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.

What happens when you do "Supersize Me" in reverse? Why, you get a documentary like "Raw for 30 Days." The film-makers of "Raw" got six type 2 diabetics with less than stellar lifestyle habits and persuaded them to switch out hamburgers and fried chicken for a raw, whole foods diet consisting of all-organic, all-vegan foods. Mmm mmm.

You can't see the movie quite yet. But you can see the preview. Just click on over to the "Raw for 30 Days" website. My source says the preview can also be viewed on YouTube or Google Video. The finished product is now in post-production and should be released in time for Spring 2008 film festivals.

The documentary was directed by Sundance Film Festival-winner Aiyana Elliott, but the concept was created by the executive producer, Mark Perlmutter. The idea is to demonstrate that type 2 diabetes can be reversed "naturally" - that is, without the aid of a battery of prescription drugs. Says Perlmutter, "The release of our nine-minute preview may be the first exposure some have to a greater understanding of controlling, if not conquering the disease."

Okay, so the premise is a little shaky. For one thing: how much can be achieved in only thirty days? For another: it's changing lifestyle habits and maintaining them over time that's key in reversing symptoms of t2 diabetes or pre-diabetes. But why be a party-pooper? After all, raising awareness about diabetes is a good thing. I would definitely like to see this film.

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."

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.

Scarborough Research, the leading local market research firm for identifying consumer and retail behaviors in the United States, took the liberty of compiling a list of the top local markets selling diabetic medications in the last 12 months. A dubious distinction it may be, these locations burn like a flame for the moths of diabetes product resellers.

Knoxville, TN, Memphis, TN, and Columbus, OH round out the top 3 local markets for diabetes medication purchasers. The Scarborough analysis also finds that Walgreens is the number one national drug store brand among diabetes medication purchasers. More than 3.1 million, or 18%, of these consumers purchased prescription drugs at Walgreens during the past year. CVS (17%), Wal-Mart (16%), Rite Aid (8%), and Eckerd Drug (4%) complete the top national drug store brands among diabetes medication purchasers.

In Charleston, Wal-Mart is the top store among diabetes medication purchasers, as over one-quarter (27%) of these consumers purchased prescription drugs there during the past year. Rite-Aid (20%), CVS (14%), Fruth Pharmacy (8%), and Kroger (5%) are other leading stores among diabetes medication purchasers.

Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label. The FDA requires numerous clinical trials to prove a drug's safety and efficacy in treating a specific symptom. Once deemed safe and effective, physicians exercise discretion for the use of the drug. It is entirely legal in the United States and in many other countries to use drugs off-label.

More physicians are discovering that many drugs are effective for off-label uses and apply to the needs of their patients. Off-label prescription drugs have become so popular that, today, 1 out of every 4 prescriptions written is off-label. The antiseizure drug gabapentin (Neurontin) is used off-label to treat people with diabetic neuropathy. Another drug used off-label is Lucentis, manufactured by Genentech. It was originally approved for age related macular degeneration, but is now in FDA trials for the treatment of diabetic macular edema. If Lucentis is approved, it would be the first drug to treat this debilitating complication of diabetes.

There are advantages and disadvantages to off-label uses. First (and foremost) is the risk versus reward. You could be the first to experience a breakthrough treatment or you could suffer irreparable consequences from the off-label use. Another consideration is feasibility - often times an off-label treatment may cost you substantially more than the other treatments approved for use. For example, without enrolling in an FDA trial to receive intravitreal injections of Lucentis - it would cost me $2,000 a pop. My peepers are precious, but my pockets aren't that deep! What off-label drug would you consider for use?(With your doctor's blessing, of course).