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The worst abuse of an embargo this medical journalist has ever seen

Larry Husten, PhD
Meds
September 12, 2011
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In general I support embargoes in medical journalism. Although the current system is far from perfect and contains all sorts of wrinkles and unexpected consequences, I support the system because it allows journalists a bit more time to work on complicated stories and to try to get them right. Recently, though, I came across the single worst abuse of an embargo that I have encountered in the course of my career as a medical journalist.

By way of background, like most medical journalists who cover cardiology, I receive press releases and announcements relating to the American College of Cardiology meetings. Many of the public relations people want to know if I’m available to speak with either a company official or a clinical investigator. I always ignore or decline these requests, though I usually respond by asking them to send along any relevant press releases, slide sets, manuscripts, etc.

In the case of a trial that I already know I probably want to cover, I will often ask the PR person if I can get access to the slides beforehand, and I assure them that I fully intend to respect the embargo. In most cases my request is turned down, for any number of good reasons: the company doesn’t have the slides, the investigator is terrified of an embargo break, etc. But often enough the request works and I’m able to save a lot of time and effort during a busy meeting by preparing some of the work beforehand.

Recently, I received a PR message from Medtronic. It included a press release announcing that pivotal data on the company’s Resolute drug-eluting stent would be presented at a late-breaking clinical trial session on Monday. The PR person asked if I planned to cover the story and offered to alert me when the embargo lifted on Monday.

I wrote back and said that I was interested in covering the story and asked if it would be possible to see the slides beforehand, on an embargoed basis of course.

I received the following response:

Hi Larry,

Per your interest in Medtronic’s late-breaking RESOLUTE US study at ACC.11,  a key component of the company’s FDA submission for U.S. approval of the Resolute drug-eluting stent, I wanted to extend to you the opportunity to be pre-briefed (under ACC’s embargo) on the one-year results on Thursday via two conversations listed below:

  • Thursday, March 31 / 2:30-3:00 pm ET
  • Embargoed briefing with Jason Fontana, PhD – Medtronic
  • Purpose: Review slides/understand data on background for R-US late-breaker
  • Thursday, March 31 / 4:40-4:20pm ET
  • Embargoed interview with Alan Yeung, MD – Stanford
  • Purpose: Obtain comments/perspective on study results/implications from R-US PI for attribution

If interested, please respond in writing that you will abide by the embargo policy and let us know as soon as possible whether this schedule works for you. Upon your approval to abide by the ACC embargo, I will send you the later this week the  DRAFT of slides for the R-US late-breaker as well as the latest PROOF of the JACC article on R-US, which will simultaneously be published at the time of podium presentation on the Monday, the 4th.

Thanks, as always, for your consideration of our news.

Best regards,

SXXXXXXX

Account Director

I responded that I would of course respect any embargo but that I was unable to commit to the pre-briefing. I recieved the following response:

Hi Larry,

While we appreciate your interest in the RESOLUTE US data, we’re not authorized to share the slides on embargo without a commitment to the embargoed pre-briefing with Dr Fontana. It’s a pre-requisite to receiving the slides and journal proofs. If you reconsider, I will be happy to arrange a time for you to speak with Dr. Fontana at your convenience. Thanks and looking forward to seeing you at ACC11.

Best,

SXXXXXXX

Account Director

So what’s the problem here? Listening to a PR pitch– err, “pre-briefing”– shouldn’t be a prerequisite for receiving embargoed materials. Access to the content shouldn’t depend on a willingness to submit to the spin cycle. I’ve never seen access to content linked so explicitly to a PR pitch. This strikes me as a very dangerous– and telling– precedent.

I asked Ivan Oransky, author of the highly regarded Embargo Watch blog, for a comment on this episode:

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This is a troubling development. There are certain conditions reporters should have no problem agreeing to, but they’re limited: Access to a study, a specific embargo time, to name a few. But requiring how something is covered, or even that a reporter must attend a particular press conference, goes too far. It reminds me of the Cetacean Society quid pro quo. What’s common to both is that PR folks have no problem making unreasonable demands.

There is a solution, of course: Reporters should refuse to agree to such embargoes. PR people will only get away with this if we left them. And if reporters do agree, they should spell out the conditions in any stories they write.

I want to raise one other troubling question: what is the role of the clinical investigator who agrees to take part in these interviews? There’s something quite unseemly about a PR person offering to arrange interviews with academics, and even worse the investigator who agrees to participate on terms dictated by the company.

It should be known that this is an extremely common occurrence. Nearly every day I receive a PR solicitation offering an interview with a clinical investigator or expert. I am nearly always uncertain about the precise nature of the relationship between the investigator and the company. Often, of course, the company pays for the clinical trial. But do the investigators get paid to do these PR briefings? If not, what about expenses? (I’ve heard rumors in the past about investigators who don’t accept honorariums but will accept very expensive first class flights and accomodations all over the world. And we’ve all seen the limousines lined up in front of the hotels during the big conventions.)

Larry Husten is a writer and editor of CardioBrief.org.

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The worst abuse of an embargo this medical journalist has ever seen
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