SMOKINCHOICES (and other musings)

September 26, 2013

Off-label use – heart patients

Latest study

Therapy, if misused, can harm hearts

By Misti Crane THE COLUMBUS DISPATCH

Doctors who use a therapy unapproved for certain heart-failure patients are doing more harm than good, according to a new study.

Dr. William Abraham, director of cardiovascular medicine at Ohio State University’s Wexner Medical Center, and colleagues from the United States, Australia and Europe looked into cardiac resynchronization therapy because of concerns that some of their peers were applying the treatment in patients without evidence that it helps them.

  • The therapy, which uses a pacemaker, has been shown to help heart-failure patients with an abnormality called “wide QRS complex,” a delay in the electrical message that tells the heart’s chambers to squeeze in unison.

Pacemaker wires placed in the lower chambers of the heart have been shown to coordinate pumping and improve health. The Food and Drug Administration has approved the treatment for those patients.

  • But some doctors are using the therapy in patients who have normal electrical messages but uncoordinated pumping, Abraham said. That disorder is called “narrow QRS complex.”

Abraham and his colleagues were hopeful that they would discover good news, but they halted the study in March after realizing that deaths and hospitalizations were far higher in the 404 narrow QRS patients who had resynchronization therapy compared with the 405 who did not.

  • Forty-five people died and 224 were hospitalized after receiving the treatment, compared with 26 who died and 194 who were hospitalized without it. Results were published online this month in the New England Journal of Medicine.
  • It’s unclear how many patients were erroneously treated, Abraham said, but the number could be “easily in the tens of thousands” in the United States.

Those with concerns should talk to their doctors, he said, adding that the resynchronization therapy should be turned off. Many devices are coupled with defibrillators that do benefit the patients, Abraham said.

  • The bigger message, he said, is that therapies shouldn’t be used in patients for whom they weren’t tested.
  • “I really think, quite frankly, that off-label use should in general occur only in the setting of clinical studies  rather than in clinical practice,” he said.

Other central Ohio doctors said it is unlikely that many patients in Columbus are in jeopardy.

  • Dr. Seth Rials, an electrophysiologist with OhioHealth Grant Medical Center, said he never used the technology in patients for whom it is not approved.   “I would not have expected it to work,” he said. “I would not subject a patient to it without any evidence that it would work.”

Dr. Christopher Frank, an electrophysiologist at Mount Carmel St. Ann’s Hospital, agreed.

“There has never been any evidence that this was a good idea,” he said, referencing a previous smaller study that also found no benefit.

Abraham, a consultant for Biotronik (one of the device makers, and funder of the study), said he knows of no evidence that device makers were pushing doctors to use the therapy outside of its approved use.

mcrane@dispatch.com

(My Comment:

We could all wish to never have to read about stories such as this again.   I have  tried to bring this to light whenever I see it because people need to know what they are dealing with and yes, up against!  To use medicines or treatments on trusting patients who have come to their doctors for help with perhaps worrisome or frightening problems and then learn that they are being “experimented on” is devastating to say the least.  This kind of off-label  use can only end in trouble, harm or death and is never condoned.  

So far, I can’t remember reading about the follow-up stories of these medical practitioners being disciplined or losing their license — for that is what is necessary.  Those with so little intelligence, discernment and ethics, should not be allowed to continue in the care of people with legitimate health problems  

If people were interested in gambling on outcomes, our Governor Kasich has given us quite a lot of opportunity for that with all the gambling casinos he has inaugurated which no governor would allow in prior days, for Ohio had always been recognized as a state devoted to “family values”. [knew it would be only a question of time before the business of gambling turned to an addiction problem — and it sure didn’t take long!].     Jan)

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