Annual Heart Failure Society Meeting Failed
Not many people can state proudly their job title when it includes the word "failure" in it. I can. I am the Director of the Heart Failure Prevention Program and of Clinical Research in the Heart Failure and Cardiomyopathy Center at North Shore University Hospital.
For me, failure simply refers to the syndrome of advanced heart disease. Of course, heart failure is not a simple matter, neither medically nor personally, as it has a risk of dying that is higher than most cancers.
Last week I attended the annual meeting of heart failure specialists. There were about 2-3 thousand people in attendance, doctors, nurses, lab researchers, trainees etc. Typically, this meeting is my favorite one of the year. It's small, focused and provides a level of intellectual stimulation that is not matched elsewhere. But this year was an exception.
Perhaps I am just getting too cynical, but I don't think so. Over heh past two years, I have completed two research projects suggesting the possibility that a standardly used drug could put people at higher risk of serious complications and death without much of a benefit to offset that risk. The medicine that concerns me is called nesiritide (Natrecor TM) and is used to treat people who are hospitalized with unstable heart failure.
Here's how I see it. In March of 2003, I presented the research that hinted that there may be a higher risk of dying within 30 days of receiving this medicine than if an alternative was used (the alternative was nitroglycerin, a very old medicine). In response, appropriately cautious doctors should have concluded that a formal study should be done to find out if the suggestion I reported was real or merely a statistical fluke. No one did, and in fact, most of my colleagues considered me unreasonable for suggesting it at all.
The full paper has now been rejected by three of the premier journals and is about to be submitted to number four. I am investigating whether I can share the reviews I received, which show how the process served to attack me instead of looking at the data.
The second research paper I did was accepted for presentation at the annual meeting of the American Heart Association in New Orleans this November. It shows more of a reason to be concerned about the safety of the medicine. I can't say anymore until November, but the full paper is currently under review at a cardiology journal for publication.
The reason that the meeting last week of the Heart Failure Society of America was such a failure is that most of my peers continued to tout the benefits of nesiritide without even acknowledging the need to study its safety further.
I had the opportunity to speak (in front of a reporter) with a leading advocate for the use of nesiritide who was the principal investigator of the key study that led to its approval by the FDA. His point of view focused on the fact that he believed that no one would fund the study. I invited him to step up to the microphone at that afternoon's session and make the following statement: "I will not use, nor will I advocate the use of, the drug nesiritide until the sponsor agrees to fund an appropriately designed trial to determine with certainty that nesiritide is not more dangerous than nitroglycerin." Needless to say, he was quite uncomfortable with the idea, and quickly stated that there was no data that suggested that there was any risk to begin with, so why even get into the discussion.
However, I believe that you, when visiting your doctor, have the same perspective that the field of medicine is supposed to have. First, prove safety then investigate usefulness. Safety cannot be assumed, there are large numbers of studies that prove this. Yet people in a position of influence, in whose hands patients entrust their lives, continue to ignore these simple facts.
Hopefully, when our research is published, it will be ignored no longer.
