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Upset Over Rezulin Article
I am writing in response to the dramatic May 2000 issue of Diabetes Health. I found the tone of your article on Rezulin strident. Of course, I am never happy to see adverse effects in a medication, but the reality of life is that all medications, including such over-the-counter medications as aspirin and Tylenol, have been responsible for deaths. We live in an imperfect world and many activities carry a hazard.
In addition, in order to keep things in perspective, I would point out that an estimated 400 persons with diabetes die every single day. That perspective, along with an evaluation of the benefits of achieving improved diabetic control and possible improvements in other factors such as cholesterol profiles, tempers my feeling about the risk-benefit ratio of medications such as Rezulin. Many of our patients noted that when they stopped taking the medication, their diabetic control worsened considerably and this greatly distressed them. With regard to the newer medications that are substitutes, we are of course hopeful that they will prove safer, but the proof will be in the long-term experience.
Harley S. Schulz, MD
San Leandro, California
Thank you for Remembering our Children
After reading the June 2000 issue of Diabetes Health, I felt compelled to write you a note. I am the mother of three children whose oldest, 10-year-old Zachary, was diagnosed with Type 1 Diabetes on March 22, 1999. Like you said in your editorial, I wish my children never had to think about diabetes. You really struck a nerve with me when you said that many parents would do anything to trade places with their children. This is exactly the way I feel. When I speak to other parents of children with diabetes, the basic idea is that non-diabetics really don't understand what it is like for a family living with diabetes.
I was very pleased to see you take a stand for our children. When my son was first diagnosed, after receiving all the necessary medical information in the hospital, nobody prepared us for what we were in store for. My first phone calls were to the American Diabetes Association and the Juvenile Diabetes Foundation. I had expected help but I was disappointed. I expected information about support groups and perhaps other contacts that could help us. Instead, I was sent membership information, donation requests and book orders. I do support these organizations and their quest for a cure-believe me when I say that I pray for that every day. But we need to support these children now, and to enhance their childhood while they are still kids!
After reading many books about children with diabetes and searching endlessly for support services in my area, I found there weren't any. With the help of a wonderful diabetes educator that I happened to meet along the way, we planned our first Children with Diabetes and their Families getaway. We managed to get a group of educators and parents together for this project. We hope that, with this project's success, we can make this a yearly affair. It seems to be that unless you are fortunate enough to live next to a major medical center or research facility, there is very little out there for children.
You asked about our wishes-mine would be that although we would love a cure, I would like to see more research money go toward programs directly related to children's support services. I realize that diabetes is not a reportable disease, but I would like to see a national or at least state registry established. This way it would be easier to find other families living with diabetes. I feel that this would be extremely beneficial to accessing needs of children. An older man with a grown son who had diabetes since childhood once told me that diabetes stole his son's youth. I am committed to not letting that happen to my child.
Once again, thank you very much for thinking of our children. I really do feel that our children are our future, and that includes children with diabetes. Keep up the good work-I will look forward to seeing more articles relating to children.
Karen M. Klush
Reader Wishes for Accountability in the News
Here's an idea that I would love to see happen. I wish that when we read things like "Cell Transplants Offer Hope For Severe Cases of Diabetes" as one of the front page headlines in the May 27 New York Times reported, these encouraging breakthroughs would not just evaporate the way they seem to now.
Here is a quote from the article: "In an important advance, researchers in Canada are reporting that transplants of insulin-producing cells have freed eight patients with a severe form of diabetes from insulin injections. The patients, who had type 1 diabetes, in which the body produces little or no insulin, no longer have any symptoms of the disease."
Talk about giving diabetics hope! But then it just disappears into the big black hole of "research." So that would head my "wish list." Breakthroughs would actually lead to something other than a quick headline.
Editors Reply: You're in luck!
Turn to page 37 for more on this story. We provide the in-depth information that you desire. We will have more on this in the next issue as well.
Nighttime Hypoglycemia Article "Was Very Good"
I am writing in response to the article "The-Dead-in-Bed Syndrome" that ran in your March issue ("The Dead-in-Bed Syndrome: Impossible to Prove, but Easier to Prevent," p. 43).
First of all, let me say that it was very good. It hit so close to home for me that it made me cry. My heart goes out to anyone who has lost a loved one this way.
My husband Doug is 30 years old and has been a type 1 for 10 years now. He has struggled with nighttime hypoglycemia and I can't tell you how many nights I have woken up to find him twitching, shaking, soaked with sweat and totally incoherent. Thank God he came through every episode without any problems, but I shudder to think what might have happened if he were alone, or if I was a sound sleeper.
One thing I would like to point out is that almost every time Doug had an episode he did not disturb the bedding. Even though he was having a diabetic seizure and would be shaking enough to wake me up, he always had the covers pulled up to his neck. He would be totally incoherent, and it would take all my strength to pull the covers down so I could test his sugar and give him a glucagon shot. Hence, the people in the article found in undisturbed beds. I know that not everyone experiences the same reactions, but Doug was experiencing some serious symptoms and did not mess up the covers.
We have also noticed that the more low sugars Doug has the more he is losing the warning signs, which is so dangerous. Doug now takes every precaution against getting a nighttime low, and he hasn't had one in over a year. We always keep a glucagon kit handy and it is a must-have for every diabetic.
Round Top, New York
Nighttime Hypoglycemia is Scary
My daughter was diagnosed with type 1 diabetes over three years ago at the age of 10. I am always interested in gaining as much information as possible about this disease and what I can do to give the best possible care. Hopefully, this will help her avoid complications and be as healthy as possible.
I have subscribed to Diabetes Health for the past three years and have always found it to be very informative and interesting. I was, however, extremely upset by a recent special feature in the March, 2000 issue.
The article was entitled, "The Dead-In-Bed Syndrome." Just the title of the article raised my anxiety level. The article went on to tell about a 17-year-old who had died in her sleep where the likely cause was a dangerously low bout of hypoglycemia. The article continues to state there is no absolute proof of sudden death occurring during nighttime sleep due to hypoglycemia, and that sudden nighttime death for any reason is uncommon.
Try telling that to a 13-year-old who already has anxiety about a severe low in the night. I think the information could have been presented in a much less sensationalized manner, especially taking into consideration the feelings of children who may be reading this article.
I feel the title, "Dead-In-Bed" is indicative of the hype of this article as well as a lack of sensitivity toward children with diabetes and their parents who already have to deal with the unpredictability of this disease.
Editor's Reply: Thank you for writing. Though we hesitated to run this story out of fear of scaring people, we take this issue very seriously and hoped our article might prevent injury. We also tried to include prevention strategies at the end of the article to complement a difficult piece of information with something positive and constructive.
We are bound to discuss issues in the language that the majority of the diabetes community recognizes. The term "dead-in-bed" is not our invention, but one that has been used in all published medical research on the syndrome for the past decade.
We never aim to frighten with out editorial content. Rather, we want our readers aware of what is going on, so they might take steps necessary to keep safe. This occasionally means candid reporting that may upset some readers.
Any suggestions you or other readers might have on how we can make the paper appropriate for younger readers are welcome. They are an important part of the diabetes community, and we want to be as sensitive to them as possible without keeping them in the dark.
Publisher and Editor-in-Chief
Readers Praise the DCCT Study
I have news regarding "Clues to the News" (May p. 4) and your request for a helpful discovery that has resulted from recent diabetes research. The National Institutes of Health funded the Diabetes Complications and Control Trial (DCCT), the seminal study that had a significant effect on the care and treatment of insulin-dependent diabetes. It was the DCCT that indicated the importance of frequent blood glucose monitoring and insulin injections as a way to control diabetes and ward off debilitating complications. Just as significant, the DCCT found that any incremental improvement in diabetes control (as measured by HbA1c tests) delays the onset of diabetes complications. The findings of the DCCT were so profound that the trial was suspended before its scheduled completion in order to make its results public and help improve the treatment of people with diabetes. The importance and influence of the DCCT continues to affect diabetes treatment today.
You asked what the DCCT gave kids. Here are a few of its results:
You claim that "we" already knew that better control reduces complications. You should be aware that some people continue to deny the connection between control and complications. After all, few people test as much as they should.
You wrote that the DCCT offered "intense care that is close to impossible for people to achieve in the real world." You are wrong. I was a DCCT experimental volunteer. I lived in the real world then, and I still live there. The DCCT taught volunteers how to take care of themselves.
If you look through your June issue, you might notice some positive influences of the DCCT, such as the emphasis that people place on controlling BGs to reduce complications, frequent testing, avoiding lows, using support people and so on.
On page 14, the article about California giving better care in order to save money states "The California program is based on the Diabetes Control and Complications Trial."
The FDA approval of the GlucoWatch reported on page 22 might not have happened if the DCCT had not scientifically and conclusively proved that better control (and more testing) means fewer complications.
In the second-to-last paragraph on page 50, the author talks about "the past [before the DCCT] when less was known about insulin therapy and the benefits of multiple daily injections."
On page 62, your pump column states, "Since the DCCT, pediatric clinicians have been challenged to find intensive regimens that better suit teenagers' changing lifestyles and promote better metabolic control."
A letter to the editor on page 66 argues "The DCCT... showed for the first time that all the effort people with diabetes put into intensive self-management actually pays off." I hope I got my point across.
Applause for Scott's Words
I'm a diabetes educator in Connecticut, and I agree with Scott King that it's time somebody raised the issue about all the money that's being spent.
There's a whole lot of money being spent on research but it doesn't seem like there's much product.
What is it that we're getting for our dollar? People keep asking for money, but what, specifically, can they tell us timewise?
Your paper is in a very good position to continue to educate people with diabetes and their families that there is hope in all this mess. I think you're on the right track. I think your articles are very good. I take a copy of the paper and bring it to the office every day.
I hope that you'll write a lot more on this in the future. It seems like diabetes is a moneymaker for lots of people, and lots of us may not get a whole lot of benefit from what's going on. I just wanted to say I really enjoy your magazine and I know a lot of my patients enjoy it, too.
Ron Clark RN, MSC
Cost of Laser Lancet Challenged
A few weeks ago I saw an advertisement in your magazine for a new home laser-lancing device. I have a lot of trouble with lancets, like heavy callusing, so I was genuinely interested in this new development.
After calling the manufacturer, I received a nice literature packet in the mail. The price of the device is high, and not covered by insurance, but along the lines of what I would be willing to pay. I found, however, to my dismay, that the thing requires an expensive consumable in the form of a "shield," which must be changed with every use. On top of the thousand dollars for the unit (several weeks' pay), the ongoing cost of operation would be more than with mechanical lancets.
I am an engineer with 27 years of experience in electronic systems, and currently president of a multinational firm manufacturing military electronics. I have been a type 1 diabetic for longer than that, and I do six to ten finger sticks a day. Additionally, I have worked on teams preparing electronic systems for FDA approval. I do not see consumables as being anything more than an additional revenue stream for the manufacturer.
Like most diabetics, I long for a noninvasive blood glucose measuring device and any related accessories. I am willing to pay four figures for one as long as that is the only expense involved. Since blood test strips are lucrative for the suppliers (some companies even give away meters to capture long-term strips customers), there is no incentive to develop a new device that does not require expensive consumables.
I have no problems with profits (in fact, I believe they are necessary as an incentive for manufacturers to produce the things we need), and I fully understand the logic behind designing an expensive consumable item into a product. However, I am free to exercise my choice as a consumer by not purchasing products whose design philosophies require a heavy ongoing expense.
If every prospective consumer would communicate similar intentions to the manufacturers and refused to purchase these types of products, I promise you they would be redesigned in short order to operate at zero cost once purchased.
To all manufacturers: work the cost of your R & D, FDA extortions, related expenses and your desired profit margin into the original cost of the product, not into operating expenses.
Reply: We asked Cell Robotics, Inc. for a response
All of us here at Cell Robotics share the concern that Mr. Uhrig has for the cost of medical devices and the on-going cost of consumables.
While the price of the Personal Lasette may seem high, it is half the price of the original clinical version and is the lowest priced high-powered laser in the world. We have made great strides and have focused our resources on lowering the cost of this device.
We are happy to report that many private insurance companies have been paying for the Personal Lasette for their customers.
The disposable film cartridge that is used by the Personal Lasette is discarded after 120 uses and is priced at $15 each. This is very close to the cost of lancets that it replaces. The laser makes a small hole in the finger by vaporizing the skin with laser light. The vapor comes off the finger in the direction of the laser and the optics that focus the laser light. The film cartridge provides a barrier between the finger and the optics. Without this barrier the laser optics would eventually be permanently damaged. We explored many solutions to eliminate this cartridge but were unable to find a solution without adding a great deal of on-going cost to everyday operation.
We hope that insurance companies will continue to pay for the Personal Lasette. The elimination of pain and soreness is an important step forward for those who hesitate to test regularly because of the pain, soreness or fear of the steel lancet.
We always welcome your readers' comments and questions.
H. Travis Lee
Cell Robotics, Inc.
Give Food a Chance
I would like to inject (pun intended) a voice of moderation into the debate between the letter-writers to Diabetes Health who obsess over how to eat: low carb, high protein, low protein, fats, Atkins diet, glycemic index, supplements and food fads in general.
Diagnosed as a diabetic in 1955, when it was called juvenile diabetes (now type 1), I was encouraged then to weigh all my food on a special scale provided by a dietitian. The only scale I've ever used is the one I weigh myself on.
While I fiercely support the DCCT results and advocate correct insulin and medication dosing, frequent meter testing, regular exercise and constant self-education about our disease, I seriously question the current over-emphasis on the need for strict adherence to food control and calorie counting. Rather, I suggest a less rigid attitude in the kitchen, freeing oneself from the shackles of diets, recipes, carb-counting, etc., while adopting moderation as the keystone instead.
Obsessiveness and compulsiveness may or may not give us diabetics some extra time on this planet, but will the stress of these behaviors make the trip worthwhile?
Santa Monica, California
Preventing a Stroke
In April 1993, my fasting lab blood glucose was 168. In February 1995, my fasting lab blood glucose was 192. In January 1997, my fasting lab blood glucose was 258, and I had plus 3 glucose in my urine. I was then told that I might have a blood sugar problem.
I hired an endocrinologist. In January 2000, my endocrinologist referred me to a cardiologist. My cardiologist determined that I needed a coronary artery bypass operation. One of my coronary arteries was 100% blocked, another was 90 percent blocked, another was 70 percent blocked, and so on.
Being a diabetic may have saved my life. Since I am a diabetic, a doctor examines me several times a year. My blood circulation problem was caught before I simply keeled over dead.
My cardiologist referred me to a heart surgeon. In early March 2000, I underwent a quintuple coronary artery bypass operation. I was released from the hospital three days after this operation.
Two days after my release from the hospital, on a Sunday evening, I had a stroke. Neither my wife nor I knew that what I was having was a stroke, and that time was of the essence. My wife made a telephone call to my cardiologist's answering service, and we waited for a return telephone call. My cardiologist was out of town. I did not get to an emergency room. The next day I was again in a hospital.
I have since learned that in the United States alone, each year, about 500,000 people have a first stroke. I understand that each 160,000 stroke victims die. Stroke is the third-leading cause of death in the United States. Many of those who survive a stroke are left with very serious health problems.
Since diabetics are more likely to have a stroke and since the effects of a stroke are often disastrous, I suggest that you publish an article about the symptoms of a stroke, along with the symptoms of a transient ischemic attack (TIA), and with the recommended response.
This information will save lives. This information may also save people from becoming disabled.
West Covina, California
Strokes obstruct the flow of blood to the brain, cutting off its energy supply and injuring it. If the obstruction continues for several minutes or more, it irreparably damages the affected area, causing disability or even death.
Prompt medical treatment is vital in preventing or minimizing the damage caused by a stroke. Call 911 immediately if you experience any of the following symptoms:
Pushy Fund Raising Tactics
Thank you for your article on diabetes non-profits in your May issue ("Diabetes Nonprofits: What Are They Doing With Your Money?" p. 29). In December I received a large packet from National Diabetes Fund. It said "thank you for volunteering to collect money in your neighborhood." At first I assumed it was from the American Diabetes Association because I have collected for the ADA in the past. I had not agreed to collect money any organizations in the past two years. Then I noticed it was addressed to my son who was nine years old at the time. My son is the only one in our family who has diabetes.
I felt it was misleading of this mailing to o say he had volunteered when he hadn't. I also noticed a small sheet of paper in the packet that said only 7% of their money goes to research. I called the Iowa Attorney General's office and found out the National Diabetes Fund was not licensed to raise funds in the state of Iowa and they had received other complaints.
It is very important to read the name of the organization carefully before pulling out the checkbook.
Women and People of Ethnicity not Variables
It is one thing for the Cooper Institute in Dallas to focus on professional, white males in its research on the correlation between alcohol consumption and type 2 diabetes. It is another thing for your magazine to headline the article "Surprising Findings for Moderate Drinkers," as if the article was going to be relevant to all your readers. Honestly, would you have used the same headline if the research subjects were black women?
The article reports that the researchers "admit" that the focus on white male subjects "may preclude accurate assessment of women and other ethnic groups." And yet, the researchers also justify their study by arguing that the very homogeneity of their subjects should be considered an advantage, "as it limits any variables."
Please take note: women and people of other ethnicities are not "variables." Like white middle class men, we demand our share of the research, and expect accuracy in your reporting.
Some People with Diabetes Fight a Second Battle-Alcoholism
You put out an excellent magazine, and here is my suggestion: how about an article about alcoholic diabetics?
The depression that often accompanies the diagnosis and the adjustment to a strict regimen is a familiar feeling for many diabetics. It makes self-medication with alcohol a most alluring (and dangerous) temptation.
I am 44 years old and have known I have diabetes (either type 1 or type 2, the physicians still are not sure) for five years. The first year or so, I was so terrified that I did everything right-lost weight, exercised diligently, gave up wine (I lived in Sonoma County at the time, and that was tough).
Then some setbacks, diabetes-related and otherwise, overwhelmed me. I've become a full-blown alcoholic, been through rehab and still struggle one day at a time to retain sobriety and control my diabetes.
It's not a kind combination. In all the internet articles, magazines, books and group sessions I consult, I have never encountered an honest discussion of alcoholism and diabetes.
Those of us who battle both diseases would appreciate more information. One of the things I admire about you and your publication is that you will wade into controversies. God knows this is one.
Covering What Other Magazines Dare Not Report
One of the most important aspects that attracted me to Diabetes Health was its coverage of vitamins and herbal supplements. Shamefully neglected by a large number of diabetes caregivers because they are not knowledgeable on the subject, vitamins and supplements can nonetheless play a part in diabetes care, along with standard treatments.
I am impressed that the editors of Diabetes Health are open-minded to this controversial issue and publish reliable articles on products that wouldn't be advocated in other quality diabetes magazines.
I am an 18-year-old type 1. When, after a half year of diabetes, I developed severe cataracts unrelated to age or slightly elevated blood sugars, I decided to investigate herbal therapy. The use of various herbal supplements, along with my prescribed medication and diabetes care, has helped me tremendously in my diabetes care and general health.
I enjoy your articles on herbal supplements, and many of them have proven to be useful to me.
Weyers Cave, Virginia
Caught in the Middle
Your publication is by far the most up-to-date on research and clinical issues. I would love to see something written about "other types" of diabetes. I was diagnosed seven years ago as a type 1 and spent 5 1/2 years dealing with extreme lows and horrible hypoglycemic unawareness.
I was given a C-peptide test in November 1998 that came back normal. I was then reclassified as a type 2 and put on two types of pills and taken off insulin. I fought with those pills for six months and am now happily back on lower doses of a Humalog/NPH combination and doing great. I am 28 years old, very active, very healthy, and 105 lbs. I am now being called a type 1 1/2. I have found very little on this, and am proof there are more than two types of diabetes!
Silver Spring, Maryland
Some Words of Praise from Our Readers
I truly enjoy your publication and recognize Diabetes Health as being honest, truly dedicated to finding a cure for diabetes, informative yet entertaining, and not motivated by any political agenda.
Thank you for providing this service. I just renewed my membership for an additional two years. . Thank you for offering a very inexpensive service. I'm looking forward to the next publication!
John T. Sherman
Although I don't agree with all of the content, I love your publication. I just wish everyone with diabetes could receive a copy. Keep up the good work.
Charles M. Alexander, MD
West Point, Pennsylvania
This summer I am co-directing a basketball camp for kids with diabetes with a patient of mine. Our goal is to provide an opportunity to learn more about diabetes in a safe environment while having fun at basketball camp. The kids will be asked to bring a buddy to camp so that friends or siblings can also learn more about diabetes. Our camp will have a different theme every day. One day the focus is on athletes and diabetes. Your June issue of Diabetes Health would be a great thing for all the kids to have. Would it be possible to get about 50 copies for our campers with diabetes? It is an inspiration for all children with diabetes and will hopefully inspire them to pursue their dreams.
Patty Gatcomb, FNP, CDE
New Haven, Connecticut
Editor's note: We are happy to send you these issues.
An Important Omission
The Diabetes Society of Santa Clara Valley happens to have one of the largest camping programs for teens and children in the country. Our camping program has now been in existence for over 25 years, and is growing all the time. We are especially unique in finding venues that appeal to teens such as our Cruise Camp, Camp Fox at Catalina Island and Surf Camp in San Diego. This makes us very different from almost every diabetes education camping program in the country. As we all know, it is very difficult to find venues that teens will participate in.
Our program consists of six residential, three family and several day camps for children and teens ages 6 to 18. Our campsites are located in the Santa Cruz Mountains, Lake Sequoia, Lake Tahoe, Santa Rosa, Sacramento and Las Vegas. We also offer scholarships to teens, children and families who otherwise could not have afforded this experience.
Thank you for the opportunity to highlight these points for your readers and for including the Diabetes Society in your publication.
Debra L. Trent
Santa Clara, California
Diabetes Health Correction
In our May article on non-profits ("Diabetes Non-profits: What Are They Doing with Your Money?" p. 29), using numbers from guidestar.org, we reported The Barton Center for Diabetes Education, Inc.'s program expenditure as only 51%, the second-lowest figure on our chart. In fact, the Barton Center spends a far greater percentage of their total revenue on their program than was reported.
In non-profit accounting, long-term expenses like the $467,000 the Barton Center spent on renovating their cabin and cafeteria facilities last year get reported as investments rather than expenses. In all but the most detailed financial reports, this can lead to gross underestimates of how much an organization spends on its program, as opposed to administrative costs.
Our evaluation of the Barton Center's financial records failed to take their renovation expenses into account. When this number is factored in, program expenses become 84% of the Barton Center's budget.
Upset Over Rezulin Article
Your publication's article in the May issue about the withdrawal of Rezulin from the marketplace was inflammatory and one-sided ("Rezulin Pulled After Death Toll Mounts," p. 22).
Questions not asked in this and most other media diatribes that would provide balance and illumination are:
How many people are injured or killed by other drugs, including over-the-counter medications?
How many hundreds of other products have or have not been recalled before?
How many have died while taking insulin or sulfonylurea medications?
If a person is allowed to take harsh chemicals that can kill or maim, such as certain chemotherapy agents, and these are prescribed and monitored by a doctor who is a specialist, wouldn't requiring prescription by a specialist be a prudent step before market recall?
Are the other glitazones (ACTOS and Avandia) safe for someone to take if they have congestive heart failure?
If liver disruption occurs and Rezulin is withdrawn, does the liver function return to normal?
Do all the glitazones have the same beneficial effect on blood fats and cholesterol that is seen with Rezulin?
Would the FDA or a person's personal physician be more likely to see the whole picture in terms of a person's life, requirements, abilities and safety issues?
Since it is not possible to be an expert in all things and one must rely on the opinions of experts, why didn't you ask anyone who may have had a qualified different opinion what their point of view was?
Rezulin may have been a good drug. It may have been safer than acetaminophen, and it may have been the only safe alternative for someone with congestive heart failure and diabetes. It may have been an excellent source of support for healthy cholesterol levels. And its problems may have been temporary.
How many now will be hurt because a premature reaction was accompanied by irresponsible reporting?
Lois Weiss RN, CDE
San Francisco, California
Jul 1, 2000