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Friday, December 10, 2010

Changing the Business of Anticoagulation

The emergence of a new generation of anticoagulants, including the direct thrombin inhibitor, dabigatran and the factor Xa inhibitor, rivaroxaban, has the potential to significantly change the business of thinning blood in the United States. For years warfarin has been the main therapeutic option for patients with health conditions such as atrial fibrillation, venous thrombosis, artificial heart valves and pulmonary embolus, which are associated with excess clotting risk that may cause adverse outcomes, including stroke and death. However, warfarin therapy is fraught with risk and liability.  The drug interacts with food and many drugs and requires careful monitoring of the prothrombin time (PT) and international normalized ratio (INR). 

Recently, when I applied for credentialing as solo practioner, I was asked by my medical malpractice insurer to detail my protocol for monitoring patients on anticoagulation therapy with warfarin.  When I worked in group practice at the Emory Clinic in Atlanta I referred my patients to Emory’s Anticoagulation Management Service (AMS), which I found to be a wonderful resource.  In fact, “disease management” clinics for anticoagulation are common amongst group practices because of the significant liability issues. Protocol based therapy and dedicated management teams improve outcomes for patients on anticoagulation with warfarin. I spoke with Dr. Donald Davis, Medical Director of the Emory Anticoagulation Management Service, who noted that the AMS was originally established as a service to promote patient safety.  However, it has also proved to be lucrative for Emory Healthcare.  Currently Emory’s AMS has expanded to seven locations in metro Atlanta and cares for 3,400 patients.   Piedmont Hospital, the Atlanta VA Medical Center and Kaiser have similar programs.  Patients on blood thinners come in as often as two to three times monthly for a nurse visit and monitoring of their PT and INR.  A patient of mine on chronic warfarin therapy recently shared his medical bills with me, questioning the high fees he was charged for each of his anticoagulation clinic visits.  Fortunately for him, his health insurance will foot those bills.

The advantage of the newer drugs, dabigatran and rivaroxaban, is that they do not require laboratory monitoring and do not appear to interact with other drugs and foods.  Dabigatran was recently approved by the FDA based on results of RE-LY,  which compared it to warfarin in patients with atrial fibrillation for prevention of stroke. At a dose of 110 mg twice daily dabigatran had similar efficacy and lower bleeding risk than warfarin. At a higher dose (150mg twice daily) it had superior efficacy and equivalent risk of hemorrhage. For now, dabigatran’s approval is limited to the prevention of stroke in patients with non-valvular atrial fibrillation.  However, the RE-COVER trial compared dabigatran to warfarin in patients with venous thromboembolism.  In this trial the drugs were found to have equivalent efficacy, though dabigatran was found to have a lesser risk of major bleeding.  Dabigatran is currently approved for use in Europe for the prevention of venous thromboembolism in patients undergoing orthopedic surgery.  It has not yet been approved for this indication in the United States. 

Another blood thinner, the factor Xa inhibitor, rivaroxaban’s efficacy has been demonstrated in the recently published results of the Acute DVT and Continued Treatment Study of the EINSTEIN program. In these trials rivaroxaban therapy was compared with standard therapy for acute DVT with enoxaparin followed by a vitamin K agonist (i.e. warfarin).  Rivaroxaban at an initial dose of 15 mg twice daily and then 20 mg once daily was found to have similar efficacy and risk.  In the Continued Treatment Trial rivaroxaban was compared with placebo and found to reduce the incidence of recurrent thrombotic events and to have an acceptable risk of bleeding. FDA approval of rivaroxaban is still pending.
There has been significant discussion about the cost of these newly developed drugs. At Publix pharmacy in Atlanta dabigatran runs $271.95 for sixty 150 mg tablets. A recent study published in the Annals of Internal Medicine found the drugs are likely to be cost-effective. After reviewing my patient’s bills from anticoagulation clinic I can attest to the likelihood that the drugs will be cost-effective when taking into account the lab and office visit fees required for monitoring.  However their use will create a shifting of reimbursement away from medical centers (anticoagulation clinics) to the pharmaceutical industry.  If insurers don’t cover the full cost of these drugs consumers could bear more costs.  Health systems, such as the Veterans Administration or Emory Healthcare, that have established anticoagulation programs, may have to reorganize as the need for intense monitoring becomes obsolete.  Will the need for reorganization slow the adoption of new anticoagulants onto hospital formularies? As with any new drug, the long term safety of dabigatran and rivaroxaban has not been proven. In 2006 a direct thrombin inhibitor, ximelagatran, was pulled from the market because it was found to cause liver toxicity. What occurs with anticoagulation adoption and use within the United States could prove to be an interesting example of how economic conflicts of interest drive medical decision-making. 

Time will tell how the new anticoagulants compare with warfarin in terms of safety and efficacy.   However, it seems likely that economics will be a factor in the way in which these drugs are adopted and used in medical practice. But, let's hope that the primary factor will be the health and quality of life of our patients.

Tuesday, November 23, 2010

What’s New in Hypertension with JNC 8 on the Horizon?

If David Letterman were to make a Top Ten list called: “Things that Doctors do that Really Matter,” treating hypertension would certainly make the cut. Hypertension is highly prevalent within our society, with about one in three U.S. adults affected. The relationship between blood pressure and cardiovascular risk is continuous and independent of other cardiovascular risk factors. Treatment of hypertension has been demonstrated to reduce risk of stroke by 35 to 40 percent and risk of myocardial infarction by 20 to 25 percent. If you are reading this thinking, “but I’ve always had low blood pressure,” here’s some cheerful news: 90 percent of adults who have normal blood pressure at age 55 will develop hypertension as they age. Thus, the detection and appropriate management of elevated blood pressure is one of the most important tasks in the practice of providing primary care to adult patients.

Those of us who treat hypertension hopefully have heard of the Joint National Committee (JNC) guidelines on hypertension. The latest set, “JNC 7,” came out in 2003. Since 1978, when the National Heart, Lung and Blood Institute (NHLBI) formed its first multidisciplinary panel (JNC 1) to review the evidence and formulate its summary, these guidelines have been the major clinical practice rule set governing appropriate treatment of hypertension. It’s been nearly a decade and JNC 8 is expected to be released in the spring of 2011.

Recently I had the pleasure of listening to a talk at the Georgia Chapter meeting of the American College of Cardiology by Dr. Keith Ferdinand, Clinical Professor of Medicine, Division of Cardiology at Emory and Chief Science Officer of the Association of Black Cardiologists. Dr. Ferdinand, who has served on previous NHLBI JNC committees reviewed the last decade of data that is likely to impact the newest set of hypertension guidelines.

Some of my take home points from this talk are listed below:

  • Evidence supports the treatment of hypertension in octogenarians. Patients treated with indapamide (a diuretic) with or without perindopril (an ace inhibitor) had 30% reduced risk of stroke and a 21% reduced risk of death from any cause.
  • The blood pressure treatment goal for diabetic patients may be revised, based on the ACCORD intensive blood pressure lowering trial, to <140/90 (currently <130/80). ACCORD found no cardiovascular benefit for the primary endpoint with more aggressive lowering of blood pressure (to <120 systolic versus <140 systolic) in high risk hypertensive diabetic patients.
  • ACCORD did find a small reduction in a secondary endpoint, total stroke and non-fatal stroke, in study participants treated to the more aggressive blood pressure goal. In addition the placebo group in ACCORD was noted to have on average relatively well controlled blood pressure.
  • The ONTARGET trials found that there is not good evidence to support either renal or cardiovascular benefit from the combined use of ace inhibitors with ARBs for high risk patients. These randomized controlled trials looked at ramipril, telmasartan, and their combined use with respect to renal and cardiovascular outcomes.
  • In refractory hypertensive patients, spironolactone 25 mg should be considered as an additional agent.
  • Amongst the class of thiazide diuretics there may be differences amongst agents and their prescribed dosages in terms of efficacy for cardiovascular risk reduction. The longer acting chlorthalidone may be more effective than the shorter acting hydrochlorothiazide. Some of the most widely cited studies providing evidence for the use of thiazides as first line treatment for hypertension are based on study of chlorthalidone or using higher doses of HCTZ (50mg) than those normally prescribed.
  • The combination of ace inhibitor (benazepril) and dihydropyridine calcium channel blockers (amlodipine) may be superior to the ace inhibitor and diuretic (hydrochlorothiazide) combination for hypertension treatment (ACCOMPLISH).
  • Atenolol is falling out of favor, with a relative lack of evidence supporting its use as a first line therapy for hypertension. More attention is likely to be given to beta blocker selection on the basis of demonstrated cardiovascular outcomes (metoprolol, carvedilol) in JNC 8.
As a primary care physician I found it very useful to hear Dr. Ferdinand’s opinion about what’s to come with respect to JNC 8’s hypertension guidelines. I already will be changing some of my practice based on this knowledge. I look forward to reading the guidelines and hearing the reaction of experts in the spring of 2011. It appears as though with hypertension, as with other fields of medicine, there will be a growing emphasis on specific drug and dose selection as opposed to class of drug selection.

Monday, November 15, 2010

Generalism as a Medical Specialty

Recently a good friend asked me to recommend an excellent primary care physician in New York City. When no one immediately came to mind, I asked a couple of doctor-friends who trained in New York. One friend, a cardiologist, gave me two names—one was a rheumatologist, who also practices general medicine, and the other an infectious disease doctor by training. My initial reaction to my cardiologist friend’s suggestion that a patient should see a subspecialist for primary care was one of slight annoyance. In my view generalism is a specialty in its own right, and the concept that primary care would be as well-delivered by a physician whose main field of interest is a medical subspecialty seemed flawed. Sure, medical subspecialists go through training in Internal Medicine just as general internists do, but I question whether they really spend time keeping current with the broad range of primary care topics that fall outside of their domain of expertise. Is primary care really something that one can practice on the side, while trying to maintain an in depth knowledge of a medical subspecialty as well?

Much attention has been drawn of to the described shortage of primary care physicians in our country. Is this why patients in New York City are seeing subspecialists for primary care? Or, is it that a general internist alone, without a subspecialty practice on the side, cannot afford to live in New York City? Another friend warned me that most primary care physicians in Manhattan are “cash only.” Relatively lower pay for primary care doctors in the United States health care system has been blamed, in part, for the primary care physician shortage. I believe that it’s more than just pay.

Just how should subspecialists and primary care doctors interact? This has been the subject of debate for years. With the advent of managed care the general internist went from the role of esteemed consultant to the role of “gatekeeper.” A term that drives many of my older colleagues into a maddened frenzy. More recently we have become “primary care physicians,” a label that I personally don’t take issue with. In the United States patients are more likely to visit a subspecialist than a primary care physician. We refer patients to subspecialists more often than in other countries who have reported better performance on quality of care parameters. In the UK patients are referred to subspecialists at about half the frequency that patients in the US are referred. Care delivered by specialists is more expensive than that delivered by primary care physicians. Are there a quality of care differences? Studies have been conflicted on this point and it seems that it depends in part on the condition in question and also on the health delivery system that the care occurs in. An interesting study in the Annals of Family Practice found that many subspecialty visits are routine follow-up of chronic conditions, or preventive, as opposed to consultation requested by a primary care physician. 

In many cases a specialist serving as primary care physician may refer to other subspecialists when conditions emerges that are beyond his or her scope of expertise. For example the cardiologist PCP may refer to an endocrinologist when a fasting blood glucose of 150 is detected, or the infectious disease PCP may refer to the nephrologist when a serum creatinine is 1.6 is detected. In my experience patients who have been managed for primary care by specialists tend to have many more doctors than those who are managed by a competent primary care physician. In some cases patients enjoy and benefit from these additional medical consultations, but many times patients come to me overwhelmed by the number of doctors they are seeing and the myriad of uncoordinated opinions that these various physicians have generated.

In our country over 100 million people suffer from a chronic condition. Amongst Medicare patients, over half have two or more chronic conditions. The Patient Centered Medical Home, with its team-based approach led by a personal physician, has been proposed as a solution to improving care within our health care system. Other primary care physicians have rejected this vision in favor of maintaining a more traditional doctor-patient relationship. However, in order to continue to provide the type of general medical care they feel is best for their patients some primary care physicians are choosing alternative models of care delivery, including retainer fee practices, which come in a variety of models, or micropractices with very low overhead and high tech solutions to improve efficiency and outcomes.

Accountable care organizations have been promoted as a means to support high quality and lower cost delivery of care. Primary care practices that exist in isolation may find it increasingly difficult to survive. Such practices should make attempts to establish linkages and improved lines of communication with their subspecialist colleagues and hospitals. The hope is that meaningful use of electronic medical records will allow such communication-- if these electronic records are not too expensive for the small medical practice to adopt.

However, it should be emphasized that whether or not primary care succeeds is not only in the hands of primary care physicians and policy makers. Placing a higher value on generalism as an esteemed specialty from within the field of medicine will help enhance the standing of primary care in our country. Medical specialists will need to embrace a changing role with better shared care if we want to solve the primary care shortage and entice new trainee into this most fascinating specialty of medicine.

Sunday, October 17, 2010

Reduced bone density: to treat or not to treat?

Osteoporosis is a condition that is sure to become increasingly diagnosed as our population ages. Osteoporosis is significant because it is associated with an increased risk of bone fracture, including fracture of the hip and vertebra, which are the cause of significant morbidity, mortality, loss of independence and medical expense in the elderly. In current clinical practice, osteoporosis is diagnosed on the basis of either the occurrence of a low-impact or fragility fracture, or on the basis of measured low bone mineral density (BMD). A low-impact fracture is one that occurs after a fall from standing height or less; a fragility fracture occurs spontaneously or with no trauma (cough, sneeze, sudden movement).

Bone strength is determined by bone density, bone “quality,” and bone microarchitecture. Of these features, bone density, or mass,  is what we are able to measure. Osteoporosis is defined by World Health Organization criteria based on a person’s bone density by dual energy x-ray absorptiometry (DXA). Osteoporosis occurs when bone density is below 2.5 standard deviations from the mean for non-Hispanic white women between ages 20 and 29 (T score < -2.5). Osteopenia is defined by bone density of between 1 and 2.5 standard deviations below the mean for non-Hispanic white women in their twenties (T score of -1 to -2.5).

In recent years a variety of effective medications have been developed and approved for treatment of low bone density. Nonetheless, there are still significant gaps in our knowledge. Last week the FDA issued a warning about an increased risk of “atypical fractures” that has been observed amongst women who take bisphosphonates, the most commonly prescribed drugs for osteoporosis. A few years ago these drugs were also linked to another rare problem, osteonecrosis of the jaw. This was primarily described in cancer patients and those on cancer medications, but the finding got patients, dentists, and oral surgeons quite worked up over the potential risks.

In clinical practice there is significant variation in the practice of screening for and treating osteoporosis and its precursor, osteopenia. According to national epidemiological data from NHANES III over 56% of women over age 50 have reduced bone density, of these 16% have osteoporosis.  In their 80s 87% of women have reduced bone density and 44% of have osteoporosis. The key to prevention and treatment is trying to figure out who and when to treat aggressively to best prevent fractures. Current guidelines by the US Preventive Services Task Force support screening women at age 65. However, many post-menopausal women under age 65 are also at risk and the conservative evidence-based USPSTF guidelines do not comment on which of these women should also be screened. Other professional guidelines, such as those issued by the National Osteoporosis Foundation, support screening younger women who are post-menopausal and who have risk factors.

A variety of clinical tools exist to help women quantify their osteoporosis risk.

Osteoporosis risk factors include:

• Low body weight (<57 kg)
• Asian or Caucasian ethnicity
• Personal history of fragility fracture
• Family history of osteoporosis
• Smoking
• Drinking > 2 glasses of alcohol per day
• Excessive caffeine intake
• Certain medications (glucocorticoids)
• Sedentary lifestyle
• Amenorrhea (lapses in menstruation prior to menopause)
• Eating disorders
• Marathon running
• Dietary deficiencies of calcium and vitamin D
• Chronic health conditions (chronic liver and kidney disease, rheumatoid arthritis)

Many women fall into these increased risk categories and thus are screened before age 65 leaving them with a diagnosis of osteopenia or osteoporosis and creating the conundrum of what to do for the remainder of a woman’s life.

In general, most women with osteopenia should not receive pharmacologic therapy unless they are higher risk, or have already suffered a fracture. Instead, they should be counseled to institute behavioral measures, such as increased weight-bearing exercise and increases in calcium and vitamin D supplementation. When these women should be rescreened is not clear, but probably no more often than every two years. Tracking the rate of bone density decline may help identify women who subsequently should receive drug therapy.

Effective pharmacologic treatments for osteoporosis are available and are, in general, well tolerated. Medication options include the bisphosphonates: alendronate, residronate, ibandronate and zoledronic acid, hormonal treatments (estrogen and selective estrogen receptor modulators), and recombinant parathyroid hormone (teriparatide). Of these options, the oral bisphosphonates, alendronate (Fosamax) and residronate (Actonel), have the most evidence supporting their efficacy in fracture prevention, and are considered first line. These drugs, however, can be somewhat inconvenient to administer because of their poor bioavailability that requires them to be taken on an empty stomach for best absorption. In addition, they are associated with gastrointestinal side effects—specifically esophagitis, and for this reason are contraindicated in patients with precancerous changes of the espophagus, “Barrett’s Esophagus.” For patients who experience gastrointestinal side effects the intravenous bisphosphonate, zoledronic acid may be administered every one to two years.

Hormonal therapies, such as estrogen, are effective treatment for low bone density. However, as indicated by the results of the Women’s Health Initiate, their use has been associated with an increased risk of breast cancer and cardiovascular disease. Raloxifene, a selective estrogen receptor modulator (SERM), is approved for both prevention and treatment of osteoporosis. Its use, while associated with a reduction in breast cancer risk, is also associated with an increased risk of thomboembolism. Its effect on cardiovascular disease appears to be neutral.

The appropriate duration of therapy and frequency of monitoring patients who are on pharmaceutical treatment are areas that remain ill-defined. Studies have indicated that 5 years of alendronate may be adequate for many average risk women. However, my experience in clinical practice is that many women are left on these drugs for years and years. Some have advocated drug “holidays” after five years of therapy. The largest randomized controlled trial looking at alendronate use and fracture outcomes was 10 years in duration, which in my view calls into question the safety of prolonged use.

Many questions remain about how to approach the treatment of aging bones to prevent the debilitating outcome of bone fracture. Seasoned clinicians have seen the problems that may occur in some cases with treating large populations of well patients for normal life processes (postmenopausal estrogen replacement therapy). Let’s hope that future research will address the question of when to treat with medication and for how long with further precision. Until then let’s use appropriate caution when prescribing medicine for normal senior bones.

Sunday, September 19, 2010

Striving for Samantha? Limited Treatment Options for Women With Low Libido

Lack of sexual interest is the most common sexual complaint in women. The latest version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), which defines psychiatric disorders, defines Hypoactive Sexual Desire Disorder (HSDD) as ‘‘persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity’’ that causes ‘‘marked distress or interpersonal difficulty.’’ Epidemiologic surveys have suggested that from 25 to 50 percent of women report prolonged periods of reduced sexual interest. A lesser but still significant number, on the order of 7 to 15 percent, may meet criteria for HSDD, where loss of sexual interest results in significant distress, and cannot be explained by a co-morbid medical or psychiatric condition, medication side effect, or substance abuse. As a clinician who cares for women I can attest for the common nature of this complaint, and feel frustrated by the lack of therapeutic options.

In June 2010 an FDA advisory board recommended against approval of Filbanserin, the latest drug developed to treat women with decreased libido. Its reason for rejection was the perceived low efficacy of the drug paired with an unacceptably high rate of side effects including dizziness, nausea and fatigue in female users. Data from trials of Filbanserin given to women with HSDD had shown promise, with a reported increased number of “sexually satisfying events” experienced by women who took the drug. The advisory board’s recommendation against approval was disappointing news to women and the physicians who treat them.

Wouldn’t it be great if there were a female Viagra? In fact Pfizer did study the use of Viagra to treat sexual dysfunction in women. However, it was found to be ineffective. The testosterone patch is another option with demonstrated efficacy that has been rejected by the FDA because of safety concerns. These patches are widely available in Europe and have been found to be effective in surgically menopausal women with reduced libido. Unfortunately, their use has been associated with increased risk of breast cancer. Incidentally, testosterone use in men has also been found to have safety concerns and is associated with increased risk of cardiovascular events based on a recent trial published in the New England Journal of Medicine.

Topical estrogen therapy, which treats vaginal dryness and atrophy in post-menopausal women, can be useful for those who experience dysparunia (pain with intercourse). Making things more comfortable certainly can help with sexual desire. However, other than this, doctors are left recommending behavioral solutions and sexual therapy for our female patients to enhance sexual interest, as their eyes glaze over--light a candle, play some music, set aside time for romance and cuddling. Not to make light of relationship and lifestyle contributors, but I wonder what a man would say if I prescribed this for his erectile dysfunction?

Why are options for women so limited? Part of the reason may be because the diagnosis of Hypoactive Sexual Desire Disorder encompasses a multi-factorial array of variables that many are skeptical about addressing with a single drug, unlike male sexuality , I suppose, which is seen as a matter of simple mechanics. Experts in the field note problems with the way that HSDD is defined and revisions to the diagnostic criteria have been proposed for the next version of DSM.

Sexual complaints are common within our culture, however they present differently in men and women. Men complain more about function and women complain more about desire. Disinterest in sex that creates distress in one person may not create distress in another. Is the current paucity of options to treat sexual dysfunction in women related to our cultural notions of appropriate sexuality? Do we really believe that women who complain of decreased libido are hysterical or neurotic? Or, that their complex and ethereal nature can’t be helped by a single drug in the same way that men with a simple mechanical issue can? Or, are we over-medicalizing normal gender differences in sexuality, applying an artificial label “HSDD,” which further pressures women to feel as though they should fantasize and desire sex in the same way as men do. Or, in contrast, have we made a cultural determination that sexuality is not as important to a maturing woman’s well-being as it is to a man’s, and for this reason have we failed to push for solutions that might carry risks that we deem outweigh the less important benefit of promoting sexual desire in women? I don’t know the answers to these questions, but they are interesting to ponder. The discussion calls to mind the character of 50-something Samantha from Sex in The City. With her healthy libido, is Samantha the woman that women want to be? Or, is she the woman that men want us to be? Or, is she the woman that scares us? Or, is she simply a fantasy?

Monday, September 6, 2010

What I Learned from Asthma

As a kid I had allergies and asthma. Because of this, for several years, my mother wrote a note excusing me from the 600 meter run in elementary school. My father took me to weekly allergy shots. At times I had eczema on my forearms and eyes, and according to my allergist, whose notes I later read, I had moderate allergic shiners (also known as dark circles under my eyes). My allergies led to frequent nosebleeds, which got me sent to the nurse’s office in school. Some nose bleeds were bad enough so that I was sent home from school. For years I was in and out of doctors’ offices frequently, when my attacks were severe enough to require treatment with epinephrine injections to afford me some relief. Otherwise, I remained perpetually wired on a daily cocktail of theophylline, Dimetapp, and an occasional albuterol tablet. Despite all of this I tried hard not to be a complete dweeb.

I remember the doctors wanting to put me on oral steroids, which my parents refused. Maybe we were “difficult” patients. My parents were concerned about the long term toxicity of steroids, particularly the possibility of stunting my growth. Perhaps they thought I had a career ahead of me in professional basketball (I am now 5 foot 10 inches). We learned that I frequently would require a course of antibiotics after I became sick with a virus. As doctors became more cautious to avoid antibiotic overuse, our insight about this frequently met some resistance by those who were not familiar with me.

When I was thirteen I was admitted to Mott Children’s Hospital in Ann Arbor, Michigan. I shared a room with two other girls, one from the Upper Peninsula of Michigan, who had some sort of intestinal issue that had required her to have multiple surgeries and hospitalizations. The girl in the bed across from me had anorexia. I remember overhearing intense discussions with her parents and being perplexed about all the talk of food. My illness seemed pretty minor in comparison.

Asthma therapy has changed a lot since the 70s and early 80s, but some of the experiences of being a patient and having a long term health condition remain the same. It was my good fortune to have had an illness that, for the most part, has resolved. Although, it still seems that I am allergic to most living things with fur, much to my children’s dismay. After spending a year living in Brazil and going through a late puberty, in high school I stopped my allergy shots and discontinued most of my medication.

Asthma has played a minimal role in my adult life. Only occasionally do I use my albuterol inhaler before I run. However, having had this illness experience has taught me a few things about caring for patients, and likely contributed to my decision to become a doctor. As a child I remember feeling guilty about my allergies, as if somehow they were volitional, or that I was deliberately trying to get attention by inventing health issues that excused me from participating in various kids’ activities. In retrospect, I am glad that my parents were” difficult” at times, refusing steroids and insisting on the antibiotics that they learned from experience would help make me well.

Here are some of the lessons that I learned:

1. People with chronic illness may feel guilty about the social effects of their illness.

2. People with chronic illness may feel that they are to blame for their illness.

3. Our current culture of personal responsibility may not be helping those with chronic illness with these perceptions, and may lead to increased depression and social isolation in those who have chronic illness.

4. Difficult patients should be listened to and usually bring up valid points.

5. Allergies are not volitional.

6. Patients with chronic illness frequently understand their health conditions better than doctors do.

7. Chronic illness care is more effective in the context of a long term collaborative relationship with one’s personal physician.

8. Family pets are hard to get rid of.

Wednesday, September 1, 2010

Continuity of Care, Lost in the Shuffle

Guest post by Kreton Mavromatis, MD, FACC, Director of Cardiac Catheterization Laboratory, Atlanta VA Medical Center, Emory University

As I entered the clinic room I saw my patient for the first time, an elderly man, slumped in his wheelchair, thin, breathing rapidly, appearing tired both physically and mentally. I wished that I had seen him before. How long had he been this way? Had he been getting worse in the last week? The last day? The last few hours? What was his attitude towards his illness? At his advanced age, how hard did he want to fight to live, to feel better? How much medical and/or surgical treatment was he willing to endure?

It was not the first time I knew of my patient. I had spoken extensively with his referring physician about his heart failure, his other medical problems, and his attitudes. Yet, despite my in depth conversation with another experienced and caring physician, I still had so many questions. If only I had had a relationship with my patient before he became so threateningly ill.

Continuity of care is “the process by which the patient and the physician are cooperatively involved in ongoing health care management toward the goal of high quality, cost-effective medical care.” In today’s healthcare systems, physicians recognize it as a single physician caring for a single patient over time. Yet in today’s healthcare systems, this has been greatly lost. From part-time ambulatory care physicians only available certain days of the week, to groups of obstetricians who have a call system where one physician covers all the others on nights and weekends, to residents whose work-hour limits force them to turnover care to another resident, continuity of care is being destroyed. And it cannot be entirely replaced by careful “sign-outs” and EMRs.

Part of the practice of medicine is a “science.” Much can be communicated in the form of words and numbers describing symptoms, physical exam findings and test results. Yes, I knew my patient was short of breath a week ago when my referring physician had last seen him. But was he short of breath at rest and was he tachypnic? What was his respiratory rate? Was he using any of his accessory muscles to breath? Was he using inter-costal muscles, or just the diaphragm? For each symptom, each physical exam finding, each test result, multiple descriptors could be used to enhance the total clinical picture of a patient. As physicians, we note many of these consciously. But all the details are rarely documented in their entirety in our notes, as doing so would not be “time-efficient.” Furthermore, even with EMRs, these details cannot be conveyed in a practical and timely manner from physician to physician.

Part of the practice of medicine is an “art.” How stoic is a patient? How fearful? How much denial does the patient have? How much fatigue is the patient experiencing? What is the patient’s attitude toward his or her current illness and treatment in the context of his or her current life? Experienced physicians can recognize the answer to these questions through repeated encounters with patients and their families, encounters which involve conversation, the assessment of the body language and facial expressions. However, expressing it verbally to another physician in a detailed qualitatitive and quantitative way is rarely possible.

The evolution of our health care system has resulted in fantastic advances in health care delivery. The use of specialists, with their knowledge of large amounts of complex information and technology, has led to the better treatment of certain individual diseases. Work-hour restrictions have reduced physician fatigue as a source of medical errors, and led to a better quality-of-life for healthcare providers. Increased physician documentation requirements have resulted in data collection that can be analyzed for the purpose of quality improvement. Yet these same “advances” are destroying continuity-of-care, and the single doctor-patient relationship over time, which I believe is so essential to the highest quality of medical care. A new emphasis on preserving and revitalizing continuity of care must be made as our healthcare system continues to evolve.

Sunday, August 15, 2010

Early Detection of Alzheimer’s Disease? Not Yet, Thanks.

Alzheimer's disease made headlines this week, first with news about a new biomarker test that is able to diagnose the disease with increased accuracy, then with a follow-up story detailing the collaborative model of data-sharing that contributed to the success of recent research.

As I read the news with interest I couldn't help but feel that in our current climate, the manner in which it was reported was somewhat ironic. Just nine months ago experts on the United States Preventive Services Task Force argued that harm, in the form of anxiety related to the detection of breast abnormalities, was too excessive to warrant screening mammograms in forty-year-old women. Just think of the anxiety that will occur if we begin screening asymptomatic adults for Alzheimer's disease.

The unfortunate reality is that despite recent gains in our ability to accurately diagnose Alzheimer's disease, there is still no therapy that has proven effective in preventing its progression. On August 3, 2010 the Annals of Internal Medicine published a summary of this year's National Institute of Health Preventing Alzheimer's Disease and Cognitive Decline Conference.

Alzheimer's disease, the most common form of dementia, is a critical field of study, given the impact that this condition will have on our aging population. At this point the main benefit of earlier and more accurate diagnosis of cognitive impairment and dementia is that it will promote more research on therapeutics on a population level. However, practically thinking, what about the burden that this type of diagnosis could have individuals who go through testing? Is it worthwhile to detect a condition early for which there is currently no definite effective therapy? What would have happened to Ronald Reagan had he had this spinal fluid test when he was sixty years old? Would he have run for president? Would we have elected him? The test may accurately predict Alzheimer's, but does it tell us when? And will happen to health insurance or long-term care insurance coverage for patients after this test is performed?

MRI's are an also an effective means for detecting changes related to Alzheimer's disease, demonstrating amyloid plaque accumulation in patients with Alzheimer's, and distinguishing these patients from those who have other types of dementia, such as vascular dementia, which might be managed differently. However, what about all of our talk of comparative efficacy? Has performing an MRI been shown to alter the outcome of patients with a cognitive impairment or dementia diagnosis? I doubt that it has. I hate to be a cynic, but who will pay for the spinal fluid test, and the MRI, and the neuropsychological testing? And then, the repeat MRIs, and biomarker tests, and neuropsychological tests when the results of the first tests are inconclusive? How frequently will these tests need to be done? These questions are at the heart of the reality that our country faces with respect to the role of medical progress, cost, and health care. But as a physician I advocate mainly for my patient, not for the health care system, so I make these diagnostic decisions collaboratively with my patients, not necessarily with the population level questions in mind.

The Alzheimer's progress is a perfect example of how our country will have to grapple with balancing exciting innovation with the appropriate use of "evidence-based" diagnostics in the coming decade. But how will diagnostics ever become evidence-based if health plans refuse to pay for them? If industry finances expensive clinical trials, should we really be attempting to regulate the cost of their drugs?

In the wonderful book by Audrey Niffenegger, The Time Traveler's Wife, the time traveler witnesses his future death. His fate is unalterable and torments him. Until there is more effective therapy, I, for one, will not be doing the Alzheimer's test. Instead, I will do my best to remain mentally and physically active, control my cardiovascular risk factors, eat my vegetables, consider taking fish oil, take an 81 mg aspirin when I am 65, and wait to see what the next decade of Alzheimer's research will bring in terms of therapeutics. Hopefully innovation will not be stifled by policy change within our country.

Wednesday, August 4, 2010

Getting Back to Medicine

Two weeks ago I opened a new medical practice. It's been a long haul. One year ago, after 12 years in practice as an academic general internist, I decided to make a change. After sifting through a wide range of opportunities within the Atlanta metropolitan area I made the decision to open a solo general internal medicine practice. Some might consider it crazy, in an era when physicians are increasingly leaving private practice in favor of large employed groups. Employed groups do offer certain advantages for physicians, including being able to negotiate better contractual rates from insurers, cost-sharing with respect to benefits and pricey equipment, including electronic health records, and more opportunity for shared night call and weekend coverage. 

However, I had just left a large employed group and was witness to the kinds of problems with patient care, access, and continuity that can occur in this type of practice setting. Cost reducing practices, implemented under the guise of efficiency, such as off-site call triage centers, tend to reduce doctor-patient communication, in favor of "teamwork" so that doctors can be left to their revenue generating activity of frenetically seeing 20 to 25 patients daily. 

What I was after was a smaller, more personal practice, where I wouldn't have to spend the first five minutes of my fifteen minute doctor-patient encounter apologizing to my patients for systemic problems that affected the care that they were receiving.

In opening my practice there were several keys decisions to make: first, my practice location. I left my old practice with a two year non-compete covenant restricting me from the practice of general internal medicine in the area where I had built my life and home for twelve years. Would I be forced to move? Or, would I add on an extra hour of driving, and practice outside of my non-competition perimeter? I grappled with this decision for six months. It's funny how many of my friends questioned the legality of this type of contract within the state of Georgia. However, the three lawyers that I spoke with felt it was too risky to violate it. Fortunately this issue is now resolved, and I have established my practice close to home and plan to have a good working relationship with the institution that I left.

Another major decision was whether or not to purchase an electronic health record. The final "meaningful use" criteria tying Medicare and Medicaid reimbursement and incentives to the adoption of electronic health records by eligible medical professionals and hospitals were released two weeks ago. Being somewhat of a techno-geek and a relative "early-adopter," I opted to shell out the cash and buy an electronic medical record (EMR), with hopes that a promised link to my main referral center would become functional in the near future. We'll see how this pans out. I am already concerned that the commercial lab that I have contracted with is hesitating on what I thought was an agreement to upload my lab data directly into my EMR.  Apparently EMR providers charge extra to "turn on" this interface.  If the lab refuses I will be left to cover that cost as well. Those of you in the process of purchasing electronic records should be sure to verify in writing all of the links and interfaces that you want to function, and who will cover the costs associated with turning them on.  Meaningful use requires that lab data is entered into one's EMR as structured data, as opposed to scanned in, which makes the data usable when looking for trends and for generating quality reports and automated reminders.   Don't get me wrong, I am still happy with my expensive new "toy," though it's taking me twenty minutes, instead of two, to type in my office note, as opposed to dictating. Hopefully that will get faster. My implementation support has been wonderful, which I am grateful about.

Finally, I had to decide on staffing. I had originally planned to hire an office manager, but with the purchase of my EMR I decided to outsource my billing to the same company, which meant that I had more flexibility. An opportunity became available for me to hire a wonderful LPN with whom I had worked for many years. I feel so fortunate to work with a capable and loyal employee, who "knows my ways," and with whom I have shared common processes and protocols in the past and who is partnering with me in this endeavor. This is the decision that I am most confident about.

As I began to see patients again two weeks ago, I was surer than ever about my career choice to become a general internist. I can only hope that in the near future my practice will become something more than an expensive hobby.  In the meantime I will continue to work on the side at Georgia Tech in student health to make ends meet.

Tuesday, August 3, 2010

Is Distance Running Really Good For Your Heart?

By guest blogger: Kreton Mavromatis, MD, Assistant Professor of Medicine, Emory University, Director of Cardiac Catheterization, Atlanta VA Hospital
It's Sunday morning, July 4th and I have just returned from running a 10K race and I am feeling good.  I run approximately 3 or 4 days per week, and I run a race or two, including a half-marathon, each year, mainly to serve as a training goal. My motivation for running is primarily so that I can afford to eat more food, my favorite daily activity. However, as a cardiologist, seeing people with heart attacks from occluded coronary arteries day-in and day-out, I have always believed that running (and exercise in general) is good for my vascular health. After all, doesn't running lower blood pressure and cholesterol, and haven't studies shown that people who exercise more live longer? In fact, prospective epidemiological studies have suggested a dose related effect, implying more exercise of greater intensity is better.
To my dismay, however, several recent studies have suggested that running may not be good for my heart or arteries after all. Mohlenkamp et al showed that 108 apparently healthy marathon runners had more coronary artery calcium (which is found in coronary artery atherosclerosis) than patients matched for age and Framingham risk score (a commonly used measure of a person's risk for cardiovascular disease based on their risk factor profile). Furthermore, they showed that the amount of coronary artery calcium, as well as the number of marathons run, was directly associated with myocardial (heart) damage, which was detected in 12% of the marathon runners. Finally, four of the runners had cardiovascular "events" over the next 2 years, all of whom had high levels of coronary artery calcium. Similarly, Schwartz et al. showed that 25 marathoners had more coronary artery plaque than 25 non-marathoners who had similar ages, blood pressure and cholesterol levels.
These studies are far from conclusive. The marathon runners may have had more predisposition to coronary artery disease than the non-runners despite similar Framingham risk scores, perhaps due to prior lifestyle differences (i.e. smoking, diet) or a more extensive family history of such disease. On the other hand, there are plausible mechanisms by which running could increase vascular disease. Intensive exercise is well-known to increase oxidative stress and inflammation, which are fundamental to the development of coronary artery disease.
Runners like me like to believe that running is good for our heart and blood vessels, based on the principle of "use it or lose it". However, maybe the cardiovascular system is more like a car (and just about everything else), the more "mileage" it has, the more likely it is to break down.

Sunday, July 4, 2010

Does Sunscreen Really Work?

This weekend I’m spending the Fourth at the beach with my family in South Carolina. Today, after spending 20 minutes slathering sunscreen on my somewhat disgruntled children and myself, I gathered up my straw hat, sunglasses, book, two kites, a couple of chairs, and several more tubes of sunscreen, making our daily exodus to the beach. Things have changed a lot since I was a teenager, back in the eighties--the Hawaiian Tropic Coconut Oil is nowhere to be found, despite my Brazilian heritage and cultural proclivity toward small bathing suits and a good tan.

But just how much protection do these bottles of SPF 30+ sunscreen actually provide us?

Skin cancer is the most common form of cancer diagnosed in the United States. There are three major types: basal cell, squamous cell and melanoma. Of those, basal cell and squamous cell are most common, accounting for about 3.5 million cases in the United States per year. Although, these types typically do not metastasize, they can be quite disfiguring, particularly after resection when they occur on the face. On a population level, melanoma is the most dangerous type of skin cancer, accounting for approximately eight thousand of the ten thousand deaths per year attributed to skin cancer.

This year the Environmental Working Group and Senator Charles Schumer brought to light concerns that have arisen about a form of vitamin A, retinyl palmitate, found in 41 percent of sunscreens. This compound has been found to accelerate the development of skin cancer in laboratory animals. Schumer and EWA were critical of the FDA for its slowness to address the existing studies and for its failure to regulate the safety and efficacy of sunscreens. Although there is significant evidence that sun exposure is a strong risk factor for skin cancer, there is relatively scant evidence that sunscreen use mitigates this risk. Randomized controlled trials have demonstrated a decreased incidence of actinic keratosis (a skin cancer precursor) and squamous cell cancer in sunscreen users. In these same trials, basal cell skin cancer was not similarly impacted. Moreover, no studies have confirmed a protective relationship with respect to melanoma incidence, and in fact several studies have shown increased risk in sunscreen users, perhaps because high SPF sunscreen users spend more time in the sun than those who user lower SPF’s.

Other factors reduce the effectiveness of sunscreen, including the failure of people to apply it appropriately, in adequate quantity, and to reapply after sweating, swimming or toweling off. A whole host of high SPF sunscreens are available, but labels touting high SPF content may be inaccurate. In addition, beyond SPF 15 the difference amongst sunscreens is minimal--SPF 15 filters 93% of UVB light, compared with SPF 30, which filters 98%. The SPF refers to the UVB blocking property. Sunscreen components that block UVA include zinc oxide, titanium dioxide and avobenzone and Mexoryl SX.

What can you do to avoid skin cancer risk?

• Avoid the sun between the hours of 10 AM and 4 PM.
• Use protective clothing when outdoors, including wide brimmed hats and shirts. Tighter weaves and darker colors do a better job, and UV protective fabric is also effective.
• Use sunscreen of SPF 30 or greater that blocks both UVA and UVB light, applied in adequate quantity, and reapplied frequently
• Avoid sunlamps and tanning equipment.
• Practice skin self-examination.

Saturday, June 19, 2010

Can the Patient Centered Medical Home Save Primary Care?

For years now we’ve been hearing about the trials and tribulations that have evolved in the practice of primary care medicine. However, the discussion has intensified in recent months with passage of national health reform. Recent publications highlight the problems. A paper in the New England Journal of Medicine by Dr.Richard Baron entitled What Keeps Us So Busy in Primary Care?discusses the time spent by primary care doctors on non-visit related work, which according to his findings, interrupts us 43 times daily. Health insurance reimbursement to physicians is “fee for service,” thus leaving all of this work uncompensated. Moreover, health insurance pays better for procedures than it does for talking to patients. These factors have contributed to perverse incentives: “see more patients, run more tests.”

With current relative shortages of primary care physicians, and the anticipation of more patients entering the health system, attracting new physicians to pursue a career in primary care is seen as critically important. However, medical students hesitate to choose it as a career because of its difficult lifestyle, lower remuneration, and the current practice environment. Yesterday I read that HHS Secretary Kathleen Sebelius announced the release of $250 million in new funding to strengthen the primary care workforce. Of this, $168 million is set aside for training more than 500 new primary care physicians by 2015. That's good news, but who is going to want to pursue this training if the value placed on our time remains so low, and the practice pace remains as hectic as it is today?

What is the answer? There are several current responses to the primary care crisis. On the one hand, the advent of retail clinics and retainer fee medical practices, and on the other hand, the Patient Centered Medical Home model, which has established itself with increasing legitimacy as the best solution. The May issue of Health Affairs was dedicated to “Reinventing Primary Care.” For those of you who have not heard of it, the “Patient Centered Medical Home” (PCMH) is a model of primary care that reorganizes the care team in a way that gets non-physicians more involved, supports patient “activation” toward improved self-care, and uses electronic systems—electronic health records and patient portals—to better manage populations of patients, particularly those with chronic illness. In many ways the Patient Centered Medical Home might really be called the Computer-Centered Medical Home.


The PCMH addresses the problem of access to primary care and is particularly appealing as a solution within certain segments of the insured population, namely, Medicaid and Medicare. Physicians have increasingly dropped Medicaid because of its very low reimbursement rates. This has made access to care, despite insurance coverage, very difficult. A similar problem may soon exist within the Medicare population, with physicians dropping or capping Medicare patients, if an acceptable solution is not reached with respect to the SGR and Medicare's payments to physicians drops further.

Intrinsic to the PCMH is the concept that primary care should be reimbursed differently. Under this model payment is both fee-for-service and additionally capitated per patient member within the practice. Results of implementation of the PCMH have been published from Group Health Cooperative in Washington and also recently from Medicare's pilots projects. The Group Health results look promising, showing overall cost savings, related to decreased inpatient and emergency room use. However, reports from the large TransforMED pilot, published in the Annals of Family Medicine, are less promising. "Working feverishly, the 36 participating family practices registered only modest improvements in quality-of-care measures but backslid in terms of how patients rated them." The authors of the summary conceded that medical home transformation "requires tremendous effort and motivation," and that most practices would need outside help, as well as adequate compensation, to make the switch."

Simulateous with the PCMH, retainer fee medicine has appeared in many areas of the United States. Similar to the PCMH, retainer fee medicine, also known as “concierge medicine,” provides extra funding to a medical practice in a capitated manner with a per patient annual fee. The difference is that in the PCMH, the hope is that insurers will provide the additional capitated funding. Another key difference is that PCMH designated practices must prove that they deliver certain elements of care to their patients. In fact, to become certified a practice needs to achieve a long and complex set of criteria. The model has been criticized as being “out of reach” for many small practices, who simply cannot afford the additional layer of clinic administration needed to complete the check list.

In contrast to the PCMH standardization, among retainer fee practices there is significant variability in the type of care delivered, the annual fee charged, and the practice's adoption of electronic systems and quality reporting. This type of practice typically emphasizes a more "Marcus Welby" approach, with emphasis placed on personal communication and the traditional doctor-patient relationship. Whereas PCMH practices emphasize care teams with more participation of non-physician members, and may in fact increase the number of patients cared for by each physician, retainer fee practices typically guarantee that they will care for fewer patients per doctor.

As I see it both the PCMH and retainer fee medicine are reasonable solutions to current short-comings. What's wrong with a "Patient-Sponsored Medical Home" practice, structured as a hybrid of these two primary care models, with built in systems to ensure quality, but also structured with the promise of a smaller patient panel for those want a more traditional doctor-patient relationship ? Can the Medical Home have it's cake and eat it too? Or, will it fail to support the personal aspects of the doctor-patient relationship, the value of which is more difficult to measure with quality metrics and clinical outcomes?