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Experimental cholesterol drug results called ‘game changing’

Rating

4 Star

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Experimental cholesterol drug results called ‘game changing’

Our Review Summary

The story was generally fairly complete.  But the cheerleading drowned out the caveats in our view.

 

Why This Matters

It strikes us as a silly and empty projection to state in the story’s 2nd sentence:

If these initial results pan out in larger trials, the drug could prove to be more effective than statins, the widely prescribed drugs which have been very successful in lowering levels of LDL – or bad cholesterol.

These were small, short-term Phase I studies.  Let’s wait until more data are in hand before the coronation.

By comparison, neither the Cardiobrief blog, nor MedPage Today, in reporting on the same studies, used any such hyperbole.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story noted that two editorial writers “caution that it will remain unclear how important this class of drugs will be. The cost of this drug will also play a role in determining which patients might use it.”

But better cost context could have easily been provided.

  •  The story could have noted that monoclonal antibodies developed for the treatment of rheumatoid arthritis, Crohns disease and others are very expensive.
  • It could have done what MedPage Today did, reporting: “A monoclonal antibody is likely to be much more expensive than current lipid-lowering options, especially now that statins are starting to go generic, so their reach won’t be as great, Stein suggested in an interview with MedPage Today.”

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

Not Satisfactory

The story stated that “the subjects who received REGN727 had a striking reduction of 60 to 65%  in LDL cholesterol, according to (the lead researcher who characterized the results of the trial as ‘pretty dramatic.’ ”

The story also quoted an American Heart Association spokesman as calling this “game changing science” – putting that phrase in the headline as well – and “a very important breakthrough.”

To describe results of potential efficacy from a small Phase I study this way without emphasizing to the general public that Phase I studies aren’t designed to focus on efficacy is troublesome.

Neither the Cardiobrief blog, nor MedPage Today, in reporting on the same studies, used any such hyperbole.

In fact, MedPage Today ended its story with the reminder: “Given the small number of subjects and the short duration of exposure, our ability to evaluate the safety profile of REGN727 in these trials was limited,” the researchers cautioned.

If a Phase I trial, which is designed to measure safety and not efficacy, is too small and short to fully evaluate safety, then making bold claims about efficacy is even more of a reach at this point. A consumer-targeted story needs to make such points with emphasis.  This story did not.

 

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

Satisfactory

The story stated that the researchers found that the drug was safe and “None of the subjects who received REGN727 discontinued the study because of adverse effects.” While true, it does not give the whole picture.  Here’s what the investigators said:

“The proportions of subjects who had at least one treatment-emergent adverse event were similar among subjects who received intravenous REGN727 and those who received placebo. As compared with subjects who received placebo, a higher proportion of subjects who received subcutaneous REGN727 had an adverse event in the single-dose and the multiple-dose studies. Headache was the most common adverse event.”

It didn’t include the caveat that the MedPage Today story did:

“Given the small number of subjects and the short duration of exposure, our ability to evaluate the safety profile of REGN727 in these trials was limited,” the researchers cautioned.

But it did report:

However, without long-term safety data and evidence that PCSK9 inhibitors truly help prevent heart disease, (two editorial writers) caution that it will remain unclear how important this class of drugs will be.

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

Not Satisfactory

Good excerpts from the story regarding the quality of the evidence:

  • “However, without long-term safety data and evidence that PCSK9 inhibitors truly help prevent heart disease, (two editorial writers) caution that it will remain unclear how important this class of drugs will be.”
  • “the trial results…represent early science which should be confirmed through larger and longer studies….He said the study methodology was thorough because it included people with high cholesterol as well as people with genetic familial high cholesterol, which is proven to be a result of impaired PCSK9 genetic function.”

Weaker points in the story regarding the quality of the evidence:

  • while making the point that the purpose of Phase I studies is “to test for side effects,” the story did not complete the thought for its general consumer audience that they are NOT designed to thoroughly evaluate efficacy – so the “game-changing…breakthrough” quotes that  dominated the story are troubling.
  • The story stated “If these initial results pan out in larger trials, the drug could prove to be more effective than statins.”  That’s a pretty big “if” to put in the second sentence of a general consumer-targeted story.

Does the story commit disease-mongering?

Satisfactory

No disease mongering.

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

Satisfactory

Mixed bag.

The story did quote the editorial writers and did seek comment from an American Heart Association spokesman.

But the story did not report, as MedPage Today did, that: “Many of the co-authors were employees of Regeneron, one of whom jointly wrote the paper with Stein.”

We’ll give the story the benefit of the doubt.

 

Does the story compare the new approach with existing alternatives?

Satisfactory

Superficial comparisons were included:

  • If these initial results pan out in larger trials, the drug could prove to be more effective than statins, the widely prescribed drugs which have been very successful in lowering levels of LDL – or  bad cholesterol.
  • A PCSK9 inhibitor, Stein said, differs from statins “because it’s unlike any other drug. With statins you get toxicity – with these drugs we don’t see any side effects with the antibody.”

Again, we’ll give the story the benefit of the doubt on this but it is too early to even suggest that the antibody won’t have any side effects.

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

Satisfactory

It’s clear from the story that this is an experimental approach.

Does the story establish the true novelty of the approach?

Satisfactory

The story explained that “Other companies including Amgen, Merck & Company, Novartis and Pfizer, are also hot on the trail developing their own PCSK9 inhibitor drugs.”

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

Satisfactory

We don’t think the story relied solely or largely on a news release.

Total Score: 7 of 10 Satisfactory

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