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More on Shingrix, the Shingles Vaccine

Recently, the FDA approved a new shingles vaccine called Shingrix. It is a two shot series with the suggestion made that the second shot should be taken 2 – 6 months after the first one. Shingrix will replace the original shingles vaccine Zostavax. Shingrix is recommended in all patients over 50 years old.

For those of you who have had the original shot, Zostavax, the new vaccine is still recommended. It is covered by Medicare Part D which means you must take it in a pharmacy or walk in center not in your doctor’s office. While this makes NO sense, it is the rule. If you have had shingles it is still recommended you take the new vaccine (Shingrix).

Shingles is a skin rash and painful skin condition caused by the chicken pox virus Varicella. When you have chicken pox and complete the infection course you are immune but the virus remains alive forever, living in sensory nerve endings along the spinal cord. One third of adults will have an outbreak of this varicella virus which will appear along the path of a sensory nerve or dermatome on one side of your body. It will go through the full cycle of rash, pustule and then scab that the chicken pox did. A significant number of patients will continue to have pain over the involved skin for prolonged time periods in what we call post herpetic neuralgia. The pain is described as severe as an eye scrape, passing a kidney stone or going through labor and delivery.

The original shingles vaccine, Zostavax, protected against the rash 51% of the time and against post herpetic neuralgia 67% of the time. This efficacy dropped to about 30% after four years. The new vaccine, Shingrix protects against the rash over 90% of the time and against the pain syndrome 85-90% of the time while lasting for more than four years.

Only five percent (5%) of patients receiving Shingrix develop side effects. The most common are fever, myalgia and chills. In view of this, I am suggesting to my patients we allow the vaccine to be on the U.S. market for a year to see the adverse event profile and, if safe, we then start the series of shots.


Cigar and Pipe Smoking Significantly Increases Mortality Risk

My male patients express to me on a regular basis their desire to continue to smoke a few cigars per day. They are quick to point out that they do not inhale the smoke like cigarette smokers do. They also point out that their use of cigars is far fewer in number than cigarettes. They all discount the risks of the smoke, its byproducts, carbon monoxide, etc.

The Journal of the American Medical Association (JAMA) has just published a research project which looked at that subject. They followed cigar and pipe smokers from 1985 until 2011 looking at the mortality rate and the cancers they sustained. Of the 357,420 participants in the study, 51,150 died. The death rate of cigar and pipe smokers was much higher than nonsmokers and those who never smoked. There was also a much higher likelihood they would sustain a tobacco related cancer such as lung, throat, esophagus, oral cavity and bladder cancer which would eventually kill them.

It was clear the risks were higher for cigarette smokers than pipe and cigar smokers. As a physician, I will continue to encourage smoking cessation of all tobacco products.

Tobacco smoking ruins your health and kills people. Let there be no confusion about that fact.

The Blood Pressure Guidelines Dilemma

The American College of Cardiology and American Heart Association recently published blood pressure control guidelines that suggest we should be treating blood pressure in 25 year olds the same way we treat it in 79 year olds and older patients. If you have any cardiovascular disease, or a 10% cardiovascular risk assessment over the next few years, they want your systolic blood pressure to be less than 130. They present excellent data explaining that as the blood pressure elevates above 130, the risk of a heart attack, stroke, vascular disease or kidney disease and, ultimately, death increase. No one is arguing these facts.

The American College of Physicians (ACP) along with the American Academy of Family Physicians (AAFP) recognizes this one size fits all in blood pressure control creates many problems. As we age, our arteries become less compliant or elastic. Stiffer arteries are more difficult to assess for blood pressure value. After we have exhausted the lifestyle changes of smoking cessation, weight loss, salt restriction and increased activity to control blood pressure; we are forced to use medications. We try to use low doses of medicines to avoid the adverse effects of the pills that the higher dosages can bring.

These medicines are costly. The more we prescribe the more patients don’t take them due to the cost. The more we prescribe, the more patients forget to take multiple pills on multiple schedules of administration. If we get the patients to take the medication we run into the problem of blood pressure precipitously dropping when patients change positions from supine to sitting to standing. If we are lucky, and the patient is well hydrated, then we may only be dealing with a brief dizzy spell. In other cases, we are left treating the consequences of a fall and injury from the fall. The more we strive to control your blood pressure to the new levels with medications the more we must consider drug interactions with prescription medicines being prescribed for other health problems seen in older Americans.

At this point, experts from the ACP Policy Board and noted hypertensive experts at the University of Chicago have suggested we follow the more liberal guidelines of the ACP individualizing our care based on the patient’s health issues. Personalizing care with individual goals makes sense to me, especially in my chronically ill patients battling blood pressure, weight control, age related orthopedic issues, and age related visual and urological issues plus other problems. We strive to do that in our practice allowing the time for discussion, questions and evaluation at each visit.

Emergencies and the Rational For Our Treatment Algorithm

We are a primary care medical office that tries to deliver personalized attentive care. We define emergencies as chest pain, significant breathing difficulty and loss of consciousness, uncontrolled bleeding or pain, sudden change in mental status and behavior or major trauma. In these situations, my office staff receiving a phone call interrupts me so I can speak with you and determine whether or not to advise you to call 911. We do this because we know with life threatening situations time is of the essence.

Emergency Medical Services at 911 can arrive within 5 minutes. They are all Advanced Cardiac Life Support (ACLS) trained and carry the equipment and medications to provide life sustaining care while you are transported to a hospital Emergency Department that has the staff, medications and equipment to keep you alive while we diagnose the problem and create a plan to rectify it.

The office staff is trained in Basic Cardiac Life Support. We do not have a defibrillator. We do not maintain and store medications to correct low blood pressure – cardiac arrhythmias. We do not have endotracheal tubes to intubate you and breathe for you. In the past, when we tried to maintain these supplies, they became outdated due to infrequent use and were expensive to replace. Since we do very few resuscitations day to day we are not as experienced or efficient as EMS and emergency department personnel are.

I realize the wait for care and institutional care settings are not pleasant. We sacrifice that for the best chance to keep you healthy. Trust me, it is no fun cancelling a scheduled patients to run to the ER and then return already behind. We do it for your comfort and security and safety.

In the recent past patients with chest pain resembling heart disease, trouble breathing and excessive bleeding have refused to call 911 and were upset when we did not bring them into the office. We do this for your health and safety not our convenience. If you would like to discuss this feel free to contact the office.

New Non Live Shingles Vaccine Approved by FDA and ACIP

For several years the Advisory Committee on Immunization Practices (ACIP) has been encouraging adults to receive the shingles vaccine or Zostavax. Shingles is a recurrence of chicken pox which we had as children. The virus lives within the nerve endings near the spinal cord and recurs following sensory nerves at unexpected times producing a chicken pox like (herpetic) rash with pain on one side of your body. The lesions follow the pattern of the chicken pox with pustules crusting over the course of a week. During the rash, patients are contagious and can transmit the chicken pox virus to people not immunized against it or those people whose immunity is diminished. As the rash subsides, a large percentage of the patients continue to have pain along the path of that sensory nerve which can last forever in a post herpetic neuralgia.

Zostavax will prevent an outbreak of shingles in about 2/3 of those who receive the shot. It prevents the post rash pain syndrome in a much higher percentage of the recipients. It was this quality that made it easy for me to recommend the vaccine to my patients and to take it myself.

The shot’s major drawback was that it involved receiving an attenuated or modulated live virus. This prevented individuals on chemotherapy or with a weakened immune system from receiving this vaccine.

To address that issue Glaxo Smith Kline developed Shingrix which is a non-live, recombinant subunit vaccine injected into the muscle on two occasions. It is touted to prevent shingles in 90% of the recipients over a four year period. It will replace Zostavax as the shingles vaccine of choice. For those of us who already received Zostavax they are recommending that we boost our immunity by receiving this new vaccine as well.

I have always been quite conservative on recommending new pharmaceutical products until they have been on the US market for at least one year. With the decreased funding of the FDA, I will wait at least a year until I see what adverse reactions occur in the US population. In the meantime I will price the product and try and learn if private insurers and/or Medicare will pay for its administration.

Why the Medicare System Can Not Stay Solvent

My spry 90 year old patient decided she had a urinary tract infection two weeks ago. She had difficulty urinating and the constant urge to void with no fever, no chills, no back pain, no bloody urine. She was advised to come in for an appointment the same morning but this didn’t suit her. The alternative choice was to see her urologist who made time available that same day. She decided this was not convenient either. I called her and took a history and attempted to negotiate a visit but she declined strongly. She chose to void into a sterile container she had at home, put it into the refrigerator for storage and start to take some ampicillin that had been prescribed for her last urinary tract infection weeks before. One day into the ampicillin therapy she had her full time aide drop the urine off at the office for a culture and analysis (It came back negative for an infection several days later). That night she could not void. She called the urologist and the covering doctor suggested she drink more water. She complied even after she developed nausea and vomiting which continued into the early morning hours. Her aide called 911 and EMS brought her to the emergency department.

This frail elderly woman has not been eating well for months. As her total protein drops and her activity diminishes decreasing her leg muscle tone, her lower extremity peripheral edema or swelling increases. Her veins drain less efficiently than in the past contributing to the swelling. She suffers from a chemical electrolyte regulatory abnormality with chronic low serum sodium. Vomiting electrolyte rich material and replacing it with electrolyte free water further diluted and lowered her serum sodium. Upon arrival in the Emergency Department, the ED physician noticed the swelling in her legs and reflex ordered a Congestive Heart Failure (CHF) lab panel. The government (CMS) has made such a big deal about recognizing CHF that physicians and hospitals are afraid to not recognize it and not treat it. If you don’t treat it there are financial penalties for the docs and the institutions. The CHF panel consists of expensive and sensitive heart muscle enzymes that elevate in a heart attack, a lipid profile and a BNP which elevates in CHF. The problem is that the heart enzymes and BNP elevate in a host of chronic conditions seen in the elderly unrelated to heart failure.

I was called into the hospital to evaluate and admit the patient in the middle of the night. A Foley Catheter was now inserted into her bladder and draining fluid. Steps had been taken to slowly correct her sodium abnormality. A urine culture was sent with the initial catheterized urine and the evaluation of her heart based on “indeterminate” heart enzymes was completed. She did not have a heart attack. She was not in heart failure. Her serum sodium rebounded slowly with a treatment called fluid restriction. Three days later she was voiding without the catheter, ambulating with her walker and aides assistance and ready to go home under the care of her aide and two daughters. She was scheduled to see me in 72 hours with the urologist to follow.

I called her the next day and she was doing fine. The next morning when I called she was constipated so we instituted a program which using over the counter medications corrected the problem. At 3 PM the next day she called my office and left a message that she wanted to speak to me. My nurse asked her if she was sick and she just repeated the need to talk to me. I called her when I finished with patients and she told me, “I am dying. I am very sick. I feel like I have to pee and I cannot. I have called 911 and I am on my way to the hospital.” When I tried to determine what the definition of “very sick” meant she couldn’t elaborate. She was not febrile. She had no chest discomfort or shortness of breath, she just couldn’t void. I called the ED and spoke to the head nurse and physician and reviewed her recent clinical course and findings. One hour later they called me to tell me she was in urinary retention and her bladder was overloaded. They placed a Foley Catheter in her bladder and ¾ of a liter of urine emptied relieving her discomfort and very sick feeling. The problem was that the ED physician saw her leg edema and sent off the CHF Lab Protocol again. This was a different ED physician than the week before. This time the Troponin I cardiac enzyme marker was in a higher in determinant range. “Steve,” he said, “her EKG is abnormal. I think she is evolving a myocardial infarction and needs to be readmitted.” I reminded him that we had completed this exercise last week with her long time cardiologist and her heart was fine. He told me he didn’t care. The risk medical legally was too high to send her home. The costs and hospital stay now start again.

This patient had daily 24 hour care by an experienced aide. Both her college educated adult children were with her. She had my office phone and cell phone as well as access to the very flexible urologist. She still chose to do it her way relying on EMS and Emergency Departments due to fear, anxiety and having no financial skin in the game. The urologist wondered why she didn’t just call him and he would have reinserted the catheter in his office. I wondered why she just didn’t call earlier so we could see her before my staff left for the evening. It didn’t matter if we were capitated, being paid for quality metrics or if the fee for service system was abolished. This strong willed independent complicated ancient senior citizen was determined to do it her way. The system runs on algorithms and protocols and generates information routinely that requires a common sense interpretation based on the clinical setting and issues. The risk of medical malpractice despite government funding this care plus the risk of government sanctions based on chronic disease protocols makes intelligent and compassionate care which is affordable almost impossible.

A Clinician’s View of the Opioid Crisis

“Do Not Get Caught.” seems to be the real rule of the law in S. Florida, where I live.

I was trained to limit the use of controlled substances, narcotics, hypnotics and sedatives. Their use can affect consciousness, ability to drive a car and work.  More severe consequences include respiratory depression and overdose from too high of a dosage or mixing too many medications and over the counter items.

The Joint Commission on Accreditation, medicine’s good housekeeping seal of approval authority, along with major medical organizations have accused clinicians of under treating pain. “Pain” is the fifth vital sign, they said.

This was accompanied by professional society leadership and academic researchers receiving grants from pharmaceutical companies touting the newer longer acting pain medications which “have very little addictive potential”. We were then informed we would be receiving evaluations and scores of our treatments of pain which would influence our reimbursement if we under treated pain.

In my current concierge medical practice I see 10 or fewer patients per day. In my previous general practice I saw 2- – 30 patients per day. I could go days without prescribing a narcotic pain medication. In most cases when I wrote out a script for a narcotic pain medication it was for a patient with a severe chronic pain problem, seeing a specialist for that problem, and requiring a pain pill because there were few effective alternatives. The patient visits to doctors and physical therapists and massage specialists and other alternative pain therapies were well documented in the medical record and mostly unsuccessful in attempts to relieve the pain.

This contrasts markedly with the opening of pain clinics in nearby counties with their own in-house prescribing pharmacies. One or two physicians wrote thousands of pain pill prescriptions per day. Patients lined up around the block to see these employed physicians of the pain clinic with many arriving in cars from other states. The cash flow generated was so vast that the clinics needed private security to protect the profits. Many of the security hired were off duty city and county police officers trying to supplement their income.

It’s hard to imagine that law enforcement and the DEA, were unable to recognize the difference between pill distributing centers and legitimate practices prescribing medications on a limited basis to individuals with documented needs. City, County and State governments gladly accepted the tax benefits, occupational license fees and pharmaceutical license fees from these sham clinics while drug dealers drove in and out of our state to obtain prescription pain medications for sale in their home towns. Of course the blame for this was placed on the doctors and dentists.

The State of Florida tightened up its laws and somehow law enforcement was given the tools to see and eradicate what was occurring right under their very noses. As prescription drugs dried up, the Mexican drug cartels got smart and flooded the market with cheap strong heroin. It was obviously the fault of the physicians and legitimate pharmacies that white working class people were buying plastic bags full of dope and inserting needles into their veins to avoid the pain of life.

As drug addiction soared, City and County Governments found it in their hearts to sit as zoning boards allowed drug rehabilitation centers to open up in the heart of their communities. There was little or no effective investigation of who was running these clinics and or their previous experience, methods and or success rates. If you want to read about where the soaring number of narcotic overdoses occur in our community – follow the zoning board’s placement of rehab centers and sobriety houses. What better way to increase your drug overdoses than to encourage unsuccessful addicts to come to your community and leave their money and their family’s money to improve the tax base and create new headaches for EMS and police officers?

Somewhere there should have been a higher level of thought by our elected and appointed officials about the consequences of bringing hundreds of drug dependent individuals into our area before they permitted these facilities to open.

Last week my advanced pancreatic cancer patient with severe back pain tried to purchase a controlled substance prescribed by his oncologist to relieve his suffering. Six pharmacies no longer stocked the product due to their fear of liability. It took hours to find a pharmacy that would order the medication for the patient. Physicians, pharmacists and law enforcement accessing our state narcotic registration website clearly can see that this patient only uses his medications as prescribed by one physician. This patient, and others like him, are victims of the government legitimizing of pain pill mills and drug rehabilitation centers in their communities.

As a physician we all have our failures in this area as well. I painfully recall the doctor’s wife I sent to a disciplined pain doctor to wean her off narcotics prescribed by a rheumatologist, urologist and gastroenterologist for legitimate reasons documented by tests and biopsies. I refilled the prescriptions for her convenience and ease never dreaming I was contributing to her problems.

I feel for my colleagues in the Emergency Department and in orthopedic offices having to daily differentiate acute pain requiring intervention with controlled substances as opposed to individuals with drug seeking personalities. This being said, the opioid crisis was caused by the most trusted members of the academic medical community in cooperation with the medical inspection and certifying agencies in concert with public officials and law enforcement looking the other way. They all made a great deal of money at the expense of the public. Now as they struggle to clean it up they give us medical and recreational marijuana.