Why Do People Hide From Bad News?
Nesiritide is a medicine for people who are hospitalized with very serious heart failure. It is FDA approved because it makes the symptom of shortness of breath a little better faster than doing nothing.
Many, many physicians use this medicine routinely in intensive care units, and lots more give it to patients in their offices who are not critically ill.
We have presented data at scientific meetings that suggests that this medicine may be risky. Specifically, it looks like this medicine may increase the risk of death within a month after it is used. Our analysis does not prove this, but is strong enough that most objective observers would likely think twice before using it.
The company that makes this medicine (Scios/J&J) and all the investigators know about our analysis. If we were wrong, all the company would need to do is release an analysis of their studies showing we made a mistake and thereby demonstrate that the medicine really is safe. Alternatively, they could perform a study that proves whether or not it is safe. They are making a couple hundred million dollars a year on this drug, but such a study would be unlikely to cost more than 30 or 40 million. (If I could get 5 million I think I could get an answer.)
The company has refused to do either of these things, and quite frankly, I don't blame them. Just as I have become more concerned as we have performed more analyses and believe it is important to make sure we know with certainty whether this commonly used medicine is safe or dangerous, they too have become very focused. They are focused on sales.
Before I can use nesiritide with confidence, I just want to be reassured it is safe. It seems pretty simple!
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.
A Nutritional Supplement That Works
In my book I make the point that to reduce the risk of dying, there are no nutritional supplements that are proven to reduce the risk of heart attacks. Yes, many supplements can affect a blood test or another, but none has been proven to reduce risk.
Because I pledge to you that I will always follow the data, I can't say that anymore. As reported by a top group of investigators, when all the scientific studies are reviewed, omega-3 fatty acids (fish oils) are beneficial.
Visit the link at the Agency for Healthcare Research and Quality
Here you will find review articles covering a broad range of information. Look at the summary of the report in the cardiovascular section about omega-3 fatty acids, or you can click this link to go directly.
Omega-3 Fatty Acids Effects on Cardiovascular Disease
