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By now many of you may have heard of the news about the drug trial in France that resulted in a death and several hospitalizations. The headlines blared that it was a drug trial gone amok.

Medical advances are happening at a rapid pace; very smart people are out there coming up with new treatments all the time, with some of them showing great promise. But great promise is not the same as great results. And because of that, we all need to proceed with caution, even outside of drug trials.

One such cautionary tale that occurred in the U.S. was the practice of performing a bone marrow transplant for breast cancer. In the late 1980s, there was promising data indicating that it worked. When insurance companies were unwilling to pay for it, patients sued. And states actually mandated coverage, passing laws to enforce it. But several controlled trials subsequently showed the treatment was not effective.

A current parallel is occurring in treatment of atrial fibrillation. In my upcoming webinar, I will discuss the Watchman device, but another device being used is called the Lariat. The heart has a small sac on its left side called an appendage; it is felt that if that sac is closed off, blood clots cannot form in it and fewer patients will have strokes. The Lariat is a device that is FDA-approved for use in abdominal surgery, but it also was shown to have promise for closing the left atrial appendage. So doctors started using it, somehow convincing their hospitals to order it despite being non-covered by insurance.

And what happened? In July the FDA issued an urgent safety bulletin reporting 45 serious adverse events and six deaths from use of the device. And to date there has not been a single controlled trial of the device to compare it to other treatments (or even to no treatment at all).

So what is the lesson here? Innovation is important, but we need to be cognizant of the safety and financial considerations of the care we provide. Perhaps the Lariat will turn out to have an important role in the treatment of select patients with atrial fibrillation, but we are not at the point where we can make that determination. 

FDA approval of a device does not mean that it is safe for everyone, or that it will be paid for by any payor, so proceed with caution.

About the Author

Ronald Hirsch, MD, FACP, CHCQM is vice president of the Regulations and Education Group at Accretive Physician Advisory Services at Accretive Health. Dr. Hirsch’s career in medicine includes many clinical leadership roles at healthcare organizations ranging from acute-care hospitals and home health agencies to long-term care facilities and group medical practices. In addition to serving as a medical director of case management and medical necessity reviewer throughout his career, Dr. Hirsch has delivered numerous peer lectures on case management best practices and is a published author on the topic. He is a member of the Advisory Board of the American College of Physician Advisors, a member of the American Case Management Association, and a Fellow of the American College of Physicians.

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