Embargo Watch

Keeping an eye on how scientific information embargoes affect news coverage

PREVAILing (lack of) wisdom: Embargoes laid bare in a mess involving Boston Scientific (and a lot of others)

with 2 comments

acc logoBy now, Embargo Watch readers will probably have heard about Boston Scientific’s PREVAIL study of the Watchman stroke/clot prevention device, findings of which were scheduled to be presented at the American College of Cardiology (ACC) meeting on Sunday but weren’t, thanks to an embargo break by the company.
As theheart.org reported:

An investor’s notice at 6:30 am PT announced the key results in the form of an email “for immediate release.” When heartwire queried the ACC and Boston Scientific about the email, Boston Scientific media spokesperson Steven Campanini responded, saying, “Due to an error with our investor-relations email system, the release went to a limited group at 6:30 am Pacific time” but insisted the embargo was still in place.

The ACC, however, disagreed and took the unprecedented step of yanking the presentation from the late-breakers and the press conference.

Boston Scientific spokesperson Steven Campanini told theheart.org that the embargo break “was an honest mistake”:

He reiterated that the investor relations email had gone out to a limited number of analysts and reporters, but he wouldn’t give a number. While the email heartwire received appeared to come from the investor-relations address, Campanini confirmed that the media and investors list are “one and the same.”

Well that seems like a problem, doesn’t it? But we’ve seen this movie before. All Wall Street analysts have to do to write about studies in the NEJM before their embargoes lift is plunk down their money for a subscription.

This may have been “an honest error,” but Boston Scientific deserves to be spanked a bit, and we need to look at the lessons of this case. The company needs to be spanked for the embargo break, because otherwise embargo agreements mean nothing.

But in the bigger picture, they need to be held accountable because they knew damn well how much credibility presenting the data at ACC would give them, and then they tried only showing their best cards, instead of all of the data. Larry Husten, who has been puzzling over the PREVAIL data release for a few weeks, wrote on March 9:

By way of background, last week the trial’s sponsor, Boston Scientific, first announced that the  principal investigator of the trial, David Holmes, would only “present the acute procedural safety results” from the trial. Then the company reversed itself two days later and announced that Holmes would present all three co-primary endpoints.

The reasoning for those decisions is convoluted, so go read Husten’s posts. (I’ve been meaning to get to this since Sunday, by the way, but somehow my day job, Retraction Watch, and other responsibilities including those at NYU’s SHERP intervened.)

For me, this whole episode is yet another illuminating window into how many different people game the carefully choreographed release of scientific findings. Look at all the players here: a publicly traded company, a high-profile scientific society, a group of academic researchers, among others. The case is likely to get only more complicated once the researchers decide where to publish their findings, adding another organization — a journal — to the list of groups that can restrict the flow of scientific information (hello, Ingelfinger!).

All of those groups get their cut of publicity and other benefits. But how was the public — on whose behalf the FDA will decide whether to approve the Watchman device — served?

Written by Ivan Oransky

March 13, 2013 at 10:18 am

Posted in Uncategorized

2 Responses

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  1. There’s potentially a much bigger problem here. According to Clinicaltrials.gov http://clinicaltrials.gov/ct2/show/record/NCT01182441?term=Watchman&rank=3 the original primary endpoint was:

    “stroke, cardiovascular death and [presumably or] systemic embolism” by six months.

    This was entered on August 12 2010, but on March 1st 2013 it was changed to three co-primary endpoints of:

    “7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention;”

    “Comparison of the composite of stroke, systemic embolism and cardiovascular/unexplained death”;

    “Comparison of ischemic stroke and systemic embolism occurring greater than 7 days post randomization”.

    These three new co primaries are to be measured at 18 months, rather than the previous 6 months. This means the original primary outcome is now to be measured at a different time point, and it has been joined by two other so called co primary outcomes!

    On the face of it this is cheating. The trial started in Nov 2010 and the primary outcome data was to have been completed by Dec 2013. By March 2013 the triallists would have had the original, six month, primary outcome results, so a change at that stage is data driven!

    However, according to Larry Husten’s blog http://www.forbes.com/sites/larryhusten/2013/03/05/late-breaking-news-confusion-over-acc-late-breaker-trial/

    “A representative from Boston Scientific told me that the endpoint changes had been put in place several years ago by Atritech, the company that developed Watchman and which was acquired by Boston Scientific. Atritech, the representative said, had neglected to update the PREVAIL ClinicalTrials.Gov website.”

    Hmm? It’s not double blind, so the lead investigators would have had a sense of how the data were going long before any formal analysis. I hope the FDA will cast a forensic eye over all this when the device comes up for licensing.

    jimgthornton

    March 16, 2013 at 4:33 am

  2. And another problem. Planned sample size 475. No mention of 2:1 randomisation ratio.

    But according to http://www.vancouversun.com/health/seniors/Boston+Scientific+device+preventing+strokes+misses+goal+study/8074462/story.html

    “The study involved 407 patients — 269 assigned to get the device and 138 to get warfarin.”

    jimgthornton

    March 17, 2013 at 6:10 am


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