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Read Original Story

A New Check for Heart Problems

Rating

2 Star

A New Check for Heart Problems

Our Review Summary

The story highlights one patient anecdote integrating a rather controversial laboratory test, high sensitivity c-reactive protein.  While it provides some of the important background, it fails to place the test in context by not providing any information suggesting the test may not be as valuable as suggested. Overall, the result is a rather one-sided story.  The reader is not provided with any real information concerning the debate, any detailed information about the JUPITER study other than the results in relative terms or more recent studies that would appear to be in conflict with the the positions stated by the interviewees.  Harms, including the side effects associated with the statins and their cost are not provided.

 

Why This Matters

Identifying risk factors for cardiovascular disease is very much a moving target with additional information either confirming or refuting the value of routine tests.  C-reactive protein and its more recent offspring, hs-CRP, has been touted by some as a definitive test as a cardiovascular risk factor.  What has not been shown is whether or not treating people with drugs and lifestyle changes simply on the basis of the test is of value.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Any story about a screening test should not only include the cost of the test (which this story did not), but more importantly, the costs of preventive care.  In this case, the use of a statin drug simply based on a rather controversial laboratory test

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story quotes the inventor of the test and an advocate for its use using the results of the Jupiter Study as a reference.  The reader is provided with virtually no information about the study or its results other than the comments of the senior researcher.  In reality, the Jupiter study did not have a control group (those with low hs-CRP levels).  A more recent and larger study demonstrated that treatment with a statin reduced events even in people with low baseline CRP levels. (see Heart Protection Study Collaborative G. C-reactive protein concentration and the vascular benefits of statin therapy: an analysis of 20,536 patients in the Heart Protection Study. Lancet. 2011;377:469–476.)

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

This is another example of a story about a screening test that didn’t provide any information about the potential harms associated.  While there are those who believe that the hs-CRP alone warrants drug treatment, this is not a universally held view.  While the statins are relatively safe, they are not without potential side effects and are relatively expensive for the twenty plus years of potentially unnecessary treatment

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story provides very little evidence to support the use of hs-CRP other than the comments of an advocate and the inventor of the test. The story provides, “The 2008 study showed that in patients with low levels of LDL—the bad cholesterol—but high hs-CRP levels, the statin Crestor reduced the risk of heart-related death, heart attacks and other serious cardiac problems by 44% compared with those given placebos.”  The relative risk doesn’t tell us much and as we noted previously, the study did not have a control group.  The more recent Heart Protection Study, included a control group and demonstrated reduced cardiovascular events in people treated with a different statin regardless of their c-reactive protein levels.

Does the story commit disease-mongering?

Not Satisfactory

We think that statements such as, “And one major study suggests that even people with minimal risk factors in their late 50s and early 60s should have the test” and “But genetic factors can also contribute to elevated CRP in people without traditional risk factors” would leave many readers with the impression that just about everyone needs to have the test performed.

For the record, the US Preventive Services Task Force states: “The U.S. Preventive Services Task Force (USPSTF) concludes that the evidence is insufficient to assess the balance of benefits and harms of using the nontraditional risk factors (including high-sensitivity C-reactive protein – hs-CRP) …to screen asymptomatic men and women with no history of CHD to prevent CHD events.”

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

Although the story did provide some information about the controversy (“While some experts don’t think the hs-CRP test adds much to current cardiovascular risk-prediction strategies,…”) the majority of the comments are made by the principal investigator/inventor and an apparent advocate of the test.  We would have liked to have seen more balance in the story.  Fewer than 20 words to wave off skepticism, the other 838 words all devoted to those who promote the test. Why, based on what is provided in the story would any expert not believe in the test? The story doesn’t give any space for that perspective.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Because of the imbalance in its framing, the story doesn’t even discuss the option of not having the test – which can be a rational choice.  The framing – “simple blood test…easily done at the same time as a cholesterol screening, and covered by most insurance” – is promotional.  Why don’t some experts think this test adds much?  What is the evidence for that perspective?  That alternative viewpoint is clearly downplayed.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story makes it clear that the test is available and most insurers will pay for it.

Does the story establish the true novelty of the approach?

Satisfactory

The story makes it clear that the c-reactive protein has been around for many years and provides a partial listing of the important studies performed.

Does the story appear to rely solely or largely on a news release?

Satisfactory

No evidence of a press release as a source.

Total Score: 3 of 10 Satisfactory

Comments (2)

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.

Marilyn Mann

July 16, 2012 at 12:41 pm

When you say JUPITER did not have a control group, I think what you mean is that JUPITER was not designed to test the benefits of screening for hsCRP, as there was no group that was not screened. There *was* a control group in the usual sense of the term, however. There was a group that received a placebo and a group that received rosuvastatin. In addition, the participants were required to be at least 50 years old for men and 60 years old for women, so all participants had at least one cardiovascular risk factor (i.e., age) other than elevated hsCRP. In addition, the majority of the participants had hypertension,16% were smokers, and some had other risk factors such as low HDL and family history of premature heart disease.

What is also interesting is that the new indication the FDA approved is as follows (from the rosuvastatin label):
“In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age greater than or equal to 50 years old in men and greater than or equal to 60 years old in women, hsCRP greater than or equal 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, CRESTOR is indicated to:
reduce the risk of stroke
reduce the risk of myocardial infarction
reduce the risk of arterial revascularization procedures”

So, in the view of the FDA, JUPITER did not show that people with elevated hsCRP and no other risk factors could benefit from a statin. FDA required other risk factors (age and at least one other risk factor). Hmmm. That would have been a useful fact for the reader of the article to know, don’t you think?

Not to mention that the woman described in the article would not have qualified for the JUPITER trial (too young).

Reply

hdemonaco

July 17, 2012 at 8:27 am

Thank you for pointing out what is clearly an incomplete description of JUPITER. What I meant to say was that unlike the JUPITER, the Heart Protection study included a cohort of high risk patients with normal CRP levels. Treatment with a statin (in this case simvastatin) , “…would prevent about 70—100 people per 1000 from suffering at least one of these major vascular events (and longer treatment should produce further benefit). The size of the 5-year benefit depends chiefly on such individuals’ overall risk of major vascular events, rather than on their blood lipid concentrations alone.”

Reply