Doctors debate value of ‘fringe’ heart treatment

Does the story adequately discuss the costs of the intervention?

Satisfactory

According to the story: “Treatments cost $90 to $150 apiece, usually are done weekly for 30 weeks and then less often, and are not covered by insurance.”

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

Satisfactory

Results are given in absolute terms: “Four years after treatment, 26.5 percent of the chelation group had [a cardiovascular complication] versus 30 percent of those given dummy infusions.” In addition, the benefits are called “small” and experts caution that chelation can’t be accepted as a mainstream heart disease treatment based on these results.

In this report (as opposed to the USA Today story) the total number of people in the study was given, but still not the number in each group who were enrolled and had the composite endpoint. This barely makes the grade.

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

Not Satisfactory

The story makes it clear that chelation has potential to cause harm, but says that the regimen used in this study “seemed safe.” We recognize that it might be difficult to get more detail than that at a conference presentation, but it’s still not quite enough information to satsify the criterion.

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

Satisfactory

The story provides many reasons to look skeptically on the findings:

• Some of the investigators were involved in insurance fraud and are convicted felons.
• The dropout rate was substantial, and the pattern of dropouts suggests that the blinding may have been compromised. 
• The findings have not been fully vetted as part of the peer review process prior to publication in a medical journal.

The story includes sufficient detail about the conduct of the study and preliminary nature of the findings, as shown above.(KF)

Does the story commit disease-mongering?

Satisfactory

No disease mongering about cardiovascular disease.

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

Satisfactory

The story raises concerns about potential pro-chelation bias among the researchers, and we’ll make the same observation we did in our review of the competing USA Today coverage: Lots of trials are led by physicians and surgeons who provide the treatment that they’re supposed to be studying for profit–whether it’s a surgical procedure or some other form of treatment. So if this constitutes bias, it’s a bias that’s endemic to medical research. There is a suggestion here that this is something we’d only see in the alternative medical community.

Other than that, no concerns: there are plenty of independent voices quoted in the story.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story mentions established treatments such as cholesterol-lowering medicines and stents to open clogged arteries.

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

Satisfactory

The story explains how practitioners and patients can obtain chelating drugs for treatment of heart disease despite lack of FDA approval for a commercial product: they order it custom-mixed from special compounding pharmacies.

Does the story establish the true novelty of the approach?

Satisfactory

The story doesn’t make any inappropriate claims about the novelty of the study. It is also clear that this is the first report from a 10-year NIH-funded trial.

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

Satisfactory

The story has enough original reporting that we can be sure it wasn’t based on a press release.