New Medications for the Treatment of Hot Flashes

AAN3PYMenopausal related hot flashes are an annoying and life altering symptom plaguing millions of adult women. Pfizer and Ligand Pharmaceuticals received approval this month for a new drug named Duavee to treat hot flashes in women who still have a uterus.

Duavee is a combination drug pairing conjugated estrogens with a selective estrogen receptor modulator (SERM) named bezedoxifine. Normally estrogens are paired with progestins with the progesterone used to prevent cellular hyperplasia in the uterus reducing the chance of a malignancy developing.  While this new medication is designed for women with menopausal related hot flashes, it is unclear whether it provides any less of a side effect or cancer risk than current estrogen and progesterone combinations.   It is additionally recommended as a treatment for osteoporosis.  Like most estrogen products, it should be used for the shortest time possible.

Several months ago the FDA approved a non-hormonal treatment of hot flashes with an antidepressant named paroxetine and marketed under the name Brisdelle.  Paroxetine is also marketed as an antidepressant under the brand name Paxil which has been available to treat depression for many years.

It is always wonderful to have new medications available to treat chronic and severe problems.  However, it remains to be seen what clear advantages Duavee brings to clinicians.

 

Parting with Delray Medical Center

Denied stampIn the spring of 1980 I spent two nights a week sitting in a construction trailer on Linton Boulevard and Military Trail with several of my colleagues, Mr. Frank Tidikis, the acting director of the soon to be constructed Delray Medical Center and officials of National Medical Enterprises, planning the new Delray Medical Center from scratch. The planning lasted almost one year and when the hospital was finally opened in 1982 I was invited to be on the initial board of directors known as the Governing Board. In those days there were no physicians in West Delray Beach so the established practitioners in Boca Raton on the staff of Boca Raton Community Hospital, and those on staff at Bethesda Hospital from Boynton Beach, comprised the original staff.

Part of the hospital construction project was the creation of a medical campus with office condominiums attracting physicians from around the country to the staff of Delray Medical Center. As that unique staff grew there was less need for doctors from Boca Raton and Boynton Beach at the thriving and growing Delray Medical Center. After serving the patients of Delray Medical Center for 18 years I decided, for personal reasons, that I was no longer needed on that staff and resigned my privileges.

Much to my surprise, many of my Boca Raton friends and patients grew older, sent their children out into the world and moved to the cosmopolitan atmosphere of Delray Beach between 2005 – 2010. They asked me to join the staff of the hospital so that I could service their needs. I re-applied for privileges in 2010 and was treated as if I had no previous relationship with the institution. I was actually interviewed for staff privileges in a Board Room that had my picture up on the wall as a founding father while I was being questioned by a member of the Medical Executive Committee who asked me if I knew the history of the hospital.

As a “new” physician I was assigned to a physician reviewer and required to report all my hospital work so it could be reviewed for quality purposes. I was very upfront with the Delray credentials committee and administration. I told them I had a small practice of less than 400 patients. I told them I kept my patients healthy and out of the hospital. I additionally told them I would primarily be caring for patients of mine who entered through the emergency department because Delray was my backup hospital.

Three months ago I received a notice saying that due to lack of activity and use of the facility they did not have enough data to review my qualifications and, under the bylaws, I was told that I had voluntary resigned. I appealed.

I sent in clinical notes from my West Boca Hospital (same parent company – Tenet Health) admissions for review and my Boca Regional Hospital admissions. I had physicians active on staff, who I worked with regularly, write letters of support and testimonial. Despite all of these efforts, my appeal was denied and they terminated my privileges as of October 1, 2013. I have again appealed.

At a time when the health care industry is being asked to reduce costs by keeping patients healthier and out of the hospital, it is ludicrous to discriminate against a physician who is doing just that. However, in some institutions “revenue” outweighs common sense.

If a patient of mine is admitted through the ER to Delray Medical Center I have made arrangements for a physician to care for them. I apologize for the inconvenience to my patients who use that facility as their primary hospital. It is important for patients taken to the Delray Medical Center ER to inform me by phone that they are there so that I may arrange for a superior physician to see you. Feel free to talk to me about it if you have any concerns or questions.

Medicare Prescription Drug Plan Open Enrollment Period

Medicare CardIt is that time of year again to review your current Medicare Part D prescription drug plan options and make changes if there is something better for you available. The open enrollment period extends until December 7th, 2013 for the 2014 calendar year. If you make no new selection you will just continue to use the product you currently have if it is still available.

To make your review you will need computer and internet access. Go to http://www.medicare.gov look for prescription drug plans and click that option. It will ask you to provide your current medications and dosage using the generic drug name and how often you take it. It will ask you to provide your zip code to find a preferred pharmacy. Enter your medications and run the program. You will get a list of the prescription programs in your area and the different options. Keep it simple. Your monthly payment will be higher if you want no deductible. Make sure the monthly payments for no deductible aren’t more expensive than the actual dollar value of the deductible. Keep it simple. If you have any questions give us a call.

Medicare Advantage is not Medicare!

MedicareCMS the parent organization of Medicare has gone to the private sector and contracted with private health insurance companies including United Healthcare, Blue Cross Blue Shield, Aetna, Cigna and others to offer a private managed care insurance product to Medicare age recipients.  CMS or “Uncle Sam” is supposed to pay a flat fee for all the services rendered to a Medicare recipient to the private insurer to cover their enrollees’ medical needs. The fee was originally 95% of what Medicare paid on the average for a Medicare patient annually. This was supposed to save the government money.  In exchange for that annual fee the insurer or Medicare Advantage plan is supposed to cover your health care, provide pharmaceutical coverage and products and provide a set of extras or enhancements such as eye glasses, sneakers, gym memberships for wellness programs. It is managed care. There are strict rules and regulations about who you can and cannot see as a physician. There is a strict formulary of medications and there are contracted institutions you must go to such as hospitals, labs and imaging centers to receive appropriate tests. For the coverage to apply you must see a physician contracted to that insurance company’s panel. Non-emergency hospital admissions, trips to the emergency room and post illness care are all subject to the approval and review of non-physician personnel before the insurance company will pay for it. You lose your choice of going to the best institution or practitioner in exchange for lower up front monthly costs, minimal or no co-pays, no out of pocket pharmaceutical donut hole costs and the extras, glasses, sneakers, gym memberships.  You are issued a Medicare identification card that is virtually indistinguishable from the card a traditional Medicare patient uses. It is less expensive to the patient and works wonderfully if you are healthy and do not need health care.  Unfortunately individuals over 65 years old usually have or develop medical issues frequently.

B.J. is an 89 year old retired physician who got his Medicare Advantage plan through his medical society in the NY metropolitan area. He suffered a series of small strokes and was hospitalized for four days after being brought to the hospital by the paramedics on an urgent basis. His speech was impaired, his strength and balance did not allow him to walk without assistance. He was swallowing poorly with food as likely to end up going down the wrong pipe and choking him as it was to get into his stomach, so nutrition was an issue.  His wife and daughter did not feel he could go from the hospital directly home because he was too weak to walk.  His elderly wife could not handle him in this weakened state.  I suggested a short stay in a skilled nursing facility for strengthening, gait and balance training and speech therapy to rejuvenate his swallowing process safely.  We checked on the bed availability at three of the facilities in our area that did a nice job with this type of problem and there was bed availability. His health insurance was a Medicare Advantage plan, the Empire plan. They wanted him to be placed in a facility that I would not send my worst enemy to. They wanted him to go home from the hospital. The hospital case manager and I spent two days arguing with them about the need for placement, extending the patient’s hospital stay by two days and then they only approved a two day stay with a reassessment to be done on the third day which was a Saturday.   Had he been a traditional Medicare patient we would have sent him to the best place for his problem and he would have been eligible to stay for 21-30 days with full coverage. Post illness care can be a problem with Medicare Advantage plans.

Then there was H.B. a 69 year old overweight hypertensive man, still running his business, with new onset of significant shortness of breath and chest heaviness when walking a short distance.  We called the cardiologist “on the plan” who set up an appointment two weeks later. I called him to discuss the need for a timelier visit but it is managed care and that is the best he could do. . The cardiologist ordered a nuclear stress test after seeing him. This required approval again and this took his staff three more days. The test was scheduled for a week after that.  He flunked that test. The cardiologist wished to perform an angiogram to look for blockages. He referred the patient to an interventional cardiologist on the plan who could not see the patient for three weeks.  He saw the patient three weeks later and recommended doing a cardiac catheterization or angiogram.  It was scheduled for the next week instead of the next day as it should have been. When the patient arrived early in the morning for his catheterization as an outpatient he was told that the insurance company had not yet approved the procedure. He lay on a gurney from 7am until 2:35 PM without getting approval, or fluids, or a meal.  At 2:40 PM they sent him home. This occurred two more times on two separate days before the approval was obtained. The angiogram showed a 97% blockage of a left main coronary artery which they could not pass a stent through.  Try as they might they could not get it through. The interventional cardiologist was the practitioner under contract to the plan not necessarily one of my top choices or the most skilled in our area for that problem. He called in a cardiovascular surgeon to bypass the lesion surgically.  He took him to the ER later that day and successfully bypassed the blockage.  He approached me after the procedure and asked me, “Why did you guys wait so long to get him tested and some treatment. He was lucky with that “widow maker lesion that he didn’t drop dead. Why did it take eight weeks to get him fixed? ”

The next few months are the open enrollment period for individuals who qualify for Medicare to either stay in the traditional program or switch to a Medicare Advantage plan.  Managed care Medicare Advantage plans work well if you are healthy and if your budget does not allow you to buy a co- insurance policy and pay any portion of your prescription medication costs. If you sign up for the Medicare Advantage plan you to relinquish your choices. Think twice before you give up your freedom and choice to save a few dollars per month.

Cold and Flu Season Coming

SneezeAs we head into fall and winter we see an increase in the number of viral respiratory illnesses in the community. Most of these are simple self-limited infections that healthy individuals can weather after a period of a few days to a week of being uncomfortable from runny noses, sinus congestion, sore throats, coughs, aches and pains and sometimes fever. There are studies out of Scandinavia conducted in extreme cold temperature environments that show that taking an extra gram of Vitamin C per day reduces the number of these infections and the severity and duration in elite athletes and Special Forces military troops. Starting extra vitamin C once you develop symptoms does little to shorten the duration or lessen the intensity of the illness. Vigorous hand washing and avoidance of sick individuals helps as well. Flu shots prevent viral influenza and should be taken by all adults unless they have a specific contraindication to influenza. A cold is not the flu or influenza. Whooping cough or pertussis vaccination with TDap should be taken by all middle aged and senior adults as well to update their pertussis immunity. We often see pictures of individuals wearing cloth surgical masks in crowded areas to prevent being exposed to a viral illness. Those cloth surgical masks keep the wearers secretions and “germs” contained from others but do nothing to prevent infectious agents others are emitting from getting through the pores of the mask and infecting them. If you wish to wear a mask that is effective in keeping infectious agents out then you need to be using an N95 respirator mask.

Once you exhibit viral upper respiratory tract symptoms care is supportive. If you are a running a fever of 101 degrees or higher taking Tylenol or a NSAID will bring the fever down. Staying hydrated with warm fluids, soups and broths helps. Resting when tired helps. Most adults do not “catch” strep throat unless they are exposed to young children usually ages 2-7 that have strep throat. Sore throats feel better with warm fluids, throat lozenges and rest.

You need to see your doctor if you have a chronic illness such as asthma , COPD, heart failure or an immunosuppressive disease which impairs your immune system and you develop a viral illness with a fever of 100.8 or higher. . If your fever is 101 or greater for more than 24 hours it is the time to contact your doctor. Breathing difficulty is a red flag for the need to contact your physician immediately.

Most of these viral illnesses will make you feel miserable but will resolve on their own with rest, common sense and plenty of fluids.

The Case for the Annual Checkup

Annual CheckupIn a Washington Post article in August 2013, writer Brian Palmer makes the case that going to your doctor when you are not ill does more harm than good. He cites the extraordinary amount of time and money wasted by routine annual physical exams and points out that routine annual testing discovers false positive items that lead to further tests, cost and ultimately potential harm.

I suspect Mr. Palmer is a thirty-something year old individual with no chronic health issues, no personal physician and a high information technology IQ which allows him to access, digest and interpret data quickly and accurately so he can self-treat his primarily self-limited illnesses.  Perhaps the relative lack of exposure to severe and chronic illness on a personal level allows one to take a cost effective politically correct stance in a world where no one will actually have a personal physician. You may be part of a constantly changing “team” or go to a corporate drug store’s walk in clinic but you will be treated by some provider who knows you only for that episode and has no desire or incentive to see you until your next health crisis.

The annual exam is designed for the physician to get to know the patient in health. For children it is a benchmarking event to see if they are meeting the physical and emotional growth parameters needed to advance to puberty and adulthood. It is usually scheduled sometime before school starts and within the session vaccinations and immunizations are given to prevent infectious disease, vision is tested to make sure the child can see well enough to compete in a school environment and basic hearing evaluations are done to make sure your child can hear what the teacher is saying. There is little radiology or laboratory testing in this age group

Adolescents still are checked for physical and emotional growth and benchmarks.  They have their vaccinations and immunizations to receive before going off to dormitories for the college years or barracks for the military. As they move toward adult hood, the annual exam provides an opportunity for screening and teaching about sexually transmitted diseases, birth control, adult habits and their consequences.  It is a time to discuss what basic screenings they will need to have as they move towards independent adult status and how frequently.

As adults age they need a doctor. Women of child bearing age usually use their obstetrician gynecologist. If they have particular problems relating to blood pressure control during pregnancy, lipid or glucose metabolism problems during pregnancy, they need an adult doctor and a checkup. The data clearly shows that this subgroup of young women develop heart disease and stroke more frequently than others and have a higher mortality at a younger age unless treated.  Mr. Palmer may find their time away from work and the cost of a history taking session discussing diet , exercise, tobacco and drug and alcohol use, a physical exam including a dilated retinal eye exam, foot exam , fasting blood sugar, lipid profile  and urinalysis looking for urinary proteins to be a waste of time and money. It can, however save a person from losing a limb or their vision or their life at a young age.

The definition of what constitutes an annual exam for purposes of Mr. Palmer’s article needs to be clarified. You can go to the Mayo Clinic and for several thousand dollars receive a top to bottom exam with enough imaging studies to look at your body from the tip of your head to your toe inside and out. This is usually accompanied by a summary consultative session and a written report to take home for your records and review.  An alternative is to make an appointment with your local family physician, general internist or obstetrician and provide a thorough medical and social history and receive a detailed examination of your body without using radiation or imaging studies.  Based on what is discovered or not discovered you then sit down with your doctor and establish a plan for maximizing your health and minimizing your chance of developing illness over the next year. There may be testing suggested but it is generally relatively inexpensive basic laboratory blood and urine testing. These are the sessions where you can discuss appropriate screening tests based on your age, gender, family history, life style, history and physical exam.  It is an opportunity for your physician to get to know you and vice-versa.  Knowing how you look and act and participate in life activities when healthy definitely does give your physician an advantage in realizing when something is different and wrong.

As you age you need a physician to coordinate your care, be your advocate and work with you to establish health care goals that are realistic and attainable. Time intensive but thorough and comprehensive reviews of your prescription medication intake plus over the counter vitamins, minerals and supplement intake saves lives. When you add in advanced age, alcohol, diminished vision, arthritic joints with loss of position sense when transferring weight as you walk, the annual exam becomes a fall prevention session.

Employers, insurers and economists would like us all to be able to travel over the internet to a website, enter our histories, enter our physical attributes and findings based on our untrained opinion and let a computer program plan, evaluate and advise us.  That level of automation and accuracy may someday come. Until then I suggest you do it the old fashioned way by seeing a doctor, giving your health history and getting a thorough and comprehensive physical exam.