I am frustrated but remain committed.
Along with three other doctors, I have performed a study of a recently approved drug for the treatment of heart failure (nesiritide, brand name "Natrecor"). When I presented the preliminary results about a year ago, it received a lot of attention because I was raising the possibility that this medicine may be associated with a previously undisclosed risk - the possibility of death after its use.
You will notice that I am a bit soft in my language. I do that intentionally. The type of study we performed is one that should be used to determine whether a large-scale formal study is necessary - without such a study we wouldn't know for sure whether this apparent risk we describe is real or a statistical quirk.
A few months ago, we submitted the paper to the New England Journal of Medicine. I did not expect them to accept it, but most people say that they provide feedback that helps make the final product much better. What we received was offensive. The two reviewers seem to have been more concerned with maintaining the status quo than considering the implications of our study for the safety of patients. I am checking to see if I can legally share specific examples. Stay tuned for that.
We did what anyone would do, we reworded parts of the paper to make sure we were as clear as possible, then sent it to another respected journal. They have had it for three weeks, so I expect we will know something by the end of May. If they accept the paper, we will have moved one step closer to convincing others that we need a formal trial to determine if this medicine is safe.
In the meantime, I have recently completed a second study of the effects of the medicine on vital organ function, and the results of this study are worrisome as well. I hope to present this study at the American Heart Association meeting this November and will submit a formal paper for publication well before then.
Stay tuned. I am frustrated that my colleagues have not realized how worrisome the data are, but despite slow going, I remain committed to the importance of a definitive trial to prove whether the nesiritide is safe for the treatment of heart disease.
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