Allergy response: About 5-10% of the diabetic population is allergic to natural analog insulins. Today, based on 25 years of human diabetic experimentation, the diabetic population is showing the same 5-10% allergic response to all the new products. Maybe that aforementioned 5-10% is the same latter 5-10%? From the looks of it - they're just allergic to insulin, rDNA, GM or natural.

Similarity to own insulin: rDNA human insulin is just like the body makes. Who wouldn't want to take human insulin? That's the propaganda. A recent research article found in a large portion of the diabetic population, their own human insulin may actually be the cause of their diabetes. Something tells me the study included the same 5-10% of diabetics mentioned in the allergy response paragraph.

Safety: Drug companies touted rDNA insulins as providing a good a warning to diabetic patients as natural analog insulins regarding low blood glucose levels. Are you kidding me? Driver and workplace accident statistics regarding diabetics indicate that the rDNA insulins do not cross the blood-brain barrier in the same manner as natural analog insulins. The part of the brain controlling endocrine response lags because it doesn't get the signal until it's too late (if it ever gets the message). The increase of diabetes-realted deaths since the introduction of rDNA insulin is remarkable! (Center for Disease Control). How safe is that?

Fact versus fiction is a scary line to smear for the sake of business. I suggest doctors, diabetes educators, and patients review the facts today and compare it to the propaganda in the 80s. There is no suppressing the truth!

Oramed is developing a soft gel insulin capsule for the treatment of diabetes. The company has recently announced it the successful completion of its clinical trial demonstrating the safety and efficacy of the oral insulin gel capsule.

The pills were shown to reduce blood sugar, with no significant adverse effects. The insulin used in the gel caps is a generic brand of human insulin. The duration of the insulin is similar to Regular. But the most beautiful thing about these gel caps is that they reintroduce the liver into glucose metabolism, thereby reducing the likelihood of dangerous lows associated with injected insulin and oral medications. This could blow away the necessity of blood sugar testing because you are regulating glucose metabolism in the liver, like a person without diabetes.

Up until now, the idea of insulin pills or tablets was inconceivable due to the fact that insulin, when swallowed, breaks down in the digestive system. Oramed's patented technology overcame the problem of digestion as well as permeability to the intestine. The company's goal is for the completion of formal Phase 1 studies in the US by mid-2008. Sign me up!

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.

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."

Ever wonder what would happen to a non-diabetic's blood sugar if they loaded up on a pile of concentrated sugar, preservatives and weird science fats? Doctors and the ADA call it prediabetes. This clip takes it to the extreme by sandwiching the center of 16 double stuff Oreos! Sometimes you have to be insanely blunt to make your point.

This is a brilliant example of the diabetes epidemic in action. In today's world -- many people are eating for convenience without realizing the consequences. More convenient equates to less nutritious - more preservatives, more sugar and even more fattening (the wrong fats, too!) The combination increases the amount of time our digestive enzymes need to work on these lab-derived ingredients. This sustains an elevated blood sugar following the time of consumption. Add the ADA definition of pre-diabetes (a blood sugar between 140 to 199 mg/dl 2 hours after a meal) and there you have it -- a potential player on Team Diabetes!

Think what would happen if this guy was in his doctor's office 2 hours after this stunt. I'd like to thank his employer for keeping him busy (whatever he's paid to do) well after the lunch hour - and protecting him from becoming another statistic. Big ups to HR for hiring this guy!! If he's not in marketing already -- you might consider a transfer and give this guy a raise. He's my Oreo hero.

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.

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."

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.

Diabetes drugs Byetta and Januvia have been declared safe and effective...for now...by researchers from Boston's Tufts-New England Medical Center. Both medications effectively reduce blood sugar by around one percent or less. This compares with older drugs like metformin, which can cause a drop of as much as two percent. On the other hand, the newer drugs are popular (and this has received tons of publicity over the last year or two) because they don't routinely cause weight gain like the older drugs and, in fact, they can even promote weight loss.

The Tufts announcement came with a caveat, however: these drugs have not been around long. This means their long-term safety is not known. As far as side effects go, one author of the study, Anastassios Pittas, told USA Today that although they didn't see anything really scary, "I would be more comfortable seeing two-and three-year data before embracing them." Pittas also acknowledges the (exorbitant) cost of Byetta and Januvia is a problem.

No new research was done to arrive at this conclusion. Rather, the researchers assessed the findings of twenty-nine previous studies. Their report has been published in the latest issue of medical-world heavyweight Journal of the American Medical Association.

The timing of this news is indeed fortunate for drug giants Merck & Co., which owns Januvia, and Amylin & Lilly, which owns Byetta. They must be very worried indeed about shaken consumer confidence following the Avandia mess, which has received a lot of publicity of late - bad, very bad, publicity that tarnished the public image of Big Pharma. And it's public image was already down about level with lawyers. (Apologies to all the lawyers out there...)

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!

British-based website Scientist Live reports on a possible link between cancer and the use of thiazolidinediones (TZDs), a class of medications used to treat diabetes. The link comes from the Vermont Diabetes Information System, which enrolled just over one thousand participants in a study that relied on self-reported patient information and lab-verified data. The authors of the study assert that the link between TZD use and increased incidence of cancer is significant even after correcting data to allow for the influence of other factors such as smoking, body mass index, and other drugs being taken by the patients.

A little background: TZDs are prescribed because they lower blood sugar levels. They work by lowering insulin resistance, making the body better able to respond to insulin without actually causing an increase in insulin production. Brand name examples of TZDs include Actos, Avandia and Metformin. A type of TZD medication was banned in Europe after it was found to cause severe liver damage. According to the Wikipedia entry on TZDs, these substances are being investigated as potential treatments for a handful of other medical problems, but are currently used just for diabetes.

If there is indeed a link between TZD usage and increased cancer risk, we really need to find out ASAP. These drugs are prescribed to treat a chronic condition, so once you're on one you're likely to stay on it long-term. Who wants to be exposed to that on top of all the other possible side-effect risks? Stay tuned.