Prostate Cancer, Digital Rectal Exams, PSA and Screening

The PSA blood test, to detect prostate cancer, clearly has saved lives according to numerous studies. The United States Preventive Task Force (USPTF) recognizes this but has decided that screening for prostate cancer is not a great idea in men aged 55-69. They point out the PSA can be elevated from an enlarged prostate, an inflamed or infected prostate, a recent orgasm while having sex and other causes.

Elevated PSAs led to trans-rectal ultrasound views of the prostate and biopsies of the prostate. These biopsies were uncomfortable, even painful, and often followed by inflammation and infection of the prostate. Many times the prostate biopsy was benign with no cancer detected. The USPTF felt the cost, worry, and potential side effects were a risk far outweighing the benefits of screening. They consequently came out against screening men in this age group.  Naturally this position produced a tidal wave of criticism from urologists and other.

So, the USPTF has produced new recommendations calling for patient education and making a shared decision whether or not to obtain a PSA measurement before you send it out. This is a bit confusing because we always discuss the pros and cons of a PSA before we draw it. Adult men are entitled to hear the pros and cons so they can make their own informed decision.

To complicate matters, a study out of McMaster University in Canada reveals physicians are poorly trained in performing a digital rectal exam. They cite the lack of experience coming out of school and going into training and cite numerous research studies showing a rectal exam is a low yield way to detect prostate cancer. They do not recommend performing digital rectal exams for prostate cancer screening.

This received much media hype and the blur between the efficiency of detecting prostate cancer via a rectal exam and the use of the rectal exam to detect rectal and colon disease has been lost. We perform digital rectal exams to detect prostate cancer and look at the perirectal area for disease. We test the strength and performance of the anal sphincter muscle. We feel for rectal polyps and growths and, in certain situations, test the stool for the presence of blood.

During my internal medicine training my teachers always required a digital rectal exam, stool blood test and slide of the stool as part of the exam. As trainees, we realized the invasiveness of the exam and did our best to be polite, gentle and caring. I always asked for permission first, and still do. How can you tell if something is abnormal if you haven’t performed normal exams?

Last but not least, Finesteride, a medicine used to shrink an enlarged prostate by inhibiting male hormones, has finally been shown to be protective against developing prostate cancer. A study published in the journal of the National Cancer Institute found that men taking it for 16 years had a 21 % lower incidence of prostate cancer.

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Cleaning Is Hazardous to Your Lungs and Overall Health

In an article published in the American Journal of Respiratory and Critical Care Medicine it was shown that women who regularly clean homes show a marked decline in pulmonary function. The study looked at 6,230 persons participating in the European Community Respiratory Health Survey over a period of 20 years.

Normally lung function declines as we age but women who were professional home cleaners, and who used cleaning sprays, declined at a far faster rate than women who did not clean at home or professionally. For unclear reasons in this study cleaning did not appear to effect the measurements on men. The study authors were quick to point out that there were very few men in the study making their conclusions on men less meaningful.

The authors looked at two main parameters, Forced Vital Capacity (the maximum amount of air exhaled after a maximum inspiration) and Forced Expiratory Volume in one second. They noted that decrease in Forced Vital Capacity is associated with decreased long term survival in patients without known pulmonary disease. They additionally noted a slight increase in the development of asthma in the home cleaners.

The authors postulated that cleaning products were “low grade irritants” and chronic exposure could lead to remodeling of the airways and resultant decline in pulmonary function. While reading this article I thought about how infrequently we read labels on the products we use to clean our homes, cars and elsewhere before using them. How often do we actually follow the health advice listed on the bottle? Should we be wearing N95 respirator type masks when using cleaning sprays and working in sparsely ventilated areas? What about children and their exposure? Should we be using these products around them and or our pets? Is it the actual spraying that exposes cleaners or does the products effects linger well after use?

These are all questions that few, if anyone, looks into or answers but certainly need to be addressed now that these findings have been published.

Lack of Vaccination Coverage in the Medical Office

This week a patient, going on a foreign trip, was required to fill out a vaccination and immunization record to obtain a visa. To his dismay he discovered his records were not available. On further questioning he realized his vaccinations were done at retail clinics and pharmacies up and down the Eastern seaboard. Yes, he had requested a record of the vaccination be sent to the office but it never arrived.

I am a firm believer in the recommendation of the CDC, American College of Physicians and Advisory Council on Immunization Practices. Their literature is displayed in my office and available as a resource to my patients. I find it abhorrent that CMS, through its Medicare Part D program, will pay for the shingles shots (Zostavax and Shingrix) and the pneumonia series (Prevnar 13 and Pneumovax 23) at the pharmacy but not at a doctor’s office. The pharmacies use these vaccinations as loss leaders to get individuals into the store hoping that they will buy additional items while there.

As a general internist and practitioner of adult medicine, I too use these vaccinations as a “loss leader.” When patients call for a vaccination and have not been seen in a long while we encourage an appointment. We check on prevention items recommended by the ACP. the AAFP and the USPTF and make sure the patients are current on mammograms, HPV or Pap testing, colonoscopies, eye exams, hearing evaluations, skin and body checkups and other essential health items. We make little or no money on vaccinations or immunizations but like the idea that once a patient is here we can provide a gentle reminder about those health tasks we all need to follow up on with some regularity.

I like the idea of making vaccinations and immunizations more convenient for patients. I just believe the same payment should be made if the patient is in your office or in the pharmacy. In addition, the law should require the pharmacy to send a record of the vaccination to the patient’s physician so we can have immunization records readily available.

The ACP, AMA, American College of Physicians and American Academy of Family Practitioners should be using their influence to encourage the Center for Medicare Services (CMS) to pay for these vaccines in doctors’ offices as well as in pharmacies and retail clinics. If encouragement doesn’t work then legal action is appropriate.

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.

Globalization, Corporate Control and Shortages of Medication

One of my online medical information websites carried a letter from the head of the Food and Drug Administration (FDA) trying to explain why there is a shortage of standard intravenous fluids to administer at hospitals and medical clinics in the United States. The author cited an extremely busy influenza season causing patients to use Emergency Departments in record numbers plus a loss of manufacturing capabilities due to damage to a production facility in Puerto Rico during a seasonal hurricane. No more, no less.

Doctors, nurses and patients are expected to believe that there is only one production center for our intravenous fluids nationally located in Puerto Rico. If it is unable to produce and ship product then health care as we know it has to change?

If this is in fact the truth, and the only reason for the lack of available IV fluids, what exactly does it have to say about our planning and leadership at the level of the FDA and CDC? Might it in fact indict the corporate model of efficiency and productivity? Is there not a Plan B and C for supplies of intravenous fluid if one source cannot supply our needs? If this is in fact the only production source then why wasn’t it a post storm FEMA national priority similar to if the NORAD intercontinental ballistic missile system had been damaged due to Hurricane Irma or Maria and we could not monitor North Korean launches?

At the same time we have a shortage of intravenous fluids, we have a shortage of injectable narcotics for pain relief. Morphine and dilaudid are in short supply. My hospital pharmacy committee and chief medical officer are now limiting injectable pain medications to immediate post-surgical cases.

Pain elsewhere in the institution should be treated with the oral pain pills we read about causing the opioid epidemic and crisis in America. There apparently is no shortage of injectable heroin on the streets of Palm Beach County, Florida. The Mexican cartels have found a way to meet the demand of its customers unlike organized healthcare which seems unable to do so.

I do not know who is responsible for insuring that we have enough materials and medications available to care for our nation. I do know they are doing a very poor job of it and would love to know who is responsible.

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.