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.
New York Times Article
Today's Science section of the New York Times has an essay focused on an important question: should you seek treatment after suffering from a disabling and possibly deadly health problem or should you proactively seek safe and scientific ways to prevent the problem in the first place? I'm not sure a NY Times essay is a place where the intricacies of such an issue can be sufficiently discussed, but it is nice to see the issue placed into the press for people to consider.
The underlying issues may seem to focus on whether you would want to take medicines to treat high blood pressure, cholesterol abnormalities and/or diabetes, but it is much more than that. Sure I am a part of the traditional medical community, using prescription drugs prior to nutritional supplements. Why not, the drugs are studied so I know the safety and effectiveness while dietary supplements are marketed based on logic and assumptions. Countless times studies have proven that logic and physiologic assumptions such as these are in fact in opposition to data when scientific studies are finally performed. So my fault is not that I believe in pharmaceutical therapy, it is that I follow data.
With that said, I consider the comparison between my views and those of Dr. Gilbert Welch. Dr. Welch is funded by grants that appear geared to prove that we are over medicalized; that diagnostic tests are overdone. He's right. In cardiovascular medicine, tests are aften used to substitute for clinical judgement, and I think this happens too much. But the article allows the reader to conclude that testing is overdone in all of medicine, according to Dr. Welch, and I don't believe that would be his point at all. Any good epidemiologist knows that diagnostic testing is invaluable for specific groups of people but not necessarily for everyone.
In my book, I make the case that treatment is ideal for many American adults, but not everyone. It just so happens that when you live in a country where 90% of people over the age of 50 have or will have high blood pressure, we have a lot of people who can benefit from blood pressure treatment. Look around. With most American overweight, it's obvious that lifestyle changes are not going to be enough. It is the same thing for high cholesterol and diabetes.
What my book also says about how to work with your doctor to get ideal care may be more important than anything I say about blood pressure, cholesterol or diabetes, more important than the risks I describe for suffering a heart attack or stroke. We need to be self-advocates, because the health care system will not look out for any of us as individuals. It is concerned with cost effectivness for society and not the risk benefit ratio for any of us as people who may be at risk.
I would be interested to hear your thoughts on the article. It is available at:
http://nytimes.com/2004/11/16/health/16essa.html
Jumping on the Bandwagon
A year and a half ago, I presented a research study at an annual cardiology meeting. Few of my colleagues wanted to have anything to do with it. They seemed to shy away from the presentation and didn't want to talk about it. It was very frustrating to present data that strongly raised the possibility that a drug given to about 10,000 people a year (and increasing numbers) may double their risk of death within the following month. Sure it made people feel better, but the effects lasted for 3-6 hours and then the drug was no better than the old-fashioned treatment.
When I presented a follow-up research study this week at the American Heart Association, it was a very different scene. People (other cardiologists) were congratulating me on our "bravery" to stand up to Johnson & Johnson and tell the Giant that their drug may be dangerous - challenging them to start a new study to prove whether or not this is so.
In reality, I was merely following whtat the data said was truth.
So while most of the people at the meeting probably preferred to use denial mechanisms and pretend that their beliefs should be followed before the data, at least some were jumping on the wagon.
In the end, one can only hope that the truth will be sought and the risk, if any, be quantified.
