How Often Do Screening Colonoscopies Result in a Complication?

Harlan Krumholz, MD is the director of the Yale Center for Outcomes Research and Evaluation (CORE). His team at Yale is being paid extraordinarily well to determine what works and what doesn’t in Medicare. Their data will theoretically allow Medicare to issue payment for services based on success rates of care without complications. His group is part of a national program promoted by the Center for Medicare Services (CMS) to spend less for more effective high quality care. This in my humble opinion is “voodoo” health care policy.

One of their areas of interest is trips to the emergency room or hospital within 7 – 14 days of a colonoscopy. They developed a formula to look at this problem and applied it to Medicare claims data in the year 2010 in NY, Nebraska, Florida and California. They found 1.6% of healthy individuals going for screening colonoscopy ended up at the hospital within seven days. They found wide variations in this rate coming from different facilities and different doctors. When the data is extrapolated to the 1.7 million Medicare beneficiaries undergoing screening colonoscopy annually it indicates there will be at least 27,000 unplanned hospital visits within seven days of the procedure.

Determining what causes complications of a screening procedure so we can determine a root cause and then prevent it is a good thing. However; the research needs to be done by independent groups not receiving funds from CMS which has a clear and strong conflict of interest!

We need to be looking at complications related to the choice of preparation, choice of colonoscopy, choice of anesthesia and whether polyps were removed and or biopsies taken. We additionally need to assess the definition of “low risk patient.”

Within the recommended age group for screening colonoscopies of 50-75 years old, very few patients are not taking prescription medications as well as supplements. The research needs to look at procedures such as CT Scan virtual colonoscopy and fecal immunochemical human occult blood testing as well for efficacy and complication rate.

There are currently DNA analysis tests of columnar epithelium colon cells sloughed during a normal bowel movement. Pre-cancerous polyps and colon cancer have distinctive DNA patterns that can be detected by looking at fecal material. There is no prep but the cost of $500 makes determining if it works and under what circumstances important. If it works then shouldn’t it be the screening test to determine who needs to have a colonoscopy? Yes, the research must be done but it must be done by agencies not affiliated with CMS with their stated goal of spending less for better service and better quality.

Vitamin D in Senior Citizens: How Much is Enough?

Vitamin D levels are the most popular blood test being billed to CMS Medicare and private insurers. The World Health Organization considers 20 ng/ml to be a normal level of 25-hydroxyvitamin D which contrasts with 30ng/ml in the USA. Vitamin D is made by the kidney when our limbs get exposed to sufficient sun light. It is low in severe and chronic states. Supplementing Vitamin D does not improve the illness except possibly in multiple sclerosis but can return the serum level to normal.

Experts in fall prevention hoped that supplying adequate vitamin D will preserve muscle function and reduce falling. About one in three elderly experience a fall annually with one fracture per five falls. In the USA this amounts to 250,000 hospital admissions for hip fracture each year. The research hope was that by raising the Vitamin D level to 30 we would reduce falls and fractures.  Unfortunately individuals 70 years or older who took 2000IU of Vitamin D a day or 60,000units per month, had more falls and a higher risk of falls than seniors who had lower serum levels and less supplementation. Their muscle function improved with higher dose vitamin D but so did the falls.

The Institute of Medicine, an independent US advisory panel advises taking 800 IU per day or 24,000 IU per month with a goal of a serum level of 21-30 and less frequent Vitamin D level monitoring.

Does Tdap Protect You From Whooping Cough?

Within the past few years an epidemic of whooping cough swept through and injured youngsters in California and Arizona. There were tragic childhood mortalities in the frail not yet vaccinated pediatric population. The researchers from the Center for Disease Control and National Institute of Health swooped in and concluded that adults, primarily grandparents, were transmitting the disease to their newly arrived and not yet immunized grandchildren. They reasoned that the adults’ immunity from their childhood vaccinations with DPT had worn off and they were unknowingly transmitting it to the youngsters after a mild adult upper respiratory tract infection with bronchitis.  We were told that in adults, Bordetella pertussis produced bronchitis indistinguishable from a viral bronchitis. This was just the type of illness health care leaders were telling physicians not to prescribe an antibiotic for in their international campaign for the prevention of antibiotic resistance developing.  Little did they know at first that in adults, the bronchitis is a mild illness but in children it is aggressive and is often lethal.  They were not originally aware that long after our adult mild bronchitis resolved we could still transmit the bordetella pertussis to our grandchildren.

Their solution was to re-immunize adults with a pertussis booster in combination with your next tetanus shot. The combination was called Tdap.  A national information campaign was undertaken to get primary care physicians to spread the word to their adult patients.  The question is does it really work? In a recently published study led by Dr. Nicola P. Klein of the Kaiser Permanente Vaccine Study Center in Northern California which appeared in the Journal Pediatrics, it seems that the vaccine is only effective for a short time in the very healthy and robust 11 and 12 year children.  Their study showed that Tdap protected young adolescents 69% of the time in the first year, 57% in the second year, 25% in the third year and only 9% in the fourth year.  The vaccine was given during an epidemic in California in whooping cough in the hopes of averting a greater infection rate.

 

The failure of the vaccine to provide long term benefits in adolescents and teenagers will lead to different immunization strategies. Tdap is already a milder form of a former vaccine, scaled down to prevent some of the rare side effects seen when it was administered.  A possible return to that previous vaccine or whole cell preparation may be needed. Another proposal calls for vaccinating pregnant women hoping that their maternal antibodies will pass to the fetus and provide long term protection.

The real question with no answer is what about the millions of adults who received Tdap with immune systems far less robust and protective than adolescents?  Are they immune and for how long?  No one knows because the research has not been done or published yet.  Still the CDC and the NIH and the American College of Physicians call for adult immunization with Tdap.  The Kaiser Permanente Study will surely establish the need for an adult efficacy investigation. Until then we will give the Tdap while we wait for answers. It does raise the question of whether our approach to adult bronchitis should include an antibiotic that treats Bordetella pertussis until a quick test is developed to distinguish it from run of the mill viral pneumonias.

Zika Fever and Virus

The Brazilian Government has asked young women to avoid becoming pregnant until they can determine how to stop the spread of Zika fever.  Pregnant women, especially those who are infected in the early stages of pregnancy are at high risk for their offspring developing microcephaly. This small brain in an even smaller skull leads to death or severe permanent neurological deficits. There are now over 3,800 children born with microcephaly in Brazil due to their mother’s infection with Zika Virus.

Zika Virus is in the family of Dengue Fever. It is transmitted by the bite of the Aedes mosquito which also transmits Chikengunya Fever. The incubation period is only 2 – 14 days producing symptoms in only one of five people who have been infected. Symptoms are generally very mild with a very low grade fever, a rash, joint and muscle pains, headache, conjunctivitis and vomiting in some. Treatment is supportive with the disease resolving in about one week.

In adults infected in Brazil there has been an upsurge of post infection Guillan – Barre syndrome which is believed to be due to the disease.  While the mode of transmission has been by mosquito in most instances there are two cases in the United States believed to be due to blood to blood transmission and or sexual fluid transmission. Both of these individuals became infected in Brazil.

The Center for Disease Control and Prevention (CDC) has noted the presence of Zika fever in South America, Central America, the Caribbean   and now Mexico.  Avoiding mosquito bites is the best way to avoid the disease. For women who are infected there is no commercial test to confirm the diagnosis.  A polymerase chain reaction RNA test available through the Florida Department of Health and research centers can be obtained one week after the onset of symptoms.

 

In the United States a protocol has been developed with obstetricians to screen pregnant women who have been infected with frequent ultrasound evaluations of the developing child to determine if the virus has affected the development of the fetus.

 

The emergence of this virus, which is devastating to developing fetuses, is leading to calls for the development of a vaccine which is “at best” years off. For now the best we can do is avoid endemic areas and be diligent in mosquito control.

Should You Stay Home When You Are Ill

Symptoms of being sick with the flu or a cold are designed genetically to protect the rest of the population from catching the disease according to researchers at the Weizmann Institute of Science in Israel. Their research findings have been published in PLos Biology. This is cold and flu season and individuals wake up daily feeling ill and miserable and wonder if they should take their antivirals and some acetaminophen and tough it out at work?

The study authors note that feeling sick is a multi-system event involving the endocrine system, the nervous system the immune system, the respiratory system and others. They cite the fact that behavior associated with being ill has been preserved over millennia of evolution. They give an example of an infectious illness which causes the patient to isolate themselves from others. While the patient may not survive the illness, the isolation behavior favors them not passing it on to others. Appetite loss prevents the disease from spreading through shared sources of food and water. Fatigue and weakness reduce the sick individuals’ independence and mobility reducing the distance and “radius” of possible infection. Other symptoms such as lost interest in others and less sexual desire and contact also reduce the transmission of disease. They cite changes in body language and personal grooming that send the message, “I am sick! Don’t come near.”

Professor G. Shakhar of the Immunology Department at Weizmann Institute made it clear that despite available medications to ease the symptoms, you are still ill and infectious and should stay home! We routinely advise patients to stay home until their temperature is less than 100.8 for 24 hours. If you have an upper respiratory tract infection with copious nasal discharge and cough related phlegm stay home to prevent getting everyone else at the office ill as well.

CDC and ACP: Stop Prescribing Antibiotics for Common Respiratory Infections

The Affordable Health Care Act has created patient satisfaction surveys which can affect a physician’s reimbursement for services rendered plus their actual employment by large insurers and health care systems. This has created a fear of not giving patients something or something they want at visits for colds, sore throats and other viral illnesses. Aaron M Harris, MD, MPH, an internist and epidemiologist with the CDC noted that antibiotics are prescribed at 100 million ambulatory visits annually and 41% of these prescriptions are for respiratory conditions. The unnecessary use of antibiotics has resulted in an increasing number of bacteria developing resistance to common antibiotics and to a surge in Emergency Department visits for adverse effects of these medications plus the development of antibiotic related colitis. To address the issue of overuse of antibiotics, Dr Harris and associates conducted a literature review of evidence based data on the use of antibiotics and its effects and presented guidelines for antibiotic use endorsed by the American College of Physicians and the Center for Disease Control.

  1. Physicians should not prescribe antibiotics for patients with uncomplicated bronchitis unless they suspect pneumonia are present”. Acute bronchitis is among the e most common adult outpatient diagnoses, with about 100 million ambulatory care visits in the US per year, more than 70% of which result in a prescription for antibiotics.” The authors suggested using cough suppressants, expectorants, first generation antihistamines, and decongestants for symptom relief.
  2. Patients who have a sore throat (pharyngitis) should only receive an antibiotic if they have confirmed group A streptococcal pharyngitis. Harris group estimates that antibiotics for adult sore throats are needed less than 2% of the time but are prescribed at most outpatient visits for pharyngitis. Physicians say it is quicker and easier to write a prescription than it is to explain to the patient why they do not need an antibiotic.
  3. Sinusitis and the common cold result in overprescribing and unnecessary use of antibiotics often. Over four million adults are diagnosed with sinusitis annually and more than 80% of their ambulatory visits result in the prescribing of an antibiotic unnecessarily. “ Treatment with antibiotics should be reserved for patients with acute rhinosinusitis who have persistent symptoms for more than ten days, nasal discharge or facial pain that lasts more than 3 consecutive days and signs of high fever with onset of severe symptoms. They also suggest patients who had a simple sinusitis or cold that lasted five days and suddenly gets worse (double sickening) qualified for an antibiotic

Last year two patients in the practice who were treated with antibiotics prescribed elsewhere for situations outside the current guidelines developed severe antibiotic related colitis. They presented with fever, severe abdominal pain and persistent watery bloody diarrhea. Usual treatment with oral vancomycin and cholestyramine did not cure the illness. One patient lost thirty pounds, the other sixty pounds. Fecal transplants were required to quell the disease. At the same time community based urine infections now require a change in antibiotic selection because so many of the organisms are now resistant to the less toxic, less expensive , less complicated antibiotics that traditionally worked.

“My doctor always gives me an antibiotic and I know my body and what it needs,” can no longer be the criteria for antibiotic use.

Dealing with Pain Physicians Should not be so Painful

The State of Florida is trying to eliminate medical practitioners and facilities which prescribe narcotics freely without doing the proper evaluations. These pill mills sell drugs for cash and the resulting overprescribing of oral narcotics has flooded the streets of Florida and nearby states with oral pills leading to increased opioid related deaths and trips to the emergency departments for drug overdoses. The frenzy has been fueled by “blue ribbon physician panels” discouraging the use of nonsteroidal anti-inflammatory drugs for pain in favor of narcotics. The Florida Legislature responded by passing draconian legislation that separated opioid pain prescribing into acute prescriptions which all physicians may prescribe and chronic prescribing. For chronic prescribing health care providers must take a course and check a special box on their licensing reapplication form every two years. Pharmacies are coming under scrutiny for providing refills of short acting narcotics for pain when they have been refilled well past the 8 week suggested limit on these medications, even if the prescription is appropriately written by a legitimate physician. The pressure on the pharmacies by the state and law enforcement has led to a policy of not stocking narcotics or filling narcotic prescriptions at many Florida pharmacies. Sick patients with well documented sources of pain and legal prescriptions search endlessly for a pharmacy to fill their pain medications.

The Florida pain law encouraged the growth of pain specialist doctors especially anesthesiologists, rheumatologists and psychiatrists. I treat an elderly population of chronically ill patients many with severe long term chronic back, hip and joint problems. They arrive at my practice with a history of long term use of nonsteroidal anti-inflammatory medications for pain relief and many are using opioid narcotics for years. When referred to many of the pain specialists they are integrated into a conveyor belt type operation using injections of medications into joints, physical therapy with very little attention paid to the patient’s medical history. Most of the pain doctors prefer using injection techniques rather than working with oral or injectable medications, physical therapy, counseling or any of the alternative therapies.. The patients receive their series usually of three shots into an area of the body and then are expected to be able to tolerate their pain. The problem is that during the series of injections and after the series of injections, if the pain relief has been incomplete or inadequate, there is little time set aside to discuss what to do when it really still hurts. The result is that the patients call a doctor who actually answers the phones and returns calls promptly even if that physician does not have a degree in pain management or a large volume practice injecting joints for pain relief. That doctor is left with the option of prescribing the very oral medications we are being advised not to use, or chasing down the pain doctor to discuss exactly how they wish to address the problem? Usually the pain doctors are very willing to take ownership of the situation and they make suggestions of oral medications for that particular instance. The problem then usually recurs before the next round of injections or shortly after. There are very few pain practices actually talking to patients, examining them and working with oral medications or transdermal medications to relieve pain. They just do not have the time to discuss the situation especially with the procedures being so much more profitable. It is much like the situation in psychiatry where so many of the practitioners see patients briefly to adjust or regulate medications but spend little time engaging in counseling or psychotherapy any more.

There are however, several local pain doctors, who have answered my calls for assistance regarding patients having multiple cognitive and behavioral problems due to chronic use of opioid medications for legitimate pain. They have spent time analyzing the situation and helped the patients successfully withdraw from ineffective treatment regimens and resume a productive life. These clinicians are few and overwhelmed with chronic pain patients. The solution to the problem is an updating or retraining of our health care provider population so that more practitioners are comfortable treating chronic pain. At the same time our elected officials and law enforcement need to establish a system which prevents prescribers of pain medications from profiting from the dispensing or distribution of these products. Until that occurs I will continue to get phone calls from patients saying, “I had my third shot three days ago and I am still in excruciating pain. I cannot reach my pain doctor but their PA says I cannot get another shot for another three months. What should I do about the terrible pain?”

Aspirin Use for Targeted Breast Cancer

The indication to take aspirin to prevent various diseases has certainly been confusing over the last few years. A Veterans Administration (VA) study in the 1950’s noted that men over 45 years of age who took an aspirin per day had fewer heart attacks and strokes. The exact dosage of aspirin to take to prevent heart attacks and strokes has been the subject of many studies and much disagreement. In more recent times researchers have questioned whether aspirin should only be taken by those individuals who already have survived a heart attack or stroke for secondary prevention.

Taking aspirin is not risk free with users having a higher risk of gastrointestinal bleeding and cerebral hemorrhage especially if head trauma was involved. Recent studies have made it even more confusing with some experts not wanting patients to take aspirin for primary prevention of a first heart attack or stroke unless their 10 year risk of an event was 6% or greater. Others thought 6% was too high a figure and suggested 3%. The guidelines and suggestions for aspirin use to prevent cardiovascular disease have certainly become more confusing and have made the decision to use it far more complicated.

As a result of the use of aspirin in prevention of vascular and heart disease, researchers noted that people who took aspirin had fewer pre-cancerous adenomatous colon polyps and less skin cancer. In a 2010 study in the Journal of Clinical Oncology, Drs. Michelle Holmes and Wendy Chen of the Harvard Medical School noticed that women with breast cancer who took one aspirin per week had a 50% lower chance of dying from breast cancer. This observational study required a more detailed sophisticated double blind study to prove the point but the authors did not receive the necessary funding to begin the research study. This left the relationship between aspirin use and breast cancer development very unclear.

In the December 22, 2015 edition of the Mayo Clinic Proceedings, Bardia A, Keenan TE, and Ebbert JO and associates published data hinting that aspirin use was associated with a lower incidence of breast cancer for women with a history of breast cancer and those with a personal history of benign breast disease. This study of 26,580 postmenopausal women followed the study participants for three years. In the online journal Internal Medicine News, Neil Skolnik, MD talked about the exciting possibility of decreasing breast cancer in this specific group of women by 30 – 40% by taking a daily aspirin.

There is no question that aspirin therapy increases the risk of bleeding especially in the GI tract and the brain. Trauma and cuts will lead to increased bleeding and blood loss. Individuals will need to discuss with their physician the pros and cons of preventive aspirin therapy for heart disease prevention, skin cancer prevention, colon cancer prevention and now breast cancer prevention based on their personal and family medical history and balance it with the risk of bleeding.

High Disability and Death Rates in Bleeds Associated with New Oral Anticoagulants

In the trailer for the movie Jaws 2 they show a swimmer in the ocean with a deep voice saying, “Just when you thought it was safe to go back into the water…” followed by the classic music associated with a shark attack and a big fin approaching the unsuspecting swimmer. I feel much the same way upon reading a Medpage Today online journal review of an article in JAMA Neurology published on December 14, 2015. Jan C. Purrucker, MD and colleagues looked at 61 consecutive patients with non-trauma related cerebral hemorrhages due to the newer oral anticoagulants Pradaxa, Xarelto and Eliquis. Overall there was a death rate of 28% at three months and “two out of 3 survivors had an unfavorable outcome.”

In October of 2015 the FDA approved the use of the antibody fragment idarucizumab (Praxbind) to reverse anticoagulation in patients bleeding from the administration of the oral anticoagulant Pradaxa. There are currently no medications to reverse the bleeding from the drugs Xarelto or Eliquis but we are promised that new products are in development. The article goes on to discuss how physicians have been forced to improvise when patients on these medications show up bleeding. They have tried fresh frozen plasma, 3-factor, 4-factor and activated prothrombin complex concentrates prothrombin complex concentrates, recombinant factor VIIa and cryoprecipitate alone or in combination with marginal success at best.

Despite there being no antidote to these blood thinners, the massive direct to consumer advertising continues on television prime time and magazines as if the products are no more dangerous than an antacid for heartburn. Coumadin or warfarin is the prototype anticoagulant working by inhibiting vitamin K dependent clotting factors. Its effects are reversible with administration of Vitamin K and clotting factors if bleeding occurs. Coumadin requires periodic blood tests (INR) to check on its efficacy and there is a long list of medications and foods that need to be avoided or adjusted while taking it. It is less convenient but safer in the sense that its effects can be reversed with medication.

The newer oral anticoagulants were championed by several studies that suggested that they were more effective in preventing embolic strokes in patients with the heart rhythm atrial fibrillation. Many experts in the field felt that those conclusions were flawed because the Coumadin group was not tightly regulated to keep their INR in a therapeutic non-clotting range thus unfairly biasing the results in favor of the newer agents.

There is no question that the newer agents are more convenient than warfarin treatment, but until there are readily available antidotes, complications seem to be more difficult to limit and control.

Does Not Testing the PSA Lead to More Advanced Prostate Cancer?

Mortality from prostate cancer has diminished by almost 40% since the introduction of the PSA test in the late 1980’s. Much of this is due to the use of the PSA blood test for screening purposes. In 2011 The US Preventive Screening Task Force strongly condemned the use of PSA screening. They felt that we were finding too many inconsequential early malignancies that would not lead to death and were being over treated. In their eyes, prostate cancer treatment with surgery and or radiation carried a high price tag with multiple long term complications and the benefit of screening was not worth the risk. Prior to the USPSTF”s 2011 recommendation against screening for prostate cancer with a PSA there were 9000 – 12,000 new cases of prostate cancer diagnosed per month. In the month following the USPSTF recommendation not to screen with PSA the number of new cases dropped by almost 1400 a month or over 12%. Over the next year the decline in prostate cancer diagnosis was 37.9 % for low-risk prostate cancer, 28.1% for intermediate risk, 23.1 5 for high risk and 1.1% for non-localized cancer. Clearly if you do not look for a disease you will not find it.

In the December issue of the Journal of Urology, Daniel Barocas, MD, of Vanderbilt University and colleagues discussed the PSA testing controversy. They too noted that the consequences of not screening for intermediate and high risk prostate cancer by performing the PSA test may lead to individuals presenting with far more advanced disease that is more difficult to treat, has more complications and ultimately leads to disease related deaths. His position was debated by two major urologists in the editorial section of the journal with no firm conclusion being reached.

In an unrelated article, the Center for Medicare Services or CMS announced that it is considering penalizing physicians who test the PSA for screening in Medicare patients beginning in 2018 as part of their paying for value and quality. They said that physicians need to present their patients with an ABN (advanced beneficiary notice) stating that Medicare will not pay for this test, before the blood is drawn or face fines and penalties.

Men in their forties and older have been put in an uncomfortable and inappropriate position by health policy leaders. The truth is we are currently unsure how and when to test for prostate cancer in men with a normal digital rectal exam (DRE). The consequences of not paying for screening will not be known or understood for easily ten to fifteen years. It is clear that early stage disease has the option to be observed for progression with minimal consequences in the short term. Not enough time has elapsed for anyone to know the long term effects of this policy change. Unfortunately, men in this age group are all guinea pigs in the public health policy laboratory while the data to reach a firm scientific conclusion is assembled. The predominant policy today is spending less and doing less. With this in mind, it is best for men to see their doctor, have an annual digital rectal exam, discuss their family history of prostate disease and reach an individual decision on PSA screening appropriate for their unique situation rather than one based on large population policy.