Friday, March 14, 2008

Friday Roundup

Since it's Friday, I can look back on the week retrospectively and say that it was a pretty good week for type 1 diabetes generally.

Another CGMS Approved by the FDA ...

I certainly wasn't the first to report it, but for what its worth, Abbott reported earlier this week that the FDA had finally approved its FreeStyle Navigator continuous glucose monitor (CGM) for sale in the US, which many expected to resolve some of the nagging issues that have plagued the Dexcom and Medtronic Minimed CGMS systems so far. I personally cannot comment because the industry as a whole has done a very poor job of securing widespread insurance coverage for these costly devices. Since all of these devices are only first or second generation, many bugs remain, and the learning curve among diabetes educators is still pretty steep. But with 3 now on the market, we may finally begin to see more coverage in the coming months. But the Navigator has a dedicated website where you can find some additional information.

... And Another CGMS On the Horizon?

Yesterday, The Boston Globe reported that a Franklin, Massachusetts company called Echo Therapeutics Inc. hopes to win approval from the US Food and Drug Administration (FDA) to market a non-invasive (needle-free), wireless, transdermal continuous glucose monitoring (tCGM) system designed to provide continuous, on-demand blood glucose readings and glucose trend data. The company expects to apply for approval on the the device as soon as late next year to both hospitals and diabetics for home use.

While the Globe article notes "To be sure, Echo is still tweaking the device. It now uses ultrasound technology to expose capillary blood vessels to measure blood-sugar levels. But in future versions, the device will scrape off the outermost layer of skin." Uh, that sounds kind of painful, kind of like the ill-fated GlucoWatch from Cygnus Inc. which won FDA approval for its device in 2000, but quickly failed for a variety of reasons. Echo says its system is superior because patients wouldn't have to use a needle to insert the sensor, which could be placed on the body like a bandage.

However, the article notes that so far, investors do not seem impressed by Echo's potential. The company's stock closed at $1.35 on Wednesday, down from a high of $31.70 in 2004. Echo's current market value is just $25 million, and Echo would likely need to raise tens of millions of dollars for clinical trials and other work to bring the product to market. The company had $2.3 million in cash as of September. I guess only time will tell.

JDRF Blogger Roundtable Goes Live

In other news, earlier this week, the first JDRF blogger round table went live on the JDRF website, and yours truly (along with some other familiar faces) are on the main page. I've had the great pleasure of meeting a number of these bloggers (Allison, Allie, Amy, Gina, and Kerri) and been on conference calls with Bernard, although we have yet to meet in person (yet). So far, I haven't yet had the chance to meet Scott, Sandra, or Manny but perhaps someday ... but I subscribe to all of their blogs, and think this provides a great forum for others, too. Additional feedback and questions will be posted on the JDRF Blogger Roundtable in the future. To have a look, please visit the website here for details. You can also click on the "Roundtable Discussion" logo under the "Other" category in the right margin of my blog.

Denise Faustman Human Clinical Trials to Begin

I have written about it in the past, but her human clinical trials have been one of the most anticipated events in diabetes research for many people. Yesterday, it was finally announced that scientists at the Massachusetts General Hospital (MGH) have initiated a phase 1 clinical trial to reverse type 1 diabetes. The ClinicalTrial.gov posted a trial announcement looking for people to participate in the first phase clinical trial.

"We are pleased to be starting human clinical trials," said Dr. Faustman. "Human trials take time, but we are making the step from curing diabetes in mice to determining whether it will work in men and women with diabetes."

Certainly, an army of people have been excited about these trials, but I would caution everyone not to get too excited just yet for the reasons I noted in my previous post (and contrary to what the article states) -- the mouse experiments used Fruends complete adjuvant, while the human clinical trials will test using a vaccine called Bacillus Calmette-Guerin (better known by its acronym BCG). I should note that subsequent trials using mice dosed with BCG do suggest that it has the same impact, but mice are not human beings, and dozens of cures have worked on mice, but so far, none have been successful in humans. That's why it is a trial ... they don't know if it will work, and if it does, what doses will work, and how those vary by weight, diabetes duration, etc. The early trial will try and establish basic dosing information and determine whether the approach actually works in people. This means that even under ideal circumstances, a lot of work remains.

David M. Nathan, MD, director of the Massachusetts General Hospital Diabetes Center (MGH), who is leading the human study at MGH, provides context, "This is the very first step in what is likely to be a long process in achieving a cure. We first need to determine whether the abnormal autoimmune cells that underlie type 1 diabetes can be knocked out with BCG vaccination, as occurred in the mouse studies."

More News on the FatalFood and Drug Administration

Apparently, after what FDA commissioner Andrew von Eschenbach (perhaps the worse FDA commissioner ever) called a national search, he has apparently decided to give the position of permanent head of the Center for Drug Evaluation and Research to Dr. Janet Woodcock. Woodcock had been the acting head since September, but there were rumors that they were considering Jesse Goodman, who oversees the biologics division, for the job (we can thank ourselves for small favors!).

Woodcock is by training, an internist and rheumatologist, and although she's seen as tough, she's also a seasoned hand, having begun her previous stint as director of the FDA's Center for Drug Evaluation and Research back in 1994. Furthermore, drug industry officials don't view her as likely to attempt wholesale reversals of agency policy.

"Dr. Woodcock's outstanding scientific credentials and historical knowledge of the complexities involved in drug safety and regulation make her uniquely qualified to oversee, as well as modernize the techniques, tools, and methods used for evaluating the safety and effectiveness of drugs throughout the product life-cycle," von Eschenbach said in a statement.

Her first and biggest task will be to implement a major law passed last year by Congress known as the Food and Drug Administration Amendments Act of 2007 (FDAAA), which aims to deliver expanded authority to the FDA to govern the safety of the U.S. food and drug supply. A key element of that legislation is that it requires more comprehensive, objective post-market safety and risk-mitigation activities from pharmaceutical, biotechnology, and medical device companies than has historically been required. As part of these new requirements, the agency will be required to hire hundreds of new staffers and figure out how to implement a raft of new powers.

Dr. Woodcock spoke in a 1997 interview on why the FDA should regulate drugs which may provide an interesting glimpse into her perspective on this issue.

5 comments:

in search of balance said...

Faustman's trial also doesn't include the spleen cells, right? I know that there were a few mixed opinions about where the regeneration came from in islet cells, but the most recent was on the spleen cell side of the fence. So this trial would likely only, at best, prove to disable the T cells that are killing our islet cells... not result in a cure. But here's to that working, so further tests including spleen cells can go forward and maybe result in a cure!! :)

B

Bad Decision Maker said...

Anyone know anything, regarding Faustmann's trail, about what stage of T1 diabetes they're talking about? Is it only newly diagnosed people that still have some beta cell function less? I'm assuming that's what it is if it works on the immune system and not regenerating beta cells in some way. Which means its likely to be useless for most of us that have had T1 for any length of time.

The stem cell work that was published last year (JAMA, April 2007) that was done in brazil was only with people that were newly diagnosed and still had some beta cell function left.

I'm not super-into the cure focus in research/the diabetes world, but I was curious about this...

Bad Decision Maker said...

Oops... I just answered my own question by reading the clinical trial announcement you linked to. It looks like they really are looking for people that aren't newly diagnosed and don't have much beta cell function left (they want low c-peptide levels).

I still would be interested in any other information or thoughts other people have about this...

Anonymous said...

I have an appointment on Monday and tTuesday with my husband to donate blood for the trials. I'm also going to volunteer for the Phase 1 trial - Dr. souza seems to think I'd have a shot at it. I'm willing to fly out from colorado, however many times it takes, to do this. I'm sick of sitting around, waiting for a cure. I have no compunctions about becomng a walking lab rat for the good doctor. It may not help me, but at some point down the line, it may help solve part of the 'cure' puzzle. Getting rid of the bad T-cells responsible for the beta cell destruction is a good start. Shoot me up with BCG and let's see if this stuff really works. Nothing ventured, nothing gained.

Anonymous said...

I believe that Faustman has indicated that she believes that the mice were cured because the reprieve from beta cell destruction allowed islet regeneration (I'm probably butchering that). I read about her research many months ago, after my daughter was diagnosed, and she was essentially responding to criticism that her technique wouldn't result in a cure b/c some repeated experiments showed that the spleen was not helping. I remember her saying something along the lines of 'the body is too smart to only regenerate iselts in one way,' and conveyed her belief that if they could kill the bad T-cells with BCG, regeneration could still take place (even without the spleen's help).