Glad Ron Artest Wasn’t There
In earlier posts, I discussed my concerns about the medicine nesiritide (Natrecor), used to treat heart failure. Although used commonly in practice, there is little data to prove its safety.
This week, theheart.org, the leading cardiology website (theheart.org) covered the presentation I made at the annual meeting of the American Heart Association in New Orleans.
The first comment during the question and answer period accused me of being dangerous. I find that incredible. Here’s why. What we did was look through the literature to review the studies that led to nesiritide’s use. None of them are studies designed to prove whether it is safe or not; they address the effect on pressures in the heart or shortness of breath when first starting the medicine. So we downloaded the FDA files on nesiritide and looked to see if they reported the effects on kidney function. Off all the parameters typically measured in clinical trials, changes in kidney function are one of the more powerful predictors of risk. If your kidney function worsens, even transiently, you are more likely to die in the hospital or within 1 to 6 months afterwards.
We performed a careful and standard statistical analysis and found that nesiritide increases the likelihood of worsening kidney function by about 50%. That means that instead of 15% of people affected, 22% were, putting them at higher risk of dying within the next few months.
The article on theheart.org cites the concerns raised by the audience, each of which we share. But it misses the point. Here is a drug used widely that may put people at risk – yet no one seems keen to do the study to ask the questions that need to be answered. Is it safe? (Sorry if the use of that phrasing gives “Marathon Man” fans heading to the dentist cause for concern.)
What kind of self-respecting doctor or researcher would stand by idly while nesiritide use is exploding through the medical community, instead of demanding a study? And where is Johnson and Johnson? They should be particularly concerned given the environment in this post-Vioxx, post-Baycol era.
I am excited at the prospect of publishing these data in a respected peer-reviewed journal. That will get the conversation going and hopefully result in the study being funded to determine the safety of nesiritide.
Until then, I am not concerned about being in conflict with a conglomerate like J&J. Unless Ron Artest is a major shareholder.
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