DrDialogue

Intuitive Eating and More

2012-01-31T04:54:00.000-08:00

Recently Personalized Primary Care Atlanta hosted an evening workshop reviewing some of today’s popular diets. Nutritionist, David Orozco, RD presented an overview of popular diets including: Atkins, South Beach, Paleo, Sugar Busters, DASH, Mediterranean, Zone, Weight Watcher’s, and the HCG diet, among others.

In his talk Mr. Orozco briefly described some key elements of “fad” diets to beware of:

A magic bullet (i.e. the hormone HCG, which, when given with a 500 kcal per day diet, results in weight loss)
Diet phases or stages, such as “Rapid Detox” and “Maintenance” phases
Celebrity testimonials and endorsements

Medical professionals agree that the DASH diet and the Mediterranean diet have the most scientific evidence to back up their potential benefit in terms of health related outcomes such as hypertension and metabolic syndrome. These two diets are also ranked #1 and #2 respectively by a US News ranking of "Best Diets." WebMD’s diet comparison tool comes very highly recommended if you are sorting through diet options.

However, Mr. Orozco advocates a different approach to dieting: “Intuitive Eating,” or “Mindful Eating.” These concepts involve gaining an understanding of one’s relationship with food and then healing it, such that an individual gains a heightened responsiveness to his or her own body signals. The premise, a kind of psychotherapeutic approach, is that intuitive eating will result in better food equilibrium and eventual healthy weight maintenance. I’ll admit that I have not yet read the book, but am eager to do so.

As I listened to the talk, I brought to the table my own perspective—I have never struggled with my weight, I am a relatively compulsive exerciser, and I enjoy cooking and eating out. Exercise alone has been shown to be an effective technique to help with weight maintenance. My personal experience (I’ve been about the same weight since age 18) is testimony to this. However, the one time that I did lose 15 pounds, I did it through calorie counting. Since then (twenty years ago), I’ll admit that I do have a conscious awareness of the caloric value of most food that I ingest. Do I eat chips, chocolate, an occasional Quarter Pounder and fries? Absolutely; but when the scale tips up five pounds I am quick to take action and cut back. For dinner tonight—homemade lentil soup with kielbasa, bacon, and carrots, brown rice, green salad with blue cheese, and a glass of Argentine Malbec; for dessert: a sliver of lemon pound cake topped with coconut gelato.

I have found that with my patients who want to achieve more than ten pounds of weight loss, a structured approach is essential—a specific action plan. Vague plans to cut back and “eat healthier” tend not to be effective. Over the years I have asked my patients who have successfully lost weight what their strategy was. Though the strategies that my patients describe are as diverse as are the array of diets on the market, a common thread seems that those who have been successful are able to articulate a clear plan of action that led to the weight loss.

I am an advocated of calorie counting and Weight Watchers (whose point system is essentially like calorie counting). My viewpoint is that for weight loss, it’s not so much the content of the food that matters, but rather the quantity and caloric value. However, there is some evidence that low carbohydrate diets may produce more weight loss than very low fat diets (i.e. the Ornish Diet) though this finding has not yet been definitively proven. A pound of fat is equal to 3500 kcal. It’s hard to lose more than a pound of fat every 7 to 10 days, and I don’t recommend it. I personally consume about 2000-2500 kcal per day (with 30-60 minutes of exercise on most days).

Here are some of my own weight loss tips:

Eat smaller portions, but don’t skip meals
Count and record your calories for at least 1-2 weeks when you begin to diet
Don’t reduce your caloric intake by more than 500 kcal per day below baseline intake (it’s too hard to maintain)
Don’t drink diet drinks and don’t drink any beverage all day long (including water)
Do have coffee or tea following a meal if you are not quite satisfied
Do enjoy a mealtime ritual at least once a day-- set the table and play some music while you dine, enjoy your oatmeal and coffee while reading the paper
Don’t snack more than once per day
Do allow yourself to feel hunger for a couple of hours before you eat
Limit refined carbohydrates and add healthy fats, but forget margarine, it’s no substitute for butter
Don’t eliminate your favorite food, save it as a treat a day or two per week
Treat yourself to meals out, but split your portion with a companion or eat an appetizer instead of an entree
Exercise 3-4 times per week, but keep in mind that adding exercise alone rarely works to achieve more than 5 to 10 pounds of weight loss
Don’t chastise yourself if you are unable to exercise, most of weight loss comes through alterations in one’s diet not through exercise
Cook at least three times per week using whole food ingredients and cook enough for two meals so that you can have leftovers
Pack your lunch and bring it to work

Once your desired weight loss is reached, this is where intuitive or mindful eating becomes important—retraining oneself toward a healthier relationship with food. Weight maintenance is the hard part. Some of you may have read a recent New York Times Magazine cover article entitled “The Fat Trap” by weekly health columnist and author of the NYT "Well" blog Tara Parker-Pope. Ms. Parker-Pope makes the case that powerful metabolic and hormonal factors make it very difficult to maintain weight loss. I personally find Ms. Parker-Pope’s viewpoint overly nihilistic, though she brings to light interesting information. A petitioned response to Ms. Parker-Pope’s piece, authored Gary Taubes and Peter Attia, MD, argues that Ms. Parker-Pope’s article neglected the important effect of insulin resistance on obesity. The authors maintain that restriction of refined carbohydrates, as opposed to overall caloric restriction, can allow overweight patients to successfully bypass some of the metabolic impediments to weight loss by reducing insulin resistance, while all the while suppressing hunger through increased protein and fat consumption. Indeed there is some medical evidence to support low carbohydrate diets.

In my own practice I have seen numerous patients lose weight successfully. The metabolic effects on cholesterol, blood sugar and blood pressure are typically profound. Remember, if you are overweight or obese, weight loss in itself is as important of a goal as is healthy eating.

How did you lose weight? Were you able to maintain it? What do you think of the intuitive eating concept? I welcome you to share your own lessons and help others.

*To learn more about intuitive eating contact David Orozco RD of T+D Wellness in Atlanta at 404-228-9704.

When is unneeded care criminal?

2012-01-09T04:32:00.000-08:00

Co-Authored by Juliet K. Mavromatis, MD, FACP, Personalized Primary Care Atlanta and Kreton Mavromatis, MD, Assistant Professor of Medicine, Emory University, Director of the Cardiac Catheterization Laboratory, Atlanta VA Medical Center

Recent media coverage has sensationalized the criminal investigation of several cardiologists for the possibility of performing fraudulent cardiac procedures. Is this a case of individuals with unethical conduct? Or, does it point toward a more systemic problem in medical care, where Medicare dollars are wasted on unneeded care? As reported in Heartwire on July 27, 2011:

"A federal jury convicted McLean, 59, on six charges of healthcare fraud relating to insurance claims he'd filed for stents deemed to have been placed unnecessarily, as well as for ordering unnecessary tests and making false entries in patient medical records…evidence brought forward suggested that McLean had performed cardiac catheterizations and implanted unnecessary cardiac stents in more than 100 patients. He then falsely recorded in the patients' medical records the existence or extent of coronary artery blockage, known as lesions, observed during the procedures in order to justify the stent and the submission of claims to healthcare benefit programs, including Medicare and Medicaid."

In a separate case the Senate Finance Committee investigated Dr. Mark Midei, an interventional cardiologist practicing in Towson Maryland, for the possibility of performing unnecessary stents and also for his relationship with Abbott Laboratories, the company that manufactures the stents that he used.
A prominent cardiologist commented in the New York Times report:

“What was going on in Baltimore is going on right now in every city in America,” saying that he routinely treats patients who have been given multiple unneeded stents. “We’re spending a fortune as a country on procedures that people don’t need.”

Coronary artery disease affects a large proportion of people in Western civilization. The disease manifests as blockages in coronary arteries limiting blood flow to heart muscle, causing heart pain, heart attacks, heart failure and/or sudden death. Heart disease kills 1 out of every 6 Americans. Coronary artery stents are metal mesh tubes that can be placed in blocked coronary arteries completely reopening them and improving blood flow to the heart muscle. Many studies (PAMI, TACTICS-TIMI 18, etc.) have shown that when used appropriately, stents can be life-saving and improve quality of life by relieving heart pains (angina) and preventing heart attacks.

However, in 2007 the COURAGE trial was published demonstrating that in some patients with coronary artery disease, there was no mortality or heart attack benefit associated with an initial treatment strategy of using stents, compared with medication treatment. The trial also found evidence that a strategy of using medications alone could potentially save money. In considering these results, several caveats must be kept in mind: patients included in the study were very select (< 1 in 15 patients considered were actually studied); they tended to have mild disease (78% had either no or only slight symptoms; patients with recent heart attacks were excluded); ~1/3 of patients initially treated with medications alone eventually required stents for their blockages anyway. In addition, patients who underwent initial treatment with stents had a quicker improvement in quality of life as compared to patients who initially were treated with medications alone. Nonetheless, this single study suggested that the need for coronary stenting is unnecessary in at least some patients with coronary artery disease, and that trying medication therapy alone in those patients is reasonable. There is ongoing investigation designed to confirm or refute the observations of the COURAGE trial.

In a New York Times editorial entitled Cut Medicare, Help Patients authors Ezekiel Emanuel and Jeffrey Liebman discuss the use of cardiac stents for treatment of symptomatic coronary artery disease suggesting that many stents are unneeded.

“Every year more than 1 million cardiac stents are placed in patients to open blocked arteries… many patients who receive stents paid for by Medicare are either experiencing no pain or have not tried medication first.”

In a review of national registry data published this year in JAMA by Chan et al. it was concluded that by current criteria 1 to 11.6 percent of stents placed may have been “inappropriate” based in part on the results of the COURAGE study.

It is important to distinguish between “unneeded care” due to fraud and “unneeded care” due to less expensive but similarly effective alternatives. Fraud implies dishonest intent. Unneeded care due to fraud is universally considered to be wrong. In contrast, calling care unneeded because there are less expensive and similarly effective alternatives is subject to a broad range of opinion. In an article that I read recently Dr. Maneesh Patel (Duke Clinical Research Institute, Durham, NC) made the important point:

"the majority of what we do in medicine is based on evidence that would fall into the category of 'uncertain' "—for example, guideline recommendations with level of evidence B or C.“

The Maryland cardiologists are accused fraud, or falsely recording the presence of significant coronary artery disease, and billing health insurance for placing stents in such patients. This is very different than choosing to treat significant coronary artery disease with a stent when medical therapy alone may also be a reasonable strategy in preventing death or myocardial infarction (heart attack).

Here’s an example: a 50 year old man was found to have calcifications in his coronary arteries on a chest CT done for follow up of cancer (presumed cured). On questioning, the patient, who has high blood pressure, high cholesterol, and a family history of heart disease, noticed some shortness of breath with exertion, potentially due to obstructive coronary artery disease. An exercise treadmill test was ordered and was positive after ten minutes. An exercise echocardiogram was ordered and showed a possible small area of reduced blood flow after ten minutes. A cardiac catheterization was ordered and an 80 percent blockage of one artery was found. A stent was placed and the patient was started on blood thinners. The patient also had 30 to 50 percent blockages in other locations and was advised to take more cholesterol and blood pressure medication.

Which of the tests/treatments in this case were unnecessary? If the coronary blockage was 40 percent and not 80 percent, the stenting here would be universally considered to be unnecessary. (Furthermore, if the physician knowingly reported this 40 percent blockage as 80 percent, stented it, and billed for it, then it would constitute fraud). If the coronary artery blockage was truly 80 percent then according to the results of the COURAGE trial, first trying medical therapy alone could be as effective as immediately using stents for the purposes of minimizing the cardiovascular mortality in this patient (but perhaps not from the point of view of immediately relieving his symptoms). In this situation, the immediate stent placement could also be considered “unnecessary.”

With a proposal to add “cost-conscious care and stewardship of resources” as one of the ACGME’s core competencies for medical trainees, and with Medicare aggressively tightening its belt in order to remain fiscally solvent, determining “unnecessary care” will depend on developing a consensus on the value of life, suffering, and the validity of extrapolating scientific data analysis to a multitude of individual specific patient situations. As health professionals and policy makers appropriately engage in this discussion about what represents effective care that health insurance should pay for, they should be careful not to equate outliers, such as doctors facing criminal charges for fraud, with accepted variation in standard practice that might encompasses care that some deem “unneeded.” Equating unneeded care with dishonest intent is bound to elicit a highly emotional response from most doctors, who are deeply committed to their professional obligation to do what they believe is best for their patients.

Are you at risk for an adverse medication reaction?

2011-12-17T06:16:00.000-08:00

Many patients express concern about being on long term medications. In my view, their concerns are well-founded. At times the treatment can be worse than the disease. According to CDC statistics 82 percent of adults are on one or more medications, and 29 percent are on five or more. Polypharmacy (the use of many drugs together, or excessive medications) is a significant problem of the elderly, and of those with chronic illness. These populations are at increased risk for drug-related adverse reactions. How can a patient assure the safety of his or her medication? Many turn to alternative medicine, under the false impression that these substances are somehow safer than those that are brought to market by the pharmaceutical industry. Others rely on medical professionals—doctors, nurses, and pharmacists-- to warn them about the possibility of drug interactions and toxicity. Electronic prescribing has improved drug safety by automating cross-checking and alerting prescribers when two drugs interact. However, in my experience electronic systems can establish such low filters for reporting drug interactions that virtually every drug prescribed may cause an alert to pop up. Which of these interactions is clinically relevant? Often clinicians must use their best guess as to whether two or more drugs in combination will be safe for a particular patient.

The cytochrome P450 enzymatic system is involved in the metabolism of many drugs. Although there are more than 50 of these enzymes, only six of them are responsible for the metabolism of 90 percent of drugs. Many significant adverse drug events result from issues that involve this pathway. Ingested substances, whether it’s grapefruit juice, a cup of coffee, an herbal product, or a prescribed medication, can alter metabolism by inducing or inhibiting the activity of the P450 enzymes. Moreover, research has revealed that there is significant genetic variation in their activity from one individual to the next. I’ve had many a patient tell me of his or her unique sensitivity to drugs. These circumstantial observations may well be founded in science, and pharmacogenetics is an emerging field that describes the genetic variation in responses to medication while one patient may have particularly efficacious P450 enzymes, another may have P450s that are slower to operate. Two or more drugs that are metabolized by the same P450 may compete and one drug may reduce the metabolism of another, causing high levels of the “substrate” drug to accumulate, and potentially cause toxicity. Other drugs may up-regulate the digestive enzyme and cause a drug to be cleared more rapidly than normal, reducing its concentration and therapeutic efficacy.

Take the popular cholesterol lowering medication simvastatin (Zocor). Simvastatin is used to lower cholesterol and has been associated with important clinical outcomes in patients who are treated with it-- including a reduction in cardiovascular death. However, its use has also been linked with an adverse drug reaction--myopathy, or muscle damage. At its extreme myopathy is known as “rhabdomyolysis,” a process that can lead to kidney failure and even death. Rhabdomyolysis occurs at a rate of 4.4 cases per 100,000 patients exposed to a “statin”-type medication (also including atorvastatin, rosuvastatin, pravastatin). The risk of myopathy is dose related and recently the FDA has warned against using the 80 mg dose of simvastatin for treatment of elevated cholesterol.

Simavastatin’s metabolism occurs in the liver with the P450 enzyme CYP3A4. Numerous other medications affect the activity of this enzyme. The calcium channel blocker amlodipine (Norvasc) is processed by the same enzyme. Patients who take amlodipine and simvastatin simultaneously may have reduced clearance of simvastatin, and may be more prone to muscle damage from the drug. Consequently the FDA advises limiting simvastatin dosing in this population to the 20 mg dose. However, enzymatic activity of CYP3A4 is genetically determined. Within the population certain individuals may be rapid or poor metabolizers of the drug, impacting the generalizability of the FDA recommendations from one person to the next.

Genetic testing for cytochrome P450 enzyme polymorphisms is not yet recommended. Yet, we are moving in that direction, and no doubt the genetic polymorphisms may prove to provide valuable insight into why particular patients may not respond to standard treatments. For example the drug Plavix (clopidogrel) is an important blood thinner that effects platelet activity and is indicated in patients who have had a stroke, or who have had stents placed for coronary artery disease. Clopidogrel is a pro-drug-- it must be converted in the liver to its active form and CYP2C19 is the predominate enzyme responsible for this conversion. Patients who are poor metabolizers of Plavix do not effectively convert the drug to its active form. In these patients, the drug is less effective at preventing heart attacks, strokes, and cardiovascular death. It is estimated that 2 to 14% of the population are poor metabolizers of Plavix; the rate varies based on racial background. With this finding, some have advocated genetic testing of all patients who need Plavix for its important indication.

Another P450 issue has emerged with Clopidogrel. The popular, and now over the counter, proton pump inhibitor (PPI) omeprazole is metabolized by the same hepatic enzyme and is an inhibitor of the enzyme, blocking the conversion of clopidogrel to its active form. However, not all PPIs have the same degree of inhibitory effect on the enzyme (CYP 2C19). The drug pantoprozole (Protonix) may be a less strong inhibitors, and therefore safer for concomitant use with Plavix.

These two examples demonstrate the complex determinants of drug metabolism—genetic and environmental—and highlight the importance of using individualized treatment plans in order to optimize therapy and reduce the risk of medication related toxicity.

*The FDA website offers a drug Index of Postmarket Safety Information for Patients and Providers. I found the website useful for specific drug information.

Should Doctors Stop Using PSA to Screen for Prostate Cancer?

2011-11-09T13:46:00.000-08:00

The United States Preventive Services Task Force (USPSTF) says yes.

Recently the influential Task Force gave the PSA (prostate specific antigen) screening test a “D” level rating, meaning that doctors should recommend against using the test for the purpose of early detection. Prostate cancer is the second leading cause of cancer death in men after lung cancer. Early detection of prostate cancer through screening with PSA was introduced into clinical practice in 1986. Over the past several decades prostate cancer mortality has fallen by approximately 30%. Statistical modeling suggests that this might correlate with the advent of screening with PSA. In addition, over the past several decades there has been an increase in prostate cancer incidence and a shift toward the detection of earlier stage cancers—likely also a result of PSA screening.

The purpose of health screening is to detect disease in an earlier stage so that preventive measures can be initiated to improve health outcomes related to that condition. However, in order to justify population level screening, the benefit associated with early detection must outweigh the harm that it potentially causes. Healthy Americans and their physicians have embraced the practice of early detection, particularly with respect to cancer, which along with Alzheimer’s disease, is the most feared illness in our population. The USPSTF analyzed available data on prostate cancer screening and treatment, including the results of the two largest clinical trials—one done in the United States and the other in Europe. The American study (PLCO) found no mortality benefit with PSA screening after a 7 to 10 year period of follow up. Its results have been criticized with the possibility that findings were “contaminated” with too many men in the control group who received screening before and during the study, reducing the apparent efficacy of PSA screening. In contrast, the European ERSPC study showed a statistically significant, but small reduction in prostate cancer mortality (20%), in men who were screened every 4 years over 9 years. Researchers found that 1,410 men would have to be screened and 48 additional cancers would have to be detected to prevent one death from prostate cancer. This efficacy is similar in magnitude (slightly greater) to the effectiveness of using mammography to screen women in their forties for breast cancer. A potential shortcoming of these studies is that the study time could have been too short to detect benefit given that prostate cancer may be very indolent.

Needless to say urologists as a professional group object to the USPSTF’s recommendation, stating on the American Urologic Association website:

The Task Force is doing men a great disservice by disparaging what is now the only widely available test for prostate cancer, a potentially devastating disease. We hold true to our current position as supported by the AUA's Prostate-Specific Antigen Best Practice Statement that, when interpreted appropriately, the PSA test provides important information in the diagnosis, pre-treatment staging or risk assessment and monitoring of prostate cancer patients. But not all prostate cancers are life-threatening. The decision to proceed to active treatment or use surveillance for a patient's prostate cancer is one that men should discuss in detail with their urologists.

The argument against using PSA to screen, itself an inexpensive blood test, is that it leads to over-diagnosis of clinically insignificant prostate cancer. Postmortem data indicate that approximately one third of men between the ages of 50 and 65 have microscopic evidence of prostate cancer. This percentage increases to over 50 percent for men in their 70s and 80s. Analysis of data suggests that early detection leads to over-zealous treatment—including radiation and radical prostatectomy. Over-treatment puts men in harm’s way with side effects related to treatment --loss of continence (ability to control urination) and erectile dysfunction. I recently read a nice discussion the magnitude of risk associated with screening by Dr. Albert Fuchs. Both physicians and patients are participants in opting for aggressive interventions for early stage cancer.

Active surveillance or “watchful waiting” is an acceptable strategy for managing elevated PSA or even biopsy proven prostate cancer. In practical terms this means that once cancer is detected it may be reasonable to do nothing aside from monitoring for evidence of prostate cancer progression. In some, this might entail monitoring the PSA velocity (or rate of increase) to help determine an appropriate time to treat. Or, in others, it might include waiting to treat until the cancer becomes symptomatic with urinary symptoms or symptoms related to prostate cancer that has spread to the bone. However it’s very difficult for patients and their doctors to sit tight with the knowledge that they might be living with cancer. I’ve discussed the difficulty with watchful waiting with respect to breast cancer in the blog: “Is Watchful Waiting too Difficult?”

As for me, I tend to find the USPSTF’s PSA screening recommendation a little too reactionary. As stated in a recent New England Journal of Medicine editorial a “C” level rating for this test might have been more appropriate. I am not completely ready to jump onto the anti-PSA bandwagon that many of my fellow internists seem to be espousing and go back to the 1970s. However, I do see that a more cautionary approach to prostate cancer detection and treatment is warranted. This will require discussion, courage, and culture change on the part of primary care physicians, urologists, and their patients alike as we try to effectively convey and accept the message that early detection of cancer is good, but that not all early cancer, or “pre-cancer,” needs early and aggressive intervention.

Screening for Inflammation with hsCRP

2011-10-07T14:32:00.000-07:00

For several years now I’ve been screening many of my patients for inflammation with their annual physical examination using blood test known as high sensitivity c-reactive protein or hsCRP. HsCRP is an inflammatory marker that has proven useful as a marker for cardiovascular risk in some individuals. Inflammation occurs when there is tissue damage. In general, ongoing inflammation is not good for one’s health. In the case of arthritis, inflammation affects bones and joints. In the case of infection, inflammation results when the immune system responds to a pathogen. In the case of cancer, inflammation occurs as cancerous cells invade healthy tissues and cause damage. More recently, inflammation has been identified as an important factor in atherosclerosis, the process that leads to cholesterol plaque accumulation in blood vessels resulting in heart attack, stroke, and peripheral vascular disease.

CRP is an acute phase reactant, so its level may go up with infection or trauma. However, in general, hsCRP levels tend to be relatively stable over time, compared with other inflammatory markers. Multiple studies have demonstrated the relationship between hsCRP elevation and cardiovascular disease. In fact, with respect to cardiovascular risk, hsCRP is said to be more predictive of cardiovascular events than LDL cholesterol levels. Three levels of risk have been identified:

Low risk hsCRP < 1 mg/L

Moderate risk hsCRP 1-3 mg/L

High risk hsCRP >3 mg/L

In the Jupiter trial healthy men and women with normal LDL cholesterol (<130) but elevated hsCRP (>2 mg/L) were randomized to receive 20 mg of Rosuvastatin or placebo. The trial was halted early when the treatment group was found to have significantly lower risk of cardiovascular events in the 1.9 years that the subjects were studied. The reduction in risk correlated with a reduction in LDL cholesterol and hsCRP levels.

In my patient population it is my experience that about 25 percent of my patients have hsCRP levels that exceed the 3 mg/L threshold for “high risk.” About 5 to 10% of my screened patients have levels that substantially exceed 3mg/L. As a generalist, I have been tasked to take action with these particular patients, bringing them back in to the office for a thorough history to exclude occult infection, ordering additional tests to screen for occult rheumatologic disorders, and to make sure cancer prevention guidelines have been followed—and at times doing additional work-ups.

Elevated CRP has also been associated with diabetes and metabolic syndrome. One patient in her 50s had an hsCRP of 28. This patient also had new onset diabetes, with a hemoglobin A1C of 8.1, LDL cholesterol of 136, and BMI of 42. After losing 70 pounds (over one year) and with resolution of her diabetes my patient’s hsCRP came down to 3. A statin was started in addition to aspirin therapy. In this case the crp did not alter my practice, though it did raise my level of concern.

Another healthy patient in her forties had a level of 3.5 mg/L. The patient, who is vegan, had an LDL of 80, an HDL of 78, a normal glucose, does not smoke, and has a body mass index of 23. Framingham risk was calculated at less than 1 percent. My patient had astutely read of an association of between elevated CRP and Alzheimer’s Disease risk (which has been described). Unfortunately, there is no clear and proven intervention to reduce this patient’s potential health risk, which is still likely low. I placed her on aspirin 81 mg daily.

Within the realm of using hsCRP for the purpose of primary prevention medical knowledge is based primarily on cardiovascular trials and outcomes. According to one expert author CRP may be at least 50% genetically pre-determined. In the case of my healthy patient in her 40’s this seems likely. I was reassured to read a summary in Circulation noting that while a relationship between high crp and cardiovascular death has been demonstrated, elevated hsCRP has not been linked to increased mortality from other causes (like cancer). At least this finding will allow me to focus on cardiovascular health when hsCRP is high, as opposed to engaging in a wild goose chase to detect occult illness.

HsCRP measurement is currently recommended only in individuals who are at intermediate risk for cardiovascular disease (defined as 10 to 20 percent chance of having a cardiovascular event in ten years). In this population it can prompt more aggressive management of risk factors, including beginning a statin for only marginally elevated cholesterol. One review in the Annals of Internal Medicine noted that while high hsCRP levels in women with intermediate or high Framingham risk correlated with worse cardiovascular outcomes, high levels in women deemed to be at low risk by Framingham did not correlate with substantially high vascular risk. Despite this finding, at times I have still found it helpful to check hsCRP within a low risk population. The test is inexpensive, it can help as a motivator to prompt lifestyle change that could prevent future increased risk, and 20 percent of heart disease may occur in those with no traditional risk factors. As a novel risk factor hsCRP has become one of many variables known to contribute to cardiovascular health. However, as an isolated finding it still may have limited utility, raising questions that at this time still have no clear cut answers.

Sifting Through the Mammogram Muck

2011-09-19T14:31:00.000-07:00

In November of 2009 the United States Preventive Services Task Force (USPSTF) revised its guideline on the use of mammography to screen for breast cancer, recommending against routine screening of women ages 40 to 49, and changing the screening interval for women ages 50 to 74 from annual screening to screening every two years. This recommendation left doctors and patients alike confused over what to do. With a backlash of public opinion protesting the new recommendations, organizations such as the American Cancer Society continue to support routine annual screening of women beginning at age forty.

What is a health-conscious woman to do? Randomized controlled trials (RCTs) have demonstrated reductions in breast cancer mortality in women screened with mammography beginning at 40. Screening is most effective in women ages 50 to 69. A meta-analysis done in 2009 for the purpose of updating breast cancer screening guidelines found very little benefit to screening women in the youngest age bracket (40-49) with mammography given the lower disease incidence and higher number needed to screen (1904) to prevent one cancer death.

In the United States, the lifetime risk of breast cancer in a woman is approximately 12 percent, or 1 in 8. The risk of a woman developing breast cancer between ages 40 and 49 is 1.45 percent, or 1 in 69, which is why if you are in your forties, you likely know several women who have been diagnosed. The risk between ages 60 and 69 is 3.45%, or 1 in 29. About 5 to 15% of mammograms are abnormal and require further follow up. The sensitivity of mammography for detecting breast cancer is about eighty five percent, with a false negative rate of about fifteen percent. However, because of the low disease prevalence in younger women, the risk of an abnormal mammogram being a true positive is less than ten percent. In fact, for a woman who has annual mammograms each year during her forties, there is an about thirty percent chance of having an abnormal during that decade. Given these statistics and the mixed study results, the USPSTF decided that the potential harm of routine mammography in women ages 40 to 49 outweighed the potential for benefit for most women, with the exception of those at highest risk.

However, recently the outcomes of a very large population based study (the SCRY study) of mammography in women ages 40 to 49 conducted in Sweden were published. In the study, women who had an average of 6 mammograms in 10 years had reduced breast cancer mortality compared with those who were not screened. The observed “number needed to screen” in order to prevent one breast cancer death was 1252 women.

What comprises high clinical risk of breast cancer? Family history and prior history of breast biopsy are important. Increased breast tissue density is also known to confer higher breast cancer risk. Clinical risk calculators may be used to quantify risk.

What about alternate screening modalities—ultrasound or MRI? Ultrasound is useful for differentiating a fluid filled cyst from a solid breast mass—however, it has limited utility for distinguishing between benign and malignant solid nodules and also cannot detect in situ breast cancer (DCIS), which typically presents as characteristic breast calcification on mammography. Breast MRI is a sensitive screening modality and is recommended for women with genetic breast cancer risk—BRCA1 and BRCA2, or with a calculated lifetime breast cancer risk of over 15 to 20%. Those with prior DCIS, lobular carcinoma in situ, atypical ductal or lobular hyperplasia, or extremely dense breast tissue may also benefit.

Given the recent recommendations and findings a dogmatic approach to breast cancer screening should no longer be the norm-- the approach should be personalized. Women should be asked about their individual history, clinical risk factors, family history and personal screening preferences during each annual visit. A clinical breast examination should be performed. If both history and examination point to low or average risk, I support screening every two years after baseline mammography is performed at age 40. With additional risk factors, including dense breast tissue, family history, previous biopsy or abnormal clinical exam, I support annual mammography beginning at age 40. At the other end of the spectrum, at this time I also support continuing to perform screening mammography in healthy and functional women who are over age 75 and whose life expectancy is greater than 10 years.

Balancing the risks and benefits of endurance exercise

2011-09-01T15:39:00.000-07:00

The health benefits of exercise are well-established. A recent study published in the Journal of the American College of Cardiology showed that one’s fitness level, as measured a person’s one mile run speed, compared to other cardiovascular risk factors, was the best single predictor of heart attack risk and life span. Studies have shown that regular exercise reduces one’s risk of obesity, diabetes, and hypertension. Exercise has been shown to benefit mood and alleviate the symptoms of depression. On a cellular level, telomere length, a marker of mitochondrial health, has been shown to be improved in those who exercise. Consequently, getting people to exercise more has been adopted as a top strategy of health promotion.

I am an exercise zealot. Growing up I swam and dove competitively. As an 18 year old, fearful of the freshman fifteen, I took on running, and have been hooked ever since. In my middle age, wanting to cross train more because of increasingly achy joints and muscles, I have ventured into bicycling. We talk much of the health benefits of these sports, but what of the risks? While exercise long term may be good, do the risks of injury and accident offset the potential for long term benefit and actually increase health care utilization? Consider three of the most commonly practiced forms of exercise: running, swimming and cycling.

As a sport, running carries the risk of overuse syndromes: runner’s knee (patella femoral syndrome), iliotibial band syndrome, plantar fasciitis, stress fractures, piriformis syndrome, and Achilles tendinitis, to name a few. Female runners may suffer from the Female Athlete Triad—amenorrhea, bone loss and disordered eating. Marathon running is known to be associated with low bone density and may also increase oxidative stress. Whether or not running is the cause of osteoarthritis of the knee is somewhat controversial. MRI demonstrates knee abnormalities in marathon runners that are not seen non-runners. Clearly in those already affected by arthritis or prior injury, running makes the condition worse. Approximately 1 in 3 runners are injured per year of running.

On the other hand swimming, as a sport, is relatively safe, unless of course you drown. It turns out that 36% of swimmers who drown in Georgia are intoxicated while swimming—alcohol and swimming don’t mix. Otherwise, shoulder bursitis and rotator tendinitis are the most common swimming related injuries.

In my view, of the three sports, biking may be most risky. Approximately one in three bikers has an accident per three years of biking. The annual rate of accident for regular bikers is about one and ten (less than running). However, in comparison with the debilitating overuse injuries of running, biking carries a more profound risk of serious injury and death. Studies show that the risk of head injury and upper facial fractures may be reduced by 60 to 70% with helmet use. Legislation requiring bike helmet use has increased compliance with this health-promoting behavior. There’s also the threat of pudendal nerve injury and for men, erectile dysfunction. A recent study showed 94% of asymptomatic male, mountain bikers had evidence of scrotal abnormality on ultrasound, presumed the result of chronic repeated microtrauma, compared to 16% of non-bikers who had abnormalities. Avid bikers will tell you that proper seat ergonomics and padded shorts help reduced these risks of saddle injury.

In a triathalon a couple of years ago I took a hair pin turn too quickly, driving off the road into a grassy embankment. Fortunately, I sustained only minor abrasions and was able to keep riding. Others are faced with more serious injury. Recently, in a tragic accident, a male physician biking across a bridge in Charleston, South Carolina was killed by a passing truck that hit him throwing him off the bridge. Bikes are no match for cars, and it's a drivers world that we live in unfortunately.

I exercise because I like getting outdoors and being active. It gives me a sense of well-being, improves my mood, makes me more confident about my physique, and seems to keep my weight in check. I hope it will result in further health benefits down the road. The positive data seems good, however when prescribing exercise to promote health it’s important to weigh the balance of risk and benefit. Despite popular notions, the practices of stretching and cross-training have not been convincingly demonstrated to reduce injury. Given the physical diversity of those who exercise and the lack of good data on what helps prevent injury, a common sense approach seems reasonable. Of course, as I write this blog with my calf resting on a bag of ice, talking common sense to an exercise enthusiast can be a challenge.

Direct to consumer genetic testing and Oprah

2011-08-06T16:19:00.000-07:00

Recently a patient shared with me her genetic profile done by 23andMe, a company that provides direct to consumer (DTC) genetic testing. Initially skeptical about the value of such testing, I have recently investigated it further. Should I be discouraging my patients from spending money on this type of screening? Does it offer any value? What are the diagnostic validity and the predictive value of these tests? How are DTC genetic tests regulated for quality and safety? These are some of the questions that I asked myself as I quickly scanned my patient’s test results.

Some of you may know that Oprah Winfrey has had genetic testing done for the purpose of exploring her ancestry. As reported by Conrad Phillip Kottak:

"Oprah Winfrey made headlines in 2005 when she reported that a DNA test had revealed her (highly unlikely) Zulu ancestry. A more plausible result in 2006 linked Oprah to the Kpelle people of Liberia and Guinea, the Bamileke people of Cameroon, and the Nikoya people of Zambia. Ever the DNA explorer, Oprah in 2011 reported her discovery, confirmed by genetic testing, that she had a younger half sister whom her mother had placed for adoption.” Window on Humanity, 5th edition, to be published October 2011 by McGraw-Hill

In medicine there are over one thousand genetic tests available for clinical use. What are genetic disorders and what do these tests screen for? In some cases genetic tests screen for diseases that are caused by a single gene, such as Cystic Fibrosis or Sickle Cell Disease. However, with increasing frequency, genetic tests screen for predisposition to diseases that are known to be multifactorial, such as type 2 diabetes, cardiovascular disease or depression. In 2010 a list of DTC genetic testing companies and the conditions that they screen for was compiled by the Genetics and Public Policy Center. Most DTC companies that market genetic tests are Internet based companies. The process involves sending a DNA sample off to the company in the form of saliva or a blood swab. The company then engages a laboratory to do genetic testing, and the testing results are returned directly to the consumer. The cost of DTC genetic testing ranges from one hundred to one thousand dollars.

Those who oppose DTC genetic testing argue that making this type of complex information available to the consumer without adequate counseling by a health professional could be dangerous, that the notion of relative risk is difficult to interpret, and that there is currently inadequate oversight of laboratories engaged in DTC genetic testing to ensure the analytic and clinical validity of tests. The FTC has issued a consumer alert warning the public that “some of these [DTC] tests lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation.” Currently the FDA regulates commercial “test kits” to ensure analytic and clinical validity. However, the FDA does not regulate laboratory-developed testing. In addition to the regulatory concerns there are also concerns about DTC genetic testing and compliance with health information privacy, HIPAA.

The American Society of Human Genetics has recently written recommendations with respect to DTC genetic tests. Regarding DTC Personal Genomics the National Human Genome Project states:

"The relationships between particular genetic variations and the presence or absence of specific diseases or traits are often tenuous and the interpretation of the findings can change over time. This makes the communication of clear and accurate genetic information challenging, even in ongoing face-to-face clinical settings. It is not known how individuals and society more broadly, might understand and interpret this information when it is provided directly to individual consumers."

Despite these cautionary stances recent studies of consumers using DTC genetic testing have indicated otherwise:

"David Kaufman of the Genetics and Public Policy Center at Johns Hopkins University conducted an NHGRI-funded survey of 1,048 people who had purchased a DTC test from 23andMe, DecodeMe, or Navigenics. Kaufman reported that nearly everyone indicated that the risk reports they received from the companies were easy to understand, though some overestimated their understanding of the results. The group also asked respondents to interpret data for two fictitious people to gauge their understanding of the risk reports. Between 4 percent and 7 percent of the respondents misinterpreted what they saw. Kaufman said that just more than three-quarters of his team's survey respondents said that they ordered the test to improve their health, and some of the respondents said that they'd been motivated to modify their behaviors in light of their test results: 15 percent changed medications or supplements, and 14 percent began exercising more."

In another study, reported in the New England Journal of Medicine in February of 2011, consumers using DTC genetic profiling had no evidence of increased psychological distress, change in diet or exercise behavior, or use of preventive screening tests as a result of their genetic testing.
Given these results, is the medical community being overly cautious? Should the average consumer be trusted to order and interpret his or her genetic profile without a medical intermediary? Many DTC companies have been shown to produce results that have a high degree of analytic validity.

In the case of my recent patient, she seems to have a very reasonable attitude. Despite the test’s prediction of low cardiovascular risk, she did not write off her high cholesterol, but was still willing to treat it with medication. We should be able to interpret relative risks in the context of complex multifactorial disease and the most recent clinical data. Though in the present its clinical applicability seems limited, in the future we will be increasingly tasked with managing this information alongside of our patients, who like Oprah, will be ever curious to learn more about their genetic origins.

Part time women in medicine: are they pulling their weight?

2011-07-12T20:18:00.000-07:00

A number of years ago I was seeing a female executive for a physical exam. As I chatted with the sixty-something female CEO she remarked: “women sell themselves short,” attributing the lack of women in top management positions to their tendency to opt for less ambitious “mommy tract” positions. While I had certainly heard these words before, that day they hit closer to home. At the time I was in year nine of employment at the Emory Clinic and feeling professional success in my job, which included a leadership position within my practice. I was the senior woman in my group, the university-based general medicine practice of Emory, and a busy and well-liked internist. Though at the time I had been recipient of various departmental awards, I was still an assistant professor—a detail that was, in fact, a chip on my shoulder. However, no woman in my practice had ever been promoted to associate professor.

When my first child was born in 1999 I had opted for “part-time” status, 75 percent of full-time, gradually increasing my work load after my second child turned four to 90 percent of full time. My husband is an interventional cardiologist and our work-life balance had been tough. Thankfully, I had a wonderful nanny who helped out at home.

Now, working full time in a medical practice that I started, I reflected on those years again after reading a recent editorial in the New York Times on part time women in medicine. The piece, Don't Quit this Day Job, authored by Karen Sibert, an anesthesiologist, argued that federal funding for residency training was wasted on women who increasingly opt for part-time positions. In fact over 50% of female physicians report seeing patients fewer than 40 hours per week (most commonly 30 to 40 hours per week), compared to men, who more commonly report spending 41 to 50 hours per week on patient care. When I posted Dr. Sibert’s editorial on Facebook it was met with a flurry of impassioned negative responses by many of my female physician colleagues, who have opted for the flexibility of part-time primarily in order to accommodate their domestic roles as primary caregivers of young children.

In my experience women working “part-time” in medicine and earning “part-time” incomes often add professional work into their unpaid time—seeing extra patients, taking equivalent call despite a part-time salary, and in the academic setting, taking on unpaid teaching, or educational administrative positions. In fact, I recognize that it was my part-time status that enabled me to participate in these types of activities and actually helped my reputation in my division, allowing me to pursue professional interests that I would not have had time for otherwise.

In the past several decades women have made significant gains toward equal status in medicine. According to statistics from the Association of American Medical Colleges, in the year that I graduated from high school, 1986, 31% of medical school graduates were women. In 1994, when I graduated from medical school, 39% of graduates were women, and in 2010 48% of medical school graduates were women. However, as in other fields, women still lag far behind men in terms of their representation in leadership positions. In terms of income, significant gaps also remain. In the past these income disparities have been attributed to differences in work hours and a tendency for female physicians to enter primary care fields. However, a provocative recent study published in Health Affairs found that an average gap of $16,819 in salary between newly trained female and male physicians could not be explained by controlling for these factors.

Why should we care about having female physicians? Studies have suggested some differences between male and female physicians.
Findings include:

Women may spend more time with their patients.
Women have different communication styles—they are perceived as more empathic and sensitive.
Women tend to employ more participatory decision-making styles, which are correlated with higher patient satisfaction.
Women tend to emphasize preventive services more.
Women are more likely to discuss lifestyle and social concerns.

Of course these observed differences are highly variable depending on the individual physicians in question. Interestingly, male gynecologists have been rated as more empathic and sensitive than male physicians in other fields. Nonetheless, there is strong female preference for female gynecologists. The interaction between gender and patient preference is complex. One interesting study looked at 10,000 patients in an HMO setting and found that male patients of female physicians were the most satisfied customers, compared with female patients of these same female physicians, who were the least satisfied group. Patients have different expectations about communication between male and female physicians and this may impact their satisfaction with care.

Going back to the female CEO, I too have been let down at times by what I have perceived as a relative lack of career ambition in some female physicians. Thinking about it, however, I’ve been equally let down by male physicians with what I viewed as misguided professional goals. If women can best manage their careers in medicine as part-time then so be it. Society will benefit, perhaps we will learn something from one another, and women in medicine are already paying the price.

ACP Leadership Day 2011

2011-06-23T06:18:00.000-07:00

Last month I attended the American College of Physician’s Leadership Day at the Capitol. The American College of Physicians is a national organization of internists--physicians who specialize in the prevention, detection and treatment of illnesses in adults. ACP is the largest medical-specialty organization and second-largest physician group in the United States after the AMA.

ACP Leadership Day brings together primary care physician advocates from all over the country to discuss national health policy and to lobby for key health regulation. I went as a representative of the Georgia Chapter along with six other physicians from our state, including our Chapter Governor, Jacqueline Fincher, MD, MACP, a medical resident and a medical student from Emory University School of Medicine and Executive Director of the Georgia Chapter, Mary Daniel. The event included a learning session in which we reviewed the ACP’s priorities. We heard from ACP president Virginia Hood and Bob Doherty, SVP, Governmental Affairs & Public Policy for ACP. Dr. Doherty also summarizes the day in his blog ACP Advocate.

Nancy Nielsen, MACP, Senior Advisor, Center for Medicare & Medicaid Innovation spoke, appealing to physicians to provide feedback to the Center on the recently proposed rule for Accountable Care Organizations, which has been criticized for its complexity and for being out of reach for smaller medical practices. We also heard from a bipartisan congressional panel that discussed the ACP priority issues in the context of current legislative considerations. As one might imagine, much of this year’s discussion focused on the national budget crisis and lack of available funds for key Accountable Care Act programs. Later in the evening, after a keynote address by Alex Castellanos, Political Strategist and Analyst at CNN, Max Baucus was awarded the Joseph F. Boyle Award for Distinguished Public Service.

The ACP supports the following legislative action:

Fix the Sustainable Growth Rate: The "SGR" is the formula used to determine physician payment by Medicare. The formula is linked to the GDP. However, with advances in technology and the aging population, health expense has outpaced inflation leading to a series of short term fixes to avoid drastic cuts in physician payment. The "fixes" continuously threaten to expire. The next expiration date is January 1^st, 2012 when physician payment will be cut by 29.5% unless action is taken. As reported recently in Modern Medicine:

"Wiping out Medicare’s accumulated debt would cost almost $300 billion, according to the Congressional Budget Office, and maintaining it with 0% updates until the end of the decade would cost more than $275 billion. With the current focus on reducing the deficit, neither of those options looks appealing."

Fund programs that support expansion of the primary care workforce: the National Health Service Corps, Section 747 Training in Primary Care Medicine and the National Health Care Workforce Commission.

Strengthen access to primary care, improve quality and lower cost by funding:

The Medicare Primary Care Incentive Program, which preserves primary care incentive payment through 2015, while enacting further reforms to strengthen primary care (Medical Homes and Accountable Care Organizations).
The Medicaid Comparability Program (ties Medicaid payment rates to Medicare rates--currently they are significantly lower).
The Center for Medicare and Medicaid Innovation. The new Center needs adequate resources to accelerate broad pilot testing of new health care delivery models to improve access, quality and value)
The Patient Centered Outcomes Research Institute, which researches the clinical effectiveness of different treatments to better inform patients and physicians in decision-making.

Improve Health Reform by supporting:

Empowering States to Innovate (allows states to opt out of ACA requirements three years early if they enact a program with equivalent coverage, i.e. Vermont).
Patient’s Freedom to Choose Act, which repeals a provision of the ACA that requires that physicians provide written authorization for over the counter drugs reimbursed by a flexible spending account or a health savings account.
State pilots to test health courts (would have medical liability cases heard by expert judges rather than lay juries).

On Thursday the Georgia Chapter broke out into small groups to speak with our legislators about these priorities. Among others, our chapter met personally with Senator Saxby Chambliss and Representative Tom Price. I was struck by various things I learned while at Leadership Day. As I spoke with a local physician who is employed by the Piedmont Physician’s Group in Atlanta I learned that this large multispecialty group is no longer accepting new Medicare patients who are enrolled in Medicare Advantage programs, and that many Piedmont physicians are also closed to new traditional Medicare patients. This speaks to the significant access issue that patients of the future will have unless Medicare is able to successfully reform, while still guaranteeing stable reimbursement for physicians.

In Washington there was significant discussion about Medicare innovation and the proposed new models of care delivery—Medical Homes and Accountable Care Organizations. Whether or not participation in such models will be feasible for small independent physician practices remains to be seen—and many are fearful. At present most physicians cannot get health insurance funding for being “Medical Home” certified. Locally, in Atlanta, several hospital-based groups are experimenting with Medical Home Pilots: Wellstar participates in a Medical Home pilot with Humana, Piedmont Physicians Group participates in a Medical Home pilot with Cigna, and Emory will soon launch a Medical Home pilot with Aetna. However, none of these pilots involve more than a single payer.

While I sensed bipartisan support for fixing the SGR, there was significantly less agreement about how to best reduce Medicare cost while improving quality of care and access.

CMS’ Administrator Don Berwick recently stated in the Health Affairs blog that health care transformation

"won’t yield to a massive top-down national project...Successful redesign of health care is a community by community task. That’s technically correct and it’s also morally correct, because in the end each local community – and only each local community – actually has the knowledge and the skills to define what is locally right"

This being said, Dr. Berwick will need to work to succeed in convincing many that implementing these ACA programs can make a positive difference on a community level in improving health care. To help reach consensus from both sides of the aisle, ACP Leadership Day was a good opportunity for practicing internists from around the country to tell their local stories, illustrating how federal policy impacts day to day practice on a micro-level. I hope that some of our messages were heard.

Osteoporosis: What about Men?

2011-05-23T20:33:00.000-07:00

Treating reduced bone density in women is a big business—from its detection with bone density screening (DXA), to its treatment with medications, such as the blockbuster bisphosphonates, to the medical care that the condition generates through referrals to specialists. It seems curious to me that men have been neglected as the objects of this frenzy.

It’s estimated that the lifetime risk of an osteoporotic fracture in women is 1 in 2, and in men that it’s 1 in 5. With our aging population, hip, femoral and vertebral fractures are a significant source of morbidity and mortality in the elderly. I’ve written about treating bone loss in women: “Osteopenia: to treat or not to treat.” A study published last year in the Annals of Internal Medicine demonstrated that although hip fractures are more common in women, they lead to higher mortality in men. In general, the onset of osteoporosis is ten year delayed in men compared with women.

Recently a middle-aged man consulted with me about osteoporosis. Several years prior a gastroenterologist had been worried about my patient’s chronic use of omeprazole, a proton pump inhibitor. Proton pump inhibitors reduce acid secretion in the stomach. Their use has been linked to reduced absorption of calcium and possibly to an increased risk of osteoporotic fractures, though this is still controversial. A bone density test was ordered and my patient’s bone density was found to be low, in fact, in the “osteoporosis” range (T score <-2.5). My patient was sent to an endocrinologist and was determined to have no secondary risk factors for osteoporosis. However, my patient was prescribed alendronate. With no clear end in sight for treatment with this medication, he asked me whether I felt it was necessary to continue.

The fact is little is known about treating men’s bones--that is, the ones in their skeletons.

A few trials have looked at DXA screening in men and found that T-scores, the measurement used to define bone loss (a “T-score” is the standard deviations from the mean for peak bone density), are as predictive of fracture risk in men as they are in women. However, the data is very limited. Bisphosphonate use has not been widely studied in male patients, particularly not in younger men with idiopathic osteoporosis. A couple of trials have looked at alendronate use in men with secondary risk factors and found it to have efficacy in preventing fractures. Best practice guidelines for treating osteoporosis in men were published in April 2011 by Gielen in BEST PRACTICE & RESEARCHCLINICAL ENDOCRINOLOGY & METABOLISM , which states:

“With the ageing of the population, male osteoporosis is an increasingly important health problem: from age 50 onward, one in three osteoporotic fractures occurs in men and fracture-related morbidity and mortality is higher than in women. In men with low BMD, 50% have an underlying cause, most often glucocorticoid excess, hypogonadism or alcohol abuse. DXA is recommended in all men from 70 years of age on and in men age 50–70 with a prior fragility fracture or clinical risk factors. Treatment decisions should be based on assessments of absolute fracture risk and not on BMD alone. Supplementation of calcium and vitamin D is essential in ageing men to prevent age-related secondary hyperparathyroidism. Bisphosphonates and PTH seem to be as effective in men as in women and should be given to men with DXA-documented osteoporosis, a prior fragility fracture or high absolute fracture risk as assessed by FRAX. Testosterone replacement can only be recommended in older men with osteoporosis who have symptoms of hypogonadism as well as total testosterone values below 250 ng/dL(9 nmol/l).”

Experts acknowledge that while bone mineral density testing may be useful, it is just one piece of the equation when it comes to assessing a person’s fracture risk. Clinical risk calculators take into account clinical risk factors and project a person’s ten year risk of suffering an osteoporotic fracture. The most widely known risk calculator is called FRAX, a tool developed by the World Health Organization. Clinical factors that contribute to fracture risk include age, body mass index, tobacco use, glucocorticoid use, alcohol use (>3 drinks per day), parental history of hip fracture, “secondary” causes of osteoporosis (low testosterone, hyperparathyroidism, hyperthyroidism and certain drugs), and the presence of rheumatoid arthritis.

In their recently released Guidelines on the Treatment of Osteoporosis the USPSTF concludes that there is insufficient evidence to support screening men for osteoporosis.

The case of my patient is a good example of how the well-intentioned use of testing may lead to information that we just don’t have good answers for yet. In the absence of firm data, the question becomes, does one opt to treat with medication, for how long, and with what sort of monitoring? And if not, then what should one suggest? Frankly, I find the relative lack of data about male osteoporosis surprising.

Henrietta Lacks, Ethical Dilemmas Then and Now

2011-05-10T13:03:00.000-07:00

Recently I read the book The Immortal Life of Henrietta Lacks by Rebecca Skloot. This book is a must read for anyone involved in medical research. The book tells the story of a woman, Henrietta Lacks, and her family. Ms. Lacks was treated for cervical cancer at John’s Hopkins in 1951. Her malignant cervical cells were harvested and disseminated to become the first "immortal" cell line widely used for scientific research, including their use in the development of the polio vaccine. The story details what occurred in the aftermath of Ms. Lacks’ death to her family, a poor African-American family living in Maryland. A family, which in today’s lingo, had very poor “health literacy.” The account brings up key ethical issues of biomedical research, which were evolving during that era.

At the time of Henrietta Lacks the concept of informed consent was still in its infancy. Institutions, such as John’s Hopkins, where Ms. Lacks received her care, did not have Institutional Review Boards (IRBs) to govern and approve their research protocols. The story of the HeLa cells began after the Nuremberg trials of World War II, which involved experimentation on concentration camp prisoners of the Holocaust and the eventual Nuremberg Code and World Medical Association’s Declaration of Helsinki in 1964, which described a code of ethics for research involving human subjects. The events of the Lacks family took place in the same era as the ”Tuskegee Experiment” (1932 -1974), conducted by the U.S. Public Health Service. Tuskegee gained notoriety by studying the natural history of untreated syphilis in poor African-American sharecroppers in Tuskegee, Alabama. Its participants were led to believe that they were receiving syphilis treatment from the Public Health Service, when in fact the treatment (penicillin) was being withheld for the sake of research. Nuremberg and Tuskegee shaped the precedent for federal regulation of biomedical research involving human subjects with the creation of the Belmont Report in 1979, which describes the core ethical principles that must be met in conducting biomedical research on human subject. At this time federal regulation was enacted calling for the implementation of IRBs to oversee human subject research in all institutions involved in conducting research. Those of us who have participated in research at academic institutions should be well aware of this history, which we all review in our IRB certification process.

What is interesting to me about the Henrietta Lacks story is comparing the evolution of biomedical research ethics in that era (1940s-70s) with the ethical dilemmas that face us today. At the time of HeLa cell dissemination informed consent was at the forefront of discussion, whereas in our current era we have struggled with two core elements of ethics in biomedical research: privacy and managing conflicts of interest. In 1996 the HIPAA privacy rule was enacted establishing nationwide security standards and safeguards for the use of electronic health care information as well as the creation of privacy standards for protected health information. HIPAA went through various iterations prior to its evolution into its current version issued in 2002. Similar to the response that occurred in reaction to federal policy outlining requirements for informed consent, researchers of today have oft complained that HIPAA has been an impediment to scientific progress and research. The latest HIPAA debate has revolved around federal requirements that medical providers and insurers notify patients in the event of discovering a privacy breech. Multiple examples of such privacy breaches have been described in the media ranging from stolen laptops to identity theft. Interestingly, in 2010 a health plan, Cignet Health, in Maryland was sued over non-compliance with HIPAA and fined a monetary penalty of 4.3 million dollars. However, the suit was not over a breach of confidentiality; rather, it was over Cignet’s refusal to allow 41 of their patients access to their own medical records.

In addition to sorting out privacy at is relates to biomedical research, medical care, and electronic communications, the other core ethical issue defining our era is conflict of interest. In 2008 Senator Charles Grassley, Republican of Iowa, brought to light conflicts of interest that were prevalent in the world of psychiatry. At the time, according to Grassley’s investigation, 30 percent of funding for the American Psychiatric Association, the premier professional organization in the field of psychiatry, came from the pharmaceutical industry. What followed suit was an unveiling of pharmaceutical ties that were reported to contaminate the thought leaders of many research institutions in all fields of medicine. My own institutional affiliate was not immune and in 2008 Charles Nemeroff, renowned researcher in psychiatry and chair of the Department of Psychiatry at Emory University gave up his title and eventually left Emory after being investigating by Grassley. Academicians can attest to the changes that have occurred in the past several years with respect to disclosures of financial interest in research centers. Is it a witch-hunt, or is the cleansing of these relationships based in true ethical conflict? After all, isn’t conflict of interest inherent in all of business?

The story of Henrietta Lacks was interesting from a historical perspective. It took decades to sort through informed consent. In contrast, the debates over health privacy and conflict of interest are still in their infancy. The fact that remains similar, however, is that the underprivileged, and medically “illiterate” are far more likely to be the subject of ethical violations than others—even in today’s era. In the case of the Lacks family, poor communication and lack of confidence on the part of the medical establishment that the family would be able to grasp the content of the discussion, resulted in a lack of informed consent. Today, who is more likely to be deidentified appropriately in a medical blog, a Hispanic patient at a county hospital, or a wealthy business executive? No wonder the underprivileged are often suspicious of traditional medicine.

Understanding Cardiovascular Risk

2011-04-15T13:14:00.000-07:00

Many express hesitation when it comes to the idea of taking cholesterol medication, or “statins.” This is despite their well documented record of efficacy and safety in the prevention of cardiovascular disease (CVD). Guidelines for the treatment of high cholesterol are based on one’s LDL (or “bad cholesterol”) level in combination with one’s determined CVD risk.

According to the National Cholesterol Education Program’s most recent Adult Treatment Program Report (ATP III) for those at lowest risk, medication may not be indicated until the LDL cholesterol is greater than 160 to 190. However, for those at highest risk, medication may be suggested when the LDL level is over 100, or even lower for some.

Who is at highest risk and how should asymptomatic adults be screened for CVD?

Recent guidelines by ACCF and AHA have been issued in 2010. Those with existing cardiovascular disease (history stroke, aortic aneurysm, coronary artery disease or peripheral vascular disease) are at highest risk for future events. Certain diseases are also considered “coronary artery disease equivalents,” because of the very high rates of cardiovascular disease in those affected. Diabetes and chronic renal insufficiency are the two most common conditions that fall into this category.

One widely used CVD risk calculator is called the Framingham Risk Score (FRS). Use of this tool is endorsed by the American Heart Association and the American College of Cardiology, and numerous other medical professional groups. The FRS uses traditional cardiac risk factors to calculate a score of one’s ten year risk of having a cardiovascular event. The major risk factors for CVD are:

Cigarette smoking

Hypertension (BP greater than or equal to 140/90 mm Hg or on antihypertensive medication)

Low HDL cholesterol (less than 40 mg/dL),

Family history of premature CHD (CHD in male first-degree relative less than 55 years; CHD in female first-degree relative less than 65 years)

Age (men greater than or equal to 45 years; women greater than or equal to 55 years)

Calculate your Framingham Risk Score

High risk is defined as a person whose likelihood of having a cardiovascular event is over 20% within ten years. Low risk is defined as a person whose likelihood of having a cardiovascular event is less than 10 %. Those at intermediate risk have a 10 to 20% chance of having a cardiovascular event within 10 years. Some further stratify intermediate risk into moderate risk (FRS of <10% but two CHD risk factors) and moderately high risk (FRS >10% and two CHD risk factors). Furthermore, some use a cut-off of 6% as the upper limit of “low risk.”

The Framingham Risk Score works well for those over 40 years old, and may work better for men than women. The key is to identify those who are at higher risk and to take action to modify that risk—lowering their blood pressure and treating their cholesterol. There are supplementary tests that can be particularly useful in patients who are intermediate risk and might benefit from more intense monitoring and intervention.

Here some tests that have clinical utility:

HS-CRP

“HS-CRP” (C-reactive protein) is an inflammatory marker that may be helpful to guide decision-making for men over 50 and women over 60 who are at intermediate cardiac risk. CRP can be lowered by interventions that improve other cardiovascular risk factors, such as exercise, weight loss, smoking cessation, statins, and antihypertensive treatments. In the JUPITER trial rosuvastatin (Crestor) 20 mg/d versus placebo was studied in the primary prevention of cardiovascular events in men and women without diabetes with LDL cholesterol > 130 mg/dL and CRP > 2 mg/L. After a median follow-up of 1.9 years, rosuvastatin was associated with a significant reduction in cardiovascular events.

Hemoglobin A1C

Hemoglobin A1C is a measure of glycemic control over several months. It is most commonly used to diagnose and monitor diabetes. However, studies have shown that in non-diabetic patients increased hemoglobin A1C levels (even within normal range) are associated with increasing risk of cardiovascular disease.

Urinalysis for the detection of microalbumin

Urine microalbumin detection is recommended annually in diabetic patients. The test is inexpensive and easy to perform. The presence of microalbuminuria has also been linked to increased cardiovascular risk in patients with hypertension and in asymptomatic adults who are at intermediate risk of cardiovascular disease.

Carotid Intima Media Thickness (IMT) by Ultrasound

This is the thickness of the vascular lining of the carotid artery. The risk of CHD events increases in a continuous fashion as carotid intima media thickness increases (RR increases approximately 15% per 0.10-mm increase in carotid IMT). This test is not performed at all centers.

Ankle Brachial Index (ABI)

The ABI is performed by doppler measurement of blood pressure in all 4 extremities at the brachial, posterior tibial, and dorsalis pedis arteries. The highest lower-extremity blood pressure is divided by the highest of the upper-extremity blood pressures, with a value of < 0.9 indicating the presence of peripheral arterial disease, which is defined as > 50% blockage. When defined in this way, the ABI has both a high sensitivity and specificity for anatomic blockage. An abnormally low ABI has also been shown to be a predictor of cardiovascular events.

Exercise ECG

An Exercise ECG, a form of cardiac “stress test,” may be useful for risk assessment in intermediate-risk asymptomatic adults (including sedentary adults considering starting a vigorous exercise program). Probably the most powerful risk marker obtained during routine exercise testing is exercise capacity; studies have consistently found that depressed exercise capacity is associated with increased cardiovascular risk.

Computed Tomography for Coronary Calcium

A cardiac CT or EBCT may be used to detect and quantify coronary calcium (CAC), a marker of atherosclerosis. It may be useful in persons at intermediate risk (6 to 20%). This test is not recommended for men less than 40 or for women less than 50 due to the very low prevalence of detectable calcium in these demographics.

In pooled data from six clinical trials, study subjects who had calcium scores of zero were found to have a low rate of cardiovascular events (0.4%) over the subsequent 3 to 5 years after testing. In subjects with high calcium scores, 400 to 1000 and >1000, the rates of cardiovascular events over the 3 to 5 year period were 4.6% and 7.1% respectively.

The recently released EISNER study found that study subjects who received cardiac CT for coronary artery calcium score were more likely than control subjects who received counseling alone to modify their cardiovascular risk profile over a 4 year period. In contrast study subjects who received calcium scoring by CT were not found to incur higher downstream medical testing or health care costs. The implication being that the test could be an effective strategy for early detection, without increasing overall cost.

Cardiovascular disease remains the most common cause of death in the American population. In the last century we have developed effective therapeutics that help prolong life, reduce and delay the risk of cardiovascular illness. Doctors should help patients understand their individual risk profiles, which are not static, but worsen with age, so that appropriate behavioral change or medication is prescribed when it is indicated.

Difficult Access and Lack of Continuity Delays Making a Correct Diagnosis

2011-04-03T15:17:00.000-07:00

A close friend of mine is hospitalized. What happened to him merits a blog. Several weeks ago my friend developed numbness in his hands, feet and tongue. Not one who particularly fancies seeing doctors, he called his primary care physician, who he had recently seen for a check-up in honor of his 50^th birthday. His own doctor was not available urgently so he saw his doctor’s partner in the same practice, who he had never met. A history, neurological exam and a battery of blood tests were performed, revealing a low vitamin B12 level of 170. My friend was told that vitamin B12 deficiency was the likely the source of his troubles, and was started on oral supplements. However, over the next several days he developed worsening numbness and weakness in his legs. Two days later he was felt increasingly unwell—now also lightheaded and faint with standing. Unable to speak with his physician, he went to the emergency room on Friday afternoon. After many hours he was assessed by a neurology resident who consulted with a senior neurologist by phone. My friend, who described lightheadedness and muscular weakness, apparently did not have many findings on exam, but lacked proprioception (position sense), which was the reason he was told he was having difficulty walking. He was sent home and instructed to take B12 injections. On Monday he called his PCP back for an appointment, alarmed by rapidly evolving symptoms of numbness and weakness. He was told that no appointments were available, so he decided to walk in to the office and asked to receive an injection of B12, which he believed would make him better. He left without being assessed by a physician. Throughout the course of the week he became progressively weaker in his legs and was not able to drive to work. By the end of the week he fell when he tried to get up from a chair and noticed a change in his voice. On Sunday, ten days after his first symptoms developed, my husband called to see if my friend could play tennis. As my friend declined, explaining the problem, it became readily apparent to us (who are both physicians) that this was not B12 deficiency. We pulled some strings and managed to get him seen by his own primary care physician the following day (he had been given a follow up appointment in ten more days). We were suspicious that this was Guillain-Barre Syndrome, which was the confirmed diagnosis two days later, after a thorough history, physical exam, lumbar puncture, electromyogram and nerve conduction studies were performed. Guillain-BarreSyndrome is an uncommon condition (1-2:100,000) where the body’s own immune response attacks one’s nerves, causing “demyelination.” In severe cases paralysis and respiratory failure can occur. My friend is now unable to walk and is receiving intravenous immunoglobulin therapy. Needless to say he has received ample good attention while in the hospital and, being very easy going, he has nothing but good things to say about his physicians and care. The prognosis for Guillain-Barre Syndrome is very good, but can require up to 6 to 12 months for a full recovery.

In my view, there are several lessons here. These were all excellent doctors that my friend encountered. So what was the problem? I have only heard my friend’s point of view, but here are some thoughts:

He was not seen by his own primary care doctor for his urgent complaint.

His primary care physician had met him only twice. Though a patient of this physician for at least five years, he had seen 3 or 4 different providers within the practice for all previous urgent issues because of a lack of available appointments with his personal physician.

His initial diagnosis may not have been presented as a hypothesis.

He may not have been given adequate instruction about what to do if his condition worsened.

He was not seen in the emergency room by an attending neurologist.

He was not given neurology follow-up.

His complaint of weakness may not have been taken seriously because it was not clearly perceived on his physical exam.

When he worsened no one initially questioned the accuracy of the diagnosis of B12 deficiency.

When my friend came to the primary care office for a second time, after his ER visit, with worsening symptoms, he was seen only by a nurse for the B12 injection (there was no MD appointment available).

The ER did not communicate directly and promptly with either the physician who had seen him several days prior, or his primary care physician.

My friend trusted the original diagnosis and that the system would take care of him adequately.

My friend did not want to be perceived as a difficult patient or as a hypochondriac, so decided to wait it out.

This case is a near miss. My friend got the care that he needed, but there was delay, inefficiency and poor communication. It’s a shame that we, as primary care physicians, have become so busy that we cannot care for our patients’ urgent needs. Fortunately, my friend was well-connected. Making a diagnosis like Guillain-Barre Syndrome and helping a patient receive timely and appropriate care is fascinating and is what makes primary care potentially so interesting and rewarding. However, when access is limited, there are ineffective channels of communication, and continuity is lacking it’s tough for even excellent doctors to function well. Atul Gawande has proposed checklists and team work as measures to improve hospital based care. In the primary care world I can see that the majority of mishaps occur at times of care transitions because of poor communication between office visits. Part of the problem is the ever expanding patient panels of primary care physicians who are so busy seeing their 20 to 30 patients daily that they are unable to manage any event that occurs outside of the context of an office visit. Personally, I am not sure that even the best checklists, care teams, or electronic systems can make up for this lack of adequate time to spend with a single physician, who knows a patient well and is able to oversee care continuously throughout health and illness.

Trading Places

2011-03-29T07:43:00.000-07:00

A Medical Student Reflection

Guest post by Satya Das, Third year medical student, Emory University School of Medicine

Two and a half months ago while studying for boards, I suffered an injury playing basketball. The injury to my left buccal mucosa required surgery. My recovery was largely unremarkable as the bruising and swelling took its course to subside. After the completion of boards and a relaxing vacation at home, I returned excitedly to Emory, ready to begin the transformation my classmates and I had undertaken nearly two years ago.

The Sunday before we began rotations I awoke to find a swollen and pulsing venous cord roughly following the contours of my facial vein. I rushed to the ER only to be placed on antibiotics and told to wait and watch. Thus began a whirlwind of events including several ER stints, referrals, CT scans, facial distension, and ultimately an incision and drainage. I had developed a buccal abscess secondary to a facial vein thrombophlebitis at my original site of surgery.

The sudden turn of events once again forced me into the role of a patient; a role I now realize no one willingly accepts. I can remember thinking to myself as I sat in the waiting area of the ER or lobbies of various specialists that I was oddly on the wrong side of those doors. I was supposed to be the one welcoming those in need of care, not the one being beckoned with an admission bracelet on my wrist.

Over the course of the next several weeks, I began to understand the frustration patients encounter while navigating through the healthcare system, bouncing from one doctor to another at times without resolution of symptoms and spending more time on hold than with actual receptionists in hopes of setting up the next appointment. My frustration nearly turned to disgust when I had to fight to obtain the necessary diagnostic imaging that would prove conclusive, even though there was no other course of conservative action left. The same system I had taken an oath to cherish was the one putting me on wits end.

This experience has had a profound impact on my outlook on what it means to be a patient. The gamut of feelings I faced, from angst to anger, has made me more sensitive to the population I hope to serve. I walked in the shoes of a patient by becoming one, and in doing so, realized there is much more to healing than taking care of one’s physical ailments. Recovery, like any other journey is a process, but it is the individual steps of the progression that determine our overall experience. As a health care provider, the way we talk to our patients, the promises we make them regarding their care, the way we deal with their setbacks are equally important as taking care of their symptoms.

Even as I write this piece today, I find myself every morning rushing to the mirror half expecting to be swollen and congested. More so than paranoia or the small venous clots I can still feel, perhaps what draws me to the mirror is the reminder some part of me will always remain a patient.

When Wheat is to Blame

2011-03-12T11:32:00.000-08:00

We’ve heard reports accusing the pharmaceutical industry of manufacturing and promoting diseases in order to boost drug sales, so called “disease mongering.” Could it be that the health food industry is doing the same? More and more of my patients and peers are going gluten-free. Does this reflect the successful marketing of this food niche? Or, is it based on a growing recognition of real disease?

Wheat can causes health problems in two main ways—food allergies and genetically-based Celiac Disease. The prevalence of Celiac Disease within the American population is approximately 1 in 100, making it, in fact, a common disorder. Ninety five percent of afflicted individuals have the genetic profile, HLA-DQ2 or HLA-DQ8. Typically 10% of first degree relatives are affected. This “auto-immune” disease is characterized by a T-cell mediated immune response to gluten, which results in inflammation in the duodenum and jejunum of the small intestine, causing destruction of the normal intestinal lining and diminishing one’s ability to absorb nutrients, such as vitamin D, calcium, and iron. The clinical manifestations include diarrhea, abdominal pain and frequently weight loss. There also can be neurologic manifestations (cerebellar ataxia and peripheral neuropathy) and a blistering skin condition called dermatitis herpetiformis. Celiac disease may be asymptomatic or minimally symptomatic for years. Those left untreated are at higher risk for osteoporosis, lymphoma and adenocarcinoma of the small bowel. Those afflicted are also more likely to have other autoimmune conditions, such as autoimmune thyroid disease and type I diabetes. The diagnosis of Celiac Disease can be made by screening a patient for particular antibodies in the blood—the endomysial antibody and the tissue transglutaminase antibody, which are highly sensitive and specific for Celiac Disease. IGG and IGA antibodies should be measured. In the past antibodies to gliadin were used as a diagnostic, however their low specificity (high false positive rate) has been recognized--approximately 10% of non-afflicted people have detectable anti-glaidin antibodies. The diagnosis of Celiac Disease is confirmed by upper endoscopy and small bowel biopsy, which shows the characteristic findings of flat crypts and lymphocytic infiltration of the intestinal epithelium. Treatment is fairly straightforward with the elimination of gluten in one’s diet. Success with treatment can be monitored through repeating the diagnostic antibody panel. Antibodies typically normalize within 6 to 9 months of instituting a gluten-free diet, with elimination of wheat, barley and rye, and possibly also oats, which may be cross-contaminated with gluten containing cereals.

Recently I diagnosed a patient after a routine physical, which uncovered unexplained severe iron deficiency (in the absence of anemia). On further questioning the patient was also having trouble with episodic diarrhea and abdominal cramping—though this had not been a major complaint at the time of his physical.

In contrast to Celiac Disease, wheat allergy refers to an immune mediated reaction characterized by increased levels of serum IgE to wheat antigens that results in clinical symptoms of allergy affecting the skin, gastrointestinal tract or respiratory tract. Diarrhea, abdominal pain, worsening of atopic dermatitis (an allergic skin rash), and asthma are common clinical manifestations. In children there are six foods implicated in the vast majority (over 80%) of food allergy—peanuts, tree nuts, milk, eggs, soy and wheat. Estimates of the prevalence of wheat allergy in the pediatric and adult population are difficult to determine but fall into the range of .5 to 3 % depending on what criteria are used for diagnosis. Many adults who have positive serum levels of wheat antibody detectable on allergy testing report no clinical manifestations of allergy. In contrast, many children whose parents report sensitivity to wheat products have no objective evidence of the allergy on either skin prick testing or serologies. While clinical symptoms of food allergy are fairly prevalent in the pediatric population, most kids tend to outgrow their allergies between ages 3 and 5. In general, the most accurate way to diagnose a suspected food allergy is through oral challenge testing performed in conjunction with serum or skin testing demonstrating an immune response.

Wheat is also a rare cause of a more severe type of allergy known as Wheat Dependent Exercise Induced Anaphylaxis (WDEIA), which manifests as anaphylaxis with exercise. Anaphylaxis is when an allergy causes massive histamine release, resulting in chest tightness, shortness of breath and collapse of the circulatory system with a dropping of blood pressure—it is life threatening. Other rare manifestations of wheat allergy are “Baker’s Asthma,” bronchial constriction triggered by the inhalation of raw wheat, and contact urticaria (hives) cause by use of topical wheat products in cosmetics.

Food is such an emotional topic for people. It’s interesting to me to see how many are eager to embrace food as the cause for, or the remedy of their ills. However, whether it’s pharma or the health food industry, one must be equally skeptical. Take the recent Federal Trade Commission complaint against POM Wonderful pomegranate juice, which accused the company of false advertising. It appears that in the case of the gluten-free market there is good reason for these products to be made available to those who truly need them. But, before you jump on the bandwagon, make sure that the evidence to blame your symptoms on wheat is solid.

For further information on Celiac Disease, the following are useful links:

http://www.mayoclinic.com/health/celiac-disease/DS00319

http://www.mayoclinic.com/health/gluten-free/MY01651

http://www.celiac.nih.gov/Materials.aspx

Georgia Healthcare Legislative Priorities 2011

2011-02-15T12:25:00.000-08:00

On February 11th I had the opportunity to join other primary care physicians at the state Capitol to lobby for healthcare legislation in Georgia. The “Day at the Capitol” was hosted by the “Patient-Centered Physicians Coalition of Georgia.” This group is comprised of members of the Georgia Chapter s of the American College of Physicians, the American Academy of Pediatrics, the Georgia Academy of Family Physicians, the Georgia Osteopathic Medical Association and the Georgia OB-Gyn Society.

We learned about key legislative issues facing our state this year. Each group presented its list of priorities. Unfortunately, as with the nation, Georgia is facing significant fiscal challenges. We heard from Alan Essig, Executive Director of the Georgia Budget and Policy Institute. Georgia’s current unemployment rate is 10.2% and the general funds budget is down 14.6 % compared to the pre-recession FY 2009 budget. Healthcare comprises 20% of the general funds budget. Education, the largest sector, comprises 53% of Georgia’s budget. Consequently, we are facing cuts to Community Health (3.8% in 2012) and the State’s Medicaid program (1% in 2011).

The legislative priorities identified by the physician coalition include:

Protect the Medicaid budget from physician cuts

In 2011 there will be a 1% cut in the Medicaid budget—we oppose this cut. As reviewed by David Cook, Director of the Georgia Department of Health and Human Services, Medicaid insures 1.6 million in the state. The ACA calls for an expansion of Medicaid beginning in 2014 to an additional 500,000 uninsured people in our state by 2019. The average Medicaid visit (cpt 99213) is reimbursed at 41 dollars (compared to 72 dollars for Medicare). Medicaid reimbursement rates have been stagnant at this level since 2003. This reality has had devastating impact on pediatricians and OB-Gyns who practice in rural Georgia and has diminished access for Medicaid patients.

Support state funding for Patient Centered Medical Home pilot programs (within Medicaid and/or the State Health Benefit program)

Although private insurers have started to fund Medical Home pilot programs, Georgia was not chosen as a location for one of the Medicare-sponsored national pilots.

Support the Prescription Drug Monitoring Act

This program would create a state wide monitoring program for the prescription of controlled substances. Several other states have similar registry programs that are alleged to have efficacy in reducing the incidence of prescription drug trafficking and abuse.

Scope of Practice

The physician coalition has safety concerns over aspects of proposed expansion to the scope of practice for non-physician medical providers; for example, the expansion of narcotic prescribing capability to physician assistants and nurse practioners.

Support the Prompt Pay Act

HB 167 requires that third party managers of health insurance programs be required to pay physicians on time (within 15 days of receipt of claims). Currently 30 to 40% of payers do not abide by this regulation. It was vetoed last year by the governor—apparently despite bipartisan support.

Support Comprehensive Tort Reform

In 2005, Georgia Governor Sonny Perdue signed SB 3, which placed caps on noneconomic damages in medical malpractice suits at $350,000. There were other components of this comprehensive tort reform legislation. In March 2010, the limit on noneconomic damages was declared unconstitutional by the Georgia Supreme Court. Other parts of the legislation were upheld.

Prepare for the Accountable Care Act

Georgia needs to begin preparation for the impact of the ACA. However, Georgia has been one of the 20 states to file suit against the federal government over its “individual mandate” to purchase health insurance. Georgia currently has the opportunity to establish its own health insurance pools for small business and individuals who are uninsured to select from. If Georgia refuses to participate in the planning process the federal government will step in to design our state’s options. The ACP encourages Georgia legislators to be active and engaged in this process. Representative Stacey Abrams (D) acknowledged that denial about the reality of the ACA could be a barrier to appropriate state planning.

At “Day at the Capitol” I sat with another internist, two pediatricians and one family practioner—from Albany, Statesboro, Brunswick and Decatur. The topic of conversation at our table was primarily a sharing of stories related to the adoption of electronic health records and the how to meet requirements for “Meaningful Use” payout. In addition, we spoke of the threat of additional cuts to Georgia Medicaid, particularly in light of the ACA expansion of 2014. This certainly remains at the forefront of concern amongst primary care physicians in our state, who are both concerned about access for their patients, but also concerned about their practices’ ability to thrive if faced with further cuts. As is pointed out in a recent New England Journal of Medicine Perspective piece, Georgia is one of eight states projected to face the biggest challenge with the ACA expansion. As noted, in these states “demand for care by newly insured patients could outstrip the supply of primary care providers.” Overall the day was very well organized. We had a great turnout and I was happy to see my fellow physicians moving beyond partisan politics to advocate for health in Georgia at a grassroots level.

The Therapeutic Relationship in "The King's Speech"

2011-02-08T12:12:00.000-08:00

Recently I saw "The King’s Speech." The film is about King George VI, Duke of York, and his struggle with a speech impediment—a stammer. The story tells of how King George IV, “Bertie,” worked with an actor turned speech therapist, “Lionel,” to overcome a chronic ailment, which was the source of significant psychosocial stress. I found myself reflecting on what aspects of the therapeutic relationship displayed within the film were so successful. Despite his lack of official credentials, I felt that Lionel Logue displayed tremendous professionalism as a care provider.

One aspect, I believe, was the genuine friendship that developed between the two men. Whether it is advisable for doctors and patients to be friends has been a matter of debate. Within the field of psychiatry this has been seen as a boundary violation that is fraught with problems. However, within other fields of medicine boundaries may not be as rigidly enforced. In my view friendship, at times, can enhance a therapeutic relationship.

Another successful aspect of this therapeutic relationship was Lionel’s exploration of not only the biologic, but the psychosocial contributors to King George’s speech disorder, which had roots in his childhood family dynamics. I am a believer in the biopsychosocial model of medicine. In order to understand and treat illness, one needs to understand not only the biological factors, but the psychological and the social context in which the illness occurs. This is also known as “holistic medicine,” though this terminology is widely misused today by those who confuse it with “naturopathy” or “homeopathy.”

A third aspect that enhanced the patient-caregiver relationship was that it was non-hierarchical, neither Lionel was “Doctor,” nor Bertie was “King.” It was important to Lionel that each man should be equal in the context of treatment—and he insisted that each call the other by his first name.

Finally, Lionel was very discreet, serving as trusted guardian of his patient’s confidential health information. He protected his patient’s privacy and autonomy.

Medical Professionalism is one of the core competencies of the American College of Graduate Medical Education used in the evaluation of medical trainees. A growing movement has attempted to define the best way to measure and teach professionalism. The core attributes of Medical Professionalism were defined by a Charter drafted in 2002. A recent paper in JAMA discusses specific behaviors and systems that support medical professionalism.
Some key elements described in The Charter are:

• Professional competence

• Honesty

• Protecting patient confidentiality

• Maintaining appropriate relationships with patients

• Commitment to scientific knowledge

• Improving quality of care

• Improving access to care

• Allocating a just distribution of resources

• Maintaining trust by managing conflicts of interest

• Participating collaboratively within the profession to maintain professional standards

I see professionalism, not as a static set of values and behaviors, but as flexible standards that are shaped throughout the course of one’s career both through observation and through trial and error.

In "The King’s Speech" Lionel admits to Bertie that he has pushed too hard, was insensitive, and took a wrong tact. He comes to apologize to his difficult patient. The willingness to admit fallibility and error is another important aspect of medical professionalism.

This film could be a great tool for teaching medical trainees.

Top Health News 2010

2011-01-01T07:40:00.000-08:00

2010 was an eventful year for health-related news. Here are some of the biggest stories from my point of view:

The Accountable Care Act was signed into law March 23, 2010. The most significant piece of health legislation since Medicare, the law is projected to expand health insurance coverage to 32 million who are currently uninsured. It aims to achieve this through the creation of state-based health benefit exchanges for individuals and small businesses that promote competition amongst health insurance plans, and through an expansion of Medicaid. The act will penalize those who do not purchase coverage, it aims to end denials based on pre-existing conditions, and will allow children to be covered under their parents policies until age 26. The legality of the individual mandate to purchase insurance has been called into question.
Why the Mayo Clinic is refusing to see Medicare patients. As Dr. Toni Brayer points out in her blog: “Medicare, the government insurance company for everyone over age 65 (and for the disabled) pays fees to primary care physicians that guarantee bankruptcy. Additionally, 70% of hospitals in the United States lose money on Medicare patients. That’s right, for every patient over age 65, it costs the hospital more to deliver care than the government reimburses.” This problem can only be expected to worsen as Medicare tightens its belt. The “SGR,” a formula that determines Medicare’s reimbursement rates to physicians, will decrease physician reimbursement by as much as 40 percent in years to come. A permanent fix to the SGR has been delayed multiple times. However, the reality is that a permanent fix is needed lest more health care providers will drop Medicare.
Final meaningful use criteria published in July 2010. Beginning in 2011 Medicare and Medicaid will provide significant financial incentives for qualified health providers to adopt and use electronic health records. The final criteria for “meaningful use” qualification were released this year and are discussed in the New England Journal of Medicine by David Blumenthal.
Dabigatran gets FDA approval for treatment of non-valvular atrial fibrillation as an alternative to warfarin. For years warfarin has been the sole option for management of conditions that cause increased morbidity and mortality related to their clotting risk. A new generation of anticoagulants has emerged and appears to offer multiple advantages over warfarin.
Transcatheter aortic valve replacement is superior to medical therapy for inoperable aortic stenosis. The year’s most important cardiology news, percutaneous, transcatheter replacement of aortic valves is a new option for high risk patients who are unable to tolerate open-heart surgery.
Early detection of Alzheimer’s Disease. The advent of a new biomarker test that is able to predict, with 100 percent accuracy, asymptomatic individuals who will develop Alzheimer’s Disease. This test has the potential to accurately identify millions of individuals who are at future risk and could be important to the future development of targeted therapeutics. However, widespread use of the test will bring up ethical and cost related dilemmas.
The AMA publishes guidelines for the ethical use of social media by physicians. Millions use Facebook, Twitter and blogs to network and transmit information. This year the AMA set forth a policy to help guide the professionalism of physician-users of social media and safeguard the doctor-patient relationship.
The Institute of Medicine questions the practice of high dose vitamin D supplementation. Vitamin D mania hit the clinics several years back with the finding that a majority of Americans are deficient, and that those with higher levels do better with respect to a number of important health outcomes. However, recently the Institute of Medicine curbed the current enthusiasm for prescribing high dose vitamin D supplementation, citing a paucity of high quality data supporting the safety of this practice.
Lung CT for early detection of lung cancer in high risk patients reduces lung cancer mortality. Lung cancer continues to be the most common cause of cancer related death in Americans. A new screening test demonstrates effectiveness in the early detection of lung cancer in those at high risk.
The mammography debate continues. In November of 2009 the U.S. Preventive Services Task Force revised its mammography recommendations, no longer recommending annual mammography for women ages 40 to 50. This recommendation made on the eve of health reform, which contradicted the guidelines of other prominent medical societies, sent many into a furor over the appropriate role of “panels,” seen as government-sponsored, in guiding medical decision-making.

The politics of prevention and screening are likely to continue to make big news in 2011. This year for the first time Medicare will begin to cover an annual wellness exam. Just last week we learned that a discussion of end-of-life, advance directives would be reimbursed as an element of the annual physical for seniors. This announcement has rekindled the “death panel” debate.

The appropriate role and political agendas of expert panels that set policy and guide medical decision-making and reimbursement are likely to continue to stir controversy, particularly as Medicare administrators begin the attempt to rein in cost, while all the while attempting to avoid the accusation of rationing health care.

Changing the Business of Anticoagulation

2010-12-10T14:06:00.000-08:00

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.

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

2010-11-23T20:24:00.000-08:00

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.

Generalism as a Medical Specialty

2010-11-15T13:51:00.000-08:00

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.

Reduced bone density: to treat or not to treat?

2010-10-17T11:59:00.000-07:00

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.

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

2010-09-19T06:34:00.000-07:00

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?

What I Learned from Asthma

2010-09-06T06:50:00.000-07:00

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.