This release touts the end of the biggest clinical trial to date on the drug Xarelto (rivaroxaban), used to prevent major adverse cardiac events such as heart attacks and strokes in people with coronary artery disease or peripheral artery disease. As we found with a recent release on the drug Repatha (which we also reviewed), this release does not provide findings from the study but instead acts more like a preview for the findings to be released at an upcoming scientific meeting.
The release describes the study parameters (number enrolled, dosage, time frame, etc.) and discusses in clear detail the drug’s availability. But it left out potential harms from Xarelto and it also doesn’t cover the drug’s costs, talk about any of the specific benefits of the drug, or compare it to other treatments. In short, it’s like a Superbowl ad for the drug without the all the fast-talking caveats at the end.
For a more general discussion of data-free drug announcements see Managing Editor Kevin Lomangino’s recent post on a “troubling PR trend.”
Coronary artery and peripheral vascular disease are both common and will continue to become more common as the population lives longer. Medications to prevent new heart attacks or loss of limbs due to peripheral artery disease are always welcome (though prevention would be cheaper).
Even when drug makers are required to disclose when it reaches “primary endpoints,” it’s to the benefit of investors, regulators, the medical community and hopeful patients to avoid hyping the results, emphasize study limitations, and highlight the lack of vetting by peers. That context is going missing in a number of announcements from big drug companies.
There is no mention of costs in the release. That’s too bad because the drug costs about $375 for a 30-day supply.
It’s worthwhile to let people know about costs. Many older people use their Medicare drug coverage to pay for the drug for the most common indication (atrial fibrillation), with a typical copay of $75 per month. For people on a fixed income, that cost is likely to be an important piece of information.
There is no quantification of benefits in the release. Instead, it says, “A complete data analysis from this study is expected to be presented at an upcoming medical meeting in 2017.” Some preliminary data at minimum is necessary to assess the drug’s usefulness.
Trials are often stopped early when they meet preset efficacy endpoints, even if the clinical differences are not earth shattering. Time will tell.
There is no mention of harms in the release. An important harm associated with Xarelto is major bleeding, which cannot be easily reversed. In the case of atrial fibrillation, there are tools available to calculate the balance of benefit (from preventing blood clots stemming from the heart) and harm (major bleed). For newer drug indications, physicians would similarly like to know how to balance benefit and risk.
The release explains that this is a “phase III” trial, which may mean something to reporters who watch clinical trials closely. It also explains that the company involved, Bayer, did the study working with the Public Health Research Institute. It gives the outlines of the study, explaining that “it has enrolled 27,402 patients from more than 600 sites across more than 30 countries worldwide. In the study, patients were randomized to receive either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone.”
As noted elsewhere in this review, we think the failure to mention the lack of vetting through independent peer review or publication is a very big omission.
The release doesn’t engage in disease mongering. It provides context about the burden of different aspects of cardiovascular disease, with estimates that are in line with other published estimates. However, it doesn’t include sources for the estimates — something we encourage writers of both news stories and releases to incorporate.
It is clear from the release that the study is being conducted by Bayer.
The release does not compare alternatives. In this case, there are several medications available to prevent cardiac and peripheral events, including aspirin and Plavix.
The release makes it clear that the drug being studied is available for prescription. It says, “Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) and is marketed under the brand name Xarelto®. Xarelto is approved for seven indications, protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other NOAC.”
The release talks about the trial being the largest to date and about the “unmet need” in this area, and the fact that the trial reached a per-specified stopping point — all of which are strong news angles.
We believe it’s out of bounds to claim “overwhelming efficacy” in the headline before any data have been provided to back up the claim. Even if they are required to make an announcement, it should be pro forma and avoid this kind of hype.
It’s also not at all clear what “overwhelming efficacy” means here. Are they referring to the size of the risk reduction or to the statistical significance of the result? It’s possible, if not likely, that a very small risk reduction is being framed as “overwhelming” simply because the result is highly statistically significant. That doesn’t mean it’s especially meaningful for patients.