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The letters we received in response to Joan Hoover's article "The DCCT Offers Nothing to Diabetic Patients" were surprising in a number of ways. Firstly, they were primarily from health professionals: doctors, researchers, nurses. Secondly, almost all of them were opposing Ms. Hoover's viewpoint. We are printing the letters (some have been edited for length) because such a response deserves consideration, but also because the letters touch on many of the reasons behind the DCCT study. Also interesting is that each letter has a different view on the DCCT.
Most People Miss the Point
In the April, 1994, issue of Diabetes Health there were a number of articles commenting on the DCCT (Diabetes Control and Complications Trial), both for and against it. Surprisingly, none of them touched on one of the main points of the DCCT results.
Although everybody acknowledges that keeping blood glucose at near-normal levels will greatly reduce complications, no one has mentioned the relationship between HbA1c levels and the incidence of retinopathy. The report from the type II diabetes on the results of the DCCT included a chart plotting both HbA1c levels and rate of retinopathy, and the implications are quite clear. A person's risk of retinopathy is reduced by half every time they reduce their HbA1c levels by two points. For example, someone who went from an HbA1c level of 13 to a level of 7 would be 1/8 as likely to get retinopathy as when they were still at 13.
Most people think the DCCT says that near-normal blood sugar levels will reduce complications. Most people are missing the point. What the DCCT actually counsels is to try the best you can, because every little bit helps.
Barry H. Ginsberg, MD, PhD
Franklin Lakes, NJ
Researcher Speaks Out
I have known and respected Joan Hoover and her writings over the last 20 years. Nevertheless, I feel that in her article (summarized in Diabetes Health, April, 1994), she has unjustly criticized the Diabetes Control and Complications Trial (DCCT), both for what it was supposed to accomplish and its importance for the future of diabetes care. She also claimed the DCCT's conclusion, namely that greater normalization of the blood sugar would reduce the deleterious eye, renal, and neural complications was "not news."
I was not involved directly in the DCCT trial, but for over 30 years my laboratory has studied islet B-cell function and the exquisite minute-to-minute regulation of insulin release that occurs in response to stimuli. Thus, intuitively, I too would have anticipated that approaches to better duplication of the normal B-cell's ability to closely regulate the blood sugar would reduce peripheral complications. Animal studies also supported the concept. Unfortunately, neither scientific intuition nor animal studies can substitute for a factual demonstration that regulating the blood sugar is beneficial in human beings. Actually, when the DCCT trial was initiated, there were some who felt that diabetic complications were determined by genetic backgrounds that we could little affect. There was also the possibility that the B-cell co-secreted, with insulin, some unknown beneficial agent that was lost during purification of insulin-an unhappy possibility for which no amount of insulin could have compensated. The DCCT trial established that improved blood glucose control was adequate to reduce complications even in the face of genetic or other unknowns. This is a very happy outcome.
Joan Hoover criticized the DCCT trial because it did not "seek knowledge of the cause of diabetes, or means of preventing or curing the disease"-the trial was never designed to do so. What it has done is to establish our goal-improved glucose regulation. The additional criticism that the methods employed in the trial to improve glucose control are currently physically demanding, expensive, and difficult to sustain for both patients and physicians is very true, and I concur with everything she wrote in this regard. Additionally, methods for current "good control" are crude when compared to what a normal B-cell can do. But the criticisms have completely ignored the near future and assume the status quo will persist. Over the past years, both scientists from other fields and industry executives have asked me (and others, I'm sure) that if they divert major resources to improve methods of blood sugar control for diabetics, would those methods (or products) be acknowledged as important treatment modalities. The answer used to be "lots of us think so;" now it is "yes!" The DCCT study has and will stimulate increased focus on those methods. Obvious examples include: 1) an indwelling or non-invasive glucose sensor connected with an insulin pump, or 2) an efficient transplant system using islets or genetically engineered "B" cells. Any of these methods would suddenly make today's treatment an historical transient and the criticisms of the trial misdirected. Considering the rapid advances in current biotechnology, we must also anticipate that completely unpredictable new approaches for achieving improved glucose control will occur. After all, in the "Long Range Plan to Combat Diabetes," sponsored by the National Institutes of Public Health and published in 1976, a major concern was that there would not be enough animal pancreases to supply the world's need for insulin. Today, because of molecular engineering the supply of insulin (structurally identical to human) is inexhaustible.
How far away are these developments? No one can be sure-but with the impetus of the results of the DCCT trial, they will come much sooner.
Gerald M. Grodsky
Professor of Biochemistry & Biophysics
University of California at San Francisco
Board Member Responds
Unfortunately, in 1994 there is no cure for diabetes, and if that is what Ms. Hoover seeks (as do we all) we are still waiting. In this light, prevention studies are now ongoing and have received funding. In regards to the DCCT offering nothing new: in the health care community, despite the knowledge that people without diabetes didn't get diabetes complications, many care givers and patients refused to accept the fact that control was important. In lectures across the country and in medical journals prior to the DCCT, tight control (the goal of normal blood sugars) was not a universally accepted concept, whether at Stanford or in Boston. The issues of control and complications are new to many practitioners who told patients that blood sugars of 200+ were OK.
As a professor, healer, and scientist, Dr. Peter Forscham, MD has said that scientific study revolves around discoveries that are the equivalent of a grain of sand. We don't understand the whole desert yet, but we are making progress. Progress from the days of using dog insulin. Progress from single injection therapy. Progress from termination of pregnancies. Progress from loose control. Nobody lost from the DCCT, but this was only a battle, not the war, and I think we all agree that there are more battles to be fought and won before diabetes and all its complications are conquered.
Alan Marcus, MD
Laguna Hills, CA
Doctor/Author Disagrees With Numbers
This letter is in response to Joan Hoover's article "The DCCT offers nothing to diabetic patients," published in the April 1994 Diabetes Health. Several of the points raised by Ms. Hoover are stated as if factual when, in my experience, they are contrary to the facts.
1) With every reference to frequent insulin injections and blood sugar monitoring, she says "every such assault upon one's body causes some scar tissue. Aside from being uncomfortable, toughened thighs and arms eventually bend needles and callused fingers won't bleed." During my first ten years with diabetes, I succeeded in destroying all of the subcutaneous fat in my thighs by injecting two daily doses of insulin. My daily injections were agonizing because of the paucity of injection sites. Every large dose injection left a lump that remained for periods ranging from several day to several weeks. For the past 25 years, I have been pursuing "intensive therapy" with a minimum of five daily insulin injections. The doses are so tiny that within a few minutes after taking an injection, I no longer remember the location of the site because there is no pain, no lump, and no inflammation. Ms. Hoover is cordially invited to examine my integument for the "scar tissue" that she describes. Although I used to bend needles on my skin 40 years ago, when I was taking 2 shots a day, this is no longer the case with multiple injections.
I have been checking my blood sugar on average of 7 times daily since 1969. Thus, I have punctured my fingers approximately 64,000 times. This comes to an average of about 6,400 finger pricks per finger. Indeed, the tissue on my fingertips tends to thicken. Whenever I think it has gotten too thick, I take a standard heel file (sold in drug stores and beauty supply stores) and file down my fingertips until they look like they came straight out of the beauty parlor.
I feel like the injections and the finger sticks, when done in the painless manner that I teach my patients, is a very small price for me to pay for surviving nearly 50 years of diabetes while looking and feeling younger and healthier than most non-diabetics my age.
2) Ms. Hoover claims "insulin therapy doubles the cost of blood testing and injection supplies to about $4000. This is rarely reimbursed. Most patients will have to do without." Ms. Hoover must be spending about 4 times the going rates for her supplies than my patients spend for theirs. If syringes are flushed with sterile saline after each use, there should be no problem with using 2 syringes weekly at an annual cost of $20. Finger stickers cost less than 10Â¢ each and last me at least two weeks. Thus, my annual cost is under $3. Blood sugar strips, unfortunately, cost about 50Â¢ each. If a patient, who is hard pressed for funds, limits his testing to 5 times daily, the strips will cost him $1000 annually. Ms. Hoover's contention that none of this is covered by insurance is absurd. All of my type I diabetic patients belonging to families with at least one employed individual have major medical insurance. I know of no major medical policy that does not pay for these supplies. Many of those who are unemployed have Medicaid, which likewise pays for these supplies.
There are now sprouting up around the country a number of mail order pharmacies that accept insurance as 100% of their bill for prescription items such as insulin syringes and blood sugar test strips. I use one of these pharmacies for myself, as do most of my patients. Thus, Ms. Hoover's $4000 cast, at worst, drops to about $1200 and for most of us, can drop to near zero.
I deliberately did not mention alcohol swabs. I have not used one since I began intensive insulin therapy in 1969 and not one of my patients uses them. I have yet to encounter one infection as a result of this practice. A number of patients, however, have commented that they are great for removing make-up and for wiping off a greasy face at the end of the day.
3) Ms. Hoover also refers to "the prohibitive cost of the round-the-clock care...." Were it really necessary for a staff of 5 individuals to treat every diabetic, and to be in constant contact with them, Ms. Hoover would be absolutely correct. However, given the right sort of regimen, patients should be able to take care of themselves without the problems encountered in the DCCT and without such intensive follow up. I managed to do this for myself long before I became a physician and my patients are able to do this for themselves.
In summary, although I, too, object to many details of the DCCT, I owe my life to "intensive thera-py."
Richard K. Bernstein, MD
Author of The Glucograph Method
Medi-Ject CEO With Strong Words
I find Joan Williams Hoover's article in the April issue of Diabetes Health and your unfortunate choice of titles for her article and the report of the New York Times article very disturbing. A casual observer would draw the conclusion that Diabetes Health's editors do not support or understand the enormous positive impact that the DCCT study will have upon the management of diabetes in the future.
Joan Williams Hoover is another matter. Here is a woman whose credentials would suggest an advocate that could understand and popularize an enlightened position. Instead, I see the equivalent of a smoker berating the Surgeon General for suggesting that an individual might have the freedom to live a longer, healthier life. I read the CompuServe diabetes bulletin board discussion, but many of those writers suffered from self-pity and lack of understanding. I would expect Ms. Hoover to be informed and looking to the future.
The DCCT study gives diabetics, diabetic researchers, and technology businesses the data needed to effect real changes in patient care and research. Let me discuss examples of how each group is affected.
Consider the patient. We can all agree that control is a relative issue and that there are plenty of diabetics in very poor control. The patient with excellent control might do the very best, but if every diabetic moved one step toward better control, that individual would lead a healthier, and perhaps longer, life.
Ms. Hoover demands better management tools and better treatments. In fact, diabetes researchers, including the Joslin Clinic, now will have a better chance to compete for public research dollars.
Ms. Hoover repeatedly bemoans the poor level of reimbursement available to the diabetic. The DCCT data will be used to improve that situation, particularly in the private insurance sector. However, the ADA has been a particularly ineffective lobby group within the public sector. Medicare and Medicaid reimbursement is forthcoming with effective public lobbying. This is an opportunity for the ADA to take a positive public posture relative to the DCCT study rather than adopt the negativism of Ms. Hoover.
Diabetes Health is a terrific publication. I look to Diabetes Health as a vehicle to inform its readers about the many long term positive consequences of careful epidemiological research, rather than capitalize on the short term observations of human frailty.
Franklin Pass, MD
Chairman/CEO Medi-Ject Corp.
The DCCT Gave Me Hope
I thank God I don't have Ms. Hoover as a CDE or diabetic counselor. As negative as she is about the DCCT, I probably would have given up and figured that control just wasn't worth the effort. The DCCT didn't find a cure, offers nothing to the patients, a great disappointment to diabetics-give me a break. Does she have diabetes or dose she just talk about it? She complains that the DCCT didn't tell us anything we didn't already know. Did she know that good control would reduce complications by over 50%? Could she prove those numbers? To me it shows, significantly, that it is worth my effort, time, inconvenience, frustration, anger, and everything else to fight for control. It won't help just 10%-20%, but big time numbers. She further complains it sets people up to fail. "Most diabetic people can't achieve this normal level." I try every day and will continue to do so because the DCCT gave me hope. Of course I'll fail, that's why they call me human. I don't have to give up because some test didn't give me a cure.
"Intensive therapy recommends doubling the frequency of blood testing & injections." Well, it is my understanding that most people inject twice a day and don't test, period. Doubling testing shouldn't be a problem, and most Americans have enough area that more injections shouldn't matter. Especially if it helps keep all your parts. Isn't that what this is all about?
"Pumps can clog, break, and cause infections." Cars, planes, etc. can break down. Do we stop using them? Personally, I've had no problem with my pump-just super BG's, more freedom, excellent HbA1c, and much better control. Perfect? No, but in spite of Ms. Hoover, I keep trying because the DCCT gives me hope that the better control I achieve, the better my chances are of being alive and kicking when my new grandchild graduates from college.
"Blood glucose monitors do not produce control." Guess this tool should be thrown out, too! It doesn't cure.
The DCCT shows that if you improve your control-at all-you will improve your chances to reduce complications. Intensive therapy is not for everyone-nothing is.
"Intensive therapy doubles the cost. This is rarely reimbursed." More states are increasing the benefits for diabetes. Case in point-New York, as of January '94, insurance companies cover strips, education, syringes, etc. It's a start!
I have insurance, but I don't have a round-the-clock medical team. In fact, for the most part, I am the team round-the-clock and I can afford that. Anyone can afford that team, if they want the results of good control. Don't wait to be spoon fed. I move around in my "Cadillac," what about you?
The exciting thing about the DCCT is that insurance companies will see the value of prevention and start paying for intensive therapy and pumps. The DCCT did not say that diabetes is "preventable."
People do not have to worry about their jobs-American Disabilities Act protects them. I certainly did not get the impression that I am now dangerous to myself and others because of the DCCT. The results stated that the chances for insulin reaction were 1 in several months and it doesn't mean that every diabetic will have their allotment. Of course, Ms. Hoover says that tight control is impossible therefore we don't have to worry about those episodes.
"The public will now see their afflictions as the result of their own negligence." Give the public some credit-they are not dumb. They may not understand diabetes and that is why people need to explain why we have to do what we do, but if they see a person with diabetes exercising, testing, watching what they eat, going to the doctors; they will not blame someone who still gets complications. They will give credit to the person for trying.
If the 1441 DCCT subjects were criticized, humiliated, and called names, why didn't any quit? I found it pretty amazing that many stayed through the entire 9 years-no matter what the reason and certainly if they were abused. "The long-awaited results of the DCCT have given to them nothing but the admonition to 'Try Harder.'" It says Try Harder because It Works and It's Worth It! Nothing is easy, life is not fair, I hate diabetes, but the DCCT gave me the hope to keep trying, keep fighting for better control. Not perfect, but as perfect as I can get it-given that I'm human.
Seneca Falls, NY
Nurse Sees Only Good
Very seldom do I feel compelled to write letters to the editors, but Joan Hoover's critique of the value of the DCCT studies prompted me to put some thoughts on paper. Of the ten problems which she identifies from the DCCT study, six are related to cost. A recent meeting with the staff of a very large HMO, which includes services to 30 million people, shows new interest is being generated as a result of the DCCT study. A leader in this HMO indicated that without the results of the DCCT, it would be impossible to approach their agency for reimbursement in care. Thus, I would like to think that the very issue that Ms. Hoover presents, high cost, can now be addressed because dollars spent in good control should show dollars saved in treatment of complications. Having worked in diabetes management 18 years, most of us were convinced, as Ms. Hoover was, that the complications were due to the hyperglycemia. However, without this study we had no tool with which we could approach "the keepers of the purse" in an effort to give assistance in diabetes management. I find the DCCT study the first positive approach towards improved care and hopefully reduction of complications.
Thank you for an excellent resource for individuals with diabetes. Diabetes Health subscriptions are on our table in our waiting area in the Diabetes Management Center. Congratulations!
Mary Ellen Good, MS, RN, CDE
Diabetes Management Center
I'm Not Alone
So! I'm not alone in my thinking...thanks Joan Hoover for your article. How right you are! As the mother of three adult children with IDDM, I sat in the assembly room in Las Vegas last year anticipating the announcement about the DCCT study. It wasn't too long before the tears started to will up because of my great disappointment! All that money just to tell me what common sense already told me and every diabetic out there! But, more importantly, they not only created more cost, and more discomfort to the patient with diabetes, but a way of life that is nearly impossible. My children have had much difficulty purchasing insurance, affording insurance, and dealing with the pre-existing condition clauses, let alone finding a doctor that they could afford to see more than once a year. Those of us that have been living with it know that diabetes dominates our way of life, but we try to work with it. Let's put our research money where it benefits the person with diabetes-find a cure, not more pressure to be perfect-certainly not more finger sticks and needle punctures!
Nancy Ann Yartz
Laguna Niguel, CA
I appreciate that so many people chose to comment on my article, "The DCCT Offers Nothing to Diabetic Patients." Limited space leaves me room for only a generic response:
I stand by my title. No one who has diabetes is any better off after the DCCT report than he was before the trial began.
People who have diabetes were cheated. They want research to find the cause, prevention, and cure for their disease. Their government provided research funds to help them. Instead, it was wasted on the DCCT.
Tight blood glucose control is very difficult to achieve, even with the most diligent effort. It cannot be achieved on command. Only the diabetic patient can make that sustained effort, and ought not to be criticized while trying.
It's interesting to note that the only adverse criticism of this article came from people who earn their living from diabetes.
Dr. Bernstein: the financial data quoted was from the National Institute of Diabetes, Digestive, and Kidney Diseases.
Dr. Grodsky: The DCCT may encourage future investments by science and industry, but please note the title of my article.
Ms. Good: Even if the DCCT persuades the "keepers of the purse" to spend more, the money won't go to the patient, who is the only person who can strive for good control.
Dr. Pass: (Diabetic) writers suffering from "self-pity and lack of understanding," is a strange way to speak of your customers.
Dr. Marcus: You say that 750,000 people will die during the 15 years it takes for medical knowledge to become medical practice. Sadly, the DCCT did not give us any new medical knowledge. There is nothing new to put into practice. No lives will be saved by the DCCT, even after 15 years.
Ms. Yartz: You most eloquently represent the diabetic families with whom I have spoken when you say "let's put our research money where it benefits the person with diabetes-find a cure, not more pressure to be perfect...."
Joan Williams Hoover
Chevy Chase, MD
[Editor's Note: The issues surrounding the DCCT study are obviously very heated, and Ms. Hoover's views, while controversial, raise important questions that need to be addressed.
The cure for diabetes is not a simple thing; if it were, we would already have it. We will only find the cure through intensive research and patience. I know that patience is difficult in light of the suffering that accompanies each minute we cannot end this disease. But we don't have the cure, so who can say what avenue of research will lead to its discovery?
I, for one, am glad that we have people like Dr. Gerald Grodsky and Ms. Joan Hoover who dedicate their lives to finding the cure for diabetes, each in their own way.]