This news story reports on research that was presented at the annual meeting of the American College of Cardiology and published simultaneously in the Journal of the American Medical Association (http://jama.ama-assn.org). It might have served its readers better if it provided a little more analysis on this important topic. The article summarizes the findings of new research suggesting that the cholesterol drug Crestor slows thickening of the carotid artery wall in certain individuals. The story quantifies the purported benefit of Crestor down to the thousandths of a millimeter, and adds a note on side effects. Unfortunately, it fails to state the cost of Crestor or the cost of screening low-risk individuals who received Crestor, does not go beyond the study’s lead author for an independent comment, and neglects to mention treatment options other than Crestor—including simple lifestyle changes or doing nothing.
We also wonder whether readers could come away from this story believing that the “disease” under study is more sinister than it really is. The researchers enrolled people who had no symptoms and whose only risk factors were age, moderately elevated cholesterol, or moderately thickened arterial walls. As the article notes, doctors don’t usually prescribe cholesterol-lower drugs for people like these. Yet readers might easily—and wrongly–conclude that these individuals are at the beginning of an inexorable journey toward a bad outcome. “Thickening of the arterial walls is a precursor to plaque buildup, which can lead to heart attacks and strokes,” according to the article. The story could have taken greater care to explain that most of these patients will face unremarkable outcomes over time. In fact, the trial investigators themselves might have provided a more nuanced interpretation of their study. “Larger, longer randomized trials focused on clinical events are needed to determine the practice implications of these findings,” they concluded in the version published simultaneously in the Journal of the American Medical Association.
The article fails to mention the cost of treatment with Crestor, either for its approved indication (lowering LDL cholesterol) or for its unapproved use at high doses to reduce carotid artery wall thickness in patients at low risk of heart attack or stroke. The story also did not describe the cost of screening a low-risk population by ultrasound to find people with moderately thickened carotid arterial walls–the subjects in the study. Even if the test were inexpensive, screening 5700 individuals to find a group of 984 to receive treatment would be costly.
The article explains that Crestor failed to reduce artery wall thickness, and instead only slowed thickening. The story quantifies the absolute benefit of the therapy on carotid artery wall thickness, the outcome the study was designed to measure. It does not quantify the absolute benefit of Crestor for patient cholesterol levels (a secondary outcome), saying only that drug lowered (bad) LDL by 49% and raised (good) HDL by 8%.
The story mentions the potential harms of treatment—muscle pain and back pain—and that these were equally common in those who took the drugs and those who took dummy pills. It did not mention that cardiovascular events linked to insufficient blood flow were more frequent in the Crestor group, though this was not statistically significant.
The story briefly and accurately describes a large randomized, controlled trial in which one group of patients received pills with drugs in them and another group of similar patients received dummy pills. It would also be helpful to note that neither the researchers nor the patients knew which pill the patients received (i.e. a “double-blind” trial).
Readers of this story might easily—and wrongly—conclude that individuals with thickened walls of the carotid artery are merely at the beginning of an inexorable journey toward a bad outcome. The article opens by noting that the subjects in this trial were at low risk of heart attacks and strokes, and closes by pointing out that Crestor is not proven to reduce heart attacks, strokes, or death. But in between it hints that the benign condition studied in this trial—thickened walls of the artery—is more sinister than it really is. “Thickening of the arterial walls is a precursor to plaque buildup, which can lead to heart attacks and strokes,” according to the story. The article could have taken greater care to explain just how low the risks are or how these people might fare over time with no treatment. The researcher is quoted as saying that the drug stops "progression of the disease." Whether the moderate thickening of the arteries in these low-risk patients is a "disease" remains open to debate.
The story interviewed a single source—an author of the study—and explains that the study was sponsored by the pharmaceutical company that makes Crestor. It does not mention that the lead author receives "grant or salary support" from this and other pharmaceutical companies. Nor does the story does cite an independent source.
The article fails to note that there are other options available for these individuals—an important lapse, since these include simple lifestyle changes or doing nothing. To hunt down low-risk people with moderate arterial wall thickening or moderately elevated cholesterol, and treat them with Crestor would be a significant change from current, conservative practices.
The article states that the cholesterol-lowering drug Crestor (a statin) has been approved by the FDA.
The story explains that the researchers examined a new use for a previously existing drug in the drug class known as statins.
No obvious use of text from a press release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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