Dr. Harry Lever Speaks Out About Problems With Generic Drugs

This Medscape article highlights the extraordinary efforts of Dr. Harry Lever, Director of the Cleveland Clinic’s Hypertrophic Cardiomyopathy Center, in educating patients and physicians alike about quality issues with generic drugs.  Dr. Lever has been instrumental in publicizing the fact that generic drugs are NOT always the same as their name brand counterparts, and that foreign generics are not put through the same level of scrutiny as drugs in the U.S.

Journalist Katherine Eban who recently published a book entitled Bottle of Lies: The Inside Story of the Generic Drug Boom is quoted in the Medscape article and has this to say:

“Dr Lever has been tireless in raising the alarm publicly, and with the FDA, about those generics that he felt were actively harming his patients, and remarkably, in case after case, he has been correct in his clinical judgments, and often far ahead of the FDA in detecting problematic drugs. His patients, many of whom I interviewed for Bottle of Lies, are grateful to him, as we all should be.”

And, in June of 2014, Dr. Lever discussed quality control issues with generic Toprol and was interviewed for this article featured in the New York Times.  Dr. Lever was alerted to the issue when many of his patients complained of a return of symptoms after having switching from the brand drug Toprol to one of the many generic formulations of the drug.

So, after all of these experiences, what does Dr. Lever himself do when prescribing drugs for his patients?  As the Medscape article goes on to say:

Despite all his misgivings, Lever still prescribes generic drugs. Brand name drugs are simply too expensive, or patients’ insurers will cover only generics. However, he does try to specify that the generics come from American companies that manufacture in this country under the eye of the FDA.

HCMBeat would like to join with Dr. Lever’s patients and thank him for his tireless efforts on behalf of HCM patients.  It is greatly appreciated.

Cardiac MRI Helps Assess Sudden Death Risk

A recent study by doctors at the Cleveland Clinic suggests that the presence of late gadolinium enhancement  (LGE) should be added to the various risk factors currently used to assess patients who are at low or intermediate risk of sudden death.  The presence and balancing of these risk factors are used by patients and doctors to determine the need for implantable cardiac defibrillators (ICDs).   LGE is an indication of cardiac scar tissue and can be seen on cardiac MRI scans.  This study recommended that LGE comprising a total of 15% or more of left ventricular mass be used as an additional risk factor. The study found that this indicator worked equally well when applied to both obstructed and non-obstructive HCM patients.

Interestingly, an earlier but recent study published by Cleveland Clinic doctors found that the risk factors currently in use to determine the need for an ICD fall short as applied to patients with the obstructive form of HCM.

Risk factors in common use today have been propounded by the American College of CardiologyAmerican Heart Association (ACC/AHA) in the U.S., while a different set of guideline and a mathematical risk calculator was promulgated more recently in Europe by the European Society of Cardiology (ESC).  You can find more about the ACC/AHA and ESC guidelines here.

A second and related finding of this study by the Cleveland Clinic, known for its large HCM program and high volume of myectomies, was that patients who undego  myectomy appear to experience a protective effect from their surgeries.  Even when found to have 25% or more LGE, patients in this study who previously underwent myectomy experienced a lower than expected rate of adverse events.