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.

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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.

Low Level Air Pollution Still Kills

These are turbulent controversial times with the United States not honoring its commitment to the Paris Climate Accord which was supposed to reduce carbon emissions into the atmosphere and help control pollution. Passions are high on both sides of the issues with coal mining and oil industry lobbyists lining up against those who believe those products accelerate global warming. It comes at a time when an ice mass the size of the state of Delaware broke off from its ice shelf home in Antarctica and floated out to sea either due to global warming or normal calving of glaciers and ice masses.

These passion provoking news stories come at the same time a major environmental study was published in the New England Journal of Medicine stating that low levels of atmospheric pollutants, well under the government’s current permitted levels, are killing 12,000 people per year over the age of 65. The study, reported by Qian Di. MS of Harvard University and colleagues, looked at 60 million Medicare beneficiaries between the years 2002-2012. They examined the levels of airborne fine particulate matter and ozone. Each small increase of particulate matter of 10ug/m3 was associated with a 7.3% increase in all-cause mortality. They concluded that there was no truly safe level of particulate matter with mortality increasing in this age group even at levels currently considered safe by current standards

When they looked at ozone levels they noted that for each increase of one part per billion, the mortality rate increase was about 1.1%. Males, blacks and Medicaid-eligible individuals had the highest risk of death from increased ozone.

According to the article’s author, “The message is clear. Air pollution kills people, even below current National Ambient Air Quality standards. The current air quality standard is not stringent enough to protect human health.” His statements are extremely meaningful since the current Trump administration and EPA director are seeking to lower the air quality standards imposed by previous Republican and Democratic administrations.

Whether you believe the planet is warming due to a natural occurring process, or due to interference by human production of pollutants, we all recognize our climate is changing. Anything we can reasonably do to slow the process down is worth considering so that our children and grandchildren have a planet to safely live on.

Now with this article in the New England Journal of Medicine it is clear we do not have to wait for massive global climate changes to kill us off quickly. Air pollution is already doing that job at levels once considered safe and tolerable. To relax the air pollution rules and regulations is just inviting more respiratory illness and death in the senior citizen population.

Write your Congressperson and Senator and protest relaxation of the EPA air pollution regulations to protect you. Maybe killing off the elderly with air pollution and global warming is in the global plan of our leaders to save money on elder health care. If you kill us you don’t have to spend money caring for us.

MRI Use in the Detection of Prostate Cancer

As men live longer the likelihood of them developing prostate cancer increases. Some experts estimate that if we biopsied the prostate of every male 80 years old or older, we probably would find prostate cancer present in almost all of them.

The PSA test has been shown to be less valuable than previously thought when discovered because it does not distinguish between an elevated level due to normal prostatic enlargement, infection or the presence of cancer.  When it is elevated due to cancer it cannot predict which tumors are aggressive and require aggressive treatment and which tumors are non-aggressive or indolent and can just be watched.  For this reason, CMS or Medicare and the United States Preventive Task Force are opposed to PSA use as a screening test.

To deal with these issues, Robert K. Nam MD, MSc, chairperson of genitourinary oncology and professor of surgery at Sunnybrook-Health Sciences Centre in Toronto, Canada has published a small preliminary study in the Journal of Urology on the use of MRI (magnetic resonance imaging) to predict the presence of and the aggressive status of prostate cancer disease.

They recruited men who knew they would be undergoing a PSA test, a MRI of the prostate and a prostate biopsy. Their preliminary results show that the MRI was a better predictor of the presence of prostate cancer than the PSA.  It was also felt to identify how aggressive the disease was which influenced treatment options offered. It was additionally felt to be very accurate in identifying when no prostate cancer was present.

Small numbers of patients were entered in this pilot study. A larger randomized controlled study is now in the planning stages to further clarify these initial findings.  At the same time in our community some of the urologists are now ordering MRI scans to elucidate what is causing an elevated PSA in individuals who have a non-diagnostic digital rectal exam and an elevating PSA.

Generics and Therapeutic Substitution – Safety and Efficacy?

Excuse me for being a “doubting Thomas,” but when I saw articles in JAMA Internal Medicine and commentaries supporting use of generics instead of brand name drugs I asked myself “Where is the proof of equivalent results and safety?”.  Generic substitution implies that the original product is no longer patented and exclusive and another firm is now producing an identical chemical version which produces the same beneficial effects on the patient.  Therapeutic substitution means your pharmaceutical insurance company or pharmacy changes the drug you are prescribed to one in the same drug class. Think of drinking Coca Cola and having the supermarket substitute a comparable brand instead.

The reason for this is simply to spend less money. Many pharmaceutical insurance companies realize if they put an obstacle in your path of obtaining your medication you likely will pay for it independently saving them money.  The authors of the JAMA articles estimate between 2010 and 2012 therapeutic substitution would have saved $73 billion. The out-of-pocket savings to the patient would have amounted to $25 billion.

I’m for saving money and spending less with certain guidelines. However; I want to know that a generic medicine is produced in a factory inspected by the Food and Drug Administration (FDA) at least as frequently as the drugs produced in North American factories. I like to know where the drug was made including country of origin, city, location and the plant’s track record for health and safety. I also want to know the generic medication produces the same drug levels and positive effects as the brand name medication and is made with no more contaminants than the original branded product.

I need reassurance that my patient isn’t receiving a counterfeit product with stolen original labeling, which has been a scam fooling pharmacists and Customs agents for years.   I would additionally like to know that the generic product, or therapeutically substituted product, works as well as the original. We know for example that Levothyroxine generics and substitutions are problematic.  We additionally know that the beta blocker carvidilol (Coreg) has certain unique properties that other beta blockers do not provide making therapeutic substitution for less expensive medications in the beta blocker class problematic.

Once this information is available it should be distributed in package inserts, online and taught in pharmaceutical, nursing and medical school courses as well as CME courses for health care professionals.

There is an abnormally perverse concern that if a pharmaceutical representative takes a health care provider out for a meal and a drink while explaining their product, we will prescribe it even if it is more expensive or doesn’t work as well.  I doubt sincerely that most physicians would do that but do believe if the cost is comparable, or less, and the efficacy is as good, they might choose the product as a viable alternative.

Antibiotic Associated Colitis Increases Risk

At least a half dozen times per week patient’s call with symptoms of a viral upper respiratory tract infection or present to the office for a visit with symptoms and signs of a cold.  These illnesses are caused by small viral particles which do not respond to antibiotic treatment.   Your body’s defense system attacks these viral particles and over a period of hours to days defeats them.   Despite years of ongoing public health announcements and handouts by doctors and nurses and attempts at patient education you find yourself negotiating with strong willed patients who want a “Z Pack” or some other antibiotic which they do not need.  “I know my body,” they argue.  “My northern or previous physician knew to always give me an antibiotic, why won’t you?”

The answer is quite simple. They do not work to shorten the course, intensity or duration of your illness. They do in fact put you at risk of developing complications of antibiotic use. When your infection requires the use of antibiotics to restore health, it is worth taking these risks. When you do not need the medication it definitely is not. This was confirmed by an article and research presented by E Erik Dubberke, MD of Washington University School of Medicine in Saint Louis, Missouri commenting on Medicare Data about the death rate associated with antibiotic related colitis infections due to Clostridia Difficile.  Bacteria normally reside in our large intestine and promote health and digestion.  When we prescribe an antibiotic it kills off the healthy and beneficial bacteria as well as the infection related bacteria. This destruction of healthy bacteria creates an environment conducive to “opportunistic “bacteria normally suppressed by the normal flora to invade and take over your gut. The resulting fever, cramping, diarrhea with blood occurs as the intestine become inflamed with colitis. One of the common opportunistic pathogens is Clostridia Difficile.

Dr. Dubberke looked at Medicare data and compared 175,000 patients older than 65 years of age and diagnosed with Clostridia difficile infection and compared them to 1.45 million control patients. He found that those with clostridia difficile infection had a 44% increased risk of death. When comparing admissions to nursing homes for treatment there was an 89% increased risk due to antibiotic related colitis care.

Antibiotics are wonderful when appropriate. They will always carry a risk of a side effect, adverse reaction or complication which is a risk worth taking in the correct setting.  It is clearly not worth the risk when your doctor tells you that it will not work.

How Much of Yourself Can You Give to Others?

I have been practicing general internal medicine for over 35 years in the same community. I have many patients who started with me in 1979 and are now in their late eighties to early nineties.  Predictably and sadly they are failing.  Not a week goes by without one or two of them moving from general medical care to palliative care, very often with the involvement of Hospice for end of life care.   Medicare may now compensate for discussion of end of life issues but anyone practicing general internal medicine or family practice has been discussing end of life issues appropriately for years with no compensation. It just comes with the territory.

Most of us still practicing primary care thrive on being able to improve our patient’s quality of life and our major compensation can be hearing about their interactions and social engagements with family and friends.  It is an accomplishment to see you’re 90 year old with multisystem disease for years, dance at her great grandchild’s wedding.  No one who cares for patients longitudinally for years is that dispassionate that they do not give up a piece of their heart and soul each time they lose a patient or have one take a turn for the worse.   When I lose a patient, if time permits, I will attend the funeral or family grieving gathering during the mourning period.  Everyone gets a personal hand written letter. Completion of the circle of life and then moving on is part of the process.

I think physicians’ families take the brunt of this caring and I am sure mine does. As much as you want to have time and patience and sympathy and empathy for your loved ones, the work truly drains your tank and reserve. When you answer the questions of the elderly and their families over and over, often the same questions, it drains you.  Unfortunately, I believe my elderly failing mother is cheated the most by this process. Last weekend when making my weekly visit she was complaining again about the same things, asking the same questions that have repeatedly and compassionately been addressed by my brother and I. My wife interjected that I sounded angry and annoyed. I was. I told her that unfortunately all the compassion and understanding in me had been drained already today and I needed time to recharge.

I saw the widow of a patient who expired last month in his nineties. I had offered to make home visits and they were declined several times by the patient and his spouse. His last week of life he asked to receive Hospice care and they assumed his care.  I called the surviving spouse and wrote what I considered a personal letter of condolence.  His wife told me she was disappointed in me for not coming up to see him one last time. I apologized for not meeting their needs but wondered inwardly, how much can I give and still have something left for myself and my loved ones?