Abnormal Cholesterol

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.

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.  

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.

Could a PCSK9 inhibitor treat YOUR cholesterol soon?

 

Climbing the mountain toward EU

and US approval is a new cholesterol treatment called evolocumab (no name yet other than AMG-145). Have you heard of the PCSK9 inhibitor family? Probably not, but it’s worth a closer look and the Amgen molecule may be the first out of the box.

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.