Dr. Barry Gustin - Medical-Legal Expert Services

Governing Cardiology organizations lately met and conferred and produce new guidelines for the evaluation and management of patients who present with cardiac ischemia and certain types of myocardial infarctions.  These guidelines constitute the current acceptable standard of practice, and should be generally followed by all medical practitioners.  In any medical-legal action, these standards with constitute the benchmark against which any alleged malpractice will be judged.  The full paper is listed below.

ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 Appropriate Use Criteria for Cardiac Computed Tomography

Cardiac Computed Tomography Writing Group; Technical Panel

Posted: 12/29/2010; J Am Coll Cardiol. 2010;56(22):1864-1894. © 2010 Elsevier Science, Inc.

A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, the Society of Cardiovascular Computed Tomography, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the North American Society for Cardiovascular Imaging, the Society for Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Magnetic Resonance

Paradigms of care are important for many reasons, the least of which, has to do with standardization, so that medical practitioners understand what constitutes the standard of practice, and know what the recommendations are for myriad medical presentations.  Who amongst us are at risk for sudden cardiac events, and what can be done about it, to identify these people and to prevent adverse health outcomes?  The American Heart Association along with the American College of Cardiology Foundation have determined new guidelines.  These guidelines are listed below and will constitute new cardiology paradigms for making healthcare needs assessments.

2010 ACCF/AHA Guideline for Assessment of Cardiovascular Risk in Asymptomatic Adults: Executive Summary

A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

In the wake of a growing number of overdose visits to emergency departments, the US Drug Enforcement Administration (DEA) has moved to make psychoactive "bath salts" (PABS) a controlled substance.

In a statement released today, the DEA announced it is using its emergency scheduling authority to temporarily control methylenedioxypyrovalerone and 2 other synthetic stimulants: mephedrone and methylone.

As of September 7, 2011, possessing and selling these chemicals or the products that contain them are both illegal in the United States for at least 1 year while the DEA and the US Department of Health and Human Services mull over whether the substances should be permanently controlled.

To get the full story from Medscape:  Click here

At least 13 people have died, and many more have become critical ill after eating cantaloupe contaminated with Listeria, in the deadliest outbreak of food-borne illness in the United States in more than a decade.  The outbreak has been reported in 18 states so far.

Listeria is a common bacteria that can be found in soil, water, decaying plant matter and manure.  A particular strain, called Listeria monocytogenes, is the culprit.  It has a very long incubation period, so it can take more than 2 months from exposure for a person to become ill.  This means that it is quite difficult to identify any particular food that would have carried the pathogen.

To read the full NY Times article about this:  Click Here

Remember years ago that Dow Corning controversy involving silicon breast implants and the connective tissue syndrome that some women developed?  Over the years much research was done which established the safety of these products.  A new study by the FDA has just been published which affirms the safely of breast implants.

Click Here to read the entire NY Times article.

Marketing drugs in the guise of supplements is illegal in the United States. Tainted Pai You Guo found where Chinese supplements are sold is just one small part of that global business. Federal authorities are struggling to identify and intercept these black-market goods, which, they warn, pose grave health risks.

The makers of legal dietary supplements — the kind found at GNC, for example — acknowledge they are reluctant to raise too many alarms. Even though there is little evidence that many dietary supplements provide real health benefits, legal supplements, from multivitamins to ginkgo biloba, are a big and growing business. Americans spent $28.1 billion on them last year, up from $21.3 billion five years ago, according to estimates from Nutrition Business Journal, a market research firm.

Many millions more are also being spent annually on black-market products, particularly those marketed for weight loss, bodybuilding and sexual enhancement. Some of these products, according to the F.D.A., contain amphetamines, synthetic steroids, laxatives and compounds like the active drug in Viagra. Officials say such products can cause heart attacks and strokes, and can damage the kidneys and liver. A few people in the United States, they say, have died after taking them.

To read this entire NY Times article, CLICK HERE

Yet another panel of scientists has found no evidence that a popular vaccine causes autism. But despite the scientists’ best efforts, their report is unlikely to have any impact on the frustrating debate about the safety of these crucial medicines.

“The M.M.R. vaccine doesn’t cause autism, and the evidence is overwhelming that it doesn’t,” Dr. Ellen Wright Clayton, the chairwoman of the panel, assembled by the Institute of Medicine, said in an interview. She was referring to a combination against measles, mumps and rubella that has long been a focus of concern from some parents’ groups.

To read the entire NY Times article, CLICK HERE

The Food and Drug Administration on Wednesday announced new safety restrictions on high-dose simvastatin, also known as Zocor, a cholesterol-lowering drug taken by an estimated 2.1 million Americans.

The agency said the 80-milligram dose caused a potentially severe muscle disease, called myopathy, especially in the first year of taking the medication.

No new patients should be put on the high dosage, the F.D.A. said, recommending that existing patients should continue only if they have used the drug for more than a year without experiencing muscle pains. Alternative statins may be safer, the agency said.

This surely will lead to a spate of product/medical liability lawsuits against the manufacturers of this drug.

The drug’s manufacturer, Merck, advised patients on Wednesday to talk to their doctors if they wanted to change their statin drug or dosage. The company said many patients would not be affected by the F.D.A. action because they were taking lower dosages or had not felt muscle pain.

The F.D.A. approved 80-milligram Zocor in 1998, seven years after it approved lower dosages of the drug. It was once Merck’s top-selling product. Since the patent expired in 2006, simvastatin has mostly been sold as a generic drug.

The new restriction also applies to Vytorin, a combination drug sold by Merck and Schering-Plough that has some formulations in the 80-milligram dose.

And the restriction applies to Simcor, a combination pill sold by Abbott Laboratories. Simcor has lower levels of simvastatin, but may cause higher levels in the body interacting with other drugs, like blood pressure medicines amlodipine and diltiazem.

Two other statins are more potent and can accomplish the same cholesterol targets at lower doses, he said, citing Pfizer’s Lipitor and AstraZeneca’sCrestor.

Some doctors have prescribed simvastatin because it is cheaper in generic form. Lipitor goes off patent in November.

Muscle aches have long been known as a possible side effect of statins. The F.D.A. issued a safety warning on high-dose simvastatin in March 2010. On Wednesday, it said a seven-year study and patient reports prove that patients taking the higher dosage have a higher risk of muscle injury than those taking a lower dose of the drug or taking other statins.

The high doses accounted for 11.7 percent of 94 million simvastatin prescriptions in the United States last year and 15.5 percent of 8.6 million Vytorin prescriptions, the industry research firm IMS Health said.