Pneumococcal Vaccine in Development May Fight All Strains of the Disease

Community acquired pneumonia (CAP) plus other infections attributable to the Pneumococcus bacteria account for 15 million infections per year including pneumonia, meningitis and bronchitis. The organism is the leading cause of death in children less than five years old.  Over the last 30 years pharmaceutical companies have developed Pneumovax 23 which covers 23 unique bacteria that cause CAP in adults and Prevnair 13 which covers 13 pneumococcal bacterial strains.  Twelve of the bacteria in Prevnair 13 are identical to the Pneumovax 23 with only one unique bacterial type included.

A group at the State University of New York at Buffalo led by Blaine Pfeifer, specializing in chemical and bacterial engineering; has developed a new approach to pneumococcal vaccination. Working with computer modeling and animals to this point, they have developed a successful vaccine that attacks pathogenic pneumococcal bacteria while leaving the beneficial and non-pathogenic subtypes alone. The vaccine reads proteins on the surface of the bacterial cells and destroys only those that show aggressive activity. The vaccine has been 100% effective against the 12 most virulent pneumococcal bacterial strains existing in animal studies.    The vaccine is being prepared for human testing in the near future.  The preliminary work was discussed in the medical magazine Medical Economics

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.

Increased Dementia Risk in Senior Citizens Due to Proton Pump Inhibitors (PPIs)

Brittany Haenisch, PhD of the German Center for Neurodegenerative Diseases in Bonn, has reported in JAMA Neurology, a study from health insurance data suggesting that taking Proton Pump Inhibitors (PPIs) such as Aciphex (omeprazole), Protonix (pantoprazole), Nexium (esomeprazole), and Prevacid (lansoprazole), was associated with a markedly increased risk of developing dementia. The correlation was stronger in men than women with a slightly increased risk for those taking Nexium.

The study, conducted from 2004 through 2011, looked at 73,679 people age 75 years or older and who were free of dementia at “baseline”.  It revealed 29,510 patients (40%) developed dementia and, of these, almost 3,000 (average age of 84) were taking a PPI medication. The authors concluded that avoiding PPIs may prevent dementia.

All of these medicines are now freely sold over the counter not requiring a prescription. Their use has dramatically increased. There is belief from animal studies that PPIs cross the blood brain barrier and effect the production of amyloid and tau protein associated with dementia. In humans, B12 levels can be lowered effecting cognitive ability. None of this data shows a clear cause and effect relationship so we cannot say PPIs hasten the onset or cause dementia. Newer well designed controlled and blinded studies will be needed for this purpose.

In the interim, I will ask my patients to reduce or avoid these medications. We can treat heartburn and indigestion with products such as antacids, weight loss, eating smaller portions and staying upright after those meals, loosening your belt at the waist and avoiding those foods that reduce lower esophageal sphincter muscle pressure leading to reflux.

There will be some with conditions such as Barret’s Esophagus, which is precancerous, and recent bleeding ulcers which require the use of PPIs for eight or more weeks and then switch to Tums, Rolaids, Gaviscon or Carafate. Some patients will need the PPIs for symptom relief beyond eight weeks and they will need to make a tough decision between symptom relief and increased dementia risk while the researchers search for the answer.

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.

Arsenic Levels Elevated in U.S. Wines

Denise Wilson, PhD, a professor at the University of Washington evaluated 65 red wines from California, New York, Washington and Oregon and found they all contained the heavy metal poison arsenic at levels of 10 parts per billion or greater. Lead was found in 58% of the wines. This would coincide with two studies published in the Journal of Environmental Health studies that showed that many U. S. Wines and beverages contained more than the limit of 10 parts per billion.

Dr. Wilson went on to say that individuals who consumed 1-2 glasses of wine per day using the same winery for their beverage should be aware of the arsenic levels of the water that supplies that winery. She counseled individuals to be aware of their total diet and its potential heavy metal content and try to limit products known to be high in arsenic and heavy metals. Dr. Wilson pointed out that the cumulative effect of these metals is very difficult to implicate as the cause of an illness but it undoubtedly has an effect. Scientists are far better at implicating heavy metals as the cause of illness in acute toxic exposure rather than a cumulative dosage.

The online periodical “Deadstate” in its March 21, 2015 issue at http://deadstate.org published a complete list of “wine brands that have allegedly been poisoning you with arsenic.” This is a list of inexpensive California wines cited in a class action suit initiated by the law firm of Kabatec Brown Kellner. They stated, “These wineries have long known about the serious health risks their products pose to customers. Instead of reducing the exposure to acceptable levels, the defendants recklessly engage in a pattern and practice of selling arsenic tainted wine to California consumers.”

There has been little research and publication in peer review journals of the presence of or health effects of heavy metals in our food and beverages. The degree of oversight of these products has been limited due to funding and lobbying of the industries. It’s probably time for a bit closer look at these allegations especially where they pertain to women of child bearing age and children. Arsenic has been detected in apple and grape juices, milk, bottled water, infant formula and cereal bars. Consumers deserve a closer look at these issues and transparency in the findings.

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.

Physical Therapy as Effective as Surgery in Lumbar Spinal Stenosis

Anthony Delitto, PT, PhD and colleagues at the University of Pittsburgh published an article in the April 7, 2015 Annals of Internal Medicine documenting that at the two year mark, physical therapy was as effective as surgical decompression in spinal stenosis of the lumbar spine. The study involved 169 patients diagnosed with spinal stenosis with imaging confirmation by either CT scan or MRI. These patients all met the accepted criteria for surgical intervention, all had agreed to and signed consent for surgery and all had leg pain with walking (neurogenic claudication). None of the patients had previous back surgery.

After all had consented to surgery they were randomly assigned to a surgical group or a physical therapy group that had exercise sessions twice a week for six weeks. They were then followed for two years. The physical therapy exercises included general conditioning plus lumbar flexion exercises.

All the participants charted their course with a self- reported survey of physical function which consisted of scores from zero to 100 on topics such as pain, function and mental health. The patients were all reassessed at 10 weeks, 6 months, 12 months and 24 months.

There was no difference between the surgical group and the physical therapy groups in the category of physical function at any time during the follow-up. Despite this 47 of the 82 patients assigned to the physical therapy group crossed over and had surgery with nearly a third in the first ten weeks. Patients crossed over to surgery for both medical and financial reasons citing the high cost of copays for physical therapy. Jeffrey Katz, MD, director or the Orthopedic and Arthritis Center at the Brigham and Women’s Hospital in Boston felt that the paper “suggests that a strategy of starting with an active, standardized physical therapy regimen results in similar outcomes to immediate decompressive surgery over the first several years.”

This paper gives us excellent data on the belief that surgery of the back should be a last resort. Since the study only looks at two years, it is hoped that continued follow-up over time will allow us to see the real life situation we see in our patients who live with this condition for decades not months.