New Approaches to Early Prostate Cancer

Men today diagnosed with early prostate cancer, Gleason Stage 7 or less, have the option of a new arm of care called watchful waiting. With periodic PSA blood tests, prostate biopsies and imaging studies; urologists and oncologists can follow the patient with disease felt to be not aggressive rather than radiate the lesion or surgically remove it as was done in the past. In some cases, they can watch it even closer with an approach called Active Surveillance. This week a new research treatment was made public.

MedPage Today published work by Steve Raman, M.D., of the UCLA Medical Center on his TULSA-PRO ablation clinical trial. One hundred-fifteen men with localized and low, or intermediate, risk prostate cancer underwent ultrasound blasting of the cancer using the MRI imaging equipment to direct the therapy. In his study, prostate volume decreased from 39 cubic centimeters before treatment down to 3.8 cubic centimeters after a year. Clinically significant cancer was eliminated in 80% of the study participants and 65% had no evidence of cancer after biopsy at one year. PSA blood levels decreased by 95%. The side effects were minimal with low rates of incontinence and impotence and few bowel complications.

The study leader noted that if prostate cancer reoccurred then the modalities of repeat ultrasound treatment, surgery or radiation were still possible. In August 2019, the FDA approved the TULSA-PRO Device for use. The procedure involves placing a rod-shaped device into the urethra. The device has ten ultrasound probes which are controlled by a computer program while the patient is observed in an MRI machine. The probes shoot out sound waves that heat and destroy the tissue the sound is directed at. The procedure is an outpatient procedure which can also be used to shrink a non-cancerous enlarged prostate from benign prostatic hypertrophy.

Free Choice of Physicians & Fee for Service Medicine Ending?

The Medicare Payment Advisory Commission is a panel of financial, economic and health policy advisors created by Congress to advise CMS (Center for Medicare Services) and Congress how to pay physicians, health care providers and facilities for services rendered. According to an online article on MedPage they are close to eliminating fee for service payments for health care. CMS has encouraged alternative delivery methods for years. For the most part this has resulted in hospital and health care systems buying up and employing doctors, mid-level providers being substituted for more highly trained doctors and these alternative systems covering care only with their panel of providers and diagnostic and treatment centers.

However, publicized figures have shown these Medicare alternative products actually cost more per patient per year than traditional Medicare. This particular article claimed a 1-2% savings.

We all see the ads for Medicare Advantage plans which, in addition to no co-pay and no deductible, provide for dental care, vision care, eye care and exercise and gym memberships. Apparently 50% of the Medicare population is now enrolled in such a program.

As a 69 year old individual paying into the Medicare system for the last 55 years I see the benefits and cost savings for seniors when they are healthy. What happens however, when you become ill? Clearly the Centers of Excellence for many of the ailments seniors contract are geographically and contractually outside the narrow networks and panels these private insurance companies run and the Accountable Care Organization run plans provide.

If I do not have coverage for the Mayo Clinic or MD Anderson Cancer Center or the Cleveland Clinic or Dana Farber Cancer Center or Johns Hopkins Medical Center then have I wasted 55 years of payments? Do I really want a nurse practitioner in south Florida directing my care off a protocol list of contracted providers or do I want a clinician who sees a dozen cases of this disease per week calling the shots?

I prefer the latter but may not have a choice but to pay out of pocket if MEDPACs recommendations are accepted by CMS and Congress and become law.

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.

A Blood Test for Irritable Bowel Syndrome?

Researchers presented a paper at the annual Digestive Disease Week meeting which introduced a commercial blood test which can help distinguish irritable bowel syndrome (IBS) from Cohn’s Disease or Ulcerative Colitis (Inflammatory Bowel Diseases) and Celiac Disease ( Gluten Sensitive Enteropathy). The test was especially effective in identifying the diarrhea predominant form of Irritable bowel syndrome. The issue was discussed today on line in the periodical MedPage Today.

Patients with Irritable Bowel Syndrome get sudden abdominal bloating, cramping and progressively watery loose bowel movements. The symptoms often occur after a meal and leave the patient frightened and exhausted. Symptoms can be prolonged and emotionally and physically incapacitate an individual. Until now physicians were forced to schedule barium enemas, small bowel x ray series and fiber optic examinations (sigmoidoscopies, colonoscopies, upper endoscopies) to distinguish irritable bowel syndrome from the more ominous inflammatory bowel diseases. Very often we needed to collect stool specimens to look for white blood cells, red blood cells, bacteria, parasites and chemical constituents. The cost, radiation exposure and risks of invasive procedures causing complications made the experience expensive and unpleasant but necessary.

The current blood tests, used in a trial of 2700 patients, detect antibodies to cytolethal distending toxin B and vinculin. Mark Pimental, MD of Cedars-Sinai Medic al Center in Los Angeles said to the tests were successful in distinguishing IBS from the other entities with specificity well above 90% and a positive predictive value of 98.6% allowing clinicians to rule out Crohn’s Disease or Ulcerative Colitis.

This is a step in the right direction but it remains to be seen when the test will be available locally through commercial labs and if it really will allow us to eliminate the many tests we now do to distinguish these problems from one another.

Real Food for Colonoscopy Preparation

Colonoscopies save lives. It is recommended that adults start having them at age 50 to detect pre malignant colon abnormalities and early colon cancer. For the physician performing the test, the colon must be clean of digested food and stool to observe the lining cells of the colon. The presence of fecal material blocks the view of the colonic mucosa. Those of us who have taken screening colonoscopies are well aware that the preparation for the test is far worse than the actual procedure (which you are usually sedated for in some manner.) Most colonoscopy preps involve starting a laxative the afternoon before the procedure and staying on clear liquids the whole day until the procedure is complete. Some preps ask you to drink large volumes of soapy flavored liquids. Others use smaller quantities of chemicals but the end result is frequent loose and watery stools until the stool looks the same on the way out as it does on the way in. At best the preparation is a necessary but unpleasant experience.

Corey Siegel, MD MS and Dough Knuth, RD along with Joshua Korzenik, MD, of Harvard Medical School have produced real food laced with PEG-3350 as a colonoscopy prep. They are so confident of this preps efficacy that they formed a company to produce it called Colonary Concepts Inc. Foods such as pasta, pretzels with dipping sauce, smoothies and nonalcoholic Pina coladas have been mixed with laxatives to produce a colonoscopy prep. They reported on their study results at Digestive Disease Week and in MedPage Today. According to the endocscopists who performed the studies on these patients, the colon was good to excellent in preparation for viewing. The patients had no problems with the prep and said they would gladly choose the real food prep again for future colonoscopies. Based on the favorable review of this prep a larger Phase II study is now in progress. This is a step forward for a necessary but uncomfortable screening procedure.

Bleeding Rates Up After Invasive Procedures With Bridge Therapy

“Dr. Reznick I need to have a tooth extracted my dentist wants me to stop my Coumadin. What do you think?”

Not a day goes by without a similar question being asked in the practice. It could be a question about stopping warfarin prior to numerous surgical interventions that need your blood to clot to provide hemostasis during and after the procedure. Many of my patients take anticoagulants because their basic heart rhythm is atrial fibrillation and they are trying to avoid the embolic strokes that can occur 2-3 times more frequently in patients with this heart rhythm. Other patients are recovering from phlebitis or a deep vein thrombosis or an embolic episode like a pulmonary embolism and are in the first six months of treatment with an anticoagulant. Many of these patients are placed on heparin infusions or injections daily to continue the anticoagulation prior to the procedure. The advantage of the heparin is that once it is stopped, you are no longer anticoagulated within minutes to hours and you can undergo surgery with a normal risk or so we thought. After the surgery , your oral anticoagulant is usually restarted after the surgical wound has stopped bleeding and in some cases you are placed back on heparin bridging or interim therapy until the oral anticoagulant is effective sometimes requiring two or three days of the interim therapy. . This practice of using a short acting anticoagulant is known as “bridging.”

In the May 26 addition of JAMA Internal Medicine online, MedPage is reporting that the risk of bleeding from bridging was much higher (2.7%) compared to a non-bridged group (0.2%) in a study of 1812 procedures in which 555 used bridging. Clinically relevant bleeding did not differ in those receiving a therapeutic dose of bridging anticoagulant as opposed to a prophylactic dosage. Over half the bleeding events were complications of the procedure, with one third related directly to the bridging agent injection. The prophylactic dose of a bridging agent is usually lower than the therapeutic dosage.

When the study looked at the patients who did not receive bridging they found that the number of recurrent venous thromboembolism cases was no different in the bridge and non-bridge groups. In this study group the risk of bleeding associated with bridging appeared to outweigh the benefits.

In commentary on the study various experts talked about the lack of necessity of using a bridging agent in a low risk patient. They defined a high risk patient as one with a chemical hypercoaguable condition, patients with recurrent thromboembolic events, a thrombotic event in the previous 4-6 weeks or a recent catastrophic thrombosis (massive pulmonary embolism). They all agreed that they probably would not bridge anyone but high risk patients. They feel most other victims of thromboembolic disease are low risk and may not need bridging.

The study had several short comings including not identifying the “bridging medications.” Did they use unfractionated heparin or enoxaparin or fodaparinux? Researchers additionally need to look at individual procedures and bridging to see if one particular type of surgery or another is more or less prone to post procedure bleeding when bridging is used. In our practice we will continue to consult with the patient’s surgeon or dentist, cardiologist, pulmonologist or hematologist to individualize the decision. With the data suggesting an increased risk of bleeding with bridging in certain groups of patients our decision making has certainly been influenced by new data.

Breath Test For Gastric Cancer

CancerHossam Haick, PhD, of the department of Chemical Engineering and Russell Berrie Nanotechnology Institute, Technion- Israel Institute of Technology in Haifa, Israel announced that they have developed a breath test for the detection of stomach cancer and precancerous lesions. The announcement was noted in Medpage Today, an online journal, and published in the Journal “Gut.” “Volatile organic compound marker detection based nonarray technology allows gastric cancer to be detected with high accuracy in a Caucasian population. The technology allows high-risk precancerous lesions to be detected via exhaled breath “even with the confounding factors of patient smoking, Heliobacter Pylori infection and alcohol use. It is extremely difficult to diagnose gastric cancer before an individual is symptomatic. Except for Japan and South Korea, almost no health care systems screen for the presence of gastric cancer in their population. These countries traditionally have very high rates of gastric cancer so they screen for it routinely in adults using upper endoscopy and imaging techniques.

“The future of cancer prevention relies on timely recognition and surveillance of precancerous lesions as well as early detection of the cancer, making higher survival rates and lower healthcare costs per patient achievable,” says Dr. Haick. “Detection of precancerous lesions would allow surveillance to be performed, making early detection of the transformation to cancer possible.” The publication in “Gut” looked at precancerous lesions but the goal is to additionally use this technique to follow a diseases progress and detect potential relapses.

At the current time this test is experimental, but large scale human testing is now underway in Europe. Hopefully a commercially available product will be released in the next few years.