Issue: 41


June: Time to be Safe!

Sometimes the exhilaration of Summer causes us to drop our guards, putting us in harm's way.  Excessive sun exposure, boating accidents, tick bites, poison ivy, forgetting to buckle up on short hauls to the beach are all shore-fire (sure-fire) ways to land in the ER if we are not careful. And here is one you may not have thought of: that kitchen guillotine! Also known as a mandolin, these razor sharp devices have the ability to add your fingertip to your favorite watermelon squash salad. Our future son-in-law, a wonderful guy and physician-in-training (but apparently a little clumsy in the kitchen!) recently had this unfortunate experience! Safety First!! 


John A. Schmidt, MD 


Flibanserin: A New Remedy for Pre-menopausal Women with Low Libido

On June 4, by an 18-6 vote, an FDA advisory committee reversed itself and recommended FDA approval of flibanserin, a new medication that addresses low sexual desire in premenopausal women. The decision has been controversial, with some saying that the committee caved to advocacy groups who may have been supported by the sponsor, Sprout Pharmaceuticals.  Hailed as the "Viagra for women," the drug could be on the market in the next six months. 


The drug is intended to treat hypoactive sexual desire disorder (HSDD).  As detailed in the on-line Executive Summary presented by Sprout, HSDD is characterized by 1) lack of satisfaction, 2) decline in sexual desire, 3) distress, and 4) lack of alternative explanations. The sponsor pointed out that women suffering from HSDD are 8-10 times more likely to report feeling unhappy, disappointed, upset, frustrated, sad, ashamed, and bitter. There are no prescription medications currently available for HSDD.


Two trials showed improvements in satisfying sexual events (SSEs). A third trial confirmed the improvement in SSEs and also showed improvement in desire. While some critics described the effect as modest, the improvement was highly statistically significant as was the reduction in distress. Treated patients were 10-12 percent more likely to respond than placebo treated controls.


The most common adverse effect was sedation (dizziness, somnolence, and fatigue) which was reduced by taking flibanserin at bedtime. The side effects were mild because only two percent of patients in the third trial discontinued the medication.


Onset of action was within the first week and sustained for at least six months.


Full FDA approval is likely. As with all new medications, the final label, pricing, and insurance coverage are to be determined.


Precision Medicine

As described in the June 4 issue of the New England Journal of Medicine, precision medicine is once again gaining traction.  A related concept is number needed to treat (NNT). For example, the NNT for insulin in a type 1 diabetic is one, meaning that every insulin deficient patient treated with insulin benefits. Similarly, every hypothyroid patient treated with levothyroxine benefits. The same can be said for essentially any medicine used to treat a deficiency syndrome (e.g. iron in iron deficiency anemia). Unfortunately, this is not the case for most medications. Consider the results with flibanserin described above. Only about 10 percent of women responded. Thus, a physician needs to prescribe the medication to 10 patients to obtain one responder. The cost/benefit ratio of the medicine is therefore increased by a factor of 10. But what if one could identify the responders in advance and prescribe the medication only to those who would benefit? Because we usually lack the tools to identify responders in advance, physicians often resort to "therapeutic trials" which is a fancy way of saying "try it and see." In the case of new medicines, this can be a very expensive and, for patients, a very frustrating approach.


Nowhere is this concept more important than in cancer chemotherapy. Patients with cancer don't have time to experiment. Nevertheless, the NNT for many new and expensive cancer therapies is often high. To address this problem, the National Cancer Institute (NCI) announced a new precision medicine trial at the American Society of Clinical Oncology (ASCO) meeting held in Chicago on June 1. Patients with tumors bearing a mutation known to be a drug target will be treated with that drug regardless of the cancer type (lung, pancreas, etc.).


A dramatic and close-to-home example of precision medicine was reported on the cover of Time magazine on March 30. The cover shows two women, both with glioblastoma, the brain tumor that killed Senator Edward (Ted) Kennedy. One of these women happens to be a Monmouth County resident and the wife of a patient in my practice. Because her brain tumor contained a certain mutation, she was given a medicine usually reserved for patients with malignant melanoma. Her brain tumor shrank and she continues to do well. The other woman's tumor had no such mutation and she has unfortunately died. It is anecdotes like these that are behind the NCI's precision medicine initiative.   


Clot Retrievers Revolutionizing the Treatment of Stroke

Stroke results when a clot blocks blood flow to the brain and is the second leading cause of death in the United States and a common cause of serious disability. As reported in the June 11 issue of the New England Journal of Medicine, a device known as a clot retriever has now been shown in five controlled randomized trials to help preserve brain tissue and neurological function in some stroke victims. The clot retriever is located on the tip of a catheter and snags the clot. The entire device including the snagged clot is then removed through a small puncture in the groin. The device is used in combination with the clot buster known as tissue plasminogen activator (TPA). According to the editorial in the same issue, the NNT (number needed to treat to help one patient) is between three and seven. This development makes it more important than ever that patients suspecting a stroke call 911 immediately and go to a Comprehensive Stroke CenterJersey Shore University Medical Center in Neptune is the only comprehensive stroke center in all of Monmouth and Ocean counties.  

Institute of Medicine Issues New Diagnostic Criteria for Chronic Fatigue Syndrome

Fatigue is probably the most common complaint in my practice and some wonder if they have Chronic Fatigue Syndrome (CFS). In February, the Institute of Medicine, a blue ribbon panel of experts, proposed three diagnostic criteria:


1) A profound reduction in the ability to engage in usual activities for more than six months not alleviated by rest. Patients with CFS typically have a long list of things they would like to do if only their body would cooperate; and


2) The worsening of symptoms after any type of exertion (physical, emotional, or cognitive). This "post exertional malaise" or feeling "wiped out" typically lasts at least 24-hours; and


3) Unrefreshing sleep. Patients with CFS typically can't remember feeling rested no matter how much time they spend in bed.


And at least one of these:


1) Cognitive impairment (some call this "fog"); or


2) The inability to remain upright and no improvement after lying down.


There is no blood test for CFS and no approved medication. However, because treatable diseases often masquerade as CFS, it is important to be evaluated. Let me know if I can help.  


FDA Bans Trans Fats!

Synthetic trans fats result from the hydrogenation of naturally occurring fats and are well documented to raise LDL (the bad cholesterol), reduce HDL (the good cholesterol), and contribute to cardiovascular diseases such as heart attack. While food companies and food chains have been busy reducing the level of trans fats in their products since 2006, they are allowed to report "0 grams of trans fats" if the product contains less than 0.5 gram per serving. On June 16, the FDA ruled that trans fats at any level are unsafe and gave companies three years to remove synthetic trans fats from all products. The FDA estimates 20,000 heart attacks and 7,000 deaths will be prevented each year. The ban does not affect red meat and dairy products such as buttermilk containing natural trans fats. Nevertheless, the American Heart Association (AHA) emphasizes eating a diet rich in fruits, vegetables, whole grains, low-fat dairy products, poultry, fish, and nuts, while limiting ingestion of red meat to reduce the total intake of trans fat (natural and synthetic) to less than one percent of daily caloric intake (20 calories or two grams of trans fat per day). The AHA endorses the use of monounsaturated and polyunsaturated fats, unhydrogenated vegetable oils (canola, sunflower, safflower, and olive oils), and soft margarine over solid margarine. While waiting for the ban to go into effect, avoid foods when the ingredient list says "partially hydrogenated". Bravo FDA!

Now Hear This!

Our youngest daughter, a physician-in-training, is to be wed to a very handsome physician-in-training on August 1 in the great city of Philadelphia! Please submit your questions and refill requests well in advance. Sign up for the Follow My Health Patient Portal to get faster service. Thank you!!


Valerie, Morgan, and I wish you a safe and wonderful June!

In This Issue
June: Time to be Safe!
Flibanserin for Women with Low Libido
Precision Medicine
Clot Retrievers
Chronic Fatigue Syndrome
FDA Bans Trans Fat
Now Hear This!


John A. Schmidt Jr., M.D.


Dr. Schmidt is one of the leading internists in Monmouth County offering Medical Home services.  

He is an Associate Attending in the Department of Medicine, Jersey Shore University Medical Center, and  Clinical Assistant Professor in the Department of Medicine at Rutgers Robert Wood Johnson Medical School.



"Summertime is always the best of what might be."

 - Charles Bowden



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John A. Schmidt Jr., MD
Meaningful Medicine in Your Medical Home
709 Seventh Avenue
Belmar, NJ 07719
Phone:  732-282-8166  
Fax:  732-280-0147 
E-Mail:  [email protected] 
Disclaimer: The articles in Healthy Living are for general information only and are not medical advice.
Discuss all medical concerns and treatment options with your physician.