Embargo Watch

Keeping an eye on how scientific information embargoes affect news coverage

Jenny Craig decides a JAMA study available online isn’t published yet — or maybe it is?

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Apologies in advance for those of you who will shed some hair as you scratch your head throughout this post. I know I did. See if you can follow along:

On October 9, JAMA published two weight loss studies,  one of which was funded by Jenny Craig. The company, according to a disclosure on the paper

had a minimal role in the design and protocol development. By contractual agreement, scientists at the University of California, San Diego, and the other participating institutions had responsibility and independence regarding data management, analysis, and publication. The funding sponsor had no role in the collection, analysis, or interpretation of the data; or in the preparation, review or approval of the manuscript.

The study — published early online to coincide with a presentation at the Obesity Society’s annual meeting in San Diego — found that the company’s diet worked best for women who got in-person counseling. Those women — who, along with everyone in the study, were paid $25 per clinic visit, and started at an average weight of 200 pounds — had lost an average of about 16 pounds after two years. That compared with about 4.5 pounds lost in the “usual care” group, which got two weight loss counseling sessions and a monthly contact.

The study seems solid, certainly solid enough to be published in JAMA. Although the results “probably represent a best-case scenario,” wrote Brown University’s Rena Wing in an editorial accompanying the study:

Given the potential of commercial weight loss programs to reach large numbers of overweight or obese individuals, it is time to directly compare the outcomes achieved in a variety of different commercial weight loss programs and to examine whether providing these programs free of charge to participants would be a cost-effective approach.

JAMA sent out a release about the study at about 2 p.m. Eastern on October 7. Its embargo lifted at 11:30 Eastern on the 9th.

Nothing unusual there. Journals often release studies early so that their authors can speak freely about the results — eg no Ingelfinger Rule to worry about. And a number of outlets — including Reuterscovered the news.

The first comment I saw from the company, however, was on October 13, in a CNN.com story, “Where’s the line between research and marketing?” (Full disclosure: My wife works at CNN, but had nothing to do with this story.)

A spokeswoman for Jenny Craig said the company would not be able to discuss the study until the print version of JAMA releases it at the end of October.

That struck me as odd. Here was a study that was published online, and the subject of coverage, but its sponsor — who had to be happy with the results — was acting as though it was under embargo.

There are journals that embargo studies that are already available online, despite my exasperation with that practice. But JAMA wasn’t doing that, and hasn’t ever done it, as far as I know.

So I asked Jenny Craig for their rationale. Director of public relations and corporate communications Kristi Roehm responded:

While we do not typically comment on our communications strategy, we are reaching out to press contacts with the positive findings of Dr. Cheryl Rock’s independent research in which trial participants on the Jenny Craig program experienced average weight loss of 10% at the one-year mark and nearly eight percent (7.9%) weight maintenance at the two-year mark, a meaningful degree of weight loss commensurate with reduced health risks. We believe this information is relevant and are thrilled it has been published in the prestigious Journal of the American Medical Association (JAMA).

I tried to get some clarification, but no dice.

It’s certainly possible that the company simply doesn’t know how journal embargoes work, because they don’t publish much research. There’s a hint of that inexperience where the paper discusses the trial registration requirement:

The clinical trials registry was initiated by the investigators in early November 2007, before any patient enrollment. When informed at that time that this was a responsibility of the industry sponsor, the responsibility of completing the registration process was reassigned. The registration was in process until March 2008, when it was finalized. The delay was not purposeful and is attributable to inexperience and personnel support limitations.

Still, JAMA’s materials are quite clear about when the embargo lifts. And if the company didn’t understand the embargo when they spoke to CNN for their story of the 13th, but now understands it, why not just say they made a mistake?

I’m not sure I’ll ever find out. I know the company is now eager to talk to reporters, based on an email their external PR agency sent out yesterday. That’s technically before the print issue of JAMA dated the 27th, which is where the study appears, is out. And their site includes PDFs of the abstract and poster presented at the obesity conference.

But they don’t seem eager to talk to me about why they told CNN what they did. Until I hear more, I’ll just scratch my head.

Written by Ivan Oransky

October 26, 2010 at 9:30 am

Posted in Uncategorized

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