Diabetes

New Essential Guide to Prescription Drugs, Upddate on Alcohol delves into alcohol poisoning and avoiding it

    two women drinking Roughly 130 million people in the US drink alcoholic beverages and many of us take alcohol for granted. Recent data compiled from the CDC reveal that roughly 6 people die a day from aclohol poisoning.

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    two women drinking Roughly 130 million people in the US drink alcoholic beverages and many of us take alcohol for granted. Recent data compiled from the CDC reveal that roughly 6 people die a day from aclohol poisoning. This sad and largely preventable death toll is related to the blood level of alcohol and also to potential drug interactions.

Surprisingly, alcohol is actually used for antifreeze poisoning, but is far more commonly used as an antianxiety/relaxation agent. So many of us know that after work cocktail or two and the effects of a drink and how it works--or do we? James Rybacki, the author of a new book on alcohol, entitles, The Essential Guide to Prescription Drugs, Update on alcohol (available from Amazon exclusively at present) was shocked to learn of the large daily number of deaths from such a common beverage. More importantly, when the new became available, he decided to update his prior publication (previously only available as a PDF) and launched a large awareness campaign to help people and thier children become more aware of risky drinking, binge drinking and important facts to help keep people safe.

While the eBook, The Essential Guide to Prescription Drugs, Update on Alcohol is currently only available from Amazon for Kindle, it will soom be available in the iBookstore and other outlets. Rybacki is quotes as saying, "the best colleague any clinician can have is a more fully informed patient and family." Very true words when it comes to alcohol.Find the book at Amazon and listed in Dr. Rybacki's vast publication list as the latest one at https://www.amazon.com/author/jamesrybacki.

Superbugs, CRE and new potent antibiotics

dr rybacki in white coat  I’m reminded of a quote from Jurassic Park where one of the actors says, “Life finds a way.” Bacteria adapt to what we try to treat them with. It’s not if, but when resistance will develop.

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dr rybacki in white coat  I’m reminded of a quote from Jurassic Park where one of the actors says, “Life finds a way.” Bacteria adapt to what we try to treat them with. It’s not if, but when resistance will develop.

The so called “superbugs” carbapenem resistant Enterobacteriaceae or CRE kills about half of the people they infect. What this means is that some bacteria have gone to college and have learned to ignore treatment with a very potent family of antibiotics called carbapenems. This family of antibiotics work by blocking the ability of bacteria to make cell walls, something vital to their living and causing infections. Some examples include meropenem and imipenem plus cilastin. Usually, antibiotics such as these are reserved for the most serious infections and are used in combination with other antibiotics in the sickest patients. I'll include content as this problem develops in The Essential Guide to Prescription Drugs.

Surprisingly, the Enterobacteriaceae are a “normal” part of the population of bacteria that live in our intestines (gut) and they tend to have strong ability to become resistant to potent antibiotics. The usual suspects in this family of bacteria include Escherichia coli (commonly known as E. Coli) and Klebsiella pneumoniae. Klebsiella pneumonia is also known as K pneumo and K pneumo carbapenemase when it has the enzyme (the ase) to metabolize carbapenem antibiotics. Additional ways these bacteria defeat potent antibiotics involve New Delhi Metallo-beta-lactamases which also work to break down the chemical structure of the antibiotic itself. Life finds a way.

Many hospitals have developed antibiotic stewardship programs to thwart development of resistance. These programs team nurses, pharmacists, physicians, microbiologists and others to help identify trends, practice strong sterilization techniques and isolation steps.

The latest emergence of the superbug problem was at a North Carolina hospital (Carolinas Healthcare system in Charlotte). 15 people had CRE when they came to the hospital, 3 had a hospital acquired infection (HAI) and one patient died. Details are unclear on how the NC patients got the superbug.The latest emergence of the superbug problem at UCLA actually relates to a device for examining the duodenum (duodenoscope) for cancer. Apparently the kind of scope used has a design flaw that makes it impossible to clean. There have been allegations that the FDA knew about this design flaw, and didn’t act. I have not seen this data and cannot comment.

In order to help contain the superbug problem, the CDC has a great toolkit from 2012 to help hospitals try to prevent these Hospital acquired infections, commonly abbreviated HAI. You can see it and read more about CRE at: www.cdc.gov/HAI/organisms/cre/

Experimental medicine for lowering cholesterol shows great promise (ETC-1002)

cannon A new potential weapon fighting cholesterol-ETC-1002 (8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid) is an experimental medicine you should know.

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cannon A new potential weapon fighting cholesterol-ETC-1002 (8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid) is an experimental medicine you should know.

What a complicated name, but not so unusual for medicines still being researched. If you go to www.clinicaltrals.gov, you can search NCT01941836 and see the research involving this fascinating potential medicine. The last publication on this novel cholesterol treatment was by Gutierrez, Rosenberg, MacDougall, et al. The title of the article was Efficacy and Safety of ETC-1002, a Novel Investigational Low-Density Lipoprotein-Cholesterol-Lowering Therapy for the Treatment of Patients With Hypercholesterolemia and Type 2 Diabetes mellitus.

This is especially interesting because people with diabetes have a 2 to 4 fold increased risk of cardiovascular disease. The study conclusions show that LDL and other fats were lowered, CRP (C-reactive protein) improved and blood sugar control (an issue with statins like Lipitor and Crestor) was NOT worsened. In English: Good changes in bad cholesterol without causing sugar problems.

Could it get better? As with many experimental medicines, phase 3 studies (the last phase before sending in the information/data to the FDA) are needed. For now, this looks like the medicine I want to take. It appears that I might lower the dose of my statin (avoiding possible statin side effects), add on ETC-1002 and get the benefit of even lower cholesterol and heart attack risk while keeping my ability to control blood sugar. As always, more to come and we will have the data here when it becomes available.

FDA announces easier road and forms for experimental (investigational) medicines

 

The FDA IS listening

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The FDA IS listening

last resort Dr. Peter Lurie from the FDA announced a large step to help people looking to investigational medicines to treat serious diseases and conditions. The FDA listened well to the vulnerable patients and to physicians trying to navigate what was a complicated course to treatment.

The new draft document is called the Individual Patient expanded Access Applications: Form FDA 3926. This is complicated in the name alone. When the process is finalized, the form will immensely simplify and accelerate the process that your doctor will have to use to get an experimental (in FDA lingo-investigational) drug or biological treatment while it is still being tested to establish safety and efficacy. As usual, I will detail the true breakthroughs in medicines and those with particular interest in The Essential Guide to Prescription Drugs.

The form is still detailed, but FDA estimates hold that a doctor will need 45 minutes versus 100 HOURS to fill in the information. Nice move from the FDA at a time when physicians and patient just want a better way to attack disease. blogs.fda.gov/fdavoice/index.php/2015/02/a-big-step-to-help-the-patients-most-in-need/

Is the FDA keeping medical devices safe?

 

Is the FDA keeping medical devices safe?

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Is the FDA keeping medical devices safe?

A new program appears to be aimed at further accomplishing exactly that. The name is MDSAP (Medical Device Single Audit Program) It could be a milestone in that people who make medical equipment and  want to sell their products in Australia, Brazil, Canada, the US and Japan. The concept seeks to have a single audit or inspection to ensure that the medical device regulatory requirements are met.

Reviews (audits) will be conducted by third party vendors and medical device regulators in the countries will be able to use these inspection reports to make their regulatory decisions. It looks like the program would standardize the information the regulators get and will reduce the need to perform routine inspections. The people who make the medical equipment may benefit by cutting down on the number of regulatory audits they have to host, letting them keep their plants active making the products they want to sell.

Time will tell if this new MDSAP will be a win win for everyone, but it appears to be just the ticket for a more standard review and fewer inspections, yet better products.  

Can weight loss help atrial fibrillation (Afib) ? Mandrola and Krumholtz say yes and support Abed et al.

lean food on plate  Can weight loss help atrial fibrillation (Afib) ?

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lean food on plate  Can weight loss help atrial fibrillation (Afib) ?

A fascinating study in JAMA was the center of a Commentary by Mandrola and Krumholtz January 22, 2015. The original study in the Journal of the American Medical Association (JAMA 2013;19:2050-60) was the Effect of weight reduction and cardiometabolic risk factor management on symptom burden and severity in patients with atrial fibrillation: a randomized clinical trial. This study asked if weight reduction and aggressive treatment of heart and metabolic risk (cardiometabolic) factors could lower the burden and severity of symptoms in atrial fibrillation. The answer is yes.

Losing weight and intensive risk factor management decreased in symptoms of atrial fibrillation AND burden of AFib as well as beneficial cardiac remodeling. The reviewers called the study disruptive in the sense that it changes the established thinking about atrial fibrillation treatment. Mandrola and Krumholtz point out that most AFib patients get care late in the disease and care is directed at preventing symptoms and controlling complications. They astutely note that existing strategies do not address root causes of atrial fibrillation-LIFESTYLE factors and the resultant structural changes in the heart.

I heartily concur with their conclusion that weight reduction and aggressive targeting of cardiometabolic risk factors should be a new standard of care in the treatment of patients with atrial fibrillation.  This again points to exercise as a medicine for the family and lowering of heart risk wherever possible! I’ll be mentioning this in my authors note for the 25th edition of The Essential Guide to Prescription Drugs. Perhaps building weight/overweight and risk into every physician and pharmacist office visit is a paradigm we can all live longer with!

New flu test may help your doctor decide if it's the flu in 15 mnutes

 

older woman Flu season this year has seen a lot of controversy erupt over what the flu vaccine covers, if it actually causes the flu and many wonder if it still helps your immune system even if it doesn't prevent the flu.

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older woman Flu season this year has seen a lot of controversy erupt over what the flu vaccine covers, if it actually causes the flu and many wonder if it still helps your immune system even if it doesn't prevent the flu.

Yes, it covers about 23% (effectiveness) of the flu (viruses that are around). No, it doesn’t cause the flu. Yes, you can still get the shot or the spray and it will challenge your immune system (boost immunity) and it will lessen the severity of the flu symptoms if you get the flu. Benefits in immunity may work in strange ways in some years and the “guess” (based on science) of the 3 or 4 viruses that will cause the flu in a given flu season isn’t always correct. Bottom line is that getting a spray or shot with even the wrong virus still boosts your immune system and offers some coverage.

As in past years, if you or a family member do get the flu, it is important to go to the doctor quickly if you plan to try to get Tamiflu. Oseltamivir (Tamiflu) is best started immediately on flu symptoms. The longer you delay, the less the benefit will be and it must be started within 48 hours. There are great symptom checkers on the CDC web site to help you tell the difference between some breathing (respiratory) infections and the flu (visit them at www.CDC.gov). Your doctor may face the treat or not to treat dilemma. This is important if you have diabetes or a heart condition or cancer as the flu can be devastating. The interesting new development is an easier/more prevalent potential use of a lab test to diagnose the flu.

Enter Alere i. Yes, Alere i. The company received a CLIA waver (Clinical Laboratory Improvement Ammendments) for their test. What this means is that the test and technology is simple enough to be used by personnel in a doctor’s office or free-standing Emergency Department. Their test is very fast (about 15 minutes) and uses the latest desirable technology (nucleic acid based) approach. This is the first CLIA waiver for such a flu (influenza A or B) test and means that you and your family could have the convenience of an accurate quick test in a non-traditional laboratory site. This will also help your doctor make treatment decisions sooner and help you get a handle on the flu or appropriate treatment if it isn’t the flu.   

Technology plus medicines, improved population health and targeted treatments for 2015. I will make mention of this test in the upcoming Essential Guide to Prescription Drugs!

 

Radon and cancer impact in your home?

 

black haired woman Could the dangers of radon be lurking in your home? There is a great article on this which does not relate to presctiption medicines, but is a real population health risk.

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black haired woman Could the dangers of radon be lurking in your home? There is a great article on this which does not relate to presctiption medicines, but is a real population health risk.

I was surprised at Radon and lack of testing and impact on population health. Time for me to get a radon test kit http://go.usa.gov/MKTW

MADD Report to the nation on drunk driving

two women drinking The MADD Report to the nation on Drunk Driving is out. This sobering report shows that progress has been made, yet we still have 6 people a day die from alcohol poisoning. This is why I put alcohol (ethanol) into the Essential Guide to Prescription Drugs, 12 top meds for 2012.

This website is not intended as medical advice, and you should consult your doctor before changing or adding any medicines or vitamins to those you may now be taking and about applying any strategies BEFORE you adopt any approach in this report. While diligent care has been taken to ensure the accuracy of the information provided during the preparation of this edition, no claim is made that all known actions, uses or side effects, strategies for cost containment, targets or cholesterol pathways are included in this report. The accuracy and currentness of information are ever subject to change relative to new guidelines, new information derived from drug research, development and general usage.