Diabetes Mine - the all things diabetes blog

NEWS FLASH: Top Orgs Band Together for New "National Diabetes Goal"

At a briefing in Washington DC today, the American Diabetes Association announced a highly ambitious (or crazy?) new National Diabetes Goal: "By 2015, 45% of Americans who are at risk of getting diabetes will know their blood glucose level and know actions to take."  If you do the math, that translates to getting about 59 million people screened and educated. By comparison, the data says that currently, only about 17% of Americans at risk -- about 22 million people -- know their blood glucose levels and what to do about diabetes.  Wow, they've got a lot of work to do. 

At least there's power in numbers, it seems: on board supporting the campaign is a virtual Who's-Who List of nearly every significant diabetes group in the country, including more than 20 diabetes health, non-profit and business advocacy organizations.

The campaign was initiated by the National Changing Diabetes Program (NCDP), a program of Novo Nordisk, which recently commissioned a landmark Gallup study surveying public knowledge and perceptions on diabetes. 

What's interesting about this Gallup study is how comprehensive it is.  The results gathered now constitute the "Societal Barometer" portion of an ongoing three-part "Triple Barometer" study:

* The Societal Barometer is based on a national public opinion survey of 2,015 adults conducted by Gallup^® for NCDP. Results showed that "almost all Americans (94%) consider diabetes a serious health issue, and half say they feel personally affected by diabetes. Yet awareness is not translating into action to prevent diabetes."   

* The second portion, an Economic Barometer, will explore how the cost burden of diabetes is distributed in the US across health care providers, public and private insurers, and individuals. The research will take place in two parts: first, they will conduct analyses of the cost differences between Type 1 and Type 2 diabetes, of diagnosed diabetes and undiagnosed diabetes, and pre-diabetes and gestational diabetes; then a second portion will survey health care providers to focus on gaps in diabetes-related reimbursements and identify areas for improved reimbursement policies (!! - inserted)

* Finally, a Clinical Barometer will assess how the quality of diabetes care is measured in the US and identify any existing gaps in these efforts and recommend improvements (insert more exclamation points).

What's interesting about this emerging National Diabetes Goal campaign is this slogan: Awareness of diabetes is not the problem; it’s time to motivate action. "People are aware of the diabetes issue, and now they need behavioral change," Senior Director of the NCDP Dana Haza tells me.

Yes indeed. But how the heck do they plan on kicking 59 million butts, if you will?  The campaign materials being distributed don't indicate much detail.  All I could find was a statement calling on those at-risk for Type 2 diabetes to ask about getting their blood glucose checked at their next doctor’s visit, and a quote encouraging American families to "take small, manageable steps — rather than drastic, unsustainable changes — to ensure long-term health."   

Small, manageable steps?  Know your numbers?  We could have told you that.  Now what?

According to Haza, the strategy is to enlist organizations and "champions outside the clinical setting" to get things moving among the patient community where they live. By that she means working with the national drug store chains, school nurses, large employers, and community ethnic groups to start prodding people to get tested and make lifestyle changes for the better.

It still sounds a little vague on the details to me.  But on the other hand, just the fact that these groups are banding together this way to attack the problem is pretty huge in itself.  In the words of the campaign brochure, "What kind of progress against diabetes could we make if we unite to achieve one ambitious goal?"  Lots, presumably.  And now they've got exactly seven years to figure it out.

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Other stuff the NCDP has accomplished:

* Remember that big study that came out in January showing that diabetes cost the nation $174 billion a year?  The NCDP was behind that, the goal being to illustrate that just 2% of that whopping sum is spent on prevention, which urgently needs to change, Haza says.

* The NCDP is behind pending legislation pushing for the establishment of a National Diabetes Coordinator.  That would be an executive-level government position -- a Surgeon General of sorts, whose job would be to focus solely on diabetes issues.
 

More Damaging Headlines: the FDA Disses Insulin Pumps

Another diabetes media blitz you won't believe.  Check out "FDA study: Insulin pumps linked to injuries, deaths in teens," an Associated Press headline that's appearing all over God's creation today. 

And I quote:

"The federal review of use by young people over a decade found 13 deaths and more than 1,500 injuries connected with the pumps. At times, the devices malfunctioned, but other times, teens were careless or took risks, the study authors wrote."

"Some teens didn't know how to use the pumps correctly, dropped them or didn't take good care of them. There were two possible suicide attempts by teens who gave themselves too much insulin, according to the analysis."

The FDA study referred to is published in the May issue of the journal Pediatrics; it reports of "adverse events and deaths in adolescents using the pumps occurred from 1996-2005."

I've been corresponding this morning with Steve Sabicer, the spokesman for Minneapolis-based Medtronic Inc. who's quoted in the AP article, and we're both wondering:  What was the FDA thinking??

"This FDA retrospective analysis fails to include ANY data on how other patients manage their diabetes, or what a 'safe' level of adverse events might be when managing such a complicated disease as diabetes.  In fact, most studies contradict this AP story and point to how insulin pump therapy reduces the incidence of adverse events and deaths in patients.  A consensus statement on the topic was published in Diabetes Care not too long ago on this very issue."

Here is a LINK to that consensus piece, which states -- and I quote:

"Based on the available evidence and the experience of the expert panel, CSII (insulin pump) therapy may be appropriate for children and youth of all ages provided that appropriate support personnel are available. CSII use in children and adolescents may be associated with improved glycemic control and improved quality of life and poses no greater, and possibly less, risk than MDI (multiple daily injection) therapy."

It's just short-sighted and frankly silly to blame the insulin pump -- again, one of the best D-tools we've ever had available -- for volatility in some young people's diabetes care.  I cringe to think what kind of repercussions these headlines will have for insurance reimbursement, which is already so tough.  Of course, again, I can only assume it's all about the money.  But talk about risks: the only way you'd get my pump away from me (as Charlton Heston might say) is to pry it out of my cold, dead hands.

More Diabetic Moms-to-Be Than Ever

Now here's a study near and dear to my heart: just this morning, Kaiser Permanente released results of the largest study ever to examine trends in diabetes and pregnancy.  They looked at both pre-pregnancy Type 1 and Type 2 diabetes, as well as gestational diabetes (GDM) in thousands of women who gave birth in 11 Kaiser Permanente hospitals in Southern California between 1999 and 2005. What they found was pretty eye-opening.  Among other things:

• There were twice as many births to women with diabetes in 2005 as there were in 1999

• Diabetes increased fivefold among women aged 19 and under giving birth and doubled among women between age 20 and 39 giving birth

• Back in 1999,10% of diabetic pregnant women had preexisting diabetes, and 90% had GDM. Whereas in 2005, 21% had preexisting diabetes and 79% had GDM.

What does it all mean, and why does it matter?

First, it means that more young people are getting diabetes, especially Type 2.  So it follows logically that more women in childbearing years will have diabetes. 

Second, this has major health implications for both mothers and babies.  In particular, there's an increased risk of miscarriage, still birth, and birth defects (just typing those words hurts).

Third: "This is really important since half the pregnancies in the United States are unplanned and unexpected. The baby's initial development occurs very early in the pregnancy, when lots of women don't even know they're pregnant.  It's really important to have your blood glucose levels in good control before you become pregnant, to avoid those risks," says lead author and investigator of the study, Dr. Jean Lawrence, of Kaiser Permanente. 

She also reminded me to note that the ADA provided funding for this study, which brought one thing to mind: awareness campaign. Sure enough, the ADA plans to use these results (to be published in the May issue of Diabetes Care) as a basis for a major outreach campaign to encourage women to be proactive about their pre- and postpartum health.

"This highlights the importance of pre-conception care for women who already have diabetes.  And women who have gestational should get screened at post-partum checkups -- to find out if they have pre-diabetes or diabetes. This is a crucial period where knowledge is power… Hopefully their blood glucose will return to normal," Dr. Lawrence says.

Amen to that.  Those of you who follow this blog regularly know that my own Type 1 diabetes cropped up after having gestational in my third pregnancy.  After the baby came, I just assumed all was well.  Nobody said much about the possibility that the diabetes might stay, or return, as it were.  I have no idea if my OB/GYN did thorough postpartum screening.  That whole period in my life is such a blur.  But it might have been nice to have a clue what was going on before landing in the hospital for a week. 

At a media conference just last week, a guy came over to ask me how likely it is that his wife, who has gestational now, will become diabetic after the baby arrives.  Who knows?  It could happen to anyone.

Although African-Americans appear most prone to all types of diabetes, the Kaiser study showed that diabetes in pregnancy is on the rise across all races and ethnic groups. The good doctor's Call-to-Action:

1) It's important to see your doctor before becoming pregnant.

2) It's important to have your blood glucose in good control before becoming pregnant.

3) Limiting obesity is the best way to reduce the rising incidence of Type 2 diabetes in young women.  "We really want active families. Everybody should be eating healthy and leading an active lifestyle."

Gotcha.  But couldn't we just put a little bit of pressure on the Guys, too? :)

[Editor's note: if this is your topic, definitely go visit DiabeticMommy.com - a great resource]

Health Care Idea-O-Matic

American Public Media, the people who bring us public radio programs, are very smart.  They not only have some very cool ideas, but they also know how to implement them.  The latest is something called the Health Care Idea Generator, an "online activity that allows the public to share ideas and solutions regarding America's health care system."

Go check it out.

It's a sort of interactive "think tank" where "ideas ranging from small improvements to sweeping overhauls can be entered and discussed."  There are special tabs to identify yourself as a Caregiver, Insurer, Employer, Uninsured or Insured patient.  But you can also just be any old slob with a suggestion about how to make health care better.  Here's the pitch:

"It's widely accepted that the American health care system is broken. But depending where you find yourself within the system, 'broken' can mean different things to different people. The Health Care Idea Generator asks ...'What challenges have you seen, and how can we tackle them?' Using this forum, people can share their ideas and rate or modify the ideas offered by others, too. Ideas can be sorted in a variety of ways—by keyword, geography, or list—to provide a range of entry points into the discussion."

So of course I went right on over and searched for "diabetes."  I found this idea, courtesy of one Dawn Lyell of Toledo, OH:

FIND COVERAGE WITH PRE-EXISTING CONDITIONS
Because I am a Type 1, insulin-dependent Diabetic, I can not buy  private insurance. Therefore it must always come from an employer. As a college student the jobs available either do not offer it or it is very poor quality. I then end up paying too much for my prescriptions and specialist visits. Right now I do not have coverage. It forces me to look into alternative ways to pay for doctor visits, prescriptions or just not get the care I need.  I am very lucky to have a doctor who goes out of her way to work with me. Government assistance is not available for me. I am one of the people who gets hospital stays written off.

My Friends, if you have any inclination at all to play with a web site like this that just might help our voices get heard, please hop on over there and add your support for Dawn's idea. I don't know if it will really change anything, but at least it might get people thinking. 

(What we really need, btw, is an Insurance-O-Matic for people with pre-existing conditions. You with me there?)

Why Testing Matters (Use It or Lose It)

Say what?  Am I really sitting here reading all these headlines about how glucose testing supposedly makes no difference for treating diabetes?  No.  Worse.  That it could actually be harmful to diabetics because they're more likely to become anxious or depressed if they check regularly?

I know I'm preaching to the choir here, but drawing this kind of doofus conclusion that subsequently gets splattered all over front page media just makes me soooo mad. 

This story originated in the peer-reviewed British Medical Journal. In a project known as the ESMON study, British researchers investigated the relationship between self-monitoring of blood sugar, actual blood sugar control and mental health. They used just under 200 people newly diagnosed with Type 2 diabetes, split them into two groups, one that monitored and one that didn't.

"Those who were self-monitoring had significantly higher scores of depression at the end of the study (by 6%), but there was no difference in levels of anxiety, general well-being or energy."

Yeah, well, they probably weren't keen on being under pressure to test all the time, especially being so new to the whole D-game.

I think I've told this story before, but I keep flashing back to that old college friend of mine who was diagnosed with Type 2 last year while I was writing my book.  He's an educated guy who runs the IT department of a small private university.  He called for a tip, embarrassed. Turns out he was sent home with a glucose meter, but given no idea what it really was supposed to do for him.

"I keep getting these numbers, and writing them down.  They're mostly pretty high.  So what does it mean?  What do I do with this information?"

I nearly screamed into the phone.

Clearly, glucose testing does absolutely NOTHING for you if you don't know what to do with the results. It's just a bunch of useless numbers that your doctor may or may not scold you over.  And why would you even consider it when you read all these reports about how testing's going to lower your quality of life?

I think all the glucose meter companies should get behind this one: we need a national awareness campaign about what the heck to do with your glucose meter (other than stare at it and get depressed). Let's push the education agenda, rather than just new models with fancy features.

Most of us Type 1s are all over it, since we have little choice.  Allow me then to provide a couple of very basic tips -- straight from our book -- that you all might like to share with any diabetic family or friends who haven't gotten a proper education about translating meter results into better health:

* test before and after specific foods or meals - you can gauge how that food effects you, and maybe cut down on it, quit it, or plan to eat it before exercising (to offset the BG spike).

* test before and after exercise - to gauge how that activity effects your blood sugar. You may not need a snack every time you go for a walk after all, for example.

* test at same time(s) every day - look for trends. Are you always high after dinner?  Always low before bedtime?  Now adjust your food or medications to compensate.

* remember, your A1c tells you how you're doing overall, but doesn't tell you diddly-squat about your day-to-day routine. Only individual daily glucose results can indicate whether you need to consider changing your breakfast menu and/or scheduling your exercise for a different time of day.

* by the way, it might help to think of it as “Glucose Checking” versus “Testing.”  It gives you information, not a valuation of your worth. No need to feel that you have to “pass” every diabetes-related test you take.

Heck, we all know that diabetes studies can lead to confusion.  I just wish they'd be a little more careful about blasting out the message that the best tools we've ever had for diabetes care aren't worth using.  Aaarggh.

 

Soul Singer Angie Stone Gives Diabetes FACE Time

Get ready for celebrity-with-diabetes interview number... heck, I don't know, I lost count.  But here goes:

"Neo-Soul" singer Angie Stone has been touring the country with her music for nearly 30 years.  For eight of them, Type 2 diabetes has accompanied her.  "Now it's time to give back," she says.  Yesterday, she helped Eli Lilly & Co. launch the new nationwide Fearless African-Americans Connected and Empowered (F.A.C.E.) Diabetes campaign, which will consist of events in churches and community centers across the country targeting African-Americans "to help individuals, families and neighborhoods overcome barriers and live successfully with diabetes."  Because there's an "an urgent need for information on diabetes" out there, the kind that will allow these folks to identify their risks, take control and learn how to better manage this disease.

So what does this Grammy-nominated vocalist have to say about her own take on the 'betes?  Read on.

DM) You say you were in denial for quite a while after your own diagnosis. What triggered you to “face the music” with diabetes?

My diagnosis experience was that I wasn’t expecting this. My mom had been recently diagnosed, but I never thought of it happening to me. I was on my way to an amusement park with family, and experiencing frequent urination. I wasn’t educated. My mom looked at me and said, "I hope it’s not what I think it is."  By  the time I got to the ticket booth all my electrolytes out, and my legs locked up. They had to get a wheelchair for me.  And lo and behold, a new diabetic was born.  It was devastating for me.

But I was in denial. I didn't have the right amount of knowledge. I thought I could manage it on my own. I didn’t know I couldn’t eat as much fruit…I thought eating fruit was healthy. I went on a fruit and juice kick, thinking I could lose the weight. I avoided meat and bread -- not knowing. Everybody encourages you to eat fruit, and you can eat plenty if you're not diabetic.  But fruit turns right into sugar in your system. When I went to the doctor, he said, "Your sugar level is 700."

You feel like food is the only issue, but once you reach the diabetes war zone, you do need medication because it doesn’t just take one day or one week to manage the situation.

DM) What's your regimen now?

I take my meds religiously. I eat properly. I walk a lot. And I like to bowl, at least twice a week.  Everyone’s medications are different, so what works for me may not be for you.  I take oral meds.

Basically the issue with me is to always be learning, it's a lot of trial and error. Every now and then you really "fall off," but mostly you do the best you can.

DM) What’s your biggest “everyday hurdle” with diabetes?

My schedule is pretty hectic. Travel and time zones throw me off of my routine. 

Now I have alarms timed on my cell phone when I’m supposed to take my meds. Wherever I go, my phone chimes. The phone is regimented for 24 hrs, no matter where you go.

DM) How strict are you in your diet?

I'm very good in my diet. It's changed tremendously. I don’t eat French fries.  I try to keep low on things that turn to sugar in your bloodstream, like white rice.  I don’t use butter and all that stuff any more. But if you eat in small portions, you can even eat the things you love. 

I was born and raised in South Carolina.  We are spiritually grounded people.  But we have just become accustomed to eating wrong and just doing certain things habitually.

My mom actually cooked a lot of veggies -- cabbage and collard greens with mustard and things.  I find you can cook those same favorite Southern Recipes with less fatty ingredients and get the same results -- like substituting Turkey for fattier meat.  If we have fried chicken, nowadays I just treat myself to  maybe one piece.

DM) Does your diabetes experience play into your music at all?

I wrote a song on my new album called Take Everything In: 

Lord knows I gotta be
True to myself to see
God's been too good to me
To take things I believe

We all know that we got better days
Even when our world is gray
Trouble don't last always
Thats why I'm leaning on my friends...

It's definitely in there.

DM) Do you have a mantra for diabetes management?

I would just honestly say that knowledge is power.  The more we know, the more we grow, the more our lives begin to show others how to live right.

DM) So what about your commitment to the FACE campaign?

Diabetes heavily affects African-Americans. But a lot of people don’t have the basic info.  A lot don't even know they have diabetes.  They don’t recognize the signs, even if it's hereditary.  Everybody’s symptoms are different -- which is why we want them to log onto the website to look up as much information as possible.  Find out if you’re a candidate, get informed.

For events, the biggest area to deliver the most influential message is through the church system. We're doing a lot there. When you tie a celebrity like me in, people come out to see me up close and personal. They see that I'm a human being just like you -- and I'm using a healthy diet, exercise, and a mental state of positivity to manage this thing.

This is really about educating our people, letting them know they’re not alone. We all suffer the same, we're all at risk. What I would like to see is everybody coming together, facing diabetes, and being open to change.  I won't be touring that much in 2008 and 2009, so I've taken this on as a priority.  I feel you have to pick and choose your battles carefully.  I've dedicated myself to this.  I pray for a cure one day.  Through awareness, we can extend life.  I like to think of myself as an advocate for extending life.

Thank you, Angie, for another view of fighting the good fight against diabetes.

Disability and Diabetes Revisited

The other day as I was filling out some forms –- checking off my gender and race -– I ran into that perennial question: Do you have any disabilities? My gut reaction is always an emphatic NO, but then I remember that delicate dilemma in our diabetic community about freedom from stigma and protection under the law.

I am reminded that advocates are working hard to pass legislation to update and refresh the Americans with Disabilities Act, which has -– according to sources at the Consortium for Citizens with Disabilities (CCD) -- been "warped" from its original intent.  The new bill is an effort to put the ADA (this time: Americans with Disabilities Act) in line with other civil rights statutes that focus on discrimination rather than on whether the person involved is disabled enough to earn protection.

A couple of examples to illustrate:

• The so-called “Sutton Trilogy” – a set of cases that set a “wellness” precedent for people with chronic illness: if you have a “mitigating measure” like prosthetic or an insulin pump that allows you to control your illness, then you’re not considered disabled enough to qualify for protection under the ADA (which kind of provides a perverse incentive to not take care of yourself, ay?)

Trouble is, an employer could say he’s not hiring you because your diabetes (or other condition) makes his insurance premiums go up -– but then the court says you’re not disabled enough for protection under the law.  D’oh!

• Williams vs. Toyota – a case that set the threshold even higher to qualify for protection under the ADA.  The courts are encouraged to look at so-called “major life activities,” i.e. are you substantially limited in something vital that “normal people” do?  A CCD spokeswoman talks about Kerry McClure, an electrician who had interviewed in-person for a job at GM.  He was hired, so he sold his house and moved his family to another state.  But when GM found out he had multiple sclerosis, they dropped him like a hot potato –- despite the fact that he’d passed all the exams and could perform top-quality work.  Still, he had no protection under the law, because the court said if he can brush his teeth, dress himself, and take the trash out, then he can perform “major life activities.”  Aargh.

“That’s just how warped the interpretation of this law has gotten –- people are too disabled for the job and not disabled enough for protection,” the CCD spokeswoman laments.

When you put it on those terms, I damn well want “disabled” protection, too.  If someone tries to edge me out of a job or other opportunity because of my diabetes, I want the law to stand up and say that discrimination is NOT OK.  Therefore I’m very grateful that advocacy groups (including our ADA) are pushing for this revamp of the Disabilities Act, which will flip the issue to put the focus the discrimination, rather than just how disabled the defendant may be. The ADA Restoration Act has good support in the Senate, and will hopefully gain a stronghold in the House within the next month or two, the CCD tells me.

Meanwhile, the The U.S. Equal Employment Opportunity Commission (EEOC) which enforces the employment provisions of the ADA, has made a list of “reasonable accommodations” for PWDs in the workplace.  Employers must provide:

•    a private area to test blood sugar levels or to take insulin
•    a place to rest until blood sugar levels become normal
•    breaks to eat or drink, take medication, or test blood sugar levels
•    leave for treatment, recuperation, or training on managing diabetes
•    modified work schedule or shift change

Them’s your rights, People.  Nice to know somebody’s looking out for us –- even if we mostly don’t feel disabled.

My Take: First Impressions, New Type 2 Implant, Test Strip Bidding War, and More

Taking a cue from Kevin, M.D., here's an "at-a-glance" roundup of my take on some news of the day:

1) Dr. Rob reports on the importance of a physician's opening remarks.  "Saying the right things at the start will make the job much easier."  Ya think?!  Nothing is worse than finally making it in to an endo visit only to be greeted with some asinine remark, like the one KK reported last week.  Of course, being a primary care physician, Dr. Rob says "I don’t really want my patients to 'come here often.'"  We PWDs have no choice, Buster.   

2) This just in: Living Cell Technologies has announced positive results of Phase 1 and 2 clinical trials of its DiabeCell® implant treatment for people with insulin-dependent diabetes.  "The cells are introduced into the abdomen of the patient in a simple procedure under local anaesthesia. The encapsulated DiabeCells do not require the use of immuno-suppressant drugs." Early results at the six-month marker show a significantly reduced need for injected insulin. OK, so the results reported only reflect the experience of a handful of patients -- and one of them, experiencing "personal social problems," still needed to increase her injected doses.  But nevertheless this looks hopeful.  More hopeful than many of the long-shot cure concepts that make splashy headlines on a regular basis, I'd say.

3) Another implant therapy, but this one is just weird. A hospital in New York is now recruiting patients for a second national clinical research study of "an investigational implantable device" called the The Tantalus® System.  It's designed to Type 2 diabetics who are overweight and do not respond to current oral anti-diabetic treatments by "sensing naturally occurring electrical activity of the stomach in real time and automatically apply electrical stimulation when a person eats."  So it's like internal shock therapy?  The patient gets "buzzed" in the stomach while eating so they'll immediately start feeling full?  Sounds kind of like a "diabetic IUD" to keep the food from taking hold, possibly with all the same health risks -- tissue perforation, infection, etc. Gross. Personally, I wouldn't be willing to take the risk with any implantable device unless it actually did something to replace the lost function of my pancreas. Thoughts?

4) Diabetic Investor David Kliff reports on a test strip bidding war spurred by recent Medicare reimbursement cutbacks.  Patients will see a up to 43% less reimbursement on mail order diabetic supplies.  In order to stay competitive, test strip manufacturers are now trying to undercut each other to become the major suppliers to the likes of Wal Mart, CVS and Walgreens, where btw, the lowest name brand product Kliff found was the Accu-Chek Active strips going for $29.34 for a box of 50.  The problem is this cost-cutting will not be passed on to consumers.  "The problem with the winning bidders is that 64% are small suppliers with revenues of $3.5 million or less," Kliff writes.  "It’s unlikely these smaller companies have the resources or sophisticated systems to process orders cost efficiently and handle the additional burden of customer service... Rather than encourage more frequent testing and patient education, CMS has done the opposite. Once again the patient is the real loser here."  Why am I not surprised?  I still think we need to create some kind of grassroots campaign to protest the ridiculously high cost of these mission-critical diabetes supplies.  Ideas welcome.

5) Finally, another weird development.  Did anyone notice that the AADE has put its patient-facing weblog on hold?  Why?  Due to lack of funding, they say.  But how expensive can it be, really, for a national organization of this caliber to run a blog?   I mean, they must have hundreds of CDEs out there who'd be willing to write something for the patient community for very little compensation. Too bad. Stay tuned on that one.

More quick looks at headlines in my Weekly Nuggets section, as always :)

Keeping Drugmakers Honest

Do you have any interest in telling the FDA what you really think about drug ads?  Well, then I have a campaign for you: check out Prescription for Change.  Consumers Union, the nonprofit publisher of Consumer Reports, is running this grassroots push to gather 50,000 signatures to dump on the FDA's doorstep -- calling for better reporting of drug side effects.

Their beef is this:

"Drug companies often fail to present the benefits and risks of the products they advertise, and it often isn't until a drug is out on the market and taken by millions that we see safety problems emerge. The easier it is for consumers to report side effects, the earlier the FDA will be able to detect potential safety hazards."

Furthermore:

"The FDA's current system for consumers to report drug side effects, called MedWatch is woefully inadequate; it's estimated to collect only 1 to 10 percent of all adverse events -- because consumers don't know about it!"

"Last year, Congress passed legislation requiring all printed drug ads to include MedWatch's 1-800 number, but left it to the FDA to determine if such information should also be included in TV ads. Their recommendation is due in March, and it's time to let the FDA know we are serious about better reporting and giving consumers this potentially life-saving information."

Check out their site to learn more.

On a related note, my buddy Fard is running an "experiment" over at his Healthcare Vox blog: can social media help clarify the debate over generic drugs? Can generics cause "a shifting profile of side effects" as the LA Times claims?  Or is that just FUD spread by Big Pharma to discourage purchase of cheaper alternatives to their products?  Fard wants to use the online forum (or his blog, at least :) to find out whether doctors or patients have any hard evidence that generic medications are not truly equivalent to their branded counterparts.  Please go drop him a comment if you'd like to get involved.

What about generic drugs for diabetes, anyway?  Are there many?  Anybody using them?  For my part, I'm still wondering if pricey insulin will ever go generic.

                ****** UPDATE 4/4/2008 ******

The Prescription for Change campaign has now exceeded expectations by gathering 56,000 signatures, and has received some excellent coverage in the LA Times -- calling for TV drug ads to list a mandatory FDA consumer hotline number.  Cool!

                        ****** ****** ******

Scandal at JDRF!

Today, a shocking revelation about the JDRF: two employees have been caught embezzling hundreds of thousands of dollars, the New York Times reports.  This is pretty well the worst news I have heard since my diagnosis with diabetes four years ago.

Imagine the fireworks!  All those parents killing themselves to raise money for JDRF, striving to fund research toward a cure.  All those dedicated walkers and cyclists doing the same.  And all the rest of us, who'd put our unconditional trust and hopes into this organization...

Naturally, bad eggs can pop up anywhere.  Let us hope that the guilty parties -- Jonathan Stenger, national director, and Jason Brown, national manager (who were both already fired late last year) -- were isolated cases of crookdom and haven't colored the rest of the organization.  Just as naturally, however, this scandal is going to leave a blot on the JDRF's rep.  I hope donations don't dry up.

To make matters worse,the foundation's president and CEO Arnold W. Donald, 53, is stepping down tomorrow supposedly due to urgent “family matters” that are unrelated to the investigation. Right.

I'm just so disappointed at the moment.  That's all I have to say.

Stem Cell Cure for Diabetic Mice, Suicide Genes, etc.

Lots of buzz last week about that exciting development in stem cell therapy: Novocell researchers in San Diego, CA, managed to control diabetes in mice using human embryonic stem cells.  A first!  Validating the concept that embryonic stem cells can be coaxed into becoming insulin-producing islet cells right inside a living organism -- rather than simply in a petri dish.

So how far off are we, really, from making this happen in humans?

Yesterday I was privileged to have a long talk with Dr. Camillo Ricordi, director of the Diabetes Research Institute in Miami, FL, who's quoted in the New York Times coverage.  He was actually a bit exasperated that he'd spent such a chunk of his time on the phone with the NYT reporter, explaining all the workings of the science, only to find himself quoted in one single sentence: "For those who say there is not much evidence that embryonic stems cells can cure diabetes, there you go."

Well, he got a chance to explain a whole lot more to me:

THE RISKS

As the NYT notes, the FDA may be hesitant to approve trying this therapy in humans because it involves injecting people with "early-stage" cells that have yet to "mature" in the body. 

"Once you put these cells in vivo they can grow in any direction.  In this study, there was also a tendency toward hypoglycemia.  Maybe the cells will have 'shutdown problems.'  Glucose levels in the 40s and 50s are of course not good," Ricordi says.

There's also that issue of developing tumors, which some of the mice did.  Ricordi says the risk is 15%, which sounds far too high for most patients' taste, I'd imagine.

ROADBLOCKS & ALTERNATIVES

Just a few days before Novocell's announcement, Dr. Douglas Melton's stem cell group at Harvard published a paper in which they were able to "map human embryonic stem cells for differentiation," Ricordi says.  This means they used screening tools to show that only a very few have the potential to become insulin-producing pancreatic cells.

This explains why others have not had success curing diabetes in mice using similar protocols; they simply weren't using the right stem cell lines, according to Ricordi.  But the right stem cell lines are going to be very hard to come by.

"With only 6,000 donors a year, and only half of those suitable for this use, you could cure a max of 3,000 patients a year at best.  But who's going to pay for this?  Once this treatment became available without the need for lifelong immuno-suppressant drugs, it would become like the lottery -- everybody would want it. We don’t want this to be some privilege restricted only to the wealthy."

He also says that human islet transplantation will be widely available much earlier than stem cell therapy.  Islet transplantation from a healthy pancreas source is already in Phase 3 trials for FDA approval, he says. 

WORK-AROUNDS

The big issue with islet cell transplantation -- and stem cell, too, when it's ready -- is the need for immuno-supressing drugs that keep the body from rejecting the implanted material.  These drugs have proven toxic to the implanted cells.  "They block the capability of the cells to replenish themselves, to regenerate... but we've changed the mix of drugs, using a different combo of drugs that have less effect on the cells ability to replenish themselves," Ricordi says.

For stem cell treatment, Ricordi and the DRI are working on another option to eliminate the risk of the cells developing into tumors or other unwanted material in the body.  They're developing so-called "suicide genes."  They would use genetic engineering to pre-program genes to self-destruct in case they don't develop in a certain way.  Pretty neat!  The genes that go bad would just automatically commit suicide.  Sound far-fetched?  Scientists have been working on it for cancer therapy for at least a decade.

BOTTOM LINE

In any case, the Novocell announcement is exciting to the science world, and therefore to us, at a very fundamental level.  "Before, there was no evidence that stem cells can cure anything,"  Ricordi says.  "Hopefully the lessons we've learned from islet transplantations will help in this effort."

Thank you, Dr. R, and a huge thanks to the DRI for the work you all do! 

Rumor Mill: OmniPods OK, Oculir Dies, Roche GLP-1 On the Way

Rumors will fly. They always do.  Don't ever think the world of health and medicine is any exception to that rule.  Here are some details I've dug up on three that readers have run by me lately:

1) "On the CWD forums of late, a few people have been citing a failure rate of 20% for pods.  Someone even said they were able to verify that with their Omnipod rep and that a manufacturing defect was found, fixed and now they are just waiting for the bad pods to 'go through the system.'” 

Wow!  That sounded unlikely.  So I check with the authorities at Insulet.  Here's what their marketing manager tells me:

"People on the product have some problems sometimes, of course, but the incidence is very low.  That 20% figure is just ridiculous!"

Now of course that's the sort of reply you'd expect from a company's marketing manager, but I have to agree that if their pod failure was approaching anything near such a high percentage, they'd be under major scrutiny and/or going out of business.  My personal experience is that I've only had three (yes 3) unexplained pod failures in an entire year of using the product.  And when it works, the product rocks, IMHO. 

2) "Back in Dec. 2005, you wrote about Oculir, Inc., a company that was developing a device to measure glucose levels by scanning the eye.  I've always remembered this and personally think it could be HUGE as (for me at least), the glucose testing is the most painful (not the shots!)... The website you noted in your blog does not seem to be working and I hope the company or the research didn't fold."

I spoke with former CEO John Burd yesterday and found out that the company has indeed been dissolved, as of December 2007.  Believe me, he's as disappointed as we are.  The laser technology necessary to obtain glucose readings from the eyes simply isn't robust enough yet, he says.

"The optics needed to shine on the eye and collect the light was a lot bigger challenge than we anticipated.  This turned into more of a research project versus a development project, and the investors weren't willing to support that."

Drat! Oculir managed to burn through most of the $7.3 million in company financing obtained in 2005.  The rest will be "redistributed," Burd says.  And he personally? 

"l'm looking for my next opportunity.  One of these days somebody’s going to crack the nut on non-invasive glucose monitoring, and I certainly would like to be part of it."

3) "I hear that Roche is developing a GLP-1 analog that has advantages over Byetta as well as Novo’s liraglutide.  My wife (Type 2, controlled nicely using a Medtronic pump) suffered too much nausea from Byetta and Symlin but was looking to try a GLP-1 in hopes of reducing her overall insulin intake.  I heard they’re starting Phase III trials on R1538 shortly but I couldn’t find anything for it on Clinicaltrials.gov.  Do you know how I might find where they will be doing trials?"

Well now, development does seem to be moving forward nicely on Roche's R1538, another injectable for Type 2 diabetics that will, as noted, will compete with Byetta. This drug was originally licensed from from Ipsen in 2003.

A number of sources report that Phase II testing of R1583 was completed in 2007, and the initial data were very encouraging. Phase III clinical trials are anticipated to begin in the first half of 2008.  But so far, all Roche has done is drop some big hints, according to Close Concerns consultancy. Their takeaway from a recent earnings call:

"The company apparently aims for a best-in-class profile for their GLP-1 candidate, R1583 (Ipsen). Phase 3 trials are anticipated to begin in 2H08 –- management made it sound like the decision was made but they also reserved just enough judgment not to push it into phase 3 in case of a surprise."

In any case, nothing on Phase III for this drug appears yet on the company's own Clinical Trials Search site. That would be the place to look when it comes time to signing up in your state.

A few product details from APM Health Europe:

"Kepler Equities believes the most important differentiating point for GLP-1 compounds, which must be injected, is dosing duration. Roche is testing once weekly and once every two weeks for R1583. 

Amylin/Lilly are likely to launch their once-weekly product (exenatide LAR) at about the same time as Novo Nordisk's liraglutide, approved for once-daily dosing in 2009.

But Kepler says Roche's R1583 formulation appears to have advantages over once-weekly exenatide LAR. R1583 is available in a pre-filled syringe and uses a thinner needle, while exenatide LAR needs to be prepared by patients.

If the clinical trials are successful, R1583 could be an important product for Roche."

Oh, and...

4) I know you're all dying for an update on Calisto's Glucoband.  All I can tell you is that they have not yet responded to any of my queries via phone or email.  Not a good sign.