Oransky: Medical study embargoes serve whom?

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Embargoes, a fairly frequent topic of discussion on Covering Health, seem to bring out strong feelings in some people.

In one recent example allegedly involving embargoes, TheStreet.com’s Adam Feuerstein attempted to combat a rumor that the New England Journal of Medicine would be publishing an article about the experimental lung cancer drug seliciclib – a rumor that was seemingly driving up the stock price of Cyclacel Pharmaceuticals.

Feuerstein looked at his advance copy of NEJM and reported that no such article was coming out. He was immediately accused by a commenter on the story of having broken the NEJM’s embargo.

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Photo by Billingham via Flickr

As Reuters Health Executive Editor – and AHCJ board member – Ivan Oransky asked, “Is saying what’s NOT in an embargoed journal breaking the embargo?” Oransky concluded that it was not a case of breaking an embargo. The ensuing discussion on Twitter and in the comments on Feuerstein’s article is interesting. For the record, the NEJM apparently sided with Feuerstein, according to a commenter on the story.

Today, Oransky weighs in on the wider topic of who is served by embargoes on medical studies:

Two weekends ago, at ScienceOnline2010, I heard an interesting thing about embargoes. Connie St. Louis, who directs the science journalism masters’ program at City University, London, told an audience that one of the reasons for embargoes on scientific journal studies is that with more eyeballs on the study before publication, it’s more likely researchers will catch flaws in papers, which can then be pulled.

In other words, just as the FDA requires drug companies to monitor drug side effects in large populations once a drug is approved, in what’s called post-marketing surveillance or phase 4 testing, because such side effects may not show up in relatively small trials, this is a sort of post-acceptance peer review. So if a reviewer doesn’t catch an error during the normal course of peer review, journals can use the embargo period as a backstop.

I hadn’t heard that before, and I consider myself fairly well-acquainted with the arguments for and against embargoes. But it reminded me again that for all the talk of embargoes serving the public by allowing reporters to write more-informed stories, there are serious questions about whether journals are the group that gains most from embargoes.

As it turned out, I was in the midst of another episode that reminded me of that. Last week, the Cochrane Library published their quarterly set of reviews. Among them was a review of whether opioid drugs, when used as prescribed, carried a high rate of addiction. Cochrane researchers found that they don’t. That’s not the biggest research finding ever, but when you run a health news wire service filled with dozens of stories a day, like I do, it’s something worth covering. Plus, opioid dependence remains a big issue, for celebrities and lawmakers alike.

That study was embargoed for 7 p.m. Eastern on the 19th. Around the same time I was reviewing it, the Annals of Internal Medicine press packet hit my desk. That packet — embargoed until 5 p.m. Eastern Monday the 18th — included a paper that said high doses of opioids, even if prescribed, increased the risk of overdose. Again, not the most shocking study ever, but researchers and advocates continue to debate whether these drugs, when used in prescribed doses, are dangerous.

I figured the best way to serve our readers would be a story that included both of these studies, both as context for the other. Trouble was, if I ran one based on the Annals study, I couldn’t mention the Cochrane review. And if I waited for the Cochrane review’s embargo to lift, a competitor might run the other story. (Yes, we think about these things.)

So I emailed Jennifer Beal, who runs media relations for the Cochrane Library’s publisher, Wiley, explaining the situation, and asking her if she would consider moving the embargo. She returned my message right away, saying politely that she couldn’t, and explaining why, in a message that I found thoughtful.

“We thought about it very carefully but felt that our guiding principle with embargoes is that we are giving media an opportunity to investigate a story fully without the pressure to publish immediately, so that the story is still ‘new’ on the day the research gets published, and is therefore available for public consumption,” she wrote. “If we were to agree to a moved embargo, it would mean that you…would be writing about a story where the research was not available for the public to read if they wish and make up their own minds.”

The opioid study, she noted, was “one of approximately 160 articles publishing on Wednesday; this is a big operation where the publication schedule is planned out a long way in advance, so it is not possible to move forward the publication date.” (In a long-planned move, Cochrane is now going monthly, which will distribute the reviews more evenly.)

Based on resource constraints, I decided we could only run one story on opioid addiction or overdose last week. We ended up running a story on the Annals study, which seemed a bit more newsworthy than the Cochrane review. As it turns out, a number of news organizations covered the Annals study — Seattle’s LocalHealthGuide ran an item, which the Seattle Times picked up; The Seattle Post-Intelligencer, and our competitors HealthDay and Bloomberg, among others. As far as I can tell, only a site called MedIndia ran a story by the Health Behavior News Service pegged to the Cochrane review.*

(I should say here that I’m a big fan of the Cochrane Library, access to which is an AHCJ benefit. Some have criticized them for rejecting everything other than randomized double-blinded controlled clinical trials, but I’d rather see more rigor than less, given how often hype and poor evidence tend to rule the day. So this isn’t really about a problem at Cochrane. It’s about how embargo policies, whether well-intentioned or not, often make me wonder whether they serve the public.)

So whom did this Cochrane embargo serve? I’d argue it didn’t serve the public, because we and others couldn’t include news of it in the story we did decide to run. You might even say it didn’t serve Cochrane either, since I’m guessing many of my colleagues decided not to run something on it for similar reasons. And their rationale for not moving the embargo at least had the public in mind.

The episode reminded me of the CDC-autism embargo fiasco last fall, in which the CDC and the journal Pediatrics refused to lift an embargo on autism rate data that many in the autism advocacy community had already reported on. To me, the Cochrane decision was more justifiable, even if I didn’t like it.

Many have questioned embargoes, notably Vincent Kiernan, in his 2006 book “Embargoed Science.” Kiernan makes a convincing argument that embargoes serve journals most, by giving reporters something to cover every month or every week. Nowadays, that’s even more true, I think, as I see an increase in papers embargoed just 1-2 days, rather than the typical 5-6.

Still, when you run a high-volume news service, as much as you’d like to, it’s not reasonable to reject all embargoes in favor of 100% enterprising reporting. Our clients would be very unhappy, and justifiably so. Instead, we can try to cover studies with as much skepticism and context as possible. But when I hear yet another reason why embargoes might help journals, as I did at ScienceOnline2010, I’m only encouraged more to challenge the idea that embargoes are there for the public, and at least force journals to defend how they handle them.

Ivan Oransky, M.D., is executive editor of Reuters Health and AHCJ treasurer. Follow him on Twitter, where he periodically gets into debates about embargoes, among other things.

*Update:

After this post was published, we heard from Lisa Esposito, editor of the Health Behavior News Service, who tells us that Medscape and Elsevier Global Medical News did cover the Cochrane opioid review.