[Updated. See bottom of story for postscript on CNBC TV reporter Mike Huckman's embargo break.]
The early release of the ARBITER 6 trial on Sunday was a roller coaster ride in more ways than one. In addition to the drama in the newsroom at the AHA as the embargo was lifted, the hastily assembled news conference couldn’t get underway until one very important participant could be summoned from a family outing at Disney’s Animal Kingdom.
A Sunday Embargo Break
Readers may be interested to learn the back story behind the early release of the ARBITER 6 results. As many may be aware, journals, industry, and scientific societies have a fairly elaborate and generally well accepted policy of releasing information to journalists prior to an embargo to facilitate better reporting of topics that are often extremely complex. Yesterday that system broke down, and it may well presage similar problems in the future, as attempts to put restraints on the flow of information become increasingly difficult in a wired world.
What happened yesterday was that the website of a small television station in Indiana mistakenly published the embargoed AP story early. The problem was noticed almost immediately, the website operator was contacted, and the story was removed from the website within minutes. At that point the AHA hoped that the embargo could still be enforced.
Unfortunately, in the space of those few minutes the story had already been found by Google and appeared in their search results, and the story was reprinted by at least one site that routinely “appropriates” content from other sites. Once the AHA and the NEJM understood the situation they quickly realized that it would be impossible to hold the embargo much longer and they hastily arranged a press conference.
The press conference wasn’t able to get started until ARBITER 6 principal investigator Allen Taylor was able to return from a family outing at Disney’s Animal Kingdom. Taylor’s family was in attendance at the press conference (see photo of Taylor’s parents, wife, and children), where they were able to observe other species of wild animals, including CNBC TV reporter Mike Huckman, who made a very big and self-congratulating point of pressing Taylor on exactly how much money he had received from Abbott. (Taylor declined to say anything beyond confirming his previous disclosures that he has received more than $10,000 from the company.)
At the two press conferences (the Monday morning press conference was retained for those reporters who missed the Sunday one) many of the usual suspects repeated and refined their positions, which we’ve covered previously. But the focus on some of the issues did sharpen.
A broad consensus emerged concerning several weaknesses of ARBITER 6. Every expert we’ve spoken to agrees that the post-hoc finding that lower levels of LDL on ezetimibe are associated with worse outcomes should not have been presented in their current format. Kastelein pointed out that this sort of analysis is data dredging along the lines of “searching for the pony” (the assumption being that if you have a whole lot of manure there must be a pony somewhere). He also pointed out that he has been unable to find any suggestion of a similar phenomenon in an analysis of data from SANDS or ENHANCE.
CardioBrief also could find no outside expert who agreed with the decision to halt the trial prematurely. Even figures like Steve Nissen have said that the trial should have continued. Paul Armstrong, who has been a member of numerous data and safety monitoring committees, said it was unprecedented for a trial to be halted on the basis of a surrogate endpoint like CIMT. Taylor’s explanation for the early termination was that the contract between the investigators and the trial subjects required them to stop the trial once the trial’s question had been answered.
In response to a question at a news conference about whether he would take any patients off ezetimibe in the wake of ARBITER 6, Taylor said that was an easy question for him to answer, since he has never actually written a prescription for the drug. When he sees other physician’s patients who are on ezetimibe, Taylor said that he does not take them off ezetimibe but leaves the decision to their physician.
Despite the fair number of criticisms aimed at ARBITER 6, nearly everyone agreed that in the wake of the trial physicians were highly likely to decrease their usage of ezetimibe and increase their use of niacin. Nature abhors a vacuum, and given the absence of clinical data on ezetimibe the ARBITER 6 data is rushing in to fill the void.
Postscript: CNBC TV reporter Mike Huckman wrote his own account on Monday of the embargo break, including this judgement of the events:
This appears to be an honest mistake.
But it could have been and should have been avoided. I ain’t perfect and there but for the grace of God go I, but I don’t understand why a major wire service pushed out a story around 18 hours before an embargo lifted. It opens wide the door for an embargo break.
There’s no reason that I can see to justify copy going out so early, especially in today’s push-button news transmission world. [emphasis added]
It needs to stop.
Fair enough, Mike. But today (Tuesday) he sent the following tweet:
I’ve been wrist-slapped by NEJM 4 tweeting it & @AHAScience lifting Arbiter media embargo on Sunday instead of Monday.Tweeted 12 mins prior.
In other words, for those of you who don’t speak Twitterese, Huckman himself broke the embargo by sending out a tweet to his thousands of followers on Twitter that the NEJM was lifting the embargo. Just to clarify: according to the NEJM‘s embargo rules (which all reporters agree to before receiving embargoed content) the fact of publication in NEJM is itself an embargoed fact until publication. In other words, a reporter can’t disclose the fact that an embargoed study is about to be published in the NEJM. This may seem a bit Talmudic but it makes quite a bit of sense, if you think about it. In any case, Huckman himself might be a bit more careful about “today’s push-button news transmission world.” Nobody’s perfect.
Update: Mike Huckman on his own CNBC blog has offered some new details about Sunday’s events and responded to this post. Mike: the animal comparison wasn’t meant to apply solely to you. It’s a big zoo out there.