Personal Responsibility In Health Care: The Slippery Slope

I am fascinated by the way “the press,” picks up on certain reports from medical journals and ignores others. In my experience, many of the headline news reports on medical journal articles focus (not so surprisingly) on subjects that are likely to raise the interest of readers or are likely to be controversial. In my opinion, the journalists miss many very noteworthy articles. For example, the January 24, 2008 issue of the New England Journal of Medicine contained an article entitled “Effect of Cost Sharing on Screening Mammography in Medicare Health Plans,” written by A.N. Trivedi and colleagues from Warren Alpert Medical School of Brown University, the Target Research Enhancement Program, Providence Veterans Affairs Medical Center- both in Providence, RI, and Brigham and Women’s Hospital, the Department of Health Care Policy, Harvard Medical School, and the Department of Health Care Policy and Management, Harvard School of Public Health- all in Boston, MA.

What is “Cost Sharing” and why should I care?

The concept of cost sharing in health care costs is not very complicated even for those not expert in economic theory. Cost sharing means that the total costs for a medical service (e.g., medication, clinic visit, laboratory test, surgical procedure) are shared. Here the cost sharing is between Medicare and the individual patient. For the patient, this could be a copay, a deductible, or a predetermined percentage of the total costs that the health care plan pays and the patient pays (e.g, 80% by the health care plan, 20% by the patient). The patient’s cost is thus over and above the basic patient cost for the health care plan.

Trivedi and colleagues remind us in the introduction to their article that previous studies have shown that policies that increase patients’ share of health care expenses, decrease their use of discretionary health services. This means that patients tend to use more health care services if they perceive them to be free- of course, the services are often not really free, since the patient might have a fixed monthly charge for the insurance. The investigators also note that patients use fewer non emergency-type health care services if there is some cost sharing. In contrast, patients do not skimp on services for problems they perceive as life-threatening (e.g, chest pain) whether or not their health care insurance plan requires cost sharing (that’s good). The question the investigators ask is here is whether cost sharing reduces the use of important preventive care procedures, in this case, mammography?

The investigators reviewed coverage for mammography within 174 Medicare managed-care plans from 2001-2004. The numbers were huge- over 500,000 observations in more than 350,000 women between the ages of 65-69. They compared rates of every-two-year breast-cancer screening in plans that required cost sharing for mammography with screening rates in plans with full coverage (i.e., no cost sharing). The investigators also analyzed data on screening rates in plans that switched from full coverage to cost sharing for mammography as compared with rates in matched control plans that did not switch to cost sharing. NOTE: I apologize for presenting the study design in such detail, but it is important for you to understand exactly what was being studied.

The study results

So, what did the study show? First, cost sharing was defined as requiring a copayment of more than $10 or coinsurance of more than 10% for screening mammography. The total cost for mammography was somewhere between $100-$150, depending on the heath care plan. For plans that required cost sharing, the average out-of-pocket patient costs averaged about $20 with the highest cost $30. Anyway, the investigators found that screening rates were about 8% lower in plans that had cost sharing compared with plans without cost sharing ( 77.5% vs. 69.2%). Screening rates were directly related to income and educational level. Perhaps, most interesting were the findings that screening rates increased by about 3% in plans that eliminated cost sharing and decreased about 6% in plans that instituted cost sharing (a net change of about 9%).

What do these findings mean?

First, whether free or with a copay, many women do not take advantage of screening mammography despite abundant evidence that mammography will detect breast cancer at an early stage and result in better outcomes. Why that is, I haven’t a clue but it might be fear that the test would detect a cancer (a form of denial)? Perhaps, it’s something as simple as the perceived inconvenience and discomfort of the procedure vs. the perceived benefit? There are lots or other possibilities. Adding cost sharing just makes things worse. For whatever reason, even small costs (the investigators call them “modest copayments”) are a barrier to health screening, at least for mammograms in Mediicare patients. The investigators conclude that for cost-effective preventive services (such as mammography), perhaps elderly Mediicare beneficiaries should be exempt from cost sharing.

What does all of this really mean?

In my opinion, this study is not only interesting, but it also raises many questions about health care policy. In this national election year, we are all caught up in rather intense political discourse, which includes many discussions about health care. The various candidates for President of the U.S. have proposed vastly different plans for health care. But, I believe there are no easy or inexpensive solutions to the present U.S. health care problems. Any high quality health care plan would need to take into account the issues raised in the mammography screening study reviewed here. For example, should cost sharing be part of all health care plans, knowing that some patients will not obtain this or that service if there are out-of-pocket costs, even if sound data show the health benefit (e.g., mammography, vaccinations). No doubt, cost sharing (really cost shifting) decreases costs for the health care plan, but not the individual plan holder. Is it a question of personal responsibility (maybe a better term is “personal choice?) or should we facilitate patients getting this or that medical service that has been shown to be of benefit? Should we mandate health care insurance for all people, or leave it up to the individual, knowing that people without health care insurance end up shifting many of their health care costs to all people with health care insurance. Does personal responsibility/personal choice trump collective responsibilities? I do not have any answers to these very difficult questions. At least we can think about these issues as we listen to the politicians rant and rave about this and that until November.

Dealing With The Wrath of One’s Relatives

Did that title catch your eye? I hope so. Before explaining about the title I want to urge you, my readers to feel free to comment on my entries. I do know that many people from all around the globe read my entries but I rarely receive comments or questions. Even criticisms (mild ones) would be welcome. I also welcome suggestions for future topics.

Now, about the title. My daughter’s daughter (that makes her child my granddaughter) just happens to have celiac disease. My daughter called me to complain that in my last entry (a case about celiac disease), I did not emphasize how important it is to have universal screening for celiac disease. I told her that whether or not to screen for this or that disease is not so simple. It is getting even more complicated daily, as new genetic tests are springing up. For example, is it worth knowing if a guy has an increased risk of developing prostate cancer? That was the question posed on the front page of the New York Times today (Thursday, January 17, 2008). The article was entitled “$300 to Learn Risk of Cancer of the Prostate,” and written by Gina Kolata. In summary, a new study to be published in the New England Journal of Medicine on January 31, 2008 (the study was published on-line on January16, 2008), shows that a new genetic test can identify men who have a particularly high risk of developing prostate cancer. The scientists identified 5 regions in DNA in which variants in the DNA were associated with increased prostate cancer risks- the greater the number of variants, the greater the risk- up to 4.5 fold with 4 or 5 variants (out of 5 possible). With a family history of prostate cancer, the risk in these “high-variant” subjects jumped to about 10-fold. Anyway, the author did a good job in addressing just how complicated it is in deciding who and when to screen for diseases. In this instance, and in a rapidly increasing number of instances, some of the same scientists who discovered the genes are involved in marketing a genetic test to determine risk. This makes it difficult to determine if their recommendations for screening are based solely on sound medical principles, or might be influenced a bit by the profit motive?

Screening for a disorder is generally defined as testing asymptomatic people for a disease or increased risk for a disease. Whether or not to screen for a disorder depends on many factors including costs. For example, if it costs millions of dollars to identify one case of this or that, is it worth it? It also depends on whether the outcome is any different with earlier diagnosis . It also matters whether the screening is to determine if someone has an increased risk of developing this or that vs. whether or not they actually have the disorder. It’s not so simple and I suspect my daughter and I will have long discussions regarding screening- both regarding celiac disease and other diseases.

This is a subject none of us will be able to ignore as more and more tests become available to determine genetic risks for this or that disorder. It’s almost like reading a detective whodunnit and ignoring the entire book except for the last chapter; do we really want to know everything about what our genetic makeup tells us what fate may well have in store for us? Don’t get me wrong. I am a strong proponent of screening and early diagnosis, but it depends on the diagnosis and what the benefit might be by the early diagnosis. Screening for “increased risks” is even trickier.

Weight Loss in an 18 Year Old Male with Type 1 Diabetes

I apologize for not having an entry for about a month- a busy time with the holidays. Best wishes to all for 2008. I want to start out the new year with a case scenario. I promise it won’t be as esoteric as one of Dr. House’s cases (for those of you who don’t watch TV, Dr. House is a rather unconventional medical sleuth).

Case History

The patient is an 18 year old white male named Chad with a history of type 1 diabetes diagnosed at age 10 years. He had generally done well with the diabetes over the years; hemoglobin A1c values had been consistently in the 7-7.5% range (hemoglobin A1c is a blood test that can provide an index of the average blood glucose over the previous 3-4 months). That’s pretty good for a teenager. The patient saw me for a routine checkup in September 2007. Things seemed fine except that I noted a 5 lb. weight loss from the previous visit. There was no change in diet or activity that might explain the weight loss. I suggested that the patient monitor his weight and notify me if he lost as much as another 5 lbs. I scheduled a follow-up clinic visit for December 2007, sooner than I would have normally done so.

Note: Since the patient seemed quite healthy based on my medical history and physical examination, I elected to carry out no special studies at the time of the visit. Some physicians might have done some detective work at that time but I was comfortable to wait and watch.

Two Months Later

I saw Chad for his scheduled follow-up visit in mid-December. He had not contacted me in the interim (I encourage patients to contact me by e-mail whenever they have questions or need something done such as a prescription refill- it works very well and even in my mostly rural state of Missouri, about 90% of families have internet access). The medical history was more or less unchanged except for, perhaps, somewhat less well controlled diabetes. Again, there was no history of anything of concern; specifically, no fatigue, no gastrointestinal symptoms, no change in appetite, no history of drug or alcohol use. The physical examination was unremarkable except for another 7 lbs. weight loss. Now the patient was beginning to look a bit underweight. I was puzzled and concerned.

The Differential Diagnosis

Now it was a question of getting serious about finding out what the problem might be. Eighteen year old males do not lose substantial amounts of weight for no reason. I first decided not to “accept” as fact my medical history. Thus I felt a “fresh” look at the problem was necessary. I first considered if the weight loss was somehow related to the diabetes. Teenage girls with diabetes all know that skipping some of their insulin injections (or turning off their insulin pumps) is the quickest and easiest way to trim down- high blood glucose levels result in large glucose losses in the urine. Every gram of glucose lost is 4 calories lost. It’s not a healthy way to lose weight but it happens. Anyway, I was satisfied that Chad’s weight loss was not from poor diabetes control (a clue would have been the presence of ketone bodies, fat breakdown products, in his urine- urine ketone tests were consistently negative). Next, I wondered about disorders associated with diabetes that might be responsible for the weight loss. Type 1 diabetes is an autoimmune disease and certain other autoimmune diseases are more common in people with type 1 diabetes than in the general population. Chronic lymphocytic thyroiditis causing hypothyroidism is the most common associated autoimmune disorder but I couldn’t have accounted for the weight loss. Hyperthyroidism from Graves Disease is another autoimmune disease slightly more common in people with diabetes than in the general population and this disorder could cause weight loss from an increased metabolic rate. Against the diagnosis was the absence of an enlarged thyroid gland, normal pulse and blood pressure, and absolutely no history of anxiety, poor sleeping, or other typical hyperthyroidism signs and symptoms. Finally I thought about celiac disease, an autoimmune disease of the small bowel caused by intolerance to gluten, a major component of wheat. Celiac disease is currently “in vogue” and recent studies have documented that it is much more common in people with diabetes and in the general population than was previously known; studies show that the prevalence of celiac disease in the general population ranges from about 0.1-1% depending on the study population. The disorder is particularly common in people with northern European backgrounds- Finland has a prevalence of 1-2%. In people with type 1 diabetes, the prevalence is 2-3 fold higher than in the general population but it varies widely depending on the criteria for diagnosis and the characterisitcs of the patient population studied. Patients with celiac disease may have no signs or symptoms pointing to the diagnosis, but a variety of gastrointestinal symptoms are common. Weight loss on the basis of decreased appetite and/or malabsorption is fairly common (remember, Chad had no gastrointestinal symptoms).
One study from Italy published several years ago ( Cerutti et. al., Diabetes Care 2004;27:1294-98) followed 4322 children with type 1 diabetes ages 4-11 years. The investigators found a prevalence of biopsy-proven celiac disease in 6.8% of the children. Risks for celiac disease were increased 3-fold if the diabetes was diagnosed before age 4 years. In 90% of cases, the diabetes was diagnosed prior to the diagnosis of celiac disease.
Back to the detective work- I next considered systemic disorders- medical conditions that could cause weight loss, particularly those without obvious signs and/or symptoms. Thus I considered, inflammatory and infectious conditions (e.g., regional enteritis, tuberculosis, AIDS, other chronic infectious processes); I considered neoplasia (e.g, lymphoma); I considered illicit drug use; I considered an eating disorder (e.g., anorexia nervosa); I considered a chronic anemia- as a primary problem or secondary to another diagnosis.

Moving from Differential Diagnosis to Diagnosis

Next, I needed to take my differential diagnosis and then order appropriate laboratory tests. This is the tricky part. Should I order every imaginable test, just a few, or do one at a time, waiting for results from one before I move to the next? Doing tests one at a time would not have been very practical here- it would have been the least expensive approach but one with the likely possibility of many, many needle sticks and return visits over several weeks. I elected to focus on the most important diagnoses and ordered the following tests: a blood count, blood inflammation tests (erythrocyte sedimentation rate and c-reactive protein) blood chemistries including tests of liver function, a drug screen, HIV testing, thyroid function testing, a chest x-ray, and a celiac test panel (this includes several tests carried out at the same time). So it was one blood stick and one chest x-ray.

Test Results

I should mention that I discussed with Chad why I ordered the tests that I did, including the drug screen and the HIV tests (he readily gave permission for me to order those tests). Next it was time to wait. The results started to come in and one by one they were all completely normal until I was waiting on only the celiac test panel. So he didn’t have a drug problem, AIDS, a hidden infection, hyperthyroidism, etc. What could it be?

Finally, after a week or so the celiac panel came back wildly positive for celiac disease. We had a diagnosis and one that could explain his weight loss. Why he had no gastrointestinal symptoms (other than weight loss), I don’t know. It is interesting that the simple celiac antibody tests (anti-gliadin IgA and IgG) were normal; the more specific anti-endomysial IgA was positive as was the very specific anti-human tissue transglutaminase test (>100 U/ml with normal < 4 U/ml).

The Next Step

So, we had a diagnosis and the next step was referral to a gastrointestinal specialist for maybe a small bowel biopsy and certainly a gluten-free diet. If the diagnosis is correct (with respect to the reason for his weight loss), Chad will begin gaining weight on the gluten-free diet. This last step in diagnosis is important. We want to be certain we have identified the cause of Chad’s weight loss.

Note: Some would argue that we should have screened Chad for celiac disease even before he had any weight loss, given the increased prevalence of the disorder in patients with type 1 diabetes. I have smart colleagues who screen all patient with type 1 diabetes for celiac disease and other equally smart ones who do not. Celiac panels are very expensive and usually “negative.” I would generally screen all patient with type 1 diabetes under age 5 years for celiac disease but not older patients unless there are some signs or symptoms suggesting the diagnosis. I do recommend autoimmune thyroid disease screening for all patients with type 1 diabetes since the prevalence of thyroid disease is 30-40% in patients with type 1 diabetes, the testing is relatively inexpensive, and most patients who will ever develop autoimmune thyroid disease, have “positive” thyroid antibodies at the time they are diagnosed with the diabetes. Maybe, I’ll change my mind about all this next year? That’s clinical medicine- still lots of room for “clinical judgment.”

IS There Really a “Crisis” in U.S. Health Care: Chicken Little vs The Optimists?

The “Group”
For quite a number of years now, I have been a member of a group composed of University of Misouri-Columbia professors. The group (which is also officially known as “The Group”), meets once a month during the academic year to hear a reasonably scholarly presentation from one of our members about whatever they wish. Invariably, presenters discuss topics related to their academic disciplines. As a physician (one of two in the group), I am expected to enlighten the attendees about something medical. Last spring, I gave a talk about the obesity epidemic and last week I spoke about type 2 diabetes, a logical extension of the talk about obesity.

My Presentation

I started out talking about what diabetes is (you already know that it’s really a group of medical disorders with three things in common- insulin deficiency, hyperglycemia, and risks for serious vascular complications). Type 2 diabetes, which used to be called maturity-onset diabetes and more recently, non-insulin-dependent diabetes (NIDDM), is the most common form of diabetes, affecting about 9.5% of the U.S. population. About 20% of people over 60 years of age have type 2 diabetes. Treating the condition accounts for a large chunk of of the money spent on health care in the U.S. (at least 35% of all Medicare expenditures!). Anyway, I was moving along through all the background information and got to the part where I stated that data show that as many as 90% of people in the U.S. with type 2 diabetes are not achieving recommended care goals, when th presentation got seriously derailed; the distinguished professors wanted to focus on how things could possibly be so bad in the richest country in the world, with the best high-tech mecical care, and which spends (by far) more than any other country in the world on health care?

Why are so many people with diabetes not achieving recommended care goals and what are the consequences?

It is much easier to address the consequences of of poor diabetes care than why it is happening. What makes diabetes serious is not the major inconvenience of the currently recommended treatment plans, but the complications that develop in so many of the patients. In fact, most of the costs of treating diabetes are for treating the complications (e.g., kidney failure, heart disease, nerve disease, peripheral vascular disease, limb amputations), all of which are preventable with currently available therapies.

The “why” part is more complicated and I will only touch on what I told my professor friends last week. First of all, U.S. health care is definitely not what it could and should be, particularly given how much money we spend on it. The U.S. is far down the list of economically developed nations in the quality of health care (as measured by longevity, infant mortality rates, etc,). The reasons include (in no order of relative importance) the following: more than 40 million people without health insurance and many more with inadequate insurance; inadequate numbers of well-trained health care providers, particularly in non-urban areas; high costs which are rising rapidly- many people cannot afford ther prescribed medications, even with insurance/Mediacare. I could go on and on and it was a bit uncomfortable presenting this information to my professor friends who seemed truly shocked by the discussion.

Where to go from here?

When it came to the part about what to do about the problems, I didn’t really have any convincing answers for my professor friends, at least in terms of a comprehensive “solution.” I have been giving this quite a bit of thought lately and will come back to health care issues soon, in future entries. Clearly, it doesn’t matter how smart a doctor is and how many great medications he has in his therapeutic armamentarium, if a patient with diabetes can’t afford the clinic visit or the medications or can’t even get an appointment for 6-7 months even with good insurance coverage, we are in trouble. We are in trouble.

A Model For Health Care That Pays For Quality:Good Luck

There was an interesting article today in the New York Times Business News section, entitled ” A Model for Health Care that Pays for Quality.” written by Milt Freudenheim. Apparently, the National Committee for Quality Assurance (NCQA), “a nonprofit focused on health care plans” (this is the organization that has for many years orchestrated reporting of quality data by HMOs and other large health care delivery organizations) is working on ways to get physicians to spend more face-to-face time with patients as a means of improving patient care outcomes. I guess the idea is to reward physicians for spending more time with patients- I assume this means paying them more? The article says that many large employers and insurers are “getting on board” with the idea, which is already being studied here and there.

How much time do physicians spend with patients now?

There are lots of data to show that the average face-to-face time between physicians and patients at clinic visits is brief- the average time is about 7 minutes. In contrast, the waiting room time before scheduled visits is quite impressively lengthy. There are also lots of data to show that many physicians do not follow recommended guidelines for patient care for this or that condition or for a given set of symptoms. I am not aware, however, of any data to show that longer encounters would make any difference in outcomes.

What is going on?

As best I can tell, employers and insurers would like to see better patient care outcomes because that’s nice (I asume that’s one reason?) and because it might have an impact on the high and steadily rising costs of health care. Of course we already know, notably from Kaiser-Permanente studies, that “better” health care saves money by resulting in better outcomes, at least in the areas of cancer, diabetes, and heart disease. Putting lots of effort into managing chronic disorders before preventable complications develop really works (I have discussed the Kaiser data in earlier entries). I do not know if focusing on physician-patient time is of any benefit. I would doubt it. I do not mean to imply that more time for patient clinic visits wouldn’t help, but trying to reward physicians who are not presently practicing high quality medicine by rewarding them simply for spending more time with their patients would not necessarily result in better care. In fact, if it is true that we have a big physician shortage and poor access to physicians by patients, slowing down the clinics will only make things worse.

What makes for a “good” physician?

It is very difficult to describe what makes one physician a good one and another one not so good. In my experience, patients generally don’t have a clue in determining which physician truly knows what he is doing or not. Often, patients mistakenly confuse the difference between a likeable doc and a competent one. It drives me crazy when I see people in a social setting who tell me how wonderful their physicians are when I know the docs are truly menaces (it is, of course, a  moral/ethical dilemma of whether to offer an opinion- so far I have been chicken to do so, unless the person is truly seeking my medical opinion about the physician).

“Good” physicians already spend what time is necessary to sort out what is going on with their patients. It may mean they make less money (time is money even in medicine) but it’s just something they have decided to do. Also, some physicians are very good at sorting things out quickly- some can never figure out what’s going on no matter how much time they take (it’s a good thing my doctoring skills are not judged by how quickly I can get New York Times cross word puzzles done!).

What should be done?

The NCQA should focus its energy on those things it knows best- developing parameters for assessing quality of care. They have already done a very good job in the area of diabetes care. They need to extend well-validated measurements of quality to many other chronic and acute conditions. Organizations can audit charts to determine how well their physicians are doing to with regard to the quality measures. These data can then be shared with the physicians (many insurers already do this).

I believe that a very worthy addition to the process is a “required” (I don’t know how to force a patient to do it, although the Japanese do) annual health assessment by ones primary care physician. This assessment could include a questionnaire that the patient fills out in advance which can help alert the physician to possible health problems and to the patient’s preventive heatlh care status (e.g., ? needing a PSA, a mammogram, herpes zoster vaccination). Of course, we will need an adequate number of primary care docs who have the necessary time to spend to accomplish all this- that is one of the biggest obstacles to my proposal.

What Causes Excessive Thirst?

There was an interesting article the other day in the New York Times Magazine section of the newspaper (Sunday, October 14, 2007). the article was entitled “Addicted to Water” and written by Lisa Sanders. The article was typical of those medical “whodunnits” that are found fairly frequently in the New York Times and in other publications, most notably, the New Yorker magazine- more or less the literary equivalent of an episode of “House” on TV (refering to Dr. House, the mean and nasty brilliant medical diagnostician).

The Medical History

The case concerns a 38 year old woman with a history of excessive thirst and urination for many years. The woman had been evaluated many times for her symptoms, primarily with tests for diabetes mellitus, which invariably turned out negative. To make a long story short, the woman was in the hospital having just given birth (by C-section) to a healthy baby. The OB-GYN intern had noted the woman had consumed a large amount of water overnight, over 3 gallons, and was concerned. The intern had the good sense to look into the situation and eventually the diagnosis, diabetes insipidus was made and appropriate treatment initiated.

Thinking About Excessive Thirst and Urination

When a patient complains about whatever to their doctor, it would seem logical that the doctor would carefully consider the complaint. Patients complain about lots of things and part of the doctor’s job is to figure out which complaints require investigation, which to ignore, and which to monitor for a while (i.e.,”if it doesn’t get better, let me know”). Often what happens is that the complaint is more or less ignored or evaluated in a cursory manner, particularly if the patient does not present the complaint as being vey important. In my opinion, all complaints about excessive thirst and/or urination should be taken seriously and evaluated. First, a good medical history, a physical examination, and then laboratory studies if indicated. As the magazine article mentioned, the first thing one tends to think about is whether the patient’s symptoms are a sign of diabetes mellitus. The patient in the story had, in fact, been tested many times over the years for diabetes mellitus and tests had always been “negative.”

Where Does Urine Come From?

The body works hard to keep itself clean, inside and out. The blood is kept “clean” in a number of ways. The lymphatic system helps filter out nasty things such as viruses and bacteria. The kidneys clean the blood by filtering out excessive water, minerals (e.g., sodium and potassium), and waste products, mostly generated by processes that use foods for energy production. Anyway, the kidneys are remarkably efficient in keeping the composition of the blood very constant; it filters the blood on a continual basis, removing waste products and retaining “the good stuff.” With respect to water (most of the blood is water, right?), the kidneys usually know just how much water to excrete and how much to retain (i.e., reabsorb after filtering). Key to this process is the hormone vasopressin (also called anti-diuretic hormone or ADH), produced in the hypothalamus and stored in the posterior part of the pituitary gland. Vasopressin acts on the kidneys to tell them how much water from the filtered blood to excrete and how much to reabsorb. If the kidneys do not get a vasopressin “message,” they do not allow reabsorption of water, leading to lots of urine production. Sometimes this is appropriate, as after a fraternity party, but at other times it is not. If a person takes a hike in the desert and forgets to take enough water along, enough vasopressin is secreted to tell the kidneys to conserve as much water as possible (if the kidneys are woring properly, some water is always being excreted to carry wastes away). It’s a great system.

The Differential Diagnosis of Excessive Thirst and/or Urination

So, if things do not seem to be working properly, what might be the cause? First, any substance in the blood that requires water to be eliminated, can lead to excessive urination (leading to thirst, right?) if present in excess. For example, excessive sugar in the blood “spills” into the urine and requires water to be excreted. Thus, patients with diabetes mellitus typically complain of excessive thirst and urination (polydipsia and polyuria. The blood sugar level has to get above about 180-200 mg/dl for sugar to “spill” into the urine, leading to excesive urination production- below that level, the sugar is reabsorbed after being filtered by the kidneys. So, it’s easy to tell if a person’s excessive thirst and/or urination is caused by diabetes mellitus- the urine will show sugar and the blood sugar level will be elevated. Why doctors kept testing the patient in the article for diabetes over and over, I can’t say, but they should have considered other possibilities when the diabetes mellitus tests were negative.

Other possibilities include psychgenic water drinking, diabetes insipidus, and kidney disease. Some people just drink and drink. Sometimes it’s just a habit and sometimes it reflects a psychological disorder. It’s generally easy to diagnose from the medical history, and if necessary, laboratory testing. Simply withholding water (under strict medical supervision) will show that before becoming dehydrated a patient with psychogenic water drinking will secrete vasopressin and concentrate his urine.

Kidney disease generally does not cause a striking increase in urine output, but the ability to concentrate urine can be conmpromised. Simple laboratory tests can determine wheter the kidneys are filtering properly.

Diabetes insipidus can be caused by actual insufficient vasopressin secretion or secretion of an abnormal form of vasopressin or kidneys that are not responsive to vasopressin (called nephrogenic diabetes insipidus). Some medications and electrolyte abnormalities can prevent the kidneys from responding to vasopressin, mimicking diabetes insipidus (e.g., high blood levels of calcium, low blood levels of potassium). “Real” diabetes insipidus is generally called central diabetes insipidus and can be idiopathic or caused by a brain disorder, generally involving the hypothalamus or the pituitary gland. Trauma is certainly a well known cause. The possibility of a serious brain disorder is a very good reason for evaluating all complaints of excessive thirst and/or urination.

Making a Diagnosis and Initiating therapy

It is generally not very difficult to make a diagnosis of diabetes insipidus but the key is to determine the mechanism if possibe- obviously, the approach is quite different depending on whether the cause is unknown (“idiopathic”) or a brain tumor. Treatment is generally easy using synthetic vasopressin, which is available in tablet form (for mild cases and for enuresis) and as a nasal spray.

What Should We Take Away From the New York Times Magazine Article?

I’m glad the patient in the article finally got diagnosed and treated but it shouldn’t have taken years and years. It was inappropriate for her to have been tested over and over fro diabetes mellitus- once should have been enough. Patients need to be sure their doctors take their complaints seriously and investigate them properly. Of course, this is where the art of medicine comes in (as opposed to the science). Not every complaint requires a ten gallon of blood and ten million dollar workup. It’s not always easy.

In an upcomoing entry, I will discuss the exact opposite sitiuation- too much vasopressin, commonly called the syndrome of inappropriate ADH or SIADH for short.

Generics Versus Brand Name Drugs

First, I apologize for not having written an entry for quite some time. I just haven’t been properly inspired by anything in particular. I was tempted to write about the SCHIP fight- President Bush vs. most of the rest of the country. I assume that anyone reading this website is quite familiar with SCHIP (you know, the program to fund medicaid for children). Anyway, there was really nothing I could add to the debates other than what I have discussed in earlier entries. Well, maybe I could add a bit more? The fight over SCHIP really has nothing to do with fiscal responsibility, which is one of the main arguments against the current bill which President Bush vetoed. The other argument is that the current bill is sort of creeping socialism- down the slippery slope to a single government-sponsored health insurance plan. Both arguments are frankly ridiculous. The costs for the current bill are like pocket change for the government. Also, the government already pays for about 60% of all health care costs. We are already way down the “slippery slope.” It is also important to remember that although the disucssions are centered aroiund the dear little children, more than 50% of total Medicaid costs are for nursing home care of the elderly who cannot get the care under Medicare as it is currently structured (a topic for a future entry?).

In my opinion, the best argument against SCHIP is that as it is admnistered in most of the U.S., participants are really “second-class citizens” and often can’t even get access to adequate health care. I love the idea of making sure all children can get high quality health care without regard to ability to pay, but SCHIP is not the way (I am encouraged a bit by some of the individual State proposals to use the SCHIP money to buy private insurance for children- that at least, moves us away from the wide-spread problem of poor access to medical care for children with Mediciaid).

Generics vs. Brand Name Drugs

Now, to what I had intended to address in this entry- drugs. I heard part of a piece on NPR the other day about problems with the generic form of the brand name drug Wellbutrin (GlaxoSmithKline). The chemical name for the drug is ibupropion hydrochloride. The drug is widely used for the treatment of depression. It has had its share of controversy, most recently because of concerns that the drug is associated with sucicidal ideation in children and adolescents. Anyway, the current issue is about whether the generic form of the drug is less effective than the brand name, which surely costs much more than the generic “equivalent.”

Pharmacokinetics 101

How can 2 tablets with the same amount of active ingredient (in this case, ibupropion hydrochloride) have different bioactivity (i.e., one drug preparation is more effective than the other)? The answer is in the details. It is well known that the inert ingredients in medications (usually called “filler”) can affect a drug’s absorption rate. Thus, the term “generic equivalent” may be a nisnomer in many cases. The only way true equivalence can be established is to perform rigorous studies comparing the brand name drug and the generic preparation. With respect to antidepressant drugs, the studies would need to address the question of whether or not the two preparations were equivalent in effectiveness and with no significant differences in side effects.

The Data

Apparently there had been quite a number of anecdotal reports of less effective control of depression with the generic form of Wellbutrin. I think many of these reports were ignored given the fact that it was people with psychological problems complaining- just the psychologically impaired patient thinking that the generic was not as good as the brand name. Even when it comes to buying dishwashing detergent, brand name loyalty is strong.

As it turns out, maybe the crazy people aren’t so crazy? Apparently, recent studies have shown that the active ingredient in the generic form of Wellbutrin is released from the tablet much more quickly after being swallowed than from the brand name tablet and thus is excreted/degraded much more quickly than with the brand name tablet. Who’d have thunk it? Actually, lots of people- the manufacturers of the generic drug, the FDA, psychologisyts and psychiatrists, and many others should have thought about it.

What does this have to do with endocrinology?

This website is obstensibly about endocrinologic matters, so what’s the relevance of antidepressant drug matters? Good question. We endocrinologist use drugs and the Wellbutrin story is very relevant to many of the medications we prescribe. For example, there has been a longstanding fight between the manufacturer of the brand name thyroid medication Synthroid (Abbott Pharmaceuticals) and the FDA about the bio-equivalence of various generic forms of the drug (the chemical name is levo-thyroxine). The generics are a bit less expensive than the brand name but a variety of studies have shown big differences in the lot-to-lot potency of some generic forms of the drug vs. the brand name. So, it is not too surprising that many endocrinologists strongly favor Synthroid over any of the generic forms of the drug. When I treat patients with generic forms of L-Thyroxine, I tend to order thyroid function tests more often than if the patient is being treated with Synthroid. I bet it ends up costing the patient (or the insurer) more to use the generic than brand name form of the medication?

A second example is a medication for treatment of diabetes insipidus, a condition that is associated with inability to control urine output. The medication is called vasopressin. It is available in tablet form for mild cases (or for treating enuresis) but patients often require a nasal spray which they typically use 1-3 times daily. There is a generic form of the drug which is quite a bit less expensive than the brand name drug (Desmopressin). Unfortunately, the generic requires refrigeration and is associated with much more nasal irritation than the brand name which can be left at room temperature and seems to cause very little nasal irritation. Same active ingredient but …………

I could list quite a few more examples, but you probably get my point. I am not necesssarily trying to defend manufacturers of brand name products which are often far more pricey than they should be. I only want to point out that before the term “generic equivalent” is given to a medication, rigorous studies need to be performed which include not only studies of bioactivity, but also of side effects and inconveniences (e.g., requiring refrigeration or not).

Good News For People With Unwanted Wrinkles

Two articles in the New York Times yesterday (August 29, 2007) should give us pause about the sorry state of health care in the U.S.

Botox

First, there was an article entitled “Botox Appointments faster than For Moles, Study Finds,” written by Natasha Singer. In summary, the article written by Jack Resneck, Jr, and colleagues reviewed a study published online August 28, 2007 in the Journal of the American Academy of Dermatology in which wait-times for Botox treatment for unwanted wrinkles and evaluations for suspicious (i.e., is it cancer?) moles were compared. The authors found that wait times for appointments for Botox treatments averaged 13 days vs. 68 days for mole evaluations. The authors concluded that dermatologists should better monitor how their patients are scheduled. No duh!

This report is not at all surprising. Who can blame dermatologists and other physicians who treat people for skin “disorders,” including those that are considered cosmetic. Treatment with Botox is lucrative while evaluation of moles is “nickle and dime” stuff. The data are just symptomatic of how bizarre the U.S. health-care system is at present. It would be easy to blame the skin docs for this situation but should we hold them to a higher standard than anyone else in business? Maybe, but I think the blame should go to our higly dysfunction health-care system.

Health Insurance Woes

The second article is actually an editorial entitled “Bleak Findings on Health Insurance.” The editorial discusses the recent Census Bureau’s report on the state of American health insurance. I haven’t read the Census Bureau’s report but according to the editorial the number of uninsured Americans has been “rising inexorably over the past six years.” Last year the number of uninsured Americans increased by more than 2 million to almost 50 million. The leading reason for the steady increase in people without insurance is the steady decline in employment-based coverage (in 2006, 22 million full-time workers have no health insurance). The number of uninsured children increased by more than half a million to almost 9 million. The editorial urges reauthorization of the expiring State Children’s Health Insurance Program (called S-CHIP) but does not give recommendations regarding the overall scary health coverage situation in the U.S.

Of course, the health insurance coverage mess does not have any impact on Botox treatment for unwanted wrinkles since the procedure is not covered by insurance. All it takes is a large supply of cash ($400-500/treatment). What to do about noncosmetic medical care? This is a very complex problem which will require a comprehensive approach if we are to achieve our potential for the best medical care in the world for all people in the U.S. As I discussed in an earlier posting, I have concerns about S-CHIP as it is currently designed given the problems with access to medical care even with S-CHIP coverage in many places in the U.S. (including in my State, Missouri).

Limiting Ads Of Junk Food To Children

The title of my entry is identical to the title of an article written by Brooks Barnes that appeared in the New York Times today (July 18, 2007, page C1). Basically, the article summarized the recent activity by 11 big food companies to change the way they advertise food to children on TV. The companies are scrambling given several law suits and the prospect of federal intervention. I find all of this quite interesting and it would also be amusing if the subject matter did not involve advertising to children for foods that are probably not so good for them. It is interesting that the food companies differentiate between “family” TV programs and those almost exclusively for children- it’s ok to advertise whatever if some adults are watching, even if many of the viewers are children and the foods being advertised are primarily for children.

Anyway, I think it’s all a little crazy and, in my opinion, the food companies are entirely disingenuous. On the other hand, maybe we are trying to blame the food companies for the poor choices that parents make? When is the last time you saw a 4 year old racing home from the supermarket on his tricycle with a box of Cocoa Puffs under his arm?

Holes In Our Health-Care System?

What happens to children with chronic diseases who become adults with chronic diseases?

Over the past 2 weeks I had 2 rather disquieting experiences that demonstrate some of the flaws in the U.S. health-care system (I use the term “system” only for convenience since some would question whether we actually have a health-care system). Both situations involved patients with type 1 diabetes mellitus trying to make the transition between childhood and young adulthood. One patient is a young woman, we’ll call Kathy; the other a young man, Kevin. Both reside in Southwest Missouri and both have been patients of mine since they were diagnosed with diabetes as infants. Both have just finished high school. Kevin is college-bound and Kathy is interested in becoming a phlebotomist. Both have been on Missouri Medicaid long-term; their parents work but have rather low-paying jobs without health insurance.

Kevin

Kevin turned 19 last week and no longer has any health-care coverage. He could obtain high-deductible health insurance through the State of Missouri “High Risk Insurance Pool” at about $800 per month. At present, the patient and family cannot afford the insurance plan thus putting Kevin in the category of “self-pay patient.” Hospitals and clinics use this term for patients who do not have health insurance or have a plan that will not cover health-care costs for the patient at that health-care facility or will not cover a particular diagnosis or procedure. The hospitals and clinics often equate “self-pay” with “no pay,” which is not always true. Regardless, medical facilities generally require a large down payment on the estimated cost of the care before service is given (emergencies are exempt, but one had better be sure it’s really an emergency- you need a medical degree to assess whether it’s really enough of an emergency).

Back to Kevin- he and his parents now have to pay for the diabetes care and supplies out-of-pocket which comes to about $4000 per year (he is on an insulin pump and does very well with his diabetes care). He had planned to attend the University of Missouri and was set to come for freshman orientation a few weeks ago. Unfortunately, the family did the math and determined that even with loans and what scholarships Kevin could obtain, the college costs and the health-care costs were beyond them. Ironically, had he gone to “Mizzou,” he was eligible for a fairly decent health-care plan at about $200 per month provided by the University. So for now, Kevin will attend a local technical school with a goal of obtaining training as a radiology technician. To keep costs down, he will live at home and work part-time. The only good thing about all of this is that he was able to get an appointment with a diabetes specialist for routine care. It was especially good that Kevin was no longer on Medicaid as that physician, like may others in the region do not accept Medicaid patients!

Kathy

Miss Kathy is a nit more complicated than Kevin. She dropped out of high school a year ago and is working at a fast-food restaurant. She intends to get her GED this summer and is interested in becoming a phlebotomist. She is 17 and still on Missouri Medicaid. She has a great primary care physician in the Joplin area who is not afraid of Mediciaid patients. I saw Kathy in clinic the other day and recommended that she transfer to adult diabetes care since she is a young adult. I gave the family the names of several endocrinologists in the Springfield, Missouri area that I know and suggested the family set up a routine clinic visit with one of the physicians. I heard back from the family today that neither physician is accepting any Medicaid patients.

I could have called the physicians and begged them to take the patient but I was not in the mood for begging. I contacted a phycisian in the Joplin, Missouri area (closer for the family than Springfield, Missouri) who is an endocrinologist and she cheerfully agreed to see the patient. The Mediciaid coverage will run out in about 16 months. I hope that by then the patient will have a job with good health coverage.

What is my point?

I don’t mind spending the time to help sort things out for my patients but it’s getting irritating how difficult it is becoming. Medicaid patients are clearly “second class” citizens in the eyes of most health-care providers and medical institutions. Even at my academic medical center, it is a well-known “secret” that many attending physicians will not see Mediciad patients except in their resident physician teaching clinics. Not even professors are immune to class bias.

What is the problem?

There are lots of problems with the U.S. health-car system but one of the most serious is that physicians are not taking the “high road” in the care of patients with no insurance, or even worse, Medicaid. We as physicians have a reponsibility to care for patients whatever their health insurance status. For sure, Mediciad is a very bad system but that’s a different issue than providing patient care. We also need to consider the long-term costs of not providing high quality medical care to patients with chronic diseases, regardless of ability to pay; for example, as I discussed in an earlier entry, the costs of paying for the treatment of preventable diabetes complications, is much greater than just preventing them! What a mess we have.  In a future entry, I will attempt to offer some simple solutions to our health-care chaos.