This story looks at new findings on the benefits of adding a monoclonal antibody drug known as Repatha to statin therapy in people with heart disease.
We liked that the story makes it clear that so far, prescribers and insurers have been underwhelmed by the evidence showing that the drug can reduce heart attacks and deaths better than already-available and far-cheaper statins. We get some behind-the-scenes details on how hard it is to get this drug covered by insurers, and given dollar figures on cost of the drug.
This new study, though, apparently “bodes well” for changing this reluctance, because researchers saw fewer heart attacks, deaths, and other serious cardiac events in the study group taking Repatha and a statin, compared to the statin-only group. Yet, the story states that the study was too small to determine if these numbers were significant.
And if that’s the case, why is this study newsworthy? Given that Bloomberg primarily has a financial audience, presumably it’s to signal to investors that the drug companies involved may finally get the evidence they need to get these expensive drugs prescribed en masse, and make everyone involved richer.
For the rest of us–especially those of us looking to better reduce our risk of death from a heart attack–the story needed a few more details: What are the harms of this drug? How big was this trial? Who were these subjects and did they already have cardiovascular disease? What are the risks of getting readers excited by findings from a study “not powered to assess effects on cardiovascular events?”
Perhaps most important, when sources are allowed to profess their “love” for a new drug, readers should be told when those sources have financial interests that might bias them.
As Amgen admits in the bottom of their news release, “The effect of Repatha® on cardiovascular morbidity and mortality has not been determined.”
This means a drug approved and marketed for heart disease hasn’t been shown to effectively treat it, yet it’s expensive and carries side effects. The drug company has a huge stake in convincing everyone these risks are worth it, and that the evidence is more compelling than it seems. Financially-minded readers want to make a good investment not predicated on hype, and readers want to take a safe, effective drug.
This is a strong point of the story, not only stating the cost but discussing it in the context of why insurers are reluctant to cover it. It states:
Sales of Repatha and Praluent, made by Regeneron and Sanofi, have been slow to ramp up because insurers have restricted their coverage, seeing the list price of about $14,000 a year as too expensive if the treatments only lower cholesterol.
The story contains a numerical chart that shows outcomes of the study related to reductions in plaque volume, plaque regression, death, heart attack, first major heart event and muscle pain (a known negative side effect). For example, it says plaque regression was measured in 64 percent of patients in the drug group who received Repatha and a stain compared to 47 percent in the group who received a placebo and a statin.
We’re also told that the study was too small to provide reliable numbers on heart attacks, death and major heart events (such as needing surgery). But if that’s the case, why allow a conflicted source to claim — without challenge — that the drugs are “lifesaving” for the right patients?
We think that quote throws the story out of balance. The story also would have been stronger if it had given readers more context to make sense of these numbers: How many patients were in each treatment group? How long did this study last?
The chart did include one side effect, muscle pain. However, it didn’t explain there are other risks that come with taking monoclonal antibody drugs, such as local allergic reactions and more severe immune reactions. Nor did it explain how common these are.
The story did not provide enough details to readers that would allow them to ascertain the quality of evidence. The story doesn’t caution that this was a conference presentation that likely received only limited peer review. We get a hint that it’s a controlled trial with a placebo group, thanks to the chart that shows outcomes among the different treatment groups. But otherwise we’re left to fill in the blanks on things like overall study size, length of trial, types of people included (did they already have cardiovascular disease?), and limitations.
The story does not disease monger. And we want to praise the story for explaining that insurers have been reluctant to cover it despite marketing pressures from the drug industry. This is because there’s a lack of evidence that it works any better than cheaper medications, something readers need to know.
This is a major shortcoming of the story. It quotes an expert source who says he “loves these drugs” and calls them “lifesaving” — even though they’ve never been shown to prolong survival — and fails to disclose to readers that the source is a paid consultant to Amgen, which makes the drug being reported on (as noted in the disclosure statement of this Medscape article). A second source complains about the difficulty of getting insurance coverage for these drugs, but the story again fails to mention that he’s a paid consultant to Regeneron, which makes a competing monoclonal antibody (noted in a different disclosure statement at Medscape).
The story discusses the primary alternative, which are statins. The story did not compare it to any other alternatives, of which there are several.
This is a strong point of the story. It’s clear the drug is approved and available, yet prescribers are overall reluctant to prescribe it to due to unclear benefits. We’re also given some insight into how complicated it is for doctors to try and get insurer approval, which has an impact on availability.
The story makes it clear that this study is novel because it demonstrates that the drug can (possibly) improve not just cholesterol levels but also arterial plaque levels, which suggests potential benefit on outcomes.
It’s clear from unique quotes and other details that this story did not rely excessively on a news release.