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PREVAIL trial’s tangled mess of news release, broken embargo, confusion over heart device data

This is an updated version (on March 17) of the post that first appeared on March 11 – with new information.

While the big American College of Cardiology conference was going on more than a week ago, you may have missed how a tangled mess in the way health care news is disseminated was on full display at conference in San Francisco.  Many journalists and bloggers tried to capture the confusion. But conflicting headlines may have just contributed to the confusion.

As with an example we wrote about last week, framing matters.

Larry Husten wrote on his CardioBrief blog about the complexity of the entire mess on March 9, and then followed with this on March 17:

“The PREVAIL trial, probably the most-anticipated late-breaker of the meeting, was pulled from the program at the last minute by the ACC leadership after Boston Scientific broke the embargo by issuing a press release several hours before the scheduled presentation.

… Forcibly linking access to the trial data with a company-arranged briefing is an egregious perversion of the embargo system. The whole point of the embargo system is to give reporters a little more time to research and understand complex stories on their own. The embargo shouldn’t be a tool for a company (or any other player) to spin the data before reporters have had a chance to examine it for themselves. Reporters should be encouraged to seek a diversity of viewpoints about the topic. In all likelihood most reporters will eventually want to learn the company’s perspective on the data, but access to the data should be entirely separate from the spin.

Spin is the key word here. In my experience, most companies don’t embark on a huge PR campaign, including aggressive pre-publication briefings and backgrounders, when their trials are truly positive. The companies are smart enough to know that in such cases their best course is to let the data speak for itself. So a big PR campaign may be a sign that something has gone wrong, such as a missed primary endpoint or an unexpected safety concern. The company usually has an explanation it wants to promulgate, such as a compelling subgroup analysis or a statistical maneuver that, presto change, turns a problematic or negative trial into a positive trial.

It seems clear that this is what happened with PREVAIL. We’ll never know with certainty what happened inside Boston Scientific in the weeks leading up to the ACC, but it seems clear that the PR campaign was designed to put forward the company’s positive spin on the trial well before  anyone else would have a chance to raise questions about the data. All the subsequent actions of the company are consistent with this view.

It’s easy to see why Boston Scientific may have wanted to spin PREVAIL. I don’t know whether, in the end, PREVAIL will be viewed as a positive or a negative trial but I do know that there will be many questions about the trial. From the preliminary results that were supposed to have been presented at the ACC, we know that the trial missed one of its three co-primary endpoints. All the outside experts who have seen the slides and with whom I’ve spoken have raised serious questions about the data. We may soon get a better view of the trial when it is presented at another meeting or when it is published, but I suspect we won’t know the real truth about PREVAIL until we see the FDA review of the data.”

Cardiac electrophysiobiologist Wes Fisher blogged:

Scandal.  Intrigue.  An heir of deception.  News organizations, some of whom have been on the receiving end of such scandal, snicker and publish accountings of the event, detail by gory detail.  The principle investigator describes his disappointment as “an awful event”  and doctors  who attended the session feel “cheated,” “penalized,” and found the event “unhelpful.”

And then the results (as they are known) appear anyway in the Wall Street Journal, on Forbes, and nearly a hundred other places on the Internet, instantly.
Can it get any better for marketing?

You see the Watchman device needs some help, especially in the era where at least one novel oral anticoagulant has shown not just equivalency, but a mortality advantage over warfarin, Watchman’s trial comparator.

And Watchman has had the difficult time getting FDA approval even though its competitor’s device, the Lariat, was (incredibly) already “approved” for sale in the US using the FDA’s own 510k exemption.

So Boston Scientific should feel good about the negative buzz about their trial.  It’ll help overcome their sales headwind provided, of course, their device gets approved by the FDA.

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